Arkansas Administrative Code
Agency 007 - Arkansas Department of Health
Division 05 - Health Facility Services
Rule 007.05.15-002 - Rules and Regulations for Critical Access Hospitals in Arkansas
Universal Citation: AR Admin Rules 007.05.15-002
Current through Register Vol. 49, No. 9, September, 2024
SECTION 1: AUTHORITY.
The following Rules and Regulations for Critical Access Hospitals in Arkansas are duly adopted and promulgated by the Arkansas State Board of Health pursuant to the authority expressly conferred by the laws of the State of Arkansas in Act 414 of 1961, as amended by Act 258 of 1971, Act 190 of 1975, Act 536 of 1977, Act 273 of 1983, Act 980 of 1985, and Act 516 of 1987, along with Acts 143 of 1987, 348 of 1987, and 399 of 1987 covered under these regulations.
SECTION 2: PURPOSE.
These rules and regulations have been prepared for the purpose of establishing a criterion for minimum standards for licensure, operation and maintenance of hospitals and related institutions in Arkansas that is consistent with current trends in patient care practices. By necessity they are of a regulatory nature but are considered to be practical minimum design and operational standards for these facilities. These standards are not static and are subject to periodic revisions in the future as new knowledge and changes in patient care trends become apparent. However, it is expected that facilities will exceed these minimum requirements and that they shall not be dependent upon future revisions in these standards as a necessary prerequisite for improved services. Hospitals and related institutions have a strong moral responsibility for providing optimum patient care and treatment for the populations they serve.
SECTION 3: DEFINITIONS.
For purposes of the regulations, the following definitions apply.
A. Administrator means the
person responsible for the management of any facility requiring licensure under
these regulations.
B. Alcohol/Drug
Abuse Inpatient Treatment Center means a distinct unit within a hospital in
which services are provided for the diagnosis, treatment and rehabilitation of
alcohol and drug abuse.
C. Basic
hospital services means the services that all licensed hospitals must provide.
Basic services consist of:
1. Governing
Body;
2. Medical Staff;
3. General Administration;
4. Patient Care;
5. Health Information;
6. Pharmacy;
7. Food and Nutrition;
8. Infection Prevention and
Control;
9. Laboratory;
10. Radiology;
11. Respiratory Therapy;
12. Emergency; and
13. Physical facility maintenance
D. Critical Access Hospital (CAH)
means a hospital located in a rural area that is:
1. Located more than a 35 mile drive (or, in
the case of mountainous terrain or in areas with only secondary roads
available, a 15 mile drive) from a hospital, or;
2. Provides 24 hour emergency care services
as determined necessary for ensuring access to emergency care in each area
served by a Critical Access Hospital;
3. Provides staffing according to Rules and
Regulations for Hospitals and Related Institutions in Arkansas;
4. Meets Centers of Medicare and Medicaid
Services (CMS) Conditions of Participation for Critical Access Hospitals;
or
5. Was operating as a licensed
Critical Access Hospital in Arkansas as of April 2007.
E. Department means the Arkansas Department
of Health.
F. Emergency Services
Facility means a facility originally operated as a licensed hospital that has
discontinued inpatient services but is licensed to continue to provide
emergency services.
G. General
Hospital means any facility used for the purpose of providing short-term
inpatient diagnostic care and treatment, including general medical care,
surgical care, obstetrical care, and specialized services or specialized
treatment.
H. Infirmary means any
facility used for the purpose of offering temporary medical care and/or
treatment exclusively for persons residing on a designated premise, e.g.,
schools, reformatories, prisons, etc. and where the persons are kept for 24
hours or more.
I. Institution
means, for the purpose of these regulations, a facility which requires a
license. Institution does not include an establishment:
1. Operated by the federal government or by
any of its agencies; or
2. Licensed
or certified by the Office of Alcohol and Drug Abuse Prevention of the Division
of Behavioral Health of the Department of Human Services as an alcohol and drug
abuse inpatient treatment center.
J. Licensee means the person to whom a
license is issued for the purpose of operating the institution described in the
application for licensure, who shall be responsible for maintaining approved
standards for the institution of any state, county, or local government unit
and any division, board, or agency thereof.
K. Observation is a designated patient status
as opposed to a designated area. Patients in observation status are those
patients requiring periodic monitoring and assessment necessary to evaluate the
patient's condition or to determine the need for possible admissions to the
hospital in an inpatient status. Usually observation status shall be for 48
hours or less.
L. Off-campus
Emergency Department means an emergency services department located off-site
from the main hospital campus but functions as a fully integrated department of
the parent hospital.
M. Outpatient
Psychiatric Center means a facility in which psychiatric services are offered
for a period of 8 to 16 hours a day, and where, in the opinion of the attending
psychiatrist, hospitalization as defined in the present licensure law is not
necessary. This definition shall not include Community Mental Health Clinics
and Centers, as they now exist.
N.
1. Outpatient Surgery Center (Ambulatory
Surgery Center) means a facility in which surgical services are offered that
require the use of general or intravenous anesthetics, and where, in the
opinion of the attending physician, hospitalization is not necessary.
2. "Outpatient surgery Center" does not
include:
a. a medical office owned and
operated by a physician or more than one (1) physician licensed by the Arkansas
State Medical Board, if the medical office does not bill facility fees to a
third party payor; or
b. a dental
office that has a Facility Permit for Moderate Sedation or a Facility Permit
for General/Deep Sedation issued by the Arkansas State Board of Dental
Examiners.
O.
Psychiatric Hospital means any facility, or a distinct part of a facility, used
for the purpose of providing inpatient diagnostic care and treatment for
persons having mental disorders.
P.
Recuperation Center means any facility or distinct part of a facility, which
includes inpatient beds with an organized Medical Staff, and with medical
services that include physician services and continuous nursing services to
provide treatment for patients who are not in an acute phase of illness but who
currently require primarily convalescent or restorative services (usually
post-acute hospital care of relatively short duration). A facility that
furnishes primarily domiciliary care is not within this definition.
Q. Rehabilitation Hospital or Facility means,
for the purpose of these regulations, an inpatient care facility, or a distinct
part of a facility, which provides rehabilitation services for two or more
disabled persons not related to the proprietor, for more than 24 hours through
an integrated program of medical and other restorative services. A disabled
person shall be considered to be an individual who has a physical or mental
condition which, if not treated, will probably result in limiting the
performance or activity of the person to the extent of constituting a
substantial physical, mental, or vocational handicap.
R. Shall means mandatory.
S. State Health Officer means the Secretary
of the State Board of Health.
T.
Surgery and General Medical Care Hospital means any facility limited to
providing short-term inpatient surgical and general medical diagnostic care and
treatment.
SECTION 4: LICENSURE AND CODES.
A. License
required. No general hospital or distinct part, critical access hospital or
distinct part, recuperation center or distinct part, infirmary, rehabilitation
facility or distinct part, outpatient surgery center, or alcohol/drug abuse
inpatient treatment center, psychiatric hospital or distinct part, outpatient
psychiatric center or emergency services facility may be established,
conducted, or maintained in the State without first obtaining a
license.
B. Exceptions to license
requirement. The following facilities do not require a license from the
Department:
1. A facility operated by the
Federal Government; and
2. A First
Aid Station.
C. Basic
services required. Every licensed hospital must provide basic
services.
D. Application for
License.
1. An applicant shall file
applications under oath with the Department upon forms provided by Health
Facility Services and shall pay annual license fee as indicated by Act 574 of
1997.
2. These fees shall be paid
into the State Treasury or refunded to the applicant if a license is denied.
The application shall be signed by the owner, if an individual or partnership,
or in the case of a corporation, by two of its officers, or in the case of a
governmental unit, by the head of the governmental department having
jurisdiction over it. The application shall set forth the full name and address
of the institution for which license is sought and such additional information
as the Department may require, including affirmative evidence of ability to
comply with such reasonable standards, rules, and regulations as may be
lawfully prescribed hereunder. The application for annual license renewal shall
be postmarked no later than January 2 of the year for which the license is
issued. The license applicant for an existing institution postmarked after the
date shall be subject to a penalty of one dollar per day for each day and every
day after January 2.
3. A license
issued hereunder shall be effective on a calendar year basis and shall expire
on December 31 of each calendar year. A license shall be issued only for the
premises and persons in the application, and shall not be transferable. Jf the
facility changes ownership the license shall expire. The license shall be
posted in a conspicuous place on the licensed premises. A license issued under
previous regulations shall be effective through the period for which it was
issued. The adequacy of cooperative agreements between hospitals in terms of
service provided by each hospital and the type of licenses issued to each
hospital shall be determined by the Arkansas Department of Health.
E. Facility Change of Ownership.
1. It shall be the responsibility of the
licensed entity to notify Health Facility Services in writing at least 30 days
prior to the effective date of change of ownership.
2. The following information shall be
submitted to Health Facility Services for review and approval:
a. License application;
b. Request for Medicare Certification (where
applicable);
c. Legal documents,
ownership agreements, the license previously issued to the facility, and other
information to support relicensure requirements; and d. Licensure fee as
indicated by Act 574 of 1997.
3. For the purpose of these regulations the
licensed entity is the party ultimately responsible for operating the facility.
The same entity also bears the final responsibility in decisions made in the
capacity of a Governing Body, and for the consequences of these
decisions.
F. Facility
Name Change and/or Address.
1. The facility
shall notify Health Facility Services of any name and/or address
change;
2. The previously issued
license shall be returned to Health Facility Services; and
3. A fee, as indicated in Act 574 of 1997,
shall be submitted to Health Facility Services for issuance of a new
license.
G. Management
Contract.
1. It shall be the responsibility
of the licensed entity to notify Health Facility Services in writing at least
30 days prior to entering into a management contract or agreement with an
organization or firm. A copy of the contract or agreement shall also be
submitted to Health Facility Services for review to assure the arrangement does
not materially affect the license status.
2. An organization or firm who contracts with
the licensed entity to manage the health care facility, subject to Governing
Body approval of operational decisions, is generally considered an agent rather
than an owner. In such instances a licensure change is not required.
H. Separate License. An individual
license shall be required for an institution maintained on separate premises
even though it is operated under the same management, except in cases where the
hospital management of a general hospital operates a detached building which
can be utilized in a limited way for general medical care. Separate licenses
are not required for separate buildings on the same grounds.
I. Temporary Licenses. This license shall be
for less than one year and for a time specified on the temporary license by the
Department.
J. Revocation of
License. The Department is empowered to deny, suspend, or revoke a license on
any of the following grounds:
1. Violation of
any of the provisions of Act 414 of 1961, as amended by Act 258 of 1971, or Act
190 of 1975, Act 536 of 1977, or Act 273 of 1983, Act 980 of 1985, or Act 516
of 1987; Act 143 of 1987, Act 399 of 1987, or Act 348 of 1987, or the Rules and
Regulations lawfully promulgated hereunder; or
2. Permitting, aiding, or abetting the
commission of any unlawful act in connection with the operation of the
institution. (Section 22, Act 414 of 1961, as amended).
3. The right of appeal of any revocation
shall be as specified in the appeal procedure of the Arkansas Department of
Health.
NOTE: If services are to be temporarily suspended, a functional program, with plans and specifications as applicable, shall be submitted to Health Facility Services for approval prior to such suspension.
K. Inspection. Any
authorized representative of the Department shall have the right to enter the
premises of any institution at any time in order to make whatever inspection
necessary in accordance with the minimum standards and regulations prescribed
herein.
L. Penalties.
1. Any person, partnership, association, or
corporation which establishes, conducts, manages, or operates any institution
within the meaning of Act 414 of 1961, as amended by Act 258 of 1971, Act 190
of 1975, Act 536 of 1977, Act 273 of 1983, Act 980 of 1985, And Act 516 of
1987; and Act 143 of 1987, Act 348 of 1987, and Act 399 of 1987, without first
obtaining a license therefore as herein provided, or who violates any portion
of this act or regulations lawfully promulgated hereunder, shall be guilty of a
misdemeanor, and upon conviction thereof shall be liable to a fine of not less
than $25.00 nor more than $100.00 for the first offense and not less than One
Hundred Dollars 100.00), nor more than $500.00 for each subsequent offense, and
each day such institution operates after a first conviction shall be considered
a subsequent offense. (Ark. Code Ann. §
20-9-202.)
2. Any institution licensed by the authority
of these regulations that has received damage due to fire, tornado, earthquake,
man-made or natural disaster shall notify the Department by telephone
immediately and follow with a preliminary report within 48 hours, and a
complete report when the incident has been thoroughly investigated. The
submitted report shall include, but not be limited to, damage to the building,
damage estimates, injuries to patients, staff and the public, etc. If the
Department is not notified, the institution shall be assessed a fine in the
amount of $50.00 for each day, or portion thereof, the incident is not reported
or $500.00 maximum.
M.
Codes. See Section 43, Physical Facilities, List of Referenced
Publications.
SECTION 5: GOVERNING BODY.
An institution shall have an organized Governing Body which shall be legally responsible for maintaining quality patient care and establishing policies for the facility. The Governing Body shall be legally responsible for the conduct of the institution.
A. Governing Body Bylaws. The Governing Body
shall adopt written bylaws which shall be available to all members of the
Governing Body. The bylaws shall ensure:
1.
Maintenance of proper standards of professional work in the hospital;
2. The Medical Staff functions in conformity
with reasonable standards of competency;
3. The method of selecting members and
officers with terms and responsibilities delineated;
4. The selection of an Administrator or Chief
Executive Officer with responsibilities for operation and maintenance of the
facility delineated. In the absence of the Administrator, an alternate with
authority to act shall be designated;
5. Methods for establishing Governing Body
committees with the duties of each committee delineated;
6. Coordination of activities and general
policies of the departments and special committees;
7. Liaison between the Governing Body and
Medical Staff with quarterly documentation;
8. Quarterly Governing Body meetings with
maintenance of minutes signed by an officer;
9. Provision for formal approval of the
organization, bylaws, rules and regulations of the Medical Staff and their
services;
10. Admission of patients
by a physician, patient choice of physician and/or dentist and emergency care
by a physician. All institutions governed by these standards shall arrange for
one or more persons duly licensed to practice medicine to be called in an
emergency. All individuals, who are not hospital employees, who make entries
into the medical record, shall be credentialed through the Medical
Staff;
11. A method of
credentialing or appointing members to the Medical Staff and other authorized
staff;
12. Methods by which Quality
Assurance/Performance Improvement (QA/PI) is established; and
13. Establishment of a quorum to be met in
order to conduct business.
B. Governing Body Minutes. The Governing Body
minutes shall include at least the following information:
1. Review, approval and revision of the
Governing Body bylaws and the Medical Staff bylaws, Rules and
Regulations;
2. Election of
officers, as indicated in the bylaws;
3. Documentation that the liaison between the
Governing Body and Medical Staff is maintained;
4. Appointment and reappointment of the
Medical Staff and other authorized staff as indicated in the bylaws;
5. Review and approval of the hospital's
annual operating budget and capital expenditure plan;
6. Review and approval of reports received
from the Medical Staff and Administration; and
7. Review and approval of the Quality
Assurance/Performance Improvement (QA/PI) plan of the facility, at least
annually, also documentation of the quarterly Quality Assurance/Performance
Improvement (QA/PI) summaries.
SECTION 6: MEDICAL STAFF.
All persons admitted and discharged to any institution governed by these standards shall be under the care of a person duly licensed to practice medicine in Arkansas (hereafter called physician or surgeon). In institutions where two or more physicians are allowed to practice there shall be an organized Medical Staff. Members of the staff shall be qualified legally and professionally for the positions to which they are appointed. Individuals who are not hospital employees, who work in the hospital shall be credentialed through the Medical Staff with approval from the Governing Body. (Refer to Section 36, Specialized Services: Emergency Services.)
Note: See Ark. Code Ann. § 17-95-107 regarding requirements for health care organizations that credential physicians/authorized staff to use the Arkansas State Medical Board's Centralized Credentials Verification Service (CCVS).
A. Credential Files of
the Medical Staff and Other Authorized Staff. An individual file shall be
maintained for each physician/other authorized staff practicing in the hospital
and shall include at least the following:
1.
Verification of age, year, and school of graduation and statement of
postgraduate or special training and experience;
2. Specific delineation of privileges
requested and granted;
3. A
detailed application signed by the applicant, the Chairman of the Credentials
Committee and an officer of the Governing Body;
4. Documentation of the applicant's agreement
to abide by the Medical Staff Bylaws and hospital requirements;
5. Verification of current Arkansas
license;
6. Verification of each
applicable physician's Drug Enforcement Agency (DEA) registration;
7. Verification of at least three
references;
8. Documentation of all
actions taken by the Medical Staff and Governing Board indicating the type of
privileges granted, approval of appointment/reappointment and other related
data;
9. Evaluation of members'
professional activities at the time of reappointment; and
10. Non-employee practitioners may be
screened through the Human Resources Department or another hospital designee.
The requested privileges and credentialing shall be approved by the Medical
Staff.
NOTE: Hospitals shall report to the appropriate professional licensing board the names of individuals whose hospital privileges have been terminated or revoked for cause.
B. Medical Staff Bylaws. The Medical Staff
Bylaws shall include at least the following information:
1. A provision stating the Medical Staff
shall be responsible to the Governing Body of the facility for the quality of
medical care provided for patients in the hospital and for the ethical and
professional practices of members;
2. A provision stating the requirements for
medical and other authorized staff membership, including allied health
professionals;
3. A provision
stating the division of the Medical Staff and clinical departments;
4. A provision stating the election of
officers, responsibilities and terms;
5. A provision establishing Medical Staff
committees, functions, frequency of meetings and composition
(quorum);
6. A provision
establishing frequency of general Medical Staff meetings, specifying attendance
requirements;
7. A provision
establishing written minutes be maintained of all Medical Staff meetings and
the minutes shall be signed by the physician chairman;
8. A provision for an appeals process which
delineates the procedures for a physician or other authorized staff to follow
in challenging staff, that if ratified by the Governing Body, adversely affects
his/her appointment or reappointment to the Medical Staff;
9. A provision establishing the designation
of a specific physician who shall direct each clinical/diagnostic
service;
10. A provision
delineating requirements for maintaining accurate and complete medical records.
(See Health Information Services, Section 14.);
11. A provision for selection and approval of
nationally recognized protocols for use in the Emergency Department;
12. A provision for approval of the bylaws
and amendments by the Medical Staff and the Governing Body; and
13. Documentation of appointments,
reappointments and approval of requested privileges to the medical and other
authorized staff as specified in the bylaws, but at least every two
years.
C. Medical Staff
Minutes. Medical Staff minutes shall include at least the following:
1. Documentation of review of committee
reports including quarterly Quality Assurance/Performance Improvement
(QA/PI);
2. Review, approval and
revision of the Medical Staff Bylaws and Rules and Regulations;
3. Election of officers as specified by the
Bylaws; and
4. Documentation of
physicians designated as chairmen of the committees to direct the services
defined in the Medical Staff bylaws.
D. Quality Assurance/Performance Improvement
(QA/PI).
1. The organization shall develop,
implement and maintain an ongoing program to assess and improve the quality of
care and services provided. A multidisciplinary committee shall meet at least
quarterly to provide oversight and direction for the program; the hospital
shall maintain minutes of the meetings. A Quality Assurance/Performance
Improvement Plan shall be developed and maintained to describe the manner in
which QA/PI activities shall be conducted in the hospital. The QA/PI plan shall
be reviewed and approved by the Chief Executive Officer, Medical Staff and
Governing Body annually.
a. All hospital and
Medical Staff programs, services, departments and functions, including
contracted services related to patient care, shall participate in ongoing
quality assurance/performance improvement activities.
b. The hospital shall collect and assess data
on the functional activities identified as priorities in the QA/PI
plan.
c. Data collected shall be
benchmarked against past performance and/or national or local
standards.
d. Improvement
strategies shall be developed for programs, services, departments and functions
identified with opportunities for improvement.
e. The effectiveness of improvement
strategies and actions taken shall be monitored and evaluated, with
documentation of conclusions regarding effectiveness.
f. Identify and reduce medical errors and
adverse patient events.
g. Approved
organizational abbreviation list.
2. Scope of QA/PI Program. The QA/PI program
shall include, but not be limited to, ongoing assessment and improvement
activities regarding the following:
a. Access
to care, processes of care, outcomes of care and hospital-specific clinical
data, including applicable Peer Review Organization (PRO)/Quality
Assurance/Performance Improvement Organization (QA/PIO) data;
b. Customer satisfaction (patients and
families, physicians and employees);
c. Staff performance as it relates to the
staff as a whole when reviewing aspects of care;
d. Complaint resolution;
e. Utilization and discharge planning data;
and f. Organizational performance.
3. Program Responsibilities. The Governing
Body shall assume overall responsibility and accountability for the
organization-wide QA/PI program. The Governing Body, Chief Executive Officer
and Medical Staff shall ensure QA/PI activities, address identified priorities
and be responsible for the development, implementation, monitoring and
documentation of improvement activities.
4. Reporting. QA/PI activities shall be
reported to the Governing Body on at least a quarterly basis and shall be
documented in the Governing Body meeting minutes.
5. Policies and Procedures. Policies and
procedures pertaining to the QA/PI program which are not contained within the
QA/PI plan shall be maintained in a manual, reviewed and approved
annually.
6. Program Evaluation. An
evaluation of the QA/PI program shall be conducted by the hospital and reported
to the Governing Body annually. The evaluation shall be based upon objective
data and shall include programs, services, departments and functions targeted
by the hospital for improvement, as well as those conducting ongoing QA/PI
activities. Changes in the QA/PI program and QA/PI plan shall be made in
response to the evaluation.
E. Discharge Planning. There shall be a
discharge plan for each patient.
1. Discharge
plans shall incorporate available community and hospital resources, such as
social, psychological, nutritional, and educational services, to meet the
medically-related needs of the patients and to facilitate the provision of
follow-up care.
2. There shall be
policies and procedures developed for discharge planning which include:
a. initiation of discharge planning at the
time of the patient's admission;
b.
reassessment of patient's condition and needs prior to the patient's
discharge;
c. patient and family
education regarding the discharge plan which includes:
1. follow-up care and treatment;
2. available community and hospital
resources; and
d.
transfers and referral processes to appropriate facilities, agencies or
outpatient services as needed for follow-up or ancillary care, including
necessary medical information.
F. Organ and Tissue Donation. The Governing
Body of each Acute Care Hospital shall cause to be developed appropriate
policies, procedures, and protocols for identifying and referring potential
organ and tissue donors. The written policies and procedures shall include but
not be limited to the following subjects:
1.
Determination and declaration of brain death;
2. Organ procurement procedure s:
a. Identifying potential donors;
b. Referring potential donors; and
c. Obtaining consent.
3. Role of attending physician;
4. Role of the procurement coordinator
(employee of procurement agencies);
5. Reimbursement for cost of
donation;
6. Liabilities associated
with donation;
7. Agreement with
organ procurement agency designated by Center for Medicare and Medicaid
Services (CMS);
8. A consent
procedure which encourages reasonable discretion and sensitivity to the family
circumstances in all decisions regarding organ and tissue donations;
9. Determination by the organ procurement
agency personnel of the suitability of the organs and/or tissues for
transplantation; and
10.
Requirements for documentation in the patient's medical record that the family
of a potential organ donor has been advised of their right to donate or decline
to donate.
SECTION 7: GENERAL ADMINISTRATION.
A.
Each institution shall have an Administrator responsible for the management of
the institution. In the absence of the Administrator, an alternate with
authority to act shall be designated. The responsibilities of the Administrator
shall include:
1. Keeping the Governing Body
fully informed of the conduct of the hospital by submitting periodic written
reports or by attending meetings of the Governing Body;
2. Conducting interdepartmental meetings at
regular intervals and maintaining minutes of the meetings;
3. Preparing an annual operating budget of
anticipated income and expected expenditures; and
4. Preparing a capital expenditure plan for
at least a three year period.
B. Policies and procedures shall be provided
for the general administration of the institution and for each department,
section or service in the facility. All policies and procedures for departments
or services shall have evidence of ongoing review and/or revision. The first
page of each manual shall have the annual review date signature of the
department supervisor and/or person(s) conducting the review.
C. An accurate daily patient census sheet as
of midnight shall be available to the Department at all times.
D. The facility shall have visitation
policies determined by the Medical Staff, Governing Body and Administration
which shall include:
1. Limitation when
patient care is hindered or disrupted; and
2. Development by the Governing Body with
advice from the Medical Staff and Infection Prevention and Control Committee
regarding persons under the age of 12 who visit critical care areas of the
hospital.
E. Provisions
shall be made for safe storage of patients' valuables.
F. Animals such as cats, dogs, birds and fish
and aquatic animals shall not be permitted in health care facilities.
Exceptions shall be made for service animals, animals that participate in pet
therapy, fish and aquatic animals in approved aquariums. (See Section 25, Pet
Therapy Program.) All exceptions shall be approved by Health Facility Services.
1. Service animals shall be permitted only
under the following guidelines:
a. Only
animals specifically trained as service animals shall be allowed into the
facility.
b. Service animals shall
not be allowed into the facility if they are unhealthy, feverish, or suffer
from gastroenteritis, fleas or skin lesions.
c. Healthy, well-groomed animals shall be
allowed to enter the facility into areas that are generally accessible to the
public (i.e., lobbies, cafeteria, and nurses stations on unrestricted units).
The owner of the animal shall be directed to inquire about the possibility of a
visit before entering a patient's room. Authorization to visit shall be given
by a unit supervisor.
d. Service
animals shall be walked before entering the facility or shall be diapered in a
manner to prevent contamination of the facility environment with excreta.
Service animals shall not be fed within the facility.
e. Petting or playing with service animals by
hospital personnel or patients shall be prohibited.
f. Owners of service animals shall be
instructed to wash their hands before having patient contact.
g. Visiting with service animals shall be
restricted in the following circumstances:
1.
The patient is in isolation for respiratory, enteric or infectious diseases or
is in protective isolation;
2. The
patient, although not in protective isolation, is immunocompromised or has a
roommate that is;
3. The patient is
in an intensive care unit, burn unit or restricted access unit of the
hospital;
4. The patient or
roommate is allergic to animals or has a severe phobia; and
5. The patient or roommate is psychotic,
hallucinating or confused or has an altered perception of reality and is not
amenable to rational explanation.
h. Animals which become loud, aggressive or
agitated shall be removed from the facility immediately.
2. Fish and aquatic animals shall not be
permitted in health care facilities without prior written approval by Health
Facility Services. Aquariums shall be approved by the Medical Staff and
Infection Prevention and Control Committee. (Turtles will not be considered for
approval.)
a. Aquariums shall meet the
following requirements:
1. Aquariums shall be
self-contained, shock proof, break proof and quiet in operation.
2. Aquariums shall be constructed or
positioned in such a manner as to be leak-proof, spill proof and to preclude
patients or staff from having direct contact with the animals or water in the
aquarium.
3. Aquariums and
associated equipment shall be cleaned frequently by appropriately trained
personnel who do not have direct contact with patients or patient care
items.
4. Aquariums shall be placed
only in areas which are accessed by the general public. Aquariums shall not be
placed in critical care areas (i.e., nursing stations, surgery, patient rooms,
ICU, etc.)
5. Aquariums shall be
kept in a state of good repair at all times.
b. There shall be written procedures for
cleaning and caring for the aquarium.
c. There shall be written procedures for
dealing with clean up in the event there is a major accident concerning the
aquarium.
d. Fish or aquatic
animals shall be of varieties that do not bite, sting and are considered
non-toxic or non-poisonous.
G. Each facility shall develop and maintain a
risk-assessed all hazards written disaster plan. The plan shall:
1. be tailored to meet specific disaster
risks present in the area, such as earthquakes, tornados, floods, nuclear
reactor failures, etc;
2. include
widespread disasters as well as disasters occurring within the local community
and hospital facility;
3. provide
for complete evacuation of the facility;
4. provide for care of mass casualties and
increased patient volume;
5.
provide for transfer of patients, including those with hospital equipment, to
an alternate site;
6. contain two
rehearsals a year, preferably as part of a coordinated drill in which other
community emergency agencies participate;and
a. one drill shall simulate a disaster of
internal nature and the other external;
b. one drill shall be planned and one shall
be "no notice;" and
c. written
reports and evaluation of all drills shall be maintained;
7. contain specific provisions to supply
food, water, generator fuel and other essential items for 72 hours (applies to
inpatient facilities only);
8.
develop, maintain and exercise redundant communication systems; and
9. facilities with AWIN (Arkansas Wireless
Information Network) issued equipment shall include regular maintenance and
personnel training for its use.
H. There shall be a posted list of names,
telephone numbers and addresses available for emergency use. The list shall
include the key hospital personnel and staff, the local police department, the
fire department, ambulance service, Red Cross and other available emergency
units. The list shall be reviewed and updated at least every six
months.
I. There shall be rules and
regulations governing the routine methods of handling and storing flammable and
explosive agents, particularly in operating rooms, delivery rooms, laundries
and in areas where oxygen therapy is administered.
J. All refrigerated areas, including
freezers, shall be provided with thermometers and records maintained to
document the temperatures checked on a daily or weekly basis, as
required.
K. The facility shall
provide access to appropriate educational references to meet the professional
and technical needs of hospital personnel.
L. A safety committee shall develop written
procedures for the reporting and prevention of safety hazards. The committee
shall meet at least quarterly or more frequently if necessary to fulfill safety
objectives. Minutes of the meeting shall be maintained.
M. All Departments and/or Services shall
receive annual education on safety, fire safety, back safety, infection
prevention and control, universal/standard precautions, disaster preparedness
and confidential information.
N.
Any hospital or related institution that closes shall meet the requirements for
new construction in order to be eligible for relicensure. Once a facility
closes, it is no longer licensed. The license shall be immediately returned to
Health Facility Services. To be eligible for licensure all the latest life
safety and health regulations shall be met. Refer to Section 4, Licensure and
Codes, item B., Application for License and item H., Revocation of
Licenses.
O. The facility
Administrator shall assure the development of policies and procedures in
accordance with Ark. Code Ann. §
20-9-307 that, upon request of the
patient, an itemized statement of all services shall be provided within 30 days
after discharge or 30 days after request, whichever is later. The policy shall
include a statement advising the patient in writing of his/her right to receive
the itemized statement of all services.
P. The facility shall establish a process for
prompt resolution of patient grievances to include the following:
1. The facility shall inform each patient
whom to contact to file a grievance.
2. The Governing Body shall approve and be
responsible for the effective operation of the grievance process unless
delegated in writing to another responsible individual.
3. The facility shall establish a clearly
explained procedure for the submission of a patient's written or verbal
grievance to the facility.
Q. A physician shall pronounce the patient
dead and document the date, time and cause of death.
R. Patient care providers not employed by the
hospital, who are involved in direct patient care, shall follow hospital
policies and procedures.
SECTION 8: PERSONNEL ADMINISTRATION.
A. Medical Attendance. The name, address, and
telephone number of the physician(s) attending each patient shall be recorded
for ready reference.
B. Qualified
Personnel. The hospital shall maintain a sufficient number of qualified
personnel to provide effective patient care and all other related services.
There shall be personnel policies and procedures available. Provisions shall be
made for orientation and continuing education.
C. Minimum Age. Personnel who care for
patients shall be a minimum of 16 years of age. For any exceptions, see Subpart
C of Part 570 of Title 29 of the Code of Federal Regulations, Child Labor
Regulations No. 3.
D. Employee
Health. It shall be the responsibility of Administration, with advice and
guidance from the Medical Staff and/or Infection Control Committee, to
establish and enforce policies concerning pre-employment physicals and employee
health. The policies shall include but are not limited to:
1. Requirements for an up-to-date health file
for each employee;
2. Annual
testing of each employee for tuberculosis. Each employee, regardless of whether
the employee is a reactor, non-reactor, or converter, shall be tested or
evaluated in accordance with the applicable section of the Tuberculosis Manual
of the Arkansas Department of Health; and
3. Work restrictions placed on hospital
personnel who are known to be affected with any disease in a communicable stage
or to be a carrier of such disease, to be afflicted with boils, jaundice,
infected wounds, diarrhea or acute respiratory infections. Such individuals
shall not work in any area in any capacity in which there is the likelihood of
transmitting disease to patients, hospital personnel or other individuals
within the hospital or a potential of contaminating food, food contact
surfaces, supplies or any surface with pathogenic organisms.
E. The licensure rules and
regulations promulgated by the Arkansas Department of Health for hospitals and
other related institutions shall be available to all personnel. All personnel
shall be instructed in the requirements of the regulations pertaining to their
respective duties.
F. Job
descriptions shall be developed for each employee and shall include the
responsibilities or actual work to be performed. The job descriptions shall
include physical, educational and licensing or certification requirements for
each job.
G. Personnel records
shall be maintained for each employee and shall include current and background
information covering qualifications for employment, records of all required
health examinations, evidence of current registration, certification, or
licensure of personnel subject to statutory regulation and an annual job
specific performance evaluation.
SECTION 9: ADMINISTRATION REPORTS.
A. All communicable diseases shall be
immediately reported to the Arkansas Department of Health. The institution
shall furnish pertinent required information related to the disease to the
Arkansas Department of Health.
B.
Occurrences which threaten the welfare, safety or health of the public such as
epidemic outbreaks, poisoning, etc., shall be reported either by phone or
facsimile to the local or State Health Officer. The institution shall furnish
other pertinent required information related to the occurrence to the Arkansas
Department of Health.
C. Immediate
capacity for disaster admissions shall be reported daily to the Disaster
Preparedness Section of the Arkansas Department of Health.
SECTION 10: PATIENT IDENTIFICATION.
Each patient admitted to the hospital shall have an identification bracelet applied during the admission process.
SECTION 11: PATIENT CARE SERVICE.
A. Organization. Nursing
Services shall be directed by a nurse executive who is a Registered Nurse
qualified by advanced education and management experience. The nurse
executive's education and experience shall be directly related to the
facility's stated mission and to the nursing care needs of the patient
population.
1. The nurse executive shall have
overall authority for the development of organization-wide nursing standards
and policies and procedures that describe how patient care needs are assessed,
evaluated and met.
2. Development
and implementation of the organization's plans for providing nursing care to
the patient shall be approved by the nurse executive.
3. Policies, procedures and standards shall
be defined, documented and accessible to the nursing staff in a written or
electronic format. Each element shall be approved by the nurse executive or
designee prior to implementation.
4. The nurse executive and nursing staff
shall collaborate with appropriate Governing Body, Medical Staff, management
and other clinical leaders in developing, implementing, revising and monitoring
patient care improvement activities.
5. The nurse executive or designee shall be
responsible for orienting and maintaining adequate numbers of qualified staff
for patient care.
6. Staff meetings
shall be conducted at least monthly for the purpose of reviewing the quality of
nursing care provided. Meeting minutes and attendance shall be
maintained.
7. If the organization
provides clinical facilities for nursing students, there shall be a written
agreement that defines:
a. The facility's
responsibilities; and
b.
Responsibilities of the educational institution, including supervision of
students and responsibilities of the instructor.
8. Clinically relevant in-service educational
programs shall be conducted at regularly scheduled intervals not less than 12
times per year. There shall be evidence of program dates, attendees, and
subject matter.
9. There shall be a
continuous QI program that is specific to the patient care administered. The
program shall reflect nursing staff participation including reports to
appropriate hospital committees.
B. Qualifications.
1. A current, valid license to practice
nursing in Arkansas shall be held by all nurses hired in the facility as well
as private duty and contract/pool nurses. There shall be a procedure to assure
all licenses are current.
2.
Licensed nursing personnel shall practice under the Nurse Practice Act of the
State of Arkansas and current Arkansas State Board of Nursing Rules and
Regulations.
3. The qualifications
required for each category of nursing staff shall be in written policy. Job
descriptions shall be available for review.
4. There shall be documented evidence of
appropriate training for all nonlicensed staff who are assigned patient care
duties.
5. The nurse executive or
designee(s) participates with administration in decisions relative to the
selection and promotion of nursing personnel based on qualifications and
capabilities and recommends the termination of employment when
necessary.
6. All licensed nursing
personnel shall be competent in life support measures.
C. Staffing.
There shall be an adequate number of Registered Nurses on duty at all times and available for bedside care of any patient when needed on a 24 hour basis. In addition, there shall be sufficient Registered Nurses to staff all patient care units. A Registered Nurse shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and competence of the nursing staff. There shall be written criteria to substantiate the assignments.
D. Evaluation and Review of Patient Care
Services.
1. There shall be established
working relationships with other services of the hospital, both administrative
and professional. The factors explaining the standard are as follows:
a. Registered Nurses confer with the
physicians relative to patient care;
b. Interdepartmental policies affecting
patient care are made jointly with the nurse executive or designee(s);
and
c. Procedures are established
for scheduling laboratory and X-ray examinations, for ordering, securing, and
maintaining supplies and equipment needed for patient care and for ordering
diets, etc.
2. There
shall be on-going review and evaluation of nursing care provided for patients.
a. A Registered Nurse plans, supervises, and
evaluates the nursing care for each patient in all settings where nursing care
is provided.
b. Each patient shall
have a plan for provision of care. Each patient plan of care shall be current.
Plans indicate patient care required, how it is to be accomplished, and the
methods, approaches, goals, and modifications necessary to ensure best results
for the patient. The patient's plan of care shall be initiated upon
admission.
c. There shall be
documentation of the nursing care provided. The following information shall be
documented:
1) The initial patient
assessment;
2) Date and time of
treatments and/or dressing changes;
3) Medication Administration Record (MAR)
including the date, time, dosage and manner of administration and the initials
of the nurse administering the medication. When personnel other than nursing
administer medication and the MAR is not utilized, a record of that ancillary
department shall comply with this requirement and be included in the medical
record;
4) Date, time, dosage and
manner of administration of all PRN medications to include reason for
administration and results;
5)
Bedtime and between meal snacks or feedings and the percentage of diets
consumed;
6) Change in patient's
appearance and/or condition;
7)
Patient complaints; and
8) Mode of
discharge and to whom the patient was discharged. If a patient expires, the
time the physician was called, time arrived, the time the patient was
pronounced dead and the fact that relatives were present shall be recorded. (If
relatives were not present, a note shall be made regarding their notification
and disposition of the patient's belongings).
d. A Registered Nurse shall observe each
patient at least once per shift and the observations shall be documented in the
patient's medical record.
NOTE: Block charting and co signatures are not acceptable.
E. Patient Care Facilities and Equipment.
1. There shall be no more beds maintained in
the building than the number of beds for which the hospital is licensed except
in the case of a public disaster or national emergency and then only as a
temporary measure.
2. No beds shall
be in the hallway or on the floor except in case of emergency.
3. Children under the age of 16 years shall
not be cared for in a room with an unrelated adult patient.
4. Provisions shall be made for safe storage
of patients' valuables.
5. All
facilities for cleaning and storage of patient care supplies and equipment
shall be used only for the purpose for which they are designed.
6. Thermometers shall not come in contact
with more than one patient without disinfection or proper covers.
7. All single-use equipment used by a patient
shall either be sent home with the patient at the time of discharge or
destroyed.
8. Only currently dated
equipment and supplies shall be available for patient care. All equipment shall
be kept clean and in good condition.
9. Observation is a designated patient status
as opposed to a designated area. Patients in observation status are those
patients requiring periodic monitoring and assessment necessary to evaluate the
patient's condition or to determine the need for possible admission to the
hospital in an inpatient status. Usually observation status shall be for 48
hours or less.
Patients in observation status may be accommodated within the facility:
a. In private, semi-private
or multi-patient rooms. Furniture shall be arranged to provide adequate room
for patient care procedures and to prevent the transmission of
infection;
b. Cubicle curtains,
privacy screens, or an approved equivalent shall be provided for patient
privacy in all multi-patient rooms. The utilization of such curtains or screens
shall be such that each patient shall have complete privacy;
c. Each room or cubicle shall be provided
with oxygen, vacuum and a nurse call button;
d. Hand hygiene facilities shall be available
within the area;
e. Hospital grade
furniture shall be provided. Bed rails shall be provided on beds;
f For each area in which a patient bed is
utilized, a reading light shall be provided for each bed. The location and
design shall be such that the light is not annoying to other
patients;
g. Patient toilets shall
be provided and accessible to all patients; and
h. Adequate space shall be provided for
medical supplies.
Patients that remain in observation status for a period of 24 hours or more shall have provided to them accommodations equivalent to the accommodations they would have if they were admitted as an inpatient.
SECTION 12: MEDICATIONS.
A. All medical
orders (medications and treatments) shall be in writing and signed by the
prescribes Telephone/verbal orders should be used infrequently. When used they
shall be given only to licensed nurses and signed by the prescriber.
B. No medication shall be dispensed or
administered without a written order signed by a licensed prescriber. A
pharmacist may receive telephone or verbal orders for medications from a
prescriber and record them on the medical record.
C. Medications shall be administered by
licensed nursing personnel in accordance with the current Arkansas Nurse
Practice Act. Other personnel may administer medications only in accordance
with their current Practice Act (e.g., Respiratory, Physical
Therapy).
D. Blood transfusions and
intravenous medications administered by licensed nursing personnel shall be in
accordance with State law. If not administered by a Registered Nurse, only
licensed nursing personnel who have documentation of training shall be
permitted to administer blood transfusions and intravenous
medications.
E. There shall be an
effective hospital procedure for reporting transfusion reactions and adverse
medication reactions.
F. All
medications shall be properly labeled and stored in a specifically designated
medication cabinet, cart or room. At nursing stations, medications shall only
be accessible to licensed nursing personnel and pharmacists. In specialty units
and treatment areas, medications shall only be accessible to licensed nursing
personnel, pharmacists, and designated licensed personnel consistent with that
unit (e.g., Respiratory, Physical Therapy).
G. Refrigeration shall be provided for the
proper storage of biologicals and other medications. Medications shall be
stored in a separate compartment or area from food. Employee foods and/or
medications shall be stored in a separate refrigeration area. An internal
thermometer shall be provided and checked daily (or at least weekly when the
unit is closed) with documentation to assure temperatures between 36°-
46° Fahrenheit (two to eight degrees Centigrade). Refrigerated controlled
substances shall meet the requirement for double-lock security.
H. Unused or damaged medications shall be
returned to the pharmacy. All medications with incorrect or soiled labels shall
be returned to the pharmacy for relabeling.
I. In addition to patients' medical records,
a record of the procurement and disposition of each controlled substance shall
be maintained at each nursing and speciality unit. Each entry on the
disposition record shall reflect the actual dosage administered to the patient,
the patient's name, the date, time, and signature of the licensed person
administering the medication. (Licensed personnel who may legally administer
controlled substances shall include only those personnel authorized by their
current Practice Act. Any error of entry on the disposition record shall follow
a policy for correction of errors and accurate accountability. If the licensed
person who procures the medication from the double-lock security is not the
licensed person who administers the medication, then both persons shall sign
the disposition record.
J. When
breakage or wastage of a controlled substance occurs, the amount given and the
amount wasted shall be recorded by the licensed person who wasted the
medication and verified by the signature of a licensed person who witnessed the
wastage. Documentation shall include or policy shall delineate how the
medication was wasted. In addition to the above referenced licensed personnel
(see I), licensed Pharmacists shall be allowed to witness wastage of controlled
substances. When a licensed person is not available to witness wastage, the
partial dose shall be sent to the Arkansas Department of Health, Pharmacy
Services and Drug Control for destruction.
K. There shall be an audit each shift change
of all controlled substances stocked on the unit. At nursing stations such
counts shall be recorded by the oncoming nurse and witnessed by the off-going
nurse. At other units, audits shall be performed by two licensed personnel. In
each case, both licensed personnel shall sign the record with notation made as
to date and time of the audit. If discrepancies are noted, the Director of
Nursing, the Department Director, as applicable, and the Director of Pharmacy
shall be notified. As with the witnessing of wastage, licensed Pharmacists
shall be allowed to witness controlled substance audits.
L. If specialty units are not staffed on
every shift, controlled substances shall be audited by two licensed personnel
on each shift that is covered by licensed personnel.
M. Controlled substances in areas that are
covered only by on-call personnel shall be audited each shift the area is used
and at least weekly; whichever time frame is less.
N. Solutions and medications for "external
use only" shall be kept separate from other medications.
O. When a patient is discharged, the unused
portion of the patient's medication may be sent home with the patient on direct
written order of the attending physician; and only after the medication has
been relabeled by the pharmacy. Documentation shall include the amount
dispensed to the patient and quantities shall be consistent with the immediate
needs of the patient.
P. Policies
and procedures shall be developed and implemented for the handling of
medications brought into the facility by the patient.
Q. All medication errors and adverse drug
reactions shall be reported to the attending physician. A copy of all
medications errors and adverse drug reactions shall be sent to the Director of
Nursing or designee, QA/PI Committee and when appropriate, to the Director of
Pharmacy.
R. Records generated by
Automatic Medication Distribution Devices shall comply with these regulations.
Policies and Procedures for the usage of Automatic Medication Distribution
Devices shall be approved administratively by Health Facility Services prior to
their usage.
S. Drug Security.
1. The pharmacist, with support from the
Pharmacy and Therapeutics (P&T) Committee, is ultimately responsible for
drug security throughout the facility; applicable licensed personnel at nursing
and specialty units shall maintain the daily security of medications at their
respective units.
2. Access to
medications shall be limited to designated licensed personnel at all
times.
3. Medications dispensed to
nursing and specialty units shall be kept locked in accordance with all Federal
and State regulations.
4.
Emergency-type medications (crash cart, crash kit), as approved by the P&T
Committee, shall be secured with a breakaway seal under the following
conditions:
a. The quantities of medication
are limited;
b. A list of
medications stocked with quantities listed is posted on the emergency cart or
container;
c. The breakage of the
seal clearly indicates that entry has occurred (and said broken seal cannot be
repaired without obvious evidence);
d. Any remaining medications shall be secured
and accessible only to licensed personnel whenever the seal has been broken and
before a new seal is installed;
e.
Applicable personnel shall check the cart for the integrity of the seal each
shift. Documentation shall reflect that the seal is intact. The emergency cart
shall be stored in an area observable by licensed personnel;
f. The quantities of a controlled substance
stocked in a cart or container shall be limited to a maximum of two single
doses of Schedule III, IV, or V drugs. No Schedule II drugs shall be included
in this stock; and
g. Pharmacy
Services shall check the condition of the carts or containers as part of the
monthly inspections of nursing and specialty units.
5. Controlled substances maintained as floor
stock at nursing and specialty units shall be stored separately from other
medication under double-lock security.
6. For patient safety, Schedule III, IV, and
V controlled substances in unit dose packages and dispensed in quantities
limited to a maximum of a two day supply, may be stored with that patient's
other medication.
7. All
medications shall be locked in the absence of immediate visual supervision by
licensed personnel.
8. When a
hospital operates an outpatient pharmacy that stocks medications in various
clinical areas, stock lists, records, and security measures shall be in
compliance with the requirements for nursing and specialty units.
9. Distribution of sample legend medications
shall not be permitted by hospitals. Samples are defined as any prescription
only medication which is not intended to be sold and is intended to promote the
sale of the medication.
10.
Medication security as provided by Automatic Medication Distribution Devices
shall comply with these regulations. Policies and procedures for security
provisions shall be approved administratively by Health Facility Services prior
to usage of Automatic Medication Distribution Devices.
SECTION 13: RESTRAINTS.
A. Restraint use should be
implemented in the least restrictive manner possible, applied in accordance
with safe and appropriate techniques and ended at the earliest possible
time.
B. Each order for the
application of restraints shall be time limited and shall include the type of
restraint to be used. Restraints orders shall not be written as a standing
order or on an as needed basis (PRN).
C. Restraints either physical or chemical
shall be applied only after less restrictive measures have failed. Restraints
shall not be used as a matter of convenience for the staff or as a tool for
disciplining the patient. When the use of a restraint is clinically indicated,
it shall be used only in accordance with the order of a physician or
non-physician licensed medical professional who has been appropriately
credentialed by the medical staff with approval by the governing
body.
D. Documentation of a
comprehensive assessment and modification to the plan of care shall include the
less restrictive measures attempted, justification for the continued need of
restraint and that the patient and/or significant other has been informed of
the reason for restraint use.
E.
Documentation in the patient's record regarding any type of restraint shall
include the times the restraint was applied, released, and discontinued, as
well as evidence of continual assessment, monitoring and re-evaluation of the
patient's condition during the restraint incident.
F. When restraint use is ordered by other
than the attending physician, the attending physician shall be informed as soon
as possible.
G. Patients in leather
or locked restraints shall be under constant observation.
H. All staff that have direct patient contact
shall have ongoing education and training in the proper and safe use of
restraints.
SECTION 14: HEALTH INFORMATION SERVICES.
A.
General Requirements.
1. A medical record
shall be maintained for each patient admitted for care in the
hospital.
2. The original or a copy
of the original (when the original is not available) of all reports shall be
filed in the medical record.
3. The
record shall be permanent and shall be either typewritten or legibly written in
blue or black ink.
4. All
typewritten reports shall include the date of dictation and the date of
transcription.
5. All dictated
records shall be transcribed within 48 hours.
6. Errors shall be corrected by drawing a
single line through the incorrect data, labeling it as "Error," initialing, and
dating the entry.
7. Additional
patient records room requirements are provided in Section 61, Physical
Facilities, and Health Information Unit.
8. Disease, operation, and physicians indices
shall be maintained (manual, abstract, or computer). Records shall be indexed
within one month following discharge. Indices maintained on computer shall be
retrievable at any time for research or quality assurance/performance
improvement monitoring.
9. Records
of discharged patients shall be coded in accordance to accepted coding
practices. Records shall be coded within one month of the patient's dictated
discharge summary.
10. Relevant
educational programs shall be conducted at regularly scheduled intervals with
no less than 12 per year. There shall be written documentation with employee
signatures, program title/subject, presenter, date, and outlines or narrative
of presented program.
11. A Master
Patient Index shall be maintained by the Health Information Services. Index
information shall include at least the full name, address, birth date, and the
medical record number of the patient. The index may be maintained manually or
on computer and shall contain the dates of all patient visits to the facility.
If the Index is maintained on computer, there shall be a policy and procedure
on permanent maintenance.
12. Birth
certificates shall be completed according to the current rules and regulations
of Vital Records, Arkansas Department of Health.
13. A unit record system shall be maintained.
A unit record is defined as all inpatient and outpatient visits for each
patient being filed together in one unit.
14. A policy and procedure manual for the
Health Information Management Department shall be developed. The manual shall
have evidence of ongoing review and/or revision. The first page of each manual
shall have the annual review date, signature of the department supervisor
and/or person(s) conducting the review.
15. A qualified individual shall be employed
to direct the hospital's Health Information Department. If a Registered Health
Information Administrator (RHIA) or a Registered Health Information Technician
(RHIT) is not employed as Director on a full-time basis by the hospital, a
consultant shall make periodic visits to evaluate functions of the Department
and train personnel.
16. All
patient records, whether stored within the Health Information Management
Department or other areas, either within the facility or away from the
facility, shall be protected from destruction by fire, water, vermin, dust,
etc.
17. Medical records shall be
considered confidential. Only authorized personnel shall have access to the
medical records. All medical records (including those filed outside the
department) shall be secured at all times. If authorized personnel are not
available, the department shall be locked. Records shall be available to
authorized personnel from the Arkansas Department of Health.
18. Release of medical information shall be
restricted by the facility's policies and procedures.
19. All medical records shall be retained in
either the original, microfilm or other acceptable methods for 10 years after
the last discharge. After 10 years a medical record may be destroyed provided
the facility permanently maintains the information contained in the Master
Patient Index. Complete medical records of minors shall be retained for a
period of two years after the age of majority.
20. Procedures shall be developed for the
retention and accessibility of the patients' medical records if the hospital or
other facility closes. The medical records shall be stored for the required
retention period and shall be accessible for patient use.
21. All entries into the medical record shall
be legible. There shall be no erasures or obliterations of the original
information contained in a medical record.
22. Medical records shall be complete and
contain all required signed documentation (including physician reports) no
later than 30 days following the patient's discharge date.
23. Patient records shall be destroyed by
burning or shredding. Patient records shall not be disposed of in landfills or
other refuse collection sites.
24.
A QA/PI program shall be continuous and specific to the services.
25. In the event of a physician's death or
permanent incapacitation, incomplete medical records shall be reviewed in a
manner approved by the Medical Staff. Approval to file incomplete medical
records shall be obtained in a manner approved by the Medical Staff and a
statement explaining the circumstances be placed in each record.
B. Authentication of Medical
Record Entries.
1. Each entry into the
medical record shall be authenticated by the individual who is the source of
the information. Entries shall include all documents, observations, notes, and
any other information included in the record.
2. Signatures shall be at least, the first
initial, last name and title. Computerized signatures may be either by code,
number, initials, or the method developed by the facility.
3. The hospital's Medical Staff and Governing
Body shall adopt a policy regarding dictation that permits authentication by
electronic or computer generated signature. The policy shall identify those
categories of the staff within the hospital that are authorized to authenticate
patient records using electronic or computer generated signatures.
4. At a minimum, the policy shall include
adequate safeguards to ensure confidentiality.
a. Each user shall be assigned a unique
identifier which is generated through a confidential code.
b. The policy shall include penalties for
inappropriate use of the identifier.
c. The user shall certify, in writing, that
he or she is the only person authorized to use the signature code.
d. The hospital shall periodically monitor
the use of identifiers; the process by which the monitoring shall be conducted
shall be described in the policy.
5. The system shall make an opportunity
available to the user to verify that the document is accurate and the signature
has been properly recorded.
6. Each
report generated by a user shall be separately authenticated.
7. A user may terminate authorization for use
of electronic or computer generated signature upon written notice to the
Director of Health Information Services.
8. Rubber stamp signatures shall be
acceptable if a letter from the physician is on file explaining that the
physician shall be the only person using the stamp and the stamp shall remain
in his/her possession at all times. The signature stamp shall be the full legal
name of the physician with his/her professional title.
9. Transcribed reports dictated by other than
the attending physician shall be signed by the credentialed individual
dictating the report and the attending physician. Dictation of reports by other
than the attending physician is limited to history, physical, discharge
summary, operative reports and progress notes. Reports dictated by resident
physicians for training purposes require only the signature of the attending
physician.
C. Electronic
Health Information
1. Policies and procedures
governing electronic health information within the organization and with
external entities shall be adopted by the Governing Body.
2. The policies and procedures shall provide
for the use, exchange, security and privacy of electronic health information.
The policies and procedures shall provide for standardized and authorized
availability of electronic health information for patient care, administrative
purposes and research. The policies and procedures will be in compliance with
current guidelines and standards as established in federal and state
status.
D. Record
Content.
1. Identification data shall include
at least the following:
a. Patient's full name
- maiden name if applicable;
b.
Patient's address, telephone number, and occupation;
c. Date of birth;
d. Age;
e. Sex;
f. Marital status (M.S.D.W.);
g. Dates and times of admission and
discharge;
h. Full name of
physician;
i. Name and address of
nearest relative or person or agency responsible for patient and occupation of
responsible party;
j. Name,
address, and telephone number of person(s) to notify in case of
emergency;
k. Medical record
number; and
2. A general
consent for medical treatment and care. This shall be signed by the patient or
guardian. Written or verbal consent shall not release the hospital or its
personnel from upholding the rights of its patients including but not limited
to the right to privacy, dignity, security, confidentiality, and freedom from
abuse or neglect.
3. Clinical
reports shall include the following and shall comply with listed requirements:
a. A History and Physical Examination (HPE)
shall be in the patient's medical record within 48 hours of the patient's
admission to the facility. The HPE must be authenticated by the attending or
treating physician and shall contain the following:
1) Family (medical) history and review of
systems - if noncontributory, the record shall reflect such;
2) Past medical history;
3) Chief complaint(s) - a brief statement of
nature and duration of the symptoms that caused the patient to seek medical
attention as stated in the patient's own words;
4) Present illness with dates or approximate
dates of onset;
5) Physical
examination;
6) Provisional or
admitting diagnosis(es); and
7)
History and physical examinations may be completed up to 30 days prior to
admission if the examination is updated at the time of admission. The updated
HPE must be authenticated by the attending or treating physician.
b. Progress notes shall be
recorded, dated and signed. The frequency of the physician's progress notes
shall be determined by the patient's condition. Dictated progress notes are
acceptable and shall be placed in the patient's medical record within 48
hours.
c. Orders including verbal
orders shall be authenticated with a legible and dated signature in a timely
manner as defined by Medical Staff By-Laws.
d. A discharge summary shall recapitulate the
significant findings and events of the patient's hospitalization and his/her
condition on discharge. The discharge summary must be authenticated by the
attending or treating physician within 30 days of the patient's discharge. The
final diagnosis shall be stated in the discharge summary.
e. Autopsy findings shall be documented in
complete protocol within 60 days and the provisional anatomical diagnosis shall
be recorded within 72 hours. A signed authorization for autopsy shall be
obtained from the next of kin and documented in the medical record before an
autopsy is performed.
f Original,
signed diagnostic reports (laboratory, X-rays, CATs, SCANs, EKGs, fetal
monitoring, EEGs) shall be filed in the patient's medical record. Physicians'
orders shall accompany all treatment procedures. Fetal monitor and EEG tracings
may be filed separately from the medical record if accessible when
needed.
g. Reports of ancillary
services (Dietary, Physical Therapy, Respiratory Care, Social Services, etc.)
shall be included in the patient's medical record.
h. Reports of Medical Consultation, if
ordered by the attending physician, shall be included in the patient's medical
record within time frames established by the Medical Staff.
E. Records of
Complementary Departments. In addition to the general record content
requirements stated above, parts F., G. and H. are required, as
applicable.
F. Surgery Records.
1. A specific consent for surgery shall be
documented prior to the surgery/procedure to be performed, except in cases of
emergency, and shall include the date, time and signatures of the patient and
witness. Consent shall be obtained by the surgeon and documented in the
patient's medical record. (Abbreviations are not acceptable.)
2. A History and Physical Examination (HPE)
on admission containing medical history and physical findings shall be
documented in the patient's medical record prior to surgery. In cases of
emergency surgery, an abbreviated physical examination, and a brief description
of why the surgery is necessary shall be included in the FIPE. (See Section 14,
Health Information Services, Record Content.) The HPE must be authenticated by
the attending or treating physician or surgeon.
3. An anesthesia report, including
preoperative evaluation and postoperative assessment, shall be documented by
the Anesthesiologist and/or Certified Registered Nurse Anesthetist (CRNA). The
pre-evaluation and post assessment shall be dated and timed.
a. Preoperative anesthesia evaluation shall
be completed prior to the patient's surgery.
b. Report of Anesthesia. A CRNA who has not
been granted authority by a facility, as a DEA registrant, to order the
administration of controlled substances shall give all orders as verbal orders
from the supervising physician, dentist, or other person lawfully entitled to
order an anesthetic.
c. Post
anesthesia assessment shall be documented in the medical record prior to the
patient's discharge, not to exceed 48 hours after the patient's surgery. If the
patient is in need of continued observation, the anesthetist shall be readily
available. Discharge criteria shall be established and approved by the Medical
Staff and Governing Body. If the patient meets the discharge criteria within a
three hour period postoperatively, a post anesthesia assessment is not
required.
4. An
individualized operative report shall be written or dictated by the physician
or surgeon immediately following surgery and shall be signed within 72 hours.
The report shall describe (in detail) techniques, findings, pre and
postoperative diagnosis, and tissues removed.
5. A signed pathological report shall be
maintained in the medical record of all tissue surgically removed. A specific
list of tissues exempt from pathological examination shall be developed by the
Medical Staff.
G.
Obstetrical Records.
1. A pertinent prenatal
record shall be updated upon admission, or history and physical examination
signed by the physician shall be available upon the patient's admission and be
maintained in the patient's medical record.
2. A record of labor and delivery,
authenticated by the physician, shall be maintained for every Obstetrical
patient.
3. Documentation of the
patient's recovery from delivery shall be maintained.
4. Nurses' postpartum record, graphics and
nurses' notes shall be maintained.
H. Newborn Records.
1. A newborn history and physical examination
shall be completed by the physician within 24 hours of birth. The following
additional data shall be required:
a. History
of the newborn delivery (sex, date of birth, type of delivery, and anesthesia
given the mother during labor and delivery); and
b. Physical examination (weight, date, time
of birth, and condition of infant after birth).
2. There shall be a consent for circumcision
(if applicable).
3. A procedure
note for circumcision shall be documented by the physician.
4. A discharge note or summary describing the
condition of the newborn at discharge and follow-up instructions given to the
mother must be prepared and included in the medical record. The discharge note
or summary must be authenticated by the attending or treating
physician.
5. Hospitals shall
comply with State Law and Health Department requirements for newborn testing.
See Rules and Regulations Pertaining to Testing of Newborn Infants
and Ark. Code Ann. §
20-15-301 et seq.
6. Birth certificates shall be completed on
all infants born in the hospital, or admitted as a result of birth in
accordance with the requirements of Vital Records, Arkansas Department of
Health.
SECTION 15: MEDICAL RECORD REQUIREMENTS FOR OUTPATIENT SERVICES, EMERGENCY ROOM AND OBSERVATION SERVICES.
A. Outpatient Records. An Outpatient record
shall be completed for each outpatient and shall include the following:
1. History and physical examination of the
patient (not applicable if for diagnostic services and/or outpatient therapy
services);
2. Orders and reports of
diagnostic services and outpatient therapy services;
3. Patient's diagnosis and summary of
treatment received recorded by the attending physician;
4. Documentation of any medications
administered;
5. Progress notes for
subsequent clinic visits recorded by applicable disciplines
(practitioners);
6. Outpatient
surgery record requirements (See also item F. of Section 14, Health Information
Services.); and
7. Discharge
instructions.
B.
Emergency Room Records. An Emergency Room Record shall be completed for each
patient who presents for treatment at the Emergency Room and shall include the
following:
1. Patient
identification;
2. Date and the
following times:
a. Admission;
b. Time physician was notified of patient's
presence in the Emergency Room;
c.
Time of physician's arrival if applicable; and d. Discharge.
3. History (when the injury or
onset of symptoms occurred);
4.
Vital signs;
5. Nurses' assessment
and physical findings;
6.
Diagnosis;
7. Record of treatment
including documentation of verbal orders and of medication quantities
administered with the initials of person(s) administering the medications.
Also, type and amount of local anesthetic, if administered;
8. Diagnostic reports with specific orders
noted;
9. Instructions to patients
for follow-up care (e.g., do not drive after receiving sedatives, return to
physician's office for removal of sutures in one week);
10. Disposition of case;
11. Signature of patient or his/her
representative;
12. Signed and
dated discharge order; and
13. The
ambulance record shall be transferred with the patient.
NOTE: Emergency Room Records shall be completed within 24 hours of the patient's visit.
C. Observation Records. A record of every
patient admitted to an observation status shall be maintained. The observation
record shall include, at a minimum:
1.
Patient identification data;
2.
Physician's diagnosis and therapeutic orders dated and timed;
3. Hi story and phy si cal;
4. Physician's progress notes, including
results of treatment;
5. Nursing
assessment by a Registered Nurse;
6. Nursing observations;
7. Results of all diagnostic
testing;
8. Medication
Administration Record;
9.
Allergies;
10. Patient
education;
11. Plan for follow-up
treatment; and
12. Referrals.
NOTE: Observation records shall be completed on patients who stay less than 24 hours.
D. Psychiatric Records. The basic medical
record requirements for psychiatric patients shall be the same as for other
patient records, with the following additions:
1. The identification data shall include the
patient's legal status (on the face sheet);
2. A proper consent or authority for
admission shall be included;
3. A
psychiatric evaluation shall be completed by the attending physician within 60
hours of admission which includes the following:
a. The patient's chief complaints and/or
reaction to hospitalization, recorded in patient's own words, if
possible;
b. History of present
illness including onset and reason for current admission;
c. Past history of any psychiatric problems
and treatment, including a record of patient's activities (social, education,
vocational, interpersonal and family relationships);
d. Past psychiatric history of patient's
family;
e. Mental status which
includes at least attitude and general behavior, affect, stream of mental
activity, presence or absence of delusions and hallucinations, estimate of
intellectual functions, judgment and an assessment of orientation and memory;
f Strengths such as knowledge,
interests, skills, aptitudes, experience, education and employment status
written in descriptive terms to be used in developing the Master Treatment
Plan; and g. Diagnostic impressions and recommendations.
4. A history and physical examination shall
be documented by a physician and shall include a neurological examination
within 24 hours of admission.
5.
Social service records, including report of interviews with patient, family
members and others shall be included for each admission. Social assessment and
plan of care shall be completed within 48 hours of admission.
6. Reports of consultation, psychological
evaluations, reports of electroencephalograms, dental records and reports of
special studies shall be included in the records when applicable.
7. An Interdisciplinary Master Treatment Plan
shall be developed for each patient and included in the medical record, within
60 hours of admission. The treatment plan shall involve all staff who have
contact with the patient and shall include (as a minimum):
a. Problems and needs relevant to admission
and discharge as identified in the various assessments, expressed in behavioral
and descriptive terms;
b. Strengths
(assets) including skills and interests;
c. Problems, both physical and mental, that
require therapeutic management;
d.
Long and short term goals describing the desired action or behavior to be
achieved. Goals shall be relevant, observable and measurable;
e. Treatment modalities individualized in
relation to patient's needs;
f
Evidence of patient's involvement in formulation of the plan;
g. Realistic discharge and aftercare
plans;
h. Nursing assessment and
progress notes integrated into the Master Treatment Plan. Reviews and revisions
of the Nursing Plan of Care shall be as required under the Section 11, Patient
Care Service;
i. Signatures of all
staff involved;
j. Date Master
Treatment Plan was implemented; and k. Staff responsibilities.
8. The treatment received by the
patient shall be documented in such a manner and with such frequency as to
assure that all active therapeutic efforts such as individual and group
psychotherapy, medication therapy, milieu therapy, occupational therapy,
industrial or work therapy, nursing care and other therapeutic interventions
are included.
9. Progress notes
shall be recorded by the physician, social worker and others involved in active
treatment modalities at least as often as the patient is seen. The notes shall
contain recommendations for revisions in the treatment plan.
10. Nursing notes shall be written as
required under the Section 11, Patient Care Service.
11. The discharge summary shall include a
recapitulation of the patient's hospitalization and recommendations from
appropriate services concerning follow-up of aftercare, as well as a brief
summary of the patient's condition on discharge.
12. The psychiatric diagnosis contained in
the final diagnosis and included in the discharge summary shall be written in
the terminology of the current American Psychiatric Association's Diagnostic
and Statistical Manual.
SECTION 16: PHARMACY.
All hospitals shall have adequate provision for pharmaceutical services regarding the procurement, storage, distribution and control of all medications. There shall be compliance with all federal and state regulations, including Laws and Regulations -Arkansas State Board of Pharmacy.
A.
Definitions.
1. Hospital Pharmacy means the
place or places in which drugs, chemicals, medicines, prescriptions or poisons
are prepared for distribution and administration for the use and/or benefit of
patients in a hospital licensed by the Arkansas Department of Health. The
Hospital Pharmacy shall also mean the place or places in which drugs,
chemicals, medicines, prescriptions or poisons are compounded for the
dispensing to hospital employees, members of the immediate families of hospital
employees, patients being discharged, and other persons in emergency
situations. Hospital Pharmacy shall also mean the provision of pharmaceutical
services as defined in the Pharmacy Practice Act by a pharmacist to a patient
of the hospital.
2. Hospital
Employee means any individual employed by the hospital whose compensation for
services or labor actually performed for a hospital is reflected on the payroll
records of a hospital.
3. Qualified
Hospital Personnel means persons other than Licensed Pharmacists who perform
duties in conjunction with the overall hospital pharmaceutical services for
inpatients.
4. Licensed Pharmacist
means any person licensed to practice pharmacy by the Arkansas State Board of
Pharmacy who provides pharmaceutical services as defined in the Pharmacy
Practice Act to patients of the hospital.
5. Unit Dose Distribution System is a
pharmacy-coordinated method of dispensing and controlling medications in
hospitals in which medications are dispensed in single unit packages for a
specific patient on orders of a physician where not more than a 24 hour supply
of said medication is dispensed, delivered, or available to the
patient.
6. Modified Unit Dose
Distribution System is a system that meets the requirement of a "Unit Dose
Distribution System," provided that up to a 72 hour supply may be sent to the
floor once a week if the system has been reviewed and approved administratively
by the Arkansas State Board of Pharmacy.
B. Hospitals maintaining and using mechanical
storage and delivery machines for legend drugs shall have such machines stocked
only by Pharmacy Services. Drugs may be obtained from such machines only by
licensed personnel in accordance with their Practice Act acting under the
prescribed rules of safety procedures as promulgated by the individual hospital
using said machine.
Limited amounts of Schedule II-V controlled substances may be stocked in the machines provided the following requirements are met:
1. Pharmacy Services possesses the only key
necessary to stock the machine; and
2. Policies and Procedures specify the
licensed personnel having access and responsibility for the medications.
The person removing a medication for administration shall record at least the patient's name and the name, strength, and amount of medication on a record that is maintained by the Pharmacy Department. The record shall also be signed by the person removing the medication. The removal of controlled substances shall comply with the record keeping requirements of Section 12, Medications. Pharmacy Services shall audit stock levels as needed to replace medications. Use of the machines shall not be to circumvent adequate pharmaceutical services.
C. Compounding, Dispensing and Distributing.
1. Compounding. The act of selecting, mixing,
combining, measuring, counting, or otherwise preparing a drug or
medication.
2. Dispensing. A
function restricted to licensed pharmacists, which involves the issuance of:
a. One or more doses of a medication in
containers other than the original, with such new containers being properly
labeled by the dispenser as to content and/or directions for use as directed by
the prescriber;
b. Medication in
its original container with a pharmacy prepared label that carries to the
patient the directions of the prescriber as well as other vital information;
and/or
c. A package carrying a
label prepared for nursing station use. The contents of the container may be
for one patient (individual prescription) or for several patients (such as a
nursing station medication container).
3. Distributing. Distributing, in the context
of this regulation, refers to the movement of a medication from a central point
to a nursing station medication center. The medication shall be in the
originally labeled manufacturer's container or in a prepackaged container
labeled according to federal and state laws and regulations, by a pharmacist or
under his direct and immediate supervision.
D. Pharmacy and Therapeutics Committee. There
is a committee of the Medical Staff to confer with the pharmacist in the
formulation of policies, explained as follows:
1. A Pharmacy and Therapeutics (P&T)
Committee, composed of at least one (1) physician, the Administrator or
representative, the director of nursing service or representative, and the
pharmacist is established in the hospital. It represents the organizational
line of communication and the liaison between the Medical Staff and the
pharmacist;
2. The Committee
assists in the formulation of broad, professional policies regarding the
evaluation, appraisal, selection, procurement, storage, distribution, use, and
safety procedures in conformance with Food and Drug Administration and
manufacturers' bulletins on the safe administration of drugs and all other
matters relating to drugs in hospitals;
3. The Committee performs the following
specific functions:
a. Serves as an advisory
group to the hospital Medical Staff and pharmacist on matters pertaining to the
choice of drugs;
b. Develops and
approves the drug formulary and all drug lists annually and makes interim
revisions as needed;
c. Establishes
standards concerning the use and control of investigational drugs and research
in the use of recognized drugs;
d.
Evaluates clinical data concerning new drugs or preparations requested for use
in the hospital;
e. Makes
recommendations concerning drugs to be stocked on the nursing unit floors and
emergency drug stocks;
f Prevents
unnecessary duplication in stocking drugs and drugs in combination having
identical amounts of the same therapeutic ingredients; and
g. Reviews and approves drug-related policies
and procedures; and
4.
The Committee develops and approves policies and procedures for all nursing
personnel assigned the responsibility of preparing and administering
intravenous (IV) admixtures. The pharmacist shall be involved in the review of
the drug order, calculations, and preparation whenever possible. The Committee
should consider the appropriate category of personnel (Registered Nurse or LPN)
and degree of training necessary to make judgments and calculations involved in
IV admixture programs;
5. The
Committee assures that medications dispensed to outpatients, Emergency Room
patients and discharged patients comply with all federal and state laws and
regulations;
6. The Committee meets
at least quarterly and reports to the Medical Staff by written
report.
E. Pharmacy
Operations. The hospital has a pharmacy directed by a licensed pharmacist. The
pharmacy is administered in accordance with accepted professional principles.
1. Pharmacy supervision. There is a pharmacy
directed by a licensed pharmacist defined as follows:
a. The Director of Pharmacy is trained in the
specialized functions of hospital pharmacy;
b. The Director of Pharmacy is responsible to
the administration of the hospital and Board of Pharmacy for developing,
supervising, and coordinating all the activities of the Pharmacy Department and
all pharmacists providing professional services in the hospital; and
c. All licensed pharmacists who provide
pharmaceutical services as defined by the Pharmacy Practice Act shall practice
under policies, procedures, and protocols approved by the Director of Pharmacy.
These policies, procedures, and protocols shall be subject to review and
approval by the Board of Pharmacy.
F. Physical Facilities. Facilities are
provided for the storage, safeguarding, preparation, and dispensing of drugs,
defined as follows:
1. Drugs are issued to
floor units in accordance with approved policies and procedures;
2. Drug cabinets on all units shall be
checked monthly by qualified pharmacy personnel. All floor stocks are properly
controlled;
3. A careful
determination of the functions of a department will regulate the space to be
allocated, the equipment necessary to carry out the functions, and the number
of personnel required to utilize the equipment and to render a given volume of
service, as these functions relate to the frequency or intensity of each
function or activity. Adequate equipment shall specifically relate to services
rendered and functions performed by the hospital pharmacy. Equipment lists will
relate to the following services and functions:
a. Medication preparation;
b. Library reference facilities;
c. Record and office procedures;
d. Sterile product manufacturing;
e. Bulk compounding (manufacturing);
f Product control (assay,
sterility testing, etc.); and
g.
Product development and special formulations for medical
staff.
4. Equipment and
supplies necessary to the hospital pharmacy's safe, efficient, and economical
operation shall include, but not be limited to:
a. Graduates capable of measuring from 0.1 ml
up to at least 500 ml;
b. Mortars
and pestles;
c. Hot and cold
running water;
d. Spatulas (steel
and non-metallic);
e. Funnels;
f Stirring rods;
g. Class A balance and appropriate
weights;
h. Typewriter or other
label printer;
i. Suitable
apparatus for production of small-volume sterile solutions;
j. Suitable containers and labels; and k.
Adequate reference library to include at least the following:
1) American Hospital Formulary
Service;
2) Pharmacology
text;
3) Each hospital pharmacy
shall have available for personal and patient use a current copy of:
The U.S.P. DI, three book set including "Drug Information for the Healthcare Professional" (two volumes) and "Advice for the Patient" (one volume)
or
The two volume set "Facts and Comparisons" (one volume) and "Patient Drug Facts" (one volume);
4) Text on compatibility of parenteral
products;
5) Current professional
journals, such as:
a) Drug Intelligence and
Clinical Pharmacy;
b) Hospital
Pharmacy; and
c) Journal of
ASHP.
5. Special locked storage space is provided
to meet legal requirements for storage of controlled drugs, alcohol, and other
prescribed drugs; and
G.
Personnel. Personnel competent in their respective duties are provided in
keeping with the size and activity of the department explained as follows:
1. The Director of Pharmacy is assisted by an
adequate number of additional licensed pharmacists and other such personnel as
the activities of the pharmacy may require to ensure quality pharmaceutical
services; and
2. The pharmacy,
depending upon the size and scope of its operations, is staffed by the
following categories of personnel:
a. Chief
Pharmacist (Director of Pharmacy);
b. One or more assistant chief pharmacists
(Assistant Director of Pharmacy);
c. Staff pharmacists;
d. Pharmacy residents (where program has been
activated);
e. Trained
non-professional pharmacy helpers (qualified hospital personnel); and f
Clerical help.
H. Emergency Pharmaceutical Services. Through
the Administrator of the hospital, the P&T Committee shall establish
policies and procedures that include, but are not limited to, the following:
1. Upon admission to the Emergency Room on an
outpatient basis and when examined by the physician where medications are
prescribed to be administered, a record shall be kept on file in the Emergency
Room admission book or a copy of the Emergency Room medication order must be
kept by the pharmacist to be readily accessible, for control and other
purposes, as required by these regulations;
2. If the physician wishes the patient to
have medication to be taken with them from the emergency room supplies, the
amounts to be taken shall be sufficient to last until medication may be
obtained from local pharmacies, in any case not to exceed a 48 hour supply. All
state and federal laws shall be observed concerning all records, labeling, and
outpatient dispensing requirements; and
3. Take home prescriptions for
anti-infectives issued to patients at the time of discharge from the Emergency
Room, dispensed by a pharmacist shall be quantities consistent with the medical
needs of the patient.
I.
Pharmacy Records and Labeling. Records are kept of the transactions of the
pharmacy and correlated with other hospital records where indicated. All
medication shall be properly labeled. Such record and labeling requirements are
as follows:
1. The pharmacy establishes and
maintains, in cooperation with the accounting department, a satisfactory system
of records and bookkeeping in accordance with the policies of the hospital for:
a. Maintaining adequate control over the
requisitioning and dispensing of all drugs and pharmaceutical supplies;
and
b. Charging patients for drugs
and pharmaceutical supplies.
2. A record of procurement and disbursement
of all controlled drugs is maintained in such a manner that the disposition of
any particular item may be readily traced;
3. The pharmacist shall receive and provide
service pursuant to the perusal of the physician's original order or a direct
copy thereof, except in emergency situations wherein the pharmacist may provide
service pursuant to a verbal order or to an oral or written transcription of
the physician's order provided that the pharmacist shall receive and review the
original or direct copy;
4. A
record shall be maintained by the pharmacy and stored separately from other
hospital records for each patient (inpatient or outpatient) containing the name
of the patient, the prescribing physician, the name and strength of the drugs
prescribed, the name and manufacturer (or trademark), the quantity and the
pharmacist's initials for all medications dispensed;
5. The label of each medication container
prepared for administration to inpatients, shall bear the name and strength of
the medication, the expiration date, and the lot or control number. The label
on the medication or the container into which the labeled medication is placed
shall bear the name of the patient and room number; and
6. The label of each outpatient's individual
prescription medication container bears the name of the patient, prescribing
physician, directions for use, and the name and strength of the medication
dispensed (unless directed otherwise by the physician) and the date of
dispensing.
J. Control
of Toxic or Dangerous Drugs. Policies are established to control the
administration of toxic or dangerous drugs with specific reference to the
duration of the order and the dosage, explained as follows:
1. The Medical Staff has established a
written policy that all toxic or dangerous medications not specifically
prescribed as to the time or number of doses, will be automatically stopped
after a reasonable time limit set by the staff;
2. The classifications ordinarily thought of
as toxic or dangerous drugs are controlled substances, anticoagulants,
antibiotics, oxytocics, and cortisone products; and
3. All deteriorated non-sterile, non-labeled,
or damaged medication shall be destroyed by the pharmacist, with the exception
of controlled substances. All controlled drugs (Schedule II, III, IV and V)
shall be listed and a copy sent, along with drugs to the Arkansas Department of
Health by registered mail or delivered in person for disposition.
K. Drugs to be dispensed.
Therapeutic ingredients of medications dispensed are included (or approved for
inclusion) in the United States Pharmacopoeia, N.F. and U.S. Homeopathic
Pharmacopoeia, or Accepted Dental Remedies (except for any drugs unfavorably
evaluated therein) and drugs approved by Ark. Code Ann. §
17-92-503, or are approved for use
by the P&T Committee of the hospital staff, explained as follows:
1. The pharmacist, with the advice and
guidance of the P&T Committee, is responsible for the specifications as to
quality, quantity, and source of supply of all drugs; and
2. There is available a formulary or list of
drugs accepted for use in the hospital which is developed and amended at
regular intervals by the P&T.
L. Policy and Procedure Manual.
1. A policy and procedure manual pertaining
to the operations of the hospital pharmacy, with updated revisions adopted by
the P&T Committee of each hospital shall be prepared and maintained at the
hospital.
2. The policy and
procedure manual shall include at a minimum, the following:
a. Provisions for procurement, storage,
distribution, and drug control for all aspects of pharmaceutical services in
the hospital;
b. Specialized areas
such as Surgery, Delivery, ICU and CCU units and Emergency Room stock and usage
of medication shall be specifically outlined;
c. A system of requisitioning supplies and
medications for nurses' stations stock shall be in written procedural form as
to limits of medications to be stocked in each nursing unit;
d. Detailed job descriptions and duties of
each employee by job title working in the Pharmacy Department shall be
developed and made a part of these policies and procedures; and
e. The Pharmacy Policy and Procedure Manual
shall be subject to review and approval by the Board of Pharmacy on request
from the Board.
M. Employee Prescription Medication.
1. There will be a prescription on file for
all prescription drugs dispensed to hospital employees and their immediate
families. These records will be kept separate from all inpatient
records.
2. The only person(s)
entitled to have employee prescriptions filled will be the employee listed on
the hospital payroll and members of their immediate family.
N. Patient Discharge Medication.
Any take-home prescription dispensed to patients at time of discharge from the
hospital shall be for drugs and quantities consistent with the immediate needs
of the patient.
O. Licensed
Pharmacist Personnel Requirements.
1. The
minimum requirements for licensed pharmacists in hospitals are:
a. A general hospital, surgery and general
medical care, maternal and general medical care hospital, chronic disease
hospital, psychiatric hospital, and rehabilitative facility licensed for
greater than 50 beds, as determined by the institution license issued by the
Arkansas Department of Health, shall require the services of one pharmacist on
the basis of 40 hours per week with such additional pharmacists as are
necessary, in the opinion of the Arkansas State Board of Pharmacy, to perform
required pharmacy duties as are necessary in keeping with the size and scope of
the services of the hospital pharmacy's safe and efficient operation. Hospitals
providing specialized or unique patient care services may request approval from
the Arkansas State Board of Pharmacy to be exempt from the requirement of a
pharmacist on duty 40 hours per week. The request for exemption shall provide
adequate written documentation to justify the services of a pharmacist such
hours as are necessary to perform required pharmacy services, followed by an
appearance before the Arkansas State Board of Pharmacy for final approval of
the request;
b. The above
classified hospitals, licensed for 50 beds or less, as determined by the
institution license issued by the Arkansas Department of Health, shall require
the services of a pharmacist such hours as, in the opinion of the Arkansas
State Board of Pharmacy and the Arkansas State Board of Health, are necessary
to perform required pharmacy duties in keeping with the size and scope of the
services of the hospital pharmacy safe, and efficient operation. The pharmacist
shall be on site at least five days per week to perform and review pharmacy
dispensing, drug utilization and drug distribution activities. A pharmacist
shall be available to provide emergency services to the staff when the pharmacy
is closed;
c. Recuperation Centers,
Outpatient Surgery Centers and Infirmaries:
1) If the infirmary, recuperation center, or
outpatient surgery center has a pharmacy department, a licensed pharmacist
shall be employed to administer the pharmacy in accordance with all state and
federal laws regarding drugs and drug control;
2) If the infirmary, recuperation center, or
outpatient surgery center does not have a pharmacy department, it has
provisions for promptly and conveniently obtaining prescribed drugs and
biologicals from a community or institutional pharmacy;
3) If the infirmary, recuperation center, or
outpatient surgery center does not have a pharmacy department but does maintain
a supply of drugs, a licensed pharmacist shall be responsible for the control
of all bulk drugs and maintain records of their receipt and disposition. The
pharmacist shall dispense drugs from the drug supply, properly labeled, and
make them available to appropriate nursing personnel;
4) All medication for patients shall be on
individual prescription basis.
2. A pharmacist in charge, who is employed at
any facility permitted by the Arkansas State Board of Pharmacy where a 40 hour
work week is required, may also be the pharmacist in charge at a hospital
licensed for 50 beds or less by the Arkansas Department of Health.
P. Responsibility of a Pharmacist
in Hospital Pharmacy.
1. The pharmacist is
responsible for the control of all medications distributed in the hospital
where he practices and for the proper provision of all pharmaceutical
services.
2. The following aspects
of medication distribution and pharmaceutical service are functions involving
professional evaluations or judgments and may not be performed by supportive
personnel:
a. Selection of the brand and
supplies of medication;
b.
Interpretation and certification of the medication ordered. This involves a
number of professional responsibilities such as the determination of:
1) Accuracy and appropriateness of dose and
dosage schedule;
2) Such items as
possible drug interactions, medication sensitivities of the patient, and
chemical and therapeutic incompatibilities; and
3) Accuracy of entry of medication order to
patient's medication profile.
c. Final certification of the prepared
medication.
Q.
Pharmacy Technicians.
1. Pharmacy technician
refers to those individuals identified by the Arkansas State Board of Pharmacy.
Exclusive of pharmacy interns, who are regular paid employees of the hospital
and assist the pharmacist in pharmaceutical services.
2. Supervision means that the responsible
pharmacist shall be physically present to observe, direct, and supervise the
pharmacy technician at all times when the pharmacy technician performs acts
specified in this regulation. The supervising pharmacist is totally and
absolutely responsible for the actions of the pharmacy technician.
3. The pharmacist and pharmacy technician(s)
shall comply with all applicable sections of Laws and Regulations of
the Arkansas State Board of Pharmacy with regards to tasks,
responsibilities, duties, ratios, and supervision in the hospital
setting.
4. There shall be
documentation by each technician of all duties and tasks performed in the
preparation and processing of medication. The pharmacist shall be responsible
for the final check and verification of all technician duties and tasks. The
performance, check, and verification shall be recorded on a record maintained
by the department which shall include the signature, initial(s), or other
identifying mark of each person.
R. Operation of Pharmacy Department When
Pharmacist is Not Present.
1. A limited
supply of backup medications may be utilized for patient needs only at times
when the pharmacist is not present. This stock shall be accessible only to
approved licensed personnel. A record shall be maintained which identifies the
medication obtained and the personnel obtaining it. The pharmacist shall then
review this record when he returns to the facility to assure compliance with
the physician's orders. Medications shall be replaced to stock as
needed.
2. At no time will the
hospital pharmacy be open and in operation unless a licensed pharmacist is
physically present except:
a. Entrance may be
obtained for emergency medication as set forth in the Pharmacy Policy and
Procedure Manual when the pharmacy is closed outside its normal operation
hours. The Medical Staff shall approve a method by which individual nursing
personnel may be authorized by name and qualification to remove only one dose
if the drug is not of the unit dose packaging type; or, if the medication is
unit dosed, enough medication to last until the pharmacist returns can be
removed. A record listing all medications obtained should be maintained, and
the pharmacist shall check for compliance with the physician's orders when he
returns to the facility. Controlled substances shall not be accessible unless
daily counts are performed and documented; and
b. When the pharmacist is summoned away from
the pharmacy and there are other qualified personnel left in the pharmacy, the
personnel left in the pharmacy shall perform only those functions authorized
within this regulation.
3. A pharmacist shall be available to provide
medication consultation.
S. Medication Utilization. The pharmacist,
with the advice and guidance of the P&T Committee, shall participate in:
1. Discussions of reports of medication
errors, with trends noted, conclusions made, and recommendations suggested. If
there are no errors to report, this shall be stated;
2. Discussions of adverse drug reactions with
trends noted, conclusions made, and recommendations suggested. Proper reports
of appropriate reactions shall be reported to the full Medical Staff and/or the
FDA reporting system. If there are no adverse reactions to report, this shall
be stated;
3. Reviews of results of
monitoring conducted according to approved criteria for antibiotics prescribed
for prophylactic and therapeutic reasons;
4. Reviews of other drug utilization in the
facility, as appropriate; and
5.
Formulation of an official record of each meeting maintained as minutes. The
written report shall be forwarded to the P&T Committee, QA/PI Committee,
and/or the Medical Staff for review and consideration, with at least a
quarterly frequency.
T.
Electronic Data Processing in Hospital Pharmacies. All hospitals utilizing
electronic data processing systems shall comply with Laws
and Regulations of the Arkansas State Board of
Pharmacy.
U.
Maintenance and Retention of Drug Records. All drug records, including but not
limited to, purchase invoices, official dispensing records, prescription and
inventory records shall be kept in such a manner that all data is readily
retrievable, and shall be retained as a matter of record by the pharmacist for
at least two years.
V. The American
Society of Health-System Pharmacists Guidelines. The American Society of
Health-System Pharmacists' most recent statement on hospital drug control
systems and Guidelines for Institutional Use of Controlled Substances shall be
required reading by hospital pharmacists
SECTION 17: FOOD AND NUTRITION SERVICES.
A. Administration.
1. The Food and Nutrition Services shall be
under the daily, including weekends, onsite supervision of a qualified
individual. The individual shall be at a minimum a certified dietary manager
and:
a. Be responsible for the daily
management of clinical and administrative dietetic aspects of the service by
formulating, reviewing and revising policies and procedures for all Food and
Nutrition Services practices;
b.
Ensure that all personnel in the service are oriented in their respective
duties;
c. Implement a maintenance
program to ensure food service facilities, equipment and utensils are
maintained in a safe, clean, sanitary manner and are replaced at specific
intervals or as needed;
d.
Participate on hospital-wide departmental committees as required;
e. Ensure that trained staff are maintained
for daily administrative and clinical nutrition practices. A minimum of a two
week current work schedule shall be posted and reflect all positions, including
the department director; and
f.
Develop, implement and maintain a system for record keeping relating to all
department functions dependent on the department's scope of services, e.g.,
patient assessments, counseling, diet instructions, temperatures, educational
programs, etc.
g. A hospital within
a hospital may contract with the host hospital for food and nutrition services.
Contracted services shall:
i. be under a
current agreement; and
ii. meet all
requirements of this section.
2. Policies and procedures shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department supervisor and/or
person(s) conducting the review.
3.
Policies and procedures shall include:
a. Job
descriptions and performance evaluations;
b. Orientation;
c. Preventive maintenance;
d. Infection prevention and control
measures;
e. Safety practices;
and
f. Cleaning of equipment and
applicable areas.
4.
Clinically relevant educational programs shall be conducted at regularly
scheduled intervals with not less than 12 per year. There shall be evidence of
program dates, attendance, and subject matter.
5. Nutrition Services shall have an ongoing
QA/PI Program that addresses both clinical and administrative issues. A
mechanism for reporting results of audits shall be provided, to include:
indicators monitored, thresholds/standards established, results, corrective
plan/corrective action taken and follow-up.
6. Time and duty schedules for all hourly
employees shall be maintained.
7.
Diet Manual shall be authorized by the Medical Staff, reviewed and revised, as
needed, to reflect current recognized dietary practices. A cover page shall be
affixed with the date of review and appropriate signatures and a copy of the
manual shall be located on each patient unit. Use of electronic diet manuals is
acceptable.
8. Menus shall:
a. Be planned/approved by the registered
dietitian and meet the nutrition needs of the patients in accordance with the
current recommended dietary guidelines of the Food and Nutrition Board,
National Research Council and the currently approved facility diet manual in
accordance with the written diet order.
b. Be dated at least one week in advance. The
current week's menus shall be posted and available in the kitchen. The meals
prepared and served shall correspond with the posted menu, or written diet
orders.
c. Not be restrictive in
nature (e.g., seasoning, fat, sodium, sugar content) unless required by a
modified/therapeutic diet order.
d.
Be of equivalent nutrition value when substitutions/changes are made.
Menus/production schedules, showing all changes, shall be retained for at least
30 days.
9. Diets shall
be in writing and signed by a physician or a mid-level practitioner if
privileged by the Medical Staff and Governing Body. Dietitians may issue orders
for patient diets if authorized by the medical staff. Notification according to
facility policy shall be made to the Nutrition Services Department on a timely
basis, kept current and include current date, the patient's name, room number
and diet order.
B. Food
Services.
1. At least three meal equivalents
shall be served daily at regular intervals, approximately five hours apart. No
more than 15 hours shall elapse between the serving of the evening meal and the
morning meal. The meals shall be served at approximately the same hour each
day.
2. Food shall be prepared in
accordance with approved menus and standardized recipes and in a manner to
conserve nutritive value, flavor and appearance.
3. Food shall meet patient needs and shall be
attractive, palatable and served at proper temperatures.
4. An identification system shall be
implemented for patient trays to ensure that each patient receives the
appropriate diet as ordered.
5.
Nourishing bedtime snacks, appropriate to the patient's needs, shall be made
available
6. Only foods prepared
and stored under the direction of Nutrition Services, in accordance with the
Rules and Regulations Pertaining to Retail Food Service
Establishments shall be served to patients.
7. All individuals who assist patients in the
preparation, heating, reheating, consumption of food, sanitation of food ware
and kitchen equipment, etc., while in the facility or on the facility grounds,
shall be under the direction of Nutrition Services and in compliance with the
Rules and Regulations Pertaining to Retail Food Service
Establishments. Documentation of educational programs on
food preparation, safety and sanitation shall be performed for all applicable
personnel (e.g., Occupational Therapy, Nursing) by Nutrition Services at least
annually.
8. Food shall not be
consumed in the kitchen.
9. Food
shall be transported in a manner that maintains safe food temperatures and
prevents contamination. Food carts shall not block corridors/exits, emergency
equipment or patient doorways.
10.
All storage containers/foodstuffs shall be stored a minimum of 6 inches above
the floor on non-porous, easily cleaned racks, dollies or shelving, in a manner
that protects the food (or food contact surfaces) from splash and other
contamination and permits easy cleaning of the storage area.
11. Plastic milk crates shall not be
permitted for storing of food or equipment, except for the intended use for
milk storage.
12. Temperature
documentation of all food refrigerators/freezers in the kitchen and cafeteria
shall be performed a minimum of three times per day at opening, mid-operation
and closing of the department.
13.
Temperature documentation of all nourishment refrigerators/freezers in patient
care areas shall be performed at least daily
14. Proper temperatures of vending machines
containing potentially hazardous foods shall be ensured daily by the facility.
Vending machines shall be equipped with a thermometer, easily visible to food
service personnel for the purposes of monitoring the temperature of the
internal environment. These machines shall have the capacity to render
themselves inoperable if temperatures in excess of 40 degrees Fahrenheit are
maintained for more than two hours. Documentation of such downtime shall be
maintained to include remedial action taken.
15. If, for any reason, the refrigeration
equipment does not maintain the appropriate temperature, action shall be taken
and a record of remedial action and downtime shall be recorded and maintained
by the facility.
16. Temperature
documentation of the dish machine shall be recorded with each meal and these
records shall be maintained by the facility. If the temperatures (and, if
applicable, dwell times) are not maintained properly, action shall be taken and
a record of remedial action, back-up procedures used and downtime shall be
maintained by the facility.
17. If
the facility uses a chemical method for sanitizing food preparation and serving
ware, a record of the water temperature, the chemical used and appropriate
parts per million (ppm) shall be maintained by the facility at each
use.
18. The temperature of the hot
and cold potentially hazardous foods shall be recorded at least at the
beginning and end of meal service that continues for more than 15 minutes. If
meal service lasts for 15 minutes or less, food temperature documentation is
required only at the beginning of food service.
19. Documentation of the testing/calibration
of food/refrigeration/freezer thermometers shall be performed according to
manufacturer's recommendations.
20.
Food thermometers shall be sanitized after each use and stored in a manner that
prevents contamination.
21. Only
dietary and authorized personnel shall be allowed in the kitchen.
22. Sanitation shall be in accordance with
the Rules and Regulations Pertaining to Retail Food Service
Establishments.
C. Food Safety/Sanitation.
1. Whole eggs and raw meat shall be stored
separately and in a way that prevents contamination of other food items in
refrigerated units.
2. Reheated
food shall attain a temperature above 165° Fahrenheit prior to placement in
steam tables, warmers, or other hot food storage units. Steam tables, warmers
or other food storage units shall not be used for the rapid heating of
potentially hazardous food.
3.
Disposable gloves shall be worn to eliminate direct handling of food. Gloves
shall be properly discarded after being used, torn or contaminated.
4. Ground beef or ground beef products shall
be cooked to an internal temperature of 160° Fahrenheit or
higher.
5. Potentially hazardous
food shall be tempered or thawed only:
a. In
designated tempering units at a temperature not to exceed 45°
Fahrenheit;
b. In general
refrigeration units at a temperature not to exceed 40°
Fahrenheit;
c. As part of the
conventional cooking process; or
d.
In a microwave, provided the food is immediately transferred to conventional
cooking process.
6.
Potentially hazardous food that is left over shall be labeled as such with the
date and time it was removed from service.
7. Potentially hazardous food shall be
chilled to a temperature below 40° Fahrenheit and retained for no longer
than 48 hours.
8. Food contact
surfaces, i.e., cutting boards, of all equipment and utensils, shall be
sanitized by immersion for at least one-half minute in clean, hot water at a
temperature of at least 180° Fahrenheit or by any other method approved by
Health Facility Services. Counter tops and other huge industrial equipment
shall be washed down with concentrated solutions.
9. Clean linens, mopheads and cloths shall be
stored in a manner to prevent contamination prior to use.
10. Soiled linens, etc., shall be stored
covered, separately from clean linen, food storage, preparation and serving
areas. Containers for holding such items shall be made of non-absorbent
materials. Soiled linens shall be removed from the department daily.
11. Food inventory shall be handled on a
first-in, first-out basis. A system for labeling and dating canned, dry and
potentially hazardous foods shall be implemented.
12. Potentially hazardous frozen foods
removed from freezer storage to be thawed shall be labeled with the date of
pull from the freezer for thawing.
13. Supplies and perishable foods for a 24
hour period and nonperishable foods for a three day period shall be on the
premises to meet the requirements of the planned menus.
NOTE: These regulations are referenced to the Arkansas Board of Health Rules and Regulations Pertaining to Retail Food Service Establishments
D. Clinical Services.
1. Clinical Dietitian/Nutritionist.
Shall be a registered dietitian, or registry eligible, and evaluate and oversee the delivery of effective nutrition care based on current, recognized nutrition practices. If not full-time, make regularly scheduled visits to accomplish the following:
a.
Review, revise and approve a current diet manual for facility use;
b. Review, revise, approve and implement
nutrition care policy and procedures, standards of nutrition care, nutrition
care protocols and the Nutrition Services QA/PI Program;
c. Coordinate nutrition care through
communication with other patient care services;
d. Provide for the initiation of nutrition
screening of all patients upon admission and periodic screening of patients
during their hospital stay;
e.
Provide for the nutrition assessment of patients at nutrition risk, as defined
by the Medical Staff, and collaborate with the physician on the findings of the
evaluation;
f. Ensure competency of
all nutrition services personnel who perform assessments, counseling, develop
care plans and participate in discharge planning;
g. Provide to the facility evidence of
continuing education hours;
h.
Perform orientation, preceptorship and ongoing training/educational programs
for staff;
i. Review and revise
nutrition counseling/diet education practices that are individualized to
patient needs;
j. Monitor the
enforcement of all policies and procedures and practices relating to food
safety and sanitation;
k. Develop,
implement and maintain a system for recording data related to patient
care;
l. Collaborate with Nursing
and Pharmacy to provide food/drug interaction counseling; and
m. If the dietitian is a consultant, submit
reports to the facility Administrator reflecting services performed at each
regularly scheduled visit.
2. Nutrition Screening and Documentation.
a. Nutrition Screening shall be completed
within 24 hours of admission on all patients to determine nutrition risk and
notify the physician and dietitian of any patients that are at nutrition
risk.
b. Psychiatric, Alcohol and
Drug and Rehabilitation patients shall be rescreened seven days from the
initial screen and at least every 14 days thereafter.
3. Nutrition Care Process.
a. A nutrition assessment of patients at
nutrition risk, as reflected in the medical record, shall include as
appropriate:
1) Anthropometric measurements
including height, weight, BMI, and goal weight
2) Abnormal pertinent laboratory
values;
3) The patient's caloric
and protein needs;
4) nutrient
intake compared to estimated needs;
5) Determination of abnormal intake or recent
weight loss/gain prior to admission;
6) An objective evaluation of the patient's
compliance with a physician ordered diet prior to admission;
7) Pertinent food/drug
interactions;
8) An evaluation of
the patient's special feeding/nutrient/fluid needs;
9) Patient's food preferences, dislikes,
allergies or intolerances; and
10)
Nutrition summary including identification of nutrition
problems
b. The patient
care plan on all patients found to be at nutrition risk shall include the
following nutrition components, as appropriate:
1) individualized nutrition
counseling;
2) discharge
planning;
3) comprehensive
nutrition assessments to include further clinical, laboratory, social or
nutrition data to assist with the ongoing evaluation;
4) follow-up care to evaluate the
effectiveness of the nutrition regimen; and
5) Any requests for alterations or
modifications to the ordered diet's nutrient content, consistency,
administration route/method or meal pattern as served in the hospital in order
to meet the nutrition needs and/or special feeding needs of the
patient.
4.
Nutrition Counseling. Documentation of nutrition counseling shall include:
a. Description of the individualized
nutrition counseling;
b. Objective
evaluation of the patient's and/or caregiver's understanding and ability to
carry out the diet order; and
c.
Plans for continued counseling and/or recommendations for post-discharge
counseling and evaluation of patient diet compliance.
5. Nutrition Monitoring and Evaluation.
a. Shall be performed when the patient is at
nutrition risk and documented in the medical record. The frequency of follow-up
nutritional care shall be determined by the patient's condition.
b. Shall be documented in the patient's
medical record on all patients at nutrition risk.
c. Shall be documented to include an
evaluation of the effectiveness of the prescribed nutrition regimen, changing
nutrition status/needs, nutrition counseling and/or recommendations to improve
patient nutrition care.
SECTION 18: INFECTION PREVENTION AND CONTROL.
A. General.
1. The facility shall develop and use a
coordinated process that effectively reduces the risk of endemic and epidemic
healthcare associated infections (HAI) in patients, health care workers and
visitors.
2. There shall be a
comprehensive list of communicable diseases for which patients shall be
isolated and for which there are visitation restrictions. The list, and other
policies and procedures for isolation, shall conform to the latest edition of
the Centers for Disease Control and Prevention, Atlanta, Georgia (CDC)
Guidelines.
3. It shall be the duty
of the Administrator or his/her designee to report all infectious or
communicable diseases in the facility to the Arkansas Department of Health,
Epidemiology, as required by the Rules and Regulations Pertaining to
Communicable Disease in Arkansas (Ark. Code Ann. §§
20-7-109, 110) and CMS mandatory
reporting requirements for Medicare certified facilities.
4. The Administrator shall designate a
qualified individual who shall:
a. Coordinate
the activities of the Infection Prevention and Control Committee;
b. Direct surveillance activities;
c. Ensure policies established by the
Committee are carried out; and
d.
Gather and report data regarding the hospital's HAI.
5. There shall be policies and procedures
establishing and defining the Infection Prevention and Control program to
include:
a. Definitions of HAI and
communicable diseases based on the current CDC or National Healthcare Safety
Network (NHSN) surveillance definitions;
b. Perform an annual facility-based risk
assessment to determine the infections that are most likely to occur in the
facility. Infections to be addressed include (but are not limited to) the
following: :
1) Ventilator associated event
(VAE);
2) Clostridium difficle
infection (CDI);
3) Central line
associated blood stream infection (CLABS); and
4) Catheter associated urinary tract
infection (CAUTI).
7) Use of
intravascular catheters.
NOTE: The facility's system for surveillance, calculation and evaluation of the incidence of HAI within the facility shall conform to CDC's National NHSN or CDC publications as applicable.
c. Calculate HAI rates;
d. Measures for assessing and identifying
patients and health care workers at risk for HAI and communicable
diseases;
e. Methods for obtaining
reports of infections and communicable diseases in patients and health care
workers in a manner and time sufficient to limit the spread of infection;
f A plan for monitoring and
evaluating at least the following areas or departments to ensure policies and
procedures are followed:
1) Inpatient and
outpatient surgery;
2)
Delivery;
3) Nursery;
4) Central sterilization and
supply;
5) Housekeeping;
6) Laundry;
7) Food and Nutrition;
8) Laboratory;
9) Nursing;
10) Maintenance;
11) Invasive specialty laboratories (special
procedures);
12) Radiology;
and
13) Hemodialysis
units.
g. Measures for
prevention of infections including but not limited to:
1) Intravenous (IV) devices;
2) Indwelling urinary catheters;
3) Ventilator care;
4) Burns; and
5) Immune suppressed patients.
h. Measures for prevention of
communicable disease outbreaks, especially Mycobacterium tuberculosis (TB). All
plans for the prevention of transmission of TB shall conform to the most
current CDC Guidelines for Preventing the Transmission of Mycobacterium
Tuberculosis in Health Care Facilities;
i. Isolation procedures and requirements for
infected, immune suppressed patients and patients colonized or infected with
resistant organisms. Procedures shall conform to the most current CDC
Guidelines.
j. Provisions for
education of patients and their families concerning infections and communicable
diseases to include hand hygiene and any isolation precautions;
k. A plan for monitoring and evaluating all
aseptic, isolation and sanitation techniques employed in the facility to ensure
that approved infection prevention and control procedures are followed;
1. Techniques for:
1) Hand hygiene including policies and
procedures that reflect facility-selected national guidelines for soap and
water as well as alcohol based hand rub if used;
2) Respiratory protection including policies
and procedures that reflect facility-selected national guidelines;
3) Asepsis/sterile technique;
4) Sterilization;
5) Sanitary food preparation;
6) Disinfection;
7) Housekeeping;
8) Linen care;
9) Liquid and solid waste disposal of both
infectious and regular waste. Disposal of infectious waste shall conform to the
latest edition of the Rules and Regulations Pertaining to the Management of
Medical Waste from Generators and Health Care Related Facilities;
10) Sharps safety;
11) Separation of clean from dirty process;
and
12) Other means of limiting the
spread of contagion.
m. Authority and indications for obtaining
microbiological cultures from patients;
n. Employee health; and
o. Visitation rules, especially for patients
in isolation, critical care, pediatrics and other special care units, including
postpartum care.
6.
There shall be an orientation program for all new health care workers
concerning the importance of infection prevention and control and each health
care worker's responsibility in the hospital's infection prevention and control
program.
7. There shall be a plan
for each employee to receive annual educational programs as indicated based on
assessments of the Infection Prevention and Control process.
8. Maintain a log of documentation of
reportable diseases.
9. No items
shall be used past the expiration date.
B. Infection Prevention and Control
Committee.
1. There shall be a
multidisciplinary committee appointed by Administration to develop, implement
and monitor direction for the Infection Prevention and Control program based on
services impacting the infection prevention and control process.
2. The Medical Staff shall appoint a
physician to serve as chairperson of the Infection Prevention and Control
Committee. Additional physician members may be appointed.
3. The Infection Prevention and Control
Committee shall meet at least quarterly. Minutes of the meetings shall reflect
the Committee's actions in monitoring and directing the hospital's Infection
Prevention and Control program.
4.
The Infection Prevention and Control Committee shall fulfill the following
responsibilities:
a. Assist in the development
and approval of all infection prevention and control policies and procedures
within the facility;
b. Ensure that
an antibiogram is prepared at least annually and compared to the previous one
to identify trends;
c. Monitor any
contractual services relative to infection prevention and control (e.g. waste
management and laundry) to ensure compliance with all applicable regulations;
and d. Review any special infection prevention and control studies conducted
within the facility; and e. Provide oversight for disinfectants and
sterilants.
C.
Employee Health.
1. There shall be policies
and procedures for screening health care workers for infectious/communicable
diseases and monitoring for health care workers exposed to patients with any
communicable diseases. The policies and procedures shall reflect
facility-selected national guidelines.
2. There shall be employee health policies
and procedures regarding preventing the transmission of infectious diseases.
The policies and procedures shall reflect facility-selected national
guidelines
3. There shall be
policies which clearly state when health care workers shall not render direct
patient care.
4. There shall be a
plan for ensuring that:
a. each health care
worker is free from TB; and
b. The
facility follows the latest tuberculosis screening and tuberculosis prevention
guidelines approved by the Arkansas Department of Health (Rules and
Regulations Pertaining to: the Control of Communicable
Diseases-Tuberculosis).
5. There shall be a plan for ensuring that
all health care workers who are exposed to blood and other potentially
infectious body fluids are offered immunizations for Hepatitis B.
SECTION 19: LABORATORY.
A. General.
1. Each Critical Access Hospital shall
provide onsite laboratory services essential to the immediate diagnosis and
treatment of patients served by the facility. Provision shall be made for the
following laboratory services:
a. Chemistry
and microscopic examination of urine;
b. Complete blood count including hemoglobin,
hematocrit, red blood cells, white blood cells and platelets;
c. Routine chemistry procedures including
blood glucose, blood urea nitrogen, sodium, potassium, chloride, arterial blood
gases and cardiac enzyme(s);
d.
Fecal occult blood;
e. Pregnancy
tests;
f Primary culturing for
transmittal to a certified laboratory;
g. Procurement, safekeeping and transfusion
of blood or blood products on an emergency basis either directly or through
written arrangement with another facility.
2. The requirements of the most current rule
of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) shall be
met.
3. All laboratory testing that
is performed at any site owned and/or operated by the facility shall be
approved, in writing, by the Governing Body. The Governing Body shall authorize
the director of the hospital laboratory to provide oversight of all testing to
ensure the quality of the laboratory services provided. A comprehensive list of
all testing sites shall be made available to the Medical Staff.
4. A laboratory shall refer specimens for
testing only to a laboratory possessing a valid Clinical Laboratory Improvement
Amendments (CLIA) certificate authorizing the performance of testing in the
specialty or subspecialty of service for the level of complexity in which the
referred test is categorized.
5.
Only results from the Critical Access Hospital laboratory or from other
approved laboratories, as determined by hospital policy, shall be placed in the
patient's medical record.
6.
Laboratory tests shall be authorized by a physician or other persons authorized
by the Medical Staff and the Governing Body to order laboratory
examinations.
7. The laboratory
shall maintain accurate counts of total patient procedures for each specialty
in which tests are performed.
8.
Current reference material, such as textbooks, shall be available for every
laboratory category in which tests are performed.
9. The laboratory shall make available to the
Medical Staff a list of all tests performed onsite, including the reference
range for each test.
B.
Personnel.
1. A member of the Medical Staff
shall be appointed to act as a liaison between the laboratory and the Medical
Staff.
2. The laboratory shall be
under the oversight of a pathologist who is board certified or eligible. A
pathologist who is not based at the hospital shall make at least a monthly
visit and submit a monthly written report to the Hospital Administrator.
NOTE: A hospital which provides only limited laboratory services (e.g., blood gas laboratory only) shall not be subject to the requirement of oversight of a pathologist.
3. The laboratory director, as defined by
CLIA 88, shall be responsible for the overall operation of the laboratory but
may delegate specific responsibilities to supervisory personnel. However, the
director remains responsible for ensuring that all duties are properly
performed and documented. The laboratory director shall be responsible for the
following:
a. Ensuring that testing systems
developed and used for each of the tests performed in the laboratory provide
quality laboratory services for all aspects of test performance, which includes
the pre-analytic, analytic and post-analytic phases of testing;
b. Ensuring that the physical plant and
environmental conditions of the laboratory are appropriate for the testing
performed and provide a safe environment in which employees are protected from
physical, chemical and biological hazards;
c. Ensuring that:
1) The test methodologies selected have the
capability of providing the quality of results required for patient
care;
2) Verification procedures
used are adequate to determine the accuracy, precision and other pertinent
performance characteristics of the method;
3) Laboratory personnel are performing the
test methods as required for accurate and reliable results;
d. Ensuring that the laboratory is
enrolled in a proficiency testing program approved by Health and Human Services
(HHS) for the testing performed and that:
1)
The proficiency testing samples are tested in the same manner as the patient
samples;
2) The results are
returned within the time frames established by the proficiency testing
program;
3) All proficiency testing
reports are reviewed by the appropriate staff to evaluate the laboratory's
performance and to identify any problems that require corrective
action;
4) An approved corrective
action plan is followed when any proficiency testing result is found to be
unacceptable or unsatisfactory;
e. Ensuring that the quality control and
quality assurance/performance improvement programs are established and
maintained to assure the quality of laboratory services provided and to
identify failures in quality as they occur;
f. Ensuring the establishment and maintenance
of acceptable levels of analytical performance for each test system;
g. Ensuring that all necessary remedial
actions are taken and documented whenever significant deviations from the
laboratory's established performance characteristics are identified and that
patient test results are reported only when the system is functioning
properly;
h. Ensuring that reports
of test results include pertinent information required for
interpretation;
i. Ensuring that
consultation is available to the laboratory's clients and to the Medical Staff
on matters relating to the quality of the test results reported and
interpretation concerning specific patient conditions;
j. Ensuring there is a sufficient number of
laboratory personnel with the appropriate education and either training or
experience to provide appropriate consultation, properly supervise and
accurately perform tests and report test results;
k. Ensuring all personnel have the
appropriate education and experience, receive the appropriate training for the
type of services offered, and have demonstrated that they can perform all
testing operations reliably to provide and report accurate results;
l. Ensuring there is documentation of
training for laboratory personnel who perform special procedures such as
arterial punctures and therapeutic phlebotomies;
m. Ensuring that qualified testing personnel
are on duty or on call at all times;
n. Ensuring that policies and procedures are
established for monitoring individuals who conduct pre-analytical, analytical
and post-analytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures and
report test results promptly and proficiently, and whenever necessary, identify
needs for remedial training or continuing education to improve skills. The
procedures for evaluation of the competency of the staff shall include, but are
not limited to the following:
1) Direct
observations of routine patient test performance, including patient
preparation, if applicable, specimen handling, processing and
testing;
2) Monitoring the
recording and reporting of test results;
3) Review of intermediate test results or
worksheets, quality control records, proficiency testing results and preventive
maintenance records;
4) Direct
observation of performance of instrument maintenance and function
checks;
5) Assessment of test
performance through testing previously analyzed specimens, internal blind
testing samples or external proficiency testing samples;
6) Assessment of problem solving
skills;
7) Evaluation and
documentation of the performance of all personnel with at least the following
frequency:
a) Semiannually during the first
year of employment in the laboratory;
b) Annually after the first year;
c) Prior to reporting patient test results if
test methodology or instrumentation changes;
o. Ensuring that an approved procedure manual
is available to all personnel responsible for any aspect of the testing
process;
p. Ensuring there is a
plan for providing continuing education for the laboratory staff and there is
documentation of each employee's participation.
q. Specifying the responsibilities and duties
of each consultant and each supervisor, as well as each person engaged in the
performance of the pre-analytic, analytic and post-analytic phases of
testing;
r. Specifying the
examinations and procedures each individual is authorized to perform, whether
supervision is required for specimen processing, test performance or result
reporting and whether supervisory or director review is required prior to
reporting patient test results;
4. There shall be a supervisor accessible at
all times when testing is performed.
5. Personnel responsible for day-to-day
supervision of the laboratory shall meet at least one of the following
qualifications:
a. A bachelor's degree in
medical technology from an accredited institution and at least one (1) year of
clinical laboratory training or experience relative to the specialties being
supervised;
b. A bachelor's degree
in a chemical, physical, biological or clinical laboratory science from an
accredited institution with at least two (2) years of clinical laboratory
training or experience relative to the specialties being supervised;
c. An associate degree in a laboratory
science or medical laboratory technology from an accredited institution with at
least two (2) years of clinical laboratory training or experience relative to
the specialties being supervised;
d. A passing score on the Clinical Laboratory
Technology Proficiency examination approved by HHS (HEW) and at least six (6)
years of clinical laboratory experience with at least two (2) years of
experience relative to the specialties being supervised;
e. Employment as a laboratory supervisor
prior to January 1, 1995, in a hospital licensed by the Arkansas Department of
Health.
6. Testing
personnel shall meet at least the following qualifications:
a. Have earned a high school diploma or
equivalent;
b. Have documentation
of training appropriate for the testing performed prior to analyzing patient
specimens. Such training shall ensure that the individual has the following:
1) Skills required for proper patient
preparation and specimen collection, to include the following:
a) Labeling;
b) Handling;
c) Preservation or fixation;
d) Processing or preparation;
e) Transportation and storage.
2) The skills required for
implementing all standard laboratory procedures;
3) The skills required for performing each
test method and for proper instrument use;
4) The skills required for performing
preventive maintenance, trouble-shooting and calibration procedures related to
each test performed;
5) A working
knowledge of reagent stability and storage;
6) The skills required to implement the
quality control policies and procedures of the laboratory;
7) An awareness of the factors that influence
test results;
8) The skills
required to assess and verify the validity of patient test results through the
evaluation of quality control sample values prior to reporting test
results.
C. Procedure Manual.
1. There shall be a procedure manual for the
performance of all analytical methods used by the laboratory readily available
and followed by laboratory personnel. Textbooks may be used as supplements but
shall not be used in lieu of the laboratory's written procedures for testing or
examining specimens. The procedure manual shall include, when applicable to the
test procedure, the following:
a.
Requirements for patient preparation, specimen collection and processing,
labeling, preservation and transportation, including criteria for specimen
rejection;
b. Procedures for
microscopic examinations, including the detection of inadequately prepared
slides;
c. Step-by-step performance
of the procedure, including test calculations and interpretation of
results;
d. Preparation of slides,
solutions, calibrators, controls, reagents, stains and other materials used in
testing;
e. Calibration and
calibration verification procedures;
f The reportable range for patient test
results as verified by the laboratory;
g. Quality control procedures for each test
to include the following:
1) Type of
control;
2) Identity of control;
3) Number of controls;
4) Frequency of testing controls;
5) Criteria for determining acceptability of
control results.
h.
Remedial actions to be taken when any of the following occur:
1) Calibration results are
unacceptable;
2) Control results
are unacceptable;
3) Equipment or
test methodologies fail;
4) Patient
test values are outside the laboratory's reportable range of patient test
results;
5) The laboratory cannot
report patient test results within its established time frames;
6) Errors in reported patient test results
are detected.
i.
Limitations in methodologies, including interfering substances;
j. Reference ranges (normal
values);
k. A list of "panic
values" with written instructions for reporting such values;
l. Pertinent literature references;
m. Appropriate criteria for specimen storage
and preservation to ensure specimen integrity until testing is
completed;
n. The laboratory's
system for reporting patient test results;
o. Description of the course of action to be
taken in the event that a test system becomes inoperable;
p. Criteria for the referral of specimens,
including procedures for specimen submission and handling and for record
keeping.
2. The procedure
manual shall be reviewed, approved, signed and dated by the current director of
the laboratory or by an individual designated by the director in compliance
with the CLIA 88 requirements.
3.
Each revision or addition to the procedure manual shall be reviewed, approved,
signed and dated by the current director of the laboratory or by an individual
designated by the director in compliance with the CLIA 88
requirements.
4. The laboratory
shall maintain a copy of each discontinued procedure for two years, with the
dates of initial use and discontinuance.
D. Record System.
1. The laboratory shall have policies and
procedures for a record system which shall assure positive identification of
patient specimens from the time of specimen collection until the time of test
completion and results reporting. The record system shall include provisions
for test requisitions, test records and test reports. The configuration of the
system may be established by the laboratory, provided all of the required
information is readily retrievable for at least two years.
2. The laboratory shall perform tests at the
written or electronic request of an authorized person.
3. Records of test requisitions or test
authorizations shall be retained for a minimum of two years.
4. The test requisition shall include:
a. Identification of the patient;
b. The name of the authorized person who
ordered the test;
c. The test(s)
requested;
d. The date the test is
to be performed;
e. For Pap smears,
the patient's last menstrual period, age or date of birth and indication of
whether the patient had a previous abnormal report, treatment or biopsy;
f Any additional information
relevant and necessary to a specific test to assure accurate and timely testing
and reporting of results (Examples: age, sex, current medications, time of
specimen collection, diagnosis, type of specimen, fasting).
5. Records of patient testing,
including instrument printouts, shall be retained for at least two years.
Immune hematology records and transfusion records shall be retained for at
least five years. (Exception: If an instrument is interfaced with a computer,
and the electronic data cannot be edited, the instrument printouts do not have
to be retained.)
6. Test records
shall provide documentation of the information required for test requisitions
as well as the following information:
a.
Unique identification of the patient specimen;
b. The date and time of specimen receipt into
the laboratory;
c. The condition
and disposition of specimens that do not meet the laboratory's criteria for
specimen acceptability;
d. The
tests and date of performance of each;
e. The time of completion of testing;
f The identity of the person who
performs each test.
7.
The laboratory report shall be sent promptly to the authorized person who
requested the test.
8. A duplicate
of each test report, including both preliminary and final reports, shall be
retained for at least two years. The duplicate may be retained electronically
as long as it contains the exact information sent to the individual ordering
the test and utilizing the test results. For test reports requiring an
authorized signature or containing personnel identifiers, the exact duplicate
must include the signature or identifiers. Immunohematology reports shall be
retained for at least five years, and pathology reports shall be retained for
at least 10 years.
9. The test
report shall include the following:
a.
Identification of the patient;
b.
Date of specimen collection;
c. The
test(s) performed;
d. Test results
and, if applicable, the units of measurement;
e. Date results were reported;
f The condition and disposition of specimens
that do not meet the laboratory's criteria for acceptability;
g. Any additional information relevant and
necessary for the interpretation of the results of a specific test (Examples:
Type of specimen, time of specimen collection, fasting).
10. The laboratory shall have policies and
procedures for referring patient specimens to reference laboratories, to
include:
a. Current list of reference
laboratories, with the following information:
1) CLIA number;
2) Specialties and subspecialties in which
the laboratory is certified;
3)
Expiration date of CLIA certificate;
b. Specimen submission and
handling;
c. Record keeping
system.
11. The
laboratory shall not revise results or information directly related to the
interpretation of results provided by a reference laboratory.
12. The laboratory shall retain an exact
duplicate of each reference laboratory report, including each preliminary and
corrected report, for at least two years. Pathology reports from reference
laboratories shall be retained for 10 years, and immunohematology reports shall
be retained for five years.
13.
The laboratory's report shall indicate the test(s) performed by a reference
laboratory and the name and address of each laboratory location at which a test
was performed.
E.
General Quality Control.
1. The laboratory
shall be constructed, arranged and maintained to ensure the space, ventilation
and utilities necessary for conducting all phases of testing.
2. The laboratory shall have appropriate and
sufficient equipment, instruments, reagents, materials and supplies for the
type and volume of testing performed and for the maintenance of quality during
all phases of testing.
3. The
manufacturer's instructions shall be followed when using an instrument, kit or
test system.
4. Components of
reagent kits of different lot numbers shall not be interchanged unless
otherwise specified by the manufacturer.
5. The laboratory shall define criteria for
those conditions that are essential for proper storage of reagents and
specimens and for accurate and reliable test system operation and test result
reporting. These conditions shall include if applicable water quality,
temperature, humidity and protection of equipment and instrumentation from
fluctuations and interruptions in electrical current that adversely affect
patient test results and test reports. There shall be documentation of the
remedial actions taken to correct problems with these conditions.
6. Reagents, solutions, culture media,
control materials, calibration materials and other supplies, as appropriate,
shall be labeled to indicate the following:
a. Identity and, when significant, titer,
strength or concentration;
b.
Recommended storage requirements;
c. Preparation and expiration
dates;
d. Other pertinent
information required for proper use.
7. Reagents, solutions, culture media,
control materials, calibration materials and other supplies shall be prepared,
stored and handled in a manner to ensure that they are not used when the
expiration date has been exceeded or when they have deteriorated or are of
substandard quality.
8. The
laboratory shall comply with the Food and Drug Administration (FDA) product
dating requirements of
21 CFR
610.53 for blood, blood products and other
biologicals and with labeling requirements in
21 CFR
809.10 for all other in vitro diagnostics.
Any exception to the product dating requirements in
21 CFR
610.53 shall be granted by the FDA in the
form of an amendment of the product license, in accordance with
21 CFR
610.53(d). All exceptions
shall be documented by the laboratory.
9. Test methodologies and equipment shall be
selected and testing performed in a manner that provides test results within
the laboratory's stated performance specifications for each test.
10. Before the laboratory reports patient
test values using a new method or device, it shall first verify or establish
for each method the performance specifications for the following performance
characteristics, as applicable:
a.
Accuracy;
b. Precision;
c. Analytical sensitivity and specificity, to
include interfering substances;
d.
Reportable range of patient test results;
e. Reference range (normal values);
f Any other performance
characteristics required for test performance;
The laboratory shall have documentation of the verification or establishment of all applicable test performance specifications and shall establish control and calibration procedures based upon those specifications.
11. The laboratory shall perform maintenance
and function checks for all equipment, instruments and test systems according
to the manufacturers' instructions. If the manufacturer does not define
maintenance or function checks, the laboratory shall establish protocols
ensuring equipment, instruments or test systems perform accurately and
reliably. Maintenance and function checks shall be performed with at least the
frequency of the manufacturer's instructions.
12. All function checks and maintenance
activities shall be documented. The function checks shall be within the
laboratory's or manufacturer's established limits before patient testing is
conducted.
13. For each method or
device the laboratory shall perform calibration procedures:
a. At a minimum, in accordance with
manufacturer's instructions, if provided, using calibration materials provided
as specified, as appropriate, and with at least the frequency recommended by
the manufacturer; and
b. In
accordance with established laboratory criteria to include:
1) The number, type and concentration of
calibration materials, acceptable limits for calibration and the frequency of
calibration; and
2) Using
calibration materials appropriate for the methodology and, if possible,
traceable to a reference method or reference material of known value;
and
c. Whenever
calibration verification fails to meet the laboratory's established acceptable
limits for calibration verification.
14. For each method or device the laboratory
shall perform calibration verification procedures:
a. At a minimum, in accordance with the
manufacturer's instructions, if provided; and
b. In accordance with established laboratory
criteria to include:
1) The number, type and
concentration of calibration materials, acceptable limits for calibration
verification, and frequency of calibration verification;
2) Calibration materials appropriate for the
methodology and, if possible, traceable to a reference method or reference
material of known value;
3)
Verification of the laboratory's established reportable range of patient test
results, which shall include at least a minimal (or zero) value, a mid-point
value, and a maximum value at the upper limit of that range;
4) Performance of calibration verification at
least every six months or when the following occur:
a) A complete change of reagents for a
procedure is introduced, unless the laboratory can demonstrate that changing
reagent lot numbers does not affect the range used to report patient test
results and control values are not adversely affected by reagent lot number
changes;
b) There is a major
preventive maintenance or replacement of critical parts that may influence test
performance;
c) Controls reflect an
unusual trend or shift or are outside the laboratory's acceptable limits and
other means of assessing and correcting unacceptable control values have failed
to identify and correct the problem;
d) The laboratory's established schedule for
verifying the reportable range for patient test results requires more frequent
calibration verification than specified by the
manufacturer.
15. All calibration and calibration
verification activities shall be documented.
16. Control Procedures - (Controls shall be
performed as defined or as otherwise defined under a specific category
heading.)
a. For each device the laboratory
shall evaluate instrument and reagent stability and operator variance in
determining the number, type and frequency of testing calibration or control
materials and establish criteria for acceptability used to monitor test
performance during a run of patient specimen(s). A run is an interval within
which the accuracy and precision of a testing system is expected to be stable,
but it cannot be greater than 24 hours or less than the frequency recommended
by the manufacturer. For each procedure, the laboratory shall monitor test
performance using calibration materials or control materials or a combination
thereof. Controls shall be performed as follows:
1) For qualitative tests, the laboratory
shall include a positive and a negative control with each run of patient
specimens. Internal procedural controls (both positive and negative) may be
used to satisfy this requirement.
2) For quantitative tests, the laboratory
shall include at least two samples of different concentrations of either
calibration materials, control materials, or a combination thereof with the
frequency not less than two levels per 24 hours of operation.
3) If calibration and control materials are
not available, the laboratory shall have an alternative mechanism to assure the
validity of patient test results.
4) Control samples shall be tested in the
same manner as patient test specimens.
5) When calibration or control materials are
used, statistical parameters (e.g., mean and standard deviation) for each lot
number of calibration or control material shall be determined through
repetitive testing. Levy-Jennings plots or other visual representation methods
shall be used to evaluate statistical data for trends and shifts. Weekly
supervisory review is required. Control values shall be evaluated as follows:
a) The stated values of assayed control
material may be used as the target values provided the stated values correspond
to the methodology and instrumentation employed by the laboratory and are
verified by the laboratory;
b)
Statistical parameters for unassayed materials shall be established over time
by the laboratory through concurrent testing with calibration materials or
control materials having previously determined statistical parameters;
and
c) Control results shall meet
the laboratory's criteria for acceptability prior to reporting patient test
results.
17. The laboratory shall document all control
activities. Documentation shall be retained for a period of two years.
Immunohematology quality control records shall be retained for a period of five
years. Cytology and histopathology quality control records shall be retained
for a period of 10 years.
F. Chemistry.
1. The following requirements apply only to
blood gas analysis, regardless of the testing site:
a. Follow the manufacturer's instructions
regarding calibration of the blood gas analyzer;
b. Test at least one (1) level of control
material each eight hours of patient testing;
c. Rotate the order in which the controls are
performed so that normal, alkalosis and acidosis levels are tested;
and
d. Test one (1) sample of
calibration material or control material each time patients are tested if the
instrument does not internally verify calibration at least every
30minutes.
2. For
electrophoretic determinations:
a. At least
one control sample shall be used in each electrophoretic cell;
b. The control sample shall contain fractions
representative of those routinely reported in the patient specimens.
G. Hematology.
1. There shall be at least two levels of
controls for non-manual hematology testing systems each eight hours in which
patient testing is performed.
2.
There shall be at least one level of control for manual cell counts each eight
hours in which patient testing is performed.
3. Manual cell counts shall be performed in
duplicate with documentation of both counts. The laboratory shall establish
criteria for the acceptable difference between duplicate counts.
4. There shall be two levels of controls for
non-manual coagulation testing systems each eight hours in which patient
testing is performed and each time a change in reagents occurs.
5. Each individual shall test two levels of
controls before performing manual coagulation testing on patient samples and
each time a change in reagents occurs.
6. Manual coagulation tests on both patient
and control specimens shall be performed in duplicate with documentation of
both times. The laboratory shall establish criteria for the acceptable
difference between duplicate times.
7. Background counts of diluents shall be
performed daily and results recorded.
8. If the microhematocrit centrifuge is used,
the maximum packing time shall be determined at least every six
months.
9. The laboratory director
shall establish written criteria for abnormal cell morphology requiring review
by a qualified physician who is board-certified or board-eligible in either
pathology or hematology.
10. The
laboratory shall maintain a file of unusual hematology slides to be used in the
orientation, training and continuing education of laboratory
personnel.
H.
Immunology.
1. The equipment, glassware,
reagents, controls and techniques for tests for syphilis shall conform to
manufacturers' specifications.
2.
The laboratory shall run serologic tests on patient specimens concurrently with
a positive serum control of known titer or controls of graded reactivity plus a
negative control. (If patient results are reported in terms of graded
reactivity, controls of graded reactivity shall be used; if patient results are
reported as a titer, controls of known titer shall be used with results
reported as a titer.)
3. The
laboratory shall employ controls that evaluate all phases of the test system to
ensure reactivity and uniform dosages when positive and negative controls alone
are not sufficient.
4. A facility
manufacturing blood and blood products for transfusion or serving as a referral
laboratory for such a facility shall meet the following:
a. Syphilis serology testing requirements of
21 CFR
606.65 (c&e) and 640.5(a);
b. HIV testing requirements of 21 CFR 610.45
; and c. Hepatitis testing requirements of
21 CFR 610.40.
I.
Immunohematology.
1. There shall be provision
for prompt ABO blood grouping, D(Rho) typing, unexpected antibody detection,
compatibility testing and laboratory investigation of transfusion reactions,
either through the facility or under arrangement with an approved facility that
is certified in Immunohematology and Transfusion Services and Blood Banking
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA
88).
2. If the facility does not
provide immunohematological or blood banking services onsite, there shall be a
written agreement with an outside laboratory or blood bank that governs the
procurement, transfer and availability of blood and blood products. The
agreement shall be reviewed and approved by the laboratory director.
3. The laboratory shall perform and document
ABO group and D(Rho) typing on all donor red cells received from outside
sources prior to transfusing.
4.
The laboratory shall perform ABO group and D(Rho) typing, unexpected antibody
detection, antibody identification and compatibility testing in accordance with
manufacturers' instructions, if provided, and as applicable, with 21 CFR Part
606 (with the exception of
21 CFR
606.20.a, Personnel) and 21 CFR 640 et
seq.
5. The laboratory shall
perform ABO group by concurrently testing unknown red cells with anti-A and
anti-B grouping reagents. For confirmation of ABO group, the unknown serum
shall be tested with known Al and B red cells. All reactions shall be
documented.
6. The laboratory shall
determine the D(Rho) type by testing and documenting the reaction of unknown
red cells with anti-D(Rho) blood grouping reagent.
7. If required in the manufacturer's package
insert for anti-D(Rho) reagents, the laboratory shall employ a control system
(Rh-hr control) capable of detecting false positive D(Rho) test
results.
8. Each day of use the
laboratory shall perform and document the following quality control checks for
each vial of antisera and reagent red cells:
a. Positive control only for ABO antisera,
ABO reagent red cells and antibody screening cells (at least one known
antibody); and
b. Positive and
negative controls for D(Rho) antisera, other antisera and anti-human globulin
(Coombs serum).
9.
Records shall identify the source and lot number of each reagent on each day of
use.
10. Policies and procedures to
ensure positive identification of a blood or blood product recipient shall be
established and followed.
11. Donor
blood and blood products shall be stored or maintained for transfusion under
conditions required to prevent deterioration and to ensure optimum integrity,
whether in the blood bank or in a remote storage refrigerator.
12. Donor blood shall be stored in a
refrigerator which meets the following criteria:
a. The refrigerator shall be connected to an
emergency power source;
b. An
audible alarm system shall monitor proper storage temperature and shall sound
at a location that is staffed 24 hours per day;
c. The refrigerator shall not be used for the
storage of hazardous or contaminated items;
d. The refrigerator shall have adequate space
to provide for segregated storage of the following:
1) Donor blood prior to completion of
tests;
2) Donor blood not suitable
for use; and
3) Autologous
units;
e. A temperature
recorder shall be connected to the refrigerator.
13. The high and low activation temperatures
of the alarm system shall be checked and documented at least quarterly. The
response to the activated alarm shall be documented.
14. The temperature recorder shall be
compared daily to a thermometer in the refrigerator. Results of the temperature
checks shall be documented.
15. The
temperature recorder chart shall be changed weekly, and the individual who
changes the chart shall initial and date it.
16. Written criteria shall be established for
daily inspection of the blood storage unit for:
a. Outdated blood;
b. Hemolysis;
c. Bacterial contamination; and
d. Unit integrity.
e. Blood shall be visually inspected at the
time of issue. Results of all inspections shall be recorded.
17. Records shall be maintained of
all blood or blood components received, cross matched, transfused, expired or
returned to the supplier.
18.
Patient's serum less than 72 hours old shall be used in the compatibility
procedure.
19. All blood for
transfusions, except for autologous transfusions, shall be tested for hepatitis
and for HIV antibodies before it is transfused. The tests for hepatitis and/or
HIV antibodies may be performed by the supplier or by the institution in which
the blood is transfused.
20.
Samples of both patient and donor blood shall be retained at least seven days
following transfusion.
21.
Procedures shall be established for the prompt investigation of all suspected
transfusion reactions. The laboratory director shall review all suspected
transfusion reactions, and a report shall be given to a committee of the
Medical Staff.
22. Criteria shall
be established for the reissuing of donor blood to ensure that the blood has
been maintained under conditions required to ensure the safety of individuals
being transfused within the facility.
23. Records of therapeutic phlebotomies shall
be maintained, detailing the patient name, date, time, amount drawn,
phlebotomist and disposition of the blood. Blood drawn as a therapeutic
phlebotomy shall not be used for transfusion.
24. A committee of the Medical Staff shall
fulfill the following responsibilities:
a.
Establish criteria for the proper use of blood and its components;
b. Monitor the transfusion of blood and its
components to ensure the established criteria for proper use are met;
c. Review the reports of suspected
transfusion reactions;
d. Establish
criteria for therapeutic phlebotomies.
25. Blood banking policies and procedures
shall conform to the current Standards for Blood Banks and Transfusion Services
of the American Association of Blood Banks.
J. Urinalysis.
1. Routine urinalysis shall be performed
within two hours of collection of the specimen unless the specimen is
refrigerated.
2. Manufacturers'
instructions shall be followed for all tests.
3. Two levels of controls shall be performed
and documented each day of patient testing utilizing an automated strip
reader.
4. A refractometer for
measuring urine specific gravity shall be checked each day of use with a low
(1.000) and upper level standard or control.
K. Microbiology.
1. Each day of use, the laboratory shall
evaluate the detection phase of direct antigen systems using an appropriate
positive and negative control organism or antigen extract. When direct antigen
systems include an extraction phase, the system shall be checked, each day of
use, using a positive organism.
2.
The laboratory shall check each batch or shipment of reagents, discs, stains,
antisera and identification systems (systems using two or more substrates) when
prepared or opened for positive and negative reactivity, as well as graded
reactivity, if applicable.
3.
Unless otherwise specified, each day of use the laboratory shall test staining
materials for intended reactivity to ensure predictable staining
characteristics.
4. The laboratory
shall check fluorescent stains for positive and negative reactivity each time
of use (unless otherwise specified).
5. The laboratory shall check each batch or
shipment of media for sterility, if it is intended to be sterile and sterility
is required for testing. Media shall be checked for its ability to support
growth and, as appropriate, selectivity/inhibition and/or biochemical
response.
6. The laboratory may use
the manufacturer's control checks of media provided the manufacturers' product
insert specifies that the manufacturer's quality control checks meet the
National Committee for Clinical Laboratory Standards (NCCLS) for media quality
control. The laboratory shall document that the physical characteristics of the
media are not compromised and report any deterioration of the media to the
manufacturer.
7. The laboratory
shall follow the manufacturer's specifications for using the media and be
responsible for the test results.
8. The following media shall be retested
using NCCLS standards for growth, inhibition and selectivity, as applicable:
a. Campylobacter agar;
b. Media for the selective isolation of
pathogenic Neisseria;
c. Media used
to isolate parasites, viruses, Mycoplasma, Chlamydia;
d. Mueller-Hinton media used for
antimicrobial susceptibility tests; and
e. Media commercially prepared and packaged
as a unit or system consisting of two or more different substrates, primarily
used for microbial identification.
9. The laboratory shall check positive and
negative reactivity with control organisms as follows:
a. Each day of use for catalase, coagulase,
beta-lactamase, and oxidase reagents and DNA probes;
b. Each week of use for Gram and acid-fast
stains and for bacitracin, optochin, ONPG, X and V discs or strips;
c. Each month of use for antisera;
d. ach week of use the laboratory shall check
XV discs or strips with a positive control;
e. For antimicrobial susceptibility tests,
the laboratory shall check each new batch of media and each lot of
antimicrobial discs or wells before or concurrent with initial use using
approved reference organisms:
1) The
laboratory's zone sizes or minimum inhibitory concentrations (MIC) for
reference organisms shall be within established limits before reporting patient
test results;
2) Each day tests are
performed the laboratory shall use the appropriate control organisms to check
the procedure unless adequate precision can be demonstrated. Once adequate
precision is demonstrated, the controls may be performed each week of use.
Documentation of precision studies is required.
10. Antibiotic sensitivities shall be
performed using a recognized method. If the Kirby-Bauer method is utilized:
a. Proper sized petri dishes shall be
used;
b. Disc zone sizes shall be
measured and recorded, or a template shall be used; and
c. A standardized inoculum shall be
used.
11. Records shall
reflect all tests used to isolate and identify organisms.
12. For laboratories performing
mycobacteriological testing, the laboratory shall:
a. Each day of use check the iron uptake test
with at least one positive and one negative acid-fast control organism. Check
all other reagents or test procedures used for identification with at least a
positive acid-fast control organism.
b. Each week of use check the fluorochrome
acid-fast stain's reactivity with a positive and a negative control
organism;
c. Each week of use check
the acid-fast stain's reactivity with a positive control organism; and d. Each
week of use, check the procedure for susceptibility tests performed on
Mycobacterium tuberculosis isolated with a strain of Mycobacterium tuberculosis
susceptible to all antimycobacterial agents tested.
13. For laboratories conducting mycological
testing, the laboratory shall:
a. Each day of
use, if using the auxanographic medium for nitrate assimilation, check the
nitrate reagents with a peptone control;
b. Each week of use check the acid-fast
stain's reactivity with a positive and a negative control organism;
and
c. Each day of use test each
drug for susceptibility tests with at least one control strain that is
susceptible to the drug and ensure that patient test results are reported only
when control results are within the laboratory's established control
limits.
14. For
laboratories performing parasitology tests, the laboratory shall:
a. Have available a reference collection of
slides or photographs and, if available, gross specimens for identification of
parasites and use these references in the laboratory for appropriate comparison
with diagnostic specimens;
b.
Calibrate and use the calibrated ocular micrometer for determining the size of
ova and parasites, if size is a critical parameter. Calibration of the
micrometer shall be checked annually or after microscope repair or major
maintenance. Documentation of the calibration is required; and
c. Check permanent stains each month of use
using a fecal sample control that will demonstrate staining
characteristics.
15. For
laboratories performing virology tests, the laboratory shall:
a. Have available host systems for the
isolation of viruses and identification methods that cover the entire range of
viruses that are etiologically related to clinical diseases for which services
are offered;
b. Maintain records
that reflect the systems used and the reactions observed; and
c. Simultaneously culture, for identification
tests, uninoculated cells or cell substrate controls as a negative control to
detect erroneous identification results.
16. A microbiological safety cabinet shall be
used when my cob acted ology or mycology cultures are manipulated. The cabinet
shall meet the following special requirements:
a. Have a face velocity of at least 75 feet
per minute;
b. Be connected to an
independent exhaust system;
c. Have
filters with 99.97 percent efficiency (based on the dioctylphthalate (DOP) test
method) in the exhaust system;
d.
Be designed and equipped to permit the safe removal, disposal and replacement
of contaminated filters; and
e. Be
provided with a means of disinfection.
17. Mycology, my cob acted ology or virology
cultures shall be disinfected prior to leaving the control of the
laboratory.
L. Pathology
(Histopathology and Cytology).
1. The
ventilation system shall be adequate to properly remove vapors, fumes and
excessive heat.
2. Staining dishes
shall be properly labeled and covered when not in use.
3. Flow charts that reflect the staining
procedure used shall be available.
4. A control slide of known reactivity shall
be included with each slide or group of slides for differential or special
stains. Reaction of the control slide with each special stain shall be
documented.
5. For cytology stains:
a. All gynecologic smears shall be stained
using a Papanicolaou (PAP) or modified PAP staining method;
b. Effective measures shall be taken to
prevent cross-contamination between gynecologic and non-gynecologic specimens
during the staining process;
c.
Non-gynecologic specimens that have a high potential for cross-contamination
shall be stained separately from other non-gynecologic specimens, and the
stains shall be filtered or changed following staining.
6. All cytology slide preparations shall be
retained for five years.
7. For
histopathology:
a. All stained slides shall
be retained at least 10 years;
b.
All specimen blocks shall be retained at least two years; and
c. All remnants of tissue specimens shall be
retained in a manner that assures proper preservation of the tissue specimens
until the portions submitted for microscopic examination have been examined and
a diagnosis has been made.
8. An exact duplicate of each test report
shall be retained for at least 10 years.
9. The following reports shall be signed to
reflect the review of a board-certified pathologist, or, as applicable, another
individual meeting the qualifications specified in the CLIA requirements:
a. All tissue pathology reports;
b. All non-gynecologic cytology
reports;
c. All gynecologic
cytology reports on smears containing cells exhibiting reactive or reparative
changes, atypical squamous/glandular cells, premalignant or malignant
condition.
NOTE: If an electronic signature is used, the laboratory shall ensure that only the authorized person can release the signature. Refer to Section 14, Health Information Services.
10. The laboratory shall compare clinical
information, when available, with cytology reports and shall compare each
malignant and premalignant gynecology report with the histopathology report, if
available, and determine the causes of any discrepancies.
11. All tissues surgically removed shall be
examined by an anatomic pathologist. The Medical Staff shall develop a list of
tissues that need not be examined.
12. A frozen section diagnosis, as reported
to the surgeon, shall be documented and signed by the pathologist at the time
the frozen section is performed. The documentation may be on the requisition, a
patient test log, or a report form.
13. Autopsy services shall be under the
supervision of a board-certified pathologist.
14. Autopsy findings in a complete protocol
shall be filed in the patient's medical record within 60 days of the autopsy. A
provisional anatomical diagnosis shall be recorded within 72hours after
autopsy. A duplicate copy of the autopsy report shall be maintained in the
laboratory autopsy file.
M. Radiobioassay.
1. Background checks shall be performed each
day at the proper window setting for each type of isotope being used, as
applicable.
2. Criteria for
unacceptable changes in background levels shall be established.
3. Safety precautions shall be written and
appropriately displayed. Film badges and/or rings shall be worn, as
applicable.
4. There shall be
written procedures to assure reliability of testing and safety of patients and
personnel.
5. All procedures for
safety and disposal of radioactive waste shall conform to the most current
Rules and Regulations for Control of Sources of Ionizing Radiation adopted and
promulgated by the Arkansas State Board of Health.
N. Quality Assurance/Performance Improvement.
1. Each laboratory shall establish a Quality
Assurance/Performance Improvement plan. The plan shall follow written policies
and procedures for a comprehensive program which monitors and evaluates the
ongoing and overall quality of the total testing process. The plan shall
evaluate the effectiveness of the laboratory's policies and procedures,
identify and correct problems, assure the accurate, reliable and prompt
reporting of test results, and assure the adequacy and competency of the staff.
As necessary, the laboratory shall revise policies and procedures based upon
the results of those evaluations.
2. All Quality Assurance/Performance
Improvement activities shall be documented.
3. The laboratory shall have an ongoing
mechanism for monitoring and evaluating the following:
a. The criteria established for patient
preparation, specimen collection, labeling, preservation and
transportation;
b. The information
solicited and obtained on the laboratory requisition for its completeness,
relevance and necessity for testing patient specimens;
c. The use and appropriateness of criteria
established for specimen rejection;
d. The completeness, usefulness and accuracy
of the test report information necessary for the interpretation or utilization
of test results;
e. The timely
reporting of test results based on testing priorities (STAT, routine,
manufacturer's instructions, etc.);
f The accuracy and reliability of test
reporting and record storage and retrieval;
g. The effectiveness of corrective actions
taken for:
1) Problems identified during the
evaluation of calibration and control data for each test method;
2) Problems identified during the evaluation
of patient test values for the purpose of verifying the reference range of a
test method;
3) Errors detected in
previously reported test results.
h. The effectiveness of corrective actions
taken for any unacceptable, unsatisfactory or unsuccessful proficiency testing
results.
4.
Laboratories that perform the same testing using different methodologies or
instruments, or perform the same test at multiple testing sites, shall have a
system that twice a year evaluates and defines the relationship between test
results using different methodologies, instruments or test sites.
5. Laboratories that perform tests that are
not challenged with a proficiency testing program shall have a system for
verifying the accuracy and reliability of its test results at least twice per
year.
6. The laboratory shall have
a mechanism to identify and evaluate patient test results that appear
inconsistent with relevant criteria such as patient age, sex, diagnosis or
pertinent clinical data, when provided; distribution of patient test results,
when available; and relationship with other test parameters, when
available.
7. The laboratory shall
have an ongoing mechanism to evaluate the effectiveness of its policies and
procedures for assuring employee competence.
8. The laboratory shall have a system in
place to document problems that occur as a result of breakdowns in
communication between the laboratory and the authorized individual who orders
or receives the results of test procedures or examinations. Corrective actions
shall be taken, as necessary, to resolve the problems and minimize
communication breakdowns.
9. The
laboratory shall have a system in place to assure that all complaints and
problems reported to the laboratory are documented. Investigations of
complaints shall be made, when appropriate, and, as necessary, corrective
actions shall be instituted.
10.
The laboratory shall have a mechanism for documenting and assessing problems
identified during quality assurance/performance improvement reviews and
discussing them with the staff. The laboratory shall take corrective actions
that prevent reoccurrences.
11. The
laboratory shall maintain documentation of all quality assurance/performance
improvement activities, including problems identified and corrective actions
taken. All quality assurance/performance improvement records shall be available
and maintained for a period of two years.
O. Safety.
1. The physical plant and environmental
conditions of the laboratory shall provide a safe environment in which
employees, as well as all other individuals, are protected from physical,
chemical and biological hazards.
2.
Safety precautions shall be established, posted and observed to ensure
protection from physical, chemical, biochemical and electrical hazards as well
as biohazardous materials.
P. Point of Care Testing.
1. The requirements under this section apply
only to the following tests which employ simple and accurate methodologies, as
defined by the Centers for Disease Control and Prevention (CDC):
a. Dipstick or tablet reagent
urinalysis;
b. Fecal occult
blood;
c. Urine pregnancy tests
(visual color comparison);
d.
Hemoglobin by single analyte instalment with self-contained or component
features to perform specimen/reagent interaction, providing direct measurement
and readout;
e. Whole blood glucose
by devices approved for home use;
f
Spun microhematocrit;
g. Whole
blood immunoassay for Helicobacter pylori;
h. Rapid test for Group A streptococcal
antigen from throat swabs; and
i.
Glycosylated hemoglobin (Hgb Ale).
2. All testing personnel shall have earned a
high school diploma or equivalent.
3. There shall be documentation that prior to
testing patients' specimens each individual has received training for each test
to be performed and has demonstrated the ability to perform all testing
operations reliably.
4.
Manufacturer's instructions for each of the tests shall be available in each
area in which the specific test is performed and shall be followed by all
testing personnel.
5. Components of
reagent kits of different lot numbers shall not be interchanged unless
otherwise specified by the manufacturer.
6. Reagents, control and calibration
materials and other supplies shall be stored and handled in a manner to ensure
that they are not used when the expiration date has been exceeded or when they
have deteriorated or are of substandard quality.
7. Quality control procedures shall be
performed in accordance with the manufacturer's instructions, at a minimum.
Additional quality control procedures shall be performed as determined by the
director of the hospital laboratory.
8. Maximum packing time of the
microhematocrit centrifuge shall be determined at least every six
months.
9. The test record system
shall include at least the following:
a.
Identification of the patient;
b.
Name of the authorized person who ordered the test;
c. Test performed;
d. Date and time of test
performance;
e. Identity of the
person who performed the test;
f
Test results; and
g. Any additional
information relevant and necessary for the interpretation of the results of a
specific test.
10. The
configuration of the test system shall be determined by the facility.
11. All required records shall be readily
retrievable for at least two (2) years.
12. Point of Care Testing shall be included
in the hospital laboratory's Quality Assurance/Performance Improvement
program.
13. Any tests other than
those specified in P(l) above shall be subject to all of the requirements of
Section 19.
SECTION 20: RADIOLOGICAL SERVICES.
A.
Radiology.
1. Each hospital shall have
shock-proof diagnostic X-ray facilities.
2. Radiological Services shall be under the
direction of a physician, who is a member of the Medical Staff.
a. The physician director shall be certified
(or eligible for examination) by the American Board of Radiology.
b. At a minimum, a board certified
radiologist shall be available on a consultative basis. Documentation of the
radiologist's visits shall be required.
3. Radiological Services shall be supervised
by a technologist who is qualified by experience or education and has at least
two years technical experience.
4.
A radiologic technologist with at least two years training shall be on duty 24
hours or on call at all times.
5.
Radiologic staff who use the radiologic equipment and administer procedures
shall have written verification of training and shall have approval in writing
by the physician director.
6.
Radiologic technologists shall not independently perform fluoroscopic
procedures.
7. Radiologic staff who
administer agents for diagnostic purposes shall have written verification of
training. . A current list of radiology employees who administer agents for
diagnostic purposes shall be approved by the physician director and maintained
by the facility.
8. Radiology
personnel who participate in direct patient care shall maintain competency in
life support measures or the equivalent.
9. Clinically relevant educational programs
shall be conducted at regularly scheduled intervals with not less than 12 per
year. There shall be evidence of program dates, attendance, and subject
matter..
10. Policies and
procedures for the department shall have evidence of ongoing review and/or
revision. The first page of each manual shall have the annual review date,
signature of the department and/or person(s) conducting the review. Policies
and procedures shall include:
a. Job
descriptions for every type employee;
b. A written list of all tests/procedures
performed by the Radiology Department and the list shall be available to the
Medical Staff;
c. Infection
prevention and control measures;
d.
The holding of patients;
e.
Orientation practices for new employees;
f. Operation of equipment;
g. Management of an adverse
reaction;
h. Cleaning and
disinfecting procedures; and
i.
Posting of signs.
11.
Radiology personnel shall receive yearly instruction in:
a. Safety precautions; and
b. Managing emergency radiation hazards and
accidents.
12. A
documented preventive maintenance and quality control program shall include:
a. Radiology personnel shall follow the
dosimetry requirements identified in the Rules and Regulations for
Control of Sources of Ionizing Radiation.
b. Preventive maintenance for all diagnostic
and therapeutic radiologic equipment to assure a safe working condition. Safety
and calibration checks shall be made according to manufacturer's directions,
not exceeding one year intervals;
c. Annual inspection of all leaded gloves,
aprons and similar protective devices at least once a year with documentation
to include: the name of the examiner, identification of the protective device
examined and the results plus corrective action taken;
d. Documentation of safety, calibration, and
inspection checks maintained for the life of the equipment; and
e. Remedial and corrective action recorded in
response to equipment "down time," with documentation to include: the piece of
equipment involved, time/date malfunction occurred, action taken, time/date
when the equipment became operational.
13. X-ray films shall not be stored in
radiologic examination rooms.
14.
X-ray films shall be filed according to a recognized filing system.
15. X-ray prescription/work requests shall be
authorized by a written and signed physician's order and shall include the
following:
a. Identification of the
patient;
b. Date the test was
ordered;
c. Physician's
name;
d. Concise statement as to
the reason why the X-ray/test was ordered; and
e. Originator's signature.
16. The radiologic report shall be
signed by a physician and shall be placed in the medical record.
17. The Radiological Services shall have an
ongoing QA/PI program that addresses patient care issues. A mechanism for
reporting results of audits shall be provided, to include: indicators
monitored, thresholds/standards, results, corrective plan/corrective action
taken and follow-up.
18. This
section establishes requirements for radiology that are in addition to, not in
substitution of the Rules and Regulations for Control of
Sources of Ionizing Radiation.
19. Actual X-ray film shall be retained for
five years.
20. X-ray films and
reports shall be stored in a room that is equipped with a smoke detection
system. An extinguishing system shall be made available.
21. Locked security shall be ensured for the
written reports maintained in the X-ray file when the storage area is not under
the direct supervision of radiology personnel.
22. Dual image viewing shall be available in
the OR, ER & Radiology areas.
23. Facilities shall maintain the capacity to
view x-ray films.
B.
Nuclear Medicine Services.
1. Nuclear
Medicine procedures shall be under the direction of a physician, qualified in
Nuclear Medicine, who is a member of the Medical Staff.
2. Nuclear Medicine services shall be
supervised by a nuclear medicine technologist who has completed certification
requirements and has at least two years technical experience.
3. Nuclear Medicine staff who use the
equipment and administer procedures shall have written verification of training
and shall have approval in writing by the physician director and Medical
Staff.
4. All radioactive materials
shall be purchased, stored, administered and disposed of in a manner consistent
with the requirements of the Rules and Regulations for
Control of Sources of Ionizing Radiation
or with the
specific condition of a Radioactive Material License issued pursuant to these
regulations.
5. The policy and
procedure manual shall be reviewed annually and revised as necessary. Included
in the manual shall be a cover page with signatures of those reviewing the
manual and a month/day/year of review. The policies and procedures shall
include:
a. Job description for each
employee;
b. A list of
tests/procedures performed by Nuclear Medicine;
c. Safety practices;
d. Management of an adverse
reaction;
e. Orientation for new
employees;
f. Operation of
equipment;
g. Cleaning and
disinfecting procedures;
h. Posting
of signs;
i. Quality
control;
j. Quality
Assurance/Performance Improvement;
k. Clean up of spills;
l. Receipt/disposal of radioactive materials;
and
m. Radiation safety
plan.
6. All nuclear
medicine personnel who participate in direct patient care shall maintain
competency in life support measures.
7. There shall be a documented preventive
maintenance and quality control program:
a.
Monitoring of nuclear medicine personnel for exposure to radiation shall be
integrated over a period not to exceed one month;
b. Nuclear medicine personnel shall follow
the dosimetry requirements identified in the Rules and Regulations for
Control of Sources of Ionizing Radiation;
c. All nuclear medicine equipment shall be
maintained in safe working condition. Preventive maintenance, safety and
calibration checks shall be made according to manufacturer's directions, not to
exceed one year interval;
d.
Documentation of all safety, calibration and inspection checks shall be
maintained for the life of the equipment; and
e.
Remedial and corrective action shall be recorded in response to
equipment "down time." Documentation shall include: the piece of equipment
involved, time/date malfunction occurred, action taken, and time/date when
equipment became operational again.
8. The nuclear medicine "hot lab" shall be
kept locked when not under the direct supervision of authorized
personnel.
9. There shall be an
emergency eye wash available in the nuclear medicine "hot lab".
10. All nuclear medicine staff who administer
agents for diagnostic purposes shall have written verification of training and
approval by the physician director and individual(s) supervising the
training.
11. Clinically relevant
educational programs shall be conducted on regularly scheduled intervals at not
less than 12 per year. There shall be evidence of program dates, attendance,
and subject matter.
12. All nuclear
medicine requests shall be authorized by a written and signed physician's order
and shall include the following:
a.
Identification of the patient;
b.
Date;
c. Physician's
name;
d. Originator's signature;
and
e. Reason/justification for the
test.
13. The nuclear
medicine report shall be signed by a physician. The original shall be placed in
the medical record.
14. Films shall
not be stored in radiologic or nuclear medicine examination rooms.
15. The storage of nuclear medicine films
shall comply with the guidelines under Section 20, Radiological
Services.
C. Guidelines
for Mobile Services. The Governing Body and Medical Staff shall approve the
provisions for establishing services in accordance with the following criteria:
1. General Considerations.
a. The installation is governed by the
following Arkansas Department of Health publications:
1)
Rules and Regulations
for Hospitals and Related Institutions in Arkansas,
Section 20, Radiological Services; and
2)
Rules and Regulations
for Control of Source of Ionizing Radiation.
b. Approvals shall be granted by
the Arkansas Department of Health:
1) Health
Facility Services; and
2) Radiation
Control and Emergency Management.
c. The mobile service provider shall maintain
fire, theft, general and professional liability insurance.
2. Operating Policies.
a. All examinations shall be authorized by a
written and signed physician's order;
b. Examinations shall be performed under the
direction of and interpreted by a qualified physician, with documented training
or experience, who is a member of the hospital's Medical Staff;
c. Examinations shall be performed by a
licensed radiologic technologist;
d. The Radiology Department shall maintain
current policies and procedures for use of the mobile units to include
infection prevention and control and safety;
e. All personnel who administer agents for
diagnostic purposes shall have written verification of training and approval by
the physician director and individual(s) supervising the training;
f. Hospital personnel shall transport
patients to and from the mobile unit according to hospital safety
policies;
g. Oxygen and emergency
medical supplies shall be maintained and readily available;
h. The hospital Pharmacy may provide
necessary medical supplies including contrast media, but proper handling and
control of dated items shall be ensured;
i. A log of all patients shall be
maintained;
j. Films shall be
maintained in the same manner as X-ray films;
k. Personnel who participate in direct
patient care shall be competent in life support measures; and
1. Contracted services shall be under current
agreement and the contractor shall fulfill all requirements of this
section.
3. Refer to Section 52,
Physical Facilities, Imaging Suite
SECTION 21: PHYSICAL THERAPY.
Licensed physical therapist means any person licensed to practice physical therapy by the Arkansas State Board of Physical Therapy.
The practice of licensed physical therapy assistants shall be performed under the supervision of the licensed physical therapist. The supervising therapist shall be readily available for consultations, evaluations and establishment of each program prior to delegation of any treatments and determination of patient discharge.
If physical therapy services are rendered by an individual who does not meet at least the assistant-level qualifications (aide/technician), a qualified physical therapist shall be on the premises and immediately available to provide assistance and direction throughout the time the services are rendered.
A. Physical therapy services
shall be provided under the direction of a physician member of the Medical
Staff.
B. Physical therapy services
shall be supervised by a physical therapist licensed by the Arkansas State
Board of Physical Therapy. Physical therapy assistants and aides shall comply
with all state licensure requirements.
C. A policy and procedure manual for Physical
Therapy shall be developed. The manual shall have evidence of ongoing review
and/or revision. The first page of each manual shall have the annual review
date, signature of the department supervisor and/or person(s) conducting the
review.
D. There shall be written
policies and procedures which shall include:
1. Job descriptions for each type of
employee;
2. Infection prevention
and control measures;
3. Standards
of care;
4. Criteria for assuring
continuous communication of the patient's therapy and progress to the
physician;
5. Assembly and
operation of equipment;
6. Physical
therapy services provided and a list of services made available to the Medical
Staff;
7. Documentation specifying
who may perform special procedures and give patient instruction; this shall be
verified by the physician director;
8. Safety practices;
9. Orientation practices for new employees;
and
10. Cleaning, disinfecting and
sterilizing procedures.
E. There shall be an adequate supply of
reference material for the physical therapist which shall include current
literature.
F. All physical therapy
prescriptions/work requests shall be authorized by a written and signed
physician's order.
G. Equipment
shall be adequate for the services offered and maintained in good repair.
1. Equipment shall be serviced, calibrated
and operated according to the manufacturer's directions.
2. All physical therapy equipment shall be
under the control of the physical therapy supervisor.
3. A preventive maintenance program shall be
implemented with periodic inspection of all equipment and appropriate records
maintained for the life of each piece of equipment.
4. All temperature-dependent patient use
equipment shall have the temperature checked and recorded before each patient
use or at least daily, if used, to ensure patient safety.
H. Physical therapy records for each patient
shall include:
1. Current written plan of
care;
2. Statement of treatment
objectives;
3. Statement of
patient's short-term and long-term rehabilitation potential;
4. Functional limitations;
5. Justification of continued rehabilitative
care; and
6. Documentation of daily
treatments.
I.
Clinically relevant educational programs shall be conducted on a regularly
scheduled interval not less than 12 times per year. There shall be evidence of
program dates, attendance and subject matter.
J. All physical therapy personnel who
participate in direct patient care shall be competent in life support
measures.
K. There shall be an
ongoing QA/PI program.
L. Hospitals
which have swimming pools shall comply with applicable sections of
Rules and Regulations Pertaining to Swimming Pools and Other Related
Facilities.
M.
Contracted physical therapy services shall be under current agreement and the
contractor shall fulfill all requirements of this Section.
SECTION 22: OCCUPATIONAL THERAPY.
In facilities with an organized Occupational Therapy Department, the following shall apply:
A. Occupational Therapy Services shall be
under the direction of a physician member of the Medical Staff.
B. Occupational Therapy Services shall be
supervised by a currently licensed therapist in the field of rehabilitation
services.
C. There shall be
sufficient occupational therapy supportive technical staff to provide
authorized Occupational Therapy Services.
D. The policy and procedure manual shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department supervisor and/or
person(s) conducting the review.
E.
There shall be written policies and procedures which shall include:
1. Job descriptions for every type of
employee;
2. Documentation
specifying who may perform special procedures and give patient instructions.
This shall be verified by the physician director;
3. Orientation practices for new
employees;
4. Occupational therapy
services provided and a list of services provided to the Medical Staff;
and
5. Safety practices.
F. Current reference material
shall be available for the occupational therapist.
G. All occupational therapy
prescriptions/work requests shall be authorized by a written and signed
physician's order.
H. Equipment
shall be adequate for the services offered and maintained in good repair.
1. Equipment shall be serviced, calibrated
and operated according to the manufacturer's directions.
2. All occupational therapy equipment shall
be under the control of the occupational therapy supervisor.
3. A preventive maintenance program shall be
implemented with periodic inspection of all equipment and appropriate records
maintained for the life of each piece of equipment.
4. All temperature-dependent patient use
equipment shall have the temperature checked and recorded before each patient
use.
When appropriate elements are planned and arranged for shared use by physical therapy patients and staff, one or both services shall be responsible for the preventive maintenance program and the retention of records.
I.
Occupational therapy records for each patient shall include:
1. Current written plan of care;
2. Statement of treatment
objectives;
3. Statement of
patient's short-term and long-term rehabilitation potential;
4. Justification of any continued
rehabilitation care; and
5.
Documentation of the patient's condition and response to treatments.
J. Clinically relevant educational
programs shall be conducted on a regularly scheduled basis at not less than 12
per year. There shall be evidence of program dates, attendance, and subject
matter.
K. All occupational therapy
personnel shall maintain competency in life support measures.
L. There shall be an ongoing QA/PI
program.
M. Contracted occupational
therapy services shall be under current agreement and the contractor shall
fulfill all requirements of this Section.
SECTION 23: SPEECH PATHOLOGY/AUDIOLOGY SERVICES.
In facilities with an organized Speech Language Pathology/Audiology Services Department, the following shall apply:
A. Speech Pathology/Audiology Services shall
be under the direction of a physician member of the Medical Staff.
B. Speech Pathology/Audiology Services shall
be supervised by a therapist who is currently licensed.
C. There shall be sufficient supportive
personnel to provide authorized speech pathology/audiology services.
D. There shall be documentation, verified by
the physician director, of who may perform special procedures and give patient
instructions.
E. Policies and
procedures shall have evidence of ongoing review and/or revision. The first
page of each manual shall have the annual review date, signature of the
department supervisor and/or person(s) conducting the review.
F. There shall be written policies and
procedures which shall include:
1. Job
descriptions for every type of employee;
2. Orientation procedures for new
employees;
3. Infection prevention
and control measures;
4. A listing
of services/treatments available to the Medical Staff; and
5. Safety practices.
G. Equipment shall be in good repair and
under the control of the therapist supervisor. Documentation of preventive
maintenance shall be maintained for the life of each piece of
equipment.
H. Current reference
material shall be available for the department.
I. Clinically relevant educational programs
shall be conducted on a regularly scheduled basis at not less than 12 per year.
There shall be evidence of program dates, attendance, and subject
matter.
J. All speech
pathology/audiology prescriptions/work requests shall be authorized by a
written and signed physician's order.
K. Speech Pathology/Audiology Services
records for each patient shall include:
1.
Current written plan of care;
2.
Statement of treatment objectives;
3. Statement of patient's short-term and
long-term rehabilitation potential;
4. Justification of any continued
rehabilitation care; and
5.
Documentation of progress notes following treatment given to
patients.
L. All Speech
Pathology/Audiology personnel shall maintain competency in life support
measures.
M. There shall be an
ongoing QA/PI program.
N.
Contracted Speech Pathology/Audiology Services shall be under current agreement
and the contractor shall fulfill all requirements of this Section.
SECTION 24: RECREATIONAL THERAPY.
In facilities with organized Recreational Therapy Services, the following shall apply:
A. Recreational
Therapy Services shall be under the direction of a physician member of the
Medical Staff.
B. Recreational
Therapy Services shall be supervised by a therapist with current
certification.
C. There shall be
sufficient Recreational Therapy supportive staff to provide authorized
Recreational Therapy Services.
D.
There shall be documentation, verified by the physician director, of who may
perform special procedures and give patient instructions.
E. The policy and procedure manual shall have
evidence of ongoing review and/or revision. The first page of the manual shall
have the annual review date, signature of the department supervisor and/or
person(s) conducting the review.
F.
There shall be written policies and procedures which shall include:
1. Job descriptions;
2. Infection prevention and control
measures;
3. Recreational Therapy
Services provided and a list of services shall be made available to the Medical
Staff;
4. Orientation practices for
new employees and volunteer personnel;
5. Assembly, operation and maintenance of all
equipment;
6. Safety
practices;
7. Security of supplies
and tools; and
8. Activities
off-campus.
G. All
equipment, tools and machines shall be in good repair and under the control of
the therapist supervisor. Documentation of preventive maintenance shall be
maintained for the life of each piece of equipment.
H. Current reference material shall be
available for the department.
I.
Clinically relevant educational programs shall be conducted on a regularly
scheduled basis at not less than 12 per year. There shall be evidence of
program dates, attendance, and subject matter.
J. All recreational therapy
prescriptions/work requests shall be authorized by a written and signed
physician's order and shall include:
1.
Identification of the patient;
2.
Date;
3. Physician's
name;
4. Type, frequency and
duration of treatment; and
5.
Originating signature.
K. Recreational Therapy Service records for
each patient shall include:
1. Current
written plan of care;
2.
Documentation of attendance by the therapist in team meetings and the
contribution by the therapist to the treatment plan;
3. Statement of treatment
objectives;
4. Statement of
patient's short-term and long-term rehabilitation potential;
5. Record of daily activity
participation;
6. Justification of
any continued rehabilitation care; and
7. Progress notes.
L. All Recreational Therapy personnel shall
maintain competency in life support measures.
M. There shall be an ongoing QA/PI
program.
N. If food and/or
nutritional service functions are offered, infection prevention and control,
storage and supervision shall be coordinated with the Dietary Department of the
facility.
O. Contracted
Recreational Therapy Services shall be under current agreement and the
contractor shall fulfill all requirements of this Section.
SECTION 25: PET THERAPY PROGRAM
Definitions.
"Program" means Pet Therapy Program.
"Pet" means an animal that has been specifically screened, trained, and authorized by the hospital to participate in the Program.
"Handler" means an individual who has been specifically credentialed and authorized by the hospital to participate in, and to accompany and control pets participating in, the Program.
A. The Program shall be approved by the
Governing Body, Medical Staff, and the Infection Prevention and Control
Committee.
B. The Infection
Prevention and Control Committee shall, in conjunction with a licensed
Veterinarian, establish the Medical Criteria that each pet shall meet in order
to participate in the Program.
C.
The hospital shall establish the Behavioral Criteria that each pet shall meet
before participating in the Program.
D. A licensed Veterinarian shall certify that
a participating pet:
1. Meets the hospital's
medical criteria; and
2. Is free of
zoonotic communicable disease causing organisms.
E. A licensed Veterinarian, a local
protection society or a pet therapy association or society shall certify that a
participating pet meets the Hospital's Behavioral Criteria.
F. Pets found to have a communicable disease
shall be excluded from the Pet Therapy Program until the pet is treated and has
one negative culture, if culturing of the causative agent is feasible. Pets
expressing behavioral problems will be excluded from the program until the
behavioral problem is remedied.
G.
Pets shall be bathed and groomed before each hospital visit. Pets shall be free
of fleas while visiting the hospital.
H. The hospital shall establish an
orientation program for the Handlers. Handlers shall attend this program before
participating in the Program. The orientation program shall include, at least,
patient confidentiality, appropriate infection prevention and control measures,
safety, and appropriate emergency protocols. Records of the orientation program
shall be kept.
I. The hospital
shall keep records of each visit the Pet makes. The records shall include, at
least, the date, the identity of the Pet, the identity of the Handler, all the
patients visited; the area in which the patient visits were made, and any
infectious condition the patient had or any type isolation the patient was in
at the time of the visit.
J. The
pet and handler shall be escorted at all times by a staff member appropriate to
the area visited. Patient safety and confidentiality shall be maintained at all
times.
K. The Pet shall be under
the direct supervision of the handler at all times and shall be on a leash or
in a crate at all times while in the hospital. Other patients, visitors, and
employees shall be discouraged from petting the pet.
L. The Hospital shall provide an area to walk
the pet. There shall be procedures for immediate clean up of all
accidents.
M There shall be
procedures for patient hand washing, visit area clean up and cleaning of the
patient's room. If a pet visits a patient in bed, the bed linens will be
changed immediately after the visit. A barrier shall be placed over the bed if
the pet is placed directly on the patient's bed.
N. The attending physician in conjunction
with the Infection Control Officer, will determine the appropriateness of the
pet visits. The attending physician shall approve and order each Pet visit. The
orders shall be documented in the medical record.
SECTION 26: SPECIALIZED SERVICES: SURGICAL SERVICES.
A. Organization and Supervision.
1. An organizational plan shall be
developed.
2. Surgical Services
shall be under the medical direction of a qualified physician or a physician
committee.
3. A Surgical Services
Registered Nurse supervisor shall be accountable and responsible for patient
care.
4. Surgical Services shall
have written policies and procedures that include:
a. Operative and special consents;
b. Fire and disaster plans;
c. Environmental control;
d. Visitor and traffic control to include
allowance for no one other than staff or professionals without the expressed
consent of the physician and operating room supervisor;
e. Safety practices;
f. Infection prevention and control
measures;
g. Care and disposition
of surgical specimens, cultures and foreign bodies;
h. Care of special equipment including
preventive maintenance contracts and records;
i. Emergency management;
j. Orientation of all personnel;
and
k. Medication accountability.
(Refer to Section 11, Patient Care Service and Section 16, Pharmacy.)
5. Clinically relevant educational
programs shall be conducted on a regularly scheduled basis not less than 12 per
year. There shall be evidence of program dates, attendance, and subject
matter.
6. A surgery schedule shall
be maintained in the surgery suite.
7. There shall be a continuous QA/PI program
that is specific to the patient care administered.
8. A current roster of physicians and
dentists with a delineation of each physician's and dentists surgical
privileges shall be accessible and available in the confidential files of the
Surgical Services Registered Nurse and in the files of the hospital
administrator.
9. The following
information shall be maintained in the surgery services log:
a. Patient's full name;
b. Hospital number;
c. Surgeon;
d. Assistant surgeon;
e. Type of anesthetic and person
administering;
f. Pre and
postoperative diagnoses;
g.
Circulating nurse;
h. Scrub
nurse(s);
i. Procedures;
j. Complications;
k. Sponge, needle, and instrument count;
l. Time of beginning and ending of
case; and
m. Other persons
present.
B.
Environment, Equipment and Supplies.
1. A safe
operating room environment shall be established, controlled and consistently
monitored.
2. At a minimum, the
following general equipment and supplies shall be in the surgical suite:
a. Call-in system;
b. Crash cart;
c. Cardiac monitor
d. Defibrillator;
e. Resuscitating equipment;
f. Suction equipment; and
g. Thoracotomy set.
3. Equipment and supplies necessary to meet
the requirements of the services provided:
a.
Stretcher;
b. Anesthetic equipment
and supplies;
c. Adjustable
operating table with waterproof pad;
d. Side tables;
e. Approved surgical light;
f. Medical gases;
g. 24 hour supply of sterile linen;
h. Wall clock; and
i. Equipment and supplies for timed scrubbing
technique.
C.
Staffing.
1. Surgical personnel including a
Registered Nurse shall be available to provide emergency surgical services on a
24 hour basis.
2. A Registered
Nurse shall be present in the operating room for the duration of the surgical
procedure. Additional auxiliary personnel shall be available as
necessary.
3. Only qualified
Registered Nurses may perform circulating duties in the operating
room.
4. There shall be
documentation of training and/or experience for all operating room personnel
assigned to surgical procedures.
SECTION 27: SPECIALIZED SERVICES: POSTANESTHESIA CARE UNIT.
A. Postanesthesia
Care Unit (PACU) Services shall be provided in a well organized manner under
the direction of a qualified physician and under the supervision of a
Registered Nurse.
B. Policies and
procedures shall have evidence of ongoing review and/or revision. The first
page of each manual shall have the annual review date, signature of the
department supervisor and/or person(s) conducting the review. Policies and
procedures shall include:
1. Lines of
authority and nursing supervision;
2. Transfer of patients from the Operating
Room to Postanesthesia Care Unit;
3. Criteria for discharge of patients from
the Postanesthesia Care Unit; and
4. The care of patients in the event the
Postanesthesia Care Unit closes (including provisions of adequate nursing
staff).
C. There shall
be adequate nursing staff in attendance with every patient during anesthesia
recovery.
D. A physician shall
order the discharge of the patient from the Postanesthesia Care Unit.
E. Equipment shall be available in accordance
with services provided.
F. The
Registered Nurse shall assess and document assessment of each PACU
patient.
G. Clinically relevant
educational programs shall be conducted on a regularly scheduled basis not less
than 12 per year. There shall be evidence of program dates, attendance, and
subject matter..
H. There shall be
an ongoing QA/PI program that is specific to the patient care
administered.
SECTION 28: SPECIALIZED SERVICES: AMBULATORY SURGERY SERVICES.
A. There shall be policies
and procedures specific to Ambulatory Surgery Services. Policies and procedures
for the department shall have evidence of ongoing review and/or revision. The
first page of each manual shall have the annual review date, signature of the
department supervisor and/or person(s) conducting the review.
B. Policies and procedures shall include:
1. Scheduling of patients for
surgery;
2. Admission and discharge
criteria;
3. Perioperative patient
care;
4. Operative and special
consents;
5. Obtaining a documented
history and physical on the patient's medical record prior to the
procedure;
6. Preoperative
assessment procedures required by the Medical Staff; and
7. Medication accountability. (Refer to
Section 11, Patient Care Service, Section 12, Medications and Section 16,
Pharmacy.)
C. A
physician shall order the discharge of the patient from the facility.
D. For additional requirements refer to
Patient Care Service, Section 11, Specialized Services: Surgical Services,
Section 26 and Specialized Services: Post anesthesia Care Unit, Section
27.
SECTION 29: SPECIALIZED SERVICES: ANESTHESIA SERVICES.
A. Organization and Staffing. Anesthesia
Services shall be provided in a well organized manner under the direction of a
qualified physician. The service is responsible for all anesthesia
administered.
B. Those
administering anesthesia shall be credentialed by Medical Staff and approved by
the Governing Body. A current roster, with delineation of privileges for those
administering anesthesia, shall be maintained and readily available.
C. Anesthesia shall be administered by the
following:
1. Anesthesiologist;
2. Physician qualified to administer
anesthesia; or
3. Certified
Registered Nurse Anesthetist (CRNA) under the supervision of a
physician.
D. Written
policies and procedures specific to Anesthesia Services shall have evidence of
ongoing review and/or revision. The first page of the manual shall have the
annual review date, signature of the department supervisor and/or person(s)
conducting the review.
E. Policies
and procedures shall include:
1. Preanesthesia
evaluation;
2. Approved anesthesia
agents;
3. Methods of delivery of
anesthesia;
4. Intraoperative
anesthesia record;
5. Post
anesthesia follow-up report;
6.
Mechanism for routine checking and maintenance of anesthesia machines and
equipment for safe use;
7.
Medication accountability. See Section 16, Pharmacy, Section 11, Patient Care
Service, and Section 12, Medications;
8. Responsibilities in the discharge of
patients from the Post anesthesia Care Unit. See Section 27, Post anesthesia
Care Unit; and
9. Infection
prevention and control measures.
F. All medications and anesthetic agents
administered to the patient shall be ordered by the prescriber and/or
anesthesia provider. This includes preoperative as well as intraoperative and
postoperative medications.
G. There
shall be an ongoing QA/PI program that is specific to the patient care
administered.
SECTION 30: SPECIALIZED SERVICES: LABOR, DELIVERY, LABOR DELIVERY RECOVERY (LDR), LABOR DELIVERY RECOVERY POST PARTUM (LDRP), POST PARTUM AND MATERNAL-CHILD EDUCATION.
A. Labor
Room and/or LDR, LDRP Room.
1. Provisions
shall be made for patients in labor in either a designated labor room and/or
birthing room. Rooms used only for labor shall be in close proximity to the
delivery room. Furniture, washable wallpaper, pictures, radio, television, and
other items may be used as long as the needs of the mother and baby are not
compromised. Items selected shall be made of durable materials, with a smooth,
impervious surface which can be easily cleaned and disinfected.
2. All beds used for labor shall be equipped
with side rails.
3. There shall be
equipment and supplies available for the examination and preparation of
patients in labor, which shall consist of the following:
a. Precipitous delivery tray;
b. Stethoscope;
c. Suction equipment;
d. Sterile gloves;
e. Emergency medications as approved by the
Pharmacy and Therapeutics Committee and supplies to include laryngoscopes,
airways, endotracheal tubes and infant ambu bags; and
f Fetal monitoring device.
4. A physician shall be
immediately available when Oxytocin is administered. "Immediately available"
shall be determined by the hospital's administrative staff, Medical Staff and
Governing Body.
5. Father or
support persons may be allowed with the patient during labor unless medically
contraindicated.
B.
Delivery Areas.
1. Hospitals offering
delivery and maternity services shall comply with the requirements of this
section. (See Section 14, Health Information Services and Section 11, Patient
Care Service.)
2. General operating
rooms may not be used for deliveries, except for major surgical deliveries.
Delivery rooms shall be separate from operating rooms and shall not be used for
any other purpose, with the exception of a tubal ligation immediately following
a delivery. Delivery rooms may be used for Caesarean sections provided the
usual operating room equipment is used, and surgical policies and procedures
related to the delivery are made a part of the labor and delivery
manual.
3. The following equipment
and supplies shall be provided:
a. Supply of
medications as approved by the Pharmacy and Therapeutics Committee;
b. Infant identification and supplies.
Identification shall be done in the delivery room at the time of birth and
shall remain in place during the entire period of hospitalization.
Identification information shall be sufficient to identify the infant(s) with
one mother. Identification bands shall be waterproof plastic with tag inserts
written in waterproof ink;
c.
Heated bassinet, crib, or incubator;
d. Supply of prophylaxis medication for the
prevention of infant blindness. The medication shall be administered within one
and one-half hours of the time of birth per written order of the
physician;
e. Commercially
manufactured delivery table/birthing bed with a waterproof non-conductive table
pad;
f Side tables for instruments
and other necessary equipment;
g.
Approved surgical light;
h. Wall
clock;
i. Equipment and supplies
for timed scrub technique and an approved disinfectant soap;
j. Apgar score chart;
k. Suction equipment (infant and adult);
l. Sphygmomanometer; an
m. Fetal monitoring device.
C. Organization.
1. Delivery services shall be under the
direction of a qualified physician and under the supervision of a Registered
Nurse. A Registered Nurse shall be present during labor, delivery and post
delivery of each patient. The birth shall be attended by a physician or a
certified nurse midwife with hospital privileges.
2. Patients shall be provided with direct
care by a Registered Nurse during labor, delivery, recovery and postpartum.
a. All patients in active labor shall be
attended and/or monitored.
b.
Qualified nurses, in adequate numbers shall be provided to meet the needs of
each patient.
3. An
on-call schedule shall be provided to ensure that a physician with obstetrical
privileges is readily available to perform obstetrical services at all times.
"Readily available" shall be determined by the hospital's Administrative Staff,
Medical Staff and Governing Body.
4. Qualified Registered Nurses shall always
be available in-house for labor and delivery patients. When there are no
patients, on-call staff may be utilized if approved by the Medical Staff and
Governing Body.
5. Procedures for
obtaining the mother's Rh factor shall be provided by the facility or
documented by the mother's attending physician upon admission.
6. When a patient presents to the hospital
for evaluation, the physician shall be notified.
7. Policies and procedures shall include:
a. Immediate delivery;
b. Obstetrical emergencies;
c. Setting up and cleaning the delivery room,
LDR or LDRP room, and C-section room;
d. Equipment requirements;
e. Visitation;
f Climate control (physical);
g. Infection prevention and control
measures;
h. Aseptic
techniques;
i. Intermittent rooming
in;
j. Anesthesia;
k. Deliveries occurring outside the delivery
area;
l. Infectious patients; and
m. Infant security.
8. A
permanent record of all deliveries shall be maintained. There shall be a
reasonable attempt to collect current information to include the following:
a. Mother's name, date of birth, maiden name,
father's name if available, hospital number, gravida-para, ABO type, Rh factor,
and length of gestational period;
b. Baby's sex, race, date of birth, time of
birth, weight, apgar score, and baby identification band number;
D. Anesthesia.
1. Only a physician, anesthesiologist or
Certified Registered Nurse Anesthetist (CRNA) shall be permitted to initiate
and reinject continual epidural or caudal anesthesia and to initiate or
continue general or regional anesthesia.
2. A physician shall be immediately available
if CRNAs are administering anesthesia. "Immediately available" shall be
determined by the hospital's Administrative Staff, Medical Staff and Governing
Body.
3. The permanent record shall
contain the names of the physician, anesthesiologist, anesthetist or
CRNA.
E. Postpartum
Care.
1. Policies and procedures shall be
developed specific to the care of maternity patients.
2. Maternity patients shall not be routinely
cared for in rooms with patients admitted for diagnosis other than
maternity.
3. After an observation
period, the infant may stay in the room with the mother for the duration of the
hospital stay.
4. Mothers with
infection, fever or other condition that could adversely affect the safety and
welfare of others shall be immediately segregated and isolated in a separate
room.
F. Maternal-Child
Education. The hospital shall develop an educational program for the care of
the obstetrical patient and infant. Policies and procedures shall include:
1. Personal hygiene;
2. Dietary instruction;
3. Care of episiotomy and perineum;
4. Care of incision;
5. Breast care;
6. Exercise program;
7. Car seat safety (Ark. Code Ann. §
27-34-101 et seq.);
8. Preventive health;
9. Referral services;
10. Infant care; and
11. Distributing educational materials for
shaken baby syndrome (Ark. Code Ann. §
20-9-1401 et seq.).
SECTION 31: NURSERY SERVICES.
The newborn nursery shall be under the direct supervision of a Registered Nurse with clinical skills in newborn nursing. The newborn nursery shall be located within or adjacent to the postpartum unit. The following requirements shall apply to all nurseries:
A. Nurseries shall not be used for any other
purpose and shall never be left unattended when occupied.
B. Infants born outside the hospital or with
proven or potential infections shall be isolated from other infants in the
Nursery. Infants with infections, skin rash, or diarrhea shall be immediately
separated and isolated.
C.
Isolettes shall not serve as a sole means of isolation. Provisions for
isolation shall be provided.
D. The
following equipment shall be provided in nurseries:
1. Individual approved type hospital
bassinets. Wicker or woven type bassinets shall not be used;
2. Metal or approved plastic diaper and waste
containers. The lids on these containers shall be operated by a foot control or
equivalent device;
3. Infant
scales;
4. Blankets and
linen;
5. Suction equipment;
and
6. Incubators suitable for the
care of premature infants provided in the ratio of at least one incubator to 20
bassinets.
E. Infant
emergency supplies:
1. Emergency medications
approved by the Pharmacy and Therapeutics Committee;
2. Infant laryngoscope;
3. Suction catheters;
4. Endotracheal tubes;
5. Stylets; and
6. Infant airways and IV supplies.
F. Strict hand hygiene techniques
shall be maintained by all personnel. A clean barrier shall be used by anyone
handling the infant.
G. Infant
clothing shall be furnished by the hospital; however, if the mother wishes to
provide clothing for the infant, hospital personnel shall examine the clothing
to make sure it meets hospital requirements. Diapers shall be available in
necessary quantities.
H. Formula
Feedings.
1. Any individually packaged,
presterilized formula delivered by an outside source shall be approved by the
facility.
2. There shall be an
adequate supply of sterile disposable ready-to-use formula bottles
available.
3. Formulas shall be
stored in enclosed cabinets.
4. The
expiration date shall be checked on each bottle prior to infant
feeding.
5. Policies and procedures
shall be developed in conjunction with the Infection Prevention and Control
Committee regarding the handling, labeling and storing (separately) of breast
milk.
6. Individual nipple shields
and breast pumps used in infant feeding shall be cleaned according to hospital
infection prevention and control policies and procedures.
7. If the facility has a breast milk bank the
policies and procedures shall be submitted to and approved by the Arkansas
Department of Health and hospital Infection Prevention and Control
Committee.
I. Rooming-In
Service. Hospitals providing a newborn nursery may provide rooming in for
infants on an intermittent or 24 hour basis based on the mother's
request.
SECTION 32: SPECIALIZED SERVICES: CRITICAL CARE.
A Critical Care Unit is a section of the hospital where intensive care nursing, necessary monitoring and treatment equipment and supplies are provided to those patients who, in the opinion of the attending physician, require such specialized services.
A. Staffing.
1. Critical Care Units shall be staffed with
a Registered Nurse each shift.
2.
All critical care nursing staff shall be oriented and trained in life support
measures, interpretation of dysrhythmias and shall demonstrate competency in
critical care nursing specific to patient types. Competency in the specific
areas shall be maintained.
B. Policies and Procedures. Procedures shall
include:
1. Admission and continuing stay
criteria;
2. Discharge
criteria;
3.
Triage/transfer;
4. Use of
protocols; and
5. Definition of the
clinical scope of the hospital's critical care service.
C. Equipment. Equipment shall include:
1. Suction;
2. Diagnostic monitoring equipment to include
electrocardiographic monitoring;
3.
"Crash Cart" containing emergency medications and supplies;
4. Defibrillator;
5. Wall clock;
6. Accommodations to maintain privacy;
and
7. Weighing device for bed
patients.
D. Isolation.
An isolation room shall be available for the treatment of potentially
infectious or immune suppressed critical care patients.
E. Pediatric Critical Care. If the facility
offers critical care for the pediatric patient there shall be:
1. Policies, procedures and equipment
specific to the needs of pediatric patients; and
2. Nursing staff oriented and trained in life
support measures, interpretation of dysrhythmias and competency in critical
care nursing specific to the pediatric patient.
SECTION 33: SPECIALIZED SERVICES: DENTAL SERVICES.
A. Dental Services
shall comply with the requirements of this section. (See Section 14, Health
Information Services, Section 11, Patient Care Services, Section 16, Pharmacy
and all applicable Sections.)
B.
Patients admitted to the hospital for dental care shall be given the same
medical appraisal as those admitted to other services. The care of dental
patients shall be the dual responsibility of the dentist and a physician on the
hospital staff.
C. Dental services
shall be under the direction of a dentist.
D. Policies and procedures shall be
provided.
SECTION 34: SPECIALIZED SERVICES: CENTRAL STERILIZATION AND SUPPLY.
A. Each hospital shall provide central
medical and surgical supply services with facilities that are responsible for
processing, sterilizing, storing, distributing supplies and equipment to all
units of the hospital. (Refer to Section 66, Physical Facilities, Central
Medical and Surgical Supply Department, for space and equipment
requirements.)
B. The central
sterilization and supply service shall be under the direct supervision of a
Registered Nurse or other qualified person who is trained in management,
aseptic procedures, supply processing and control methods which are applicable
to central sterilization and supply service.
C. Policies and procedures shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department and/or person(s)
conducting the review.
D. Policies
and procedures shall include:
1. Job
descriptions;
2. Infection
prevention and control measures;
3.
Assembly and operation of equipment;
4. Safety practices;
5. Orientation for new employees;
6. Care and cleaning of equipment;
7. Evaluation of:
a. Cleaning effectiveness; and
b. Sterilizing effectiveness.
8. Receiving, decontaminating,
cleaning, preparing, disinfecting and sterilizing reusable items;
9. Assembling and wrapping of packs (to
include the double-wrapped techniques);
10. Storage and distribution of sterile
equipment/medical supplies;
11. Use
of chemical indicators and biological spore tests for sterilizers;
12. Recalling and disposing/reprocessing of
outdated sterile supplies;
13.
Cleaning and disinfecting of surfaces, utensils, and equipment;
14. Specifications for cold-liquid
sterilization and gas sterilization (if used); and
15. Collection and disposal of supplies
recalled by the manufacturer.
E. There shall be an ongoing QA/PI program
specific to the area.
F.
Precautions shall be exercised to prevent the mixing of sterile and unsterile
supplies and equipment. The precautions shall be set forth in written
policies.
G. Procedures shall be
developed for unloading and transporting flash sterilized items. The procedures
shall be developed with the assistance of the Infection Prevention and Control
Committee and shall provide for the aseptic transfer within the physical
constraints of the facility.
H.
Relevant educational programs shall be conducted on a regularly scheduled basis
not less than 12 per year. There shall be written documentation with employee
signature, program title/subject, presenter, date and outline or narrative of
presented program.
I. A liaison
with the Infection Prevention and Control Committee shall be
maintained.
J. Records shall be
maintained of all autoclave loads, both routine and immediate use or"flash,"
which shall include the date, time, lot number (on routine loads), the time at
temperature (where a recorder is not available), item(s) sterilized and shall
identify the person performing the task.
1.
Autoclaves shall meet the following requirements:
2. The efficacy of autoclaves, both for
routine and immediate use or "flash" use, shall be determined weekly through
the use of biological spore monitors:
3. The results of all biological spore
monitoring shall be reported to the Infection Prevention and Control Committee;
and
4. Failures of the biological
spore test shall be brought to the attention of the Infection Prevention and
Control Officer or designee immediately so the appropriate surveillance
measures can be initiated.
NOTE: All materials sterilized from the date of the biological spore monitor failure to the last successful biological spore monitor shall be re-sterilized before use.
K. All autoclaves within the facility shall
be maintained in accordance with the manufacturer's written directions. Records
shall be maintained of all maintenance and repairs for the life of the
equipment.
L. Chemical indicators
for sterility shall be used with each cycle
M. The facility shall validate compliance and
efficacy of the sterilization policy through the quality review process. The
sterilization policy shall describe the mechanism used to determine the shelf
life of sterilized packages. The policy shall:
1. Be consistent with published industry
standards (AAMI and APIC).
2.
Stress that sterility is related to integrity of pack regardless of whether
expiration dating or event-related expiration is utilized.
SECTION 34: SPECIALIZED SERVICES: CENTRAL
STERILIZATION AND SUPPLY.
A. Each hospital
shall provide central medical and surgical supply services with facilities that
are responsible for processing, sterilizing, storing, distributing supplies and
equipment to all units of the hospital. (Refer to Section 66, Physical
Facilities, Central Medical and Surgical Supply Department, for space and
equipment requirements.)
B. The
central sterilization and supply service shall be under the direct supervision
of a Registered Nurse or other qualified person who is trained in management,
aseptic procedures, supply processing and control methods which are applicable
to central sterilization and supply service.
C. Policies and procedures shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department and/or person(s)
conducting the review.
D. Policies
and procedures shall include:
1. Job
descriptions;
2. Infection
prevention and control measures;
3.
Assembly and operation of equipment;
4. Safety practices;
5. Orientation for new employees;
6. Care and cleaning of equipment;
7. Evaluation of:
a. Cleaning effectiveness; and b. Sterilizing
effectiveness.
8.
Receiving, decontaminating, cleaning, preparing, disinfecting and sterilizing
reusable items;
9. Assembling and
wrapping of packs (to include the double-wrapped techniques);
10. Storage and distribution of sterile
equipment/medical supplies;
11. Use
of chemical indicators and biological spore tests for sterilizers;
12. Recalling and disposing/reprocessing of
outdated sterile supplies;
13.
Cleaning and disinfecting of surfaces, utensils, and equipment;
14. Specifications for cold-liquid
sterilization and gas sterilization (if used); and
15. Collection and disposal of supplies
recalled by the manufacturer.
E. There shall be an ongoing QA/PI program
specific to the area.
F.
Precautions shall be exercised to prevent the mixing of sterile and unsterile
supplies and equipment. The precautions shall be set forth in written
policies.
G. Procedures shall be
developed for unloading and transporting flash sterilized items. The procedures
shall be developed with the assistance of the Infection Prevention and Control
Committee and shall provide for the aseptic transfer within the physical
constraints of the facility.
H.
Relevant educational programs shall be conducted on a regularly scheduled basis
not less than 12
per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.
I. A
liaison with the Infection Prevention and Control Committee shall be
maintained.
J. Records shall be
maintained of all autoclave loads, both routine and immediate use or"flash,"
which shall include the date, time, lot number (on routine loads), the time at temperature (where a recorder is not available), item(s) sterilized and shall identify the person performing the task.
1. Autoclaves shall meet the following
requirements:
2. The efficacy of
autoclaves, both for routine and immediate use or "flash" use, shall be
determined weekly through the use of biological spore monitors:
3. The results of all biological spore
monitoring shall be reported to the Infection Prevention and Control Committee;
and
4. Failures of the biological
spore test shall be brought to the attention of the Infection Prevention and
Control Officer or designee immediately so the appropriate surveillance
measures can be initiated.
NOTE: All materials sterilized from the date of the biological spore monitor failure to the last successful biological spore monitor shall be re-sterilized before use.
K. All autoclaves within the facility shall
be maintained in accordance with the manufacturer's written directions. Records
shall be maintained of all maintenance and repairs for the life of the
equipment.
L. Chemical indicators
for sterility shall be used with each cycle
M. The facility shall validate compliance and
efficacy of the sterilization policy through the quality review process. The
sterilization policy shall describe the mechanism used to determine the shelf
life of sterilized packages. The policy shall:
1. Be consistent with published industry
standards (AAMI and APIC).
2.
Stress that sterility is related to integrity of pack regardless of whether
expiration dating or event-related expiration is utilized.
N. Event-related dating of sterile packs is
acceptable.
|
ALLOWABLE SHELF LIFE |
|
|
Double-wrapped Muslin |
Use for rapid turn-around items only in well controlled environment, < 30 days |
|
Double-wrapped Muslin Placed in a Plastic Dust Cover Then Heat Sealed or Bonded |
Event related |
|
Paper or Polypropylene Peel Pack (Paper, Plastic or Tyvek/Mylar) |
Event related and/or per manufacturer's instructions |
|
Rigid Containers, Caskets, etc. |
Per manufacturer's instructions |
NOTE:
1. Sterile
storage areas shall maintain a temperature of no more than 75°F and a
relative humidity of no more than 70%. Ventilation shall be 10 air changes per
hour and shall follow clean to dirty flow.
2. The interior of the dust cover shall not
be considered sterile.
3. Packages
that are wet, dropped on the floor, compressed or torn shall be
rejected.
4. The lot number or
control number and expiration statement shall be visible through the package or
another tag shall be placed on the outside.
5. Containers for sterilization systems shall
be scientifically proven suitable for the specific sterilization cycle used;
the container system shall be verified as the correct one for the cycle.
(Manufacturer's instructions shall be followed.)
6. Double-wrapped shall mean the end results
of the wrapping technique will yield a two-ply covering.
7. The date of sterilization and load control
number shall be placed on each sterilized pack.
O. Immediate use or "flash" (autoclaving)
shall be restricted to unplanned or emergency situations. Flash sterilization
shall never be used as a convenience to compensate for inadequate inventories
of instruments or implantables. Flash sterilization of implantables shall be
restricted to the direst circumstances.
P. Items which are to be immediate use flash
sterilized shall be cleaned and decontaminated before the sterilization
process.
Q. Traffic areas in which
immediate use or flash sterilization is carried out shall be restricted to
authorized personnel wearing surgical attire consisting of surgical scrubs,
shoe covers, masks and hair covers. The sterilizer shall not be located
adjacent to any potential sources of contamination such as scrub sinks,
clinical sinks or hoppers, wash sinks, linen or trash disposal areas.
R. For immediate use or flash sterilization,
minimal time at effective temperature shall conform to the following:
|
AUTOCLAVE |
LOAD |
MINIMAL TIME AT TEMPERATURE |
|
Gravity |
Nonporous (Simple Metal Instruments) |
3 minutes at 132EC (270EF) |
|
Gravity |
Porous (Towels, Rubber, Plastic) Nonporous Mix |
10 minutes at 132EC (270EF) |
|
Gravity |
Nonporous with Lumens, Deep Grooves, Sliding Parts |
10 minutes at 132EC (270EF) |
|
Gravity/Prevacuum |
Complex Devices, Air-powered Drills |
Per Manufacturer's Instructions |
|
Prevacuum |
Nonporous |
3 minutes at 132EC (270EF) |
|
Prevacuum |
Porous/Nonporous |
4 minutes at 132EC (270EF) |
S.
Items that previously have been packaged, sterilized, and issued, but not used
may be returned to the sterile storage area if the integrity of the packaging
has not been compromised and there is no evidence of contamination; such items
may be dispensed when needed.
Items that previously have been packaged, sterilized and issued to the patient care units or other areas where the environment is not controlled shall be discarded if they are single use items, or unwrapped and reprocessed through decontamination if they are reusable.
T. Sterile materials shall be stored eight to
ten inches from the floor and at least 18 inches from the ceiling and at least
two inches from outside walls. Items shall be positioned so that packages are
not crushed, bent, compressed, or punctured and sterility is not
compromised.
U. All sterilization
techniques other than steam (plasma, ethylene oxide, chemical, etc.) shall
follow the manufacturer's directions and meet all state and federal
regulations.
SECTION 35:
SPECIALIZED SERVICES: RESPIRATORY CARE.
A.
Respiratory Care Services shall be under the direction of a physician member of
the Medical Staff.
B. Respiratory
Care Services, including equipment, shall be supervised by a qualified and
trained respiratory therapist.
C.
There shall be sufficient personnel qualified and trained in respiratory care
to provide respiratory care services.
1.
Services may be performed by an assistant only when a qualified and trained
respiratory therapist is readily available for consultation; and
2. Personnel qualified and trained in
respiratory care shall be on the premises whenever continuous ventilatory
support is provided to patients.
D. All respiratory care personnel shall
maintain competency in:
1. Life support
measures;
2. Isolation techniques;
and
3. Safety techniques for oxygen
and oxygen equipment.
E.
The policy and procedure manual shall have evidence of ongoing review and/or
revision. The first page of the manual shall have the annual review date and
signature of the department supervisor and/or person(s) conducting the
review.
F. Policies and procedures
shall include:
1. Job descriptions;
2. Documentation, verified by the physician
director, of who may perform special procedures and give patient
instructions;
3. Safety
practices;
4. Handling, storage and
dispensing of therapeutic gases;
5.
Infection prevention and control measures;
6. Assembly and operation of
equipment;
7. Respiratory care
services provided and a list of services shall be available to the Medical
Staff;
8. Steps to take in the
event of an adverse reaction;
9.
Cleaning, disinfecting and sterilizing procedures; and
10. Orientation policies for new
employees.
G. Clinically
relevant educational programs shall be conducted on a regularly scheduled basis
not less than 12 per year. There shall be evidence of program dates,
attendance, and subject matter.
H.
If arterial blood gases are performed the Respiratory Care department shall
subscribe to a nationally recognized proficiency testing program for blood
gases and meet the quality control requirements for clinical
laboratories.
I. The Respiratory
Care Service shall have sufficient equipment and adequate facilities
appropriate for safety and effective provision of care.
1. Equipment shall be serviced calibrated,
and operated according to manufacturers' directions.
2. An approved safety system shall be used
with therapeutic gases.
3.
Resuscitation, ventilatory and oxygenation support equipment shall be available
for patients of all sizes.
4.
Ventilators for continuous assistance or controlled breathing shall be equipped
with alarm systems.
5. A preventive
maintenance program shall be implemented and records maintained for the life of
the equipment.
J. All
Respiratory Care prescription/work requests shall specify the type, frequency
and duration of each treatment, and, as required, the type and dose of
medication and the type of diluent and oxygen or medical air.
K. Respiratory Care reports of blood gas
results shall be prepared in duplicate and signed by the therapist responsible
for the procedure/test. The original shall be placed in the patient's medical
record and the copy retained in the department file.
L. Accurate records shall be maintained
regarding the type and duration of each treatment given.
These records shall be correlated with the patient's medical record.
M. Respiratory Care
documentation for each patient shall include:
1. Current written plan of care to include
goals and objectives;
2.
Instructions to patient or patient's family; and
3. Type and duration of the treatment
given.
N. When oxygen is
being administered to a patient:
1. Patients,
visitors and personnel shall be apprised of the fire hazard; and
2. If the patient is in a tent, alcohol or
rub-on lotion shall not be used.
O. Oxygen shall be humidified in accordance
with physician's orders.
P. If
reusable reservoirs are used to humidify the oxygen, the reservoirs shall be
cleaned and disinfected to a high-level of disinfection. (A high-level
disinfection can be expected to kill all microorganisms with the exception of
high numbers of bacterial endospores. Only sterile solutions and diluents shall
be used in humidification and nebulizing equipment. Nebulizers (inline and
hand-held), between treatments on the same patient, shall be disinfected to a
high level and rinsed in sterile water or, if a small volume medication
nebulizer, air dried. All other semicritical equipment shall be cleaned and
disinfected in accordance with the Center for Disease Control and Prevention's
Guidelines.
Q. After use, all
equipment shall be returned to a central location for thorough cleaning,
servicing and disinfecting before use on another patient.
R. There shall be an ongoing QA/PI
program.
S. Contracted Respiratory
Care Services shall be under current agreement and the contractor shall fulfill
all requirements of this section.
NOTE: The National Fire Protection Association Vol. 99, Health Care Facilities, is a mandatory reference for developing safety regulations for Respiratory Care Services.
SECTION 36: SPECIALIZED SERVICE: EMERGENCY
SERVICES.
NOTE: Federal EMTALA requirements apply
A. Every licensed hospital shall have a
dedicated emergency department. The following hospitals are excepted:
1. Psychiatric hospitals;
2. Rehabilitation hospitals;
3. Long term acute care hospitals;
and
4. Prison hospitals.
B. The hospital's emergency
department shall have organized services, procedures, and nationally recognized
protocols for emergencies.
C.
Diagnostic and treatment equipment, medications, supplies and space shall be
adequate in terms of the size and scope of services provided. Resuscitation and
life support equipment shall include but not be limited to:
1. Airway control and ventilation equipment
including laryngoscope and endotracheal tubes, valve-mask resuscitator, sources
of oxygen, pulse oximeter, CO2 monitoring;
2. Suction devices;
3. Standard IV fluids and administration
devices, including IV catheters;
4.
Intravenous fluid and blood warmers;
5. Sterile surgical sets for standard ED
procedures;
6. Gastric lavage
equipment; and
7. Blood pressure
monitoring equipment.
D.
Each emergency department shall have diagnostic imaging and diagnostic
laboratory capabilities available twenty-four (24) hours per day, seven (7)
days per week. Such laboratory services shall include:
1. Standard analyses of blood, urine, and
other body fluids;
2. Blood typing
and cross-matching;
3. Coagulation
studies;
4. Comprehensive blood
bank or access to a community central blood band and adequate hospital storage
facilities; and
5. Blood gases and
pH determination.
E. An
inventory list of all supplies and equipment including all items on the crash
cart, shall be checked each shift and after each use.
F. The location and telephone number of the
nearest poison control center and a list of poison antidotes shall be posted in
the emergency department.
G.
Screening examination
Each patient presenting to the emergency department ("ED") shall have a medical screening examination by a qualified medical personnel. The examination shall be completely documented.
H. Treatment and Disposition
1. If a patient is screened as having an
emergency medical condition, a physician shall be contacted to discuss the
assessment findings and patient's condition. A physician shall determine
disposition of the patient.
2. If a
patient is screened as having a non-emergency medical condition, a hospital may
allow treatment and disposition of the patient by a physician or non-physician
licensed medical professional. This individual must be appropriately
credentialed by the medical staff with approval by the governing body to
provide non-emergent medical care in the Emergency Department.
I. Physician availability
1. Arrangements shall be provided, such as a
duty or on-call roster, to ensure a physician is available for all emergency
patients as determined by the screening examination.
2. Arrangements shall be made for obtaining
specialized medical services.
J. Staffing.
1. The Emergency Service shall be under the
supervision of a Registered Nurse.
2. All patient care personnel assigned to the
emergency department shall receive orientation and be competent in life support
measures.
3. An Advanced Cardiac
Life Support (ACLS) or Pediatric Advanced Life Support (PALS) (as appropriate)
trained person shall be in-house and immediately available.
4. The Registered Nurse shall assume the
responsibility for the nursing functions of the Emergency Services. This
includes:
a. Supervision;
b. Evaluation of the patient's emergency
nursing care needs;
c. The
assignment of nursing care for each patient to other nursing personnel in
accordance with the patient's needs and the preparation and competence of the
nursing staff;
d. Supplies and
equipment;
e. The emergency
department record (See Section 7, General Administration and Sections 15,
Medical Record Requirements for Outpatient Services, Emergency Room and
Observation Services.); and
f.
Maintenance of an emergency department log.
5. Emergency Medical Technician (EMT).
Pursuant to the Arkansas Emergency Medical Service Act Ark. Code Ann.
§§
20-13-201 et.seq., if a hospital
allows an Arkansas Certified Emergency Medical Technician to perform specified
procedures within the Emergency Room or be a member of a hospital code team the
following action shall be taken:
a. The
Medical Staff shall approve the privileges granted to the individual EMT with
concurrence of the hospital's Governing Body. Specific policies governing the
supervision and the procedures to be performed by an EMT shall be developed by
the Medical Staff and approved by the hospital's Governing Body. In no event
shall an EMT perform a procedure that he/she is not certified to do by the
Office of Emergency Services of the Arkansas Department of Health;
b. Approved EMT's shall function in
accordance with physician's orders and under the direct supervision of either
the physician or Registered Nurse responsible for Emergency Services;
c. Students in EMT training programs approved
by the Office of Emergency Medical Services of the Arkansas Department of
Health shall be trained by qualified instructors within the hospital under
guidelines established by the Medical Staff and approved by the Governing Body;
and d. A roster with the delineation of privileges shall be maintained and
readily available.
K. Medications. (See Section 16, Pharmacy and
Section 12, Medications.)
L.
Off-Campus Emergency Departments (off-campus EDs). Off-campus EDs shall meet
all requirements for hospital EDs. Off-campus EDs shall:
1. Function as a department of the parent
hospital.
2. Be fully integrated
into the parent hospital's systems and operations.
a. Medical staff must be part of the parent
hospital's single organized medical staff.
b. Nursing personnel must be part of the
hospital's single organized nursing service.
c. Emergency laboratory and imaging services
must be available 24 hours/day, 7 days/week.
d. Quality assessment/performance improvement
(QAPI) program must be integrated into the parent hospital's QAPI
program.
e. Records must be
maintained as part of the hospital's single medical record system.
f Infection prevention and control practices
must meet the requirements of the parent hospital's infection control policies
and practices.
g. Emergency
services must meet accepted standards of practice for hospital emergency
department.
h. Patients who require
further care must have access to all services of the main hospital.
3. Be open 24 hours per day, 7
days per week.
M.
Emergency Services Facility. The Arkansas Department of Health may license
under Ark. Code Ann. §
20-9-218, hospitals which have
discontinued inpatient services to continue to provide emergency services if
there is no other hospital Emergency Service in the community.
1. The Emergency Services Facility shall be
subject to inspection and to all other provisions of Ark. Code Ann.
§§
20-9-201 et. seq. and
20-13-201 et. seq., as
amended.
2. The Emergency Services
Facility shall have agreements with licensed hospitals to accept patients who
are in need of inpatient hospital services.
3. An emergency facility shall not have
licensed inpatient beds, however, at least one holding/observation bed shall be
provided for patient use not to exceed 24 hours.
4. Emergency Service Facilities shall
provide, or contract to provide emergency ambulance services licensed by the
Arkansas Department of Health, that include radio communication and patient
telemetry. It is further required that contractual agreements be made for
patient air transport services.
5.
Policies and procedures shall be developed and approved by Health Facility
Services of the Arkansas Department of Health, prior to issuance of a license,
and the facility may not provide services without a license.
6. Clinically relevant educational program
shall be conducted on a regularly scheduled basis not less than 12 per year.
There shall be evidence of program dates, attendance, and subject
matter.
7. There shall be an
ongoing QA/PI program that is specific to the patient care
administered.
SECTION
37: SPECIALIZED SERVICE: PSYCHIATRIC SERVICES.
A. Psychiatric care units in general
hospitals shall meet the construction requirements of Section 48, Psychiatric
Nursing Unit, and shall in all respects comply with the requirements of Section
42, Physical Facilities, Patient Accommodations (Adult Medical, Surgical,
Communicable or Pulmonary Disease) except furniture, equipment and supplies may
be modified by the attending physician on an individual patient basis as
verified by signed orders.
B.
General Requirements.
1. Each psychiatric
care unit shall have a written plan describing the organization of services or
the arrangement for the provision of such services to meet patient
needs.
2. The services shall
include, but not be limited to, diagnostic evaluation, individual or group
therapy, consultation and rehabilitation.
3. The unit shall be under the direction and
management of a psychiatrist who is qualified by training and experience for
examination by the American Board of Psychiatry and Neurology or the American
Osteopathic Board of Neurology and Psychiatry and licensed in the State of
Arkansas.
4. The Program Director
of the unit shall be an individual with at least two years administrative
experience.
5. The unit shall
furnish, through the use of qualified personnel, psychological services, social
work services, occupational therapy, recreational therapy and psychiatric
nursing.
6. The unit shall have a
qualified Director of Nursing with a Master's Degree or be qualified by
education and experience in the care of the mentally ill. If the director does
not meet the qualifications, there shall be regular documented consultation by
a qualified Registered Nurse.
7.
Staffing for the unit shall ensure the presence in the unit of a Registered
Nurse at all times. There shall be adequate numbers of Registered Nurses,
Licensed Practical Nurses, and mental health workers to provide the care
necessary under each patient's active treatment program.
8. The unit shall provide or have available,
psychological services to meet the needs of the patients.
9. There shall be a social service staff to
provide services in accordance with accepted standards of practice and
established policies and procedures.
10. The unit shall provide a therapeutic
activities program. The program shall be appropriate to the needs and interests
of the patients and be directed toward restoring and maintaining optimal levels
of physical and psychosocial functioning.
11. There shall be a procedure for referrals
for needed services.
12. There
shall be adequate space, equipment and supplies for services to be provided
effectively and efficiently in functional surroundings that are readily
accessible to the patients. All space, equipment and facilities, both within
the psychiatric facility and those utilized outside the facility, shall be well
maintained and shall meet applicable federal, state and local requirements for
safety, fire, health and sanitation.
13. Policies and procedures shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department director and/or
person(s) conducting the review.
14. Clinically relevant educational program
shall be conducted on a regularly scheduled basis not less than 12 per year.
There shall be evidence of program dates, attendance, and subject
matter.
15. Staff meetings shall be
held at least monthly. Dated minutes of each meeting shall be kept in
writing.
16. There shall be an
ongoing program for orientation of staff.
17. All psychiatric services personnel shall
maintain competency in life support measures.
18. There shall be an ongoing QA/PI
program.
C. Medical
records shall include at least:
1.
Identification data including patient's legal status;
2. Admitting psychiatric diagnosis as well as
diagnoses of medical problems;
3.
Reason for the patient's admission;
4. Social service records including reports
of interviews with patients, family members and others and a social history and
assessment;
5. Psychiatric
evaluation (See Section 15, Medical Record Requirements for Outpatient
Services, Emergency Room, Observation Services and Psychiatric Records);
and
6. Treatment plan (See Section
15, Medical Record Requirements for Outpatient Services, Emergency Room,
Observation Services and Psychiatric Records).
D. Medications. (See Section 16,
Pharmacy.)
E. Food and Nutritional
Services. (See Section 17, Food and Nutrition Services.)
F. Organization of psychiatric nursing units
and services in general hospitals:
1. Medical
direction shall be provided by a qualified psychiatrist and under the
supervision of a Registered Nurse, qualified by training and experience in
psychiatric nursing.
2. In addition
to the requirements set forth for Nursing Services in Section 11, Patient Care
Service, policies and procedures shall be developed specific to the care of the
psychiatric patient.
G.
Supplies and equipment shall be commensurate with the type of services
offered.
H. Medical Records (See
Section 15, Medical Record Requirements for Outpatient Services, Emergency
Room, Observation Services and Psychiatric Records).
SECTION 38:
SPECIALIZED SERVICE: CARE
OF PATIENTS WITH PULMONARY DISEASE IN CRITICAL ACCESS HOSPITALS.
A. In addition to the Patient Care Services
requirements set forth in Section 11, the policies and procedures shall include
specialized procedures specific to respiratory disease patients and shall
include:
1. Collection of sputum;
2. Utilization of respiratory care;
3. Skin test procedures;
4. Tuberculosis control program for
personnel;
5. Follow-up service for
patients after discharge from the hospital; and
6. Provision for individual patient's plan of
care.
SECTION
39:
OUTPATIENT PSYCHIATRIC CENTERS.
Any facility in which psychiatric services are offered for a period of 8 to 16 hours a day, and where, in the opinion of the attending psychiatrist, hospitalization, as defined in the present licensure law, is not necessary, is considered an Outpatient Psychiatric Facility. This definition does not include Community Mental Health Clinics and Centers as they now exist. Such facilities shall conform with applicable sections if those services are provided within the facility. Such facilities shall conform with applicable sections of Section 75, Physical Facilities, Outpatient Care Facilities.
A. General Requirements.
1. Each psychiatric facility shall have a
written plan describing the organization of outpatient services or the
arrangement for the provision of such services to meet patient needs.
2. The outpatient services shall include, but
not be limited to, diagnostic evaluation, individual or group therapy,
consultation and rehabilitation.
3.
The center shall be under the direction and management of a psychiatrist who is
qualified by training and experience requirements for examination by the
American Board of Psychiatry and Neurology or the American Osteopathic Board of
Neurology and Psychiatry and licensed in the State of Arkansas.
4. The Program Director of the Outpatient
Center shall be an individual with at least two years of administrative
experience.
5. The center shall
furnish, through the use of qualified personnel, psychological services, social
work services, occupational therapy, recreational therapy and psychiatric
nursing.
6. The center shall have a
qualified Director of Nursing with a Master's Degree or be qualified by
education and experience in the care of the mentally ill. If the director does
not meet the qualifications, there shall be regular documented consultation by
a qualified Registered Nurse.
7.
Staffing for the center shall insure the presence in the center of a Registered
Nurse during the hours the unit is open. There shall be adequate numbers of
Registered Nurses, Licensed Practical Nurses and mental health workers to
provide the care necessary under each patient's active treatment
program.
8. The center shall
provide or have available, psychological services to meet the needs of the
patients.
9. There shall be a
social service staff to provide services in accordance with accepted standards
of practice and established policies and procedures.
10. The center shall provide a therapeutic
activities program. The program shall be appropriate to the needs and interests
of the patients and be directed toward restoring and maintaining optimal levels
of physical and psychosocial functioning.
11. There shall be a procedure for referrals
for needed services that are not provided directly by the facility.
12. There shall be adequate space, equipment
and supplies for outpatient services to be provided effectively and efficiently
in functional surroundings that are readily accessible and acceptable to the
patients and community services. All space, equipment and facilities, both
within the psychiatric facility and those utilized outside the facility, shall
be well maintained and shall meet applicable federal, state and local
requirements for safety, fire, health and sanitation.
13. Policies and procedures shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department supervisor and/or
person(s) conducting the review.
14. Clinically relevant educational program
shall be conducted on a regularly scheduled basis not less than 12 per year.
There shall be evidence of program dates, attendance, and subject
matter.
15. Regular staff meetings
shall be held at least monthly. Dated minutes of each meeting shall be kept in
writing.
16. There shall be an
ongoing program for orientation of staff.
17. There shall be an ongoing QA/PI
program.
B. Medical
records shall include at least:
1.
Identification data including patient's legal status;
2. Admitting psychiatric diagnosis as well as
diagnoses of medical problems;
3.
The reasons for the patient's admission to this level of care;
4. Social service records including reports
of interviews with patients, family members and others and a social history and
assessment;
5. Psychiatric
evaluation (See Section 37, Specialized Services: Psychiatric
Services.);
6. Treatment plan (See
Section 37, Specialized Services: Psychiatric Services.);
and
C. Medications.
Outpatient Services utilizing medications in therapeutic programs shall fulfill
the requirements in Section 16, Pharmacy.
D. Food and Nutritional Services. (See
Section 17, Food and Nutrition Services.)
E. Physical Facilities. The Outpatient
Psychiatric Centers shall comply with Section 75, Physical Facilities,
Outpatient Care Facilities.
SECTION
40: REHABILITATION HOSPITALS AND UNITS.
A. General Requirements.
1. Rehabilitation Hospital means a hospital
or a distinct part of a hospital as designated in Section 3, Definitions, of
these regulations which is used for the primary purpose of providing
rehabilitative services as so defined and shall comply with Sections 1,
Authority, through Section 38, Specialized Services: Care of Patients with
Pulmonary Disease in General Hospitals. Each hospital or unit shall have the
capability of providing or arranging for emergency services 24 hours per day,
seven days per week.
2. Any
comprehensive physical rehabilitative program shall provide through the use of
qualified professional personnel, at a minimum, the following clinical
services:
a. Physical therapy;
b. Occupational therapy;
c. Speech therapy; and d. Social services or
psychological services.
NOTE: May be provided under contract or arrangement on an as needed basis.
3.
A physician qualified by training, experience and knowledge of rehabilitative
medicine shall be appointed as the Medical Director.
4. Nursing Services shall be under the direct
supervision of a Registered Nurse who has a Master's Degree or be qualified by
education and experience in Rehabilitative Nursing. If the Registered Nurse
does not have the required credentials, a Master's prepared Registered Nurse
shall be available as a consultant. The number of Registered Nurses, Licensed
Practical Nurses and other nursing personnel shall be adequate to formulate and
carry out the nursing components of the individual treatment plan for each
patient. There shall be a Registered Nurse on duty 24 hours per day, seven days
per week, to plan, assign, supervise and evaluate nursing care and to provide
for the delivery of nursing care to patients.
5. A physician licensed in the State of
Arkansas shall be responsible for each patient's general medical condition as
needed. Medical services shall be available 24 hours per day, seven days per
week as needed. Upon admission there shall be written orders for the immediate
care of the patient.
6. Policies
and procedures shall be developed. The manual shall have evidence of ongoing
review and/or revision. The first page of the manual shall have the annual
review date, signature of the department supervisor and/or person(s) conducting
the review.
7. Clinically relevant
educational programs shall be conducted on a regularly scheduled basis not less
than 12 per year. There shall be evidence of program dates, attendance, and
subject matter.
8. Regular staff
meetings shall be held at least monthly. Dated minutes of each meeting shall be
kept in writing.
9. There shall be
an ongoing QA/PI program.
B. Special Medical Record Requirements.
(Refer also to Section 14, Health Information Services.) The medical record
shall include:
1. Reason for referral to
physical rehabilitation services or admission to the comprehensive physical
rehabilitation program;
2. History
and physical examination including patient's clinical condition, functional
strengths and limitations, indications and contra-indications for specific
physical rehabilitative services and prognosis;
3. Goals of treatment and the treatment plan,
including any problem that may affect the outcome of physical rehabilitation
services, and criteria for the discontinuation of services;
4. Interdisciplinary treatment plans to
include measurable goals of treatment and criteria for discharge. The plan
shall include ongoing assessments as required by the patient's medical
condition. Documentation of patient and family in the development of the
treatment plan and resolution of problems and rehabilitation
potential;
5. A discharge summary
that includes recommendations for further care; and
6. Patient evaluation procedures, including
treatment plan for each patient based on the functional assessment and
evaluation. The initial treatment plan shall be developed within 24 hours, and
a comprehensive individualized plan developed no later than one week after
admission and updated at least monthly. The plan shall state the rehabilitative
problem, goals and required therapeutic services, as well as prognosis,
anticipated length of stay and discharge disposition.
C. Physical Environment. The Rehabilitation
Facility shall comply with Section 42, Physical Environment.
D. Physical Facilities. The Rehabilitation
Facility shall comply with Section 76, Physical Facilities, and Rehabilitation
Facilities.
SECTION 41:
RECUPERATION CENTERS.
Any facility which includes inpatient beds with an organized Medical Staff, and with medical services including physician services and continuous nursing services to provide treatment for patients who are not in an acute phase of illness but who currently require primarily convalescent or restorative services, shall be considered a recuperation center and shall comply with applicable Sections 1, Authority, through 72, Physical Facilities, Electrical Standards.
A. Quality
Assurance/Performance Improvement, Infection Prevention and Control, Pharmacy
and Therapeutics, and Utilization Review.
1.
The Recuperation Center shall maintain a Quality Assurance/Performance
Improvement Committee consisting of the Nurse Manager, Medical Director, and at
least three other members of the center's staff, which shall meet at least
quarterly to provide oversight and direction for the center's quality
assurance/performance improvement activities. Minutes of the Quality
Assurance/Performance Improvement Committee shall be maintained.
2. QA/PI activities shall include ongoing
monitoring, with identification of opportunities for improvement, actions
taken, and evaluation of the results of actions. QA/PI activities shall be
reported at least quarterly to the Medical Staff and Governing Body through the
hospital-wide QA/PI program.
3.
Reporting of all infection prevention and control, medication and utilization
review issues specific to the center shall be evident in the minutes of the
hospital-wide Infection Prevention and Control, Pharmacy and Therapeutics and
Utilization Review Committees. Frequency of reporting shall be defined in
policies and procedures consistent with State laws.
B. Patient identification. Patient armbands
shall not be routinely used. Reasonable measures shall be used to identify
patients.
C. Restraints. See
Section 13, Restraints.
D.
Documentation Requirements.
1. An assessment
of the patient's needs shall be completed by a Registered Nurse on
admission.
2. Each assessment shall
be coordinated with all health professionals.
3. The interdisciplinary team shall develop a
comprehensive care plan based on the patient's identified needs, measurable
goals of treatment, methods of intervention, and documentation of resolution or
continuance. There shall be documentation of the patient and family's
participation in the development of the care plan.
4. Verbal/telephone orders shall be reduced
to writing and countersigned by the physician.
E. Physical Environment. The requirements in
Section 44, Physical Facilities, Patient Accommodations (Adult Medical,
Surgical, Communicable or Pulmonary Disease) shall apply to recuperation
centers with the following exceptions:
1. The
patient dining, recreation, and day room(s) may be in separate or adjoining
rooms and shall have a total of 35 square feet per patient bed.
2. Patient corridors shall have handrails on
both sides of the corridors. A clear distance of one and one-half inches shall
be provided between the handrail and the wall. The top of the gripping surface
of handrails shall be 32 inches minimum and 36 inches maximum above the finish
floor. Ends of handrails and grab bars shall be constructed to prevent snagging
the clothes of patients. Exception, special care areas such as those serving
children.
F. Health
Information Services. Applicable parts of item D. of Section 14, Health
Information Services and Section 15, Medical Record Requirements for Outpatient
Services, Emergency Room, Observation Services and Psychiatric
Records.
G. Nursing Services. A
Registered Nurse shall observe each patient at least once per shift and the
observations shall be documented in the patient's medical record.
SECTION 42:
PHYSICAL
ENVIRONMENT.
A. Building and Grounds.
1. The building and equipment shall be
maintained in a state of good repair at all times.
2. Facilities and their premises shall be
kept clean, neat and free of litter, rubbish.
3. Rooms for gas fired equipment shall not be
used for storage except for noncombustible materials.
4. Portable equipment shall be supervised by
the department having control of such equipment and shall be stored in areas
which are not accessible to patients, visitors, or untrained
personnel.
5. Exit Access Corridors
shall be maintained clear and unobstructed of stationary and non-patient
related portable equipment. Stationary or portable non-patient care furnishings
or equipment shall not be stored in an Exit Access Corridor. Any portable
equipment such as a gurney, wheelchair, linen care, etc. that is not actively
used within a 30 minute time period is considered "Stored". The facility's fire
plan and training program shall address the relocation of these items during a
fire. Exit Access Corridors for Health Care Occupancies are those aisles,
corridors and ramps required for exit access that are located outside of a
"suite of sleeping rooms" greater than 5,000 sq. ft. or "suite of rooms"
greater than 10,000 sp. Ft (area is defined as occupiable net floor space).
Encroachments on the width of the means of egress in an Exit Access Corridor by
stationary objects or furnishings shall not be allowed. The width of the means
of egress in an Exit Access Corridor shall be defined by physical means such as
corridor walls, columns, or other approved methods. The means of egress may
provide both visual and physical barrier design characteristics conducive to
establishing a common egress that provides for either a change in floor texture
or self-illumination in the dark.
Alternative consideration: the Means of Egress Requirements for Health Care Occupancies of NFPA 101 (or equivalency per Section 43 of these regulations).
6. Each
hospital shall develop a written preventive maintenance plan. This plan shall
be available to the Department for review at any time. Such plans shall provide
for maintenance as recommended by manufacturer, applicable codes, or
designer.
7. The hand washing
facilities in visitors' rest rooms and the handwashing facilities used by staff
personnel shall be equipped with a soap dispenser, and a towel
dispenser.
8. A supply of hot water
for patient use shall be available at all times. A weekly hot water temperature
log shall be maintained.
9.
Heating, ventilating and air-conditioning (HVAC) systems shall be operated, and
maintained in a manner to provide a comfortable and safe environment for
patients, personnel, and visitors. An air filter change out log shall be
maintained.
B.
Maintenance and Engineering.
1. The physical
plant and equipment maintenance programs shall be under the direction of a
person qualified by training and/or experience and licensed where
required.
2. Equipment Management
Program (EMP). There shall be a preventive maintenance program designed to
assure the electrically powered patient care equipment used to monitor,
diagnose, or provide therapy, performs properly and safely. This program shall
be administered by individuals qualified through training and/or experience or
by procuring a contractual maintenance agreement. The following are minimum
program elements:
a. A current list of
electrically powered patient care equipment shall be maintained regardless of
location or ownership;
b. Each
device, or identical group of devices, shall have a procedure establishing
minimum criteria against which performance and safety are measured. The
elements of these procedures shall be based on the manufacturer's
directions;
c. Each device shall be
tested at intervals of not more than six months unless there is documented
evidence that less frequent testing is justified;
d. Historical records documenting acceptable
performance as established by the procedures shall be maintained;
e. A program to identify and repair equipment
failures shall be maintained;
f
User or owner departments shall be notified of the status of their equipment
when it will be out of service more than 24 hours;
g. There are operator and maintenance
instructions for each device, or group of similar devices on the electrically
powered patient care equipment list; and
h. Individuals shall be trained to operate
and maintain equipment used in the performance of their duties. This training
shall be documented.
3.
Utilities Management Program (UMP). There shall be a preventive maintenance
program designed to assure that the physical plant equipment and building
systems perform properly and safely. This program shall be administered by
individuals qualified through training and/or experience or by procuring a
contractual agreement. This program shall consist of at least the following
minimum elements:
a. A list of physical plant
equipment and/or building system(s) shall be maintained regardless of location
or ownership;
b. Equipment and/or
building system(s), shall have a procedure establishing minimum criteria
against which performance and safety are measured. The elements of these
procedures shall be based on the manufacturer's directions and/or the
experience of the repair technician or operator;
c. Equipment and/or building system(s), shall
be tested, serviced, or inspected at intervals of not more than 12months unless
there is documented evidence that less frequent service is justified;
d. Historical records documenting acceptable
performance as established by the procedures shall be maintained;
e. A program to identify and repair equipment
failures shall be maintained;
f
User or owner departments shall be notified of the status of their equipment or
system when it will be out of service for more than 24hours;
g. There shall be operator and/or maintenance
instructions for each piece of equipment or building system on the list;
and
h. Individuals shall be trained
to operate and maintain physical plant equipment and/or building systems. This
training shall be documented.
4. Life Safety Management Program (LSM).
There shall be a preventive maintenance program designed to assure that all
circuits of fire alarm and detection systems shall be inspected, tested and
maintained in accordance with NFPA 72. Analog detection devices that provide
automatic self testing are exempt from the quarterly testing requirement. This
program shall be administered by individuals qualified through training and/or
experience or by procuring a contractual maintenance agreement. This program
shall consist of the following minimum elements:
a. A list of all fire protection equipment or
component groups shall be maintained;
b. Equipment and/or component groups, shall
have a procedure establishing minimum criteria against which performance and
safety are measured. The elements of these procedures shall be based on the
manufacturer's recommendations and/or the experience of the repair technician
or operator;
c. Fans or dampers in
air handling and smoke management systems shall be reliable and functional at
all times;
d. Automatic fire
extinguishing systems shall be inspected and tested annually; actual discharge
of the fire extinguishing system is not required. Records documenting
acceptable performance as established by the procedures shall be
maintained;
e. A program to
identify and repair equipment and/or component group failures shall be
maintained;
f Systems for
transmitting fire alarms to the local fire department shall be reliable and
functional at all times;
g. There
shall be operator and maintenance instructions for each piece of equipment
and/or component group on the list;
h. Individuals shall be trained to operate
and maintain all equipment and/or component group on the list; and i. Portable
fire extinguishers shall be clearly identified.
5. Emergency Procedures Program (EPP). There
shall be written emergency procedures or a disaster management plan for utility
system disruptions or failures which address the specific and concise
procedures to follow in the event of a utility system malfunction or failure of
the water supply, hot water system, medical gas system, sewer system, bulk
waste disposal system, natural gas system, commercial power system,
communication system, boiler or steam delivery system.
a. These procedures shall be kept separate
from all other policy and procedure manuals as to facilitate their rapid
implementation.
b. These procedures
shall contain but are not limited to the following information:
1. A method of obtaining alternative sources
of essential utilities;
2. A method
of shutoff and location of valves for malfunctioning systems;
3. A method of notification of hospital staff
in affected areas; and
4. A method
of obtaining repair services.
6.
Policies and procedures shall include job descriptions and orientation
practices for employees.
7.
Policies and procedures shall have evidence of ongoing review and/or revision.
The first page of each manual shall have the annual review date, signature of
the department supervisor and/or person(s) conducting the review.
8. Relevant educational programs shall be
conducted at regularly scheduled intervals with no less than six per year.
There shall be evidence of program dates, attendance and subject
matter.
9. The department director
shall ensure that all employees annually attend mandatory educational programs
on the fire safety, back safety, infection prevention and control, universal
precautions, emergency procedures and disaster preparedness or make provisions
to conduct these departmentally.
10. There shall be sufficient supervisory and
support personnel to provide maintenance services in relation to the size and
complexity of the facility and the services that are provided.
11. An ongoing QA/PI program with a liaison
with the Infection Prevention and Control and Safety Committees.
C.
Environmental Services.
1. The environmental
services shall be under the direction of a person qualified by training and/or
experience and licensed where required.
2. There shall be written policies and
procedures which include:
a. Cleaning of the
physical plant;
b. The use, care,
and cleaning of equipment; and
c.
Specific cleaning methods used for:
1)
Operating rooms;
2) Delivery
rooms;
3) Nurseries/infant care
units;
4) Emergency
rooms;
5) Isolation areas;
and
6) Other units as
appropriate.
d. Job
descriptions;
e. Orientation
practices;
f Safety
practices;
g. Infection prevention
and control measures;
h. Methods
used for evaluation of cleaning effectiveness;
i. Personal hygiene;
j. The selection of housekeeping and cleaning
supplies; and
k. The proper use of
housekeeping and cleaning supplies.
3. The policy and procedure manual shall have
evidence of ongoing review and/or revision. The first page of each manual shall
have the annual review date, signature of the department and/or person(s)
conducting the review.
4. Relevant
in-service educational programs shall be conducted at regularly scheduled
intervals with no less than six per year. There shall be written documentation
with employee signatures, program title/subject, presenter, date, and outline
or narrative of presented program.
5. Expendable supplies (i.e., soap, paper
products, etc.) shall be stored in a manner that shall prevent their
contamination prior to use.
6.
Solutions, cleaning compounds, disinfectants, vermin control chemicals, and all
other potentially hazardous substances that are used in connection with
environmental services shall be:
a. Kept in
containers which accurately reflect at least the following:
1) Content name;
2) Concentration of solution;
3) Expiration date and lot number;
b. Stored in a secured area. Under
no circumstances shall these substances be stored in or near food storage or
food preparation areas;
c. Selected
by the director of environmental services or other appointed qualified person.
The Infection Prevention and Control Committee shall initially approve the list
of chemicals used in the facility and thereafter, any additions or deletions to
the list.
7. A designee
from this department shall be a member of the Infection Prevention and Control
Committee.
8. The use of common
towels and common drinking utensils shall be prohibited.
9. Dry, or untreated dusting, sweeping, or
mopping, except vacuum type cleaning shall be prohibited within the
facility.
10. There shall be an
ongoing QA/PI Program with a mechanism for reporting results.
D. Linen Services.
1. Laundry services shall be under the
direction of a person qualified by training and/or experience and licensed
where required.
2. There shall be
sufficient support personnel to provide linen services in relation to the size
and complexity of the facility and the services that are provided.
3. There shall be written policies and
procedures which include:
a. Collection of
soiled, wet, and contaminated linen;
b. Transporting of soiled, wet, and
contaminated linen to the laundry service or to a designated area for
commercial pick-up;
c. Storage of
soiled, wet, and contaminated linen until laundering or being picked up by the
commercial laundry;
d. Storage of
clean linen; and
e. Specific
laundry requirements (type detergent, sours, bleach, time and temperatures
used) for washing:
1) New linen;
2) Diapers;
3) Soiled, wet, and contaminated
linen.
f Personal
hygiene;
g. Evaluation of
washing/cleaning effectiveness;
h.
Job descriptions;
i. Orientation
practices for new employees;
j.
Safety practices; and
k. Infection
prevention and control measures.
4. Policies and procedures for Linen Services
shall have evidence of ongoing review and/or revision. The first page of the
manual shall have the annual review date, signature of the department
supervisor and/or person(s) conducting the review.
5. Relevant in-service educational programs
shall be conducted at regularly scheduled intervals with no less than six per
year. There shall be written documentation with employee signature, program
title/subject, presenter, date and outline or narrative of presented
program.
6. Facility linen service:
a. Sorting of soiled laundry shall be done in
a designated area;
b. Tables or
bins shall be provided for sorting of soiled laundry;
c. Lint traps shall be provided on dryers and
shall be cleaned regularly;
d.
Prerinsing shall be done in the laundry service not in showers, bathtubs or
lavatories;
e. Removal of solid
soil shall be done in soiled utility rooms or rooms that are designated for
this purpose;
f Patient clothing may
be washed in the patient area if a separate equipped laundry room is
available;
g. A rinsing sink shall
be provided in the soiled linen area of the laundry;
h. Hot water supplied to laundry areas shall
be in accordance with Table 9 of the Appendix;
i. Linen contained in hot water soluble
plastic bags (identified as being contaminated) shall be placed directly into
the washing machine without being removed from the bag for sorting;
j. A lavatory equipped with wrist action
controls, a soap dispenser and a towel dispenser shall be provided in the
laundry for use by the personnel;
k. Personnel with infectious disease or open
wounds shall not be permitted in the laundry; and
l. Personnel assigned to laundry duties shall
wash their hands:
1) After handling wet or
soiled laundry;
2) Before leaving
the laundry;
3) After using the
toilet; and
4) As often as is
necessary to maintain good hygiene.
NOTE: Laundry equipment and installation requirements are set forth in Section 64, Physical Facilities, Linen Service.
7. Soiled linen from
isolation areas, surgical cases, etc., shall be placed into impervious bags
and, if leakage occurs, bagged into a second bag with proper identification.
Suitable precautions shall be taken in transport, handling, and processing.
8. Soiled, wet, and contaminated
linens shall be transported in a closed container.
9. Soiled, wet, and contaminated linens shall
be stored in closed containers or impervious bags in designated areas off the
floor. Areas for storage of soiled, wet, and contaminated linens shall have
forced ventilation to the outside of the building.
10. All new clothing, linen and diapers shall
be laundered before being used.
11.
There shall be a designated area for the storage of clean linens.
12. The linen service within the facility
shall have a capacity sufficient to process a continuous supply of clean
laundry ready for use.
13.
Temperature used in the dryer will depend on the type fabric. An employee shall
be present at all times when the dryer is in operation.
14. There shall be an ongoing QA/PI Program
with a mechanism for reporting results.
15. Linen Service shall include a written
contingency plan indicating an alternative provision that may be followed in
the event the laundry is unable to meet the production demand of the
facility.
16. Separate containers
for the disposal of infectious waste and sharps shall be located in the soiled
linen sorting area.
17. Laundry
workers handling infectious linens shall wear protective equipment, including
but not limited to waterproof, puncture-resistant gloves, protective
over-clothing, and where necessary, face shields or goggles.
18. Facilities which do not have linen
services:
a. The facility shall determine that
all launderable items are processed in a commercial laundry in accordance with
standards set forth in this section and shall conduct annual onsite inspections
of the commercial laundry and shall require written verification of compliance
by the laundry.
b. Soiled, wet, and
contaminated laundry shall be stored in a designated area until pick up by the
commercial laundry;
c. A designated
clean area shall be provided for receiving clean laundry and shall be separate
from the soiled linen area;
d.
Clean linen shall be packaged and protected from contamination during
transportation and storage.
19. Refer to Section 18, Infection Prevention
and Control, for additional requirements.
E. Safety Services.
1. There shall be an effective program to
enhance safety within the facility and grounds. The program shall be monitored
by a Safety Committee appointed by the Administrator. Committee members may be
selected from areas such as Administration, Nursing, Maintenance, Housekeeping,
Laboratory, Respiratory Care, Rehabilitation Services, the Medical Staff and
others as appropriate.
2. The
Safety Committee shall meet a minimum four times per year to fulfill safety
objectives. Minutes of each meeting shall be recorded and kept in the
facility.
3. The Administrator
shall designate a specific individual to carry out policies established by the
Committee and to gather data for the Committee to study safety related
incidents.
4. Safety policies and
procedures shall have evidence of ongoing review and/or revision. The first
page of each manual shall have the annual review date, signature of the
department supervisor and/or person(s) conducting the review. Safety policies
and procedures shall include:
a. Facility
wide hazard surveillance program;
b. Response to medical-device recalls and
hazard notices;
c. Safety
education;
d. Reporting of all
accidents, injuries, and safety hazards;
e. External and internal disaster
plans;
f Fire safety; and
g. Safety devices and operational
practices.
5. The
orientation program for the facility shall include the importance of general
safety, fire safety and the responsibility of each individual to the
program.
6. The Safety Committee
shall have the following functions:
a.
Monitoring the results of the safety program and analyzing the effectiveness of
the program annually;
b. Monitor
fire drills and disaster drills at required intervals;
c. Conclusions, recommendations, and actions
of the committee shall be reported to the Board at a minimum annually;
and
d. Ensuring each department or
service shall have a safety policy and procedure manual within their own area
that is a part of the overall facility safety manual and establishes safety
policies and procedures specific to each area.
7. Fire extinguishers shall be provided in
adequate numbers, of the correct type, and shall be properly located and
installed. Personnel shall be trained in the proper use of fire extinguishers
and equipment. Personnel shall follow procedures in fire containment and
evacuating patients in case of fire or explosion. There shall be an annual
check of all fire extinguishers by qualified persons in accordance with the
applicable sections of the National Fire Protection Association's Standard 10
(NFPA 10). The date the check was made and the initials of the inspector shall
be recorded on the fire extinguisher or on a tag attached to the
extinguisher.
8. Any fire or
disaster event at the facility shall be reported immediately to the Arkansas
Department of Health by telephone 501-661-2201 during regular working hours or
to 501-661-2136 after normal working hours, holidays and weekends. If any
fire(s) or disaster is not reported to the Department, the facility is subject
to a fine, refer to item J. of Section 4, Licensure and Codes.
9. There shall be policies and procedures
governing the routine methods of handling and storing flammable and explosive
agents, particularly in operating rooms, delivery rooms, laundries and in areas
where oxygen therapy is administered.
10. There shall be keys available to assure
prompt access to all locked areas. All doors shall be devised so they can be
opened from the inside of the locked area. Special door locking devices are
acceptable in limited areas. Usage is subject to all codes and
regulations.
11. All required exit
doors shall remain unlocked per NFPA requirements.
12. A list of Material Safety Data Sheets
(MSDS) for solutions, cleaning compounds, disinfectants, vermin control
chemicals, and other potentially hazardous substances used in connection with
the facility shall be readily available to the Safety Committee, Emergency
Room, Environmental Services and as directed by facility policy and
procedures.
SECTION
43:
PHYSICAL FACILITIES.
A. General Considerations.
1. The requirements set forth herein have
been established by the Department and constitute minimum requirements for the
design, construction, renovation, and repair of facilities requiring licensure
under these regulations.
2.
Facilities shall be accessible to the public, staff, and patients with physical
disabilities. Minimum requirements shall be those set forth by the Arkansas
State Building Services, Minimum Standards and Criteria -Accessibility for the
Physically Disabled Standards.
3.
Projects involving renovation and additions to existing facilities shall be
programmed and phased to minimize disruption of the existing functions. Access,
exits and fire protection shall be maintained for the occupant's and the
facility's safety.
4. Codes and
Standards. Nothing stated herein shall relieve the owner from compliance with
building codes, ordinances, and regulations which are enforced by city, county,
or other State jurisdictions. Where such codes, ordinances, and regulations are
not in effect, the owner shall consult the state building codes for all
components of the building type which are not specifically covered by these
minimum requirements. In location where there is a history of tornadoes,
floods, earthquakes or other regional disasters, planning and design shall
consider the need to protect the occupants and the facility.
B. Occupancy: Each licensed
facility or portion of a licensed facility shall be classified as indicated
below:
1. General Hospital: A facility or
portion of a facility licensed by the Department as a General Hospital that
provide for patient care, treatment, or diagnosis on a 24 hour basis and
provides treatment or anesthesia for patients that renders the patients
incapable of taking action for self-preservation under emergency conditions
without the assistance of others.
2. Mobile, Transportable, and Relocatable
Unit: A portion of a facility licensed by the Department that meets the
definitions provided in Section 54 for mobile, transportable, and relocatable
units.
3. Outpatient Care Facility:
A portion of a facility licensed by the Department that provides patient care,
treatment or diagnosis on a less than 24 hour basis and does not provide
treatment or anesthesia for patients that renders the patients incapable of
taking action for self-preservation under emergency conditions without the
assistance of others.
Outpatient care facilities may be utilized on occasion by hospital inpatients provided that such use is limited to a less than 24 hour basis.
4. Rehabilitation
Facility: A facility or portion of a facility licensed by the Department as a
Rehabilitation Facility.
5.
Non-Healthcare Occupancy: A portion of a licensed facility that does not
contain areas intended for patient care, treatment, or diagnosis and does not
contain equipment (mechanical, electrical, plumbing, communication, fire alarm,
etc.) that serves areas intended for patient care, treatment, or
diagnosis.
C. Multiple
Occupancy: Facilities may contain more than one occupancy (as described above)
provided each different occupancy is separated from all other occupancies by a
2-hour fire resistive rated smoke barrier.
D. Construction Projects: Each construction
project shall be classified as indicated below:
1. Addition: A project that increases the
floor area of a licensed facility.
2. Repair: A project that provides for the
repair or renewal of a licensed facility or portion of a licensed facility
solely for the purpose of its maintenance.
3. Simple Renovation: A project other than
repair that meets all of the criteria listed below:
a. The project does not increase the floor
area of a licensed facility.
b. The
project does not change the occupancy of a licensed facility or portion of a
licensed facility.
c. The project
does not involve more than two (2) smoke compartments.
d. The smoke compartments affected by the
project were completely protected by an automatic sprinkler system prior to the
project or the project provides for the installation of a complete automatic
sprinkler system in all smoke compartments that are affected by the
project.
E.
Applicable Requirements Based upon Occupancy:
1. Existing Facilities: Existing facilities
that do not comply with these regulations shall be permitted to continue in
service, provided the lack of conformity with these regulations does not
present a serious hazard to the occupants as determined by Health Facility
Services or other authorities having jurisdiction.
2. General Hospital: Facilities or portions
of facilities classified as a General Hospital occupancy shall be designed,
constructed, and renovated in accordance with the Sections of these regulations
listed below and all publications and Appendices referenced by these Sections.
a. Section 42
b. Section 43
c. Section 44 through 53
d. Sections 54 through 76
3. Mobile, Transportable, and
Relocatable Unit: Facilities or portions of facilities classified as a Mobile,
Transportable, and Relocatable Unit occupancy shall be designed, constructed,
and renovated in accordance with the Sections of these regulations listed below
and all publications and Appendices referenced by these Sections.
a. Section 42
b. Section 43
c. Section 54
4. Outpatient Care Facility: Facilities or
portions of facilities classified as Outpatient Care Facility occupancy shall
be designed, constructed, and renovated in accordance with the Sections of
these regulations listed below and all publications and Appendices referenced
by these Sections.
a. Section 42
b. Section 43
c. Section 75
5. Rehabilitation Facility: Facilities or
portions of facilities classified as an Outpatient Care Facility occupancy
shall be designed, constructed, and renovated in accordance with the Sections
of these regulations listed below and all publications and Appendices
referenced by these Sections.
a. Section
42
b. Section 43
c. Section 76
6. Non-Healthcare Occupancy Facilities or
portions of facilities classified as a Non-Healthcare occupancy shall be
designed, constructed, and renovated in accordance with the Sections of these
regulations listed below and all publications and Appendices referenced by
these Sections.
a. Section 42
b. Section 43
F. Applicable Requirements Based upon the
Type of Project:
1. General:
a. Where renovation work is done within an
existing facility, all new work, or additions, or both, shall comply, insofar
as practical with applicable sections of these regulations and appropriate
sections of National Fire Protection Association (NFPA) 101 Life Safety Code
covering new occupancies. Where major structural elements make total compliance
impractical or impossible, exceptions will be considered.
b. In renovation projects and projects
involving additions to existing facilities, only that portion of the total
facility affected by the project shall comply with applicable sections of these
regulations and with appropriate parts of NFPA 101 covering new occupancies.
Existing portions of the facility that are not included in the project but
essential to the functioning of a complete facility shall comply (at a minimum)
with the appropriate sections of NFPA 101 covering existing occupancies.
Existing portions of the facility that receive less then substantial amounts of
new work, shall also comply (at a minimum) with the appropriate sections of
NFPA 101 covering existing occupancies.
c. Facilities or portions of facilities shall
be permitted to be occupied during construction, renovation, and repair only
where required means of egress and required fire protection features are in
place and continuously maintained for the portion occupied or where alternate
life safety measures acceptable to Health Facility Services and other
authorities having jurisdiction are in place.
2. Addition, Simple Renovation, and Complex
Renovation shall be designed, constructed, and renovated in accordance with the
applicable Sections of these regulations and all Appendices and publications
referenced by these Sections.
3.
Repair projects shall be designed and constructed in a manner that does not
diminish the safety level that existed prior to the start of the
work.
G. Project Review
and Approval Process.
1. Coordination: Health
Facilities Services will coordinate the review and approval process for all
offices of the Department.
2.
Addition or Complex Renovation Projects shall be reviewed and approved by
Health Facility Services as indicated below:
a. Drawing Review and Approval Process:
1) Submission of Plan Review Fee: A plan
review fee in the amount of one percent of the total cost of construction or
$500.00, whichever is less, shall be paid for the review of plans and
specifications. The plan review fee check is to be made payable to Arkansas
Department of Health. A detailed estimate shall accompany the plans unless the
maximum fee of $500.00 is paid.
2)
Submission of Functional Program: Refer to Section 43, Paragraph H.
3) Submission of Site Location: Refer to
paragraph Section 43, Paragraph I.
4) Submission of Preliminary Plans: Refer to
Section 43, Paragraph J.
5) Review
of Functional Program, Site Location, and Preliminary Plans: Health Facility
Services shall review the Functional Program, Site Location, and Preliminary
Plans and forward a written response with comments to the Facility.
6) Submission of Final Construction
Documents: Refer to Section 43, Paragraph K.
7) Review and Approval of Final Construction
Documents: Health Facility Services shall review the Final Construction
Documents and forward a written response with comments to the Facility and the
Design Professional. Health Facility Services shall have a minimum of six (6)
weeks to review Final Construction Documents. The written response shall
indicate whether or not the Final Construction Documents are approved. If the
Final Construction Documents are not approved, the written response shall
indicate the design modifications required to secure
approval.
b. Approval to
Begin Construction: Facilities may proceed with Addition and Complex Renovation
projects after receiving a letter from Health Facility Services stating that
the Final Construction Documents have been reviewed and approved and after
receiving approval from other authorities having jurisdiction.
c. Site Inspections During Construction:
Refer to Section 43, Paragraph L.
d.
Final Site Inspection: Refer to Section 43, Paragraph M.
2. Repair: Repair projects do not require
Health Facility Services review and approval.
3. Simple Renovation Projects submitted to
Health Facility Services shall be reviewed and approved by Health Facility
Services as indicated below:
a. Drawing
Review and Approval Process:
1) Submission of
Plan Review Fee: A plan review fee in the amount of one percent of the total
cost of construction or $500.00, whichever is less, shall be paid for the
review of plans and specifications. The plan review fee check is to be made
payable to the Arkansas Department of Health. A detailed estimate shall
accompany the plans unless the maximum fee of $500.00 is paid.
2) Submission of Functional Program: Refer
to Section 43, Paragraph H.
3)
Submission of Final Construction Documents: Refer to Section 43, Paragraph
K.
4) Review and Approval of Final
Construction Documents: Health Facility Services shall review the Final
Construction Documents and forward a written response with comments to the
Facility. Health Facility Services shall have a minimum of six (6) weeks to
review Final Construction Documents. The written response shall indicate
whether or not the Final Construction Documents are approved. If the Final
Construction Documents are not approved, the written response shall indicate
the design modifications required to secure approval.
b. Approval to Begin Construction: Facilities
may proceed with Simple Renovation projects after receiving a letter from
Health Facility Services stating that the Final Construction Documents have
been reviewed and approved and after receiving approval from other authorities
having jurisdiction.
c. Site
Inspections During Construction: Refer to Section 43, Paragraph L.
d. Final Site Inspection: Refer to Section
43, Paragraph M.
H. Functional Program.
The facility shall supply for each project (other than repair project) a functional program that describes the purpose of the project and indicates the estimated cost of construction.
I. Site Location.
1. Location.
a. The site of any medical facility should be
easily accessible to the community and to service vehicles such as fire
protection apparatus.
b. Facilities
should be located with due regard to the accessibility by public transportation
for patients, staff, and visitors, and availability of competent medical and
surgical consultation.
c. The
facility should have security measures for patients, personnel, and the public
consistent with the conditions and risks inherent in the location of the
facility. These measures shall include a program designed to protect human and
capital resources.
d. The facility
should be located to provide reliable utilities (water, natural gas, sewer and
electricity).
e. The site should
afford good drainage and shall not be subject to flooding nor be located near
insect breeding areas, excessive noise, nor other nuisance producing locations,
nor near airports, railways, air pollution, penal institutions (except prison
infirmaries), or a cemetery.
2. Roads and Parking.
a. Paved roads and walks shall be provided
within the lot lines to provide access to the main entrance and service
entrance, including loading and unloading docks for delivery trucks. Hospitals
having an organized emergency services department shall have the emergency
entrance well marked to facilitate entry from the public roads or streets
serving the site. Access to the emergency entrance shall not conflict with
other vehicular traffic or pedestrian traffic. Paved walkways shall be provided
for necessary pedestrian traffic.
b. Each facility shall have parking spaces to
satisfy the minimum needs of patients, employees, staff, and visitors. In the
absence of a formal parking study, each facility shall provide not less than
one space for each day shift staff member and employee plus one space for each
patient bed. This ratio may be reduced in an area convenient to a public
transportation system or to a public parking facility if proper justification
is given and provided that approval of any reduction is obtained from the
Department. Additional parking shall be required to accommodate outpatient and
other services when they are provided. Space shall be provided for emergency
and delivery vehicles.
3.
Subsoil Investigation. Subsoil investigation shall be made to determine the
subsurface soil and water conditions. The investigation shall include a
sufficient number of test pits or test borings to determine, in the judgment of
the architect and the structural engineer, the true subsurface conditions.
Results of the investigation shall be available in the form of a soil
investigation report or a foundation engineering report. The investigation
shall be made in close cooperation with the architect and structural engineer
and shall contain detailed recommendations for foundation design and gradings.
The following is a general outline of the suggested scope of soil
investigation:
a. The borings or test pits
shall extend into stable soils well below the bottom of any proposed
foundations. A field log of the borings shall be made and the thickness,
consistency, and character of each layer recorded;
b. The amount and elevation of groundwater
encountered in each pit or boring and its probable variation with the seasons
and effect on the subsoil shall be determined. High or low water levels of
nearby bodies of water affecting the ground level shall also be
determined;
c. Laboratory tests
shall be performed to determine the safe bearing value and compressibility
characteristics of the various strata encountered in each pit or
boring;
d. Maximum depth of frost
penetration below surface of the ground shall be recorded;
e. Tests shall be made to determine whether
the soil contains alkali in sufficient quantities to affect concrete
foundations;
4.
Approval. The new building site shall be inspected and approved by the
Department before construction begins.
J. Preliminary Plans: Preliminary plans
submitted to Health Facility Services shall include minimum the following
information:
1. Floor plans drawn to scale
that indicate room names, room dimensions, corridor dimensions, locations of
fire resistive rated partitions, and locations of rated smoke
barriers.
2. An existing floor plan
indicating existing spaces and exits and their relationship to the new
construction (renovation projects only)
3. Building sections that establish the
proposed construction type and fire rating. Sections shall be drawn at a scale
sufficiently large to clearly present the proposed construction
system.
4. A site plan that
indicates the location of proposed roads, walks, service and entrance courts,
parking and orientation.
5. Simple
horizontal and vertical space diagrams that indicate the relationship of
various departments and services to each other the general room arrangement in
each department.
6. A narrative
description of proposed mechanical, electrical, and fire protection
systems.
K. Final
Construction Documents.
1. Construction
Documents shall be prepared by an architect and/or professional engineer
licensed by the State of Arkansas.
2. Architectural construction documents shall
be prepared by an architect and engineering construction documents (structural,
mechanical, electrical, and civil) shall be prepared by a qualified engineer.
The documents shall be stamped with appropriate seals for each
discipline.
3. Periodic observations
of construction shall be provided and documented by each design professional.
Design professionals shall verify that the construction is in accordance with
the construction documents and that the Record Drawings are properly
maintained.
4. The construction
contract shall contain a provision to withhold progress payments to the
contractor until the Record Drawings are current.
5. Final Construction Documents shall include
drawings and specifications. Separate drawings and specifications shall be
prepared for each of the following branches of work: architectural, structural,
mechanical, electrical, life safety and fire protection.
6. The drawings shall include the following
information:
a. Architectural.
1) Approved plan showing all new topography,
newly established levels and grades, existing structures on the site (if any),
new buildings and structures, roadways, walks, and the extent of the areas to
be planted. All structures and improvements removed under the construction
contract. A print of the survey included with the working drawings.
2) Plan of each floor, roof, and all
intermediate levels.
3) Elevations
of each exterior wall.
4) Sections
through building.
5) Scale details
as necessary to properly indicate portions of the work.
6) Schedule of finishes.
b. Equipment.
1) Large scale drawings of typical and
special rooms indicating all fixed equipment and major items of furniture and
movable equipment.
2) The furniture
and movable equipment not included in the construction contract shall be
indicated by dotted lines.
c. Structural.
1) Plans of foundations, floors, roofs, and
all intermediate levels shall show a complete design with sizes, sections, and
the relative location of the various members and schedule of beams, girders,
and columns.
2) Dimensional floor
levels, column centers and offsets.
3) Special openings.
4) Details of all special connections,
assemblies, and expansion joints.
5)
Name of the governing building code.
d.
Mechanical.
1) Heating, piping,
and air-conditioning systems:
a) Steam heated
equipment, such as sterilizers, warmers, and steam tables;
b) Heating and steam mains and branches with
pipe sizes;
c) Diagram of heating
and steam risers with pipe sizes;
d)
Sizes, types, and heating surfaces of boilers and oil burners, if
any;
e) Pumps, tanks, boiler
breeching and piping, and boiler room accessories;
f) Air-conditioning systems with required
equipment, water refrigerant piping, and ductwork showing required fire
smoke/dampers;
g) Air quantities
for all room supply, return, and exhaust ventilating duct openings;
h) A ventilation schedule specifying the
following information: room number, room name, room volume (ft3), required room
air changes, required outside air changes, required air movement relative to
adjacent area, required air filtration (% efficiency), required room total
supply air quantity (CFM), required room exhaust air quantity (CFM), design
room total supply air quantity (CFM), design room return air quantity (CFM),
design outside air quantity(CFM), design room exhaust air quantity (CFM),
design room air filtration (% efficiency), room design summer ('F) dry bulb/wet
bulb (DB/WB), room design winter ('F) DB/WB, outside air design summer ('F)
DB/WB, and outside air design winter ('F) DB/WB.
i) Air filter design pressure drop both clean
and dirty.
2) Plumbing,
drainage, and standpipe systems:
a) Size and
elevation of street sewer, house sewer, house drains, and street water
main;
b) Locations and size of
soil, waste, and vent stacks with connections to house drains, clean outs,
fixtures and equipment;
c) Size and
location of hot and cold circulating mains, branches, and risers from the
service entrance and tanks;
d)
Riser diagram to show all plumbing stacks with vents, water risers, and fixture
connections;
e) Gas, oxygen, and
special connections;
f) Standpipe
and sprinkler systems;
g) Plumbing
fixtures and equipment which require water and drain
connections;
3) Elevators
and dumbwaiters: Details and dimensions of shaft, pit and machine room, pit
sumps with alarms when required, sizes of car platform and doors.
4) Kitchens, laundry, refrigeration, and
laboratories detailed at a satisfactory scale (1/4 inch scale) to show the
location, size, and connection of all fixed and moveable
equipment.
e. Electrical.
1) All electrical wiring, outlets, smoke
detectors, and equipment which require electrical connections.
2) Electrical service entrance with switches,
and feeders to the public service feeders, characteristics of the light and
power current and transformers and their connections, if located in the
building.
3) Plan and diagram
showing main switchboard power panels, light panels and equipment. Diagram of
feeder and conduit sizes with a schedule of feeder breakers or
switches.
4) Light outlets,
receptacles, switches, power outlets, and circuits.
5) Telephone layout showing service
entrance, telephone switchboard, terminal boxes, and telephone
outlets.
6) Nurse call systems with
outlets for beds, nurse's stations, door signal lights, annunciators, and
wiring diagrams.
7) Staff paging
and doctor's in-and-out registry systems with all equipment wiring, if
provided.
8) Fire alarm and or
security system with stations, signal devices, control board, and wiring
diagrams.
9) Emergency electrical
system with outlets, transfer switch, source of supply, feeders, and circuits.
10) Medical gas alarm
systems.
11) All other electrically
operated systems and equipment.
f Life Safety and Fire Protection.
1) Limits of each smoke
compartment.
2) Location of each
smoke barrier wall.
3) Dimensions
and gross areas of each smoke compartment.
4) Location of each fire rated wall or
partition, fire separation wall and horizontal exit.
5) Location of each exit sign, fire pull
station, and extinguisher cabinet and extinguisher.
6) Travel distance(s) from the most remote
location(s) in the building to an exit as defined by NFPA 101 (i.e., horizontal
exit, exit passageway, enclosed exit stair, exterior exit
door).
g. Specifications.
1) Specifications shall supplement the
drawings to fully describe types, sizes, capacities, workmanships, finishes,
and other characteristics of all materials and equipment and shall include the
following:
a) Cover or title sheet with
architectural seal;
b)
Index;
c) General
conditions;
d) General
requirements;
e) Sections
describing material and workmanship in detail for each class of
work.
h. All
construction documents and specifications shall be approved by the Department
prior to the beginning of construction and a letter shall be issued from the
licensing agency granting approval to commence with construction. The
Department shall have a minimum of six weeks to review construction documents
and specifications. Health Facility Services shall coordinate the plan review
with other Divisions in the Department. Penalties for starting construction
without Department approval see Section 4.1, Licensure and
Codes.
L. Site
Inspection During Construction. The Department shall inspect the project during
the construction process as indicated below:
1. This Department is to be notified when
construction begins and a construction schedule shall be submitted to determine
inspection dates.
2.
Representatives from the Department shall have access to the construction
premises and the construction project for purposes of making whatever
inspections deemed necessary throughout the course of construction.
3. Any deviation from the accepted
construction documents shall not be permitted during construction, until the
written request for change(s) in the construction is approved by this
Department.
M. Final Site
Inspection.
1. Upon completion of
construction and prior to the approval by the Department to occupy and use the
facility, the owner shall be furnished a complete set of recorded drawings and
a complete set of installation, operation, and maintenance manuals and parts
lists for the installed equipment.
2. A list of final site inspection items has
been provided in the Table 5 of the Appendix.
3. No facility shall occupy any new structure
or major addition or renovation space until the appropriate permission has been
received from the local building and fire authorities and licensing
agency.
N. Referenced
Publications.
1. General: These regulations
include references to other codes and standards. The most current codes and
standards adopted at the time of this publication are used. Later issues will
normally be acceptable where requirements for function and safety are not
reduced; however, editions of different dates may have portions renumbered or
re-titled. Care shall be taken to ensure that appropriate sections are
used.
2. Publications adopted in
whole by these regulations are as listed below:
a. American National Standards Institute
(ANSI) Standard A17.1, "American National Standard Safety Code for Elevators,
Dumbwaiters, Escalators and Moving Stairs."
b. American Society of Civil Engineers,
(ASCE), "Minimum Design Loads for Buildings and Other Structures."
c. Arkansas Building Authority, Minimum
Standards and Criteria -Accessibility for the Physically Disabled
Standards.
d. National Council on
Radiation Protection (NCRP), Report No. 33, "Medical X-ray and Gamma Ray
Protection for Energies Up to 10 MeV Equipment Design and Use, 1986."
e. National Council on Radiation Protection
(NCRP), Report No. 49, "Medical X-ray and Gamma Ray Protection for Energies up
to 10 MeV Structural Shielding Design and Evaluation, 1976."
f National Council on Radiation Protection
(NCRP), Radiation Protection Design Guidelines for 0. Ipi29100, MeV Particle
Accelerator Facilities.
g.
National Fire Protection Association 101, "Life Safety Code, 2000 Edition".
Note that "Mandatory References" are listed in Chapter 2 of this
document.
h. Rules and Regulations
Pertaining to the Management of Regulated Waste from Health Care Related
Facilities, Arkansas Department of Health.
3. Publications adopted in part (only the
sections specifically identified by these regulations are applicable) by these
regulations are as listed below:
a. American
Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE),
"Handbook of Fundamentals" and "Handbook of Applications."
b. American Society of Heating,
Refrigerating and Air Conditioning Engineers (ASHRAE), Standard 52, "Method of
Testing Air Cleaning Devices Used in General Ventilation for Removing
Particulate Matter."
c.
Illuminating Engineering Society of North America, IESNA Publication CP29,
"Lighting for Health Care Facilities."
4. A partial list of other publications that
are applicable to the design and construction of healthcare facilities that are
not a part of these regulations but may be enforced by other authorities having
jurisdiction is provided below:
a. Arkansas
State Fire Prevention Code Volumes I, II, and III (based on the 2000
International Building Code).
b.
Arkansas State Mechanical Code, Arkansas Department of Health.
c. Arkansas State Plumbing Code, Arkansas
Department of Health.
d. Arkansas
Boiler Code, Arkansas Department of Labor.
5. Publications that are not a part of these
regulations but potentially helpful as reference material in the design and
construction of healthcare facilities are as listed below:
a. American Institute of Architects (AIA),
"Guidelines for Design and Construction of Hospital and Health Care Facilities
2001 Edition".
b. American Society
of Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE), "HVAC
Design Manual for Hospitals and Clinics".
O. Availability of Codes and Standards.
Referenced publications can be ordered, if they are Government publications,
from the Superintendent of Documents, U.S. Government Printing Office (GPO),
Washington, DC 20402. Copies of non-government publications can be obtained at
the addresses listed below.
1. Air
Conditioning and Refrigeration Institute, 1501 Wilson Boulevard, Arlington, VA
22209.
2. American National
Standards Institute, 1430 Broadway, New York, NY 10018.
3. American Society of Civil Engineers, 345
East 47th Street, New York, NY 10017
4. American Society for Testing and
Materials, 1916 Race Street, Philadelphia, PA 19103.
5. American Society of Heating,
Refrigerating, and Air Conditioning, 1741 Tullie Circle, NE, Atlanta GA
30329.
5. Arkansas State Building
Services, 1515 West 7th Street, Suite 700, Little Rock, AR 72201.
7. Arkansas Department of Labor, 10421 West
Markham, Little Rock, AR 72205.
8.
Illuminating Engineering Society of North America (TESNA), 120 Wall Street,
17th Floor, New York, NY 10005.
9. National Council on Radiation Protection
and Measurement, 7910 Woodmont Avenue, Suite 1016, Bethesda, MD
20814.
10. National Fire Protection
Association, 1 Batterymarch Park, Post Office Box 9101, Quincy, MA
02269-9101.
11. International
Building Code Congress International, Inc., 900 Montclair Road, Birmingham, AL
35213.
P.
Interpretations of Requirements.
1.
Memorandum of Understanding: Conflicts between the Arkansas Fire Prevention
Code and NFPA 101 Life Safety Code are to be resolved using the Memorandum of
Understanding as indicated below:
a. The
Arkansas Fire Prevention Code is the fire prevention code for the State of
Arkansas.
b. When the Arkansas
State Fire Prevention Code conflicts with the chapters of NFPA 101 Life Safety
Code governing new and existing health care and ambulatory health care
occupancies (Chapters 18, 19, 20, and 21), the provisions of the Life Safety
Code shall govern.
c. Requirements
found only in the Arkansas Fire Prevention Code (requirements not addressed by
NFPA 101) may be provided at the option of the facility (compliance with these
requirements is not mandatory).
2. Safety Improvement Plans: Nothing in these
regulations shall be construed as restrictive to a facility that chooses to do
work as a part of a long-range safety improvement plan. These regulations do
not prohibit a single phase of improvement. All hazards to life and safety all
areas of noncompliance should be corrected as soon as possible.
3. Provisions in Excess of Regulatory
Requirements: Nothing in these regulations shall be construed to prohibit a
better type of building construction, an additional means of egress, or an
otherwise safer condition than that specified by the minimum requirements of
these regulations.
4. Equivalency:
a. Insofar as practical, these minimum
standards have been established to obtain a desired performance result.
Prescriptive limitations, when given, such as exact minimum dimensions or
quantities, describe a condition that is recognized as a practical standard for
normal operation.
b. It is the
intent of these regulations to permit and promote equivalency concepts. Nothing
in these regulations shall be construed as restricting innovations that provide
an equivalent level of performance with these regulations in a manner other
than that which is prescribed by these regulations, provided that no other
safety element or system is compromised in order to establish
equivalency.
c. Health Facility
Services may approve alternate methods, procedures, design criteria, and
functional variations from these regulations, because of extraordinary
circumstances, new programs, new technology, or unusual conditions when the
facility can effectively demonstrate that the intent of the regulations is met
and that the variation does not reduce the safety or operational effectiveness
of the facility below that required by the exact language of the
regulations.
d. When contemplating
equivalency allowances, Health Facility Services may use a variety of expert
sources to make equivalency findings. Health Facility Services will document
the reasons for approval or denial of equivalency to the facility.
e. National Fire Protection Association
(NFPA) document 101A is a technical standard for evaluating equivalency to
certain Life Safety Code 101 requirements. The Fire Safety Evaluation System
(FSES) is a widely recognized method for establishing a safety level equivalent
to the Life Safety Code. The use of the FSES process may be useful for
evaluating existing facilities that will be affected by renovation.
SECTION 44:
PHYSICAL FACILITIES, PATIENT ACCOMMODATIONS (ADULT MEDICAL, SURGICAL,
COMMUNICABLE OR PULMONARY DISEASE).
NOTE: See other sections of this document for Special-Care area units such as Post anesthesia Care Unit, Critical Care Units, Rehabilitation Units, Pediatric Units, Postpartum Care Units and/or other specialty units.
A. Patient Rooms. Each patient
room shall meet the following requirements.
1. Maximum room capacity shall be two
patients.
2. In new construction,
patient rooms shall have a minimum of 100 square feet of clear floor area per
bed in semi-private rooms and 120 square feet of clear floor are for single-bed
rooms, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or
vestibules. The dimensions and arrangement of rooms shall be such that there is
a minimum of three feet between the sides and foot of the bed and any wall,
other fixed obstruction or another bed. In semi-private bed rooms, a clearance
of four feet shall be available at the foot of each bed to permit the passage
of equipment and beds.
Minor encroachments, including columns and lavatories, that do not interfere with functions may be ignored when determining space requirements for patient rooms. Where renovation work is undertaken, every effort shall be made to meet the above minimum standards.
3. Each patient room shall have a window with
outside exposure and where the operation of windows or vents requires the use
of tools or keys, such devices shall be on the same floor and easily accessible
to staff. The windowsills shall not be higher than three feet above the floor
and shall be above the grade. Patient rooms in new construction intended for 24
hour occupancy shall have windows. If operable windows are installed, such
devices shall be permanently secured or restricted to inhibit possible escape
or suicide.
4. Nurse patient
communication station shall be provided in accordance with item G. of Section
72, Physical Facilities, Electrical Standards.
5. Hand washing stations shall be provided to
serve each patient room. These hand washing stations shall be located in the
toilet room.
6. Each patient shall
have access to a toilet room without having to enter the general corridor area.
One toilet room shall serve no more than four patient beds and no more than two
patient rooms. In new construction, an additional hand washing station or
sanitizing station shall be placed in the patient room where the toilet room
serves more than one bed. The toilet room shall contain a water closet and a
hand washing station and the door shall swing outward or be double
acting.
7. Each patient shall have
within the room a separate wardrobe or closet that is suitable for hanging full
length garments and for storing personal items.
8. Visual privacy from casual observation by
other patients and visitors shall be provided for each patient in semi-private
rooms with cubicle curtains or equivalent built-in or movable dividers.
Provisions for privacy is not required within psychiatric or alcohol and drug
units. The method for providing privacy shall not obstruct passage of other
patients either to the entrance, toilet or lavatory. All curtains shall have a
flame spread of 0 to 25 and shall comply with NFPA 13 requirements for clear
space below sprinklers.
9. Each
room shall communicate directly with a corridor without passage through another
patient's room.
10. Rooms existing
partially below grade level shall not be used for patients unless they are dry,
well ventilated and are otherwise suitable for occupancy.
11. Beds shall be arranged to provide
adequate room for all patient care procedures and to prevent the transmission
of infections.
12. Individual
approved hospital type beds shall be provided. Bed rails shall be provided on
beds for children.
13. A reading
light shall be provided for each patient bed. The location and design shall be
such that the light is not annoying to other patients.
14. A bedside table with drawer shall be
provided for each bed. The lower portion of the table and/or enclosed shelves
shall be provided for individual nursing care equipment.
B. Service Areas. Each service area may be
arranged and located to serve more than one nursing unit but at least one such
service area shall be provided on each nursing floor. Some of the service areas
may be combined in a single space. The following service areas shall be located
in or readily available to each nursing unit:
1. Nursing Station. Facilities for charting,
clinical records, work counter,
communication system, space for supplies and convenient access to hand washing stations shall be provided. It may be combined with or include centers for reception and communication.
2. Dictation area shall be provided. This
area shall be adjacent to but separate from the nurses' station;
3. Toilet room(s) for staff convenient to
nurses' station (may be unisex).
4.
Lounge facilities for staff. These facilities may be on another
floor.
5. Individual closets or
compartments for the safekeeping of coats and personal effects of nursing
personnel. These shall be located convenient to the nurses' station of
personnel or in a central location;
6. Multi-purpose room(s) for staff, patients,
patients' families for patient conferences, reports, education, training
sessions, and consultation. The rooms shall be accessible to each nursing unit.
One such room may serve several nursing units and/or departments.
7. Examination/treatment room(s). Such rooms
may be omitted if all patient rooms are single-bed rooms. It shall have a
minimum floor area of 120square feet excluding space for vestibule, toilet,
closets, and work counters (whether fixed or movable). Centrally located
examination and treatment room(s) may serve more than one nursing unit on the
same floor. The room shall contain a lavatory or sink equipped for handwashing,
work counter, storage facilities, and a desk, counter or shelf space for
writing. The emergency treatment room may be used for this purpose if it is
conveniently located to the patient rooms.
8. Clean workroom or clean supply room. If
the room is used for preparing patient care items, it shall contain a work
counter, a handwashing fixture and storage facilities for clean and sterile
supplies. If the room is used only for storage and holding as part of a system
for distribution of clean and sterile materials, the work counter and
handwashing fixture may be omitted. Soiled and clean workrooms or holding rooms
shall be separated and have no direct connection.
9. Soiled workroom or soiled holding room.
This room shall be separate from the clean workroom. The soiled workroom shall
contain a clinical sink (or equivalent flushing-rim fixture). The room shall
contain a lavatory (or handwashing fixture). The above fixtures shall both have
a hot and cold mixing faucet. The room shall have a work counter and space for
separate covered containers for soiled linen and waste. Rooms used only for
temporary holding of soiled material may omit the clinical sink and work
counter. If the flushing-rim clinical sink is eliminated, facilities for
cleaning bedpans shall be provided elsewhere.
10. Medication Station. Provisions shall be
made for distribution of medications. This may be done from a medicine
preparation room or unit, from a self-contained medicine dispensing unit, or by
another approved system
a. Medicine
preparation room. This room shall be designed to allow for visual supervision
by the nursing staff. It shall contain a work counter, a sink adequate for
handwashing, refrigerator, and locked storage for controlled drugs. When a
medicine preparation room is to be used to store one or more self-contained
medicine dispensing units, the room shall be designed with adequate space to
prepare medicines with the self-contained medicine dispensing unit(s)
present.
b. Self-contained medicine
dispensing unit. A self-contained medicine dispensing unit may be located at
the nurses' station, in the clean workroom, or in an alcove, provided the unit
has adequate security for controlled drugs and adequate lighting to easily
identify drugs. Convenient access to handwashing stations shall be provided.
(Standard cup-sinks provided in many self-contained units are not adequate for
handwashing.)
11. Clean
Linen Storage. A separate closet or a designated area within the clean workroom
shall be provided. If a closed cart system is used, storage may be in an
alcove. Carts shall be out of the path of traffic.
12. Nourishment Station. This shall contain a
sink equipped for handwashing, equipment for serving nourishment between
scheduled and unscheduled meals, refrigerator, storage cabinets, and ice maker
units to provide ice for patients' service and treatment. Ice for human
consumption shall be from self-dispensing units. Handwashing stations shall be
in or immediately accessible to the nourishment station;
13. Equipment Storage Room. This shall be for
equipment such as IV. stands, inhalators, air mattresses, and
walkers;
14. Parking for stretchers
and wheelchairs. This shall be located out of path of normal traffic;
15. Showers and bathtubs. When individual
bathing facilities are not provided in patient rooms, there shall be at least
one shower and/or bathtub for each 12 beds without such facilities. Each
bathtub or shower shall be in an Individual room or enclosure that provides
privacy for bathing, drying, and dressing. Special bathing facilities,
including space for attendant, shall be provided for patients on stretchers,
carts, and wheelchairs at the ratio of one per 100 beds or a fraction thereof.
This may be on a separate floor if convenient for use.
16. Emergency Equipment Storage. Space for
emergency equipment such as a "crash cart" shall be provided and shall be under
control of the nursing staff;
17.
Environmental Services Closet. See Section 65, Physical Facilities, Cleaning
and Sanitizing Carts and Environmental Services, for detailed
requirements.
C.
Airborne Infection Isolation Room(s). Rooms for patients who are suffering from
infections shall be provided at the rate of 1 for each 30 beds or fraction
thereof. These may be located within each nursing unit or placed together in a
separate unit. See also Section 32, Physical Facilities, Critical Care Unit for
the requirements of Critical Care Units. Psychiatric and Alcohol/Drug Unit(s)
beds need not be included in the bed count ratio to establish the number of
rooms. Each isolation room shall be a single-bed room and planned as required
for a normal patient room except as follows:
1. Each airborne infection isolation room
shall have an anteroom for handwashing, gowning, and storage of clean and
soiled materials located directly outside the entry door to the patient
room.
2. Airborne infection
isolation room perimeter walls, ceiling, and floors, including penetrations,
shall be sealed tightly so that air does not infiltrate the environment from
the outside or from other spaces.
3. Airborne infection isolation room(s) shall
have self-closing devices on all room exit doors
4. Separate toilet, bathtub (or shower) and
handwashing stations are required for each airborne infection isolation
room.
5. Airborne infection
isolation rooms may be used for noninfectious patients when not needed for
patients with airborne infectious disease.
6. Windows shall not be operable without the
use of a key or tool controlled by the nursing staff.
7. Each room shall have a permanently
installed visual mechanism to constantly monitor the pressure status of the
room when occupied by patients with an airborne infectious disease.
D. Protective Isolation Rooms. In
facilities where procedures such as organ transplants, burn therapy, and
immunosuppressive treatments are performed, special design provisions,
including special ventilation, may be necessary to meet the needs of the
functional program. Refer to Table 4 of the Appendix for air pressure and
ventilation. Each protective isolation room shall be a single-bed room and
planned as required for a normal patient room except as follows:
1. Each protective isolation room shall have
an anteroom for handwashing, gowning, and storage of clean and soiled materials
located directly outside the entry door to the patient room.
2. Protective isolation room perimeter walls,
ceiling, and floors, including penetrations, shall be sealed tightly so that
air does not infiltrate the environment from the outside or from other
spaces.
3. Protective isolation
room(s) shall have self-closing devices on all room exit doors.
4. Separate toilet, bathtub (or shower), and
handwashing stations are required for each protective isolation room.
5. Protective isolation rooms may be used for
nonimmunosuppressed patients, except airborne infectious patients are
prohibited.
6. Windows shall not be
operable without the use of a key or tool controlled by the nursing
staff.
E. Seclusion
Rooms. Each hospital shall provide one or more single-bed rooms for patients
needing close supervision if suitable psychiatric facilities are not available
elsewhere in the community. Such rooms shall comply with the applicable
requirements in Section 48, Physical Facilities, Psychiatric Nursing
Unit.
F. Observation Rooms.
Patients in observation status may be accommodated within the facility:
1. In private, semi-private or multi-patient
rooms. Furniture shall be arranged to provide adequate room for patient care
procedures and to prevent the transmission of infection;
2. Cubicle curtains, privacy screens or an
approved equivalent shall be provided for patient privacy in all multi-patient
rooms. The utilization of such curtains or screens shall be such that each
patient shall have privacy;
3. Each
room or cubicle shall be provided with (a) oxygen; (b) vacuum; and (c) a nurse
call button unless direct observation is afforded and maintained;
4. Hand hygiene facilities shall be available
within the area;
5. Hospital grade
furniture shall be provided. Bed rails shall be provided on beds;
6. For each area in which a patient bed is
utilized, a reading light shall be provided for each bed. The location and
design shall be such that the light is not annoying to other
patients;
7. Patient toilets shall
be provided and accessible to all patients; and
8. Adequate space shall be provided for
medical supplies.
SECTION
45:
PHYSICAL FACILITIES, CRITICAL CARE UNIT.
The Critical care units require special space and equipment considerations for effective staff functions. In addition, space arrangement shall include provisions for immediate access of emergency equipment from other departments. Critical care units shall comply in size, number and type with these standards and with the functional program. The following standards are intended for the more common types of critical care services and shall be appropriate to needs defined in functional programs. Where specialized services are required, additions and/or modifications shall be made as necessary for efficient, safe, and effective patient care.
A. Critical Care (General). The following
shall apply to all types of critical care units unless otherwise noted. Each
unit shall comply with the following provisions:
1. The location shall offer direct access by
the emergency, respiratory care, laboratory, radiology, surgery, and other
essential departments and services as defined by the functional program. It
shall be located so that the medical emergency resuscitation teams may be able
to respond promptly to emergency calls within minimum travel time. The location
shall be arranged to eliminate the need for through traffic.
2. In new construction, where elevator
transport is required for critically ill patients, the size of the cab and
mechanisms and controls shall meet the specialized needs.
3. In new construction, each patient room (or
multiple bed space for neonatal or pediatric units) shall have a minimum of 200
square feet of clear floor area with a minimum headwall width of 113 feet per
bed, exclusive of anterooms, vestibules, toilet rooms, closets, lockers,
wardrobes, and/or alcoves. In renovation of existing critical care units, every
effort shall be made to meet the above minimum standards. If it is not possible
to meet the above square foot standards, the Entity having jurisdiction may
grant approval to deviate from this requirement. In such cases, rooms shall be
no less than 130square feet.
4.
View panels to the corridor shall be required and shall have means to provide
visual privacy. Where only one door is provided to a bed space, it shall be at
least four feet wide and arranged to minimize interference with movement of
beds and large equipment. Sliding doors shall not have floor tracks and shall
have hardware that minimizes jamming possibilities. Where sliding doors are
used for access to cubicles within a suite, a three foot wide swinging door may
also be provided for personnel communication. The sliding doors shall swing
out.
5. Each patient bed area shall
have space at each bedside for visitors and provisions for visual privacy from
casual observation by other patients and visitors. For both adult and pediatric
units, there shall be a minimum of eight feet between beds.
6. Each patient bed shall have visual access,
other than skylights, to the outside environment with not less than one outside
window in each patient bed area. In renovation projects, clerestory windows
with windowsills above the heights of adjacent ceilings may be used, provided
they afford patients a view of the exterior and are equipped with appropriate
forms of glare and sun control. Distance from the patient bed to the outside
window shall not exceed 50 feet. When partitioned cubicles are used, patients'
view to outside windows may be through no more than two separate clear vision
panels.
7. Nurse/patient
communication shall be provided in accordance with item G. of Section72,
Physical Facilities, Electrical Standards. The communication station for the
unit shall include provisions for an emergency code resuscitation alarm to
summon assistance from outside the critical care unit.
8. Handwashing fixtures shall be convenient
to nurse stations and patient bed areas. There shall be at least one
handwashing fixture for every three beds in open plan areas, and one in each
patient room. The handwashing fixture or sanitizing station shall be located
near the entrance to the patient cubicle or room, shall be sized to minimize
splashing water onto the floor, and shall be equipped with hands-free operable
controls.
9. Nurses' station shall
have space for counters and storage. It may be combined with or include centers
for reception and communication. There shall be direct or remote visual
observation between the nurses' station and all patient beds in the critical
care unit.
10. Each unit shall
contain equipment for continuous monitoring, with visual displays for each
patient at the bedside and at the nurses' station. Monitors shall be located to
permit easy viewing and access but not interfere with access to the
patient.
11. Emergency equipment
storage space that is easily accessible to the staff shall be provided for
emergency equipment such as a emergency cart.
12. Medication Station. Provisions shall be
made for distribution of medications. This may be done from a medicine
preparation room or unit, from a self-contained medicine dispensing unit, or by
another approved system:
a. Medicine
preparation room. This room shall be designed to allow for visual supervision
by the nursing staff. It shall contain a work counter, a sink adequate for
handwashing, refrigerator, and locked storage for controlled drugs. When a
medicine preparation room is to be used to store one or more self-contained
medicine dispensing units, the room shall be designed with adequate space to
prepare medicines with the self-contained medicine dispensing unit(s)
present.
b. Self-contained medicine
dispensing unit. A self-contained medicine dispensing unit may be located at
the nurses' station, in the clean workroom, or in an alcove, provided the unit
has adequate security for controlled drugs and adequate lighting to easily
identify drugs. Convenient access to handwashing stations shall be provided.
(Standard cup-sinks provided in many self-contained units are not adequate for
handwashing.)
13. At
least one airborne infection isolation room with anteroom shall be provided.
The number of airborne infection isolation rooms shall be determined based on
an infection control risk assessment; as per the primary catchment area by the
facility. Each room shall contain only one bed and shall comply with the
requirements of item C. of Section 44, Physical Facilities, Patient
Accommodations (Adult Medical, Surgical, Communicable or Pulmonary Disease).
However, the requirement for the bathtub (or shower) may be eliminated.
Compact, modular toilet/sink combination units may replace the requirement for
a "toilet room." Special ventilation requirements are found in Table
4.
14. The following additional
service spaces shall be immediately available within each critical care area
(Note: These additional spaces may be shared by more than one critical care
unit provided that direct access is available from each unit.):
a. Securable closets or cabinet compartments
for the unit personnel;
b. Clean
workroom or clean supply room. If the room is used for preparing patient care
items, it shall contain a work counter, a handwashing fixture and storage
facilities for clean and sterile supplies. If the room is used only for storage
and holding as part of a system for distribution of clean and sterile supply
materials, the work counter and handwashing fixture may be omitted. Soiled and
clean workrooms or holding rooms shall be separated and have no direct
connection;
c. Clean linen storage.
There shall be a designated area for clean linen storage. This may be within
the clean workroom, a separate closet or an approved distribution system on
each floor. If a closed cart system is used, storage may be in an alcove. It
shall be out of the path of normal traffic and under staff control;
d.. Soiled workroom or soiled holding room.
This room shall be separate from the clean workroom. The soiled workroom shall
contain a clinical sink or equivalent flushing-rim fixture. The room shall
contain a lavatory or handwashing fixture. The above fixtures shall have a hot
and cold mixing faucet. The room shall have a work counter and space for
separate covered containers for soiled linen and a variety of waste types.
Rooms used only for temporary holding of soiled material may omit the clinical
sink and work counter. If the flushing-rim clinical sink is eliminated,
facilities for cleaning bedpans shall be provided elsewhere;
e. Nourishment Station. There shall be a
nourishment station with sink, work counter, refrigerator, storage cabinets,
and equipment for hot and cold nourishments between scheduled meals. The
nourishment station shall include space for trays and dishes used for
nonscheduled meal service. Provisions and space shall be included for separate
temporary storage of unused and soiled dietary trays not picked up at meal
time. Handwashing stations shall be in or immediately accessible from the
nourishment station;
f Ice machine.
There shall be available equipment to provide ice for treatments and
nourishment. Ice-making equipment may be in the clean work room or at the
nourishment station. Ice intended for human consumption shall be from
self-dispensing ice makers;
g.
Equipment storage room or alcove. Appropriate room(s) or alcove(s) shall be
provided for storage of large items of equipment necessary for patient care and
as required by the functional program. Its location shall not interfere with
the flow of traffic; and
h. X-ray
viewing equipment.
15.
The following shall be provided and may be located outside the unit if
conveniently accessible.
a. A visitors'
waiting room shall be provided with access to telephones and toilets. One
waiting room may serve several critical care units.
b. Staff lounge(s) and toilet(s) shall be
located so that staff may be recalled quickly to the patient area in
emergencies. The lounge shall have telephone or intercom and emergency code
alarm connections to the critical care unit it serves. One lounge may serve
adjacent critical care areas.
c. A
special procedures room shall be provided if required by the functional
program.
d. Multipurpose room(s)
for staff, patients, and patients' families for patient conferences, reports,
education, training sessions, and consultation shall be provided. These rooms
shall be accessible to each nursing unit.
e. A housekeeping room shall be provided
within or immediately adjacent to the critical care unit. It shall not be
shared with other nursing units or departments. It shall contain a service sink
or floor receptor and provisions for storage of supplies and housekeeping
equipment.
f Storage space for
stretchers and wheelchairs shall be provided in a strategic location, without
restricting normal traffic.
g.
Laboratory, radiology, respiratory care, and pharmacy services shall be
available. These services may be provided from the central departments or from
satellite facilities as required by the functional program.
B. Coronary Critical
Care Unit. In addition to the standards set forth in Section 45, Physical
Facilities, Critical Care Unit, the following standards apply to the coronary
critical care unit:
1. Each coronary patient
shall have a separate room for acoustical and visual privacy.
2. Each coronary patient shall have access to
a toilet in the room. (Portable commodes may be used in lieu of individual
toilets, but provisions shall be made for their storage, servicing, and odor
control.)
C. Pediatric
Critical Care. If a facility has a specific pediatric critical care unit, the
functional program shall include consideration for staffing, isolation, and the
safe transportation of critically ill pediatric patients, along with life
support and environmental systems, from other areas. In addition to the
standards previously listed for critical care units, each pediatric critical
care unit shall include:
1. Space at each
bedside for family, visitors and nursing staff;
2. In new construction, each patient space
(whether separate rooms, cubicles, or multiple bed space) shall have a minimum
of 200 square feet of clear floor area with a minimum headwall width of 13 feet
per bed, exclusive of anterooms, vestibules, toilet rooms, closets, lockers,
wardrobes, and/or alcoves;
3.
Consultation/demonstration room within, or convenient to, the pediatric
critical care unit for private discussions;
4. Provisions for formula storage. These may
be outside the pediatric critical care unit but shall be available for use at
all times;
5. Separate storage
cabinets or closets for toys and games for use by the pediatric patients;
and
6. Examination and treatment
room(s).
D. Newborn
Intensive Care Units. Each Newborn Intensive Care Unit (NICU) shall include or
comply with the following:
1. The NICU shall
have a clearly identified entrance and reception area for families. The area
shall permit visual observation and contact with all traffic entering the unit.
A scrub area shall be provided at each public entrance to the patient care
area(s) of the NICU. All sinks shall be hands-free operable and large enough to
contain splashing;
2. At least one
door (44inches minimum) to each room in the unit to accommodate portable X-ray
equipment;
3. There shall be
controlled access systems to the unit from the Labor and Delivery area, the
Emergency Room or other referral entry points;
4. When viewing windows are provided,
provision shall be made to control casual viewing of infants;
5. Noise control shall be a design
factor;
6. Provisions shall be made
for indirect lighting in all nurseries. Provisions shall be made for multiple
lighting levels;
7. A central area
shall serve as a nurses' station, shall have space for counters and storage,
and shall have convenient access to handwashing stations. It may be combined
with or include centers for reception and communication and patient
monitoring;
8. Each patient care
space shall contain a minimum of 120 square feet per bassinette excluding sinks
and aisles. There shall be an aisle for circulation adjacent to each patient
care space with a minimum width of three feet;
9. An airborne infection isolation room is
required in at least one level of nursery care. The room shall be enclosed and
separated from the nursery unit with provisions for observation of the infant
from adjacent nurseries or control area(s);
10. Blood gas lab facilities shall be
immediately accessible;
11. A
respiratory care work area and storage room shall be provided;
12. A consultation/demonstration/breast
feeding room shall be provided convenient to the unit;
13. Charting and dictation space for
physicians shall be provided;
14.
Medication station shall be provided;
15. Clean workroom or clean supply room shall
be provided. See Section 44.B.8, Physical Facilities, Patient Accommodations
(Adult Medical, Surgical, Communicable or Pulmonary Disease);
16. Soiled workroom or soiled holding room
shall be provided. See Section 44.B.9, Physical Facilities, Patient
Accommodations (Adult Medical, Surgical, Communicable or Pulmonary
Disease);
17. A lounge, locker room
and staff toilet within or adjacent to the unit suite for staff use shall be
provided;
18. Space shall be
provided for emergency equipment that is under direct control of the nursing
staff, such as a emergency cart. This space shall be located in an area
appropriate to the functional program, but out of normal traffic;
19. One environmental services closet shall
be provided for the unit. It shall be directly accessible from the unit and be
dedicated for the exclusive use of the neonatal critical care unit. It shall
contain a service sink or floor receptor and provisions for storage of supplies
and housekeeping equipment; and
20.
Space shall be provided for the following:
a.
A visitors' waiting room;
b.
Nurses' station; and c. Multipurpose room(s) for staff, patients and patients'
families for patient conferences, reports, education, training sessions, and
consultation. These rooms shall be accessible to each nursing unit. They may be
on other floors if convenient for regular use. One such room may serve several
nursing units and/or departments.
SECTION 46:
PHYSICAL FACILITIES,
NURSERY UNITS.
Normal newborn infants shall be housed in nurseries that comply with the standards below. All nurseries other than pediatric nurseries shall be convenient to the postpartum nursing unit and obstetrical facilities. The nurseries shall be located and arranged to preclude the need for nonrelated pedestrian traffic. No nursery shall open directly into another nursery. There should be one breastfeeding/pumping room readily available for mothers of NICU babies to pump breastmilk.
A. General.
Each nursery shall contain the following:
1.
At least one lavatory, equipped with hands-free handwashing station, for each
eight infant stations;
2. Glazed
observation windows to permit the viewing of infants from public areas,
workrooms, and adjacent nurseries;
3. Convenient, accessible storage for linens
and infant supplies at each nursery room;
4. A consultation/demonstration/breast
feeding or pump room shall be provided convenient to the nursery. Provision
shall be made, either within the room or conveniently located nearby, for sink,
counter, refrigeration and freezing, storage for pump and attachments, and
educational materials. The area provided for the unit for these purposes, when
conveniently located, may be shared;
5. Enough space shall be provided for parents
to stay 24hours;
6. An airborne
infection isolation room is required in or near at least one level of nursery
care. The room shall be enclosed and separated from the nursery unit with
provisions for observation of the infant from adjacent nurseries or control
area(s). All airborne infection isolation rooms shall comply with the
requirements of Section 44.C, Patient Accommodations (Adult Medical, Surgical,
Communicable or Pulmonary Disease), except for separate toilet, bathtub, or
shower;
7. Workroom(s). Each
nursery room shall be served by a connecting workroom. The workroom shall
contain scrubbing and gowning facilities at the entrance for staff and
housekeeping personnel, work counter, refrigerator, storage for supplies and a
hands-free handwashing fixture. One workroom may serve more than one nursery
room provided that required services are convenient to each. The workroom
serving the full-term and continuing care nurseries may be omitted if
equivalent work and storage areas and facilities, including those for scrubbing
and gowning, are provided within that nursery. Space required for work areas
located within the nursery is in addition to the area required for infant care.
Adequate provision shall be made for storage of emergency cart(s) and equipment
out of traffic and for the sanitary storage and disposal of soiled waste.
a. When the functional program includes a
mother-baby couplet approach to nursing care, the workroom functions described
above may be incorpo-rated in the nurse station that serves the postpartum
patient rooms.
b. Neonate
examination and treatment areas. Such areas, when required by the functional
program, shall contain a work counter, storage facilities and a hands-free
handwashing station, c. Neonate formula facilities. Where infant formula is
prepared on-site, direct access from the formula preparation room to any
nursery room is prohibited. The room may be located near the nursery or at
other appropriate locations in the hospital, but shall include
1) Cleanup facilities for washing and
sterilizing supplies. This area shall include a handwashing station, facilities
for bottle washing, a work counter and sterilization equipment.
2) Separate room for preparing infant
formula. This room shall contain warming facilities, refrigerator, work
counter, formula sterilizer, storage facilities and a handwashing
station.
3) Refrigerated storage
and warming facilities for infant formula accessible for use by nursery
personnel at all times.
8. Commercial neonate formula. If a
commercial infant formula is used, the separate cleanup and preparation rooms
may be omitted. The storage and handling may be done in the nursery workroom or
in another appropriate room in the hospital that is conveniently accessible at
all hours. The preparation area shall have a work counter, a handwashing
station and storage facilities.
9.
Housekeeping/environmental services room. A housekeeping/environmental services
room shall be provided for the exclusive use of the nursery unit. It shall be
directly accessible from the unit and shall contain a service sink or floor
receptor and provide for storage of supplies and housekeeping
equipment.
10. Charting space.
Charting facilities shall have linear surface space to ensure that staff and
physicians may chart and have simultaneous access to information and
communication systems.
B. Newborn Nursery
1. Each newborn nursery room shall contain no
more than 16stations. The minimum floor areas shall be 24 square feet per
bassinet, exclusive of auxiliary work areas. When a rooming-in program is used,
the total number of bassinets provided in these units may be appropriately
reduced, but the newborn nursery shall not be omitted in its entirety from any
facility that includes delivery services. (When facilities use a rooming-in
program in which all infants are returned to the nursery at night, a reduction
in nursery size may not be practical.)
2. Baby holding nurseries may replace
traditional nurseries with baby holding nurseries in postpartum and
labor-delivery- recovery-postpartum (LDRP) units. The minimum floor area per
bassinet, ventilation, electrical, and medical vacuum and gases shall be the
same as that required for a full-term nursery. These holding nurseries should
be next to the nurse station on these units. The holding nursery shall be sized
to accommodate the percentage of newborns who do not remain with their mothers
during the postpartum stay.
C. Continuing Care Nursery For hospitals that
provide continuing care for infants requiring close observation (for example,
low birth-weight babies who are not ill but require more hours of nursing than
do normal neonates), the minimum floor space-shall be 50 square feet per
bassinet, exclusive of auxiliary work areas, with provisions for at least 4
feet between and at all sides of each bassinet.
D. Pediatric Nursery To minimize the
possibility of cross infection, each nursery room serving pediatric patients
shall contain no more than eight bassinets; each bassinet shall have a minimum
clear floor area of 40 square feet. Each room shall contain a lavatory equipped
for hands-free handwashing, a nurse's emergency calling system and a glazed
viewing window for observing infants from public areas and workrooms.
(Limitation on number of patients in a nursery room does not apply to the
pediatric critical care unit.)
SECTION 47:
PHYSICAL FACILITIES,
PEDIATRIC AND ADOLESCENT UNIT.
The unit shall meet the following standards:
A. Patient Rooms. Each patient room shall
meet the following standards:
1. Maximum room
capacity shall be four patients.
2.
The space requirements for pediatric patient beds shall be the same as for
adult beds due to the size variation and the need to change from cribs to beds
and vice-versa. See Section 44, Patient Accommodations (Adult Medical,
Surgical, Communicable or Pulmonary Disease), for requirements. Additional
provisions for hygiene, toilets, sleeping, and personal belongings shall be
included where the program indicates that parents will be allowed to remain
with young children. See Sections 45, Physical Facilities, Critical Care Unit
and 46, Physical Facilities, Newborn Nursery Units for pediatric critical care
units and for newborn nurseries.
3.
Each patient room shall have a window in accordance with Section 44, Physical
Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or
Pulmonary Disease).
B.
Examination/Treatment Rooms. This room shall be provided for pediatric and
adolescent patients. A separate area for infant examination and treatment may
be provided within the pediatric nursery workroom. Examination/treatment rooms
shall have a minimum floor area of 120square feet. The room shall contain a
handwashing fixture; storage facilities; and a desk, counter, or shelf space
for writing. This room is not required if all rooms are private.
1. Multipurpose or individual room(s) shall
be provided within or adjacent to areas serving pediatric and adolescent
patients for dining, education and developmentally appropriate play and
recreation, with access and equipment for patients with physical restrictions.
If the functional program requires, an individual room shall be provided to
allow for confidential parent/family comfort, consultation, and teaching.
Insulation, isolation and structural provisions shall minimize the transmission
of impact noise through the floor, walls or ceiling of these multipurpose
room(s).
2. Space for preparation
and storage of infant formula shall be provided within the unit or other
convenient location. Provisions shall be made for continuation of special
formula that may have been prescribed for the infant prior to admission or
readmission.
3. Patient toilet
room(s) with handwashing stations in each room, in addition to those serving
bed areas, shall be conveniently located to multipurpose room(s) and to each
central bathing facility.
4.
Storage closets or cabinets for toys and educational and recreational equipment
shall be provided.
5. Storage space
shall be provided to permit exchange of cribs and adult beds. Provisions shall
also be made for storage of equipment and supplies (including cots or
recliners, extra linen, etc.) for parents who stay with the patient
overnight.
6. A least one airborne
infection isolation room shall be provided in each pediatric unit. The total
number of infection isolation rooms shall be determined by an infection
prevention and control risk assessment. Airborne infection isolation room(s)
shall comply with the requirements of item C. of Section 44, Physical
Accommodations (Adult Medical, Surgical, Communicable or Pulmonary
Disease).
7. Separate clean and
soiled workrooms or holding rooms shall be provided as described in Section 44
B.8 and B.9, Physical Accommodations (Adult Medical, Surgical, Communicable or
Pulmonary Disease).
SECTION 48:
PHYSICAL FACILITIES,
PSYCHIATRIC NURSING UNIT.
When part of a general hospital, these units shall be designed for the care of inpatients. Nonambulatory inpatients may be treated in a medical unit until their medical condition allows for transfer to the psychiatric nursing unit. Provisions shall be made in the design for adapting the area for various types of psychiatric therapies.
The environment of the unit should be characterized by a feeling of openness with emphasis on natural light and exterior views. Various functions should be accessible from common areas while not compromising desirable levels of patient privacy. Interior finishes, lighting and furnishings should suggest a residential rather than an institutional setting. These should, however, conform with applicable fire safety codes. Security and safety devices should not be presented in a manner to attract or challenge tampering by patients.
Where glass fragments pose a hazard to certain patients, safety glazing and/or other appropriate security features shall be used.
Details of such facilities should be as described in the approved functional program. Each nursing unit shall provide the following:
A. Patient Rooms. The
patient room requirements noted in Section 44, Physical Accommodations (Adult
Medical, Surgical, Communicable or Pulmonary Disease), shall be applied to
patient rooms in psychiatric nursing units except as follows:
1. A nurses' call system is not required; but
if it is included, provisions shall be made for easy removal or for covering
call button outlets;
2.
Bedpan-flushing devices shall be omitted from patient room toilets;
3. Handwashing stations are not required in
patient rooms;
4. Visual privacy in
multibed rooms (e.g., cubicle curtains) is not required;
5. The ceiling and the air distribution
devices, lighting fixtures, sprinkler heads, and other appurtenances shall be
of a tamper-resistant type;
6. Each
patient room shall be provided with a private toilet that meets the following
requirements:
a. The door shall not be
lockable from within;
b. The door
shall be capable of swinging outward; and c. The ceiling shall be of
tamper-resistant construction and the air distribution devices, lighting
fixtures, sprinkler heads and other appurtenances shall be of the
tamper-resistant type.
7. Patient rooms, exclusive of toilet rooms,
closets, lockers, wardrobes, alcoves, or vestibules, shall be at least 100
square feet for single-bed rooms and 80 square feet per bed for multiple-beds
rooms. The dimensions and room arrangement criteria of Section 44 does not
apply.
B. Service
Areas. The standards noted in Section 44, Physical Accommodations (Adult
Medical, Surgical, Communicable or Pulmonary Disease), shall apply to services
areas for psychiatric nursing units with the following modifications:
1. A secured storage area shall be provided
for patients' belongings that are determined to be potentially harmful (e.g.,
razors, nail files, cigarette lighters); this area shall be controlled by
staff;
2. Medication station shall
include provisions for security against unauthorized access;
3. Food service within the unit may be one,
or a combination, of the following:
a. A
nourishment station;
b. A
kitchenette designed for patient use with staff control of heating and cooking
devices; and
4. Storage
space for stretchers and wheelchairs may be outside the psychiatric unit,
provided that provisions are made for convenient access as needed for disabled
patients;
5. In psychiatric nursing
units, a bathtub or shower shall be provided for each six beds not otherwise
served by bathing facilities within the patient rooms. Bathing facilities shall
be designed and located for patient convenience and privacy;
6. A separate charting area shall be provided
with provisions for acoustical privacy. A viewing window to permit observation
of patient areas by the charting nurse or physician may be used if the
arrangement is such that patient files cannot be read from outside the charting
space;
7. At least two separate
social spaces, one appropriate for noisy activities and one for quiet
activities shall be provided. The combined area shall be a minimum of 40 square
feet per patient with a minimum of 120 square feet for each of the two spaces.
This space may be shared by dining activities;
8. Space for group therapy shall be provided.
This may be combined with the quiet space noted above in item 7 when the unit
accommodates not more than 12 patients, and when at least 225 square feet of
enclosed private space is available for group therapy activities;
9. Patient laundry facilities with an
automatic washer and dryer shall be provided. The following elements shall also
be provided, but may be either within the psychiatric unit or immediately
accessible to it unless otherwise dictated by the functional program;
10. Rooms (s) for examination and treatment
shall have a minimum floor area of 120 square feet. Examination and treatment
room(s) for medical-surgical patients may be shared by the psychiatric unit
patients. (These may be on a different floor if conveniently
accessible.)
11. Separate
consultation room(s) with minimum floor space of 100 square feet each, provided
at a room-to-bed ratio of one consultation room for each 12 psychiatric beds.
The room(s) shall be designed for acoustical and visual privacy and constructed
to achieve a noise reduction of at least 45 decibels. This room is not required
if all rooms are private;
12.
Psychiatric units each containing 15 square feet of separate space per patient
for patient therapy/multipurpose use, with a minimum total area of at least 200
square feet, whichever is greater. Space shall include provision for
handwashing, work counter(s), storage, and displays. This space may serve more
than one nursing unit. When psychiatric nursing unit(s) contain less than 12
beds, the therapy and other functions may be performed within the noisy
activities area, if at least an additional 10 square feet per patient served is
included; and
13. A conference and
treatment planning room for use by the psychiatric unit.
C. Seclusion Treatment Room. There shall be
at least one seclusion room for up to 24 beds or a major fraction thereof. If a
facility has more than one psychiatric nursing unit, the number of seclusion
rooms shall be a function of the total number of psychiatric beds in the
facility. Seclusion rooms may be grouped together.
1. The seclusion room is intended for
short-term occupancy by a violent or suicidal patient. The room(s) shall be
located for direct nursing staff supervision. Each room shall be for only one
patient. It shall have an area of at least 60 square feet and shall be
constructed to prevent patient hiding, escape, injury or suicide. Where
restraint beds are required by the functional program, 80 square feet shall be
required.
2. Room doors shall be
designed with hardware that will permit the doors to swing out. Outside corners
shall be omitted where possible. The ceiling shall be of tamper-resistant
construction and the air distribution devices, lighting fixtures, sprinkler
heads, and other appurtenances shall be of the tamper-resistant type. The walls
shall be completely free of objects. Special fixtures and hardware for
electrical circuits shall be used. Minimum ceiling height shall be nine feet.
Doors shall be three feet eight inches wide and shall permit staff observation
of the patient while also maintaining provisions for patient privacy. Seclusion
treatment rooms shall be accessed by an anteroom or vestibule which also
provides direct access to a toilet room. The toilet room and anteroom shall
provide for safe management of the patient.
3. Where the interior of the seclusion room
is padded with combustible materials, these materials shall be of a type
acceptable to NFPA standards. The room area, including floor, walls, ceilings,
and all openings shall be protected with not less than one-hour-rated
construction.
SECTION
49:
PHYSICAL FACILITIES, SURGICAL FACILITIES
A. General Operating Room(s). At least one
general operating room shall be provided for each 50 beds or major fraction
thereof up to 200 beds. Over 200 beds, additional operating room needs shall be
based on the projected surgical workload. In new construction, each room shall
have a minimum clear area of 400 square feet exclusive of fixed or wall-mounted
cabinets and built-in shelves, with a minimum of 20 feet clear dimension
between fixed cabinets and built-in shelves, and a system for emergency
communication with the surgical suite control station. X-ray film illuminators
for handling at least four films simultaneously shall also be provided. In
renovation projects, every effort shall be made to meet the floor space
requirements indicated above. In no event shall the clear floor area be less
than 360 square feet with a minimum dimension of 18 feet.
B. Specialty Operating Rooms for
cardiovascular, orthopedic, neurological, and other procedures that require
additional personnel and/or large equipment. When included, this room shall
have, in addition to the above requirements for general operating rooms, a
minimum clear area of 600 square feet, with a minimum of 20 feet clear
dimension exclusive of fixed or wall-mounted cabinets and built-in shelves.
When open-heart surgery is performed, an additional room in the restricted area
of the surgical suite shall be designated as a pump room where extra corporeal
pump(s), supplies and accessories are stored and serviced. When complex
orthopedic and neurosurgical surgery is performed, additional rooms shall be in
the restricted area of the surgical suite which shall be designated as
equipment storage rooms for the large equipment used to support these
procedures. Appropriate plumbing, medical gases, and electrical connections
shall be provided in the pump storage room. When included, a room for
orthopedic surgery shall, in addition to the above, have enclosed storage space
for splints and traction equipment. Storage outside the operating room shall be
conveniently located. If a sink is used for the disposal of casting material,
an appropriate trap shall be provided. In renovation projects, every effort
shall be made to meet the floor space requirements indicated above. In no event
shall the clear floor area be less than 400 square feet (except for Orthopedic
procedures shall be 360 square feet) with a minimum dimension of 18
feet.
C. Room(s) for Surgical
Cystoscopic and Endo-Urologic Procedures. When provided and/or required by the
written functional program, the cystoscopic and endo-urologic procedures
room(s) shall follow these requirements. A scrub sink or large lavatory shall
be provided within or adjoining the cystoscopy room. In new construction, these
rooms shall have a minimum clear area of 350 square feet, exclusive of fixed or
wall-mounted cabinets and built-in shelves with a minimum of 15 feet clear
dimension between fixed cabinets and built-in shelves.
Additional clear space may be required by the functional program to accommodate special functions in one or more of these rooms. An emergency communications system shall connect with the Surgical Suite control station. Facilities for the disposal of liquid wastes shall be provided. If a floor drain is installed to provide for disposal of liquid wastes, it shall be completely insulated from ground by means of an insulating type floor drain and nonconductive waste connections. The drain shall also be provided with a flushing device. X-ray viewing capability to accommodate at least four films simultaneously shall be provided. In renovation projects, every effort shall be made to meet the clear floor space requirements indicted above for construction. In no event shall the clear floor space be less than 250 square feet.
D. Endoscopy
The endoscopy suite may be divided into three major functional areas: the procedure room(s), instrument processing room(s), and patient holding/preparation and recovery room or area.
NOTE: When invasive procedures are to be performed in this unit on persons who are known or suspected of having airborne infectious diseases, these procedures should not be performed in the operating suite. These procedures shall be performed in a room meeting airborne infections isolation ventilation requirements or in a space using local exhaust ventilation.
1. Procedures Room(s)
a. Each procedure room shall have a minimum
clear area of 200 square feet (15.58 square meters) exclusive of fixed cabinets
and built-in shelves.
b. A
freestanding handwashing fixture with hands-free controls shall be available in
the suite.
c. Refer to Table 11 for
medical gas station outlets.
d.
Floor covering shall be monolithic and joint free.
e. A system for emergency communication shall
be provided.
f Procedure rooms
shall be designed for visual and acoustical privacy for the
patient.
2. Instrument
Processing Room(s)
a. Dedicated processing
room(s) for cleaning and disinfecting instrumentation shall be provided. In an
optimal situation, cleaning room(s) shall be located between two procedure
rooms. However, one processing room may serve multiple procedure rooms. Size of
the cleaning room(s) is dictated by the amount of equipment to be processed.
Cleaning rooms shall allow for flow of instrumentations from the contaminated area to the clean area, and finally to storage. The clean equipment rooms, including storage, should protect the equipment from contamination.
b. The
decontamination room shall be equipped with the following:
1) Two utility sinks remote from each
other.
2) One freestanding
handwashing fixture.
3) Work
counter space(s).
4) Space and
plumbing fixtures for automatic endoscope cleaners, sonic processor, and flash
sterilizers (where required).
5)
Ventilation system. Negative pressure shall be maintained and minimum of 10 air
changes per hour shall be maintained. A hood is recommended over the work
counter. All air shall be exhausted to the outside to avoid recirculation
within the facility.
6) Outlets for
vacuum and compressed air.
7) Floor
covering shall be monolithic and joint free.
3. Patient Holding/Prep/Recovery Area. The
following elements shall be provided in this area:
a) Each patient cubicle shall be equipped
with oxygen and suction outlets.
b)
Cubicle curtains for patient privacy.
c) Medication preparation and storage with
handwashing stations.
d) Toilet
facilities (may be accessible from patient holding or directly from procedure
room(s) or both).
e) Change areas
and storage for patients' personal effects.
f) Nurses reception and charting area with
visualization of patients.
g) Clean
utility room or area.
h)
Environmental Services closet.
E. Service Areas. Individual rooms shall be
provided when so noted; otherwise alcoves or other open spaces which shall not
interfere with traffic may be used. Services, except the soiled workroom and
the janitor's closet, may be shared with and organized as part of the
obstetrical facilities if the approved functional program reflects this sharing
concept. Service areas shall be arranged to avoid direct traffic between the
Operating and Delivery Suites. The following areas shall be provided.
1. Control station located to permit visual
surveillance of all traffic which enters the Operating Suite.
2. A supervisor's office or station. The
number of offices, stations, and teaching areas in the surgical suite shall
depend upon the functional program.
3. Sterilizing facilities conveniently
located to serve all operating rooms. The sterilizing facility shall have work
counter space and a handwashing sink. When the functional program indicates
that adequate provisions have been made for replacement of sterile instruments
during surgery, sterilization facilities in the Surgical Suite shall not be
required.
4. Medication
Distribution. Provisions shall be made for storage and distribution of
medications. This may be done from a medication preparation room or unit, from
a self-contained medication dispensing unit, or by another system approved by
the Department. If used, a medication preparation room or unit shall be under
visual control of nursing staff. It shall contain a work counter, sink,
refrigerator, and double-locked storage for controlled substances with
convenient access to handwashing stations provided. Each blood bank
refrigerator shall be on an emergency power circuit.
5. Scrub Facilities. Two scrub stations shall
be provided near the entrance to each operating room; however two scrub
stations may serve two operating rooms if the scrub stations are located
adjacent to the entrance of each operating room. Scrub facilities shall be
arranged to minimize any incidental splatter on nearby personnel or supply
carts. In new construction, view windows at scrub stations permitting
observation of room interiors shall be provided. The scrub sinks shall be
recessed into an alcove out of the main traffic areas. Equipment and supplies
for timed scrub technique shall be available at each scrub sink with manual
and/or automatic two way controls.
6. Soiled Workroom. An enclosed soiled
workroom (or soiled-holding room that is part of a system for the collection
and disposal of soiled material) for the exclusive use of the surgical suite
shall be provided. It shall be located in the restricted area. The soiled
workroom shall contain a flushing-rim clinical sink or equivalent flushing-rim
fixture, a work counter, a handwashing fixture, and space for waste
receptacles, and soiled linen receptacles. Rooms used only for temporary
holding of soiled material may omit the flushing-rim clinical sink and work
counters. However, if the flushing-rim clinical sink is omitted, other
provisions for disposal of liquid waste shall be provided. This room shall not
have direct connection with operating rooms or other sterile activity rooms.
Soiled and clean work or holding rooms shall be separated.
7. Clean Workroom or a Clean Supply Room. A
clean workroom is required when clean materials are assembled within the
surgical suite prior to use, or following the decontamination cycle. It shall
contain a work counter, a handwashing fixture, storage for clean supplies, and
space to package reusable items. The storage for sterile supplies shall be
separated from this space. If the room is used only for storage and holding as
part of a system for distribution of clean and sterile supply materials, the
work counter and handwashing fixture may be omitted. Storage space for sterile
and clean supplies shall be adequate for the functional plan. The space shall
be moisture and temperature controlled and free from cross traffic.
8. The location of sterilization for surgical
instruments and the direction of flow from the decontamination location to the
sterile location shall be addressed by the written functional program.
a. An operating room suite design with a
sterile core shall provide for no cross traffic of staff and supplies from the
decontaminated/soiled areas to the sterile/clean areas.
b. The use of facilities outside the
operating room for soiled/decontaminated processing and clean assembly and
sterile processing shall be designed to move the flow of goods and personnel
from dirty to clean/sterile without compromising standard precautions or
aseptic techniques in both departments. This room shall have no direct opening
into an operating room.
9. Anesthesia storage shall be provided in
accordance with NFPA 99.
10.
Medical gas storage facilities. Main storage of medical gases may be outside or
inside the facility in accordance with NFPA99. Provision shall be made for
additional separate storage of reserve gas cylinders necessary to complete at
least one day's procedures.
11 An
anesthesia workroom for testing and storing anesthesia equipment shall contain
a work counter, sink and racks for cylinders.
12. Equipment storage room(s) for equipment
and supplies used in the Surgical Suite. Each surgical suite shall provide
sufficient storage area to keep the exit access corridor free of equipment and
supplies, but not less than 150 square feet or 50 square feet per OR, whichever
is greater.
13. Staff Dressing
Room. Appropriate room(s) shall be provided for males and females working
within the Surgical Suite. The room(s) shall contain lockers, showers, toilets,
lavatories equipped for handwashing, and space for donning scrub suits and
boots. These room(s) shall be arranged to provide a one-way traffic pattern so
personnel entering from outside the Surgical Suite can change, shower, gown,
and move directly into the Surgical Suite.
14. Stretcher storage area out of direct line
of traffic.
15. Staff lounge and
toilet facilities. Separate or combined lounges for males and females shall be
provided. Lounge(s) shall be located to permit use without leaving the Surgical
Suite and to provide convenient access to the Recovery Room
16. Dictation and report preparation area.
This may be accessible from the lounge area.
17. Phase II recovery. Where outpatient
surgeries are to be part of the surgical suite, and where outpatients receive
Class B or Class C sedation, a second Phase II or step-down recovery room shall
be provided. The room shall contain handwashing stations, a nurse station with
charting facilities, clinical sink, provision for bedpan cleaning, and storage
space for supplies and equipment. In addition, the design shall provide a
minimum of 50 square feet for each patient in a lounge chair with space for
additional equipment described in the functional program and for clearance of 4
feet between the sides of the lounge chairs and the foot of the lounge chairs.
Provisions shall be made for the isolation of infectious patients. Provisions
for patient privacy such as cubicle curtains shall be made. In new
construction, at least one door shall access the PACU without crossing
unrestricted corridors of the hospital. A patient toilet shall be provided with
direct access to the Phase II recovery unit for the exclusive use of patients.
A staff toilet shall be provided with direct access to the working area to
maintain staff availability to patients. Handwashing stations with hands-free
operable controls shall be available with at least one for every four lounge
chairs uniformly distributed to provide equal access from each patient
bed.
18. Change areas for
outpatients and same-day admissions. If the functional program defines
outpatient surgery as part of the surgical suite, a separate area shall be
provided where outpatients may change from street clothing into hospital gowns
and be prepared for surgery. This would include a waiting room, locker(s),
toilet(s), and clothing change or gowning area. Changing may also be
accommodated in a private holding room or cubicle
19. Provisions shall be made for patient
examination, interviews, preparation, testing, and obtaining vital signs of
patients for outpatient surgery.
20. Patient holding area. In facilities with
two or more operating rooms, an area shall be provided to accommodate stretcher
patients waiting for surgery. This holding area shall be under the visual
control of the nursing staff.
21.
Storage areas for portable X-ray equipment, stretchers, fracture tables,
warming devices, auxiliary lamps, etc. These areas shall be out of corridors
and traffic.
22. Emergency
equipment storage under direct control of the nursing staff and not obstructing
the corridor.
23. Environmental
Services closet. See Section 65, Physical Facilities, Cleaning and Sanitizing
Carts and Environmental Services, for detailed requirements.
24. Area for preparation and examination of
frozen sections. This may be part of the general laboratory if immediate
results are obtainable without unnecessary delay in the completion of
surgery.
25. Ice machine. An ice
machine shall be provided to provide ice for treatments and patient use. Ice
intended for human consumption shall be from self-dispensing ice
makers.
26. A waiting room, with
toilets, telephones, and drinking fountains conveniently located. The toilet
room shall contain handwashing stations. If outpatients, as defined by the
written functional program, are required to wait in this area, then a separate
area shall be provided. Provisions shall be made for examinations, interviews,
testing, and obtaining vital signs. A separate area shall be provided where
outpatients may change from street clothing into hospital gowns.
27. Ethylene Oxide Sterilization Facilities.
Where ethylene oxide is used for sterilization, provisions shall be made for
complete exhaust of gases to the exterior. When the door is opened, arrangement
shall ensure that gases are pulled away from the operator. Provisions shall be
made for appropriate aeration of supplies. Aeration cabinets shall be vented to
the outside. Where aeration cabinets are not used in ethylene oxide processing,
provision for isolated area mechanically vented to the outside for aeration,
OSHA standards shall be met.
F. Preoperative Patient Holding Area.
1. Preoperative Patient Holding Area(s). In
facilities with two or more operating rooms, areas shall be provided to
accommodate stretcher patients as well as sitting space for ambulatory patients
not requiring stretchers. These areas shall be under the direct visual control
of the nursing staff and may be part of the recovery suite to achieve maximum
flexibility in managing surgical case loads. Each stretcher station shall be a
minimum of 80 square feet and shall have a minimum clearance of 4 feet on the
sides of the stretchers and the foot of the stretcher. Provisions shall be made
for the isolation of infectious patients. Provisions for patient privacy such
as cubicle curtains shall be made.
G. Post-anesthetic care units (PACUs):
1. Each PACU shall contain a medication
station; handwashing stations; nurse station with charting facilities; clinical
sink; provisions for bedpan cleaning; and storage space for stretchers,
supplies, and equipment. Additionally, the design shall provide a minimum of 80
square feet for each patient bed with a space for additional equipment
described in the functional program, and for clearance of at least 5 feet
between patient beds and 4 feet between patient bedsides and adjacent walls.
Provisions shall be made for the isolation of infectious patients. Provisions
for patient privacy such as cubicle curtains shall be made. In new
construction, at least one door to the recovery room shall access directly from
the surgical suite without crossing public hospital corridors.
2. An airborne infection isolation room is
not required in a PACU. Provision for the recovery of a potentially infectious
patient with an airborne infection shall be determined by the Infection
Prevention and Control Risk Assessment.
3. A staff toilet shall be located within the
working area to maintain staff availability to patients.
4. Handwashing stations with hands-free
operable controls shall be available with at least one for every four beds
uniformly distributed to provide equal access from each patient bed.
SECTION 50:
PHYSICAL FACILITIES, OBSTETRICAL FACILITIES.
General obstetrical unit shall be located and designated to prohibit non-related traffic through the unit. When delivery and operating rooms are in the same suite, access and service arrangements shall be such that neither staff nor patients need to travel through one area to reach the other. Except as permitted otherwise herein, existing facilities being renovated shall, as far as practicable, provide all the required support services.
A. Postpartum Unit.
1. Postpartum Room.
a. A postpartum room shall have a minimum of
lOOsquare feet of clear floor area per bed in multi-bedded rooms and 120square
feet of clear floor area in single-bed rooms. These areas shall be exclusive of
toilet rooms, closets, alcoves, or vestibules. Where renovation work is
undertaken, every effort shall be made to meet the above minimum standards. If
it is not possible to meet the above square -foot standards, the authorities
having jurisdiction may grant approval to deviate from this requirement. In
such cases, existing postpartum patient rooms shall have no less than 80 square
feet of clear floor area per bed in multiple-bed rooms and 100 square feet in
single-bed rooms.
b. In
multi-bedded rooms there shall be a minimum clear distance of four feet between
the foot of the bed and the opposite wall, three feet between the side of the
bed and nearest wall, and four feet between beds.
c. The maximum number of beds per room shall
be two.
2. The following
support services for this unit shall be provided.
a. Nurses' station.
b. Nurse office.
c. Charting facilities.
d. Toilet room for staff.
e. Staff lounge.
f Lockable closets or cabinets for personal
articles of staff.
g.
Consultation/conference room(s).
h.
Patients' lounge. The patients' lounge may be omitted if all rooms are
single-bedded rooms
i. Clean
workroom or clean supply room. A clean workroom is required if clean materials
are assembled within the obstetrical suite prior to use. It shall contain a
work counter, a handwashing fixture, and storage facilities for clean and
sterile supplies. If the room is used only for storage and holding as part of a
system for distribution of clean and sterile supply materials, the work counter
and handwashing fixtures may be omitted. Soiled and clean workrooms or holding
rooms shall be separated and have no direct connection.
j. Soiled workroom or soiled holding room for
the exclusive use of the obstetrical suite. This room shall be separate from
the clean workroom. The soiled workroom shall contain a clinical sink (or
equivalent flushing-rim fixture) and a handwashing fixture. The above fixtures
shall have a hot and cold mixing faucet. The room shall have work counter and
space for separate covered containers for soiled linen and waste. Rooms used
only for temporary holding of soiled material may omit the clinical sink and
work counter. If the flushing-rim clinical sink is omitted, facilities for
cleaning bedpans shall be provided elsewhere.
k. Medication station. Provision shall be
made for storage and distribution of drugs and routine medications. This may be
done from a medicine preparation room or unit, from a self-contained medicine
dispensing unit, or by another approved system. If used, a medicine preparation
room or unit shall be under visual control of nursing staff. It shall contain a
work counter, sink, refrigerator, and double-locked storage for controlled
substances. Convenient access to handwashing stations shall be provided.
(Standard cup-sinks provided in many self-contained units are not adequate for
handwashing.)
l. Clean linen
storage may be part of a clean workroom or a separate closet. When a closed
cart system is used, the cart shall be stored out of the path of normal
traffic.
m. Nourishment station
shall contain sink, work counter, ice dispenser, refrigerator, cabinets, and
equipment for serving hot or cold food. Space shall be included for temporary
holding of unused or soiled dietary trays.
n. Equipment storage room. Each unit shall
provide sufficient storage area(s) located on the patient floor to keep its
required corridor width free of equipment and supplies, but not less than 10
square feet per postpartum room and 20 square feet per each LDR or LDRP outside
of the patient room.
o. Storage
space for stretchers and wheelchairs shall be provided in a strategic location,
out of corridors and away from normal traffic.
p. When bathing facilities are not provided
in patient rooms, there shall be at least one shower and/or bathtub for each
six beds or fraction thereof.
q. A
housekeeping room shall be provided for the exclusive use of the obstetrical
suite. It shall be directly accessible from the suite and shall contain a
service sink or floor receptor and provisions for storage of supplies and
housekeeping equipment.
r.
Examination/treatment room and/or multipurpose diagnostic testing room shall
have a minimum clear floor area of 120square feet. When utilized as a
multipatient diagnostic testing room, a minimum clear floor area of 80square
feet per patient shall be provided. An adjoining toilet room shall be provided
for patient use.
s. Emergency
equipment storage shall be located in close proximity to the nurses'
station.
4. Airborne
infection isolation room(s). An airborne infection isolation room is not
required for the obstetrical unit. Provisions for the care of the perinatal
patient with an airborne infection shall be determined by the Infection
Prevention and Control Risk Assessment.
B. Cesarean/Delivery Suite.
1. Caesarean/delivery room(s) shall have a
minimum clear floor area of 360 square feet with a minimum dimension of 16 feet
exclusive of built-in shelves or cabinets. There shall be a minimum of one such
room in every obstetrical unit.
2.
Delivery room(s) shall have minimum clear area of 300 square feet exclusive of
fixed cabinets and built-in shelves. An emergency communication system shall be
connected with the obstetrical suite control station.
3. Infant resuscitation shall be provided
within the cesarean/delivery room(s) and delivery rooms with a minimum clear
floor are of 40 square feet in addition to the required area of each room or
may be provided in a separate but immediately accessible room with a clear
floor area of 150 square feet. Six single or three duplex electrical outlets
shall be provided for the infant in addition to the facilities required for the
mother.
4. Labor room(s) (LDR or
LDRP rooms may be substituted). In renovation projects, existing labor rooms
may have a minimum clear area of 100 square feet per bed.
Where LDRs or LDRPs are not provided, a minimum of two labor beds shall be provided for each Caesarean room and/or delivery room. In facilities that have only one Caesarean delivery room, two labor rooms shall be provided. Each room shall be designed for either one or two beds with a minimum clear area of 120square feet per bed. Each labor room shall contain a handwashing fixture and have access to a private toilet room. One toilet room may serve two labor rooms. Labor rooms shall have controlled access with doors that are arranged for observation from a nurses' station. At least one shower (which may be separate from the labor room if under staff control) for use of patients in labor shall be provided. Windows in labor rooms, if provided, shall be located, draped, or otherwise arranged to preserve patient privacy from causal observation from outside the labor room.
5. Recovery room(s). (LDR or LDRP rooms may
be substituted.) Each recovery room shall contain at least two beds and have a
nurses' station with charting facilities located to permit visual control of
all beds. Each room shall include stations for handwashing and dispensing
medicine. A clinical sink with bedpan flushing device shall be available, as
shall storage for supplies and equipment. There shall be enough space for baby
and crib and a chair for the support person. There shall be the ability to
maintain visual privacy of the new family.
6. Service Areas.
a. Individual rooms shall be provided as
indicated in the following standards; otherwise, alcoves or other open spaces
that do not interfere with traffic may be used.
b. The following services shall be provided:
1) A control/nurse station located to
restrict unauthorized traffic into the suite.
2) Soiled workroom or soiled holding room.
This room shall be separate from the clean workroom. The soiled workroom shall
contain a clinical sink (or equivalent flushing-rim fixture). The room shall
contain a handwashing fixture. The above fixtures shall have a hot and cold
mixing faucet. The room shall have a work counter and space for separate
covered containers for soiled linen and waste. Rooms used only for temporary
holding of soiled material may omit the clinical sink and work counter. If the
flushing-rim clinical sink is eliminated, facilities for cleaning bedpans shall
be provided elsewhere.
3) Fluid
waste disposal.
c. The
following services may be shared with the surgical facilities if the functional
program reflects this concern. Where shared, areas shall be arranged to avoid
direct traffic between the delivery and operating rooms.
1) A supervisor's office or
station.
2) A waiting room, with
toilets, telephones, and drinking fountains conveniently located. The toilet
room shall contain handwashing stations.
3) Sterilizing facilities with high-speed
sterilizers convenient to all Caesarean/delivery rooms. Sterilization
facilities shall be separate from the delivery area and adjacent to clean
assembly. High-speed autoclaves shall only be used in an emergency situation
(i.e., a dropped instrument and no sterile replacement readily available).
Sterilization facilities would not be necessary if the flow of materials were
handled from a central service department based on the usage of the delivery
room (DR).
4) A drug distribution
station with handwashing stations and provisions for controlled storage,
preparation, and distribution of medication.
5) Scrub facilities for Caesarean and
delivery rooms. Two scrub stations shall be provided adjacent to entrance to
each Caesarean/delivery room. Scrub facilities should be arranged to minimize
any splatter on nearby personnel or supply carts. In new construction, view
windows at scrub stations to permit the observation of room
interiors.
6) Clean workroom or
clean supply room. A clean workroom shall be provided if clean materials are
assembled within the obstetrical suite prior to use. If a clean workroom is
provided it shall contain a work counter, sink equipped for handwashing and
space for storage of supplies. A clean supply room may be provided when the
narrative program defines a system for the storage and distribution of clean
and sterile supplies.
7) Medical
gas storage facilities. Main storage of medical gases may be outside or inside
the facility in accordance with NFPA99. Provision shall be made for additional
separate storage of reserve gas cylinders necessary to complete at least one
day's procedures.
8) A clean
sterile storage area readily available to the delivery room: size to be
determined on level of usage, functions provided, and supplies from the
hospital central distribution area.
9) An anesthesia workroom for cleaning,
testing, and storing anesthesia equipment. It shall contain a work counter,
sink, and provisions for separation of clean and soiled items.
10) Equipment storage room(s) for equipment
and supplies used in the obstetrical suite.
11) Staff clothing change areas. The clothing
change area shall be designed to encourage one-way traffic and cross-traffic
between clean and contaminated personnel. The area shall contain lockers,
showers, toilets, handwashing stations, and space for donning and disposing
scrub suits and booties.
12) Male
and female support persons change area (designed as described above).
13) Lounge and toilet facilities for
obstetrical staff convenient to delivery, labor, and recovery areas. The toilet
room shall contain handwashing stations.
14) An on-call room(s) for physician and/or
staff may be located elsewhere in the facility.
15) Environmental Services Closet. See
Section 65, Physical Facilities, Cleaning Sanitizing Carts and Environmental
Services for detaled requirements.
16) An area for storing stretchers out of the
path of normal traffic.
C. LDR and LDRP Facilities. When provided by
the narrative program, delivery procedures in accordance with birthing concepts
may be performed in the LDR or LDRP rooms. LDR room(s) may be located in a
separate LDR suite or as part of the Caesarean/Delivery suite. The postpartum
unit may contain LDRP rooms. These rooms shall have a minimum of 250square feet
of clear floor area with a minimum dimension of 13feet, exclusive of toilet
room, closet, alcove, or vestibules. There should be enough space for crib and
reclining chair for support person. An area within the room but distinct from
the mothers area shall be provided for infant stabilization and resuscitation.
See Table 4 of the Appendix for medical gas outlets. These outlets shall be
located in the room so that they are accessible to the mother's delivery area
and infant resuscitation area. When renovation work is undertaken, every effort
shall be made to meet the above minimum standards. If it is not possible to
meet the above square-foot standards, the authorities having jurisdiction may
grant approval to deviate from this requirement. In such cases, existing LDR or
LDRP rooms may have a minimum clear area of 200 square feet.
Each LDR or LDRP room shall be for single occupancy and have direct access to a private toilet with shower or tub. Each room shall be equipped with handwashing facilities (handwashing stations with hands-free operation area acceptable for scrubbing). Examination lights may be portable, but shall be immediately accessible.
Finishes shall be selected to facilitate cleaning and with resistance to strong detergents. Window(s) shall be provided for LDRP room(s). Windows or doors within a normal sightline that would permit observation into the room shall be arranged or draped as necessary for patient privacy. Additional requirements for windows are provided above in A2.a.
SECTION 51:
PHYSICAL FACILITIES, EMERGENCY SUITE.
A. General. The following shall be provided:
1. Grade-level well-marked, illuminated, and
covered entrance with direct access from public roads for ambulance and vehicle
traffic. Entrance and driveway shall be clearly marked. If a raised platform is
used for ambulance discharge, a ramp shall be provided for pedestrian and
wheelchair access. The emergency vehicle entry cover shall provide shelter for
both the patient and the emergency medical crew during transfer from an
emergency vehicle into the building.
2. Paved emergency access to permit discharge
of patients from automobiles and ambulances, and temporary parking convenient
to the entrance.
3. Reception,
triage, and nurses' station shall be located to permit staff observation and
control of access to treatment area, pedestrian and ambulance entrances, and
public waiting area. The triage area requires special consideration. As the
point of entry and assessment for patients with undiagnosed and untreated
airborne infections, the triage area shall be designed and ventilated to reduce
exposure of staff, patients and families to airborne infectious diseases. If
determined by the infection prevention and control risk assessment, one or more
separate, enclosed spaces designed and ventilated as airborne infection
isolation rooms shall be required.
4. Wheelchair and stretcher storage shall be
provided for arriving patients. This shall be out of traffic with convenient
access from emergency entrances.
5.
Public waiting area with toilet facilities, drinking fountains, and telephones
shall be provided. The hospital shall conduct infection prevention and control
risk assessment to determine if the emergency department waiting area shall
require special measures to reduce the risk of airborne infection transmission.
These measures may include enhanced general ventilation and air disinfection
similar to inpatient requirements for airborne infection isolation
rooms.
6. Communication center
shall be convenient to nurses' station and have radio, telephone, and
intercommunication systems.
7.
Examination and Treatment Room(s). Examination and treatment room(s) shall have
minimum floor area of 120 square feet. The room shall contain work counter(s);
cabinets; handwashing stations; supply storage facilities; examination lights;
a desk, counter, or shelf space for writing; and a vision panel adjacent to
and/or in the door. When treatment cubicles are in open multiple-bed areas,
each cubicle shall have a minimum of 80square feet of clear floor space and
shall be separated from adjoining cubicles by curtains. Handwashing stations
shall be provided for each four treatment cubicles or major fraction thereof in
multiple-bed areas. For oxygen and vacuum requirements, see Table 4 of the
Appendix. Treatment/exam rooms used for pelvic exams should allow for the foot
of the examination table to face away from the door.
8. Trauma/cardiac rooms for emergency
procedures, including emergency surgery, shall have at least 250 square feet of
clear floor space. Each room shall have cabinets and emergency supply shelves,
X-ray film illuminators, examination lights, and counter space for writing.
Additional space with cubicle curtains for privacy may be provided to
accommodate more than one patient at a time in the trauma room. Provisions
shall be made for monitoring the patient. There shall be storage provided for
immediate access to attire used for universal precautions. Doorways leading
from the ambulance entrance to the cardiac trauma room shall be a minimum of
five feet wide to simultaneously accommodate stretchers, equipment, and
personnel. In renovation projects, every effort shall be made to have existing
cardiac/trauma rooms meet the above minimum standards.
9. Orthopedic and cast work. These may be in
separate room(s) or in the trauma room. They shall include storage for splints
and other orthopedic supplies, traction hooks, X-ray film illuminators, and
examination lights. If a sink is used for the disposal of plaster of paris, a
plaster trap shall be provided. The clear floor space for this area shall
depend on the functions program and the procedures and equipment accommodated
here.
10. Scrub stations located in
or adjacent and convenient to each trauma and/or orthopedic room.
11. Convenient access to radiology and
laboratory services.
12. Poison
Control Center and EMS Communications Center may be part of the work and
charting area.
13. Provisions for
disposal of solid and liquid waste. This may be a clinical sink with bedpan
flushing device within the soiled workroom.
14. Storage area out of line of traffic for
stretchers, wheelchairs and emergency equipment;
15. A toilet room for patients. Where there
are more than eight treatment areas, a minimum of two toilet facilities, with
handwashing stations(s) in each toilet room, will be required.;
16. Soiled workroom for the exclusive use of
the emergency suite. This room shall be separate from the clean workroom. The
soiled workroom shall contain a clinical sink or equivalent flushing type
fixture, work counter, sink equipped for handwashing, waste receptacle and
linen receptacle. This room shall be separate from the clean workroom and shall
have separate access doors.
17.
Clean workroom or clean supply room. A clean work room is required if clean
materials are assembled within the emergency suite prior to use. It shall
contain a work counter, a handwashing fixture, and storage facilities for clean
and sterile supplies. If the room is used only for storage and holding as part
of a system for distribution of clean and sterile supply materials, the work
counter and handwashing fixtures may be omitted. Soiled and clean workrooms or
holding rooms shall be separated and have no direct connection.
18. Nurses' Station(s). Facilities for
charting, clinical records, work counter, communication system, space for
supplies and convenient access to handwashing stations shall be provided.
Visual observation of all traffic into the suite, where feasible.
19. Securable closets or cabinet compartments
for personnel.
20. Staff lounge.
Convenient and private access to staff toilets, lounge, and lockers shall be
provided.
21. Housekeeping room. A
housekeeping room shall be directly accessible from the unit and shall contain
a service sink or floor receptor and provisions for storage of supplies and
housekeeping equipment.
22.
Security station. A security system should be located near the emergency
entrances and triage/reception area. The non-selective 24-hour accessibility of
the emergency dictates that a security system reflecting local community needs
be provided.
23. At least one
airborne infection isolation room shall be provided. The need for additional
airborne infection isolation rooms or for protective environment room shall be
as determined by the Infection Prevention and Control Risk Assessment. See
Section 44.C for requirements.
24.
Bereavement Room shall be located within or adjacent to the emergency suite. A
telephone shall be provided.
25.
Secured holding room in accordance with the functional program. At least one
holding/seclusion room of 80 square feet shall be provided. This room shall
allow for security, patient and staff safety, patient observations, and
soundproofing.
26. Decontamination
area. A decontamination area shall be provided. The functional program shall
define the location of the area and the types of exposure (i.e., nuclear,
biological, chemical) to be considered. The location of the area shall be
permitted to be on the exterior perimeter of the facility adjacent to the
ambulance entrance or built within the walls of the facility.
SECTION 52:
PHYSICAL FACILITIES, IMAGING SUITE.
A.
General.
1. Equipment and space shall be as
required by the functional program.
2. A certified physicist or other qualified
expert shall specify the type, location, and amount of radiation protection to
be installed in accordance with the final approved department layout and
equipment selections. Where protected alcoves with view windows are required, a
minimum of one foot six inches between the view window and the outside
partition edge shall be provided. Radiation protection requirements shall be
incorporated into the specifications and the building plans.
3. Radiation Control and Emergency Management
shall be notified when any existing and/or new equipment has been relocated or
introduced into the facility. Radiation Control approval for the equipment(s)
and space(s) shall be obtained prior to use.
B. Angiography.
1. Space shall be provided as required by the
functional program.
2. A control
room shall be provided as necessary to meet the needs of the functional
program. A view window in the control room shall be provided to permit full
view of the patient.
3. A viewing
area shall be provided.
4. A scrub
sink located outside the staff entry to the procedure room shall be provided
for use by staff.
5. A patient
holding area shall be provided.
6.
Storage for portable equipment and supplies shall be provided.
7. Provision shall be made within the
facility for extended post-procedure observation of outpatients.
C. Computerized Tomography (CT)
Scanning.
1. A control room shall be provided
which is designed to accommodate the computer and other controls for the
equipment. A view window shall be provided to permit full view of the patient.
The angle between the control and equipment centroid shall permit the control
operator to see the patient's head.
2. The control room shall be located to allow
convenient film processing.
3. A
patient toilet room shall be convenient to the procedure room, and if directly
accessible to the scan room, arranged so that a patient may leave the toilet
without having to reenter the scan room.
D. Diagnostic X-ray (e.g., Tomography,
Radiography/Fluoroscopy Rooms, Mammography). Radiology rooms shall be of a size
to accommodate the functional program. Each X-ray room shall include a shielded
control alcove. This area shall be provided with a view window designed to
provide full view of the examination table and the patient at all times,
including full view of the patient when the table is in the tilt position or
the chest X-ray is being utilized. For mammography machines with built-in
shielding for the operator, the alcove may be omitted when approved by the
certified physicist or state radiation protection agency.
E. Magnetic Resonance Imaging (MRI).
1. Space shall be provided as required by the
functional program.
2. A control
room shall be provided with full view of the MRI.
3. A computer room shall be
provided.
4. A patient holding area
should be located near the MRI unit.
5. Cryogen venting shall comply with
manufacturer's recommendations.
F. Ultrasound.
1. Space shall be provided as required by the
functional program.
2. A patient
toilet room, accessible from the procedure room, shall be provided.
G. Support Spaces. The following
spaces are common to the imaging department and are minimum requirements unless
stated otherwise.
1. Patient Waiting Area.
The area shall have a seating capacity in accordance with the functional
program.
2. Control Desk and
Reception Area.
3. Holding Area. A
convenient holding area under staff control shall be provided to accommodate
patients on stretchers or beds.
4.
Patient Toilet Rooms. Toilet rooms shall be provided convenient to the waiting
rooms and shall be equipped with an emergency call system. Separate toilets
with handwashing stations shall be provided with direct access from each
radiography/fluoroscopy room so that a patient may leave the toilet without
having to reenter the radiography/fluoroscopy room. Rooms used only
occasionally for fluoroscopy procedures may utilize nearby patient toilets if
they are located for immediate access.
5. Patient Dressing Rooms. Dressing rooms
shall be provided convenient to the waiting areas and X-ray rooms. Each room
shall include a seat or bench, mirror, and provisions for hanging patients'
clothing.
6. Staff Facilities.
Toilets may be outside the suite but shall be convenient for staff use. In
larger suites of three or more procedure rooms, toilets internal to the suite
shall be provided.
7. Image
Storage. Provisions shall be provided by the facility for the active and
inactive image storage. A room with cabinet or shelves for filing patient image
for immediate retrieval shall be provided. A room or area for inactive image
storage shall be provided. It may be outside the imaging suite, but shall be
under imaging's administrative control and properly secured to protect films
against loss or damage.
8. Storage
for Unexposed Image. Storage facilities for unexposed images shall include
protection of film against exposure or damage and shall not be warmer than the
air of adjacent occupied spaces.
9.
Provisions for image viewing, individual consultation, clerical spaces and
charting shall be provided.
10.
Contrast Media Preparation. This area shall be provided with sink, counter, and
storage to allow for mixing of contrast media. One preparation area, if
conveniently located, may serve any number of rooms. When prepared media is
used, this area may be omitted, but storage shall be provided for the
media.
11. Image Processing Room. A
darkroom shall be provided for image processing unless the processing equipment
normally used does not require a darkroom for loading and transfer. When
daylight processing is used, the darkroom may be minimal for emergency and
special uses. Image processing shall be located convenient to the procedure
rooms and to the quality control area.
12. Quality Control Area. An area shall be
provided near the processor for viewing film immediately after it is processed.
All view boxes shall be illuminated to provide light of the same color value
and intensity for appropriate comparison of several adjacent images.
13. Cleanup Facilities. Provisions for
cleanup shall be located within the suite for convenient access and use and
shall include service sink or floor receptacle as well as storage space for
equipment and supplies. If automatic film processors are used, a receptacle of
adequate size with hot and cold water for cleaning the processor racks shall be
provided.
14. Handwashing Stations.
Handwashing stations shall be provided within each procedure room unless the
room is used only for routine screening such as chest X-rays where the patient
is not physically handled by the staff. Handwashing stations shall be provided
convenient to the MRI room, but need not be within the room.
15. Clean Storage. Provisions shall be made
for the storage of clean supplies and linens. If conveniently located, storage
may be shared with another department.
16. Soiled Holding. Provisions shall be made
for soiled holding. Separate provisions for contaminated handling and holding
shall be made. Handwashing stations shall be provided.
17. Provision shall be made for locked
storage of medications and drugs.
H. Cardiac Catheterization Lab.
Note: The number of procedure rooms and the size of the prep, holding, and recovery areas shall be based on expected utilization.
1. The cardiac catheterization lab is
normally a separate suite, but may be within the imaging suite when the
appropriate sterile environment is provided. It may be combined with
angiography in low usage situations.
2. The procedure room shall be a minimum of
400square feet exclusive of fixed and movable cabinets and shelves.
3. A control room or area for the efficient
functioning of the X-ray and image recording equipment. A view window
permitting full view of the patient from the control console shall be
provided.
4. An equipment room or
enclosure large enough to contain x-ray transformers, power modules, and
associated electronics and electrical gear shall be provided.
5. Scrub facilities with hands free operable
controls shall be provided adjacent to the entrance of procedure rooms, and
shall be arranged to minimize incidental splatter on nearby personnel, medical
equipment, or supplies.
6. The
following shall be available for use by the cardiac catheterization suite:
a. A viewing room;
b. A film file room.
7. Staff change area(s) shall be provided and
arranged to ensure a traffic pattern so that personnel entering from outside
the suite can enter, change their clothing, and move directly into the cardiac
catheterization suite.
8. A patient
preparation, holding, and recovery area or room shall be provided and arranged
to provide visual observation before and after the procedure.
9. A clean workroom or clean supply room
shall be provided. If the room is used for preparing patient care items, it
shall contain a work counter and handwashing sink. If the room is used only for
storage and holding of clean and sterile supply materials, the work counter and
handwashing stations may be omitted.
10. A soiled workroom shall be provided which
shall contain a handwashing and a clinical sink (or equivalent flushing rim
fixtures). When the room is used for temporary holding of soiled materials, the
clinical sink may be omitted.
11. A
housekeeping closet containing a floor receptor or service sink and provisions
for storage of supplies and housekeeping equipment shall be provided.
SECTION 53:
PHYSICAL FACILITIES, NUCLEAR MEDICINE.
A. Equipment and space shall be provided to
accommodate the functional program.
B. A certified physicist or other qualified
expert representing the owner shall specify the type, location, and amount of
radiation protection to be installed in accordance with final approved
department layout and equipment selection. These specificaitons shall be
incorporated into the plans.
C.
Floors and walls shall be constructed of materials that are easily
decontaminated in case of radioactive spills.
D. If radiopharmaceutical preparation is
performed onsite, an area adequate to house a radiopharmacy shall be provided
with appropriate shielding. This area should include adequate space for storage
of radionuclides, chemicals for preparation, dose calibrators, and record
keeping. Floors and walls should be constructed of easily decontaminated
materials. Vents and traps for radioactive gases should be provided if such are
used. Hoods for pharmaceutical preparation shall meet applicable standards. If
pre-prepared materials are used, storage and calculation area may be
considerable smaller than that for on-site preparation. Space shall provide
adequately for dose calibration, quality assurance, and record keeping. This
area may still require shielding from other portions of the
facilities.
E. Nuclear medicine
area when operated separately from the imaging department shall include the
following as required to accommodate the functional program:
1. Space adequate to permit entry of
stretchers, beds, and able to accommodate imaging equipment, electronic
consoles, and if present, computer terminals;
2. A darkroom onsite available for film
processing. The darkroom should contain protective storage facilities for
unexposed film that guard the film against exposure or damage;
3. When the functional program requires a
centralized computer area, it should be a separate room with access terminals
available within the imaging rooms.
4. Provisions for cleanup located within the
suite for convenient access and use. It shall include service sink or floor
receptacle as well as storage space for equipment and supplies;
5. Film storage with cabinets or shelves for
filing patient film for immediate retrieval;
6. Inactive film storage under the
departmental administrative control and properly secured to protect film
against loss or damage;
7. A
consultation area with view boxes illuminated to provide light of the same
color value and intensity for appropriate comparison of several adjacent
films;
8. Provisions for
physicians, assistants and clerical office space, individual consultation,
viewing, and charting of film;
9.
Waiting areas out of traffic, under staff control, with seating capacity in
accordance with the functional program. If the department is routinely used for
outpatients and inpatients at the same time, separate waiting areas with
screening or visual privacy between the waiting areas;
10. A private area for dose administration
located near the preparation area;
11. A holding area for patients on stretchers
or beds which may be provided and may be combined with the dose administration
area with visual privacy between the areas;
12. Patient dressing rooms convenient to the
waiting area and procedure rooms. Each dressing room shall include a seat or
bench, a mirror, and provisions for hanging patient's clothing;
13. Toilet rooms convenient to waiting and
procedure rooms;
14. Staff
toilet(s) convenient to the nuclear medicine laboratory;
15. Handwashing stations within each
procedure room;
16. Control desk
and reception area;
17. Storage
area for clean linen with a handwashing station;
18. Provisions shall be made for holding
soiled material. Such provision shall include a handwashing station.
19. Separate provision shall be made for
holding contaminated material (exposed to radiation).
F. Positron Emission Tomography (PET).
1. Space should be provided as necessary to
accommodate the functional program.
2. PET scanning is generally used in
experimental settings and requires space for a scanner and for a cyclotron. The
scanner room should be a minimum of 300 square feet.
3. Where a cyclotron room is required, it
should he a minimum of 225 square feet with a 16 square foot space safe for
storage of parts, which may need to cool down for a year or more.
4. Both a hot (radioactive) lab and a cold
(nonradioactive) lab may be required, each a minimum of 250 square
feet.
5. A blood lab of a minimum
of 80 square feet should be provided.
6. A patient holding area to accommodate two
stretchers should be provided.
7. A
gas storage area large enough to accommodate bottles of gas should he provided.
Each gas will be piped individually and may go to the cyclotron or to the lab.
Ventilation adequate for the occupancy is required. Compressed air may be
required to pressurize a water circulation system.
8. Significant radiation protection may be
required since the cyclotron may generate high radiation.
9. Special ventilation systems together with
monitors, sensors, and alarm systems may be required to vent gases and
chemicals.
10. The heating,
ventilating, and air conditioning system will require particular attention;
highest pressures should be in coldest (radiation) areas and exhaust should be
in hottest (radiation) areas. Redundancy may be important.
11. The cyclotron is water cooled with
de-ionized water. A heat exchanger and connection to a compressor or connection
to chilled water may be required. A redundant plumbing system connected to a
holding tank may be required to prevent accidental leakage of contaminated
water into the regular plumbing system.
G. Radiotherapy.
1. Rooms and spaces shall be provided as
required by the functional program. Equipment manufacturers recommendations
should be sought and followed, since space requirements may vary from one
machine to another and one manufacturer to another. The radiotherapy suite may
contain one or both electron beam therapy and radiation therapy.
2. Cobalt, linear accelerators, and
simulation rooms require radiation protection. A certified physicist
representing the owner or appropriate state agency shall specify the type,
location, and amount of protection to be installed in accordance with final
approved department layout and equipment selection. This information shall be
Incorporate into the floor plans.
3. Cobalt rooms and linear accelerators shall
be sized in accordance with equipment requirements and shall accommodate a
stretcher for litter-borne patients. Layouts shall provide for preventing the
escape of radioactive particles. Openings into the room, including doors,
ductwork, vents, and electrical raceways and conduits, shall be baffled to
prevent direct exposure to other areas of the facility.
4. Simulator, accelerator, and cobalt rooms
shall be sized to accommodate the equipment with patient access on a stretcher,
medical staff access to the equipment and patient, and service
access.
5. Flooring shall be
adequate to meet load requirements for equipment, patients, and personnel.
Provision for wiring raceways, ducts, or conduit should be made in floors and
ceilings. Ceiling mounted equipment should have properly designed rigid support
structures located above the finished ceiling. The ceiling height is normally
higher than 8'-0" (2.44 meters). A lay-in type of ceiling should be considered
for ease of installation, service, and remodeling.
6. Additional Support Areas for Linear
Accelerator:
a. Mold room with exhaust hood
and handwashing facility.
b. Block
room with storage. The block room may be combined with the mold room.
7. Additional Support Areas for
Cobalt Room:
H. General
Support Areas. The following areas shall be provided unless they are accessible
from other areas such as imaging:
1. A
stretcher holding area adjacent to the treatment rooms, screened for privacy
which may be combined with a seating area for outpatients;
2. Exam rooms as specified by the functional
program. Each shall be a minimum of 120square feet and equipped with a
handwashing station;
3. Darkroom
convenient to the treatment room(s) and the quality control area. Where
daylight processing is used, the darkroom may be minimal for emergency use. If
automatic film processors are used, a receptacle of adequate size with hot and
cold water for cleaning the processor racks shall be provided either in the
darkroom or nearby;
4. Patient
gowning area with provision for safe storage of valuables and clothing. At
least one space should be large enough for staff-assisted dressing;
5. Business office and/or reception/control
area;
6. Housekeeping room equipped
with service sink or floor receptor and large enough for equipment or supplies
storage;
7. Image file area;
and
8. A storage area for
unprocessed media.
I.
Optional Support Area. The following areas may be required by the functional
program:
1. Quality control area with view
boxes illuminated to provide light of the same color value and
intensity;
2. Computer control area
normally located just outside the entry to the treatment room(s);
3. Dosimetry equipment area;
4. Hypothermia room (may be combined with an
exam room);
5. Consultation
room;
6. Oncologist's office (may
be combined with consultation room);
7. Physicist's office (may be combined with
treatment planning);
8. Treatment
planning and record room; and
9.
Work station/nutrition station.
SECTION 54:
PHYSICAL FACILITIES,
MOBILE, TRANSPORTABLE, AND RELOCATABLE UNITS.
A. General. This section applies to mobile,
transportable, and relocatable structures.
B. Definitions.
1. Mobile Unit - Any premanufactured
structure, trailer, or self-propelled unit equipped with a chassis on wheels
and intended to provide medical services on a temporary basis.
2. Transportable Unit - Any premanufactured
structure or trailer, equipped with a chassis on wheels, intended to provide
medical services on an extended basis.
3. Relocatable Unit - Any structure, not on
wheels, built to be relocated at any time and provide medical
services.
C. General
Considerations.
1. Classifications. These
facilities shall be classified as either a small outpatient facility, large
outpatient facility, ambulatory surgery center, or a hospital based upon the
definitions provided in the Rules and Regulations, the program functional and
construction type.
2. Applicable
Requirements. Facilities classified as a small outpatient clinic shall be
designed in accordance with the requirements stipulated in Section 75, Physical
Facilities, Outpatient Care Facilities. Facilities classified as a large
outpatient facility shall be designed in accordance with the requirements
stipulated in item F. of Section 75, Physical Facilities, Outpatient Care
Facilities. Facilities classified as a hospital shall be designed in accordance
with the requirements stipulated in Section 43, Physical Facilities.
3. These requirements shall be applicable to
mobile, transportable, and relocatable structures, when such structures are
used to provide shared medical services on an extended or a temporary
basis.
4. When any mobile unit,
transportable and relocatable unit(s) are situated in a fixed location and
rendered immobile they shall be classified and designed as a health care
facility.
D. Common
Elements for Mobile, Transportable, and Relocatable Units.
1. Site Conditions.
a. Access for the unit to arrive shall be
taken into consideration for space planning. Turning radius of the vehicles,
slopes of the approach (six (6) percent maximum), and existing conditions shall
be addressed.
b. Gauss fields of
various strengths of magnetic resonance imaging (MRI) units shall be considered
for the environmental effect on the field homogeneity and vice versa. Radio
frequency interference shall be considered when planning the site.
c. Sites shall be provided with properly
sized power, including emergency power, water, waste, telephone, and fire alarm
connections.
d. Site shall have
level concrete pads or piers and be designed for the structural loads of the
facility.
e. Site utilizing MRI
systems shall consider providing adequate access for cryogen-servicing of the
magnet. Storage of dewars also shall be included in space planning.
f It is recommended that each site provide a
covered walkway or enclosure to ensure patient safety from the outside
elements.
g. Diesel exhaust of the
tractor and/or unit generator shall be 25feet away from the fresh air intake of
the facility.
h. Each facility
shall provide a means of preventing unit movement, either by blocking the
wheels or by providing pad anchors.
i. Sites shall provide hazard-free patient
drop-off zones and adequate parking.
j. The facility shall provide waiting space
for patient privacy and patient and staff toilets as close to the unit docking
area as possible.
k. Each site
shall provide access to the unit for wheelchair/stretcher patients.
l. Mobile units shall be provided with
handwashing stations unless each site can provide handwashing stations within a
25foot proximity to the unit. Transportable and relocatable units shall be
provided with handwashing stations.
E. General Standards for Details and Finishes
for Unit Construction.
1. Horizontal sliding
doors and power-operated doors shall comply with NFPA 101.
2. Units shall be permitted a single means of
egress as permitted by NFPA 101.
3.
All glazing in doors shall be safety or wire glass.
4. Units shall be equipped with fire
detection and alarm systems. In relocatable and transportable units these
systems shall be connected to the central fire alarm system.
5. Radiation protection for X-ray and gamma
ray installations shall be in accordance with Arkansas Rules and Regulations
for Control of Sources of Ionizing Radiation.
6. Interior finish materials shall be class A
as defined in NFPA 101.
7. Textile
materials having a napped, tufted, looped, woven, nonwoven, or similar surface
shall be permitted on walls and ceilings provided such materials have a class A
rating and rooms or areas are protected by an automatic extinguishment or
sprinkler system.
8. Fire retardant
coatings shall be permitted in accordance with NFPA 101.
9. Curtains and draperies shall be
noncombustible or flame retardant and shall pass both the large and small scale
tests required by NFPA 101. Fire retardant coatings shall be permitted in
accordance with NFPA 101.
F. Mechanical Standards.
1. Air conditioning, heating, ventilating,
ductwork, and related equipment shall be installed in accordance with NFPA 90A,
Standard for the Installation of Air Conditioning and Ventilation
systems.
2. Plumbing Standards.
a. Plumbing and other piping systems shall be
installed in accordance with the Arkansas State Plumbing Code.
b. Mobile units, requiring sinks, shall not
be required to be vented through the roof. Ventilation of waste lines shall be
permitted to be vented through the sidewalls or other acceptable locations.
Transportable and relocatable units shall be vented through the roof per model
plumbing codes.
c. Backflow
prevention shall be installed at the point of water connection on the
unit.
d. Medical gases and suction
systems, if installed, shall be in accordance with NFPA 99.
G. Electrical Standards
1. All electrical material and equipment,
including conductors, controls, and signaling devices, shall be installed in
compliance with applicable section of NFPA 70 and NFPA 99 and shall be listed
as complying with available standards of listing agencies or other similar
established standards where such standards are required.
2. The electrical installations, including
alarm, nurse call, and communication systems, shall be tested to demonstrate
that equipment installation and operation is appropriate and functional. A
written record of performance tests on special electrical systems and equipment
shall show compliance with applicable codes and standards.
3. Data processing and/or automated
laboratory or diagnostic equipment, if provided, may require safeguards from
power line disturbances.
4. Main
switchboards shall be located in an area separate from plumbing and mechanical
equipment and shall be accessible to authorized persons only. Switchboards
shall be convenient for use, readily accessible for maintenance, away from
traffic lanes, and located in dry, ventilated spaces free of corrosive or
explosive fumes, gases, or any flammable material. Overload protective devices
shall operate properly in ambient room temperatures.
5. Panelboards serving normal lighting and
appliance circuits shall be located on the same level as the circuits they
serve.
6. Lighting shall be
engineered to the specific application.
7. The Illuminating Engineering Society of
North America (IES) has developed recommended lighting levels for health care
facilities. The reader should refer to the IES Handbook (1993).
8. Approaches to buildings and parking lots
and all occupied spaces shall have fixtures for lighting that can be
illuminated as necessary.
9.
Consideration should be given to the special needs the elderly. Excessive
contrast in lighting levels that make effective sight adaptation difficult
should be minimized.
10. A portable
or fixed examination light shall be provided for examination, treatment, and
trauma rooms.
11. Duplex
grounded-type receptacles (convenience outlets) shall be installed in all areas
in sufficient quantities for tasks to be performed as needed. Each examination
and work table shall have access to a minimum of two duplex
receptacles.
12. At inhalation
anesthetizing locations, all electrical equipment and devices, receptacles, and
wiring shall comply with applicable sections of NFPA 99 and NFPA 70.
13. Fixed and mobile x-ray equipment
installations shall conform to articles 517 and 660 of NPFA 70.
14. Emergency lighting and power shall be
provided for in accordance with NFPA 99, NFPA 101, AND NFPA 110.
15. The fire alarm system shall be as
described in NFPA 101 AND WHERE APPLICABLE NFPA 72.
16. Terminating devices for
telecommunications and information systems wiring shall be located on the unit
that the terminating devices serve. These terminating devices shall be
accessible to authorized personnel only.
17. Special air conditioning and voltage
regulation shall be provided when recommended by the manufacturer.
SECTION 55:
PHYSICAL FACILITIES, LABORATORY SERVICES.
A. Facilities necessary for providing
laboratory services described in the narrative program shall be provided. The
laboratory shall be constructed, arranged and maintained to ensure adequate
space, ventilation and utilities necessary for conducting all phases required
of testing in accordance with current CLIA regulations refer to Section
19.
B. Specimen collection
facilities shall be provided. These facilities may be located outside the
laboratory suite. The blood collection area shall have a work counter, space
for patient seating, and handwashing facilities. Urine and feces collection
room(s) shall be equipped with a water closet and a lavatory.
C. Provisions shall be made for safety from
physical, chemical and biological hazards. There shall be eye flushing devices,
appropriate storage of flammable liquids, emergency spill kit(s) and fire
extinguishers as required by NFPA 99.
E. Locker and toilet facilities for
laboratory staff shall be located convenient to the laboratory area.
SECTION 56:
PHYSICAL
FACILITIES, REHABILITATION THERAPY DEPARTMENT.
A. Common Elements. Each rehabilitative
therapy department shall include the following, which may be shared or provided
as separate units for each service:
1. Office
and clerical space with provisions for filing and retrieval of patient
records.
2. Reception and control
station(s) with visual control of waiting and activities area. (This may be
combined with office and clerical space.)
3. Patient waiting area(s) out of traffic
with provision for wheelchair patients.
4. Patient toilets with handwashing stations
accessible to wheelchair patients.
5. Space(s) for storing wheelchairs and
stretchers out of traffic while patients are using the services. These spaces
may be separate from the service area but shall be conveniently
located.
6. A conveniently
accessible housekeeping room and service sink for housekeeping use.
7. Locking closets or cabinets within the
vicinity of each work area for securing staff personal effects.
8. Convenient access to toilets and
lockers.
9. Access to a
demonstration/conference room.
10.
Lockable storage for medications.
B. Physical Therapy. If physical therapy is
part of the service, the following at least, shall be included:
1. Individual treatment area(s) with privacy
screens or curtains. Each such space shall have not less than 70 square feet of
clear floor area.
2. Handwashing
stations for staff either within or at each treatment space (one handwashing
station may serve several stations).
3. Exercise area and facilities.
4. Clean linen and towel storage.
5. Storage for equipment and
supplies.
6. Separate storage for
soiled items.
7. Patient change
area. (If required by the functional program.)
C. Occupational Therapy. If this service is
provided, at least the following shall be included:
1. Work areas and counters suitable for
wheelchair access.
2. Handwashing
stations.
3. Storage for supplies
and equipment.
4. An area for daily
living activities shall be provided. It shall contain an area for a bed,
kitchen counter with appliances and sink, bathroom, and a
table/chair.
D.
Prosthetics and Orthotics. If this service is provided, at least, the following
shall be included:
1. Work space for
technicians;
2. Space for
evaluating and fitting, with provisions for privacy;
3. Space for equipment, supplies and
storage.
E. Recreation
Therapy. NOTE: Recreation therapy assists patients in the development and
maintenance of community living skills through the use of leisure-time activity
tasks. These activities may occur in a recreation therapy department, in
specialized facilities (e.g., gymnasium), multipurpose space in other areas
(e.g., the nursing unit), or outdoors. If this service is provided, at least,
the following shall be included:
1. Activity
areas suitable for wheelchair access;
2. Handwashing stations if required by the
program;
3. Storage for supplies
and equipment;
4. Secured storage
for supplies and equipment potentially harmful;
5. Remote electrical switching for equipment
potentially harmful.
F.
Speech, Hearing, and Audio Therapy. If this service is provided, at least, the
following shall be included:
1. Space for
evaluation and treatment of patients. The space shall be protected with
acoustical treatment of walls and finishes.
2. Space for equipment storage and
supplies.
G. Respiratory
Care. If respiratory care is part of the service, the following, at least,
shall be included as a minimum:
1. Storage of
equipment and supplies.
a. Space and utilities
for cleaning and sanitizing equipment. Provide physical separation of the space
for receiving and cleaning soiled materials from the space for storage of clean
equipment and supplies. Appropriate local exhaust ventilation shall be provided
if glutaraldehyde or other noxious disinfectants are used in the
cleaning.
b. If respiratory
services, such as testing and demonstration for outpatients are part of the
program, additional facilities and equipment shall be provided as necessary for
the appropriate function of the service, including but not limited to:
1) Patient waiting area with provision for
wheelchairs;
2) Reception and
control station;
3) Patient toilets
and handwashing facilities;
4)
Room(s) for patient education and demonstration;
2. Cough-Inducing and
Aerosol-Generating Procedures. All cough-inducing procedures performed on
patients who may have suspected or active infectious Mycobacterium tuberculosis
shall be performed in rooms that meets the requirements for airborne infection
control.
SECTION
57:
PHYSICAL FACILITIES, MORGUE AND NECROPSY.
These facilities shall be directly accessible to an outside entrance and shall be located to avoid movement of bodies through public areas. The following elements shall be provided when autopsies are performed within the hospital:
A. Refrigerated
facilities for body-holding;
B.
Autopsy Room. This room shall contain:
1. Work
counter with sink equipped for handwashing;
2. Storage space for supplies, equipment, and
specimens;
3. Autopsy
table;
4. A deep sink for washing
of specimens;
5. A housekeeping
service sink or receptor for cleanup and housekeeping.
NOTE: If autopsies are performed outside the facility, only a well ventilated, temperature-controlled, body-holding room need be provided.
SECTION
58:
PHYSICAL FACILITIES, PHARMACY.
The size and type of services to be provided in the pharmacy can largely depend upon the type of medication distribution system used, number of patients to be served, and extent of shared or purchased services. This shall be described in the functional program. The pharmacy room or suite shall be located for convenient access, staff control, and security. Facilities and equipment shall be as necessary to commodate the functions of the program. See Section 16, Pharmacy, for additional requirements. (Satellite facilities, if provided, shall include those items required by the program.) As a minimum, the following elements shall be included:
A. Dispensing.
1. A pickup and receiving area.
2. An area for reviewing and
recording.
3. An extemporaneous
compounding area that includes a sink and sufficient counter space for
medication preparation.
4. Work
counters and space for automated and manual dispensing activities.
5. An area for temporary storage, exchange,
and restocking of carts.
6.
Security provisions for medications and personnel in the dispensing counter
area.
B. Manufacturing.
1. A bulk compounding area.
2. Provisions for packaging and
labeling.
3. A quality control
area.
C. Storage (may be
cabinets, shelves, and/or separate rooms or closets).
1. Bulk storage.
2. Active storage.
3. Refrigerated storage.
4. Volatile fluids and alcohol storage
constructed according to applicable fire safety codes for the substances
involved.
5. Double-locked storage
for controlled substances.
6.
Storage for general supplies and equipment not in use.
D. Administration.
1. An area for education and training (may be
in a multipurpose room shared with other departments).
2. An area for patient counseling and
instruction (may be in a room separate from the pharmacy).
3. A separate area for office
functions.
E. Other.
1. Handwashing stations shall be provided
within each separate room where open medication is handled and readily
accessible.
2. Provide for
convenient access to toilet and locker.
3. If unit dose procedure is used, provide
additional space and equipment for supplies, packaging, labeling, and storage,
as well as for the carts.
4. If IV
solutions are prepared in the pharmacy, provide a sterile work area with a
laminar-flow work station designed for product protection. The laminar-flow
system shall include a nonhydroscopic filter (HEPA) rated at 99.97 percent, as
tested by DOP tests and have a visible pressure gauge for detection of filter
leaks or defects.
5. Hoods used for
chemotherapy shall be lOOpercent exhausted to the exterior.
6. As a minimum the partitions enclosing the
pharmacy shall extend from the floor to the deck above, with gypsum board on
both sides of metal studs.
SECTION 59:
PHYSICAL FACILITIES,
DIETARY FACILITIES.
Construction, equipment, and installation shall comply with the standards specified in FDA U.S. Public Health Service Food Code. Food service facilities shall be designed and equipped to meet the requirements of the functional program. These may consist of an onsite conventional food preparing system, a convenience food service system, or an appropriate combination of the two. The following shall be provided:
A. Receiving/Control Areas. Provide an area
for the receiving and control of incoming dietary supplies. This area shall be
separated from the general receiving area and shall contain the following: a
control station, and a breakout for loading, uncrating, and weighing
supplies;
B. Storage Spaces. A
minimum of four days' supplies shall be stocked. (In remote areas, this number
may be increased to accommodate length of delivery in emergencies). All food
shall be stored clear of the floor. Lowest shelf shall not be less than 12
inches above the floor or shall be closed in and sealed tight for ease of
cleaning;
C. Cleaning supplies
storage. Provide a separate storage room for the storage of non- food items
such as cleaning supplies that might contaminate edibles.
D. Food Preparation Facilities. Conventional
food preparation systems shall have adequate space and equipment for preparing,
cooking, and baking. Convenience food preparation systems shall have adequate
space for equipment for thawing, portioning, cooking, and/or baking. These
areas shall be as close as possible to the user (i.e., tray assembly and
dining);
E. Assembly and
Distribution Areas. A patient tray assembly area shall be located within close
proximity to the food preparation and distribution areas;
F. Food Service Carts. A cart distribution
area shall provide space for storage, loading, distribution, receiving, and
sanitizing of food service carts. The cart traffic shall be designed to
eliminate any danger of cross circulation between outgoing food carts and
incoming, soiled carts, and the cleaning and sanitizing process. Cart
circulation shall not traffic through food processing areas;
G. Handwashing Stations. These shall be
operable without the use of hands and be readily accessible at locations
throughout the dietary department;
H. Dining Area. There shall be dining space
for ambulatory patients, staff, and visitors which is separate from the food
preparation and distribution areas;
I. Area for Receiving, Scraping, and Sorting
Soiled Tableware. Area shall be adjacent to ware washing and separate from food
preparation areas. A handwashing fixture shall be conveniently
available;
J. Dishwashing Space. An
area shall be located in a room separate from food preparation and serving
areas. Commercial-type dishwashing equipment shall be provided. Clean and
soiled dish areas shall be separated with an opening in the partition between
the clean and soiled dish area large enough for the dishwasher and ventilation
of the area. The clean dish area may be either a separate room or a portion of
the kitchen. A lavatory shall be conveniently available. The soiled dish area
shall be so located as to prevent soiled dishes from being carried through the
food preparation area;
K. Ware
Washing Facilities. They shall be designed to prevent contamination of clean
wares with soiled wares through cross-traffic. The clean wares should be
transferred for storage or use in the dining area without having to pass
through food preparation areas;
L.
Pot Washing Facilities including multi-compartmented sinks of adequate size for
intended use shall be provided convenient to using service. Supplemental heat
for hot water to clean pots and pans may be by booster heater or by steam
jet.
M. Waste Storage Room. A food
waste storage room shall be conveniently located to the food preparation and
ware washing areas but not within the food preparation area. It shall have
direct access to the hospital's waste collection and disposal
facilities.
N. Storage Rooms and
Areas. A room for cans, carts, mobile tray conveyors, and cleaning and
sanitizing carts shall be provided. There shall be a separate storage room for
the storage of non-food items that might contaminate edibles (i.e., cleaning
supplies). A separate space or room for the storage of cooking wares, extra
trays, flatware, plastic and paper products, and portable equipment is
required;
O. Toilets and Locker
Spaces. Lockers, if provided in the dietary facility, shall be for the
exclusive use of the dietary staff. Toilets and lockers shall not open directly
into the food preparation areas, but shall be in close proximity to
them;
P. Office(s). Dietary service
manager/supervisor offices shall be conveniently located for visual control of
receiving area and food preparation areas;
Q. Environmental Closet. A closet shall be
provided for the exclusive use of the dietary department to contain a floor
sink and space for mops, pails, and supplies. Where hot water or steam is used
for general cleaning, additional space within the room shall be provided for
the storage of hoses and nozzles;
R. Ice Making Equipment. Equipment shall be
convenient for service and easily cleaned. It shall be provided for both drinks
(self-dispensing equipment), and for general use (storage bin type
equipment);
S. Commissary or
Contract Services from Other Areas. If a service is used, above items may be
reduced as appropriate. The process of food delivery shall insure freshness,
retention of hot and cold, and avoidance of contamination. If delivery is from
outside sources, protection against weather shall be provided. Provisions shall
be made for thorough cleaning and sanitizing of equipment to avoid mix of
soiled and clean equipment;
T.
Equipment. Mechanical devices shall be heavy duty, suitable for intended use
and easily cleaned. Movable equipment shall have heavy duty locking casters. If
equipment is to have fixed utility connections, it shall not be equipped with
casters. Walk-in coolers, refrigerators, and freezers shall be insulated at
floor, walls and top. Coolers and refrigerators shall be capable of maintaining
a temperature down to freezing. Freezers shall be capable of maintaining a
temperature of 20°below zero Fahrenheit. Coolers, refrigerators, and
freezers shall be thermostatically controlled to maintain desired temperature
settings in increments of two degrees or less. Interior temperatures shall be
visible from the exterior. Controls may include audible and visible high and
low temperature alarm. Time of alarm shall be automatically recorded. Walk-in
units may be lockable from outside but shall have release mechanism for exit
from inside at all times. Interior shall be lighted. All shelving shall be
corrosion resistant, easily cleaned, and constructed and anchored to support a
loading of at least lOOpounds per linear foot. All cooking equipment shall be
equipped with automatic shut off devices to prevent excessive heat buildup.
Under counter conduits, piping, and drains shall be arranged to not interfere
with cleaning of floor below or of the equipment;
SECTION 60:
PHYSICAL FACILITIES,
ADMINISTRATION AND PUBLIC AREAS.
The following areas shall be provided:
A. Facility entrance, at grade level,
sheltered from the weather, and able to accommodate wheelchairs;
B. Lobby, which shall include:
1. Reception and information counter or
desk;
2. Waiting
space(s);
3. Public toilet
facilities (one for each sex);
4.
Public telephone(s);
5. Drinking
fountain(s);
C.
Interview space(s) for private interviews relating to social service, credit,
and admissions;
D. General or
individual office(s) for business transactions, medical and financial records,
and administrative and professional staffs;
E. Multipurpose room(s) with provisions for
the use of visual aids for conferences, meetings, and health education. One
multipurpose room may be shared by several services;
F. Storage for office equipment and supplies;
and
G. Staff toilet
facilities.
SECTION 61:
PHYSICAL FACILITIES, HEALTH INFORMATION UNIT.
The following rooms and areas shall be provided:
A. Health Information Director's office or
space;
B. Review and dictating
room(s) or spaces;
C. Work area for
sorting, recording, or microfilming records;
D. Medical record storage (Refer to Section
61 A.26); and
Rooms for patient medical records and archived patient medical records that remain onsite shall be kept in a one hour fire rated enclosure or protected by a sprinkler system; protected by a security system and a smoke detection system. Circulating records at the nurses' station or in active working areas are excluded from this requirement. The records shall be protected against undue destruction from dust, vermin, water, etc
SECTION 62:
PHYSICAL FACILITIES, CENTRAL MEDICAL AND SURGICAL SUPPLY DEPARTMENT.
The following areas shall be provided:
A. Separate Soiled and Clean Work Areas
1. Soiled Workroom. This room shall be
physically separated from all other areas of the department. Work space shall
be provided to handle the cleaning and initial sterilization/disinfection of
all medical/surgical instruments and equipment, work tables, sinks, flush-type
devices, and washer/sterilizer decontaminators. Pass-through doors and
washer/sterilizer decontaminators shall deliver into clean processing
area/workrooms.
2. Clean
Assembly/Workroom. This workroom shall contain handwashing stations, workspace,
and equipment for terminal sterilizing of medical and surgical equipment and
supplies. Clean and soiled work areas shall be physically separated.
B. Storage Areas
Clean/Sterile Medical/Surgical Supplies. A room shall be provided for the breakdown of clean/sterile bulk supplies. Storage for packs etc., shall include provisions for ventilation, humidity, and temperature contraol.
C.
Administrative/Changing Room
If required by the functional program, this room shall be separate from all other areas and provide for staff to change from street clothes into work attire. Lockers, sink, and showers shall be made available within the immediate vicinity of the department.
D. Storage Room for Patient Care and
Distribution Carts
This area shall be adjacent, easily available to clean and sterile storage, and close to main distribution point to keep traffic to a minimum and to ease work flow.
SECTION 63:
PHYSICAL FACILITIES,
CENTRAL SUPPLY AND RECEIVING.
In addition to supply facilities in individual departments, a central storage area shall also be provided. General stores may be located in a separate building onsite with provisions for protection against inclement weather during transfer of supplies. The following shall be provided:
A. Off-street unloading facilities;
B. Receiving area;
C. General Storage Room(s). General storage
rooms(s) with a total area of not less than 20feet per inpatient bed shall be
provided. Storage may be in separate, concentrated areas within the institution
or in one or more individual buildings onsite. A portion of this storage may be
provided offsite; and
D. Additional
Storage Room(s). Additional storage areas for outpatient facilities shall be
provided in an amount not less than five percent of the total area of the
outpatient facilities. This may be combined with and in addition to the general
stores or be located in a central area within the outpatient department. A
portion of this storage may be provided offsite.
SECTION 64:
PHYSICAL FACILITIES, LINEN
SERVICES.
1. A separate room for
receiving and holding soiled linen until ready for pickup or
processing.
2. A central, clean
linen storage and issuing room(s), in addition to the linen storage required at
individual patient units.
3. Cart
storage area(s) for separate parking of clean- and soiled-linen carts out of
traffic.
4. A clean linen
inspection and mending room or area. If not provided elsewhere, a clean linen
inspection, delinting, folding, assembly and packaging area should be provided
as part of the linen services. Mending should be provided for in the linen
services department. A space for tables, shelving, and storage should be
provided.
5. Handwashing stations
in each area where unbagged, soiled linen is handled.
B. If linen is processed in a laundry
facility that is not part of the licensed facility provisions shall also be
made for:
1. A service entrance, protected
from inclement weather, for loading and unloading of linen.
2. Control station for pickup and
receiving.
3. The hospital is
responsible to insure the commercial laundry does comply with Section 42,
Physical Environment.
C.
If linen is processed in a laundry facility that is part of the licensed
facility, the following shall be provided in addition to that of Section 64 A:
1. A receiving, holding, and sorting room for
control and distribution of soiled linen. Discharge from soiled linen chutes
may be received within this room or in a separate room.
2. Laundry processing room with commercial
type equipment that can process at least a seven-day supply within the regular
scheduled workweek. This may require a capacity for processing a seven-day
supply in a 40-hour week.
3.
Storage for laundry supplies.
4.
Employee handwashing stations in each room where clean or soiled linen is
processed and handled.
5.
Arrangement of equipment that will permit an orderly workflow and minimize
cross-traffic that might mix clean and soiled operations.
6. Conveniently accessible staff lockers,
showers, and lounge.
SECTION 65:
PHYSICAL FACILITIES,
CLEANING AND SANITIZING CARTS, EMPLOYEE FACILITIES AND ENVIRONMENTAL
CLOSETS.
A. Facilities shall be
provided to clean and sanitize carts serving the central medical and surgical
supply department, dietary facilities, and linen services. These may be
centralized or departmentalized or offsite as required by the written
narrative.
B. Lockers, lounges,
toilets, etc. should be provided for employees and volunteers. These should be
in addition to, and separate from, those required for medical staff and
public.
C. Each environmental
services closet shall contain a floor receptor and/or services sink and storage
space for environmental services equipment (cart, bucket, etc.) and supplies.
There shall be at least one environmental services closet for each
floor.
SECTION 66:
PHYSICAL FACILITIES, ENGINEERING SERVICE AND EQUIPMENT AREAS.
Space shall be included in all mechanical and electrical equipment rooms for proper maintenance of equipment. Provisions shall also be made to provide for equipment removal and replacement. The following shall be provided:
A. Boilers, mechanical
equipment, and electrical equipment shall be located in ventilated rooms or
buildings except as noted below:
1. Rooftop
air conditioning and ventilation equipment installed in weatherproof
housings;
2. Standby generators
where the engine and appropriate accessories (i.e., batteries) are properly
heated and enclosed in a weatherproof housing as recommended by the
manufacturer;
3. Cooling towers and
heat rej ection equipment;
4.
Electrical transformers and switchgear where required to serve the facility and
where installed in a weatherproof housing;
5. Medical gas parks and equipment;
6. Air cooled chillers where installed in a
weatherproof housing;
7. Waste
processing equipment. Site lighting, post indicator valves, and other equipment
normally installed on the exterior of the building;
8. Site lighting, post indicator valves, and
other equipment normally installed on the exterior of the building;
and
9. Exhaust fans.
B. Engineer's office with file
space and provisions for secured storage of facility drawings, records,
manuals, etc. The engineer's office shall be a separate and distinct space
dedicated for the purpose;
C.
General maintenance shop(s) for repair and maintenance as required by the
functional program;
D. Storage room
for building maintenance supplies. Storage for solvents and flammable liquids
shall comply with applicable NFPA codes;
E. Yard equipment and supply storage shall be
located so equipment may be moved directly to exterior without interfering with
other work;
F. Separate area or
room specifically for storage, repair, and testing of electronic and other
medical equipment. The amount of space and type of utilities will vary with the
type of equipment involved and types of outside contracts used.
SECTION 67:
PHYSICAL
FACILITIES, WASTE PROCESSING SERVICES.
A. Hazardous Waste and Antineoplastic Agent
Disposal. The facility shall have policies and procedures for the
identification, segregation, labeling, storage, transport and disposal of
hazardous waste. The policies and procedures shall conform with the latest
edition of Hazardous Waste Management Regulation 23, Arkansas Department of
Environmental Quality, Little Rock, Arkansas. Within the facility, hazardous
waste, especially antineoplastic agents, shall be labeled in a manner that it
shall be easily recognized from all other waste. The facility shall compile a
list of all antineoplastic agents used in the facility. The facility shall have
policies and procedures for the clean up of spills, decontamination and
treatment of personnel exposed to hazardous waste and antineoplastic agents.
B. Radioactive Waste Disposal. The
facility shall have policies and procedures for the identification,
segregation, labeling, storage, transport and disposal of radioactive waste and
materials. All policies and procedures shall conform to the most current Rules
and Regulations for Control of Sources of Ionizing Radiation, Arkansas
Department of Health, Little Rock, Arkansas. The facility shall maintain
records of all radioactive waste and materials which have been
disposed.
C. Regulated Medical
Waste (Infectious Waste) Disposal. The facility shall have policies and
procedures for the identification, segregation, labeling, storage, transport
and disposal of Regulated Medical Waste. All policies and procedures shall
conform to the latest edition of the. The facility shall have policies and
procedures for the clean up of spills, and for decontamination and treatment of
personnel exposed to regulated medical waste.
D. Solid Waste Disposal (Non-Infectious
Waste). The facility shall have policies and procedures for the identification,
segregation, labeling, storage, transport and disposal of solid waste. Policies
and procedures shall conform with the latest edition of the Solid Waste
Management Regulation 22, Arkansas Department of Environmental Quailty, Little
Rock, Arkansas.
E. Nuclear Waste
Disposal: The facility shall have policies and procedures for the
identification, segregation, labeling, storage, transport and disposal of
nuclear waste. All policies and procedures shall conform to the Code of Federal
Regulations; title X, parts 20 and 35, concerning the handling and disposal of
nuclear materials in health care facilities.
F. Containers of hazardous and antineoplastic
agent waste, radioactive waste, and regulated medical waste shall be closed
except when receiving waste. Containers have swinging lids or lids that are
easily contaminated are prohibited. Open containers shall be emptied between
patients and the container disinfected. Containers shall be kept closed except
when receiving waste.
G. Other
Waste. The facility shall have policies and procedures for the identification,
segregation, labeling, storage, transport, and disposal of any waste not
specifically mentioned in this section.
SECTION 68:
PHYSICAL FACILITIES,
DETAILS AND FINISHES.
All details for alteration or expansion projects as well as for new construction shall comply with the following.
A. Details.
1. Compartmentation, exits, automatic
extinguishing systems, and other details relating to fire prevention and fire
protection shall comply with requirements listed in the NFPA referenced codes
and be shown on the Fire Protection Plan. The Fire Safety Evaluation System
(FSES) is an acceptable means of determining Life Safety Code
compliance.
2. Minimum corridor
width shall be eight feet clear without projections. Increased width shall be
provided at elevator lobbies and other places where conditions may demand more
clearance. All service or administrative corridors shall not be less than
44inches in width. Doors to patient rooms shall be a minimum door size of three
feet eight inches wide and seven feet high to provide clearance for movement of
beds and other equipment. Alternatively NFPA 101 shall be deemed to meet
requirements.
3. Items such as
drinking fountains, telephone booths, and vending machines, shall be located so
as not to project into exit access corridors. Incidental items shall be
determined by the licensing agency.
4. Rooms containing bathtubs, sitz baths,
showers, and water closets, subject to occupancy by patients, shall be equipped
with doors and hardware which shall permit access from the outside in any
emergency.
5. All doors between
corridors, rooms, or spaces subject to occupancy, except elevator doors, shall
be of the swing type. Openings to showers, baths, patient toilets, ICU patient
compartments with the break away feature, and other such areas not leading to
fire exits shall be exempt from this standard.
6. All patient room doors located on exit
access corridors shall have positive latching hardware.
7. Doors to patients' toilet rooms and other
rooms needing access for wheelchairs shall have a minimum width of 36inches for
new facilities.
Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
8 Windows shall be designed so that persons
cannot accidentally fall out of them when they are open or shall be provided
with security screens. Operation of windows shall be restricted to inhibit
possible escape or suicide. Where the operation of windows or vents require the
use of tools or keys, tools or keys shall be on the same floor and easily
accessible to staff.
9. Glass
doors, lights, sidelights, borrowed lights, and windows located within 12inches
of a door jamb (with a bottom frame height of less than 60inches above the
finished floor) shall be constructed of safety glass, wired glass, or plastic,
break resistant material that creates no dangerous cutting edges when broken.
Similar materials shall be used for wall openings in active areas such as
recreation rooms and exercise rooms, unless otherwise required for fire safety.
Safety glass-tempered or plastic glazing materials shall be used for shower
doors and bath enclosures. Plastic and similar materials used for glazing shall
comply with the flame-spread ratings of NFPA 101. Safety glass or plastic
glazing materials, as noted above, shall also be used for interior windows and
doors, including those in pediatric and psychiatric unit corridors. In
renovation projects, only glazing within 18inches of the floor shall be changed
to safety glass, wire glass, or plastic, break-resistant material. NFPA 101
contains additional requirements for glazing in exit corridors, etc.,
especially in buildings without sprinkler systems.
10. Where labeled fire doors are required,
these shall be certified by an independent test laboratory as meeting the
construction requirements equal to those for fire in NFPA Standard 80.
Reference to a labeled door shall be construed to include labeled frame and
hardware.
11 Trash chutes shall be
in accordance with NFPA standard 82. In addition, linen and refuse chutes shall
meet or exceed the following requirements:
a.
Service openings to chutes shall not be located in corridors or passageways but
shall be located in a room which complies with NFPA 101;
b. Service openings to chutes shall have
approved self-closing Class B one and one-half hour labeled fire
doors;
c. Minimum cross-sectional
dimensions of gravity chutes shall not be less than two feet;
d. Chutes shall discharge directly into
collection rooms separate from incinerator, laundry, or other services.
Separate collection rooms shall be provided for trash and for linen. Chute
discharge into collection rooms shall comply with NFPA 101;
e. Gravity chutes shall extend through the
roof with provisions for continuous ventilation as well as for fire and smoke
ventilation. Openings for fire and smoke ventilation shall have an effective
area of not less than that of the chute cross-section and shall be not less
than four (4) feet above the roof and not less than six (6) feet clear of other
vertical surfaces.Fire and smoke ventilating openings may be covered with
single strength sheet glass.
12. Dumbwaiters, conveyors, and material
handling systems shall comply with NFPA 101.
13. Thresholds and expansion joint covers
shall be installed flush with the floor surface to facilitate use of
wheelchairs and carts. Expansion and seismic joints shall be constructed to
restrict the passage of smoke.
14.
Grab bars shall be provided in all patients' toilets, showers, tubs, and sitz
baths. The bars shall have one and one-half inch clearance to walls and shall
have sufficient strength and anchorage to sustain a concentrated load of
250pounds.
15. Soap dishes, soap
dispensers and/or other devices shall be provided at showers, bath tubs, and
all handwashing stations except scrub sinks.
16. Location and arrangement of handwashing
stations shall permit proper use and operation. All sinks, except public
toilets, janitor closets, and sinks used by patients only, shall have foot,
knee, or wrist blade faucets. Particular care shall be given to the clearances
required for blade-type operating handles.
17. Mirrors shall not be installed at
handwashing fixtures in food preparation areas, nurseries, clean and sterile
supply areas, scrub sinks, or other areas where asepsis is essential.
Provisions for hand drying shall be included at all handwashing stations except
scrub sinks. Paper units shall be enclosed to protect against dust or soil and
to insure single unit dispensing.
18. Lavatories and handwashing stations shall
be securely anchored to withstand an applied downward vertical load of not less
than 250pounds on the front of the fixture.
19. Radiation protection requirements of
X-ray and gamma ray installations shall conform with Rules and Regulations for
Control of Sources of Ionizing Radiation, Arkansas Department of
Health.
20. The minimum ceiling
height shall be seven feet ten inches with the following exceptions:
a. Boiler rooms shall have ceiling clearances
not less than two feet six inches above the main boiler header and connecting
piping.
b. Ceilings in
radiographic, operating and delivery rooms, and other rooms containing
ceiling-mounted equipment or ceiling-mounted surgical light fixtures shall be
of sufficient height to accommodate the equipment or fixtures and their normal
movement.
c. Ceilings in corridors,
storage rooms, and toilet rooms shall be not less then seven feet eight inches
in height. Ceiling heights in small, normally unoccupied spaces may be
reduced.
d. Seclusion treatment
rooms shall have a minimum ceiling height of nine feet.
21. Recreation rooms, exercise rooms, and
similar spaces where impact noises may be generated shall not be located
directly over patient bed area, delivery or operating suites, unless special
provisions are made to minimize such noise.
22. Rooms containing heat-producing equipment
(such as boiler or heater rooms and laundries) shall be insulated and
ventilated to prevent any floor or partition surface from exceeding a
temperature of 10°Fahrenheit above ambient room temperature.
23. Noise reduction criteria shown in Table 2
of the Appendix shall apply to partition, floor, and ceiling construction in
patient areas. (Careful attention shall be given to penetrations.)
24. Approved fire extinguishers shall be
provided in locations throughout the building in accordance with NFPA Standard
No. 10. Extinguishers located in exit corridors shall be recessed.
25. Offsite buildings or freestanding
buildings used for storage of archived patient medical records shall be built
of noncombustible materials and provide security and smoke detection systems
for the records. Records shall be arranged in an accessible manner and stored
at least six inches above the floor. Records shall be protected against undue
destruction from dust, vermin, water, etc. X-ray film storage are not required
to meet the above requirements.
26.
Light fixtures shall be provided with protective covers in food preparation,
serving areas, and patient care and treatment spaces. Protective light fixture
covers are not required in corridors.
27. Minimum distance between patient room
windows and adjacent structures shall be 30 feet (new construction
only).
28. A panic bar releasing
device shall be provided for all required exit doors subject to patient traffic
(new construction only).
29. Doors
in smoke barrier partitions shall comply with NFPA 101.
30. Fire rated roof-ceiling assemblies shall
be listed with a nationally recognized laboratory.
31. Mechanical smoke door coordinators shall
not be used. Adjustable hydraulic closures or the full length header type shall
be used.
32. Corridor partitions,
smokestop partitions, horizontal exit partitions, exit enclosures, and fire
rated walls required to have protected openings shall be effectively and
permanently identified with signs or stenciling in a manner acceptable to
Health Facility Services. Such identification shall be above any decorative
ceiling and in concealed spaces.
B. Finishes.
1. Cubicle curtains and draperies shall be
noncombustible or rendered flame retardant and shall pass both the large and
small scale tests of NFPA Standard 701 and the requirements of NFPA 13 when
applicable.
2. Flame spread, fuel
contributed, smoke density, and critical radiant flux of finishes shall comply
with NFPA 101.
3. Floors in areas
and rooms in which anesthetic agents are stored or administered to patients
shall comply with NFPA Standard 99. Conductive flooring may be omitted in
anesthetizing areas where a written resolution is signed by the hospital board
stating that no flammable anesthetic agents shall be used and appropriate
notices are permanently and conspicuously affixed to the wall in each such area
and room.
4. Floor materials shall
be easily cleanable and have wear resistance appropriate for the location
involved. Floors in areas used for food preparation or food assembly shall be
water resistant and grease-proof. Joints in tile and similar material in such
areas shall be resistant to food acids. In all areas frequently subject to wet
cleaning methods, floor-materials shall not be physically affected by
germicidal and cleaning solutions. Floors that are subject to traffic while wet
(such as shower and bath areas, kitchens, and similar work areas) shall have a
non-slip surface. Any facility designed to install carpet shall have prior
approval from the Arkansas Department of Health. The prior approval in part
shall be contingent upon submission of a laboratory test report from an
approved independent laboratory indicating that the proposed carpet meets or
exceeds the requirements listed in NFPA 101 and agreement by the Department as
to the specific areas in which carpet is to be used. In all carpet
installations no rubber backings or rubber padding shall be permitted except in
cases where the carpet and backing are tested as an integral component and the
integral component meets the requirements listed in NFPA 101. Carpet shall not
be allowed in the following areas or rooms: operating rooms, delivery rooms,
emergency rooms, intensive care units, nursery, recovery, kitchens,
laboratories, LDR and LDRP rooms, clean and soiled holding/workrooms, and
isolation rooms. Operating rooms shall have a seamless floor.
5. Wall bases in kitchens, operating rooms,
soiled workrooms, and other areas which are frequently subject to wet cleaning
methods shall be made integral and coved with the floor, tightly sealed within
the wall, and constructed without voids that can harbor insects.
6. Wall finishes shall be washable. In the
vicinity of plumbing fixtures, shall be smooth and water resistant.
7. Floors and walls penetrated by pipes,
ducts, and conduits shall be tightly sealed to minimize entry of rodents and
insects.
8. Ceilings in
food-preparation and storage areas, shall be cleanable with routine
housekeeping equipment.
9.
Operating rooms, trauma rooms, delivery rooms for Caesarean sections, and
protective isolation rooms shall have ceilings with a smooth finish plaster or
gypsum board surface with a minimum of fissures equipped with access panels
where needed.
10. In psychiatric
patient rooms, toilets, and seclusion rooms, ceiling construction shall be
smooth finish plaster or gypsum board surface with a minimum of fissures.
Ceiling-mounted air and lighting devices shall be security type.
Ceiling-mounted sprinkler heads shall be of the concealed type.
11. Ceilings shall be cleanable and in the
following areas shall be washable, waterproof, smooth finish plaster or gypsum
board or vinyl faced acoustic panels: cardiac cath labs, surgical suite
corridors, delivery suite corridors, central sterilization suite, autopsy
rooms, bacteriology, mycology, media preparation rooms, glass washing rooms
located in the labs, soiled holding rooms, soiled and clean utility rooms,
emergency suite-treatment rooms and trauma rooms.
12. Finished ceilings may be omitted in
mechanical, electrical, equipment spaces and shops.
13. Finished ceilings shall be provided for
corridors in patient areas.
14.
Sound sensitive areas such as neonatal intensive care may have special floor
and ceiling treatments.
SECTION 69:
PHYSICAL FACILITIES,
CONSTRUCTION, INCLUDING FIRE RESISTIVE REQUIREMENTS.
A. Design. Every building and every portion
thereof shall be designed and constructed to sustain all dead and live loads in
accordance with American Society of Civil Engineers, (ASCE), "Minimum Design
Loads for Buildings and Other Structures."
B. Foundations. Foundations shall rest on
natural solid bearing if a satisfactory bearing is available at reasonable
depths. Proper soil-bearing values shall be established in accordance with
recognized standards. If solid bearing is not encountered at practical depths,
the structure shall be supported on drive piles or drilled piers designed to
support the intended load without detrimental settlement, except that one story
buildings may rest on a fill designed by a soils engineer. When engineered fill
is used, site preparation and placement of fill shall be performed under the
direct full-time supervision of the soils engineer. The soils engineer shall
issue a final report on the compacted fill operation and certification of
compliance with the job specifications. All footings shall extend to a depth
not less than one foot below the estimated maximum frost line.
C. Construction.
1. Construction shall comply with the
applicable requirements of NFPA 101, and the Arkansas Fire Protection Code
Volumes I and II and Arkansas State Building Services, Minimum Standards and
Criteria - Accessibility for the Physically Disabled Standards.
NOTE: NFPA 101 generally covers fire/safety requirements only, whereas most model codes also apply to structural elements. The fire/safety items of NFPA 101 would take precedence over other codes in case of conflict. In the event NFPA 101 does not specifically address a life safety requirement found only in the Arkansas Fire Prevention Code, compliance with the requirement is not mandatory. Appropriate application of each would minimize problems. For example, some model codes require closers on all patient doors. NFPA 101 recognizes the potential fire/safety problems of this requirement and stipulates that if closers are used for patient room doors, smoke detectors shall also be provided within each affected patient room.
2. For renovation projects, the extent of new
construction shall be determined by the licensing agency. Construction shall
comply with applicable requirements of NFPA 101.
D. Free-standing Buildings (For Patient Use).
Buildings of this element category are considered to be greater than 30feet
from the hospital or separated from the hospital by two hour fire resistance
rated construction. Buildings housing non-sleeping patient areas shall comply
with NFPA 101.
E. Free-standing
Buildings. Separate free-standing buildings over 30 feet from an inpatient
facility housing the boiler plant, laundry, shops, or general storage shall be
built in accordance with applicable building codes for such
occupancy.
F. Interior Finishes.
Interior finish materials shall comply with the limitations as indicated in
NFPA 101. If a separate underlayment is used with any floor finish materials,
the underlayment and the finish material shall be tested as a unit. Tests shall
be performed by an approved independent testing laboratory.
G. Insulation Materials. Building insulation
materials, unless sealed on all sides and edges, shall have a flame spread
rating of 25or less and a smoke developed rating of 150or less when tested in
accordance with NFPA 255.
H. Flood
Protection. Executive Order No 11296 was issued to minimize financial loss from
flood damage to facilities constructed with federal assistance. In accordance
with that order, possible flood effects shall be considered when selecting and
developing the site. Insofar as possible, new facilities shall not be located
on designated flood plains. Where this is unavoidable, consult with the Corps
of Engineers regional office for the latest applicable regulations pertaining
to flood insurance and protection measures that may be required.
I. Elevators. All hospitals having patient
facilities (such as bedrooms, dining rooms, or recreation areas) or critical
services (such as operating, delivery, diagnostic, or therapeutic) located on
other than the grade-level entrance floor shall have electric or hydraulic
elevators. Installation and testing of elevators shall comply with ANSI/ASME
A17.1 for new construction and ANSI/ASME A17.3 for existing facilities. (See
ASCE 7-93 for seismic design and control systems requirements for elevators.)
1. In the absence of an engineered traffic
study the following guidelines for number of elevators shall apply:
a. At least one hospital-type elevator shall
be installed when one to 59 patient beds are located on any floor other than
the main entrance floor.
b. At
least two hospital-type elevators shall be installed when 60 to 200 patient
beds are located on floors other than the main entrance floor, or where the
major inpatient serves are located on a floor other than those containing
patient beds. (Elevator service may be reduced for those floors providing only
partial inpatient services.)
c. At
least three hospital-type elevators shall be installed where 201to 350patent
beds are located on floors other than the main entrance floor, or where the
major inpatient services are located on a floor other than those containing
patient beds.(Elevator service may be reduced for those floors which provide
only partial inpatient services.)
d. For hospitals with more than 350 beds, the
number of elevators shall be determined from a study of the hospital plan and
the expected vertical transportation requirements.
2. Hospital-type elevator cars shall have
inside dimensions that accommodate a patient bed with attendants. Cars shall be
at least five feet eight inches wide by nine feet deep. Car doors shall have a
clear opening of not less than four feet wide and seven feet high. In
renovations, existing elevators that can accommodate patient beds used in the
facility will not be required to be increased in size.
NOTE: Additional elevators installed for visitors and material handling may be smaller than noted above, within restrictions set by standards for disabled access.
3.
Elevators shall be equipped with a two way automatic level-maintaining device
with an accuracy of one-fourth inch.
4. Each elevator, except those for material
handling, shall be equipped with an independent keyed switch for staff use for
bypassing all landing button calls and responding to car button calls
only.
5. Elevator call buttons and
controls shall not be activated by heat or smoke. Light beams, if used for
operating door reopening devices without touch, shall be used in combination
with door-edge safety devices and shall be interconnected with a system of
smoke detectors. This is so the light control feature will be overridden or
disengaged should it encounter smoke at any landing.
6. Field inspections and tests shall be made
and the owner shall be furnished with written certification stating the
installation meets the requirements set forth in this section as well as all
applicable safety regulations and codes.
SECTION 70:
PHYSICAL FACILITIES,
MECHANICAL REQUIREMENTS.
A. General.
1. Prior to acceptance of the facility, all
mechanical systems shall be tested and operated to demonstrate to the owner or
his designated representative that the installation and performance of these
systems conform to design intent. Test results shall be documented for
maintenance files.
2. Upon
completion of the special systems equipment installation contract, the owner
shall be furnished with a complete set of manufacturers' operating,
maintenance, and preventive instructions, parts list, and complete procurement
numbers and descriptions. Operating staff shall be provided with instructions
for proper operation of systems and equipment.
3. Rotating mechanical equipment, shall be
mounted on vibration isolators as required to prevent unacceptable
structure-borne vibration.
4.
Supply and return mains and risers for cooling, heating, and steam systems
shall be equipped with valves to isolate the various sections of each system
and each piece of equipment.
B. Thermal and Acoustical Insulation.
1. Insulation within the building shall be
provided to conserve energy, protect personnel, prevent vapor condensation, and
reduce noise.
2. Insulation on cold
surfaces shall include an exterior vapor barrier. Material that will not absorb
or transmit moisture will not require a separate vapor barrier.
3. Insulation, including finishes and
adhesives on the exterior surfaces of ducts, piping, and equipment, shall have
a flame-spread rating of 25or less and a smoke-developed rating of 50or less as
determined by an independent testing laboratory in accordance with NFPA
255.
4. Interior duct linings shall
not be used. This requirement shall not apply to air terminals and sound
attenuation devices that have special coverings over such linings.
5. Existing accessible insulation within
areas that are renovated shall be inspected and addressed, as
appropriate.
C. Steam
and Hot Water Systems and Pressure Vessels.
1.
All pressure vessels shall meet the requirements of the Arkansas Boiler
Inspector, Arkansas Department of Labor.
D. Air Conditioning, Heating and Ventilating
Systems.
1. The systems shall be designed to
provide the dry bulb temperatures noted in Table 3 of the appendix. The systems
shall be designed and operated to provide the relative humidity noted in Table
3 of the appendix.
2. All rooms and
areas in the facility used for patient care shall have provisions for
ventilation. The ventilation rates shown in Table 4 shall be used only as
minimum standards; they do not preclude the use of higher, more appropriate
rates. Fans serving exhaust systems shall be located at the discharge end and
shall be readily serviceable. Air supply and exhaust in rooms for which no
minimum total air change rate is noted may vary down to zero in response to
room load. For rooms listed in Table 4 where VAV systems are used, minimum
total air change shall be within limits noted. Temperature control shall also
comply with these standards. To maintain asepsis control, airflow supply and
exhaust should generally be controlled to ensure movement of air from "clean"
to :less clean" areas, especially in critical areas. The ventilation systems
shall be designed and balanced according to the requirements shown in Table 4
and in the applicable notes.
3.
Exhaust systems may be combined to enhance the efficiency of recovery devices
required for energy conservation. Local exhaust systems shall be used whenever
possible in place of dilution ventilation to reduce exposure to hazardous
gases, vapors, fumes, or mists. Airborne infection isolation rooms shall not be
served by exhaust systems incorporating energy recovery devices that permit
cross-contamination.
4. Fresh air
intakes shall be located at least 25feet from exhaust outlets of ventilating
systems, combustion equipment stacks, medical-surgical vacuum systems, plumbing
vents, or areas that may collect vehicular exhaust or other noxious fumes.
(Prevailing winds and/or proximity to other structures may require greater
clearances.) Plumbing and vacuum vents that terminate at a level above the top
of the air intake may be located as close as lOfeet. The bottom of outdoor air
intakes serving central systems shall be as high as practical, but at least six
feet above ground level, or, if installed above the roof, three feet above roof
level. Exhaust outlets from areas that may be contaminated shall be above roof
level and arranged to minimize recirculation of exhaust air into the
building.
5. In new construction
and major renovation work, air supply for operating and delivery rooms
(excluding LDR/LDRP rooms) shall be from ceiling outlets near the center of the
work area. Return air shall be near the floor level. Each operating and
delivery room shall have at least two return-air inlets located as remotely
from each other as practical. (Design should consider turbulence and other
factors of air movement to minimize fall of particulates onto sterile
surfaces.) Where extraordinary procedures, such as organ transplants, justify
special designs, installation shall properly meet performance needs as
determined by applicable standards. These special designs should be reviewed on
a case-by-case basis. Temperature shall be individually controlled for each
operating and cesarean section room.
6. The operating and delivery room (excluding
LDR/LDRP rooms) room ventilation systems should operate at all times to
maintain the "air movement relationship to adjacent areas." The cleanliness of
the spaces is compromised when the ventilation system is shut down, e.g.,
airflow from a less clean space such as the corridor can occur, and standing
water can accumulate in the ventilation system (near humidifiers or cooling
coils).
7. In new construction and
major renovation work, air supply for rooms used for invasive procedures such
as autopsy rooms, cardiac cath labs, cystoscopic rooms, trauma rooms, endoscopy
rooms, bronchoscopy rooms, and/or rooms where anesthesia gases are used shall
be from ceiling outlets near the center of the room and/or work area. Return or
exhaust air inlets shall be near the floor level. Exhaust inlets for anesthesia
evacuation and other special applications shall be permitted to be installed in
the ceiling.
8. Each space
routinely used for administering inhalation anesthesia and inhalation analgesia
shall be served by a scavenging system to vent waste gases. If a vacuum system
is used, the gas-collecting system shall be arranged so that it does not
disturb patients' respiratory systems. Gases from the scavenging system shall
be exhausted directly to the outside. The anesthesia evacuation system may be
combined with the room exhaust system, provided the part used for anesthesia
gas scavenging exhausts directly to the outside and is not part of the
recirculation system. Scavenging systems are not required for areas where gases
are used only occasionally, such as the emergency room, offices for routine
dental work, etc.
9. The bottoms of
ventilation openings shall be at least three inches above the floor.
10. The space above ceilings in new
construction shall not be used as plenum space to supply to, return air from,
or to exhaust air from any patient room, operating room, trauma room, critical
care room, delivery room, endoscopy room, cardiac cath lab, bronchoscopy room,
autopsy room, exam room, treatment room, airborne infection isolation room,
protective environment room, radiology suite, laboratory suite, soiled
workroom, soiled holding, physical therapy and hydrotherapy, ETO-sterilizer
room, sterilizer equipment room, and central medical and surgical supply areas
or rooms. Plenum return air space conforming to NFPA 90A requirements shall be
acceptable in areas where it is not listed above.
11. All central ventilation or air
conditioning systems shall be equipped with filters with efficiencies equal to,
or greater than, those specified in Table 1 of the Appendix. Where two filter
beds are required, filter bed number one shall be located upstream of the air
conditioning equipment and filter bed number two shall be downstream of any fan
or blowers. Filter efficiencies, tested in accordance with ASHRAE 52-92, shall
be average. Filter frames shall be durable and proportioned to provide an
airtight fit with the enclosing ductwork. All joints between filter segments
and enclosing ductwork shall have gaskets or seals to provide a positive seal
against air leakage. A manometer or equal equivalent method of monitoring high
and low pressure drop shall be installed across each filter bed having a
required efficiency of 90 percent or more including hoods requiring HEP A
filters.
12. If duct humidifiers
are located upstream of the final filters, they shall be located in a manner to
prevent condensation on the surface of the filters. Ductwork with duct-mounted
humidifiers shall have a means of water removal. An adjustable high-limit
humidistat shall be located downstream of the humidifier to reduce the
potential of condensation inside the duct. All duct take-offs should be
sufficiently downstream of the humidifier to ensure complete moisture
absorption. Steam humidifiers shall be used. Reservoir-type water spray or
evaporative pan humidifiers shall not be used.
13. Air-handling duct systems shall be
designed with accessibility for duct cleaning, and shall meet the requirements
of NFPA 90 A.
14. Ducts that
penetrate construction intended to protect against X-ray, magnetic, RFI, or
other radiation shall not impair the effectiveness of the protection.
15. Fire and smoke dampers shall be
constructed, located, and installed in accordance with the requirements of NFPA
101, 90A, and the specific damper's listing requirements. Fans, dampers, and
detectors shall be interconnected so that damper activation will not damage
ducts. Maintenance access shall be provided at all dampers. All damper
locations shall be indicated on design drawings. Dampers should be activated by
fire or smoke sensors, not by fan cutoff alone. Switching systems for
restarting fans may be installed for fire department use in venting smoke after
a fire has been controlled. However, provisions should be made to avoid
possible damage to the system due to closed dampers. When smoke partitions are
required, heating, ventilation, and air conditioning zones shall be coordinated
with compartmentation insofar as practical to minimize need to penetrate fire
and smoke partitions.
16. Hoods and
safety cabinets may be used for normal exhaust of a space provided that minimum
air change rates are maintained. If air change standards in Table 4 of the
Appendix do not provide sufficient air for proper operation of exhaust hoods
and safety cabinets (when in use), supplementary makeup air (filtered and
preheated) shall be provided around these units to maintain the required
airflow direction and exhaust velocity. Use of makeup air will avoid dependence
upon infiltration from outdoor and/or from contaminated areas. Makeup systems
for hoods shall be arranged to minimize "short circuiting" of air and to avoid
reduction in air velocity at the point of contaminant capture.
17. Laboratory hoods shall meet the following
general standards:
a. Have an average face
velocity of at least 75 feet per minute.
b. Have an exhaust fan located at the
discharge end of the system.
c.
Have an exhaust duct system of noncombustible corrosion-resistant material as
needed to meet the planned usage of the hood.
18. Laboratory exhaust and ventilation
systems shall comply with NFPA 45.
19. Laboratory hoods shall meet the following
special standards:
a. Fume hoods, and their
associated equipment in the air stream, intended for use with perchloric acid
and other strong oxidants, shall be constructed of stainless steel or other
material consistent with special exposures, and be provided with a water wash
and drain system to permit periodic flushing of duct and hood. Electrical
equipment intended for installation within such ducts shall be designed and
constructed to resist penetration by water. Lubricants and seals shall not
contain organic materials. When perchloric acid or other strong oxidants are
only transferred from one container to another, standard laboratory fume hoods
and the associated equipment may be used in lieu of stainless steel
construction.
b. In new
construction and major renovation work, each hood used to process infectious or
radioactive materials shall have a minimum face velocity of 90 feet per minute
with suitable pressure-independent air modulating devices and alarms to alert
staff of fan shutdown or loss of airflow. Each shall also have filters with
99.97 percent efficiency (based on dioctyl-phthalate (DOP) test method) in the
exhaust stream, and be designed and equipped to permit the safe removal,
disposal, and replacement of contaminated filters. Filters shall be as close to
the hood as practical to minimize duct contamination. Fume hoods intended for
use with radioactive isotopes shall be constructed of stainless steel or other
material suitable for the particular exposure and shall comply with NFPA 801,
Facilities for Handling Radioactive Materials. Radioactive isotopes used for
injections, etc. without probability of airborne particulates or gases may be
processed in a clean-workbench-type hood where acceptable to the Nuclear
Regulatory Commission.
20. Exhaust hoods handling grease-laden
vapors in food preparation centers shall comply with NFPA 96. All hoods over
cooking ranges shall be equipped with grease filters, fire extinguishing
systems, and heat-actuated fan controls. Cleanout openings shall be provided
every 20feet and at changes in direction in the horizontal exhaust duct systems
serving these hoods. (Horizontal runs of ducts serving range hoods should be
kept to a minimum.
21. The
ventilation system for anesthesia storage rooms shall conform to the
requirements of NFPA 99.
22. The
ventilation system for the space that houses ethylene oxide (ETO) sterilizers
should be designed to:
a. Provide a dedicated
(not connected to a return air or other exhaust system) exhaust system. Refer
to 29 CFR Part 1910.1047.
b. All
source areas shall be exhausted, including the sterilizer equipment room,
service/aeration areas, over the sterilizer door, and the aerator. If the ETO
cylinders are not located in a well-ventilated, unoccupied equipment space, an
exhaust hood shall be provided over the cylinders. The relief valve shall be
terminated in a well-ventilated, unoccupied equipment space, or outside the
building. If the floor drain which the sterilizer(s) discharges to is not
located in a well-ventilated, unoccupied equipment space, an exhaust drain cap
shall be provided (coordinate with local codes).
c. Ensure that general airflow is away from
sterilizer operator(s).
d. Provide
a dedicated exhaust duct system for ETO. The exhaust outlet to the atmosphere
should be at least 25feet away from any air intake.
23. An audible and visual alarm shall
activate in the sterilizer work area, and a 24hour staffed location, upon loss
of airflow in the exhaust system.
24. Rooms with fuel-fired equipment shall be
provided with sufficient outdoor air to maintain equipment combustion
rates.
25. Gravity exhaust may be
used, where conditions permit, for nonpatient areas such as boiler rooms,
central storage, etc.
26. The
energy-saving potential of variable air volume systems is recognized and these
standard herein are intended to maximize appropriate use of that system. Any
system utilized for occupied areas shall include provisions to avoid air
stagnation in interior spaces where thermostat demands are met by temperatures
of surrounding areas.
27. Special
consideration shall be given to the type of heating and cooling units,
ventilation outlets, and appurtenances installed in patient-occupied areas of
psychiatric units. The following shall apply:
a. All air grilles and diffusers shall be of
a type that prohibits the insertion of foreign objects. All exposed fasteners
shall be tamper-resistant.
b. All
convector or HVAC enclosures exposed in the room shall be constructed with
round corners and shall have enclosures fastened with tamper-resistant
screws.
c. HVAC equipment shall be
of a type that minimizes the need for maintenance with the room.
28. Rooms or booths used for
sputum induction, aerosolized pentamidine treatments, and other high-risk
cough-inducing procedures shall be provided with local exhaust ventilation. See
Table 4 of the Appendix for ventilation requirements.
29. Non-central air handling systems, i.e.,
individual room units that are used for heating and cooling purposes (fan-coil
units, heat pump units, etc.) in areas permitted by Table 4 to utilize air
recirculated by means of a room unit shall be equipped with permanent
(cleanable) or replaceable filters. The filters shall have a minimum efficiency
of 68percent weight arrestance. These units may be used as recirculating units
only. All outdoor air requirements shall be met by a separate central air
handling system with the proper filtration, as noted in Table 1 of the
Appendix.
30. For special needs
pharmacy work area and equipment requirements refer to Laws and Regulations -
Arkansas State Board of Pharmacy.
SECTION 71:
PHYSICAL FACILITIES,
PLUMBING AND OTHER PIPING SYSTEMS.
All plumbing systems shall be designed and installed in accordance with the requirements of the latest edition of the Arkansas State Plumbing Code and the latest edition of the Laws, Rules, and Regulations Governing Boiler Inspection, Arkansas Department of Labor.
A. Plumbing Fixtures.
1. The material used for plumbing fixtures
shall be nonabsorbent acid-resistant material.
2. The water supply spout for lavatories and
sinks required in patient care areas (except patient rooms) shall be mounted so
that the discharge point is a minimum distance of five inches above the rim of
the fixture.
3. All fixtures used
by medical and nursing staff and all lavatories used by patients and food
handlers shall be trimmed with valves which can be operated without the use of
hands. Where blade handles are used for this purpose, they shall not exceed
four and one-half inches in length, except that handles on clinical sinks shall
be not less than six inches long. (Automatic controls are acceptable.) Scrub
sinks shall be trimmed with foot, knee or ultrasonic controls.
4. Clinical sinks shall have an integral trap
in which the upper portion of the water trap provides a visible seal.
5. Shower bases and tubs shall provide
non-slip walking surfaces.
B. Potable Water Supply Systems.
1. Systems shall be designed to supply water
at sufficient pressure to operate all fixtures and equipment during maximum
demand periods.
2. Each water
service main, branch main, riser, and branch to a group of fixtures shall be
valved. Stop valves shall be provided at each fixture. Appropriate panels for
access shall be provided at all valves where required.
3. Backflow preventers (vacuum breakers)
shall be installed on hose bibs, laboratory sinks, janitors' sinks, bedpan
flushing attachments, autopsy tables, and on all other fixtures to which hoses
or tubing can be attached.
4.
Bedpan flushing devices shall be provided in each inpatient toilet room.
Installation is optional in psychiatric and alcohol-abuse units where patients
are ambulatory
5. The following
standards shall apply to hot water systems:
a.
The water-heating system shall have sufficient supply capacity at the
temperatures and amounts indicated in Table 9 of the Appendix. Water
temperature is measured at the point of use or inlet to the
equipment.
b. Hot-water
distribution systems serving patient care areas shall be under constant
recirculation to provide continuous hot water at each hot water outlet. The
temperature of hot water for showers and bathing shall be appropriate for safe
and comfortable use. (See table 9 of the Appendix).
6. Water distribution systems shall be
arranged to provide hot water at each hot water outlet at all times. (See table
9 of the Appendix).
C.
Drainage Systems. The following standards shall apply to drainage systems:
1. Drain lines used for acid waste disposal
shall be made of acid-resistant material.
2. Drain lines serving some types of
automatic blood-cell counters shall be of carefully selected material that will
eliminate potential for undesirable chemical reactions
3. Drainage piping should not be installed
within the ceiling or exposed in operating and delivery rooms, nurseries, food
preparation centers, food serving facilities, food storage areas, central
services, electronic data processing areas, electric closets, and other
sensitive areas. Where exposed overhead drain piping in these areas is
unavoidable, special provisions shall be made to protect the space below from
leakage, condensation, or dust particles.
4. Floor drains shall not be installed in
operating and delivery rooms.
5. If
a floor drain is installed in cystoscopy, it shall contain a nonsplash,
horizontal-flow flushing bowl beneath the drain plate. Note: Floor drains in
cystoscopy operating rooms have been shown to disseminate heavily contaminated
spray during flushing. Unless regularly with large amounts of fluid, the trap
tends to dry out and permit passage of gases, vapors, odors, insects and vermin
directly into the operating room. For new construction, if a floor drain is
insisted upon by the users, the drain plate should be located away from the
operative preferably with a closed system of drainage. Alternative methods
include (a) an aspirator/trap installed in a wall connected to the collecting
trough of the operating table by a closed, disposable tube system, or (b) a
closed system using portable collecting vessels. (See NFPA 99.)
6. Drain systems for autopsy tables shall be
designed to positively avoid splatter or overflow onto floors or back siphonage
and for easy cleaning and trap flushing.
7. Building sewers shall discharge into
community sewage. Where such a system is not available, the facility shall
treat sewage in accordance with local and state regulations.
8. Kitchen grease traps shall be located and
arranged to permit easy access without the need to enter food preparation or
storage areas. Grease traps shall be of capacity required and shall be
accessible from outside of the building without need to interrupt any
services.
9. Where plaster traps
are used, provisions shall be made for appropriate access and
cleaning.
10. In dietary areas,
floor drains and/or floor sinks shall be of a type that can be easily cleaned
by removal of cover. Provide floor drains or floor sinks at all "wet equipment"
(i.e., ice machines) and as required for wet cleaning of floors. Provide
removable stainless steel mesh in addition to grilled drain cover to prevent
entry of large particles of waste which might cause stoppages. Location of
floor drains and floor sinks shall be coordinated to avoid conditions where
locations of equipment make removal of covers for cleaning difficult.
D. The installation, testing, and
certification of nonflammable medical gas and air systems shall comply with the
requirements of NFPA 99. (See Table 11 of the Appendix for rooms that require
station outlets.)
E. Clinical
vacuum system installations shall be in accordance with NPFA 99. (See Table 11
of the Appendix for rooms that require station outlets.)
F. All piping, except control-line tubing,
shall be identified. All valves shall be tagged, and a valve schedule shall be
provided to the facility owner for permanent record and reference.
G. When the functional program includes
hemodialysis, continuously circulated filtered cold water shall be
provided.
H. Provide condensate
drains for cooling coils of a type that may be cleaned as needed without
disassembly. Provide air gap where condensate drains empty into floor drains.
Provide heater elements for condensate lines in freezer or other areas where
freezing may be a problem.
I. No
plumbing lines may be exposed overhead or on walls where possible accumulation
of dust or soil may create a cleaning problem or where leaks would create a
potential for food contamination.
SECTION 72:
PHYSICAL ENVIRONMENT,
ELECTRICAL STANDARDS
A. General.
1. All electrical material and equipment,
including conductors, controls, and signaling devices, shall be installed in
compliance with and maintained per applicable sections of NFPA 70 and NFPA 99
and shall be listed as complying with available standards of listing agencies,
or other similar established standards where such standards are required.
Maintenance and testing of receptacles in patient care areas shall be performed
at initial installation, replacement or servicing of devices. Records shall be
maintained of all tests, rooms or areas tested, with itemized pass/fail
indicators.
2. The electrical
installations, including alarm, nurse call, and communication systems, shall be
tested to demonstrate that equipment installation and operation is appropriate
and functional. A written record of performance tests on special electrical
systems and equipment shall demonstrate compliance with applicable codes and
standards.
3. Shielded isolation
transformers, voltage regulators, filters, surge suppressors, and other
safeguards shall be provided as required where power line disturbances are
likely to affect data processing and/or automated laboratory or diagnostic
equipment.
B. Main
switchboards shall be located in an area separate from plumbing and mechanical
equipment and shall be accessible to authorized persons only. Switchboards
shall be convenient for use, readily accessible for maintenance, away from
traffic lanes, and located in dry, ventilated spaces free of corrosive or
explosive fumes, gases, or any flammable material. Overload protective devices
shall operate properly in ambient room temperatures.
C. Lighting.
1. The Illuminating Engineering Society of
North America (IES) has developed recommended lighting levels for health care
facilities. The reader should refer to the IES Handbook.
2. Approaches to buildings and parking lots,
and all occupied spaces within buildings shall have fixtures that can be
illuminated as necessary.
3.
Patient rooms shall have general lighting and night lighting. A reading light
shall be provided for each patient. Reading light controls shall be readily
accessible to the patient(s). Incandescent and halogen light sources which
produce heat shall be avoided to prevent burns to the patient and/or bed linen.
The light source should be covered by a diffuser or lens.
Flexible light arms, if used, shall be mechanically controlled to prevent the lamp from contacting the bed linen. At least one night light fixture in each patient room shall be controlled at the room entrance. Lighting for coronary and intensive care bed areas shall permit staff observation of the patient while minimizing glare.
4. Operating and delivery rooms shall have
general lighting in addition to special lighting units provided at surgical and
obstetrical tables. General lighting and special lighting shall be on separate
circuits.
5. Nursing unit corridors
shall have general illumination with provisions for reducing light levels at
night.
6. Light intensity for staff
and patient needs should generally comply with health care guidelines set forth
in the IES publication. Consideration should be given to controlling intensity
and/or wavelength to prevent harm to the patient's eyes (i.e., retina damage to
premature infants and cataracts due to ultraviolet light). Many procedures are
available to satisfy lighting requirements, but the design should consider
light quality as well as quantity for effectiveness and efficiency.
7. An examination light shall be provided for
examination, treatment, and trauma rooms.
8. Light intensity of required emergency
lighting shall follow IES guidelines. Egress and exit lighting shall comply
with NFPA 101.
D.
Receptacles.
1. Each operating and delivery
room shall have at least six receptacles convenient to the head of the
procedure table. Each operating room shall have at least 16simplex or eight
duplex receptacles. Where mobile X-ray, laser, or other equipment requiring
special electrical configurations is used, additional receptacles distinctively
marked for X-ray or laser use shall be provided.
2. Each patient room shall have
duplex-grounded receptacles. There shall be one at each side of the head of
each bed; one for television, if used; and one on every other wall. Receptacles
may be omitted from exterior walls where construction or room configuration
makes installation impractical. Nurseries shall have at least two
duplex-grounded receptacles for each bassinet. Outlets for general care areas
and critical care areas shall be provided for as defined by NFPA 99 and NFPA
70.
3. Duplex-grounded receptacles
for general use shall be installed approximately 50feet apart in all corridors
and within 25feet of corridor ends. Receptacles in pediatric and psychiatric
unit corridors shall be of the tamper resistant type. Special receptacles
marked for X-ray use shall be installed in corridors of patient areas so that
mobile equipment may be used anywhere within a patient room using a cord length
of 50feet or less. If the same mobile X-ray unit is used in operating rooms and
in nursing areas, receptacles for X-ray use shall permit the use of one plug in
all locations. Where capacitive discharge or battery-powered X-ray units are
used, special X-ray receptacles are not required.
4. Electrical receptacle cover plates or
electrical receptacles supplied from the emergency systems shall be
distinctively colored or marked for identification. If color is used for
identification purposes, the same color shall be used throughout the
facility.
5. For renal dialysis
units, two duplex receptacles shall be on each side of a patient bed or lounge
chair. One duplex receptacle on each side of the bed shall be connected to
emergency power.
E.
Equipment.
1. At inhalation anesthetizing
locations, all electrical equipment and devices, receptacles, and wiring shall
comply with applicable sections of NFPA 99 and NFPA 70.
2. Fixed and mobile X-ray equipment
installations shall conform to articles 517 and 660 of NFPA 70.
3. The X-ray film illuminator unit or units
for displaying at least two films simultaneously shall be installed in each
operating room, specified emergency treatment rooms, and X-ray viewing room of
the radiology department. All illuminator units within one space or room shall
have lighting of uniform intensity and color value.
4. Ground-fault circuit interrupters (GFCI)
shall comply with NFPA 70. When ground-fault circuit interrupters are used in
critical areas, provisions shall be made to ensure the other essential
equipment is not affected by activation of one interrupter.
5. In areas such as critical care units and
special nurseries where a patient may be treated with an internal probe or
catheter connected to the heart, the ground system shall comply with applicable
sections of NFPA 99 and NFPA 70.
F. Nurse/Patient Communication Station.
1. In patient areas, each patient room shall
be served by at least one nurse/patient communication station for two way voice
communication. All primary nurse call systems shall be of the
electrical/electronic nature.
The signal shall activate an annunciator panel at the nurse station, a visible signal in the corridor at the patient's door, and at other areas defined by the functional program. Each bed shall be provided with a call device. Two call devices serving adjacent beds may be served on one calling station. Calls shall activate a visible signal in the corridor at the patient's door, in the clean workroom, in the soiled workroom, medication, charting, nourishment, and examination/treatment room(s) and at the nurses' station. In multi-corridor nursing units, additional visible signals shall be installed at corridor intersections. In rooms containing two or more nurse/patient communication stations, indicating lights shall be provided at each station. Nurse/patient communication stations at each calling station shall be equipped with an indicating light which remains lighted as long as the voice circuit is operating.
2. An emergency
call system shall be provided at each inpatient/outpatient toilet, bath and
shower room. An emergency call shall be accessible to a collapsed patient on
the floor. Inclusion of a pull cord within four to six inches from the floor
will satisfy this standard. The emergency call shall be designed so that a
signal activated at a patient's calling station will initiate a visible and
audible signal distinct from the regular nurse/patient communication station
that can be turned off only at the patient calling station. The signal shall
activate an annunciator panel at the nurse station, a visible signal in the
corridor at the patient's door, and at other areas defined by the narrative
program. Provisions for emergency calls will also be provided in outpatient and
treatment areas where patients are subject to incapacitation.
3. In areas such as critical care, recovery
and pre-op, where patients are under constant visual surveillance, the
nurse/patient communication call may be limited to a bedside button or station
that activates a signal readily seen at the control station.
4. A staff emergency assistance system for
staff to summon additional assistance shall be provided in each operating,
delivery, recovery, emergency examination and/or treatment area, and in
critical care units, nurseries, special procedure rooms, cardiac
catheterization rooms, stress-test areas, triage, outpatient surgery admission
and discharge areas, and areas for psychiatric patients including seclusion and
security rooms, anterooms and toilet rooms serving them, communal toilet and
bathing facility rooms, and dining, activity, therapy, exam and treatment
rooms. This system shall annunciate audibly or visually in the clean work room,
in the soiled work room, medication, charting, nourishment, and
examination/treatment room(s) if provided and at the administrative center of
the nursing unit with back up to another staffed area from which assistance can
be summoned.
5. A nurse/patient
communication station is not required in psychiatric nursing units, but if it
is included, provisions shall be made for easy removal, or for covering call
button outlets. In psychiatric nursing units all hardware shall have
tamper-resistant fasteners.
G. Emergency power shall be provided in
accordance with NFPA 99, NFPA 101, and NFPA 110.
H. Emergency electrical generators shall have
a minimum 48hours of on-site fuel.
I. All health care occupancies shall be
provided with a fire alarm system in accordance with NFPA 101 and NFPA 72.
J. Telecommunications and
Information Systems.
1. Locations for
terminating telecommunications and information system devices shall be
provided.
2. A room shall be
provided for telecommunications and information systems. Special air
conditioning and voltage regulations shall be provided when recommended by the
manufacturer.
K.
Annuciator alarm panels for Emergency Systems including but not limited to such
as the fire alarms, medical gas and emergency generators shall be located
according to the functional program and shall be located in prominent locations
easily observed and accessible by staff at all times.
SECTION 73:
HYPERBARIC SUITE
A. General
1. The number of treatment stations should be
based upon the expected workload and may include several work shifts per
day.
2. The location should offer
convenient access for outpatients. Accessibility to the unit from parking and
public transportation should be a consideration.
B. Treatment Areas
1. Hyperbaric chambers for multiple occupancy
(Class A) should be installed in accordance with NFPA 99.
2. Hyperbaric chambers for individual
patients (Class B) should be installed in accordance with NFPA 99 in a room or
suite adequately sized to provide the following clearances: chamber and side
wall, 5 feet; between chambers, 6 feet; and between the chamber headboard and
the wall, 3 feet. A minimum passage space of 4 feet shall be provided at the
foot of each chamber in addition to the required clearances for sliding
patients' platforms in end-loading chambers.
C. Functional Elements. The following support
spaces should be provided and may be shared with adjacent departments.
1. Patient waiting area. The area should be
out of traffic, under staff control, and should have seating capacity in
accordance with the functional program. When the hyperbaric suite is routinely
used for outpatients and inpatients at the same lime, separate waiting areas
should be provided with screening for visual privacy between the waiting
areas.
2. A control desk and
reception area should be provided.
3. A holding area under staff control should
accommodate inpatients on stretchers or beds. Stretcher patients should be out
of the direct line of normal traffic. The patient holding area may be omitted
for two or fewer individual hyperbaric chamber units.
4. Toilet rooms for the use of patients
should be provided with direct access from the hyperbaric suite.
5. Dressing rooms for outpatients should be
provided and should include a seat or bench, mirror, and provisions for hanging
patients' clothing and for securing valuables. At least one dressing room
should be provided to accommodate wheelchair patients.
6. An appropriate room for individual and
family consultation with referring physicians should be provided for
outpatients.
7. A clean storage
space should be provided for clean supplies and linens. Handwashing stations
should be provided with hands-free operable controls. When a separate storage
room is provided, it may be shared with another department when conveniently
located.
8. A soiled holding room
should be provided with waste receptacles and soiled linen receptacles Storage
for patients' belongings should be provided.
9. A housekeeping room should be provided and
should contain a floor receptor or service sink and storage space for
housekeeping supplies and equipment; it should be located nearby.
10. Appropriate areas should be available for
male and female personnel for staff clothing change area and lounge. The areas
should contain lockers, shower, toilet, and handwashing stations.
11. A waiting room, toilet with handwashing
stations, drinking fountain, public telephone, and seating accommodations for
waiting periods should be available or accessible to the unit.
D. Electrical Requirements
1. Grounding of hyperbaric chambers should be
connected only to the equipment ground in accordance with NFPA 99 and NFPA
70.
2. Additional grounds such as
earth or driven grounds should not be permitted.
SECTION 74:
PHYSICAL
FACILITIES, HELICOPTER LANDING AREA.
Helicopter landing area (if provided) shall be documented.
A. Safe planning for the helicopter
service shall include the following:
1. Plot
plan showing the heliport for Department of Health files and inspection;
and
2. More than one
approach/departure route.
B. Service shall be as close to the emergency
service at the hospital as can be accomplished safely. The Department of Health
will consider that a helicopter landing area does exist upon repeated or
regular use of a location.
C. See
NFPA 418 for rooftop heliports.
NOTE: If there are wire obstacles, wire markers are available at no charge. They shall be picked up at the Arkansas Department of Aeronautics.
SECTION
75:
PHYSICAL FACILITIES, OUTPATIENT CARE FACILITIES.
A. General Considerations. See Section 43.A,
Physical Facilities.
1. This section applies
to the outpatient care unit licensed under the facility as a department and
under the rule of the Governing Body. An outpatient care unit can be a part of
the facility or a separate freestanding facility. An outpatient unit within the
main facility building shall be located so outpatients do not traverse
inpatient areas.
2. The general
standards set forth in the following sections shall apply to each of the items
below:
a. Outpatient psychiatric
centers;
b. Primary care outpatient
centers; and c. Diagnosis and/or treatment centers.
3. Each element provided in the outpatient
care facility shall be described in the written functional program and meet the
requirements outlined herein as a minimum.
B. General Construction Considerations. See
Section 43.A, Physical Facilities.
C. Site Location, Inspection, Approval and
Subsoil Investigation. See Section 43.D-M, Physical Facilities.
D. Construction Documents. See Section 43 .K,
Physical Facilities.
E. Codes and
Standards. New/existing Outpatient Care Facilities which do not meet the
criteria of the NFPA, Life Safety Code Volume 101 for healthcare and/or
ambulatory healthcare occupancies may be classified as a Business Occupancy as
defined in LSC 101, Chapter 26 (new)/27 (existing) with exceptions noted within
these regulations.
F. General
Requirements for Outpatient Care Facilities. As needed the following elements
shall be provided to satisfy the functional program.
1. Functional Program. See Section 43,
Physical Facilities.
2. Parking.
Each facility should provide adequate parking for staff and patients.
3. Patient Privacy. Each facility design
shall ensure patient audible and visual privacy and dignity during interview,
examination, treatment and recovery.
4. Administration and Public Areas. The
following shall apply to each outpatient care facility described herein with
additions and/or modification as noted for each specific type.
a. Entrance. Located at grade level and able
to accommodate wheelchairs.
b.
Public services shall include:
1)
Conveniently accessible wheelchair storage;
2) A reception and information counter or
desk;
3) Waiting space(s). Where an
organized pediatric service is part of the outpatient care facility, provisions
shall be made for separating pediatric and adult patients;
4) Public toilets;
5) Drinking fountain; and
6) Public telephones.
c. Interview space(s). Private interviews
related to social services, credit, etc. shall be provided.
d. General or individual offices for business
transactions, records, administrative and professional staffs shall be
provided.
e. Clerical space or
rooms for typing, clerical work, and filing, separated from public areas for
confidentiality, shall be provided.
f Multipurpose room(s) equipped for visual
aids shall be provided for conferences, meetings and health education
purposes.
g. Special storage for
staff personal effects with locking drawers or cabinets (may be individual
desks or cabinets) shall be provided. Such storage shall be near individual
work stations and staff controlled.
h. General storage facilities for supplies
and equipment shall be provided as needed for continuing operation.
i. In new construction and renovation where
hemodialysis or hemoperfusion are routinely performed, there shall be a
separate water supply and a drainage facility that do not interfere with
handwashing.
5. General
purpose examination rooms. For medical, and similar examinations, rooms shall
have a minimum floor area of 80square feet, excluding vestibules, toilets, and
closets. Room arrangement shall permit at least two feet eight inches clearance
at each side and at the foot of the examination table. A handwashing fixture
and a counter or shelf space for writing shall be provided.
6. Special- purpose examination rooms. Rooms
for special clinics such as eye, ear, nose, and throat examinations, if
provided, shall be designed and outfitted to accommodate procedures and
equipment used. A handwashing stations and a counter or shelf space for writing
shall be provided.
7. Treatment
Room(s). Rooms for diagnosis and/or treatment if provided, shall have a minimum
floor area of 120square feet, excluding vestibule, toilet, and closets. The
minimum room dimension shall be lOfeet. A handwashing fixture and counter or
shelf for writing shall be provided.
8. Observation room(s). Observation rooms for
the isolation of suspect or disturbed patients shall have a minimum floor area
of 80 square feet and shall be convenient to a nurse or control station. This
is to permit close observation of patients and to minimize possibilities of
patients' hiding, escape, injury, or suicide. An examination room may be
modified to accommodate this function. A toilet room with lavatory should be
immediately accessible.
9. Control
Station. A work counter, communication system, space for supplies, and
provisions for charting shall be provided.
10. Medication Distribution Station. This may
be a part of the control station and shall include a work counter, sink,
refrigerator, and locked storage forbiologicals and medications.
11. Clean Holding. A separate room or closet
for storing clean and sterile supplies shall be provided. This storage shall be
in addition to that of cabinets and shelves.
12. Soiled Holding. Provisions shall be made
for separate collection, storage, and disposal of soiled materials.
13. Sterilizing Facilities. A system for
sterilizing equipment and supplies shall be provided, if required by the
narrative program.
14. Wheelchair
Storage Space. Such storage shall be out of the direct line of
traffic.
15. The need for and
number of required airborne infection isolation rooms shall be determined by an
infection control risk assessment. When required, the airborne infection
isolation room(s) shall comply with the general requirements of Section
44.C.
16. Imaging Suite. See
Section 52, Physical Facilities, Imaging Suite.
17. Laboratory. See Section 55, Physical
Facilities, Laboratory Services.
18. Rehabilitation Services. See Section 76,
Physical Facilities, Rehabilitation Facilities.
19. Environmental Services, Safety Services,
Physical Environment. See Section 43, Physical Facilities.
20. Staff Facilities. See Section 66,
Physical Facilities, Engineering Service and Equipment Areas
21. Waste Processing Services. See Section
67, Physical Facilities, Waste Processing Services.
22. Social Spaces/Group Therapy. See Rules
and Regulations for Hospitals and Related Institutions in Arkansas, Section,
Physical Facilities for Psychiatric Hospitals - F.3 Service Areas
23. Details shall comply with the following
standards:
a. Minimum patient corridor width
shall be five feet. Staff only corridors may be 44 inches wide.
b. Each building shall have two exits that
are remote from each other. Other details relating to exits and fire safety
shall comply with NFPA 101 and the standards outlined herein.
c. Items such as drinking fountains,
telephone booths, vending machines, etc., shall not restrict corridor traffic
or reduce corridor width below the minimum. Out of traffic storage space for
portable equipment shall be provided.
d. The minimum nominal door width for patient
use shall be three feet. If the outpatient facility services hospital
inpatients, the minimum nominal width of doors to rooms used by hospital
inpatients transported in beds shall be three feet eight inches.
e. Doors, sidelights, borrowed lights, and
windows glazed to within 18 inches of the floor shall be constructed with
safety glass, wired glass, or similar materials. Glazing materials used for
shower doors and bath enclosures shall be safety glass or plastic.
f Threshold and expansion joints covers shall
be flush with the floor surface.
g.
Handwashing stations shall be located and arranged to permit proper use and
operation.
h. Provisions for hand
drying shall be included at all handwashing facilities.
i. Radiation protection for X-ray and gamma
ray installations shall be in accordance with the rules and regulations of the
Arkansas Department of Health.
j.
The minimum ceiling height shall be seven feet eight inches.
24. Finishes shall comply with the
following:
a. Cubicle curtains and draperies
shall be noncombustible or flame-retardant and shall pass both the large- and
small-scale tests required by NFPA 701.
b. The flame spread and smoke development
ratings of finishes shall comply with NFPA 101, Chapter 38.
c. Floor materials shall be readily cleanable
and appropriately wear-resistant.In all areas subject to wet cleaning, floor
materials shall not be physically affected by liquid germicidal and cleaning
solutions. Floors subject to traffic while wet, including showers and bath
areas, shall have a nonslip surface.
d. Wall finishes shall be washable, and in
the proximity of plumbing fixtures, shall be smooth and water
resistant.
e. Wall bases in areas
frequently subject to wet cleaning methods shall be monolithic and coved with
the floor, tightly sealed to the wall, and constructed without voids.
f Floor and wall areas penetrated
by pipes, ducts, and conduits shall be tightly sealed to minimize entry of
rodents and insects. Joints of structural elements shall be similarly
sealed.
25. Provision
for Disasters. See Section 42, Physical Environment.
26. Mechanical, Plumbing and Electrical.
a. Small Outpatient Clinics that provide
space and equipment serving four or fewer direct patient care workers at one
time shall comply with the following minimum requirements:
1) Emergency lighting shall be connected to
rechargeable back-up batteries as a means of emergency illumination.
2) A protected premises fire alarm system as
defined in Chapter 3, NFPA 72 is required.
b. Large Outpatient Facilities that provide
space and equipment for more than four direct patient care workers at one time
shall comply with the following minimum requirements:
1) Emergency lighting and power shall be
provided in accordance with NFPA 99, NFPA 101, and NFPA 110.
2) Any fire alarm system shall be as required
by NFPA 101 and installed per NFPA 72.
3) The installation, testing, and
certification of nonflammable medical gas and air systems shall comply with the
requirements of NFPA 99.
4)
Clinical vacuum system installed shall be in accordance with NFPA 99.
5) All electrical material and equipment
shall be installed, tested and certificated in accordance with NFPA 70 and NFPA
99.
6) The mechanical system shall
comply with Section 70, Physical Facilities, Mechanical Requirements, with the
following exceptions:
a) Redundant space
heating and water heating capability are not required, unless required by the
written functional program;
b)
Ducted return air systems are not required, unless required by the written
narrative.
c) Stand-by fuel for
space and water heating is not required.
7) A nurses emergency call system shall be
provided for all patient use at each patient toilet, bath, sitz bath and shower
room. This system shall be accessible to a patient lying on the floor.
Inclusion of a pull cord shall satisfy this standard.
8) Fire extinguisheds) shall be provided and
be easily accessible per NFPA requirements.
SECTION 76:
PHYSICAL FACILITIES, REHABILITATION FACILITIES.
A. General Considerations. Rehabilitation
facilities may be organized under hospitals(organized departments of
rehabilitation), outpatient clinics, rehabilitation centers, and other
facilities designed to serve either single- or multiple-disability categories
including but not limited to: cerebrovascular, head trauma, spinal cord injury,
amputees, complicated fractures, arthritis, neurological degeneration, genetic,
and cardiac. In general, rehabilitation hospitals shall have larger space
requirements than general hospitals, have longer lengths of stay and have less
institutional and more residential environments.
B. General Construction Considerations. See
Section 43.A, Physical Facilities.
C. Site Location, Inspection, Approval and
Subsoil Investigation. See Section 43.D-M, Physical Facilities.
D. Construction Documents. See Section 43 .K,
Physical Facilities.
E. Codes and
Standards. See Section 43.A and O, Physical Facilities.
F. Functional Units and Service Areas.
1. Required units. Each rehabilitation
facility shall contain a medical evaluation unit and shall provide the
following service areas, if the services are not otherwise conveniently
accessible to the facility and appropriate to program functions:
a. Psychological services;
b. Social services;
c. Vocational services;
d. Patient dining, recreation and day
spaces;
e. Dietary;
f Personal care facilities;
g. Space for teaching activities of daily
living;
h. Administration
Department;
i. Medical
Records;
j. Engineering service and
equipment areas;
k. Laundry
Services;
l. Housekeeping
Rooms;
m. Employees'
facilities;
n. Nursing unit;
76-2
o. Physical therapy;
p. Occupational therapy; and
q. Speech and hearing.
2. Optional Units. The following special
services areas, if required by the functional program, shall be provided as
outlined in these sections. The sizes of the various departments will depend
upon the services to be provided:
a.
Sterilizing facilities;
b.
Prosthetics and orthotics;
c.
Dental;
d. Radiology;
e. Pharmacy;
f Laboratory;
g. Home health;
h. Outpatient services; and
i. Therapeutic pool.
G. Evaluation Unit.
1. Office(s) for Personnel.
2. Examination Rooms. The rooms shall have a
minimum floor area of 140 square feet excluding such spaces as the vestibule,
toilet, closet, and work counter (whether fixed or movable). The minimum room
dimension shall be ten feet. The room shall contain a lavatory or sink equipped
for handwashing, a work counter and storage facilities, and a desk, counter, or
shelf space for writing.
3.
Evaluation Rooms. The room areas shall be arranged to permit appropriate
evaluation of patient needs and progress and to determine specific programs of
rehabilitation. Rooms shall include a desk and work area for the evaluators,
writing and work space for patients, and storage for supplies. Where the
facility is small and workload light, evaluation may be done in the examination
room.
4. Laboratory Facilities.
Facilities shall be provided within the rehabilitation department or through
contract arrangement with a nearby hospital or laboratory service for
hematology, clinical chemistry, urinalysis, cytology, pathology, and
bacteriology. If these facilities are provided through contract, the following
minimum laboratory services shall be provided in the rehabilitation facility:
a. Laboratory work counter(s) with a sink,
and gas and electric service;
b.
Handwashingstations;
c. Storage
cabinet(s) or closet(s); and
d.
Specimen collection facilities. Urine collection rooms shall be equipped with a
water closet and lavatory. Blood collection facilities shall have space for a
chair and work counter.
5. Imaging Facilities. Imaging facilities, if
required by the functional program, shall be in accordance with Section 52,
Physical Facilities, Imaging Suite.
H. Psychological Service. Office(s) and work
space for testing, evaluation, and counseling shall be provided.
I. Social Service. Office space(s) for
private interviewing and counseling shall be provided.
J. Vocational Services. Office(s) and work
space for vocational training, counseling, and placement shall be
provided.
K. Dining, Recreation,
and Day Spaces.
The following standards shall be met for patient dining, recreation, and day spaces (areas may be in separate or adjoining spaces):
1. Inpatient and residents
shall have a total of 55 square feet per bed.
2. Outpatients, if dining is part of the day
care program, a total of 55 square feet per person shall be provided. If dining
is not part of the program, at least 35 square feet per person shall be
provided for recreation and day spaces.
3. Storage spaces shall be provided for
recreation equipment and supplies.
L. Dietary Department. See Section 59,
Physical Facilities, Dietary Facilities.
M. Personal Care Unit for Inpatients. A
separate room with appropriate fixtures and utilities shall be provided for
patient grooming. The activities for daily living unit may serve this
purpose.
N. Activities for Daily
Living Unit. An area for teaching daily living activities shall be provided. It
shall include a bedroom, bath, kitchen, and space for training stairs.
Equipment shall be functional. The bathroom shall be in addition to other
toilet and bathing requirements. The daily living area shall be similar to a
residential environment for the purpose of facilitating the patient's skill for
daily living.
O. Administration
Department and Medical Records. See Sections 60, Physical Facilities,
Administration and Public Areas.
P.
Engineering Service and Equipment Areas. See Section 66, Physical Facilities,
Engineering Service and Equipment Areas.
Q. Laundry Services. See Section 64, Physical
Facilities, Linen Service.
R.
Housekeeping Rooms. See Section 65, Physical Facilities, Cleaning and
Sanitizing Carts and Environmental Services.
S. Employee Facilities. See Section 66,
Physical Facilities, Engineering Service and Equipment Areas.
T. Nursing.
1. The nursing units for rehabilitation
facilities shall follow the standards as described in Section 44, Physical
Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or
Pulmonary Disease), with the following exceptions:
a. Patient Rooms. Minimum areas exclusive of
toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules shall be 140
square feet in single-bed rooms and 125 square feet per bed in semi-private
rooms.
b. Each patient shall have
access to a toilet room without having to enter the general corridor area. One
toilet room shall serve no more than four beds and no more than two patient
rooms. The toilet room shall contain a water closet, a handwashing fixture and
a tub and/or shower. The handwashing fixture may be omitted from a toilet room
that serves single-bed and two bed rooms if each such patient's room contains a
handwashing fixture. Each toilet room shall be of sufficient size to ensure
that wheelchair users and staff shall have access.
c. Each patient shall have access to a
wardrobe, closet, or locker with minimum clearance of one foot ten inches by
one foot eight inches. A clothes rod and adjustable shelf shall be
provided.
2. Nursing
Unit Service Areas shall follow the standards described in Section 44, Physical
Facilities, Patient Accommodations (Adult Medical, Surgical, Communicable or
Pulmonary Disease), with the following exceptions:
a. Patient Bathing Facilities. At least one
island-type bathtub and/or gurney shower shall be provided in each nursing
unit. Each tub and/or shower shall be in an individual room or privacy
enclosure that provides space for the private use of bathing fixtures, for
drying and dressing, and for a wheelchair and an assistant. Showers in central
bathing facilities shall be at least four feet square, curb-free and designed
for use by a wheelchair patient;
b.
At least one room on each floor containing a nursing unit shall be provided for
toilet training. It shall be accessible from the nursing corridor. A minimum
clearance of three feet shall be provided at the front and at each side of the
water closet. The room shall also contain a lavatory; and
c. Handrails shall be provided on both sides
of corridors used by patients. A clear distance of one and one-half inches
shall be provided between the handrail and the wall, and the top of the rail
shall be 34 inches minimum and 36 inches maximum above the floor. Exceptions
for height shall be for special care areas such as those serving
children.
U.
Sterilizing Facilities. See Section 65, Physical Facilities, Cleaning and
Sanitizing Carts and Environmental Services.
V. Rehabilitation Therapy. See Section 56,
Physical Facilities, Rehabilitation Therapy Department.
W. Pharmacy Unit. See Section 58, Physical
Facilities, Pharmacy.
X. Details
and Finishes. See Section 68, Physical Facilities, Details and
Finishes.
Y. Design and
Construction, Including Fire-Resistant Standards. See Section 69, Physical
Facilities, Construction, Including Fire Resistive Requirements.
Z. Waste Processing Services. See Section 67,
Physical Facilities, Waste Processing Services.
AA. Elevators. See Section 72, Physical
Facilities, Electrical Standards.
BB. Mechanical, Plumbing and Electrical
Standards. See Sections 71, 72 and 75.F.22.
TABLE 1
|
Filter Efficiencies for Central Ventilation and Air Conditioning Systems in Health Care Facilities |
|||
|
Area Designation |
No. Filter Beds |
Filter Bed No.1(%) |
Filter Bed No.21 (%) |
|
All areas for patient care, treatment, and diagnosis, and those areas providing direct service or clean supplies such as sterile and clean processing. |
2 |
30 |
90 |
|
Protective Environment Room |
2 |
30 |
99.97 |
|
Laboratories |
1 |
80 |
- |
|
Administrative, Bulk Storage, Soiled Holding Areas, Food Preparation Areas, and Laundries |
1 |
30 |
- |
1These requirements do not apply to small outpatient clinics or outpatient clinics that do not perform invasive applications or procedures.
Notes: The filtration efficiency ratings are based on average dust spot efficiency per ASHRAE 52.1 1992.
Additional roughing or prefilters should be considered to reduce maintenance required for filters with efficiencies higher than 75 percent.
TABLE 2
|
Sound Transmission Limitations in Health Care Facilities |
||
|
Airborne Sound Transmission Class (STC)1 |
||
|
Partitions |
Floors |
|
|
NEW CONSTRUCTION2 |
||
|
Patients = Room to Patients = Room |
45 |
40 |
|
Public Space to Patients = Room3 |
55 |
40 |
|
Service Areas to Patients = Room4 |
65 |
45 |
|
Patient room access corridor5 |
45 |
45 |
|
Exam room to exam room |
45 |
- |
|
Exam room to public space |
45 |
- |
|
Toilet room to public space |
45 |
- |
|
Consultation rooms/ conference rooms to public space |
45 |
- |
|
Consultation rooms/ Conference rooms to patient rooms |
45 |
- |
|
Staff lounges to patient rooms |
45 |
- |
|
Existing Construction2 |
||
|
Patient room to patient room |
35 |
40 |
|
Public space to patient room3 |
40 |
40 |
|
Service areas to patient room4 |
45 |
45 |
1. Sound transmission class (STC) shall be determined per ASTM Standard E90 and E413. Where partitions do not extend to the structure above, sound transmission through ceilings and composite STC performance shall be considered.
2. Treatment rooms shall be treated the same as patient rooms
3. Public space includes lobbies, dining rooms, recreation rooms, treatment rooms, and similar spaces.
4. Service areas include kitchens, elevators, elevator machine rooms, laundries, garages, maintenance rooms, boiler and mechanical equipment rooms, and similar spaces of high noise. Mechanical equipment located on the same floor or above patient rooms, offices, nurses stations, and similar occupied space shall be effectively isolated from the floor.
5. Patient room access corridors contain composite walls with doors/windows and have direct access to patient rooms.
TABLE 3
Temperature and Relative Humidity Requirements
|
Area Designation |
Dry Bulb Temperatures °F1 |
Relative Humidity (%) Minimum-Maximum2 |
|
Operating Rooms, Delivery Rooms, Endoscopy, and Bronchoscopy |
68-73 |
20-60 |
|
Newborn Intensive Care and Newborn Nursery Suite |
72-78 |
30-60 |
|
Recovery, Intensive Care, Trauma Rooms, Procedure Rooms, and Radiological X-ray (Surgical/Critical Care and Catheterization) |
70-75 |
30-60 |
|
Clean Work Room and ETO Sterilizer Room |
75 |
30-60 |
|
Sterile Storage |
75 |
70 (max) |
1Where temperature ranges are indicated, the systems shall be capable of maintaining the rooms at any point within the range. A single figure indicates a heating or cooling capacity of at least the indicated temperature. Nothing in these guidelines shall be construed as precluding the use of temperatures different than those noted when the patient's comfort and medical conditions make different temperatures desirable. Unoccupied areas such as storage rooms shall have temperatures appropriate for the function intended.
2Humidification systems serving anesthetizing locations shall be designed in accordance with NFPA 99 paragraph 5-4.1.1.
TABLE 4
Ventilation, Medical Gas, and Air Flow Requirements in Health Care Facilities1
|
Area Designation |
Air Movement Relationship To Adjacent Area |
Minimum Air Changes Outside Air Per Hour3 |
Minimum Total Air Changes Per Hour4,5 |
Air Recirculated By Means of Room Unit7 |
All Air Exhausted Directly Outdoor6 |
|
SURGERY AND CRITICAL CARE AREAS |
|||||
|
Operating/Surgical Cystoscopic Rooms 8,g |
Out |
3 |
15 |
No |
Optional |
|
Delivery Room 8 |
Out |
3 |
15 |
No |
Optional |
|
Recovery Rooms |
- |
2 |
6 |
No |
Optional |
|
Critical Care and Intensive Care |
- |
2 |
6 |
No |
Optional |
|
Newborn intensive care |
- |
2 |
6 |
No |
Optional |
|
Treatment Roomio |
- |
- |
6 |
Optional |
Optional |
|
Trauma Room10 |
Out |
3 |
15 |
No |
Optional |
|
Anesthesia gas storage |
In |
- |
8 |
Optional |
Yes |
|
Endoscopy |
In |
2 |
6 |
No |
Optional |
|
Bronchoscopy 9 |
In |
2 |
12 |
No |
Yes |
|
ER Waiting Room |
In |
2 |
12 |
No |
Yes 11,12 |
|
Triage |
In |
- |
12 |
No |
11 Yes |
|
Radiology waiting rooms |
In |
2 |
12 |
Optional |
11,12 Yes |
|
Procedure room |
Out |
3 |
15 |
No |
Optional |
|
NURSING AREAS |
|||||
|
Patient Room |
- |
2 |
6 |
Optional |
Optional |
|
Toilet Room |
In |
- |
10 |
Optional |
Yes |
|
Newborn Nursery Suite |
- |
2 |
6 |
No |
Optional |
|
Protective environment room 9,14 |
Out |
2 |
12 |
No |
Optional |
|
Airborne Infectious Isolation, Bronchoscopy 9, 15 Room |
In |
2 |
12 |
No |
Yes |
|
Isolation alcove or anteroom |
In/Out |
- |
10 |
No |
Yes |
|
Labor/Delivery/Recovery (LDR) |
- |
2 |
6 |
Optional |
Optional |
|
Labor/Delivery/ Recovery/ Post Partum (LDRP) - |
- |
2 |
613 |
Optional |
Optional |
|
Patient Corridor |
- |
- |
2 |
Optional |
Optional |
|
ANCILLARY AREAS |
|||||
|
Radiology X-ray (Surgical/Critical Care & Catheterization) |
Out |
3 |
15 |
No |
Optional |
|
Radiology X-ray (Diagnostic & Treatment)16 |
- |
- |
6 |
Optional |
Optional |
|
Radiology Darkroom |
In |
- |
10 |
No |
Yes |
|
Lab General |
- |
- |
6 |
Optional |
Optional |
|
Lab Biochemistry |
Out |
- |
6 |
No |
Optional |
|
Lab Cytology |
In |
- |
6 |
No |
Yes |
|
Lab Glass Washing |
In |
- |
10 |
Optional |
Yes |
|
Lab Histology |
In |
- |
6 |
No |
Yes |
|
Lab Microbiology 16 |
In |
- |
6 |
No |
Yes |
|
Lab Nuclear Med |
In |
- |
6 |
No |
Yes |
|
Lab Pathology |
In |
- |
6 |
No |
Yes |
|
Lab Serology |
Out |
- |
6 |
No |
Optional |
|
Lab Sterilizing |
In |
- |
10 |
Optional |
Yes |
|
Autopsy9 |
In |
- |
1712 |
No |
Yes |
|
Nonrefrigerated body holding room |
In |
- |
10 |
Optional |
Yes |
|
Pharmacy |
Out |
- |
4 |
Optional |
Optional |
|
DIAGNOSTIC AND TREATMENT AREAS |
|||||
|
Examination Room |
- |
- |
6 |
Optional |
Optional |
|
Medication Room |
Out |
- |
4 |
Optional |
Optional |
|
Treatment Room |
- |
- |
6 |
Optional |
Optional |
|
Physical Therapy and Hydrotherapy |
In |
- |
6 |
Optional |
Optional |
|
Soiled Workroom or Soiled Holding |
In |
- |
10 |
No |
Yes |
|
Clean Workroom or Clean Holding |
Out |
- |
4 |
Optional |
Optional |
|
STERILIZING AND SUPPLY AREAS |
|||||
|
ETO Sterilizer Room |
In |
- |
10 |
No |
Yes |
|
Sterilizer Equipment Room |
In |
- |
10 |
Optional |
Yes |
|
Central Supply Soiled or Decontamination Room |
In |
- |
6 |
No |
Yes |
|
Central Supply Clean Workroom17 |
Out |
- |
4 |
No |
Optional |
|
Sterile Storage |
Out |
- |
4 |
Optional |
Optional |
|
SERVICE AREAS |
|||||
|
Food Preparation Centers17 |
- |
- |
10 |
No |
Optional |
|
Warewashing |
In |
- |
10 |
No |
Yes |
|
Dietary Day Storage |
In |
- |
2 |
Optional |
Optional |
|
Laundry, General |
- |
- |
10 |
Optional |
Yes |
|
Soiled Linen Sorting and Storage |
In |
- |
10 |
No |
Yes |
|
Clean Linen Storage |
Out |
- |
2 |
Optional |
Optional |
|
Soiled Linen and Trash Chute Room |
In |
- |
10 |
No |
Yes |
|
Bedpan Room |
In |
- |
10 |
Optional |
Yes |
|
Bathroom |
In |
- |
10 |
Optional |
Optional |
|
Janitor's Closet |
In |
- |
10 |
No |
Yes |
Notes for Table 4
1. The ventilation rates in this table cover ventilation for comfort, as well as for asepsis and odor control in areas of acute care hospitals that directly affect patient care and are determined based on healthcare facilities being predominantly "No Smoking" facilities per Ark. Code Ann.§ 20-27-704 et seq.. Where smoking may be allowed, ventilation rates will need adjustment. Areas where specific ventilation rates are not given in the table shall be ventilated in accordance with ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality; and ASHRAE Handbook-HVAC Applications. Specialized patient care areas, including organ transplant units, burn units, specialty procedure rooms, etc., shall have additional ventilation provisions for air quality control as may be appropriate. OSHA standards and/or NI0SH criteria require special ventilation requirements for employee health and safety within healthcare facilities.
2. Design of the ventilation system shall provide air movement which is generally from clean to less clean areas. If any form of variable air volume or load shedding system is used for energy conservation, it shall not compromise the corridor-to-room pressure balancing relationships or the minimum air changes required by the table. Where the air movement relationship is "In (negative) or Out (positive)", the air movement relationship shall not be reversible. Rooms with reversible airflow provision for the purpose of switching between "In" and "Out" are not acceptable.
3. To satisfy exhaust needs, replacement air from the outside is necessary. Table 4 does not attempt to describe specific amounts of outside air to be supplied to individual spaces except for certain areas such as those listed. Distribution of the outside air, added to the system to balance required exhaust, shall be as required by good engineering practice. Minimum outside air quantities shall remain constant while the system is in operation.
4. Number of air changes may be reduced when the room is unoccupied if provisions are made to ensure that the number of air changes indicated is reestablished any time the space is being utilized. Adjustments shall include provisions so that the direction of air movement shall remain the same when the number of air changes is reduced. Areas not indicated as having continuous directional control may have ventilation systems shut down when space Is unoccupied and ventilation is not otherwise needed, if the maximum infiltration or exfiltration permitted in Note 2 is not exceeded and if adjacent pressure balancing relationships arc not compromised. Air quantity calculations shall account for filter loading such that the indicated air change rates are provided up until the time of filter change-out.
5. Air change requirements indicated are minimum values. Higher values should be used when required to maintain indicated room conditions (temperature and humidity), based on the cooling load of the space (lights, equipment, people, exterior walls and windows, etc.).
6. Air from areas with contamination and/or odor problems shall be exhausted to the outside and not recirculated to other areas. Note that individual circumstances may require special consideration for air exhaust to the outside, e.g., in intensive care units in which patients with pulmonary infection are treated, and rooms for burn patients.
7. Recirculating room HVAC units refers to those local units that are used primarily for heating and cooling of air, and not disinfection of air. Because of cleaning difficulty and potential for buildup of contamination, recirculating room units shall not be used in areas marked "No." However, for airborne infection prevention and control, air may be recirculated within Individual isolation rooms if HEP A filters are used. Isolation and intensive care unit rooms may be ventilated by reheat induction units in which only the primary air supplied from a central system passes through the reheat unit. Gravity-type heating or cooling units such as radiators or convectors shall not be used m operating rooms and other special care areas.
8. National Institute for Occupational Safety and Health (NIOSH) Criteria Documents regarding Occupational Exposure to Waste Anesthetic Gases and Vapors, and Control of Occupational Exposure to Nitrous Oxide indicate a need for both local exhaust (scavenging) systems and general ventilation of the areas in which the respective gases are utilized.
9. Differential pressure shall be a minimum of 0.01" water gauge (2.5 Pa). If alarms are installed, allowances shall be made to prevent nuisance alarms of monitoring devices.
10. The term trauma room as used here is the operating room space in the emergency department or other trauma reception area that is used for emergency surgery. The first aid room and/or "emergency room" used for initial treatment of accident victims may be ventilated as noted for the "treatment room." Treatment rooms used for Bronchoscopy shall be treated as Bronchoscopy rooms. Treatment rooms used for cryosurgery procedures with nitrous oxide shall contain provisions for exhausting waste gases.
11. In a ventilation system that recirculates air, HEPA filters can be used in lieu of exhausting the air from these spaces to the outside. In this application, the return air shall be passed through the HEPA filters before it is introduced into any other spaces.
12. If it is not practical to exhaust the air from the airborne infection isolation room to the outside, the air may be returned through HEPA filters to the air-handling system exclusively serving the isolation room.
13. Total air changes per room for patient rooms, labor/delivery/recovery rooms, and labor/deli very/recovery/postpartum rooms may be reduced to 4 when supplemental heating and/or cooling systems (radiant heating and cooling, baseboard heating, etc.) are used.
14. The protective environment airflow design specifications protect the patient from common environmental airborne infectious microbes (i.e., Aspergillus spores). These special ventilation areas shall be designed to provide directed airflow from the cleanest patient care area to less clean areas. These rooms shall be protected with HEPA filters at 99.97 percent efficiency for a 0.3 micron sized particle in the supply airstream. These Interrupting filters protect patient rooms from maintenance-derived release of environmental microbes from the ventilation system components. Recirculation 11EPA filters can be used to increase the equivalent room air exchanges. Constant volume airflow is required for consistent ventilation for the protected environment. It the facility determines that airborne infection isolation is necessary for protective environment patients, an anteroom shall be provided. Rooms with reversible airflow provisions for the purpose of switching between protective environment and airborne infection isolation functions are not acceptable.
15. The infectious disease isolation room described in these guidelines is to be used for isolating the airborne spread of infectious diseases, such as measles, varicella, or tuberculosis. The design of airborne infection isolation (All) rooms should include the provision for normal patient care during periods not requiring Isolation precautions. Supplemental recirculating devices may be used in the patient room, to increase the equivalent room air exchanges; however, such recirculating devices do not provide the outside air requirements. Air may be recirculated within individual isolation rooms if HEPA filters are used. Rooms with reversible airflow provisions for the purpose of switching between protective environment and All functions are not acceptable.
16. When required, appropriate hoods and exhaust devices for the removal of noxious gases or chemical vapors shall be provided per NFPA 99.
17. Food preparation centers shall have ventilation systems whose air supply mechanisms arc interfaced appropriately with exhaust hood controls or relief vents so that exfiltration or infiltration to or from exit corridors does not compromise the exit corridor restrictions of NFPA 90A, the pressure requirements of NFPA 96, or the maximum defined in the table. The number of air changes may be reduced or varied to any extent required for odor control when the space is not in use.
TABLE 6 Dog Behavioral Screening Exam
|
Initial Observation: A room with minimal distraction is an appropriate test area. Allow the dog to investigate this area for several minutes without the tester present. The tester should enter the room, notQspeak, stand still at a discreet distance and observe the dog for about 15 seconds. Record the initial response. |
||
|
ACCEPTABLE |
QUESTIONABLE |
OTHER |
|
Holds Ground |
Crouches |
No response |
|
Approaches Tester |
Hackles Up |
|
|
Hackles Normal |
Lips Puffed |
|
|
Lips Normal |
Moves Stiff-Legged |
|
|
Sniffs Tester |
Growls |
|
|
Retreats |
||
|
Barks |
||
|
Avoids Eye Contact |
||
|
Stares At You |
||
|
Whines |
||
|
TEST 2 |
||
|
Approaching the Dog: After initial brief observation, approach the dog with hand extended at the dog=s nose level, palm and fingers pointed downward. Do not rush in, but do not approach dog in a cautious or apprehensive manner. Walk up to the dog in a normal stride until your hand is within six to 12 inches of the dogs nose. Say nothing and wait for the dog to make the next move. |
||
|
ACCEPTABLE |
QUESTIONABLE |
OTHER |
|
Extends Head or Steps Forward to Sniff Hand |
Turns Head Away or Tries to Ignore Hand |
Stares At You |
|
Seeks Attention by Nudging or Leaning into Tester |
Pulls Back or Retreats |
No Response |
|
Acts Playful by Barks or Actions |
Raises Hackles |
|
|
Licks Hand 9 |
with Playful Barking |
|
|
Lips Puffed |
||
|
Overly Exuberant |
||
|
Bares Teeth (Don't Confuse with grin) |
||
|
TEST 3 |
||
|
Handling the Dog If the dog has not been eliminated by |
||
|
Pulls Back or Retreats |
Meets You, But With Head Lowered and Eyes Averted |
|
|
Growls |
Attempts to Lick Your Face |
|
|
Becomes Playful |
Lips Puffed |
|
|
Enjoys Brushing |
Raises Hackles |
|
|
Quivers or Cowers |
||
|
Barks |
||
|
Rolls Over on Back |
||
|
Submissively Urinates |
||
|
Snaps, Bites |
||
|
Shows Whites of Eyes |
||
|
Overly Exuberant (Jumps Up) |
||
|
Overly Sensitive to Grooming of Certain Areas |
||
|
Aloof |
||
|
TEST 4 |
|
Interacting with the Dog: See if he/she will retrieve a ball. Walk away briskly, sit on floor and call dog. Lay the dog down, then roll him/her over, rub his/her belly. Will he/she allow this subordination? Have a assistant place a novel stimulus such as a large stuffed animal or mirror close behind the dog when he/she is distracted. Does he/she have the self-confidence to investigate? How does the dog react to sudden arm movement? |
|
TEST 5 |
||
|
Sound Sensitivity: While casually interacting with the dog. have an assistant make a loud noise without warning (e.g.. hitting a metal pan with a spoon). |
||
|
ACCEPTABLE |
QUESTIONABLE |
OTHER |
|
Notices, But Continues Previous Activity |
Flees |
|
|
Notices, Investigates |
Cowers |
|
|
Startles, But Recovers Quickly |
Freezes |
|
|
Trembles |
||
|
Urinates |
||
|
Moves As If To Attack |
||
|
TEST 6 |
|
|
Pain Threshold: While playing with dog, briefly pinch the webbing between his/her toes or pull hair from his side to determine pain tolerance. |
|
|
Tries to Pull Away, But Shows Forgiveness |
Growls |
|
Yelps, But is Not Aggressive |
Snaps |
|
Trusts You, Allows Further Petting |
Acts Fearful |
|
Acts Distrustful |
|
|
TEST 7 |
|
Reacting to Unexpected Events (Choose One): Owner is to be present at all times. (Assess response using response categories from Test 5.) |
|
A. Have your assistant hide around a corner, out of sight, with a noisy utility shopping cart. Walk with dog toward the intersection as the assistant rolls the cart in front of the dog as close as possible. Record the dog=s reaction. |
|
B. While the dog is playing with you and is distracted, have the assistant hide in the closet and behind the door. Lead the dog to within six feet of the hiding place and have the assistant suddenly jump out at the dog and open an umbrella. Note reactions. |
|
TEST 8 |
|
Manners: Test the dog for basic obedience commands such as heel and sit-stay. |
TABLE 8 RECORD RETENTION TIME FRAMES
|
DEPARTMENT |
DOCUMENT |
RETENTION TIME |
|
Administrative |
Governing Body |
Permanent |
|
Medical Staff |
Permanent |
|
|
Executive Committee |
Permanent |
|
|
Other Hospital Committees |
2 years |
|
|
Medical Records |
Original/Microfilm Adult/mpatient/Outpatient Electrocardiogram Strips/ Interpretations Electroencephalogram/ Interpretations |
10 years after last discharge plus 2 years past majority. Facility shall maintain information in the master patient index |
|
Minor/Inpatient/Outpatient Electrocardiogram Strips/ Electroencephalogram/ Original/Microfilm Fetal Monitor Strips Interpretations Interpretations |
||
|
Radiology |
Films |
Films |
|
Nuclear Medicine |
Films |
Facility shallt maintain information in the master patient index. |
|
Laboratory |
Blood Gas Reports |
2 years |
|
Patient Specimens |
2 years |
|
|
Control Documentation |
2 years |
|
|
Immunohematology |
5 years |
|
|
Immumohematology Quality Control Records |
5 years |
|
|
Cytology: Histopathology Quality Control Records |
10 years |
|
|
Cytology: Slide Preparation |
5 years |
|
|
Transfusions |
5 years |
|
|
Blood Donor Samples |
7 days post transfusion |
|
|
Quality Assurance |
2 years |
|
Pathology Lab |
Pathology Reports |
10 years |
|
Reference Pathology |
2 years |
|
|
Preliminary/Corrected |
Exact duplicate |
|
|
Histopathology |
Stained Slides |
10 years |
|
Specimen Blocks |
2 years |
|
|
Pharmacy |
All drug records to include: official records purchase invoices Prescription records Inventory records, etc. |
2 years |
TABLE 9
|
REQUIRED TEMPERATURES |
||
|
MEDICATIONS |
Refrigerators |
36-4 F |
|
Medication Storage Room |
59-86 F |
|
|
DIETARY1 |
Temperature of Food at Bedside |
Hot Foods = 140 F |
|
Cold Foods = 40 F |
||
|
Temperature of Heated Food Prior to Hot Holding |
160 F |
|
|
Temperature of Heated Leftovers Prior to Hot Holding |
165 F |
|
|
Temperature for Thawing Potentially Hazardous Food |
Tempering Units = 45 F or less |
|
|
Refrigerator = 40 F or less |
||
|
Refrigerators |
40 F |
|
|
Freezers |
OF |
|
|
Single Tank Stationary Rack Dual Temperature Machine |
Wash Temperature = 150 F |
|
|
Final Rinse Temperature = 180 F |
||
|
Single Tank Conveyor Machine |
Wash Temperature = 160 F |
|
|
Final Rinse Temperature = 180 F |
||
|
Multi-tank Conveyor Machine |
Wash Temperature = 150 F |
|
|
Final Rinse Temperature = 180 F |
||
|
Pumped Rinse Temperature = 160 F |
||
|
Single Tank Pot, Pan & Utensil Washer |
Wash Temperature = 140EF |
|
|
Final Rinse Temperature = 180EF |
||
|
Manual Ware washing |
Wash Temperature = 110EF |
|
|
Rinse Temperature = 120°G - 140°F |
||
|
Chemical Sanitation (Manual or Mechanical) |
Sanitation Temperature = > 171°F or Immersion in 75EF water and 50 ppm of hypochlorite for at least 1 minute or other method approved by Arkansas Department of Health |
|
|
All Cutting Board Surfaces |
Immersion in clean, hot water of > 180°F for at least 30 seconds or any other method approved. |
|
|
LAUNDRY |
Water |
Nothing under 120 F |
|
Water with Chlorine Bleach |
150 parts per million ppm (parts per million) |
|
|
CLINICAL |
Gallons per hour per bed |
105T- 120°F |
Notes:
1. Provisions shall be made to provide 180°F rinse water at ware washer, (may be by a separate booster.)
2. Provisions shall be made to provide 160°F hot water at the laundry equipment when needed. (This may be a steam jet or separate booster heater.) However, this does not imply that all water used would be at this temperature. Water temperatures required for acceptable laundry results will vary. Lower temperatures may be adequate for most procedures in many facilities but the higher 160°F should be available when needed for special conditions.
TABLE 10
Central6 Station Outlets for Oxygen, Vacuum (Suction), and Medical Air Systems in Hospitals and Related Institutions1
|
Location |
Oxygen |
Vacuum |
Medical Air |
|
Patient Rooms (medical & surgical) |
1/bed |
1/bed |
- |
|
Examination/Treatment (medical, surgical, endoscopy & postpartum care) |
1/room |
1/room |
- |
|
Isolation - Infectious and protective (medical & surgical) |
1/bed |
1/bed |
- |
|
Security Room (medical, surgical, & postpartum) |
1/bed |
1/bed |
- |
|
Critical Care (general) |
3/bed |
3/bed |
1/bed |
|
Isolation (critical) |
3/bed |
3/bed |
1/bed |
|
Coronary Critical Care |
3/bed |
2/bed |
1/bed |
|
Pediatric Critical Care |
3/bed |
3/bed |
1/bed |
|
Newborn Intensive Care |
3/bassinet |
3/bassinet |
3/bassinet |
|
Newborn Nursery (full-term) |
2 1/4 bassinets |
2 1/4 bassinets |
2 1/4 bassinets |
|
Pediatric and Adolescent |
1/bed |
1/bed |
1/bed |
|
Pediatric Nursery |
1/bassinet |
1/bassinet |
1/bassinet |
|
Psychiatric Patient Rooms |
- |
- |
- |
|
Seclusion Treatment Room |
- |
- |
- |
|
General Operating Room |
2/room |
3/room |
- |
|
Cardio, Ortho, Neurological |
2/room |
3/room |
- |
|
Orthopedic Surgery |
2/room |
3/room |
- |
|
Surgical Cysto & Endo |
1/room |
3/room |
- |
|
Post-anesthesia Care Unit |
1/bed |
3/bed |
1/bed |
|
Anesthesia Workroom |
1 per workstation |
- |
1 per workstation |
|
3 Phase II Recovery |
1/bed |
3/bed |
- |
|
Postpartum Bedroom |
1/bed |
1/bed |
1/bed |
|
Cesarean/Delivery Room |
2/room |
3/room |
1/room |
|
Infant Resuscitation Statiom |
1/bassinet |
1/bassinet |
1/bassinet |
|
Labor Room |
1/room |
1/room |
1/room |
|
OB Recovery Room |
1/bed |
3/bed |
1/room |
|
5 Labor/Delivery/Recovery (LDR) |
2/bed |
2/bed |
- |
|
5 Labor/Delivery/Recovery (LDRP) |
2/bed |
2/bed |
- |
|
Initial Emergency Management |
1/bed |
1/bed |
- |
|
Triage Area (definitive emergency care) |
1/station |
1/station |
- |
|
Definitive Emergency Care Exam/Treatment Rooms |
1/bed |
1/bed |
1/bed |
|
Definitive Emergency Care Holding Area |
1/bed |
1/bed |
- |
|
Trauma/Cardiac Room(s) |
2/bed |
3/bed |
1/bed |
|
Orthopedic & Cast Room |
1/room |
1/room |
- |
|
Cardiac Catheterization Lab |
2/bed |
2/bed |
2/bed |
|
Autopsy Room |
- |
1 per workstation |
1 per workstation |
Notes for Table 11:
1. For any area or room not described above, the facility clinical staff shall determine outlet requirements after consultation with the authority having jurisdiction.
2. Four bassinets may share one outlet that is accessible to each bassinet.
3. If Phase II recovery area is a separate area from the PACU, only one vacuum per bed or station shall be required
4. When infant resuscitation takes place in a room such as cesarean section/delivery or LDRP, then the infant resuscitation services shall be provided in that room in addition to the minimum service required for the mother.
5. Two outlets for mother and two for one bassinet.
6. Facilities with medical gas requirements in more than one area shall be equipped with central systems.
TABLE 11 VERBAL ORDERS
|
Basic Premise: |
Verbal orders may be used when there is no reasonable alternative to obtaining a written order. |
|
State Health Rules: |
Permit licensed nurses and pharmacist (for drugs only) to take verbal orders and no one else. Section 12, Medications and Section 14, Health Information Services. |
|
Practical Application: |
Health professionals other than nurses may take verbal orders pertaining directly to their profession under specified circumstances |
|
Situation to Address: |
1. Doctor in the department away from nurses' station. 2. Doctor calls the department |
|
Policy Statement Parts: |
1. Who are the authorized receivers? 2. Repeat order back for accuracy. 3. Identify ordering doctor. 4. Identify receiver by name and title. 5. The receiver of the order must enter the order on the medical record, and then sign first initial, last name and title. |
|
Hospital Administration Responsibility: |
1. Policy must be in writing, and approved by the Medical Staff and Governing Body (including identification of receivers). 2. Policy must be made a part of applicable department manuals. 3. Inservice training provided for all personnel involved. 4. Establish an effective monitoring system. |
|
Outpatient Department (Emergency Services is Not outpatient): |
1. The therapist or other authorized receivers may take a verbal or telephone order from the doctor. 2. Must document on outpatient medical record. 3. Doctor must authenticate the order on his next visit. |
RATIONALE
The Division of Health Facility Services has received numerous requests for a variance in the regulations relating to who may receive doctors orders for hospital inpatients and outpatients. This office realizes the communication problems involved between every expanding service departments of hospitals and the multiplicity of diagnostic treatment, therapy, and therapeutic duties necessary for coordinating of patient care. Other certification and accrediting organizations have also realized the communication difficulty.
The reason and intent of the regulation was, and still is, to coordinate all inpatient care through nursing service. The patients' medical record must be maintained at the nurses' station to coordinate and implement physician orders for patient care and services.
It is the intent of this policy to have both communication between departments and also assure all physician orders and services rendered to patients are promptly documented on the patients chart. In order to maintain continuity of care on an inpatient basis, it is necessary that all aspects of the patients' treatment be coordinated through the nursing service of the facility.
TABLE 12 THIRD PARTY REPROCESSING OF SINGLE USE ITEMS
The Office of Compliance Center of Devices and Radiological Health of the Food and Drug Administration (FDA) provides guidelines for third party reprocessing of devices labeled for single use provided the reprocessing firm complies fully with all FDA regulatory requirements.
The Arkansas Department of Health will recognize FDA guidelines.
--------------------------------------------------------------------METHODS FOR DISPOSAL------------------------------------------------------------------
A. Managed in such a manner that final disposition shall be a sanitary landfill in accordance with the most current ADPC&E Solid Waste Management Codes. Liquids are prohibited in solid waste landfills.
B. Discharge at the health care related facility into a POTW.
C. Interment in accordance with mortuary regulations and may involve cremation service.
Disclaimer: These regulations may not be the most recent version. Arkansas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
