Section 503.37 - [Effective 11/29/2024] Infection Control Standards(a) A center shall develop, implement, and enforce written infection control policies and procedures to minimize the transmission of infection. Policies shall include educational course requirements; cleaning and laundry requirements; and decontamination, disinfection, sterilization, and storage of sterile supplies.(b) Universal/standard precautions. (1) Ensure that all staff complies with universal/standard precautions.(2) Establish procedures for monitoring compliance with universal/standard precautions.(3) Enforce a policy to ensure compliance of the center and all of the health care workers within the center with the Health and Safety Code, Chapter 85, Subchapter I, concerning the prevention of the transmission of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) by infected health care workers.(4) Require its health care workers to complete educational course work or training in infection control and barrier precautions, including basic concepts of disease transmission, scientifically accepted principles and practices for infection control and engineering and work practice controls.(c) Cleaning and laundry. (1) Adopt policies and procedures on cleaning the center.(2) Adopt policies and procedures for the handling, processing, storing, and transporting of clean and dirty laundry.(3) A center may provide cleaning and laundry services directly or by contract in accordance with Occupational Safety and Health Association standards.(d) Policies shall include receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of critical items (reusable items), as well as those for the assembly, wrapping, storage, distribution, and quality control of sterile items and equipment. (1) Supervision. Shall be under the supervision of the clinical director.(2) Quantity of sterile surgical instruments. Ensure that surgical instruments are sufficient in number to meet the needs of the center.(3) Inspection of surgical instruments. (A) All instruments shall undergo inspection before being packaged for reuse or storage. Routine inspection of instruments shall be made to assure clean locks, crevices, and serrations.(B) Inspection procedures shall be thorough and include visual and manual inspection for condition and function. (i) Cutting edges shall be checked for sharpness; tips shall be properly aligned, and instruments shall be clean and free from buildup of soap, detergent, dried blood, or tissue.(ii) There shall be no evident cracks or fissures, and the hinges shall work freely.(iii) There shall be no corrosion or pitting of the finish.(iv) Rachets shall hold and be routinely tested.(C) Instruments needing maintenance shall be taken out of service and repaired by a qualified surgical instruments repair person.(D) Instrument identification shall not damage the instrument or its protective finish or compromise the sterilization process.(4) Items to be disinfected and sterilized. (A) Critical items. (i) Must be sterilized in accordance with this subsection.(ii) All items that come in contact with a sterile field during an operative procedure must be sterile.(B) Semi-critical items. High-level disinfection shall be used for semi-critical items.(C) Noncritical items. Intermediate-level or low-level disinfection shall be used for noncritical items.(5) Equipment and sterilization procedures. Effective sterilization of instruments depends on performing correct methods of cleaning, packaging, arrangement of items in the sterilizer, and storage. The following procedures shall be included in the written policies as required in this paragraph to provide effective sterilization measures. (A) Equipment. A center shall provide sterilization equipment adequate to meet the requirements for sterilization of critical items. Equipment shall be maintained and operated to perform, with accuracy, the sterilization of critical items.(B) Sterilizers. Steam sterilizers (saturated steam under pressure) shall be utilized for sterilization of heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions.(C) Environmental requirements. Where cleaning, preparation, and sterilization functions are performed in the same room or unit, soiled or contaminated supplies and equipment shall be physically separated from the clean or sterilized supplies and equipment. (i) A center shall have a sink for hand washing. This sink shall not be used for cleaning instruments or disposal of liquid waste.(ii) A center shall have a separate sink for cleaning instruments and disposal of liquid waste. Hand washing may only be performed at this sink after it has been disinfected.(D) Preparation for sterilization. (i) 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.(ii) One of the following methods of cleaning and decontamination shall be used as appropriate. (I) Manual cleaning. Manual cleaning of instruments at the sink is permitted.(II) Ultrasonic cleaning. The water must be changed more than once a shift. The chambers shall be covered to prevent potential hazards to personnel from aerosolization of the contents.(III) Washer-sterilizers. These machines must reach a temperature of 140 degrees Celsius (285 degrees Fahrenheit).(IV) Washer-decontaminator machines.(iii) 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.(E) Packaging. (i) All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized, and to provide an effective barrier to microorganisms. Acceptable packaging includes peel pouches, perforated metal trays, or rigid trays. Muslin packs must be limited in size to 12 inches by 12 inches by 20 inches with a maximum weight of 12 pounds. Wrapped instrument trays must not exceed 17 pounds.(ii) All items shall be labeled for each sterilizer load as to the date and time of sterilization, the sterilizing load number, and the equipment.(F) External chemical indicators. (i) 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.(ii) The indicator results shall be interpreted according to the manufacturer's written instructions and indicator reaction specifications.(G) Biological indicators. (i) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used.(ii) Biological indicators shall be included in at least one run a month.(iii) If a test is positive, the sterilizer shall immediately be taken out of service. A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations.(iv) All available items shall be recalled and reprocessed if a sterilizer malfunction is found; and a list of all items which were used after the last negative biological indicator test shall be submitted to the administrator.(H) Sterilizers. Sterilizers shall be used according to manufacturer's written instructions.(I) Maintenance of sterility. (i) Items that are properly packaged and sterilized will remain sterile indefinitely unless the package becomes wet or torn, has a broken seal, is damaged in some way, or is suspected of being compromised.(ii) All packages must be inspected before use. If a package is torn, wet, discolored, has a broken seal, or is damaged, the item may not be used. The item must be returned to sterile processing for reprocessing.(J) Commercially packaged items. Commercially packaged items are considered sterile according to the manufacturer's instructions.(K) Storage of sterilized items. The loss of sterility is event-related, not time related. The center shall ensure proper storage and handling of items in a manner that does not aid the compromise of the packaging of the product. (i) Sterilized items shall be transported so as to maintain cleanliness, sterility, and to prevent physical damage.(ii) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity.(iii) Sterilized items shall be positioned so that the packaging is not crushed, bent, compressed, or punctured.(iv) Storage of supplies shall be in areas that are designated for storage.(L) Disinfection. (i) The manufacturer's written instructions for the use of disinfectants shall be followed.(ii) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution currently in use.(iii) Disinfectant solutions shall be kept covered and used in well-ventilated areas.(M) Performance records. (i) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of two years.(ii) Each sterilizer shall be monitored during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained either manually or machine generated and shall include: (I) the sterilizer identification;(II) sterilization date and time;(IV) duration and temperature of exposure phase;(V) identification of operator(s);(VI) results of biological tests and dates performed; and(VII) time-temperature recording charts from each sterilizer.(N) Preventive maintenance of all sterilizers shall be performed according to policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A record shall be maintained for each sterilizer, retained at least two years, and shall be available for review.26 Tex. Admin. Code § 503.37
Transferred from 25 TAC § 137.37 Texas Register, Volume 49, Number 45, November 8, 2024, TexReg 9022 eff. 11/29/2024