Central Service Regulations For Hospitals


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CENTRAL SERVICE REGULATIONS FOR
HOSPITALS
Last updated July 2014
Legal disclaimer: The International Association of Healthcare Central Service Materiel Management (IAHCSMM) provides the information in this document for informational purposes only and does not offer legal advice. IAHCSMM recommends that individuals or healthcare facilities consult with their attorneys for answers to legal questions. The information in this document should not be considered complete or exhaustive and may not reflect the most current information. As a result, IAHCSMM does not represent that the information contained herein is complete, accurate and up to date.

STATE Alabama

CITATION

REGULATORY LANGUAGE

ALABAMA STATE BOARD OF HEALTH
ALABAMA DEPARTMENT OF PUBLIC HEALTH
DIVISION OF LICENSURE AND CERTIFICATION CHAPTER 420-5-7: HOSPITALS

SURGICAL DEPARTMENT
(1) Disposable equipment is recommended for administering care to patients in isolation.
(2) The central sterilizing and supply room should be located adjacent to the surgical department.

Ala. Admin. Code r. 420-5-7, Appendix B

Alaska

TITLE 7. HEALTH AND SOCIAL SERVICES PART
1. ADMINISTRATION CHAPTER 12. FACILITIES
AND LOCAL UNITS ARTICLE 12. GENERAL
PROVISIONS
7 Alaska Admin. Code 12.730

7 AAC 12.730. Central service (a) If a facility processes sterilized instruments and supplies, it must meet the requirements in this section. If a facility receives sterilized instruments and supplies from another entity through contract or agreement, the facility must ensure the contractor meets the requirements in this section.
(b) A facility must maintain a separate area for processing, decontamination, if necessary, and storage of sterile supplies and materials.
(c) A facility must develop and implement written policies and procedures for the cleaning, antimicrobial processing, and storage of supplies and equipment to prevent the transmission of infection through their use.

(d) Traffic in an area designated for processing, decontamination, and storage of supplies must be restricted to properly attired authorized personnel. Birth centers, frontier extended stay clinics, and nursing homes are not required to comply with this subsection.

(e) Shipping cartons may not be stored with sterile products.

(f) A facility must retain records of bacteriological efficiency monitoring of autoclaves at recommended frequency for three years.

(g) Instructions for the operation of autoclaves must be posted near the equipment.

(h) Each facility must maintain a retrieval system for supplies whose sterility is questionable.

(i) A hospice agency that does not provide inpatient care on agency premises is exempt from the requirements of this section.

Arizona Arkansas

NONE
007 DEPARTMENT OF HEALTH
05 HEALTH FACILITY SERVICES
002. CRITICAL ACCESS HOSPITALS

Section 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 Section62, 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 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 Control Committee and shall provide for the aseptic transfer within the physical constraints of the facility.
H. Relevant educational programs shall be conducted at regularly scheduled intervals with no 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 Control Committee shall be maintained.
J. Records shall be maintained of all autoclave loads, both routine and "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.
K. Autoclaves shall meet the following requirements:

1. The efficacy of autoclaves, both for routine and "flash" use, shall be determined weekly through the use of biological spore monitors; 2. The results of all biological spore monitoring shall be reported to the Infection Control Committee; and 3. Failures of the biological spore test shall be brought to the attention of the Infection 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 resterilized before use. L. 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.
M. Chemical indicators for sterility shall be used with each cycle.
N. The facility shall validate compliance and efficacy of the sterilization policy through the quality review process. The sterization 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.
O. Event-related/Indefinite dating of sterile packs is acceptable.
NOTE: 1. Stock rotation shall be based on the "first in-first out" principle. 2. Sterile storage areas shall maintain a temperature (75:F) and a relative humidity of 70%. Ventilation shall be 10air changes per hour and shall follow clean to dirty flow. 3. The interior of the dust cover shall not be considered sterile.

4. Indefinitely dated items shall be labeled with the date of sterilization and state "contents sterile unless package is damaged." Packages that are wet, dropped on the floor, compressed, or torn shall be rejected. 5. The lot number or control number and expiration statement shall be visible through the package or another tag shall be placed on the outside. 6. 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.) 7. Double-wrapped shall mean the end results of the wrapping technique will yield an envelope within an envelope. 8. The date of sterilization and load control number shall be placed on each sterilized pack.
P. 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.
Q. Items which are to be flash sterilized shall be cleaned and decontaminated before the sterilization process.
R. Traffic areas in which 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.
S. For flash sterilization, minimal time at effective temperature shall conform to the following:
T. Items that previously have been packaged, sterilized, and issued, but not used may be

California

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.

U. Sterile materials must be stored 8 to 10 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.

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

TITLE 22. SOCIAL SECURITY
DIVISION 5. LICENSING AND CERTIFICATION OF
HEALTH FACILITIES, HOME HEALTH
AGENCIES, CLINICS, AND REFERRAL AGENCIES CHAPTER 1. GENERAL
ACUTE CARE HOSPITALS ARTICLE 8. PHYSICAL PLANT

§ 70831. Central Sterile Supply
(a) Each hospital shall provide, prepare, sterilize and store sufficient sterile supplies and medical and surgical equipment and shall dispense them to all services in the hospital. The operation of this service shall be carried out in an area designated, equipped and staffed for this purpose.
(b) A person shall be designated to be in charge of the central sterile supply.
(c) There shall be written procedures developed and maintained pertaining to the cleaning, preparation, disinfection and sterilization of utensils, instruments, solutions, dressings and other articles.

(d) There shall be effective separation of soiled or contaminated supplies and equipment

from the clean and sterilized supplies and equipment.
(e) Sterile supplies and equipment shall be stored in clean cabinets, cupboards or other satisfactory spaces. An orderly system of rotation of supplies shall be used so that supplies stored first will be used first. § 72619. Space and Equipment for Autoclaving, Sterilizing and Disinfecting

TITLE 22. SOCIAL SECURITY
DIVISION 5. LICENSING AND CERTIFICATION OF
HEALTH FACILITIES, HOME HEALTH
AGENCIES, CLINICS, AND REFERRAL AGENCIES CHAPTER 3. SKILLED NURSING FACILITIES ARTICLE 6. PHYSICAL PLANT

(a) A facility shall:
(1) Maintain disposable sterile supplies in the amount necessary to meet the anticipated needs of the patients, or (2) Maintain autoclave equipment, or (3) Make contractual arrangements for outside autoclaving and sterilizing services.
(b) If a facility maintains a central supply and sterilizing area, it shall include but not be limited to:
(1) An autoclave or sterilizer, which shall be maintained in operating condition at all times.

(A) Autoclaves shall be equipped with time recording thermometers in addition to the standard mercury thermometers, except for portable sterilizers and autoclaves.

(B) Instructions for operating autoclaves and sterilizers shall be posted in the area where the autoclaves and sterilizers are located.

(2) Work space. (3) Storage space for sterile supplies. (4) Storage space for unsterile supplies. (5) Equipment for cleaning and sterilizing of utensils and supplies.

Colorado

(c) The facility shall provide for:

(1) Effective separation of soiled and contaminated supplies and equipment from the clean and sterilized supplies and equipment. (2) Clean cabinets for the storage of sterile supplies and equipment. (3) An orderly system of rotation of supplies so that the supplies stored first shall be used first and that multi-use supplies shall be reautoclaved as they become outdated. (4) Dating of materials sterilized. (5) Loading of the autoclave or sterilizer. (6) Checking of recording and indicating thermometers. Recording thermometer charts shall be on file for one year. (7) Conducting monthly bacteriological tests. Reports of test results for the last 12 months shall be retained on file. (8) Length of aeration time for materials that are gas-sterilized.

DEPARTMENT OF PUBLIC HEALTH AND
ENVIRONMENT HEALTH FACILITIES AND EMERGENCY MEDICAL
SERIVCES
6 CCR 1011-1 (2013)
6 CCR 1011-1. STANDARDS FOR HOSPITALS AND HEALTH FACILITIES

5.101 ORGANIZATION AND STAFFING
(1) All hospitals shall provide central medical-surgical supply services with facilities for processing, sterilizing, storing, and dispensing supplies and equipment for all departments/services of the hospital. (2) The central medical-surgical supply services shall be organized as a service under the immediate supervision of a person who is competent in management, asepsis, supply processing, and control methods.
(3) Sufficient supporting personnel shall be assigned to the service and properly trained in central medical-surgical supply services.

CHAPTER II - GENERAL LICENSURE STANDARDS

5.102 PROGRAMMATIC FUNCTIONS (1) Continuous supervision shall be maintained throughout receiving, cleaning,

Connecticut Delaware

processing, sterilizing, and storing. A combination of controls or indicators shall be used to determine the effectiveness of the sterilization process. Bacteriological methods shall be used to evaluate the effectiveness of sterilization, by at least monthly cultures with records maintained.

(2) Written policies and procedures shall be established for all functions of central medical-surgical supply services. Such written procedures shall include, but not be limited to, obtaining, cleaning, processing, sterilizing, storing and issuing supplies. These policies and procedures shall be periodically reviewed by the Infection Control Committee, as applicable.

(3) Policies shall be established to provide supervision and training programs for all personnel involved in central medical-surgical supply operations and services.

(4) Water used for sterile solutions shall be distilled and sterilized in flasks which are resistant to heat, chemical, and electrical action.

(5) Dry heat and special chemical methods are available and acceptable for sterilization of materials which would be damaged by pressurized steam.

NONE

AGENCY 7. DEPARTMENT OF NATURAL RESOURCES
AND ENVIRONMENTAL CONTROL
SUB-AGENCY 1000. DIVISION OF AIR AND WASTE MANAGEMENT;
AIR QUALITY MANAGEMENT SECTION

Section 9.0 Emission Standards for Hospital Ethylene Oxide Sterilizers. 9.2 Definitions.
"Hospital central services staff" means a healthcare professional, including manager and technician, who is either directly involved in or responsible for sterile processing at a hospital.
"Medically necessary circumstances" means circumstances that a hospital central services staff, a hospital administrator, or a physician concludes, based on generally

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Central Service Regulations For Hospitals