PURPOSE: This rule specifies the manner in which central services shall be organized and integrated in a hospital.

1. (1) Central services shall be organized and integrated with patient care services in the hospital.
2. (2) The director of central services shall be qualified by education, training and experience in aseptic technique, principles of sterilization and disinfection and distribution of medical/surgical supplies. The director shall be responsible to an administrative officer or a qualified designee.
3. (3) Sufficient supervisory and support staff shall be assigned as related to the scope of services provided.
4. (4) Sufficient space and equipment shall be provided for the safe and efficient operation of the services as determined by the scope of hospital services delivered.
5. (5) Policies and procedures shall define the activities of all services provided. Sterilization and disinfection standards of practice shall be established. The principles of the Association for Practitioners in Infection Control, Association of Operating Room Nurses, Center for Disease Control and Prevention, American Society for Healthcare Central Service Personnel, Association for the Advancement of Medical Instrumentation, and others may be utilized to establish facility standards of practice for central services.
6. (6) Written procedures shall specify how items stored in central services can be obtained when central services is considered closed.
7. (7) Reprocessed packaged item(s) shall be identified as to content, show evidence of sterilization and be labeled indicating the sterilizer used and the load/cycle number. A policy on the shelf life of a packaged sterile item shall be established in accordance with acceptable standards of sterilization and dependent on the quality of the packaging material, storage conditions and the amount of handling of the item.
8. (8) Central services shall maintain documentation from the manufacturer that packaging material utilized for reprocessing is appropriate for this use. Expiration dates shall comply with the packaging material utilized.
9. (9) Sterile medical-surgical packaged items shall be handled only as necessary and stored in vermin-free areas where controlled ventilation, temperature and humidity are maintained. The integrity of sterile items shall be maintained throughout reprocessing, storage, distribution and transportation.
10. (10) Preventive maintenance of equipment shall be done as recommended by the manufacturer or as specified by hospital policy. Records shall be maintained as specified by hospital policy. Records shall include documentation that items processed by steam have undergone sufficient time, temperature and pressure and that items processed by ethylene oxide have undergone sufficient time, temperature, gas concentration and humidity to obtain pathogenic microbial kill.
11. (11) Ethylene oxide sterilized items shall be aerated as specified by hospital policy based on the manufacturer’s recommendations to eliminate the hazards of toxic residue for both patient and staff.
12. (12) Principles of sterilization and disinfection as approved by the hospital’s infection control committee shall apply throughout the hospital when central services activities are decentralized.

AUTHORITY: sections 192.006 and 197.080, RSMo 2000 and 197.154, RSMo Supp. 2007.* This rule previously filed as 19 CSR 30-20.021(3)(A). Original rule filed June 27, 2007, effective Feb. 29, 2008. *Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo 2004.