Current through Reg. 49, No. 38; September 20, 2024
(a) A limited
services rural hospital (LSRH) staff qualified by education, training, and
experience shall supervise all supplies and equipment sterilization in an LSRH.
An LSRH shall ensure:
(1) staff responsible
for sterilizing supplies and equipment participate in a documented continuing
education program;
(2) new
employees receive initial orientation and on-the-job training; and
(3) staff using chemical disinfectants
received training on their use.
(b) An LSRH shall adopt, implement, and
enforce written policies and procedures for performing decontamination and
sterilization activities.
(1) Policies shall
include the receiving, cleaning, decontaminating, disinfecting, preparing, and
sterilizing of reusable items, as well as the assembly, wrapping, storage,
distribution, and quality control of sterile items and equipment.
(2) The infection control program shall
review and approve the written policies at least every other year.
(c) An LSRH shall provide
equipment adequate for supplies and equipment sterilization as needed. The LSRH
shall maintain and operate sterilization equipment to accurately sterilize the
various materials required for sterilization.
(d) Where cleaning, preparation, and
sterilization functions are performed in the same room or unit, the physical
facilities, equipment, and policies and procedures for their use, shall
effectively separate soiled or contaminated supplies and equipment from clean
or sterilized supplies and equipment. An LSRH shall provide hand-washing
facilities and a separate sink for safe disposal of liquid waste.
(e) An LSRH shall clearly label all
containers for solutions, drugs, flammable solvents, ether, alcohol, and
medicated supplies to indicate contents.
(1)
Containers sterilized by the LSRH shall be labeled to be identifiable before
and after sterilization.
(2)
Sterilized items shall have a load control identification that indicates the
sterilizer used, the cycle or load number, and the date of
sterilization.
(f) An
LSRH shall ensure staff use the appropriate sterilizer, as indicated in the
following paragraphs, when sterilizing materials and items. An LSRH shall use:
(1) steam sterilizers (saturated steam under
pressure) to sterilize heat-and moisture-stable items according to the
manufacturer's written instructions;
(2) ethylene oxide (EO) sterilizers for
processing heat and moisture sensitive items (the LSRH shall use and vent EO
sterilizers and aerators according to the manufacturer's written instructions);
and
(3) flash sterilizers only for
emergency sterilization of clean, unwrapped instruments approved by the
manufacturer for flash sterilization and according to the manufacturer's
written instructions.
(g)
Before sterilization, an LSRH shall reduce the bioburden by:
(1) thoroughly cleaning, decontaminating, and
preparing all items in a clean, controlled environment;
(2) arranging all articles in preparation for
sterilization so all surfaces will be directly exposed to the sterilizing agent
for the prescribed time and temperature; and
(3) packaging all wrapped articles in
preparation for sterilization in materials recommended for the specific type of
sterilizer and material to be sterilized.
(h) An LSRH shall use external chemical
indicators, also known as sterilization process indicators, on each package in
preparation for sterilization, including items being flash sterilized to
indicate that items have been exposed to the sterilization process.
(1) The LSRH shall interpret indicator
results according to manufacturer's written instructions and indicator reaction
specifications.
(2) The LSRH shall
maintain a log with the load identification, indicator results, and
identification of the contents of the load.
(i) An LSRH shall use biological indicators
to verify the performance of waste treatment equipment and processes (or
sterilization equipment and processes). The LSRH shall:
(1) monitor the sterilizing process efficacy
using reliable biological indicators appropriate for the type of sterilizer
used;
(2) include biological
indicators in at least one run each week of use for steam sterilizers, at least
one run each day of use for low-temperature hydrogen peroxide gas sterilizers,
and every load for EO sterilizers;
(3) include biological indicators in every
load that contains implantable objects;
(4) maintain a log with the load
identification, biological indicator results, and identification of the
contents of the load; and
(5) take
a sterilizer out of service immediately if a test is positive and shall:
(A) recall and reprocess implantable items if
a biological indicator test (spore test) is positive;
(B) recall and reprocess all available items
when a sterilizer malfunction is found and submit a list of those items not
retrieved in the recall to infection control; and
(C) not put a malfunctioning sterilizer back
into use until it has been serviced and successfully tested according to the
manufacturer's recommendations.
(j) An LSRH shall adopt, implement, and
enforce written policies, approved by the infection control program, for the
use of chemical disinfectants. The LSRH:
(1)
shall follow the manufacturer's written instructions for the use of
disinfectants;
(2) shall mark an
expiration date, determined according to manufacturer's written
recommendations, on the container of disinfection solution currently in
use;
(3) shall keep disinfectant
solutions covered and used in well-ventilated areas;
(4) may use chemical germicides that are
registered with the United States Environmental Protection Agency as
"sterilants" either for sterilization or high-level disinfection; and
(5) shall provide training to all staff and
personnel who use chemical disinfectants on their use.
(k) The LSRH shall maintain performance
records for all sterilizers for each cycle. The LSRH must retain and have these
records available for review for at least five years.
(l) The LSRH shall continuously monitor each
sterilizer during operation for pressure, temperature, and time at desired
temperature and pressure. A record shall be maintained and shall include:
(1) the sterilizer identification;
(2) sterilization date;
(3) cycle number;
(4) contents of each load;
(5) duration and temperature of exposure
phase (if not provided on sterilizer recording charts);
(6) identification of operators;
(7) results of biological tests and dates
performed;
(8) time-temperature
recording charts from each sterilizer;
(9) gas concentration and relative humidity
(if applicable); and
(10) any other
test results.
(m) An LSRH
shall comply with the following requirements for storing sterilized items.
(1) The LSRH shall transport sterilized items
so as to maintain cleanliness and sterility and to prevent physical
damage.
(2) The LSRH shall store
sterilized items in well-ventilated, limited access areas with controlled
temperature and humidity.
(3) The
LSRH shall adopt, implement and enforce a policy that describes the mechanism
used to determine the shelf life of sterilized packages.
(n) Qualified personnel shall perform
preventive maintenance of all sterilizers according to adopted, implemented,
and enforced policy on a scheduled basis, using the sterilizer manufacturer's
service manual as a reference. An LSRH shall:
(1) maintain a preventive maintenance record
for each sterilizer,
(2) retain
these records for at least two years, and
(3) ensure their availability for review at
the facility within two hours of request by HHSC.
