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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 135AMBULATORY SURGICAL CENTERS
SUBCHAPTER CPHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS
RULE §135.52Construction Requirements for a New Ambulatory Surgical Center

    (A) On-site linen processing. When on-site linen processing is provided, soiled and clean processing operations shall be separated and arranged to provide a one-way traffic pattern from soiled to clean areas. The following rooms and items shall be provided:

      (i) a soiled linen processing room which includes areas for receiving, holding, sorting, and washing;

      (ii) a clean linen processing room which includes areas for drying, sorting, folding, and holding prior to distribution;

      (iii) supply storage cabinets in the soiled and clean linen processing rooms;

      (iv) a hand washing fixture with hands-free operable controls within the soiled linen processing room; and

      (v) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room.

    (B) Off-site linen processing. When linen is processed off site, the following rooms or items shall be provided:

      (i) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room; and

      (ii) a soiled linen holding room or area located within the surgical suite. Soiled linen holding may be combined with the soiled workroom.

  (7) Medical waste processing. Space and facilities shall be provided for the safe storage and disposal of waste as appropriate for the material being handled and in compliance with all applicable rules and regulations.

  (8) Pharmacy. A pharmacy work room or alcove shall be provided and located separate from patient and public areas and under the direct supervision of staff. A work counter, refrigerator, medication storage, and locked storage for biologicals and drugs shall be provided. A hand washing fixture with hands-free operable controls shall be located in the pharmacy room or alcove.

  (9) Postoperative recovery suite.

    (A) General. A postoperative recovery suite shall be distinct and separate from preoperative areas. The postoperative recovery suite shall be arranged to provide a one-way traffic pattern from the restricted surgical corridor to the postoperative recovery suite, and then to the extended observation rooms or discharge.

    (B) Postanesthesia care unit. A minimum of one patient station per operating room, plus one additional station, shall be provided.

      (i) In a multiple-bed postoperative recovery area, the clearance between the side of a bed/gurney and a wall/partition shall be a minimum of three feet. The clearance between sides of beds/gurneys shall be a minimum of four feet six inches. The minimum distance at the foot of the bed/gurney shall not be less than six feet for single load area/room or nine feet for double load area/room. Four feet of the passage space at the foot of the bed may be shared between two beds/gurneys. The fixed and moveable cabinets and shelves shall not encroach upon the bed/gurney clear floor space/area.

      (ii) The minimum clear floor space in a private postoperative recovery room shall be 100 square feet exclusive of aisles and fixed and moveable cabinets and selves. A minimum of nine feet width shall be provided for the head wall.

    (C) Patient toilet. A toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be provided. The toilet room may be shared with the preoperative patient holding area, if located conveniently between both areas.

    (D) Hand washing fixture. One hand washing fixture with hands-free operable controls shall be provided for every four recovery beds or fraction thereof in open wards. Fixtures shall be uniformly distributed. One hand washing fixture shall be provided within each single-bed recovery room.

    (E) Extended observation rooms. Separate supervised rooms or areas may be provided for patients who are sufficiently stabilized to leave the postanesthesia care unit, but require additional time in the facility for observation or comfort measures prior to being discharged.

      (i) When individual rooms are provided for extended observation, the rooms shall have an area of at least 60 square feet. When such rooms include a bed or recliner, a minimum clearance of three feet at the foot and on each side of the bed or recliner shall be provided.

      (ii) When an open or ward area for extended observation is provided, the minimum clearance from the bed or recliner to the side wall shall not be less than three feet; and a space of four feet shall be provided at the foot of each bed or recliner. The minimum clearance between beds or recliners shall not be less than three feet.

      (iii) A toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be provided. The toilet room may be shared with the postoperative recovery area, if located conveniently between both areas.

  (10) Preoperative patient holding room.

    (A) General. A preoperative holding area shall be provided and arranged in a one-way traffic pattern so that patients entering from outside the surgical suite can change, gown, and move directly into the restricted corridor of the surgical suite. The holding area shall be separate from the postoperative recovery suite and the restricted corridor.

    (B) Patient station. A minimum of one patient station per operating room shall be provided.

      (i) When individual rooms are provided, the minimum clear floor space in a private preoperative holding room shall be 80 square feet exclusive of aisles and fixed and moveable cabinets and shelves. The rooms shall include a bed or recliner with a minimum clearance of three feet at the foot and on each side of the bed or recliner.

      (ii) In a multiple-bed preoperative holding area, a minimum area of 60 square feet shall be provided for each patient station. The minimum clearance from the gurney or bed to a sidewall shall not be less than three feet. A space of four feet shall be provided at the foot of the gurney or bed and the minimum clearance between gurneys or beds shall not be less than four feet six inches.

      (iii) Space shall be made available for storing and securing patient's personal effects.

      (iv) One hand washing fixture with hands-free operable controls shall be provided for every four preoperative beds or fraction thereof in open wards. Fixtures shall be uniformly distributed. One hand washing fixture shall be provided within each single-bed preoperative holding room.

    (C) Patient toilet. A toilet room with handicapped accessible water closet and hand washing facilities shall be provided. The toilet room may be shared with the postoperative recovery suite, if located conveniently between both areas.

    (D) Duty station. A hand washing fixture with hands-free operable controls and a counter or shelf space for writing shall be provided for staff use within or convenient to the preoperative area. The staff hand washing fixture with hands-free operable controls shall be separate from and in addition to patient toilet accommodations.

  (11) Radiology.

    (A) Special requirements. When radiology services are provided on site, the following minimum facilities shall be provided:

      (i) film processing facilities, if used;

      (ii) viewing capabilities;

      (iii) storage facilities for exposed film, if used, located in rooms or areas constructed in accordance with the NFPA 101, §38.3.2.1 and §38.3.2.2; and

      (iv) dressing area(s) shall be required, depending on services provided, with convenient access to toilets, and may be shared with patient changing/preoperative rooms.

    (B) Fluoroscopy room. When fluoroscopy services are provided on site in a dedicated fluoroscopy room, a toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be directly accessible to the room.

  (12) Soiled workroom. In addition to the soiled workroom provided in the surgical suite, a separate soiled workroom(s) shall be required when a treatment room is provided, except as allowed in subparagraph (B) of this paragraph.

    (A) Special requirements. The workroom(s) shall contain a clinical sink or equivalent flushing type fixture, work counter, designated space for waste and linen receptacles, and a hand washing fixture with hands-free operable controls.

    (B) Shared functions. The soiled workroom required in support of a treatment room may be combined with a surgical suite soiled work room with two means of entry. A separate door into the soiled workroom shall serve a treatment room located outside the surgical suite.

  (13) Surgical staff clothing change area.

    (A) Surgical staff changing rooms. Appropriately sized areas shall be provided for male and female personnel working within the surgical suite. These areas shall contain lockers, showers, toilets, hand washing fixtures with hands-free operable controls, and space to change into scrub suits and boots. Separate locker/changing rooms shall be provided for male and female staff. The shower and toilet room(s) may be unisex. These areas shall be arranged to provide a traffic pattern so that personnel entering from outside the surgical suite can shower, change, and move directly into the restricted areas of the surgical suite.

    (B) Surgical staff lounge. When a surgical staff lounge is provided, the lounge shall be located to permit the use without leaving the surgical suite and may be accessed from the clothing changing rooms. The surgical staff lounge shall not have direct access from outside the surgical suite. When the lounge is remote from the clothing change rooms, toilet facilities and a hand washing fixture with hands-free operable controls accessible from the lounge shall be provided.

  (14) Sterilizing facilities. A system for sterilizing equipment and supplies shall be provided. Sterilizing procedures may be done on site or off site, or disposables may be used to satisfy functional needs.

    (A) Off-site sterilizing. When sterilizing is provided off site and disposables and prepackage surgical supplies are used, the following rooms shall be provided near the operating room.

      (i) Soiled holding room. A room for receiving contaminated/soiled material and equipment from the operating room shall be provided. The room shall be physically separate from all other areas of the suite. The room shall include a work counter(s) or a table(s), clinical sink or equivalent flushing type fixture, equipment for initial disinfection and preparation for transport to off-site sterilizing, and a hand washing fixture with hands-free operable controls. The soiled holding room may be combined with the surgical suite soiled workroom.

      (ii) Clean workroom. A clean workroom shall be provided for the exclusive use of the surgical suite. The workroom shall contain a work counter with space for receiving, disassembling and organizing clean supplies, storage cabinets or shelving, and a hand washing fixture with hands-free operable controls.

      (iii) Sterilizer equipment. Sterilizer equipment shall be located in a separate room convenient to the operating room(s), in an alcove adjacent to the restricted corridor, or in the clean workroom.

    (B) On-site sterilizing facilities. When sterilizing facilities are provided on site they shall be located near the operating room and provide the following rooms.

      (i) Receiving/decontamination room. The receiving/decontamination room shall be physically separate from all other areas of the surgical suite. The room shall include a work counter(s) or table(s), clinical sink or equivalent flushing type fixture, equipment for initial washing/disinfection, and a hand washing fixture with hands-free operable controls. Pass-through dutch doors, windows, and washer/sterilizer decontaminators shall serve in delivering material to the clean workroom. The receiving/decontamination room may be combined with the surgical suite soiled workroom.

      (ii) Clean/assembly workroom. The clean/assembly workroom shall include a counter(s) or table(s) with space for organizing, assembling, and packaging of medical/surgical supplies and equipment, equipment for terminal sterilizing, and a hand washing fixture with hands-free operable controls. Clean and soiled work areas shall be physically separated.

      (iii) Sterile storage. A storage room for clean and sterile supplies shall be provided. The storage room shall have adequate areas and counters for breakdown of manufacturers' clean/sterile medical/surgical supplies. This room may be combined with the clean assembly/workroom.

      (iv) Cart storage room or alcove. The storage space for distribution carts shall be adjacent to clean and sterile storage area(s) and close to main distribution points.

  (15) Surgical suite. The surgical suite shall be arranged to preclude unrelated traffic through the suite. The surgical suite shall contain at least one operating room and all surgical service areas required under subparagraph (B) of this paragraph.

    (A) Operating room. The operating room(s) shall have a clear floor area of at least 240 square feet exclusive of fixed or moveable cabinets, counters, or shelves. The minimum clear dimension between built-in cabinets, counters, and shelves shall be 14 feet.

    (B) Surgical service areas.

      (i) Restricted corridor. The restricted corridor shall serve as the primary passageway for staff and patients within the surgical suite. The following rooms and areas shall have direct access to the restricted corridor:

        (I) preoperative patient holding area;

        (II) operating room(s);

        (III) postoperative recovery suite;

        (IV) soiled workroom;

Cont'd...

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