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 and locations of all services provided, be reviewed and kept current per hospital policy, and be readily available to staff. Sterilization and disinfection standards of practice shall be established, kept current, and approved by the hospital’s infection control committee.
6. (6) Written procedures shall specify how items stored in central services can be obtained when central services is considered closed.
7. (7) Reprocessed, reusable 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 not be performed less frequently than 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 have been processed in accordance with the manufacturer’s recommendations to obtain pathogenic microbial kill.
11. (11) Hospital policy shall be developed based on the manufacturer’s recommendations to eliminate the hazards from processed items to patients and staff.

AUTHORITY: section 192.006, RSMo 2000, and sections 197.080 and 197.154, RSMo Supp. 2013.* This rule previously filed as 19 CSR 30-20.021(3)(A). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed Dec. 31, 2013, effective Aug. 30, 2014.

*Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995; and 197.154, RSMo 2004.