Section 0940-05-16-.15 - HOSPITAL CENTRAL STERILE SUPPLY AND CONTROL(1) Sterilizing equipment must be under the supervision of a qualified individual. This qualification consists of a working knowledge of basic bacteriology and principles of sterilization gained through education and experience.(2) Sterilizer function must be checked by bacterological, mechanical and chemical indicators.(3) Autoclave functions will be monitored daily by use of mechanical and chemical indicators. Autoclaves equipped with vacuum pumps must be monitored once daily with an appropriate test to verify proper mechanical function. Biological testing must be conducted a minimum of once weekly using a heat-resistant, spore-forming organism.(4) Ethylene oxide sterilizers must be checked with mechanical and chemical indicators to verify proper operation of the sterilizer. In addition, each cycle of the sterilizer must be tested with a suitable bacteria.(5) All bacteria must be cultured at the temperature recommended by the supplier.(6) Precautions must be taken so that soiled supplies cannot contaminate sterile supplies. Sterile supplies must be packaged and stored in a manner that will protect the sterility of the contents. There must be separation between decontamination and preparation areas.(7) Infection control policies and procedures must be developed pertaining to the control of infection by screening and treatment of sick employees and orientation of all central supply personnel in aseptic techniques and in the prevention of contamination through the handling, cleaning and sterilizing of contaminated supplies and equipment.(8) All packages or containers must be appropriately labeled. If processed by sterilizing, the label must remain legible. In addition, the label must contain an expiration date.(9) A written policy governing expiration dates and procedures for collecting out-of-date or recalled supplies must be formulated.(10) Storage must be provided for keeping equipment and supplies in a clean, convenient and orderly manner.(11) In lieu of closed storage spaces, dust covers sealed to exclude outside air may be used.Tenn. Comp. R. & Regs. 0940-05-16-.15
Original rule filed May 26, 1988; effective July 11, 1988.Authority: T.C.A. § 33-2-504.