Current through Reg. 49, No. 38; September 20, 2024
(a)
Anesthesia services. If the hospital furnishes anesthesia services, these
services shall be provided in a well-organized manner under the direction of a
qualified physician. The anesthesia service is responsible for all anesthesia
administered in the hospital.
(1)
Organization and staffing. The organization of anesthesia services shall be
appropriate to the scope of the services offered. Anesthesia shall be
administered only by:
(A) a qualified
anesthesiologist;
(B) a physician
(other than an anesthesiologist);
(C) a dentist, oral surgeon, or podiatrist
who is qualified to administer anesthesia under state law; or
(D) a certified registered nurse anesthetist
who is under the supervision, as set forth in the Medical Practice Act, Texas
Occupations Code, Title 3, Subtitle B, and the Nursing Practice Act, Texas
Occupations Code, Chapter 301, of the operating physician or of an
anesthesiologist who is immediately available if needed.
(2) Delivery of services. Anesthesia services
shall be consistent with needs and resources. Policies on anesthesia procedures
shall include the delineation of pre-anesthesia and post-anesthesia
responsibilities. The policies shall ensure that the following are provided for
each patient.
(A) A pre-anesthesia evaluation
by an individual qualified to administer anesthesia under paragraph (1) of this
subsection shall be performed within 48 hours prior to the procedure.
(B) An intraoperative anesthesia record shall
be provided. The record shall include any complications or problems occurring
during the anesthesia including time, description of symptoms, review of
affected systems, and treatments rendered. The record shall correlate with the
controlled substance administration record.
(C) A post-anesthesia follow-up report shall
be written by the person administering the anesthesia before transferring the
patient from the recovery room and shall include evaluation for recovery from
anesthesia, level of activity, respiration, blood pressure, level of
consciousness, and patient color.
(i) With
respect to inpatients, a post-anesthesia evaluation for proper anesthesia
recovery shall be performed after transfer from recovery and within 48 hours
after the procedure by the person administering the anesthesia, registered
nurse (RN), or physician in accordance with policies and procedures approved by
the medical staff.
(ii) With
respect to outpatients, immediately prior to discharge, a post-anesthesia
evaluation for proper anesthesia recovery shall be performed by the person
administering the anesthesia, RN, or physician in accordance with policies and
procedures approved by the medical staff.
(b) Dietary services. The facility
shall have organized dietary services that are directed and staffed by adequate
qualified personnel. However, a facility that has a contract with an outside
food management company or an arrangement with another facility may meet this
requirement if the company or other facility has a dietitian who serves the
facility on a full-time, part-time, or consultant basis, and if the company or
other facility maintains at least the minimum requirements specified in this
section, and provides for the frequent and systematic liaison with the facility
medical staff for recommendations of dietetic policies affecting patient
treatment. The facility shall ensure that there are sufficient personnel to
respond to the dietary needs of the patient population being served.
(1) Organization.
(A) A facility shall have an employee who is
qualified by experience or training to serve as director of the food and
dietetic service, and be responsible for the daily management of the dietary
services. This employee shall be full-time in a hospital; the crisis
stabilization unit employee does not have to be full-time.
(B) There shall be a qualified dietitian who
works full-time, part-time, or on a consultant basis. If by consultation, such
services shall occur at least once per month for not less than eight hours. The
dietitian shall:
(i) be currently licensed
under the laws of this state to use the titles of licensed dietitian or
provisional licensed dietitian, or be a registered dietitian;
(ii) maintain standards for professional
practice;
(iii) supervise the
nutritional aspects of patient care;
(iv) make an assessment of the nutritional
status and adequacy of nutritional regimen, as appropriate;
(v) provide diet counseling and teaching, as
appropriate;
(vi) document
nutritional status and pertinent information in patient medical records, as
appropriate;
(vii) approve menus;
and
(viii) approve menu
substitutions.
(C) There
shall be administrative and technical personnel competent in their respective
duties. The administrative and technical personnel shall:
(i) participate in established departmental
or facility training pertinent to assigned duties;
(ii) conform to food handling techniques in
accordance with paragraph (2)(E)(vii) of this subsection;
(iii) adhere to clearly defined work
schedules and assignment sheets; and
(iv) comply with position descriptions which
are job specific.
(2) Director. The director shall:
(A) comply with a position description which
is job specific;
(B) clearly
delineate responsibility and authority;
(C) participate in conferences with
administration and department heads;
(D) establish, implement, and enforce
policies and procedures for the overall operational components of the
department to include, but not be limited to:
(i) quality assurance;
(ii) frequency of meals served;
(iii) non-routine occurrences; and
(iv) identification of patient
trays;
(E) maintain
authority and responsibility for the following, but not be limited to:
(i) orientation and training;
(ii) performance evaluations;
(iii) work assignments;
(iv) supervision of work and food handling
techniques;
(v) procurement of
food, paper, chemical, and other supplies, to include implementation of
first-in first-out rotation system for all food items;
(vi) menu planning; and
(vii) ensuring compliance with Chapter 228 of
Title 40 (relating to Retail Food).
(3) Diets. Menus shall meet the needs of the
patients.
(A) Therapeutic diets shall be
prescribed by the physician(s) responsible for the care of the patients. The
dietary department of the facility shall:
(i)
establish procedures for the processing of therapeutic diets to include, but
not be limited to:
(I) accurate patient
identification;
(II) transcription
from nursing to dietary services;
(III) diet planning by a dietitian;
(IV) regular review and updating of diet when
necessary; and
(V) written and
verbal instruction to patient and family. It shall be in the patient's primary
language, if practicable, prior to discharge. What is or would have been
practicable shall be determined by the facts and circumstances of each
case;
(ii) ensure that
therapeutic diets are planned in writing by a qualified dietitian;
(iii) ensure that menu substitutions are
approved by a qualified dietitian;
(iv) document pertinent information about the
patient's response to a therapeutic diet in the medical record; and
(v) evaluate therapeutic diets for
nutritional adequacy.
(B) Nutritional needs shall be met in
accordance with recognized dietary practices and in accordance with orders of
the physician(s) responsible for the care of the patients. The following
requirements shall be met.
(i) Menus shall
provide a sufficient variety of foods served in adequate amounts at each meal
according to the guidance provided in the Recommended Dietary Allowances, as
published by the Food and Nutrition Board, National Academy of Sciences,
National Research Council, Tenth edition, 1989, which may be obtained by
writing the National Academy Press, 2101 Constitution Avenue, Box 285,
Washington, D.C. 20055, telephone (888) 624-8373.
(ii) A maximum of 15 hours shall not be
exceeded between the last meal of the day (i.e. supper) and the breakfast meal,
unless a substantial snack is provided. The facility shall adopt, implement,
and enforce a policy on the definition of "substantial" to meet each patient's
varied nutritional needs.
(C) A current therapeutic diet manual
approved by the dietitian and medical staff shall be readily available to all
medical, nursing, and food service personnel. The therapeutic manual shall:
(i) be revised as needed, not to exceed 5
years;
(ii) be appropriate for the
diets routinely ordered in the facility;
(iii) have standards in compliance with the
RDA;
(iv) contain specific diets
which are not in compliance with RDA; and
(v) be used as a guide for ordering and
serving diets.
(c) Governing body.
(1) Legal responsibility. There shall be a
governing body responsible for the organization, management, control, and
operation of the facility, including appointment of the medical staff. For
facilities owned and operated by an individual or by partners, the individual
or partners shall be considered the governing body.
(2) Organization. The governing body shall be
formally organized in accordance with a written constitution or bylaws which
clearly set forth the organizational structure and responsibilities.
(3) Meeting records. Records of governing
body meetings shall be maintained.
(4) Responsibilities relating to the medical
staff. The governing body shall:
(A) ensure
that the medical staff has current bylaws, rules, and regulations which are
implemented and enforced;
(B)
approve medical staff bylaws and other medical staff rules and
regulations;
(C) determine, in
accordance with state law and with the advice of the medical staff, which
categories of practitioners are eligible candidates for appointment to the
medical staff;
(D) ensure that
criteria for selection include individual character, competence, training,
experience, and judgment;
(E)
ensure that under no circumstances is the accordance of staff membership or
professional privileges in the facility dependent solely upon certification,
fellowship or membership in a specialty body or society;
(F) ensure the process for considering
applications for medical staff membership and privileges affords each candidate
for appointment procedural due process;
(G) ensure in granting or refusing medical
staff membership or privileges, the facility does not differentiate on the
basis of the academic medical degree;
(H) ensure that equal recognition is given to
training programs accredited by the Accreditation Council on Graduate Medical
Education and by the American Osteopathic Association if graduate medical
education is used as a standard or qualification for medical staff membership
or privileges for a physician;
(I)
ensure that equal recognition is given to certification programs approved by
the American Board of Medical Specialties and the Bureau of Osteopathic
Specialists if board certification is used as a standard or qualification for
medical staff membership or privileges for a physician;
(J) ensure that the medical staff is
accountable to the governing body for the quality of care provided to
patients;
(K) ensure that a
facility's credentials committee acts expeditiously and without unnecessary
delay when a candidate for appointment submits a completed application, as
defined by each hospital, for medical staff membership or privileges, in
accordance with the following:
(i) The
credentials committee shall take action on the completed application not later
than the 90th day after the date on which the application is
received;
(ii) The governing body
shall take final action on the application for medical staff membership or
privileges not later than the 60th day after the date on which the
recommendation of the credentials committee is received; and
(iii) The facility must notify the applicant
in writing of the facility's final action, including a reason for denial or
restriction of privileges, not later than the 20th day after the date on which
final action is taken;
(L) ensure the facility complies with the
requirements for reporting to the Texas Medical Board the results and
circumstances of any professional review action in accordance with the Medical
Practice Act, Occupations Code, §
160.002
and §
160.003.
(5) Facility administration. The
governing body shall appoint a chief executive officer or administrator who is
responsible for managing the facility.
(6) Patient care. In accordance with facility
policy, the governing body shall ensure that:
(A) every patient is under the care of a
physician. This provision is not to be construed to limit the authority of a
physician to delegate tasks to other qualified health care personnel to the
extent recognized under state law;
(B) patients are admitted to the facility
only by members of the medical staff who have been granted admitting
privileges; and
(C) a physician is
on duty or on-call at all times.
(7) Contracted services. The governing body
shall be responsible for services furnished in the facility whether or not they
are furnished directly or under contracts. The governing body shall ensure that
a contractor of services (including one for shared services and joint ventures)
furnishes services in a safe and effective manner that permits the facility to
comply with all applicable rules and standards for contracted
services.
(8) Nurse staffing. The
governing body shall adopt, implement and enforce a written nurse staffing
policy to ensure that an adequate number and skill mix of nurses are available
to meet the level of patient care needed. The governing body policy shall
require that hospital administration adopt, implement and enforce a nurse
staffing plan and policies that:
(A) require
significant consideration be given to the nurse staffing plan recommended by
the hospital's nurse staffing committee and the committee's evaluation of any
existing plan;
(B) are based on the
needs of each patient care unit and shift and on evidence relating to patient
care needs;
(C) ensure that all
nursing assignments consider client safety, and are commensurate with the
nurse's educational preparation, experience, knowledge, and physical and
emotional ability;
(D) require use
of the official nurse services staffing plan as a component in setting the
nurse staffing budget;
(E)
encourage nurses to provide input to the nurse staffing committee relating to
nurse staffing concerns;
(F)
protect from retaliation nurses who provide input to the nurse staffing
committee; and
(G) comply with
subsection (j) of this section.
(d) Infection control. The facility shall
provide a sanitary environment to avoid sources and transmission of infections
and communicable diseases. There shall be an active program for the prevention,
control, and investigation of infections and communicable diseases.
(1) Organization and policies. A person shall
be designated as infection control coordinator. The facility shall ensure that
policies governing prevention, control and surveillance of infections and
communicable diseases are developed, implemented and enforced.
(A) There shall be a system for identifying,
reporting, investigating, and controlling nosocomial infections and
communicable diseases between patients and personnel.
(B) The infection control coordinator shall
maintain a log of all reportable diseases and nosocomial infections designated
as epidemiologically significant according to the facility's infection control
policies.
(C) There shall be a
written policy for reporting all reportable diseases to the local health
authority or the Infectious Disease Epidemiology and Surveillance Division,
Department of State Health Services, Mail Code 2822, P.O. Box 149347, Austin,
TX 78714-9347, in accordance with Chapter 97 of Title 40 (relating to
Communicable Diseases).
(2) Responsibilities of the chief executive
officer (CEO), medical staff, and chief nursing officer (CNO). The CEO, the
medical staff, and the CNO shall be responsible for the following.
(A) The facility-wide quality assurance
program and training programs shall address problems identified by the
infection control coordinator.
(B)
Successful corrective action plans in affected problem areas shall be
implemented.
(3)
Universal precautions. The facility shall adopt, implement, and enforce a
written policy to monitor compliance of the facility and its personnel and
medical staff with universal precautions in accordance with Health and Safety
Code, Chapter 85, Subchapter I (relating to the Prevention of Transmission of
HIV and Hepatitis B Virus by Infected Health Care Workers).
(e) Laboratory services. The
facility shall provide directly, or have available adequate laboratory services
to meet the needs of its patients.
(1)
Facility laboratory services. A facility that provides laboratory services
shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA
1988), in accordance with the requirements specified in 42 Code of Federal
Regulations (CFR), §§ 493.1 - 493.1780. CLIA 1988 applies to all
facilities with laboratories that examine human specimens for the diagnosis,
prevention, or treatment of any disease or impairment of, or the assessment of
the health of, human beings.
(2)
Contracted laboratory services. The facility shall ensure that all laboratory
services provided to its patients through a contractual agreement are performed
in a facility certified in the appropriate specialties and subspecialties of
service in accordance with the requirements specified in
42 CFR Part
493 to comply with CLIA 1988.
(3) Adequacy of laboratory services. The
facility shall ensure the following.
(A)
Emergency laboratory services shall be available 24 hours a day.
(B) A written description of services
provided shall be available to the medical staff.
(C) The laboratory shall make provision for
proper receipt and reporting of tissue specimens.
(4) Chemical hygiene. A facility that
provides laboratory services directly shall adopt, implement, and enforce
written policies and procedures to manage, minimize, or eliminate the risks to
laboratory personnel of exposure to potentially hazardous chemicals in the
laboratory which may occur during the normal course of job
performance.
(f) Linen
and laundry services. The facility shall provide sufficient clean linen to
ensure the comfort of the patient. The facility, whether it operates its own
laundry or uses commercial service, shall ensure the following.
(1) Employees of a facility involved in
transporting, processing, or otherwise handling clean or soiled linen shall be
given initial and follow-up inservice training to ensure a safe product for
patients and to safeguard employees in their work.
(2) Clean linen shall be handled,
transported, and stored by methods that will ensure its cleanliness.
(3) All contaminated linen shall be placed
and transported in bags or containers labeled or color-coded.
(4) Employees who have contact with
contaminated linen shall wear gloves and other appropriate personal protective
equipment.
(5) Contaminated linen
shall be handled as little as possible and with minimum agitation. Contaminated
linen shall not be sorted or rinsed in patient care areas.
(6) All contaminated linen shall be bagged or
put into carts at the location where it was used.
(A) Bags containing contaminated linen shall
be closed prior to transport to the laundry.
(B) Whenever contaminated linen is wet and
presents a reasonable likelihood of soak-through of or leakage from the bag or
container, the linen shall be deposited and transported in bags that prevent
leakage of fluids to the exterior.
(C) All linen placed in chutes shall be
bagged.
(D) If chutes are not used
to convey linen to a central receiving or sorting room, then adequate space
shall be allocated on the various nursing units for holding the bagged
contaminated linen.
(7)
Linen shall be processed as follows:
(A) If
hot water is used, linen shall be washed with detergent in water with a
temperature of at least 71 degrees Centigrade (160 degrees Fahrenheit) for 25
minutes. Hot water requirements specified in Table 5 of §
510.131(e) of
Title 40 (relating to Tables) shall be met.
(B) If low temperature (less than or equal to
70 degrees Centigrade) (158 degrees Fahrenheit) laundry cycles are used,
chemicals suitable for low-temperature washing at proper use concentration
shall be used.
(C) Commercial dry
cleaning of fabrics soiled with blood also renders these items free of the risk
of pathogen transmission.
(8) Flammable liquids shall not be used in
the laundry.
(g) Medical
record services. The facility shall have a medical record service that has
administrative responsibility for medical records. A medical record shall be
maintained for every individual who presents to the hospital for evaluation or
treatment.
(1) The organization of the medical
record service shall be appropriate to the scope and complexity of the services
performed. The facility shall employ adequate personnel to ensure prompt
completion, filing, and retrieval of records.
(2) The facility shall have a system of
coding and indexing medical records. The system shall allow for timely
retrieval by diagnosis and procedure, in order to support medical care
evaluation studies.
(3) The
facility shall adopt, implement, and enforce a policy to ensure that the
facility complies with Health and Safety Code, §
576.005
(relating to Confidentiality of Records) and Chapter 611, (relating to Mental
Health Records).
(4) The medical
record shall contain information to justify admission and continued
hospitalization, support the diagnosis, and describe the patient's progress and
response to medications and services. Medical records shall be accurately
written, promptly completed, properly filed and retained, and
accessible.
(5) The facility shall
use a system of author identification and record maintenance that ensures the
integrity of the authentication and protects the security of all entries to the
records.
(A) The author of each entry shall be
identified and shall authenticate his or her entry.
(B) Authentication shall include signatures,
written initials, or computer entry.
(C) Use of signature stamps by physicians may
be allowed in facilities when the signature stamp is authorized by the
individual whose signature the stamp represents. The administrative offices of
the facility shall have on file a signed statement to the effect that he or she
is the only one who has the stamp and uses it. Delegation of use to another
individual shall not be acceptable.
(D) A list of computer codes and written
signatures shall be readily available and shall be maintained under adequate
safeguards.
(E) Signatures by
facsimile shall be acceptable. If received on a thermal machine, the facsimile
document shall be copied onto regular paper.
(6) Medical records (reports and printouts)
shall be retained by the facility in their original or legally reproduced form
for a period of at least ten years. Films, scans, and other image records shall
be retained for a period of at least five years. For retention purposes,
medical records that shall be preserved for ten years include:
(A) identification data;
(B) the medical history of the
patient;
(C) evidence of a physical
examination and psychiatric evaluation;
(D) admitting diagnosis;
(E) diagnostic and therapeutic
orders;
(F) properly executed
informed consent forms for procedures and treatments specified by the medical
staff, or by federal or state laws if applicable, to require written patient
consent;
(G) treatment
plans;
(H) clinical observations,
including the results of therapy and treatment, all orders, nursing notes,
medication records, vital signs, and other information necessary to monitor the
patient's condition;
(I) reports of
procedures, tests, and their results, including laboratory, pathology, and
radiology reports;
(J) results of
all consultative evaluations of the patient and appropriate findings by
clinical and other staff involved in the care of the patient;
(K) discharge summary with outcome of
hospitalization, disposition of care, and provisions for follow-up care;
and
(L) final diagnosis with
completion of medical records within 30 calendar days following
discharge.
(7) If a
patient was less than 18 years of age at the time he was last treated, the
facility may authorize the disposal of those medical records relating to the
patient on or after the date of his 20th birthday or on or after the 10th
anniversary of the date on which he was last treated, whichever date is
later.
(8) The facility shall not
destroy medical records that relate to any matter that is involved in
litigation if the facility knows the litigation has not been finally
resolved.
(9) If a licensed
facility should close, the facility shall notify the department at the time of
closure the disposition of the medical records, including the location of where
the medical records will be stored and the identity and telephone number of the
custodian of the records.
(h) Medical staff.
(1) The medical staff shall be composed of
physicians and may also be composed of podiatrists, dentists and other
practitioners appointed by the governing body.
(A) The medical staff shall periodically
conduct appraisals of its members according to medical staff bylaws.
(B) The medical staff shall examine
credentials of candidates for medical staff membership and make recommendations
to the governing body on the appointment of the candidate.
(2) The medical staff shall be well-organized
and accountable to the governing body for the quality of the medical care
provided to patients.
(A) The medical staff
shall be organized in a manner approved by the governing body.
(B) If the medical staff has an executive
committee, a majority of the members of the committee shall be doctors of
medicine or osteopathy.
(C) Records
of medical staff meetings shall be maintained.
(D) The responsibility for organization and
conduct of the medical staff shall be assigned only to an individual
physician.
(E) Each medical staff
member shall sign a statement signifying they will abide by medical staff and
hospital policies.
(3)
The medical staff shall adopt, implement, and enforce bylaws, rules, and
regulations to carry out its responsibilities. The bylaws shall:
(A) be approved by the governing
body;
(B) include a statement of
the duties and privileges of each category of medical staff (e.g., active,
courtesy, consultant);
(C) describe
the organization of the medical staff;
(D) describe the qualifications to be met by
a candidate in order for the medical staff to recommend that the candidate be
appointed by the governing body; and
(E) include criteria for determining the
privileges to be granted and a procedure for applying the criteria to
individuals requesting privileges.
(i) Mobile, transportable, and relocatable
units. If the facility provides diagnostic procedures or treatments in mobile,
transportable, or relocatable units, the facility shall adopt, implement and
enforce procedures which address the potential emergency needs for those
inpatients who are taken to mobile units on the facility premises for
diagnostic procedures or treatment.
(j) Nurse staffing.
(1) The hospital shall establish a nurse
staffing committee as a standing committee of the hospital. As used in this
subsection, "committee" or "staffing committee" means a nurse staffing
committee established under this paragraph.
(A) The committee shall be composed of:
(i) at least 60% registered nurses who are
involved in direct patient care at least 50% of their work time and selected by
their peers who provide direct care during at least 50% of their work
time;
(ii) members who are
representative of the types of nursing services provided at the hospital;
and
(iii) the chief nursing officer
of the hospital who is a voting member.
(B) Participation on the committee by a
hospital employee as a committee member shall be part of the employee's work
time and the hospital shall compensate that member for that time accordingly.
The hospital shall relieve the committee member of other work duties during
committee meetings.
(C) The
committee shall meet at least quarterly.
(D) The responsibilities of the committee
shall be to:
(i) develop and recommend to the
hospital's governing body a nurse staffing plan that meets the requirements of
paragraph (2) of this subsection;
(ii) review, assess and respond to staffing
concerns expressed to the committee;
(iii) identify the nurse-sensitive outcome
measures the committee will use to evaluate the effectiveness of the official
nurse services staffing plan;
(iv)
evaluate, at least semiannually, the effectiveness of the official nurse
services staffing plan and variations between the plan and the actual staffing;
and
(v) submit to the hospital's
governing body, at least semiannually, a report on nurse staffing and patient
care outcomes, including the committee's evaluation of the effectiveness of the
official nurse services staffing plan and aggregate variations between the
staffing plan and actual staffing.
(2) The hospital shall adopt, implement and
enforce a written official nurse services staffing plan. As used in this
subsection, "patient care unit" means a unit or area of a hospital in which
registered nurses provide patient care.
(A)
The official nurse services staffing plan and policies shall:
(i) require significant consideration be
given to the nurse staffing plan recommended by the hospital's nurse staffing
committee and the committee's evaluation of any existing plan;
(ii) be based on the needs of each patient
care unit and shift and on evidence relating to patient care needs;
(iii) require use of the official nurse
services staffing plan as a component in setting the nurse staffing
budget;
(iv) encourage nurses to
provide input to the nurse staffing committee relating to nurse staffing
concerns;
(v) protect nurses who
provide input to the nurse staffing committee from retaliation; and
(vi) comply with this subsection.
(B) The plan shall:
(i) set minimum staffing levels for patient
care units that are:
(I) based on multiple
nurse and patient considerations; and
(II) determined by the nursing assessment and
in accordance with evidence-based safe nursing standards; and
(ii) include a method for
adjusting the staffing plan shift to shift for each patient care unit to
provide staffing flexibility to meet patient needs;
(iii) include a contingency plan when patient
care needs unexpectedly exceed direct patient care staff resources;
(iv) include how on-call time will be
used;
(v) reflect current standards
established by private accreditation organizations, governmental entities,
national nursing professional associations, and other health professional
organizations;
(vi) include a
mechanism for evaluating the effectiveness of the official nurse services
staffing plan based on patient needs, nursing-sensitive quality indicators,
nurse satisfaction measures collected by the hospital, and evidence based nurse
staffing standards; and
(vii) be
used by the hospital as a component in setting the nurse staffing budget and
guiding the hospital in assigning nurses hospital wide.
(C) The hospital shall make readily available
to nurses on each patient care unit at the beginning of each shift the official
nurse services staffing plan levels and current staffing levels for that unit
and that shift.
(3) The
hospital shall annually report to the department on:
(A) whether the hospital's governing body has
adopted a nurse staffing policy;
(B) whether the hospital has established a
nurse staffing committee that meets the membership requirements of paragraph
(1) of this subsection;
(C) whether
the nurse staffing committee has evaluated the hospital's official nurse
services staffing plan and has reported the results of the evaluation to the
hospital's governing body; and
(D)
the nurse-sensitive outcome measures the committee adopted for use in
evaluating the hospital's official nurse services staffing plan.
(4) Mandatory overtime. The
hospital shall adopt, implement and enforce policies on use of mandatory
overtime.
(A) As used in this subsection:
(i) "on-call time" means time spent by a
nurse who is not working but who is compensated for availability; and
(ii) "mandatory overtime" means a requirement
that a nurse work hours or days that are in addition to the hours or days
scheduled, regardless of the length of a scheduled shift or the number of
scheduled shifts each week. Mandatory overtime does not include prescheduled
on-call time or time immediately before or after a scheduled shift necessary to
document or communicate patient status to ensure patient safety.
(B) A hospital may not require a
nurse to work mandatory overtime, and a nurse may refuse to work mandatory
overtime.
(C) This section does not
prohibit a nurse from volunteering to work overtime.
(D) A hospital may not use on-call time as a
substitute for mandatory overtime.
(E) The prohibitions on mandatory overtime do
not apply if:
(i) a health care disaster,
such as a natural or other type of disaster that increases the need for health
care personnel, unexpectedly affects the county in which the nurse is employed
or affects a contiguous county;
(ii) a federal, state, or county declaration
of emergency is in effect in the county in which the nurse is employed or is in
effect in a contiguous county;
(iii) there is an emergency or unforeseen
event of a kind that:
(I) does not regularly
occur;
(II) increases the need for
health care personnel at the hospital to provide safe patient care;
and
(III) could not prudently be
anticipated by the hospital; or
(iv) the nurse is actively engaged in an
ongoing medical or surgical procedure and the continued presence of the nurse
through the completion of the procedure is necessary to ensure the health and
safety of the patient. The nurse staffing committee shall ensure that
scheduling a nurse for a procedure that could be anticipated to require the
nurse to stay beyond the end of his or her scheduled shift does not constitute
mandatory overtime.
(F)
If a hospital determines that an exception exists under subparagraph (E) of
this paragraph, the hospital shall, to the extent possible, make and document a
good faith effort to meet the staffing need through voluntary overtime,
including calling per diems and agency nurses, assigning floats, or requesting
an additional day of work from off-duty employees.
(G) A hospital may not suspend, terminate, or
otherwise discipline or discriminate against a nurse who refuses to work
mandatory overtime.
(k) Outpatient services. If the facility
provides outpatient services within the facility, written policies and
procedures describing the operation of the services shall be adopted,
implemented and enforced.
(l)
Pharmacy services. The facility shall provide pharmaceutical services that meet
the needs of the patients.
(1) License. A
facility that stores and dispenses prescription drugs for administration to a
patient by a person authorized by law to administer the drug, shall be
licensed, as required, by the Texas State Board of Pharmacy.
(2) Organization. The facility shall have a
pharmacy directed by a licensed pharmacist.
(3) Medical staff. The medical staff shall be
responsible for developing policies and procedures that minimize drug errors.
This function may be delegated to the facility's organized pharmaceutical
services.
(4) Pharmacy management
and administration. The pharmacy or drug storage area shall be administered in
accordance with accepted professional principles.
(A) Standards of practice as defined by state
law shall be followed regarding the provision of pharmacy services.
(B) The pharmaceutical services shall have an
adequate number of personnel to ensure quality pharmaceutical services
including emergency services.
(i) The staff
shall be sufficient in number and training to respond to the pharmaceutical
needs of the patient population being served. There shall be an arrangement for
emergency services.
(ii) Employees
shall provide pharmaceutical services within the scope of their license and
education.
(C) Drugs and
biologicals shall be properly stored to ensure ventilation, light, security,
and temperature controls.
(D)
Records shall have sufficient detail to follow the flow of drugs from entry
through dispensation.
(E) There
shall be adequate controls over all drugs and medications including floor
stock. Drug storage areas shall be approved by the pharmacist, and floor stock
lists shall be established.
(F)
Inspections of drug storage areas shall be conducted throughout the hospital
under pharmacist supervision.
(G)
There shall be a drug recall procedure.
(H) A full-time, part-time, or consulting
pharmacist shall be responsible for developing, supervising, and coordinating
all the activities of the pharmacy services.
(i) Direction of pharmaceutical services may
not require on premises supervision but may be accomplished through regularly
scheduled visits in accordance with state law.
(ii) A job description or other written
agreement shall clearly define the responsibilities of the
pharmacist.
(I) Current
and accurate records shall be kept of the receipt and disposition of all
scheduled drugs.
(i) There shall be a record
system in place that provides the information on controlled substances in a
readily retrievable manner which is separate from the patient record.
(ii) Records shall trace the movement of
scheduled drugs throughout the services, documenting utilization or
wastage.
(iii) The pharmacist shall
be responsible for determining that all drug records are in order and that an
account of all scheduled drugs is maintained and reconciled with written
orders.
(5)
Delivery of services. In order to provide patient safety, drugs and biologicals
shall be controlled and distributed in accordance with applicable standards of
practice, consistent with federal and state laws.
(A) All compounding, packaging, and
dispensing of drugs and biologicals shall be under the supervision of a
pharmacist and performed consistent with federal and state laws.
(B) Drugs and biologicals shall be kept in a
locked storage area.
(i) A policy shall be
adopted, implemented, and enforced to ensure the safeguarding, transferring,
and availability of keys to the locked storage area.
(ii) Dangerous drugs as well as controlled
substances shall be secure from unauthorized use.
(C) Outdated, mislabeled, or otherwise
unusable drugs and biologicals shall not be available for patient
use.
(D) When a pharmacist is not
available, drugs and biologicals shall be removed from the pharmacy or storage
area only by personnel designated in the policies of the medical staff and
pharmaceutical service, in accordance with federal and state laws.
(i) There shall be a current list of
individuals identified by name and qualifications who are designated to remove
drugs from the pharmacy.
(ii) Only
amounts sufficient for immediate therapeutic needs shall be removed.
(E) Drugs and biologicals not
specifically prescribed as to time or number of doses shall automatically be
stopped after a reasonable time that is predetermined by the medical staff.
(i) Stop order policies and procedures shall
be consistent with those of the nursing staff and the medical staff rules and
regulations.
(ii) A protocol shall
be established by the medical staff for the implementation of the stop order
policy, in order that drugs shall be reviewed and renewed, or automatically
stopped.
(iii) A system shall be in
place to determine compliance with the stop order policy.
(F) Drug administration errors, adverse drug
reactions, and incompatibilities shall be immediately reported to the attending
physician and, if appropriate, to the facility-wide quality assurance program.
There shall be a mechanism in place for capturing, reviewing, and tracking
medication errors and adverse drug reactions.
(G) Abuses and losses of controlled
substances shall be reported, in accordance with applicable federal and state
laws, to the individual responsible for the pharmaceutical services, and to the
chief executive officer, as appropriate.
(H) Information relating to drug interactions
and information on drug therapy, side effects, toxicology, dosage, indications
for use, and routes of administration shall be immediately available to the
professional staff.
(i) A pharmacist shall be
readily available by telephone or other means to discuss drug therapy,
interactions, side effects, dosage, assist in drug selection, and assist in the
identification of drug induced problems.
(ii) There shall be staff development
programs on drug therapy available to facility staff to cover such topics as
new drugs added to the formulary, how to resolve drug therapy problems, and
other general information as the need arises.
(I) A formulary system shall be established
by the medical staff to ensure quality pharmaceuticals at reasonable
costs.
(m)
Quality assurance. The governing body shall ensure that there is an effective,
ongoing, facility-wide, data-driven quality assurance (QA) program to evaluate
the provision of patient care.
(1)
Implementation plan. The facility-wide QA program shall be on-going and have a
written plan of implementation.
(A) All
organized services related to patient care, including services furnished by
contract, shall be evaluated.
(B)
Nosocomial infections and medication therapy shall be evaluated.
(C) All medical services performed in the
facility shall be evaluated as they relate to appropriateness of diagnosis and
treatment.
(2)
Implementation. The facility shall take and document appropriate remedial
action to address deficiencies found through the QA program. The facility shall
document the outcome of the remedial action.
(3) Discharge planning. The facility shall
have an effective, ongoing discharge planning program that facilitates the
provision of follow-up care.
(A) Discharge
planning shall be completed prior to discharge.
(B) Patients, along with necessary medical
information, shall be transferred or referred to appropriate facilities,
agencies, or outpatient services, as needed for follow-up or ancillary
care.
(C) Screening and evaluation
before patient discharge from facility. In accordance with 42 Code of Federal
Regulations (CFR), Part 483, Subpart C (relating to Requirements for Long Term
Care Facilities) and the rules of the Department of Aging and Disability
Services (DADS) set forth in 40 TAC Chapter 17, (relating to Preadmission
Screening and Resident Review (PASRR)), all patients who are being considered
for discharge from the facility to a nursing facility shall be screened, and if
appropriate, evaluated, prior to discharge by the facility and admission to the
nursing facility to determine whether the patient may have a mental illness,
intellectual disability or developmental disability. If the screening indicates
that the patient has a mental illness, intellectual disability or developmental
disability, the facility shall contact and arrange for the local mental health
authority designated pursuant to Texas Health and Safety Code, §
533.035,
to conduct prior to facility discharge an evaluation of the patient in
accordance with the applicable provisions of the PASRR rules. The purpose of
PASRR is:
(i) to ensure that placement of the
patient in a nursing facility is necessary;
(ii) to identify alternate placement options
when applicable; and
(iii) to
identify specialized services that may benefit the person with a diagnosis of
mental illness, intellectual disability, or developmental disability.
(n)
Radiology services. When radiology services are provided, written policies and
procedures shall be adopted, implemented and enforced which describe the
radiology services provided in the facility and how employee and patient safety
will be maintained.
(1) Proper safety
precautions shall be maintained against radiation hazards. This includes
adequate shielding for patients, personnel, and facilities.
(2) Inspection of equipment shall be made
periodically. Defective equipment shall be promptly repaired or
replaced.
(3) Radiation workers
shall be checked, by the use of exposure meters or badge tests, for amount of
radiation exposure. Exposure reports and documentation shall be available for
review.
(4) Radiology services
shall be provided only on the order of individuals with privileges granted by
the medical staff and of other physicians or practitioners authorized by the
medical staff and governing body to order such services.
(5) Personnel.
(A) A qualified full-time, part-time, or
consulting radiologist shall supervise the ionizing radiology services and
shall interpret only those radiology tests that are determined by the medical
staff to require a radiologist's specialized knowledge. For purposes of this
section a radiologist is a physician who is qualified by education and
experience in radiology in accordance with medical staff bylaws.
(B) Only personnel designated as qualified by
the medical staff shall use the radiology equipment and administer
procedures.
(6) Records.
Records of radiology services shall be maintained. The radiologist or other
individuals who have been granted privileges to perform radiology services
shall sign reports of his or her interpretations.
(o) Respiratory care services. When
respiratory care services are provided, written policies and procedures shall
be adopted, implemented, and enforced which describe the provision of
respiratory care services in the facility. Personnel qualified to perform
specific procedures and the amount of supervision required for personnel to
carry out specific procedures shall be designated in writing.
(p) Waste and waste disposal.
(1) Special waste and liquid/sewage waste
management.
(A) The hospital shall comply with
the requirements set forth by the department in §§
1.131-
1.137 of
Title 40 (relating to Definition, Treatment, and Disposition of Special Waste
from Health Care Related Facilities) and the Texas Commission on Environmental
Quality (TCEQ) requirements in 30 TAC §330.1207(relating
to Generators of Medical Waste).
(B) All sewage and liquid wastes shall be
disposed of in a municipal sewerage system or a septic tank system permitted by
the TCEQ in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage
Facilities).
(2) Waste
receptacles.
(A) Waste receptacles shall be
conveniently available in all toilet rooms, patient areas, staff work areas,
and waiting rooms. Receptacles shall be routinely emptied of their contents at
a central location(s) into closed containers.
(B) Waste receptacles shall be properly
cleaned with soap and hot water, followed by treatment of inside surfaces of
the receptacles with a germicidal agent.
(C) All containers for other municipal solid
waste shall be leak-resistant, have tight-fitting covers, and be
rodent-proof.
(D) Non-reusable
containers shall be of suitable strength to minimize animal scavenging or
rupture during collection operations.