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RULE §511.73Sterilization

(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.

Source Note: The provisions of this §511.73 adopted to be effective October 5, 2023, 48 TexReg 5668

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