Section 216-RICR-40-10-13.8 - Physical Plant and Equipment13.8.1New ConstructionA. All new construction shall be subject to the provisions of R.I Gen. Laws Chapters 23-28.1 and 23-27.3, and § 13.2(A) of this Part above.B. In addition, any other applicable state and local laws, codes and regulations shall apply. Where there is a difference between codes, the code having the more stringent standard shall apply.C. All plans for new construction or the renovation, alteration, extension, modification or conversion of an existing facility that may affect compliance with §13.8.2 of this Part shall be reviewed by a licensed architect, acceptable to the Director. Said architect shall certify that the plans conform to the construction requirements of §13.8.2 of this Part, prior to construction. The facility shall maintain a copy of the plans reviewed and the architect's signed certification, for review by the Department of Health upon request. 1. In the event of non-conformance for which the facility seeks a variance, the general procedures outlined in §13.9.2 of this Part shall be followed. Variance requests shall include a written description of the entire project, details of the non-conformance for which the variance is sought and alternate provisions made, as well as detailing the basis upon which the request is made. The Department may request additional information while evaluating variance requests.2. If variances are granted, a licensed architect shall certify that the plans conform to all construction requirements of §13.8.2 of this Part, except those for which variances were granted, prior to construction. The facility shall maintain a copy of the plans reviewed, the variance(s) granted and the architect's signed certification, for review by the Department upon request.D. Upon completion of construction, the facility shall provide written notification to the Department describing the project, and a copy of the architect's certification. The facility shall obtain authorization from the Department prior to occupying/re-occupying the area. At the discretion of the Department, an on-site visit may be required.13.8.2Physical FacilityA. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall meet the fire and safety provisions of R.I Gen. Laws Chapters 23-28.1 and shall conform to all state and local building codes.B. A building entrance shall be located at grade level and able to accommodate wheelchairs.C. An elevator shall be provided where patient care is provided at other than street level. The cab size shall be large enough to accommodate a stretcher and an attendant.D. Administrative and public areas shall include at least the following: 1. A lobby area including a waiting area, conveniently accessible wheelchair storage;2. Reception/information desk, accessible public toilets, public telephone(s) and drinking fountain(s);3. Interview space for private interviews relating to admission, credit, etc.;4. General and individual office space for business transactions, records and administrative and professional staff. These shall be separate from public and patient areas with provisions for confidentiality of records. Enclosed office spaces for administration and consultation shall be provided.5. General storage facilities.E. A system for sterilizing equipment and supplies shall be provided. When sterilization is provided off-site, adequate sterile supplies shall be provided. If on-site processing facilities are provided, they shall include the following:1. Soiled workroom: This room shall be physically separated from all other areas of the facility. Work space shall be provided to handle the cleaning and terminal sterilization/disinfection of all medical/surgical instruments and equipment. The soiled workroom shall contain work table(s), sink(s), flush-type device(s) and washer/sterilizer decontaminator(s) or other decontamination equipment. Pass-through doors and washer/sterilizer decontaminators should deliver into clean processing areas/workrooms.2. Clean Assembly/Workroom and Sterilization Area: Clean and soiled work areas should be physically separated. This room is exclusively for the inspection, assembly and packaging and sterilization of medical/surgical supplies and equipment. The room shall contain handwashing facilities, work space and equipment for terminal sterilizing of medical and surgical equipment and supplies. The assembly work area should contain work tables, counter, storage facilities for back-up supplies and a drying cabinet or equipment. Access to the sterilization room should be restricted.3. Alternatively, based on the scope of the practice, a single utility room may be adequate for clean and soiled activities, provided the room includes a sink for cleaning instruments/equipment, a hand wash sink, adequate work counter space, and allow for instrument/equipment processing to flow from soiled area, to clean area, to sterilization, and finally to storage, without crossing paths. a. Clean/Sterile Supplies - Storage: Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.F. Provisions shall be made to separate pediatric from adult patients. This shall include pre- and post-operative care areas and should allow for parental presence.G. At least one room shall be provided for examination and testing of patients prior to surgery, assuring both visual and audible privacy. Exam rooms shall have a minimum floor area of 80 square feet, excluding vestibules, toilets and closets. Room arrangement should permit at least 2 feet 8 inches clearance at each side and the foot of the examination table. A handwashing fixture and a counter or shelf space for writing shall be provided.H. Each operating room shall have a minimum clear area of 250 square feet, exclusive of cabinets and shelves. Additional clear area may be required to accommodate the functional plan, which may require additional staff or equipment. There shall be at least one x-ray film illuminator in each room.I. A room for post-anesthesia recovery shall be provided as required by volumes and procedure type. At least 3 feet shall be provided at each side and at the foot of each bed. If pediatric surgery is part of the program, separation from the adult section and space for parents shall be provided. Bedpans and bedpan-cleaning facilities shall be provided in this area.J. A designated supervised recovery lounge shall be required for patients who do not require post-anesthesia recovery but need additional time for their vital signs to stabilize before safely leaving the facility. This lounge shall contain space for staff and family members and provisions for privacy. It shall have convenient access to toilets. Hand washing and nourishment facilities must be provided.K. The surgical service area must include a drug distribution station. Provisions shall be made for storage and preparation of medications administered to patients. Locked storage, including a refrigerator and double-locked storage for controlled substances shall be provided. Convenient access to handwashing facilities shall be provided.L. Scrub facilities shall be provided near the entrance to each operating room and may service two operating rooms if needed. Scrub facilities shall be arranged to minimize incidental splatter on nearby personnel or supplies.M. The surgical service area must include a soiled work area, containing a clinical sink or equivalent flushing-type fixture, a work counter sink for handwashing and waste receptacle(s).N. Fluid waste disposal facilities shall be provided, convenient to operating rooms. A clinical sink or equivalent equipment in a soiled workroom shall meet this standard.O. Provisions shall be made for cleaning, testing, and storing anesthesia equipment. If a separate workroom, it shall contain a work counter, sink and racks for cylinders. Provisions shall be made for the separate storage of clean and soiled items. Provisions shall be made for the separate storage of reserve gas cylinders. 1. If flammable agents are present in an operating/procedure room, the room shall be constructed and equipped in accordance with the standards of publication number 56A, (1975) of the National Fire Protection Association.2. If only non-flammable agents are present in the operating/procedure room, the room shall be constructed and equipped in accordance with the standards of publication number 56G, (1975) of the National Fire Protection Association.P. Equipment storage area(s) for equipment and supplies used in the surgical service shall be provided.Q. Appropriate change areas shall be provided for staff working within the surgical area. Change area(s) shall contain toilets, lavatories for handwashing, and space for donning scrub attire.R. Provisions shall be made for patients to change from street clothing into hospital gowns, if required by the functional program, and prepare for surgery. This should include waiting areas, toilets, changing areas, and space for administration of medication. Provisions shall be made for securing patients' clothing and personal effects.S. If stretcher storage provided, at least the following minimal facilities shall be provided: 1. Laboratory work counter with sink, vacuum, gas and electrical services.2. Lavatory or counter sink equipped for handwashing. shall be provided, convenient for use and out of the way of normal traffic.T. Physician ambulatory surgery centers/ podiatry ambulatory surgery centers having three (3) or more operating rooms shall provide a lounge area for surgical staff and a staff toilet room shall be provided near the recovery area.U. Space containing a floor receptacle or service sink and storage space for housekeeping supplies and equipment shall be provided.V. Provisions shall be made for convenient access to and use of emergency equipment at both surgical and recovery areas. 1. If laboratory services are2. Storage cabinet(s) or closet(s).3. Specimen collection facilities.W. If radiology services are provided, at least the following minimal facilities shall be provided: 2. Film processing facilities4. Storage facilities for exposed film5. Dressing rooms, as required by services provided, with convenient toilet access.X. Heating and ventilation systems shall be capable of maintaining adequate ventilation and temperature for the comfort and safety of patients and staff.Y. If the physician ambulatory surgery center/ podiatry ambulatory surgery center includes an endoscopy suite, the following minimal facilities must be provided: 1. Each procedure room shall have a minimum clear area of 200 square feet, exclusive of fixed cabinets and built-in shelves, and be designed for visual and acoustical privacy. Oxygen, vacuum and medical air shall be provided.2. Dedicated processing room(s) for cleaning and disinfecting instrumentation must be provided. Cleaning rooms should allow for the flow of instrumentation from the contaminated area to the clean area, and, finally, to storage.3. The decontamination room shall be equipped with the following: two utility sinks remote from each other; freestanding handwashing fixture; work counter space: space and plumbing for automatic endoscope cleaners, sonic processor and flash sterilizer (where required); and outlets for vacuum and compressed air. Negative pressure shall be maintained in the decontamination room and all air should be vented to the outside to avoid recirculation within the physician ambulatory surgery center/ podiatry ambulatory surgery center.13.8.3Emergency PowerA. Each physician ambulatory surgery center/ podiatry ambulatory surgery center shall be equipped with an alternate emergency energy power source with a minimum two (2) hour capability.B. The emergency electrical power system shall have a sufficient capacity to supply power to maintain the operation of the operating/procedure room and other life-support systems, and lighting of egress, fire detection equipment, alarm and extinguishing systems.C. Monthly testing of emergency power shall be documented and reports retained for at least three (3) years.13.8.4Lighting and Electrical ServicesAll electrical and other equipment used in the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be maintained free of defects that could be a potential hazard to patients or personnel. Periodic calibration and/or preventive maintenance of equipment shall be provided and documentation of all testing shall be maintained for at least three (3) years.
13.8.5PlumbingA. All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of R.I. Gen. Laws Chapter 23-27.3.B. All plumbing shall be installed in such a manner as to prevent back siphonage or cross-connections between potable and non-potable water supplies.13.8.6Water SupplyWater shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the physician ambulatory surgery center/ podiatry ambulatory surgery center and shall be adequate in volume and pressure for all purposes including fire fighting.
13.8.7Medical Waste DisposalMedical waste as defined in the Medical Waste Regulations, 250-RICR- 140-15-1, promulgated by the Rhode Island Department of Environmental Management, shall be managed in accordance with the provisions of the aforementioned regulations.
13.8.8Waste Water DisposalIf a municipal sanitary sewer system is available, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall be connected to the system, if feasible. If a municipal sanitary sewer system is not available, the physician ambulatory surgery center/ podiatry ambulatory surgery center shall meet the standards set forth by the Department of Environmental Management.
216 R.I. Code R. § 216-RICR-40-10-13.8