Section 509.57 - Sterilization(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;(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.26 Tex. Admin. Code § 509.57
Adopted by Texas Register, Volume 48, Number 48, December 1, 2023, TexReg 7072, eff. 12/4/2023