| (a) A person qualified by education, training, and
experience shall supervise the sterilization of all supplies and equipment.
Staff responsible for sterilizing supplies and equipment shall participate
in a documented continuing education program. New employees shall
receive initial orientation and on-the-job training. Staff using chemical
disinfectants shall have received training on their use.
(b) The facility shall adopt, implement, and enforce
written policies and procedures for decontamination and sterilization
activities. Policies shall include receiving, cleaning, decontaminating,
disinfecting, preparing, and sterilizing reusable items, as well as
assembling, wrapping, storing, distributing, and quality control of
sterile items and equipment. The infection control practitioner or
committee shall review and approve these written policies at least
every other year.
(c) Every facility shall provide equipment adequate
for sterilizing supplies and equipment, as needed. Equipment shall
be maintained and operated to accurately sterilize the various materials
required.
(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. Hand-washing facilities shall
be provided, and a separate sink shall be provided for safe disposal
of liquid waste.
(e) All containers for solutions, drugs, flammable
solvents, ether, alcohol, and medicated supplies shall be clearly
labeled to indicate contents. Containers that are sterilized by the
facility shall be labeled to be identifiable before and after sterilization.
Sterilized items shall have a load control identification that indicates
the sterilizer used, the cycle or load number, and the sterilization
date.
(f) A facility shall comply with the following sterilizer
requirements.
(1) Steam sterilizers (saturated steam under pressure)
shall be used to sterilize heat- and moisture-stable items. Steam
sterilizers shall be used according to manufacturer's written instructions.
(2) Ethylene oxide (EO) sterilizers shall be used for
processing heat- and moisture-sensitive items. EO sterilizers and
aerators shall be used and vented according to the manufacturer's
written instructions.
(3) Flash sterilizers shall be used only for emergency
sterilization of clean, unwrapped instruments and porous items.
(g) A facility shall comply with the following sterilization
preparation requirements.
(1) All items to be sterilized shall be prepared to
reduce the bioburden. All items shall be thoroughly cleaned, decontaminated,
and prepared in a clean, controlled environment.
(2) All articles to be sterilized shall be arranged
so all surfaces will be directly exposed to the sterilizing agent
for the prescribed time and temperature.
(3) All wrapped articles to be sterilized shall be
packaged in materials recommended for the specific type of sterilizer
and material to be sterilized.
(h) A facility shall comply with the following external
chemical indicator requirements.
(1) External chemical indicators, also known as sterilization
process indicators, shall be used on each package to be sterilized,
including items being flash sterilized to indicate that items have
been exposed to the sterilization process.
(2) The indicator results shall be interpreted according
to manufacturer's written instructions and indicator reaction specifications.
(3) A log shall be maintained with the load identification,
indicator results, and identification of the contents of the load.
(i) Biological indicators are commercially available
microorganisms (e.g., United States Food and Drug Administration-approved
strips or vials of Bacillus species endospores) that can be used to
verify the performance of waste treatment equipment and processes
or sterilization equipment and processes.
(1) The efficacy of the sterilizing process shall be
monitored with reliable biological indicators appropriate for the
type of sterilizer used.
(2) Biological indicators shall be included 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) Biological indicators shall be included in every
load that contains implantable objects.
(4) A log shall be maintained with the load identification,
biological indicator results, and identification of the contents of
the load.
(5) If a test is positive, the sterilizer shall immediately
be taken out of service.
(A) Implantable items shall be recalled and reprocessed
if a biological indicator test (spore test) is positive.
(B) All available items shall be recalled and reprocessed
if a sterilizer malfunction is found, and a list of those items not
retrieved in the recall shall be submitted to infection control.
(C) A malfunctioning sterilizer shall not be put back
into use until it has been serviced and successfully tested according
to the manufacturer's recommendations.
(j) A facility shall comply with the following disinfection
requirements.
(1) The facility shall adopt, implement, and enforce
written policies, approved by the infection control committee, for
the use of chemical disinfectants.
(2) The manufacturer's written instructions for the
use of disinfectants shall be followed.
(3) An expiration date, determined according to manufacturer's
written recommendations, shall be marked on the container of disinfection
solution currently in use.
(4) Disinfectant solutions shall be kept covered and
used in well-ventilated areas.
(5) Chemical germicides that are registered with the
United States Environmental Protection Agency as "sterilants" may
be used either for sterilization or high-level disinfection.
(6) All staff personnel using chemical disinfectants
shall receive training on their use.
(k) A facility shall comply with the following performance
record requirements.
(1) Performance records for all sterilizers shall be
maintained for each cycle. These records shall be retained and available
for review for a minimum of five years.
(2) Each sterilizer shall be monitored continuously
during operation for pressure, temperature, and time at desired temperature
and pressure. A record shall be maintained and shall include:
(A) the sterilizer identification;
(B) sterilization date;
(C) cycle number;
(D) contents of each load;
(E) duration and temperature of exposure phase (if
not provided on sterilizer recording charts);
(F) identification of operator or operators;
(G) results of biological tests and dates performed;
(H) time-temperature recording charts from each sterilizer;
(I) gas concentration and relative humidity (if applicable);
and
(J) any other test results.
(l) Storage of sterilized items shall comply with the
following requirements.
(1) Sterilized items shall be transported to maintain
cleanliness and sterility and to prevent physical damage.
(2) Sterilized items shall be stored in well-ventilated,
limited access areas with controlled temperature and humidity.
(3) The facility shall adopt, implement, and enforce
a policy that describes the mechanism used to determine the shelf
life of sterilized packages.
(m) Qualified personnel shall perform preventive maintenance
of all sterilizers on a scheduled basis according to adopted, implemented,
and enforced policy, using the sterilizer manufacturer's service manual
as a reference. A preventive maintenance record shall be maintained
for each sterilizer. These records shall be retained at least two
years and shall be available for review at the facility within two
hours of request by the Texas Health and Human Services Commission.
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