(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 this title (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 §134.131(e) of this title (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.
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