| (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.
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