Current through Reg. 49, No. 38; September 20, 2024
(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.
