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007.05.10-34. Specialized Services: Central Sterilization and Supply.

AR ADC 007.05.10-34Arkansas Administrative CodeEffective: February 5, 2021

West's Arkansas Administrative Code
Title 007. Department of Health
Division 05. Health Facility Services
Rule 10. Rules for Critical Access Hospitals in Arkansas (Refs & Annos)
Effective: February 5, 2021
Ark. Admin. Code 007.05.10-34
007.05.10-34. Specialized Services: Central Sterilization and Supply.
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:
1. Job descriptions;
2. Infection prevention and control measures;
3. Assembly and operation of equipment;
4. Safety practices;
5. Orientation for new employees;
6. Care and cleaning of equipment;
7. Evaluation of:
a. Cleaning effectiveness; and
b. Sterilizing effectiveness.
8. Receiving, decontaminating, cleaning, preparing, disinfecting and sterilizing reusable items;
9. Assembling and wrapping of packs (to include the double-wrapped techniques);
10. Storage and distribution of sterile equipment/medical supplies;
11. Use of chemical indicators and biological spore tests for sterilizers;
12. Recalling and disposing/reprocessing of outdated sterile supplies;
13. Cleaning and disinfecting of surfaces, utensils, and equipment;
14. Specifications for cold-liquid sterilization and gas sterilization (if used); and
15. Collection and disposal of supplies recalled by the manufacturer.
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.
1. Autoclaves shall meet the following requirements:
2. The efficacy of autoclaves, both for routine and immediate use or “flash” use, shall be determined weekly through the use of biological spore monitors:
3. The results of all biological spore monitoring shall be reported to the Infection Prevention and Control Committee; and
4. 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.
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:
1. Be consistent with published industry standards (AAMI and APIC).
2. Stress that sterility is related to integrity of pack regardless of whether expiration dating or event-related expiration is utilized.
N. 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 days
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
NOTE:
1. Sterile storage areas shall maintain a temperature of no more than 75°F and a relative humidity of no more than 70%. Ventilation shall be 10 air changes per hour and shall follow clean to dirty flow.
2. The interior of the dust cover shall not be considered sterile.
3. Packages that are wet, dropped on the floor, compressed or torn shall be rejected.
4. The lot number or control number and expiration statement shall be visible through the package or another tag shall be placed on the outside.
5. Containers for sterilization systems shall be scientifically proven suitable for the specific sterilization cycle used; the container system shall be verified as the correct one for the cycle. (Manufacturer's instructions shall be followed.)
6. Double-wrapped shall mean the end results of the wrapping technique will yield a two-ply covering.
7. The date of sterilization and load control number shall be placed on each sterilized pack.
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:
AUTOCLAVE
LOAD
MINIMAL TIME AT TEMPERATURE
Gravity
Nonporous (Simple Metal Instruments)
3 minutes at 132EC (270EF)1
Gravity
Porous (Towels, Rubber, Plastic) Nonporous Mix
10 minutes at 132EC (270EF)1
Gravity
Nonporous with Lumens, Deep Grooves, Sliding Parts
10 minutes at 132EC (270EF)1
Gravity/Prevacuum
Complex Devices, Air-powered Drills
Per Manufacturer's Instructions
Prevacuum
Nonporous
3 minutes at 132EC (270EF)1
Prevacuum
Porous/Nonporous
4 minutes at 132EC (270EF)1
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.

Credits

Amended Jan. 1, 2016; Feb. 5, 2021.
[FN1]
So in original. Probably should read "132°C (270°F)".
<Statutory authority: Promulgated under the Authority of Ark. Code Ann. § 20-7-123, 20-9-201 et seq.>
Current with amendments received through May 15, 2024. Some sections may be more current, see credit for details.
Ark. Admin. Code 007.05.10-34, AR ADC 007.05.10-34
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