1. (a)

   1. (1) Each hospital shall provide central medical and surgical supply services with facilities that are responsible for processing, sterilizing, storing, and distributing supplies and equipment to all units of the hospital.
   2. (2) Refer to 20 CAR § 41-165, physical facilities — central medical and surgical supply department for space and equipment requirements.
2. (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 that are applicable to central sterilization and supply service.

3. (c)

   1. (1) Policies and procedures shall have evidence of ongoing review and/or revision.

   2. (2) The first page of each manual shall have the:

      1. (A) Annual review date; and
      2. (B) Signature of the department and/or person or persons conducting the review.

4. (d) Policies and procedures shall include:

   1. (1) Job descriptions;
   2. (2) Infection prevention and control measures;
   3. (3) Assembly and operation of equipment;
   4. (4) Safety practices;
   5. (5) Orientation for new employees;
   6. (6) Care and cleaning of equipment;

   7. (7) Evaluation of:

      1. (A) Cleaning effectiveness; and
      2. (B) Sterilizing effectiveness;
   8. (8) Receiving, decontaminating, cleaning, preparing, disinfecting, and sterilizing reusable items;
   9. (9) Assembling and wrapping of packs to include the double-wrapped techniques;
   10. (10) Storage and distribution of sterile equipment/medical supplies;
   11. (11) Use of chemical indicators and biological spore tests for sterilizers;
   12. (12) Recalling and disposing/reprocessing of outdated sterile supplies;
   13. (13) Cleaning and disinfecting of surfaces, utensils, and equipment;
   14. (14) Specifications for cold-liquid sterilization and gas sterilization, if used; and
   15. (15) Collection and disposal of supplies recalled by the manufacturer.
5. (e) There shall be an ongoing QA/PI program specific to the area.

6. (f)

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

7. (g)

   1. (1) Procedures shall be developed for unloading and transporting flash-sterilized items.

   2. (2) The procedures shall:

      1. (A) Be developed with the assistance of the Infection Prevention and Control Committee; and
      2. (B) Provide for the aseptic transfer within the physical constraints of the facility.

8. (h)

   1. (1) Relevant educational programs shall be conducted on a regularly scheduled basis of not less than twelve (12) per year.

   2. (2) There shall be written documentation with:

      1. (A) Employee signature;
      2. (B) Program title/subject;
      3. (C) Presenter;
      4. (D) Date; and
      5. (E) Outline or narrative of presented program.
9. (i) A liaison with the Infection Prevention and Control Committee shall be maintained.

10. (j)

    1. (1) Records shall be maintained of all autoclave loads, both routine and immediate use or “flash” that shall:

       1. (A) Include the date, time, lot number on routine loads, the time at temperature where a recorder is not available, and item or items sterilized; and
       2. (B) Identify the person performing the task.

    2. (2) Autoclaves shall meet the following requirements:

       1. (A) The efficacy of autoclaves, both for routine and immediate use or “flash” use, shall be determined weekly through the use of biological spore monitors;
       2. (B) The results of all biological spore monitoring shall be reported to the Infection Prevention and Control Committee; and
       3. (C) Failures of the biological spore test shall be brought to the attention of the Infection Prevention and Control Officer or designee immediately so the appropriate surveillance measures can be initiated.
    3. (3) Note. All materials sterilized from the date of the biological spore monitor failure to the last successful biological spore monitor shall be resterilized before use.

11. (k)

    1. (1) All autoclaves within the facility shall be maintained in accordance with the manufacturer’s written directions.
    2. (2) Records shall be maintained of all maintenance and repairs for the life of the equipment.
12. (l) Chemical indicators for sterility shall be used with each cycle.

13. (m)

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

    3. (3) The policy shall:

       1. (A) Be consistent with published industry standards (AAMI and APIC); and
       2. (B) Stress that sterility is related to integrity of pack regardless of whether expiration dating or event-related expiration is utilized.

14. (n)

    1. (1) Event-related dating of sterile packs is acceptable.

       	ALLOWABLE SHELF LIFE
       Double-wrapped Muslin	Use for rapid turn-around items only in well controlled environment, < 30
       Double-wrapped Muslin Placed in a Plastic Dust Cover Then Heat Sealed or Bonded	Event related
       Paper or Polypropylene Peel Pack (Paper, Plastic or Tyvek/Mylar)	Event related and/or per manufacturer’s instructions
       Rigid Containers, Caskets, Etc.	Per Manufacturer’s Instructions

    2. (2) Note.

       1. (A)
15. (i) Sterile storage areas shall maintain a:
16. (a) (a) Temperature of no more than seventy-five degrees Fahrenheit (75°F); and

17. (b) (b) Relative humidity of no more than seventy percent (70%).

    1. (ii) Ventilation shall:
18. (a) (a) Be ten (10) air changes per hour; and

19. (b) (b) Follow clean to dirty flow.

    1. (B) The interior of the dust cover shall not be considered sterile.

       1. (C) Packages that are wet, dropped on the floor, compressed, or torn shall be rejected.
       2. (D) The lot number or control number and expiration statement shall be visible through the package or another tag shall be placed on the outside.

       3. (E)

          1. (i)
20. (a) (a) Containers for sterilization systems shall be scientifically proven suitable for the specific sterilization cycle used.

21. (b) (b) The container system shall be verified as the correct one for the cycle.

    1. (ii) Manufacturer’s instructions shall be followed.

       1. (F) Double-wrapped shall mean the end results of the wrapping technique will yield a two-ply covering.
       2. (G) The date of sterilization and load control number shall be placed on each sterilized pack.

22. (o)

    1. (1) Immediate use or “flash” (autoclaving) shall be restricted to unplanned or emergency situations.
    2. (2) Flash sterilization shall never be used as a convenience to compensate for inadequate inventories of instruments or implantables.
    3. (3) Flash sterilization of implantables shall be restricted to the direst circumstances.
23. (p) Items that are to be immediate-use flash-sterilized shall be cleaned and decontaminated before the sterilization process.

24. (q)

    1. (1) Traffic areas in which immediate use or flash sterilization is carried out shall be restricted to authorized personnel wearing surgical attire consisting of:

       1. (A) Surgical scrubs;
       2. (B) Shoe covers;
       3. (C) Masks; and
       4. (D) Hair covers.

    2. (2) The sterilizer shall not be located adjacent to any potential sources of contamination such as:

       1. (A) Scrub sinks;
       2. (B) Clinical sinks or hoppers;
       3. (C) Wash sinks;
       4. (D) Linen; or
       5. (E) Trash disposal areas.
25. (r) For immediate use or flash sterilization, minimal time at effective temperature shall conform to the following:

    AUTOCLAVE	LOA	MINIMAL TIME AT TEMPERATURE
    Gravity	Nonporous (Simple Metal Instruments)	3 minutes at 132ΕC (270ΕF)
    Gravity	Porous (Towels, Rubber, Plastic) Nonporous Mix	10 minutes at 132ΕC (270ΕF)
    Gravity	Nonporous with Lumens, Deep Grooves, Sliding Parts	10 minutes at 132ΕC (270ΕF)
    Gravity/Prevacuum	Complex Devices, Air-powered Drills	Per Manufacturer’s Instructions
    Prevacuum	Nonporous	3 minutes at 132ΕC (270ΕF)
    Prevacuum	Porous/Nonporous	4 minutes at 132ΕC (270ΕF)

26. (s)

    1. (1)

       1. (A) Items that previously have been packaged, sterilized, and issued but not used may be returned to the sterile storage area if:

          1. (i) The integrity of the packaging has not been compromised; and
          2. (ii) There is no evidence of contamination.
       2. (B) Such items may be dispensed when needed.

    2. (2) 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:

       1. (A) Discarded if they are single-use items; or
       2. (B) Unwrapped and reprocessed through decontamination if they are reusable.

27. (t)

    1. (1) Sterile materials shall be stored:

       1. (A) Eight to ten inches (8” – 10”) from the floor;
       2. (B) At least eighteen inches (18”) from the ceiling; and
       3. (C) At least two inches (2”) from outside walls.

    2. (2) Items shall be positioned so that:

       1. (A) Packages are not crushed, bent, compressed, or punctured; and
       2. (B) Sterility is not compromised.

28. (u) All sterilization techniques other than steam (plasma, ethylene oxide, chemical, etc.) shall:

    1. (1) Follow the manufacturer’s directions; and
    2. (2) Meet all state and federal regulations.

Codification Notes: “AAMI” means Association for the Advancement of Medical Instrumentation. "APIC" means Association for Professionals in Infection Control and Epidemiology. "QA/PI" means quality assurance/performance improvement.