Current through Register Vol. 49, No. 9, September, 2024
SECTION 1
: PREFACE. These Rules
and Regulations have been prepared for the purpose of establishing criteria for
minimum standards for licensure, operation and maintenance of Abortion
Facilities. By necessity they are of a regulatory nature but are considered to
be practical minimum design and operational standards for their facility type.
These standards are not static and are subject to periodic revisions. It is
expected Abortion Facilities will exceed these 'minimum requirements and will
not be dependent upon future revisions as a necessary prerequisite for improved
services.
SECTION 2
:
AUTHORITY. These Rules and Regulations for Abortion Facilities 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 509 of 19S3.
SECTION
3
: DEFINITIONS.
Abortion -the purposeful termination of a human
pregnancy by any person with an intention other than to produce a live birth or
to remove a dead unborn fetus.
(1) An
abortion procedure may be performed in an Abortion Facility during the first
twenty (20) weeks of a woman's pregnancy; and
(2) After the twentieth
(20th) week of a woman's pregnancy, an abortion
procedure must be performed in a hospital licensed by the Arkansas Department
of Health.
Abortion Facility - any facility maintained for the primary
purpose of providing care in the purposeful termination of human pregnancies
with an intention other than to produce a live birth.
Act-Act 509 of 1983.
Administrator - an individual designated to provide daily
supervision and administration of the Abortion Facility.
Consent - a signed and witnessed voluntary
agreement for the performance of an abortion.
Department - the Arkansas Department of
Health.
Division - the Division of Health Facility
Services.
Director - the Chief Administrative Officer in the
Division of Health Facility Services.
Hospital - Any acute care facility established for
the purpose of providing inpatient diagnostic care and treatment.
Patient - any woman receiving services in the
facility.
Registrant - the individual, partnership, or corporation on
whom rests the primary responsibility for maintaining approved standards in the
facility.
SECTION
4
: LICENSING.
A.
Application for License. Application for a license or renewal of a license for
an Abortion Facility shall be made to the Arkansas Department of Health on
forms provided by the Division of Health Facility Services. The application
shall set forth the complete name and address of the Abortion Facility for
which the license is sought and any additional information as required by the
Arkansas Department of Health.
B.
Availability of Emergency Services. The Abortion Facility shall be within
thirty (30) minutes of a hospital which provides gynecological or surgical
services.
C. Fee. In accordance
with Section 5 of Act 891 of 1997, each application for initial licensure of an
Abortion Facility shall be accompanied by a fee of one thousand dollars
(S1000). The fee shall be payable to die Arkansas Department of
Health.
D. Renewal of License. A
license, unless revoked, shall be renewable annually upon payment of a fee of
one thousand dollars (SI 000) to the Arkansas Department of Health accompanied
by an application for relicensure. The application for annual license renewal
along with the fee shall be postmarked no later than January 2 of the year for
which the license is issued.
E.
Issuance of License. A license shall be issued only for the premises and person
or persons reflected in the application and shall be posted in a conspicuous
place in the Abortion Facility. The license shall be effective on a calendar
year basis and shall expire on December 31 of each calendar year. The license
shall not be transferrable and shall expire if a change of ownership
occurs.
F. Change of Ownership. It
shall be the responsibility of the Abortion Facility to notify the Division of
Health Facility Services in writing at least thirty (30) days prior to the
effective date of a change of ownership. The following information shall be
submitted for review and approval:
1. License
application;
2. One thousand
dollars (S1000) change of ownership fee; and
3. Legal documents, ownership agreements, and
otherinformation to support relicensure requirements.
G. Management Contract. It shall be the
responsibility of the Abortion Facility to notify the Division of Health
Facility Services in writing at least thirty (30) days prior to entering into a
management contract or agreement with an organization or firm. A copy of the
contract or agreement shall be submitted for review to assure the arrangement
does not effect the license status.
H. Closure. Once an Abortion Facility closes,
it shall no longer be considered licensed. The license issued to the Abortion
Facility shall be returned to the Division of Health Facility Services. To be
eligible for relicensure, the Abortion Facility shall meet requirements for new
construction and all the current life safety and health regulations.
I. Inspection. Any authorized representative
of the Arkansas Department of Health shall have the right to enter upon or into
the premises of any Abortion Facility at any time in order to make whatever
inspection it deems necessary in order to assure minimum standards and
regulations are met.
SECTION
5
: GOVERNING BODY. An Abortion Facility shall have
an organized Governing Body, consisting of at least one (1) member, which may
be the Medical Director, with local representation which shall be legally
responsible for maintaining patient care and establishing policies for the
facility and shall be legally responsible for the conduct of the facility.
A. The Governing Body Bylaws. The Governing
Body shall adopt written bylaws which shall ensure the following:
1. Maintenance of professional standards of
practice;
2. Terms,
responsibilities and methods of selecting members and officers;
3. Methods by which Quality Improvement is
established; and
4. Compliance with
federal, state and local laws.
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, rules, regulations and protocols;
2. Review and approval of the Quality
Improvement Plan for the facility at least annually, and review of Quality
Improvement summaries at least quarterly.
C. Quality Improvement (QI) Program.
1. The Abortion Facility shall develop,
implement, and maintain a QI program to include:
a. Collection of data on the functional
activities identified as priorities in QI and benchmark against past
performance and national or local standards; and
b. Development and implementation of
improvement plans for identified issues, with monitoring, evaluation and
documentation of effectiveness.
2. The scope of the QI Program shall include,
but not be limited to, activities regarding the following:
a. Assessment of processes and outcomes
utilizing facility-specific clinical data;
b. Evaluation of patient
satisfaction;
c. Evaluation of
staff performance according to facility protocols; and;
d. Complaint resolution;
3. The facility shall evaluate the
effectiveness of the QI Program annually and establish priorities for the QI
Program.
SECTION
6
: GENERAL ADMINISTRATION.
A. Each facility shall have an Administrator
responsible for the management of the facility. The Medical Director may also
function as facility administrator.
B. Policies and procedures shall be provided
for the general administration of the facility and for each service. All
policies and procedures shall have evidence of ongoing review and/or revision.
The first page of each manual shall have the annual review date and signatures
of the person(s) conducting the review.
C. Provisions shall be made for safe storage
of patients' valuables.
D. Each
facility shall develop and maintain a written disaster plan which includes
provisions for complete evacuation of the facility. The plan shall provide for
widespread disasters as well as for a disaster occurring within the local
community or the facility. The disaster plan shall be rehearsed at least twice
a year. One (1) drill shall simulate a disaster of internal nature and the
other external. Written reports and evaluation of all drills shall be
maintained.
E. There shall be
posted a list of names, telephone numbers, and addresses available for
emergency use. The list shall include the key facility 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 (6) months.
F.
There shall be current reference material available onsite to meet the
professional and technical needs of Abortion Facility personnel including
current books, periodicals, and other pertinent materials.
G. All employees shall be required to have
annual inservices on safety, fire safety, back safety, infection control,
standard precautions, disaster preparedness and confidential
information.
H. Procedures shall be
developed for the retention and accessibility of the patients' medical records
if the Abortion Facility closes.
I.
Any Abortion Facility 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 referenced National
Fire Codes (NFPA) and health regulations shall be met.
J. Written consent for the performance of an
induced abortion must be obtained and signed by the patient prior to the
procedure and after counseling by a qualified professional. Written or verbal
consent shall not release the facility or its personnel from upholding the
rights of patients including, but not limited to, the right to privacy,
dignity, security, confidentiality, and freedom from abuse or
neglect.
K. Each facility shall
have a Medical Director who shall be a physician currently licensed to practice
medicine in Arkansas, and who shall be responsible for the direct coordination
of all medical aspects of the facility program.
L. There shall be written policies and
procedures developed and approved by the Medical Director and Administrator
which define the care provided at the facility.
M. Policies and procedures shall include, but
not be limited to the following:
1. Personnel
policies; +-
2.
Provision of medical and clinical services;
3. Provision of laboratory
services;
4. Examination of fetal
tissue;
5. Disposition of medical
waste;
6. Emergency
services;
7. Criteria for
discharge;
8. Medical
records;
9. Medication
administration;
10.
Anesthesia/analgesia/sedation administration;
11. Counseling services;
12. Patient education;
13. Infection control, including
post-operative surveillance;
14.
Fire, safety, and disaster preparedness;
15. Housekeeping;
16. Laundry;
17. Preventive maintenance; and
18. Processing and/or storage of sterile
supplies.
SECTION
7
: PATIENT CARE SERVICES. An Abortion Facility shall
have an adequate number of personnel qualified under this section available to
provide direct patient care as needed.
A.
Qualifications.
1. Only physicians who are
currently licensed to practice medicine in Arkansas may perform abortion
procedures.
2. All facility
personnel, medical and others, shall be licensed to perform the services they
render when such services require licensure under the laws of the State of
Arkansas. Documentation of current licensure shall be maintained in the
personnel file for each employee.
3. Providers of patient counseling shall, at
a minimum, possess current licensure as a nurse, Social Worker, or documented
experience an training in a related field. Special training in counseling which
is deemed acceptable by the Department shall be required.
4. All clinical staff of the facility shall
be required to provide documentation of training and continued competence in
cardiopulmonary resuscitation (CPR) or its equivalent.
B. Staffing Requirements.
1. There shall be a sufficient number of
Registered Nurses in the facility at all times when patients are
present.
2. Registered Nurses shall
be on duty to supply or supervise all nursing care of patients in preparation,
during the abortion procedure, during the recovery period, and until discharge
by the attending physician.
C. Authority and responsibilities of all
patient care staff shall be clearly defined in written policies.
D. Services shall be organized to ensure
management functions are effectively conducted. These functions shall include,
but are not limited to:
1. Review of policies
and procedures at least annually to reflect current standards of
care;
2. Establishment of a
mechanism for review and evaluation of care and services provided at the
facility;
3. Orientation and
maintenance of qualified staff for provision of patient care;
4. Provision of staff development, including
at least twelve (12) inservice education programs for professional staff
annually; and
5. Provision of
current nursing literature and reference materials.
E. Patients shall have access to twenty-four
(24) hour telephone consultation with either a Registered Nurse or physician
associated with the facility.
F. A
Registered Nurse shall plan, supervise, and evaluate the nursing care of each
patient from admission to the facility through discharge.
G. Counseling services shall be provided for
each patient, as follows:
1. Prior to the
procedure, the patient shall be counseled regarding the abortion procedure,
alternatives to abortion, informed consent, medical risks associated with the
procedure, potential post-operative complications, community resources and
family planning;
2. Documentation
of counseling shall be included in the patient's medical record;
3. If counseling is performed in groups, the
patient shall be offered an opportunity to meet privately with a qualified
counselor;
4. Each patient shall be
assessed by a Registered Nurse for counseling needs postprocedure;
5. Written instructions for post-procedure
care shall be given to the patient at discharge, to include at least the
following:
a. Signs and symptoms of possible
complications;
b. Activities
allowed and to be avoided;
c.
Hygienic and other post-discharge procedures to be followed;
d. Abortion Facility emergency telephone
numbers available on a twenty-four (24) hour basis; and e. Follow up
appointment, if indicated.
6. The patient shall be counseled regarding
Rh typing and shall be given Rh immune globulin, if indicated.
'r'
SECTION 8
: PROGRAM
REQUIREMENTS.
A. Admission Evaluation.
Every woman seeking to have an abortion shall be registered by the facility and
evaluated by means of a history, physical examination, counseling, and
laboratory tests.
1. Verification of
Pregnancy. Pregnancy testing shall be available to the patient and may precede
actual registration by the facility. No abortion shall be performed unless the
examining physician verifies the patient is pregnant. Pregnancy test results
shall be filed in the patient's medical record.
2. History and Physical Examination. Prior to
the abortion, a medical history shall be obtained and recorded. The patient
shall be given an appropriate physical examination, as determined by the
physician, which may include testing for sexually transmitted diseases. The
facility shall report positive test results for sexually transmitted diseases
to the Department of Health, as required. Pelvic examinations shall be
performed only by qualified personnel, as defined by their Practice
Acts.
3. Pre-procedure Tests. The
following are required prior to an abortion procedure: hematocrit or
hemoglobin, Rh typing, and onsite proof of pregnancy, such as pregnancy test,
copy of a pregnancy test or ultrasound. Other testing may be performed
according to facility policy.
4.
Counseling. Patient counseling services shall be offered prior to initiation of
any abortion procedure and if indicated following the procedure. In addition to
verbal counseling, patients shall be given and allowed to keep printed
materials.
B. Transfer.
The Abortion Facility shall have written procedures for emergency transfer of a
patient to an acute care facility.
C. Operative Procedures. Only physicians
licensed to practice medicine in Arkansas shall order diagnostic tests,
medications, or perform abortions.
1.
Anesthetic agents shall be administered only by a physician qualified to
administer anesthetic agents or by a Certified Registered Nurse Anesthetist
(CRNA).
2. Discharge criteria,
developed by the clinical staff and approved by the Governing Body, may be
utilized to evaluate patients' medical stability for discharge. Patients may be
discharged only on the order of a physician. Patients receiving sedation shall
be discharged in the company of a responsible adult.
D. Complications. Emergency drugs, oxygen and
intravenous fluids shall be available to stabilize the patient's condition,
when necessary. An ambu bag, suction equipment and endotracheal equipment shall
be located in the clinical area for immediate access. All clinical staff shall
have documented current competency in cardiopulmonary resuscitation
(CPR).
E. Report of Induced
Termination. In accordance with Act 120 of 1981, each induced termination of
pregnancy which occurs in Arkansas shall be reported to the Division of Health
Statistics on a monthly basis by the person in charge of the Abortion Facility
in which the induced termination of pregnancy was performed.
F. Denial, Suspension or Revocation of
Registration. Registration does not guarantee adequacy of individual care,
treatment, personal safety, fire safety or the well-being of any patient of
arKA.bortion Facility. The Department may deny, suspend or revoke registration
on the following grounds: violation of any of the provisions of the Act or
Rules and Regulations lawfully promulgated hereunder; and/or conduct or
practices detrimental to the health or safety of patients and employees of any
such facilities. This provision shall not be construed to have any reference to
healing practices authorized by law.
SECTION 9
: HEALTH INFORMATION
SERVICES. The Abortion Facility shall maintain a system for the
completion and storage of the medical record. The record shall provide a format
for continuity and documentation of legible, uniform, complete, and accurate
patient information readily accessible and maintained in a system that ensures
confidentiality.
A. General Requirements.
1. The Abortion Facility shall adopt a record
form for use that contains information required for transfer to an acute care
facility.
2. Record reviews with
criteria for identification of problems and follow up shall be reported to the
Medical Director at least quarterly.
3. Responsibility for the processing of
records is assigned to an individual employed by the Abortion
Facility.
4. All medical records
shall be retained in either the original, microfilm, or other acceptable
methods for ten (10) years after the last discharge.
5. The original or a copy of the original
(when the original is not available) of all reports shall be filed in the
medical record.
6. The record shall
be permanent and shall be either typewritten or legibly written in blue or
black ink.
7. All typewritten
reports shall include the date of dictation and the date of
transcription,
8. All dictated
records shall be transcribed within forty-eight (48) hours.
9. Errors shall be corrected by drawing a
single line through the incorrect data, labeling it as "error", initialing, and
dating the entry.
10. Policies and
procedures for Health Information Services shall be developed. The manual shall
have evidence of ongoing review and/or revision. The first page of the
manual(s) shall have the annual review date and signatures of the person(s)
conducting the review.
11. Medical
records shall be protected to ensure confidentiality, prevent loss, and ensure
reasonable availability.
12. All
medical records, whether stored within the facility or away from the facility
shall be protected from destruction by fire, water, vermin, dust,
etc.
13. Medical records shall be
considered confidential. All medical records (including those filed outside the
facility) shall be secured at all times. Records shall be available to
authorized personnel from the Arkansas Department of Health.
14. Written consent of the patient or legal
guardian shall be presented as authority for release of medical information.
There shall be policies and procedures developed concerning all phases of
release of information.
15.
Original medical records shall not be removed from the facility except upon
receipt of a subpoena duces tecum by a court having authority for issuing such
an order.
16. Medical records shall
be complete and contain all required signed documentation no later than thirty
(30) days following the patient's discharge.
17. After the required retention period,
medical records may be destroyed by burning or shredding. Medical records shall
not be disposed of in landfills or other refuse collection sites.
18. Each entry into the medical record shall
be authenticated by the individual who is the source of the information.
Entries shall include all observations, notes, and any other information
included in the record.
19.
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.
20.
There shall be policies and procedures approved by the Arkansas Department of
Health for use of computerized medical record.
B. Record Content. Each record shall include
but not be limited to documentation of:
1.
Demographic and patient information;
2. Informed consent;
3. Complete family, medical, social,
reproductive, nutrition, and behavioral history if pertinent to the procedure
performed;
4. Initial physical
examination, evaluation of risk status, and laboratory test results;
5. Appropriate referral of patients, as
indicated;
6. Documentation of each
periodic examination;
7. Patient
counseling regarding the abortion procedure, alternatives to abortion, informed
consent, medical risks associated with the procedure, potential postoperative
complications, available community resources, and family planning;
8. Patient education regarding post-procedure
signs and symptoms of possible complications, activities allowed and to be
avoided, hygienic and other post-discharge procedures to be followed, telephone
numbers to access emergency care, and follow-up appointments; and
9. Operative and post-operative
records.
SECTION
10
: INFECTION CONTROL FOR ABORTION FACILITIES.
A. General.
1. The facility shall develop and use a
coordinated process that effectively reduces the risk of endemic and epidemic
nosocomial infections in patients, and health care workers.
2. The facility shall follow standard Center
for Disease Control and Prevention (CDC) precautions.
3. There shall be policies and procedures
establishing and defining the Infection Control Program, including:
a. Definitions of nosocomial infections which
conform to the current CDC definitions;
b. Methods for obtaining reports of
infections in patients and health care workers in a manner and time sufficient
to limit the spread of infections;
c. Measures for assessing and identifying
patients and health care workers at risk for nosocomial infections and
communicable diseases;
d. Measures
for prevention of infections;
e.
Provisions for education of patients concerning infections;
f. Plans for monitoring and evaluating all
aseptic and sanitation techniques employed within the facility to ensure
approved infection control procedures are followed;
g. Techniques for:
1) Handwashing;
2) Scrub technique;
3) Asepsis;
4) Sterilization;
5) Disinfection;
7)
Linen care;
8) 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;
9) Policy for disposal of products of
conception;
10) Sharps and needle
disposal;
11) Separation of clean
from dirty processes; and
12) Other
means of limiting the spread of contagion.
h. A requirement that disinfectants,
antiseptics, and germicides be used in accordance with the manufacturer's
directions;
i. Employee
health;
4. There shall be
an orientation program for all new health care workers concerning the
importance of infection control and each health care worker's responsibility in
the facility's Infection Control Program.
5. There shall be a plan for each employee to
receive annual inservices and educational programs, as indicated, based upon
assessment of the infection control process.
B. Employee Health.
1. The facility shall develop policies and
procedures fox screening health care workers for communicable diseases and
monitoring health care workers exposed to patients with any communicable
diseases.
2. There shall be
policies regarding health care workers with infectious diseases or carrier
states. The policies shall clearly state when health care workers shall not
render direct patient care.
NOTE: Health care workers employed by the facility who are
afflicted with any disease in a communicable stage, or while afflicted with
boils, jaundice, infected wounds, diarrhea, or acute respiratory infections,
shall not work in any area in any capacity in which there is a likelihood of
such person contaminating food, food contact surfaces, supplies, or any surface
with pathogenic organisms or transmitting disease to patients, facility
personnel or other individuals within the facility.
3. There shall be a plan for ensuring that
each health care worker has an annual tuberculosis skin test or is evaluated in
accordance with guidelines approved by the Arkansas Department of
Health Rules and Regulations Pertaining to
Communicable Disease; Section 11 Section 13 - Arkansas
Department of Health Tuberculosis Program Amendment
22394 Adopted in February, 1994.
4. There shall be a plan for ensuring that
all health care workers who are frequently exposed to blood and other
potentially infectious body fluids are offered immunizations for hepatitis
B.
SECTION
11: PHARMACEUTICAL SERVICES.
A. Organization.
1. Abortion Facilities shall have provisions
for pharmaceutical services regarding the procurement, storage, distribution
and control of all medications. The Abortion Facility shall be in compliance
with all state and federal regulations.
2. Pharmaceutical services shall be under the
direction of a licensed pharmacist if required by State law. In case the
Abortion Facility does not require a licensed pharmacist, the Medical Director
shall assume the responsibility of directing Pharmaceutical Services. A
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. The pharmacist or Medical Director shall
make provisions that shall include, but not be limited to:
a. Development and implementation of pharmacy
policies and procedures;
b. Annual
review and revisions of pharmacy policies and procedures, with documentation of
dates of review;
c. Maintenance of
medications in the Abortion Facility to meet the needs of the population
served:
d. Maintenance of
medications in the Abortion Facility to ensure accountability; and
e. Proper storage of
medications.
B. Staffing. Pharmaceutical services shall be
provided by a licensed pharmacist or Medical
Director as required by State law. If the service is provided
by a consulting pharmacist, it may be done so on a consulting basis. Onsite
consultation by the pharmacist shall be required at least monthly.
Documentation of each consultation visit shall be recorded and maintained at
the Abortion Facility. Documentation of each visit shall include compliance
with, but not be limited to:
1. Proper
storage of drugs;
2. Disposal of
medications no longer needed, discontinued, or outdated;
3. Proof of receipt and administration of
controlled substances and proper storage of such medications;
-I C
4. Verification that medications in stock
conform to the specified quantities on posted lists;
5. Proper labeling; and
6. Maintenance of emergency carts or kits.
If the service is under the direction of the Medical Director,
he/she may designate the above required monthly documentation to a licensed
nurse.
C.
Policies and Procedures. There shall be pharmacy policies and procedures to
include, but not be limited to:
1. Detailed
job description of the licensed pharmacist and/or Medical Director;
2. Procurement of medications;
3. Distribution and storage of
medications;
4. A listing of stock
medications with minimum and maximum quantities to b.e maintained in the
Abortion Facility;
5. A listing of
medications with exact quantities to be maintained in emergency kits;
6. Destruction of deteriorated, non-sterile,
unlabeled, or damaged medications;
7. Listing controlled substances to be
destroyed on the proper forms and either sending a copy of the form with the
medications to the Arkansas Department of Health by registered mail or
delivering the form and medications in person;
8. Maintenance of all drug records for a
minimum of two (2) years;
9.
Maintenance of medications brought to the Abortion Facility;
10. Drug recalls;
11. Reporting of adverse drug reactions and
medication errors to the attending physician and the Governing Body;
12. Accountability of controlled
substances;
13. Reporting of
suspected drug loss, misuse, or diversion, according to state law;
and
14. Use of Automatic Medication
Dispensing Devices, if applicable.
D. Drug storage and security. Medications
maintained at the Abortion Facility shall be properly stored and safeguarded to
ensure:
1. Locked storage of all
medications;
2. Proper lighting and
ventilation, as required by the manufacturer;
3. Proper temperature controls with daily
temperature documentation of medication refrigerators to ensure storage between
thirty-six (36) and forty-six (46) degrees Fahrenheit, or two (2) to eight (8)
degrees Centigrade;
4. Separate
storage of biologicals and medications from food;
5. Accessibility to licensed personnel only;
and
6. Proper use of any Automatic
Medication Dispensing Devices.
E. Controlled Substances. The following shall
be adhered to in the maintenance of controlled substances in the Abortion
Facility:
1. Controlled drugs shall be double
locked;
2. A record of the
procurement and disposition of each controlled substance shall be maintained in
the Abortion Facility and be readily retrievable. Each entry on the disposition
record shall reflect the actual dosage administered to the patient, the
patient's name, date, time, and signature of the licensed person administering
the medication. The signature shall consist of a first initial, last name, and
title. (Licensed personnel who may legally administer controlled substances
shall include only those personnel authorized by their current Practice Act and
licensed by the Arkansas State Medical Board or Arkansas State Board of
Nursing.) 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 medication from the double locked security is not the licensed
person who administers the medication, then both persons shall sign the
disposition record;
3. When
breakage or wastage of a controlled substance occurs, the amount given and
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 how the medication was wasted. In addition
to the above referenced licensed personnel, 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, Division of Pharmacy Services and Drug Control
for destruction;
4. There shall be
an audit each shift change of all controlled substances stocked in the Abortion
Facility which shall be recorded by an oncoming nurse and witnessed by an
off-going nurse. If only one (1) shift exists, an audit shall be conducted at
the opening and closing of the abortion facility daily. If discrepancies are
noted, the Director of Nursing, Pharmacy Consultant and/or Medical Director
shall be notified. As with the witnessing of wastage, licensed pharmacists
shall be allowed to witness controlled substance audits;
5. Records generated by Automatic Dispensing
Devices shall comply with these requirements.
F. Medications.
1. All verbal or telephone orders for
medications shall be received by a licensed nurse or Registered Pharmacist and
reduced to writing into the patient's medical record. Verbal or telephone
orders shall be countersigned by the practitioner within twenty-four (24)
hours. Signed facsimile orders are acceptable, provided the facsimile paper is
of a permanent nature.
2. The
Abortion Facility may procure medications for its patients through community
pharmacists, or medications may be procured through the facility's
physician.
SECTION
12
: PHYSICAL FACILITIES, ABORTION FACILITIES.
A. Definitions.
1. Accessible - barrier free; approachable by
all peoples including those with physical disabilities.
2.
Addition - an extension or
increase in floor area and/or height of an existing building, or
structure.
3.
Alter or
Alteration - any change(s) and modification in construction,
occupancy, installation, or assembly of any new structural components, and any
change(s) to the existing structural component, in a sysiem, building, and
structure.
4.
And/Or
(in a choice of two (2) code provisions) - signifies use of both
provisions shall satisfy the code requirements and use of eitherjprovision is
acceptable, also. The most restrictive provision shall govern. Where there is a
conflict between a
* general requirement and a specific requirement, the specific
or restrictive requirement shall be applicable.
5. Architect - a duly registered professional
licensed by the Arkansas State Board of Architects to use the title
"architect."
6. Corridor - a
passage way into which compartments or rooms open and which is enclosed by
partitions and/or walls and a ceiling, or a floor/roof deck above.
7. Engineer - duly registered professional
licensed by the Arkansas Board of Registration for Professional Engineers and
Land Surveyors to use the title
"engineer.'1
8. New construction - the assembly of a new
free standing structure.
9.
Renovation - construction performed within an existing facility.
10. Room - a separate, enclosed space, with
doorway(s), for the one (1) named function.
11. Toilet - a room designed exclusively for
a water closet and lavatory.
B. Plan Review. Plans for all new
construction and/or alterations shall include site requirements, preliminary
drawings, submission of plan review fee, final construction documents, letter
of approval for construction documents, site observation and final site
observation.
1. No new mechanical,
electrical, plumbing, fire protection, or medical gas system shall be
installed, nor any such existing system materially altered or extended, until
complete drawings and specifications for installation, alteration, or
extensions have been submitted to the Division for review and
approval.
2. Site Requirements.
a. The site location shall be easily
accessible to the community and to service vehicles such as fire protection
apparatus.
b. The Abortion Facility
shall have security measures for patients, personnel, and the public consistent
with the conditions and risks inherent in the location of the facility.
c. Site utilities shall be
reliable (water, natural gas, sewer, electricity and communication). The water
supply shall have the capacity to provide normal usage plus fire fighting
requirements. The electricity shall be of stable voltage and
frequency.
d. The site shall afford
good drainage and shall not be subject to flooding.
e. Soil bearing capacity shall be sufficient
to support the building and paved areas.
f. Paved access roads and walks shall be
provided within the boundary of the property to public service and emergency
entrances.
g. Paved parking spaces
shall be provided to satisfy the needs of patients, employees, staff, and
visitors. In the absence of a formal parking study, each facility shall provide
not less than one (JJ space for each day shift staff member and employee plus
one (1) space for each patient bed/recliner. Parking spaces shall be provided
for emergency and delivery vehicles.
3. Preliminary Drawings. Schematic drawings
for the Abortion Facility shall be submitted to the Division. These drawings
shall illustrate a basic understanding of the architectural, mechanical,
electrical and plumbing systems. Schematic drawings shall include schematic
plans, building sections, exterior elevations (all *a. sides), preliminary
finish schedule, and general notes. Code criteria shall be submitted that is
specific to the proposed facility and exhibits a knowledge of the building and
fire code requirements including but not limited to construction type, fire
protection ratings, means of egress and smoke compartmentalizarion. Drawings
shall be at a scale to clearly represent the intent. A graphic and or written
scale and directional arrow shall be on each drawing.
4. Submission of Plan Review Fee. A plan
review fee in the amount of one (1) percent of the total cost of construction
or five hundred dollars (S500.00). whichever is less, shall be paid for the
review.of drawings and specifications. The plan review fee check is to be made
payable to the Division of Accounting. Arkansas Department of Health. A
detailed estimate must accompany the plans unless the maximum fee of
five-hundred dollars (S5J30.00) is paid. The Division will coordinate review of
plans for all Arkansas Department of Health offices.
5. Final Construction Documents.
a. Plans and specifications shall be prepared
by an architect and or engineer licensed by the State of Arkansas. The
architect and engineer shall prepare and submit construction documents with the
respective seals for each professional discipline. Architectural construction
documents shall be prepared by an architect, and engineering (mechanical,
electrical, civil and structural) construction documents shall be prepared by
an (mechanical, electrical, civil and structural) engineer. Periodic
observations of construction shall be provided and documented by each design
professional to assure that the plans and specifications are followed by the
contractor, and that ":as build" prints are kept
current. The interval for periodic observation shall be determined and approved
by the Division prior to beginning construction.
b. Working drawings and specifications shall
be prepared in a manner that clearly defines the scope of the work and is
consistent with the professional standard of practice for architects and
engineers. Working drawings and specifications shall be complete for contract
purposes.
c. Final construction
documents shall be reviewed and approved by the Division prior to the beginning
of construction. The Division shall have a minimum of six (6j weeks to review
final construction documents after which time an approval letter shall be
issued. Plan review with other Health Department Divisions shall be coordinated
by the Division.
6. Site
Observation During Construction. The Abortion Facility shall be observed during
construction and before occupancy .
a. The
Division shall be notified when construction begins and a construction schedule
shall be submitted to determine inspection dates.
b. Representatives from the Division shall
have access to the construction premises and the construction project for
purposes of making whatever inspections deemed necessary throughout the course
of construction.
c. Any deviation
from the approved construction documents shall not be permitted until a written
construction addenda or change order is approved by the Division.
7. Final Site Observation.
a. Upon completion of construction and prior
to occupancy approval by the Division, the owner shall be furnished one (1)
complete set of contract documents, plans and specifications showing all
construction, fixed equipment, and mechanical and electrical systems as
installed or built. In addition, the owner shall be furnished a complete set of
installation, operation, and maintenance manuals and parts lists for the
installed equipment.
b. No Abortion
Facility shall occupy any new construction, addition, renovation and'or
alteration until approval has been granted from all city, county, and other
state regulatory agencies in addition to the Division.
C. General Considerations.
1. The requirements set forth herein have
been established as minimum requirements for new construction, addition(s),
renovation(s) and alteration(s) in Abortion Facilities requiring licensure
under these regulations.
2.
Abortion Facilities undertaking new construction, an_ addition, renovation,
and/or alteration shall minimize disruption of existing functions. Access,
exits and fire protection shall be maintained for occupancy safety.
3. The building and equipment shall be
maintained in a state of good repair at all times.
4. The premises shall be kept clean, neat,
free of litter and rubbish.
D. Codes and Standards.
1. Nothing stated herein shall relieve the
owner from compliance with building, fire, subdivision and zoning codes,
ordinances, and regulations of city, county and other state agencies.
2. Compliance with referenced codes and
standards shall be that of the latest edition(s).
3. Accessibility requirements shall be those
set forth by the Arkansas State Building Services, Minimum Standards and
Criteria - Accessibility for the Physically Disabled Standards.
4. Electrical Systems. Electrical devices
shall be installed in accordance with NFPA 70, National Electrical
Code.
5. Mechanical Systems.
a. HVAC systems shall be installed in
accordance with the Arkansas State Mechanical Code.
b. Air ventilation and filtering requirements
shall be in accordance with ASHRAE Standard 62, Ventilation for Acceptable
Indoor Air Quality and ASHRAE 52, Filter Efficiencies.
6. Plumbing and Gas Systems.
a. Plumbing systems shall be installed in
accordance with the Arkansas State Plumbing Code.
b. Gas systems shall be installed in
accordance with the Arkansas State Gas Code.
7. New Abortion Facilities shall meet the
criteria of NFPA 101, Life Safety Code, Chapter 26, New Business Occupancies.
Existing buildings proposed for use as Abortion Facilities shall meet the
criteria of NFPA 101, Life Safety Code, Chapter 27, Existing Business
Occupancies. Both new Abortion Facilities and existing buildings proposed for
use as Abortion Facilities shall meet the following additional requirements:
a. Emergency lighting shall be connected to
rechargeable back-up (ninety (90) minute minimum duration) batteries as a means
of emergency illumination for procedure rooms, corridors, stairways, exit signs
and at the exterior of each exit.
b. A protected premises fire alarm system as
defined in NFPA 72, National Fire Alarm Code, Chapter 3 shall be
required.
c. Fire extinguisher(s)
shall be easily accessible and shall be provided, located, and inspected as
defined in NFPA 10, Standard for Portable Fire Extinguishers.
d. At least two (2) separate exits that are
remote from each oiher shall be provided on every story of Abortion Facility
use.
e. The minimum clear door
opening for patien|_use shall be two (2) feet eight (8) inches.
f. Gas fired equipment rooms shall be
separated with one (1) hour fire resistance partitions.
g. No operable fireplace shall be permitted.
Inoperable fireplace(s) shall be sealed at the upper and lower portions of the
flue.
h. Cabinets or casework in
patient use areas shall be furred to the ceiling above or provided with sloping
tops to facilitate cleaning.
i. A
panic bar releasing device shall be provided for all required exit doors
subject to patient traffic.
j.
Medical gas, air and vacuum systems, if provided, shall meet installation,
testing, maintenance and certification criteria of NFPA 99, Standard for Health
Care Facilities.
E. Design Considerations.
1. Each Abortion Facility design shall ensure
patient acoustic and visual privacy during interview, examination, treatment
and recovery.
2. The premises shall
be kept free from insect and vermin infestation.
3. The building shall be well ventilated at
all times with a comfortable temperature maintained.
4. Space and facilities shall be provided for
the sanitary storage and disposal of waste by incineration, containment or
removal, or by a combination of these techniques.
5. Waiting/Reception area(s) shall be
provided "with sufficient seating for the maximum number of people that may be
waiting at any one (1) time. A reception and information counter or desk shall
be provided.
6. A barrier free
public toilet rooms shall be provided. This room may be conveniently located
outside the Abortion Facility as part of shared tenant spaces in the same
building.
7. Public telephone(s)
shall be provided.
8. A
housekeeping room with mop sink shall be provided.
9. Storage space shall be provided for both
administrative and clinical needs.
10. A business office room shall be
provided.
11. A medical records
storage room shall be provided. This room shall protect records against undue
destruction from dust, vermin, water, smoke and fire. It shall be constructed
as a one (1) hour fire resistance rated enclosure and protected by a smoke
detection system connected to the fire alarm. Storage for records shall be
accessible and at least six (6) inches above the floor.
12. A consultation room shall be
provided.
13. An examination room
shall be provided. The examination room shall have a minimum floor area of
eighty (SO) square feet excluding fixed millwork. vestibule, toilet and
closets. The room shall contain an examination table and chair, charting
counter or desk, instrument table and shelves, handwashing sink and equipment
storage as needed. Room arrangement shall permit at least three (3) feet
clearance at each side and at the foot of the examination table. Entry door
swing and view angles shall maximize patient privacy. This room may be combined
with the procedure room.
14. A
procedure room shall be provided. The procedure room shall have a minimum floor
area of one-hundred-twenty (120) square feet excluding fixed millwork,
vestibule, toilet and closets. The minimum room dimension shall be ten (10)
feet. The room shall contain a handwash sink with hands-free controls, soap
dispenser and single service towel dispenser.
15. One (1) or more recovery rooms shall be
provided. A recovery room shall have a minimum of sixty (60) square feet per
patient excluding fixed millwork, vestibule, toilet and closets. The room shall
contain a bed or a washable, reclining chair. Multi-patient recovery rooms
shall be provided with cubicle curtains for patient privacy.
16. A clean work room shall be provided
sufficient in size to process clean and sterilize supply materials and
equipment. This room shall contain a handwash sink, work counter and autoclave
adequate in size to sterilize the equipment in use.
17. A soiled work room shall be provided.
This room shall contain a handwash sink and work counter.
18. At least one (1) barrier free, patient
toilet room shall be provided for each recovery room.
F. Interior Finishes.
1. Interior finishes shall meet the flame
spread and smoke development requirements of NFPA 101, Life Safety
code.
2. Finished floors, ceilings
and walls shall be provided for all rooms and spaces except mechanical and
electrical rooms.
3. Procedure
rooms and soiled work rooms shall have a monolithic finish floor and base,
stain resistant for its intended use and integral with each other (i.e., sheet
vinyl floor with continuous sheet vinyl base). Seams in the monolithic floor
and base shall be chemically welded.
4. Toilet rooms, clean work rooms,
housekeeping rooms and examination rooms (when combined with the procedure
room) shall not have a carpeted floor finish.
RULES ANB REGULATIONS FOR ABORTION FACILITIES
5. Procedure rooms, soiled work rooms and
clean work rooms shall have smooth, washable, moisture resistant, ceilings of
gypsum board, plaster or mylar faced lay-in ceiling tiles.
6. Wall finishes for all rooms shall be
smooth, moisture resistant and washable.
en