A. Each hospital shall provide central medical and surgical supply services with facilities that are responsible for processing, sterilizing, storing, distributing supplies and equipment to all units of the hospital. (Refer to Section 66, Physical Facilities, Central Medical and Surgical Supply Department, for space and equipment requirements.)

B. The central sterilization and supply service shall be under the direct supervision of a Registered Nurse or other qualified person who is trained in management, aseptic procedures, supply processing and control methods which are applicable to central sterilization and supply service.

C. Policies and procedures shall have evidence of ongoing review and/or revision. The first page of each manual shall have the annual review date, signature of the department and/or person(s) conducting the review.

D. Policies and procedures shall include:

E. There shall be an ongoing QA/PI program specific to the area.

F. Precautions shall be exercised to prevent the mixing of sterile and unsterile supplies and equipment. The precautions shall be set forth in written policies.

G. Procedures shall be developed for unloading and transporting flash sterilized items. The procedures shall be developed with the assistance of the Infection Prevention and Control Committee and shall provide for the aseptic transfer within the physical constraints of the facility.

H. Relevant educational programs shall be conducted on a regularly scheduled basis not less than 12 per year. There shall be written documentation with employee signature, program title/subject, presenter, date and outline or narrative of presented program.

I. A liaison with the Infection Prevention and Control Committee shall be maintained.

J. Records shall be maintained of all autoclave loads, both routine and immediate use or “flash,” which shall include the date, time, lot number (on routine loads), the time at temperature (where a recorder is not available), item(s) sterilized and shall identify the person performing the task.

NOTE: All materials sterilized from the date of the biological spore monitor failure to the last successful biological spore monitor shall be re-sterilized before use.

K. All autoclaves within the facility shall be maintained in accordance with the manufacturer's written directions. Records shall be maintained of all maintenance and repairs for the life of the equipment.

L. Chemical indicators for sterility shall be used with each cycle

M. The facility shall validate compliance and efficacy of the sterilization policy through the quality review process. The sterilization policy shall describe the mechanism used to determine the shelf life of sterilized packages. The policy shall:

N. Event-related dating of sterile packs is acceptable.

NOTE:

O. Immediate use or “flash” (autoclaving) shall be restricted to unplanned or emergency situations. Flash sterilization shall never be used as a convenience to compensate for inadequate inventories of instruments or implantables. Flash sterilization of implantables shall be restricted to the direst circumstances.

P. Items which are to be immediate use flash sterilized shall be cleaned and decontaminated before the sterilization process.

Q. Traffic areas in which immediate use or flash sterilization is carried out shall be restricted to authorized personnel wearing surgical attire consisting of surgical scrubs, shoe covers, masks and hair covers. The sterilizer shall not be located adjacent to any potential sources of contamination such as scrub sinks, clinical sinks or hoppers, wash sinks, linen or trash disposal areas.

R. For immediate use or flash sterilization, minimal time at effective temperature shall conform to the following:

S. Items that previously have been packaged, sterilized, and issued, but not used may be returned to the sterile storage area if the integrity of the packaging has not been compromised and there is no evidence of contamination; such items may be dispensed when needed.

Items that previously have been packaged, sterilized and issued to the patient care units or other areas where the environment is not controlled shall be discarded if they are single use items, or unwrapped and reprocessed through decontamination if they are reusable.

T. Sterile materials shall be stored eight to ten inches from the floor and at least 18 inches from the ceiling and at least two inches from outside walls. Items shall be positioned so that packages are not crushed, bent, compressed, or punctured and sterility is not compromised.

U. All sterilization techniques other than steam (plasma, ethylene oxide, chemical, etc.) shall follow the manufacturer's directions and meet all state and federal regulations.