CENTRAL SERVICE REGULATIONS FOR AMBULATORY SURGERY CENTERS

CENTRAL SERVICE REGULATIONS FOR AMBULATORY SURGERY CENTERS 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 CITATION REGULATORY LANGUAGE Alabama Alaska Arizona Arkansas California Colorado Delaware Florida Georgia Hawaii TITLE 11. DEPARTMENT OF 11-95. FREESTANDING SURGICAL OUTPATIENT FACILITIES HEALTH 11-95-9 Construction requirements. CHAPTER 95. (j) There shall be adequate scrub-up facilities and work areas for the preparation, FREESTANDING SURGICAL sterilization, and storage of instruments and supplies. OUTPATIENT FACILITIES Idaho Illinois

Indiana TITLE 410. INDIANA STATE DEPARTMENT OF HEALTH ARTICLE 15. HOSPITAL LICENSURE RULES RULE 2.5. REQUIRED AMBULATORY OUTPATIENT SURGICAL CENTER SERVICES 410 IAC 15-2.5-1 Infection control program Sec. 1. (a) The center shall provide a safe and healthful environment that minimizes infection exposure and risk to patients, health care workers, and visitors. (b) The center shall maintain a written, active, and effective center-wide infection control program. Included in this program must be a system designed for the identification, surveillance, investigation, control, and prevention of infections and communicable diseases in patients and health care workers. (c) The infection control program must identify and evaluate trends or clusters of center generated infections or communicable diseases. (d) The center shall designate a person qualified by training or experience as responsible for the ongoing infection control activities and the development and implementation of policies governing control of infections and communicable diseases. (e) The chief executive officer, medical staff, and nursing manager shall: (1) be responsible for the implementation of successful corrective action plans in affected problem areas and ensure that infection control policies are followed; and (2) provide for appropriate infection control input into plans for renovation and new construction to ensure awareness of federal, state, and local rules that affect infection control practices as well as plan for appropriate protection of patients and employees during construction or renovation. (f) The center shall establish a committee to monitor and guide the infection control program in the center as follows: 2

(1) The infection control committee shall be a center or medical staff committee, that meets at least quarterly, with membership that includes, but is not limited to, the following: (A) The person directly responsible for management of the infection surveillance, prevention, and control program as established in subsection (d). (B) A representative from the medical staff. (C) A representative from the nursing staff. (D) Consultants from other appropriate services within the center as needed. (2) The infection control committee responsibilities must include, but are not limited to, the following: (A) Establishing techniques and systems for identifying, reviewing, and reporting infections in the center. (B) Recommending corrective action plans, reviewing outcomes, and assuring resolution of identified problems. (C) Reviewing employee exposure incidents and making appropriate recommendations to minimize risk. (D) Written reports of quarterly meetings. (E) Reviewing and recommending changes in procedures, policies, and programs which are pertinent to infection control. These include, but are not limited to, the following: (i) Sanitation. 3

(ii) Universal precautions, including infectious waste management. (iii) Cleaning, disinfection, and sterilization. (iv) Aseptic technique, invasive procedures, and equipment usage. (v) Reuse of disposables. (vi) A patient isolation system. (vii) A system, which complies with state and federal law, to monitor the immune status of health care workers exposed to communicable diseases. (viii) An employee health program to determine the communicable disease history of new personnel as well as an ongoing program for current personnel as required by state and federal agencies. (ix) Requirements for personal hygiene and attire that meet acceptable standards of practice. (x) A program of linen management. (g) Sterilization of equipment and supplies must be provided, within the scope of the service offered, in accordance with acceptable standards of practice or manufacturer's recommendations and applicable state laws and rules, 410 IAC 1-4. Sterilization services must be directed by a qualified person or persons and must provide for the following: (1) Biological indicators must be used to check sterilization processes at least monthly. Chemical sterilizing indicators must be used to check the sterilizing process of individual packs. (2) Written policies and procedures must be available and followed by personnel 4

responsible for sterilizing equipment and supplies, including, but not limited to, the following: (A) Minimum time and temperature for processing various size bundles and packs. (B) Instructions for loading, operating, cleaning, and maintaining sterilizers. (C) Instructions for cleaning, packaging, storing, labeling, and dispensing of sterile supplies. (D) Procedure for maintaining and recording the particular sterilizing cycle. (E) Sterilization of heat labile reusable equipment. (3) Records of results must be maintained and evaluated periodically in accordance with 410 IAC 15-2.4-2 to include, but not be limited to, the following: (A) Records of recording thermometers or a daily record of the sterilizing cycle (date, time, temperature, pressure, and contents) for each sterilizer load. (B) Results of biological indicators used in testing the sterilizing processes. (h) Environmental surfaces and equipment not requiring sterilization which have been contaminated by blood or other potentially infectious materials shall be cleaned then decontaminated in accordance with acceptable standards of practice and applicable state laws and rules, 410 IAC 1-4. (i) The center, whether it operates its own laundry or uses outside laundry service, shall ensure that the laundry process complies with a recognized laundry standard as follows: 5

(1) Clean linen must be separated from soiled linen at all times as follows: (A) Contaminated linens must be clearly identified and bagged. (B) Clean linen must be covered during transit, and separate containers or carts must be provided for transporting thereof. (2) Central clean linen storage space must be provided as follows: (A) If commercial laundry services are utilized: (i) a soiled linen collection room must be provided; and (ii) a hand washing facility is required in each area where unbagged soiled linen is handled. (B) If laundry is processed in the center: (i) a laundry processing room must be provided; (ii) clean linen storage and mending must be separated from soiled linen handling and storage; and (iii) employee hand washing facilities shall be available in each room where clean or soiled linen is processed and handled. Iowa Kansas 6

Kentucky Louisiana Maine Maryland Massachusetts TITLE 902. CABINET FOR HEALTH AND FAMILY SERVICES DEPARTMENT FOR PUBLIC HEALTH CHAPTER 20. HEALTH SERVICES AND FACILITIES 902 KAR 20:101. Facility specifications; ambulatory surgical center. Section 11. Central Medical and Surgical Supply Department. The following areas shall be separated from each other: (1) Receiving and cleanup room. Space for cleaning equipment and disposing or processing of unclean articles shall be provided. (2) Clean workroom. This room shall be divided into work space, clean storage area, sterilizing facilities, and storage area for sterile supplies. (3) Unsterile supply storage area. May be located in an area other than this department. Section 12. Engineering Service and Equipment Areas. The following shall be provided: (1) Room(s) for boilers, mechanical equipment, and electrical equipment. (2) Refuse storage room. This shall be located convenient to service entrance. (3) Waste processing services: (a) Provide space and facilities for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, or removal, or by a combination of these techniques. (b) If provided, the incinerator shall be in a separate room, in a designated area within the boiler room, or placed outdoors. 7

Michigan DEPARTMENT OF COMMUNITY HEALTH MEDICAL SERVICES ADMINISTRATION HEALTH MAINTENANCE ORGANIZATIONS PART 7. FACILITY STANDARDS MICH. ADMIN. CODE R 325.6730 (2014) R 325.6730 Sinks, sterilization equipment, and storage space in freestanding outpatient facility. Rule 730. The following provisions apply to freestanding outpatient facilities: (a) A sink with a gooseneck outlet shall be available in, or adjacent to, examination and procedure rooms. (b) Sterilization equipment shall be provided to process all medical supplies which require sterilization between each use. Equipment shall have sufficient capacity to accommodate the work load of the facility. Adequate space for sterilization equipment shall be provided. (c) Storage space shall be available for the storage of clean linen, equipment, and supplies. (d) A janitor's closet with service sink shall be available. Minnesota DEPARTMENT OF HEALTH CHAPTER 4675 OUTPATIENT SURGICAL CENTERS Minn. R. 4675.1100 (2013) 4675.1100 GENERAL SERVICE AREAS The general service areas shall include the following elements: B. A clean supply room for receiving, storage, and assembly of clean and sterile supplies. It shall contain a sterilizer unless sterile supplies are received from a central supply service or a commercial supplier. 8

Mississippi Missouri Montana Nebraska AGENCY 15. DEPARTMENT OF HEALTH SUB-AGENCY 016. PART 16: HEALTH FACILITIES; SUBPART 1: HEALTH FACILITIES LICENSURE AND CERTIFICATION CHAPTER 042. MINIMUM STANDARDS OF OPERATION FOR AMBULATORY SURGICAL FACILITIES CMSR 15-016-042 (2014) CHAPTER 042. MINIMUM STANDARDS OF OPERATION FOR AMBULATORY SURGICAL FACILITIES TITLE 37: PUBLIC HEALTH AND HUMAN SERVICES CHAPTER 106: HEALTH CARE FACILITIES SUB-CHAPTER 5: OUTPATIENT CENTERS FOR SURGICAL SERVICES MONT. ADMIN. R. 37.106.515 (2014) 37.106.515 SURGICAL AND RELATED SERVICES Subchapter 23 Central Sterile Supply. Rule 42.23.1 Policies and procedures shall be maintained for method of control used in relation to the sterilization of supplies and water and a written policy requiring sterile supplies to be reprocessed at specific time periods. These areas shall be separated: 1. Receiving and clean-up area, to contain a two-compartment sink with two drain-boards. 2. Pack make-up shall have autoclaves, work counter and unsterile storage. 3. Sterile storage area should have pass-through to corridor. (8) Suitable equipment for rapid and routine sterilization is available to ensure the operating room materials are sterile. Sterilized materials are packaged, labeled, and stored in a manner to maintain sterility and identify sterility dates. Sterility requirements also include: (a) processes for cleaning and sterilization of supplies and equipment must comply with manufacturer's instructions and recommendations; and (b) internal and external indicators are used to demonstrate the safe processing of items undergoing high level disinfection and sterilization (9) Periodic calibration and preventive maintenance, or both of equipment is provided. 9

Nevada CHAPTER 449. MEDICAL AND OTHER RELATED FACILITIES SURGICAL CENTERS FOR AMBULATORY PATIENTS General Provisions 449.97428 "Sterilization" defined. (NRS 441A.120, 449.037) "Sterilization" means a process using medical equipment, including, without limitation, a dry heat sterilizer or an autoclave, to destroy all forms of microbial life. New Hampshire New Jersey New Mexico North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee CHAPTER 449. MEDICAL AND OTHER RELATED FACILITIES SURGICAL CENTERS FOR AMBULATORY PATIENTS General Provisions "Reprocess" means the process of subjecting a single-use medical device that has been previously used on a patient to additional cleaning, disinfection or sterilization, manufacturing steps, including, without limitation, repackaging and relabeling, and testing of the technical and functional safety of the device to make the device ready for safe use on another patient. 10

Texas TITLE 25. HEALTH SERVICES PART 1. DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 131. FREESTANDING EMERGENCY MEDICAL CARE FACILITIES SUBCHAPTER C. OPERATIONAL REQUIREMENTS 131.56. Sterilization (a) A person qualified by education, training, and experience shall supervise the sterilization of all supplies and equipment. Staff responsible for the sterilization of supplies and equipment shall participate in a documented continuing education program. New employees shall receive initial orientation and on-the-job training. Staff using chemical disinfectants shall have received training on their use. (b) Written policies and procedures for the decontamination and sterilization activities performed shall be adopted, implemented, and enforced. Policies shall include the receiving, cleaning, decontaminating, disinfecting, preparing, and sterilizing of reusable items, as well as the assembly, wrapping, storage, distribution, and quality control of sterile items and equipment. The infection control practitioner or committee shall review and approve these written policies at least every other year. (c) Every facility shall provide equipment adequate for sterilization of supplies and equipment as needed. Equipment shall be maintained and operated to perform, with accuracy, the sterilization of the various materials required. (d) Where cleaning, preparation, and sterilization functions are performed in the same room or unit, the physical facilities, equipment, and policies and procedures for their use, shall effectively separate soiled or contaminated supplies and equipment from clean or sterilized supplies and equipment. Hand-washing facilities shall be provided and a separate sink shall be provided for safe disposal of liquid waste. (e) All containers for solutions, drugs, flammable solvents, ether, alcohol, and medicated supplies shall be clearly labeled to indicate contents. Containers that are sterilized by the facility shall be labeled so as to be identifiable before and after sterilization. Sterilized items shall have a load control identification that indicates the sterilizer used, the cycle or load number, and the date of sterilization. 11

(f) Sterilizers. (1) Steam sterilizers (saturated steam under pressure) shall be used to sterilize heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions. (2) Ethylene oxide (EO) sterilizers shall be used for processing heat and moisture sensitive items. EO sterilizers and aerators shall be used and vented according to the manufacturer's written instructions. (3) Flash sterilizers shall be used for emergency sterilization of clean, unwrapped instruments and porous items only. (g) Preparation for sterilization. (1) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated, and prepared in a clean, controlled environment. (2) All articles to be sterilized shall be arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature. (3) All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized. (h) External chemical indicators. (1) External chemical indicators, also known as sterilization process indicators, shall be used on each package to be sterilized, including items being flash sterilized to indicate that items have been exposed to the sterilization process. (2) The indicator results shall be interpreted according to manufacturer's written 12

instructions and indicator reaction specifications. (3) A log shall be maintained with the load identification, indicator results, and identification of the contents of the load. (i) Biological indicators are commercially-available microorganisms (e.g., United States Food and Drug Administration approved strips or vials of Bacillus species endospores) that can be used to verify the performance of waste treatment equipment and processes (or sterilization equipment and processes). (1) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used. (2) Biological indicators shall be included in at least one run each week of use for steam sterilizers, at least one run each day of use for low-temperature hydrogen peroxide gas sterilizers, and every load for EO sterilizers. (3) Biological indicators shall be included in every load that contains implantable objects. (4) A log shall be maintained with the load identification, biological indicator results, and identification of the contents of the load. (5) If a test is positive, the sterilizer shall immediately be taken out of service. (A) Implantable items shall be recalled and reprocessed if a biological indicator test (spore test) is positive. (B) All available items shall be recalled and reprocessed if a sterilizer malfunction is found and a list of those items not retrieved in the recall shall be submitted to infection control. (C) A malfunctioning sterilizer shall not be put back into use until it has been 13

serviced and successfully tested according to the manufacturer's recommendations. (j) Disinfection. (1) Written policies, approved by the infection control committee, shall be adopted, implemented, and enforced for the use of chemical disinfectants. (2) The manufacturer's written instructions for the use of disinfectants shall be followed. (3) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution currently in use. (4) Disinfectant solutions shall be kept covered and used in well-ventilated areas. (5) Chemical germicides that are registered with the United States Environmental Protection Agency as "sterilants" may be used either for sterilization or high-level disinfection. (6) All staff personnel using chemical disinfectants shall have received training on their use. (k) Performance records. (1) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of five years. (2) Each sterilizer shall be monitored continuously during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained and shall include: 14

(A) the sterilizer identification; (B) sterilization date; (C) cycle number; (D) contents of each load; (E) duration and temperature of exposure phase (if not provided on sterilizer recording charts); (F) identification of operator(s); (G) results of biological tests and dates performed; (H) time-temperature recording charts from each sterilizer; (I) gas concentration and relative humidity (if applicable); and (J) any other test results. (l) Storage of sterilized items. (1) Sterilized items shall be transported so as to maintain cleanliness and sterility and to prevent physical damage. (2) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity. (3) The facility shall adopt, implement and enforce a policy which describes the mechanism used to determine the shelf life of sterilized packages. 15

Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming TITLE 12. HEALTH AGENCY NO. 5. DEPARTMENT OF HEALTH HOSPITALS, NURSING HOMES, AND RELATED INSTITUTIONS AND SERVICES CHAPTER 410. REGULATIONS FOR THE LICENSURE OF HOSPITALS IN VIRGINIA PART IV. OUTPATIENT SURGICAL HOSPITALS: ORGANIZATION, OPERATION, AND DESIGN STANDARDS FOR EXISTING AND NEW FACILITIES ARTICLE 4. PATIENT CARE SERVICES 12 VAC 5-410-1210 (m) Qualified personnel shall perform preventive maintenance of all sterilizers according to adopted, implemented, and enforced policy on a scheduled basis, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review at the facility within two hours of request by the department. 12 VAC 5-410-1210. Sterile supply services A. Adequate provisions shall be maintained for the processing, sterilizing, storing, and dispensing of clean and sterile supplies and equipment. B. Written procedures shall be established for the appropriate disposal of pathological and other potentially infectious waste and contaminated supplies. 16