SECTION 511.163. Spatial Requirements

(a) Administration and public suite.

(1) Architectural requirements. The following rooms or areas shall be provided.

(A) Primary entrance. An entrance at grade level shall be accessible and protected from inclement weather with a drive under canopy for loading and unloading passengers.

(B) Lobby. A main lobby shall be located at the primary entrance and shall include a reception and information counter or desk, waiting space, public toilet facilities, public telephones, drinking fountain, and storage room or alcove for wheelchairs.

(C) Admissions area. An admissions area shall include a waiting area, work counters or desk, private interview spaces, and storage room or alcove for wheelchairs. The waiting area and wheelchair storage may be shared with similar areas located in the main lobby.

(D) General or individual offices. Office space shall be provided for business transactions, medical and financial records, and administrative and professional staffs.

(E) Multipurpose rooms. A multipurpose room or rooms shall be provided for conferences, meetings, and health education purposes including provisions for showing visual aids.

(F) Storage. Storage for office equipment and supplies shall be provided. The construction protection for the storage room or area shall be in accordance with National Fire Protection Association 101, Life Safety Code, 2012 edition (NFPA 101) §18.3.2.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter (relating to General Construction Requirements).

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(b) Cart cleaning and sanitizing unit.

(1) Architectural requirements.

(A) Facilities. Cart cleaning, sanitizing, and storage facilities shall be provided for carts serving central services, dietary services, and linen services.

(B) Location. Cart facilities may be provided for each service or be centrally located.

(C) Hand washing fixtures. Hand washing fixtures shall be provided in cart cleaning, sanitizing, and storage areas.

(2) Details and finishes. When interior cart cleaning facilities are provided, details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Flooring. Flooring in the cart cleaning and sanitizing unit shall be of the seamless type, or ceramic or quarry tile as required by §511.162(d)(2)(B)(iii)(III) or (IV) of this subchapter.

(B) Ceilings. Ceilings in the cart cleaning and sanitizing unit shall be the monolithic type as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) Hand washing fixtures. Hand washing fixtures shall be provided with hot and cold water. Hot and cold water fixtures shall be provided in cart cleaning and sanitizing locations regardless of whether they are interior or exterior.

(B) Floor drains and floor sinks. Where floor drains or floor sinks are installed, they shall be of a type that can be easily cleaned by removal of the cover. Removable stainless steel mesh shall be provided in addition to a grilled drain cover to prevent entry of large particles of waste that might cause stoppages. Floor drains and floor sinks shall be located to avoid conditions where removal of covers for cleaning is difficult.

(5) Electrical requirements. Electrical requirements shall be in accordance with §511.162(d)(5) of this subchapter.

(c) Central sterile supply suite.

(1) Architectural requirements.

(A) General. When surgical services are provided, the following rooms or areas shall be provided.

(i) Decontamination room. This room shall be physically separated from all other areas of the suite. The room shall include work counters or tables, flush type utility sink, equipment for initial disinfection, and hand washing facilities with hands-free operable controls. Materials shall be transferred from the decontamination room to the clean assembly room by way of pass-through doors, windows, or washer equipment. The dirty side of the decontamination room may be combined with a soiled utility room if all functions for each space are provided within the room.

(ii) Clean and assembly room. The room shall include counters or tables, equipment for sterilizing, and hand washing facilities with hands-free operable controls. Clean and soiled work areas shall be physically separated.

(iii) Breakdown storage room. A storage room for breakdown of supplies shall be provided. The storage room shall have adequate areas and counters for breakdown of prepackaged supplies.

(iv) Sterile and clean supply room. A sterile and clean supply room shall be provided. Storage of sterile and clean supplies shall not occur within the breakdown room.

(v) Equipment storage. An equipment storage room shall be provided.

(vi) Cart storage room. The storage room for distribution carts shall be adjacent to clean and sterile storage and close to main distribution points.

(vii) Multipurpose room. The equipment storage and cart storage room may be combined into a multipurpose room.

(B) Service areas. The central supply suite shall provide the following service areas.

(i) Office space. Office space for director of central services.

(ii) Staff toilets. Facilities may be outside the unit but must be convenient for staff use and shall contain hand washing fixtures with hands-free operable controls.

(iii) Locker room. When provided, the locker room for staff shall include lockers, toilets, lavatories, showers, and male and female dressing rooms or cubicles. A central changing locker room may be shared and made available within the immediate area of the central sterile supply suite.

(iv) Housekeeping room. A housekeeping room shall be provided and contain a floor receptor or service sink and storage space for housekeeping supplies and equipment. The housekeeping room shall be located on the decontamination or soiled side of the central sterile supply suite.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details. Mirrors shall not be installed at hand washing fixtures in clean and sterile supply areas.

(B) Finishes.

(i) Flooring. Flooring used in the decontamination room and the clean assembly room shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Ceilings. Ceilings in the decontamination room, clean assembly room, and supply storage room shall be the monolithic type as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical Requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Ventilation, humidity, and temperature control. The sterile supply room and the clean and assembly room shall include provisions for ventilation, humidity, and temperature control.

(B) Ethylene oxide (EO) sterilizers. When provided, installations of EO sterilizers shall comply with the requirements of 30 TAC §106.417 (relating to Ethylene Oxide Sterilizers) administered by the Texas Commission on Environmental Quality (TCEQ), and the following requirements.

(i) EO sterilizer requirements. All source areas shall be exhausted, including the sterilizer equipment room, service and aeration areas, over sterilizer door, and the aerator. If the EO cylinders are not located in a well-ventilated unoccupied equipment space, an exhaust hood shall be provided over the cylinders. The relief valve shall be terminated in a well-ventilated, unoccupied equipment space, or outside the building.

(ii) Airflow. General airflow shall be away from sterilizer operators and towards the sterilizers.

(iii) Exhaust. A dedicated exhaust fan and an exhaust duct system shall be provided for EO sterilizers. The exhaust outlet to the atmosphere shall be located on the highest roof, directed upward, and not less than 25 feet from any air intake. A legible warning sign shall be provided to identify the exhaust stack on the roof.

(iv) Alarm. An audible and visual alarm located in sterilizer work area and a 24-hour staffed location shall be activated upon loss of airflow in the exhaust system.

(C) Filtration. Filtration requirements for air handling units serving the central sterile supply suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter (relating to Tables).

(D) Ducts. Duct linings exposed to air movement shall not be used in ducts serving the central sterile supply suite unless terminal filters of at least 90 percent efficiency are installed downstream of linings. This requirement shall not apply to mixing boxes and acoustical traps that have special coverings over such lining.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter. When medical gas systems are provided, the systems shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) Drainage and waste piping. Drainage and waste piping shall not be installed within the ceiling or installed in an exposed location in sterile areas unless precautions are taken to protect the space below from leakage and condensation from necessary overhead piping. Any required secondary protection shall be labeled, "code required secondary drain system" every 20 feet in a highly visible print or label.

(B) Plumbing lines. No plumbing lines may be exposed or on walls where possible leaks would create a potential of contamination of the sterile areas.

(C) Compressed air requirements. The compressed air required for the decontamination room shall not be connected to the medical air piping distribution system such as supporting breathable air for respiratory assistance needs, anesthesia machines, intermittent positive pressure breathing machine (IPPB), etc. A separate compressed air supply source shall be provided for maintenance and equipment needs for facility support use.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph. An electrical circuit or circuits to equipment in wet areas shall be provided with ground fault circuit interrupters (GFCIs).

(d) Dietary suite.

(1) Architectural requirements.

(A) General. Construction, equipment, and installation shall comply with all applicable local and state requirements for food safety and handling and food service.

(B) Food service facilities. Food services shall be provided by an on-site food preparation system or an off-site food service system or a combination of the two. The following minimum functional elements shall be provided on site regardless of the type of dietary services.

(i) Dining area. Provide dining space for ambulatory patients, staff, and visitors. These spaces shall be separate from the food preparation and distribution areas.

(ii) Receiving area. This receiving area shall have direct access to the outside for incoming dietary supplies or off-site food preparation service and shall be separate from the general receiving area. The receiving area shall contain a control station and an area for breakout for loading, unloading, uncrating, and weighing supplies. The entrance area to the receiving area shall be covered from the weather.

(iii) Storage spaces. Storage spaces shall be convenient to receiving area and food preparation area and shall be located to exclude traffic through the food preparation area. Regardless of the type of food services provided, the facility shall provide storage of food for emergency use for a minimum of four calendar days.

(I) Storage space. Storage space shall be provided for bulk, refrigerated, and frozen foods.

(II) Cleaning supply storage. This room or closet shall be used to store nonfood items that might contaminate edibles. This storage area may be combined with the housekeeping room.

(iv) Food preparation area. Counter space shall be provided for food preparation work, equipment, and an area to assemble trays for distribution for patient meals.

(v) Ice-making equipment. Ice-making equipment shall be provided for both drinks and food products (self-dispensing equipment) and for general use (storage-bin type equipment).

(vi) Hand washing. Hand washing fixtures with hands-free operable controls shall be conveniently located at all food preparation areas and serving areas.

(vii) Food service carts. When a cart distribution system is provided, space shall be provided for storage, loading, distribution, receiving, and sanitizing of the food service carts. The cart traffic shall be designed to eliminate any danger of cross-circulation between outgoing food carts and incoming soiled carts, and the cleaning and sanitizing process. Cart circulation shall not be through food processing areas.

(viii) Ware washing room. A ware washing room equipped with commercial type dishwasher equipment shall be located separate from the food preparation and serving areas. Space shall be provided for receiving, scraping, sorting, and stacking soiled tableware and for transferring clean tableware to the using areas. Hand washing facilities with hands-free operable controls shall be located within the soiled dish wash area. A physical separation to prevent cross-traffic between "dirty side" and "clean side" of the dish wash areas shall be provided.

(ix) Pot washing facilities. A three compartmented sink of adequate size for intended use shall be provided convenient to the food preparation area. Supplemental heat for hot water to clean pots and pans shall be by booster heater or by steam jet.

(x) Waste storage room. A food waste storage room shall be conveniently located to the food preparation and ware washing areas but not within the food preparation area. It shall have direct access to the LSRH's waste collection and disposal facilities.

(xi) Sanitizing facilities. Storage areas and sanitizing facilities for garbage or refuse cans, carts, and mobile tray conveyors shall be provided. All containers for trash storage shall have tight-fitting lids.

(xii) Housekeeping room. A housekeeping room shall be provided for the exclusive use of the dietary department. Where hot water or steam is used for general cleaning, additional space within the room shall be provided for the storage of hoses and nozzles.

(xiii) Office spaces. An office shall be provided for the use of the food service manager or the dietary service manager. In smaller LSRHs, a designated alcove may be located in an area that is part of the food preparation area.

(xiv) Toilets and locker spaces. A toilet room with at least one hand washing fixture with hands-free operable controls shall be provided for the exclusive use of the dietary staff. A toilet room shall not open directly into the food preparation areas, but must be in close proximity to them. For larger LSRHs, a locker room or space for lockers shall be provided for staff belongings.

(C) Additional service areas, rooms, and facilities. When an on-site food preparation system is used, in addition to the items required in subparagraph (B) of this paragraph, the following service areas, rooms and facilities shall be provided.

(i) Food preparation facilities. When food preparation systems are provided, there shall be space and equipment for preparing, cooking, and baking.

(ii) Tray assembly line. A patient tray assembly and distribution area shall be located within close proximity to the food preparation and distribution areas.

(iii) Food storage. When food is prepared on site, the storage room shall be adequate to accommodate food for a seven calendar day menu cycle.

(iv) Additional storage rooms. An additional room or rooms shall be provided for the storage of cooking wares, extra trays, flatware, plastic and paper products, and portable equipment.

(v) Drying storage area. Provisions shall be made for drying and storage of pots and pans from the pot washing room.

(D) Equipment. Equipment for use in the dietary suite shall meet the following requirements.

(i) Mechanical devices. Mechanical devices shall be heavy duty, suitable for the use intended, and easily cleaned. Where equipment is movable, provide heavy duty locking casters. Equipment with fixed utility connections shall not be equipped with casters.

(ii) Panels. Floor, wall, and top panels of walk-in coolers, refrigerators, and freezers shall be insulated. Coolers and refrigerators shall be capable of maintaining a temperature down to freezing. Freezers shall be capable of maintaining a temperature of 20 degrees below 0 degrees Fahrenheit. Coolers, refrigerators, and freezers shall be thermostatically controlled to maintain desired temperature settings in increments of two degrees or less. Interior temperatures shall be indicated digitally and visible from the exterior. Controls shall include audible and visible high and low-temperature alarm. The time of alarm shall be automatically recorded.

(iii) Walk-in units. Walk-in units may be lockable from the outside but must have a release mechanism for exit from inside at all times. The interior shall be lighted. All shelving shall be corrosion-resistant, easily cleaned, and constructed and anchored to support a load of at least 100 pounds per linear foot.

(iv) Cooking equipment. All cooking equipment shall be equipped with automatic shutoff devices to prevent excessive heat buildup.

(E) Vending services. When vending machines are provided, a dedicated room or an alcove shall be located so that access is available at all times.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Food storage. Food storage shelves shall not be less than four inches above the finished floor and the space below the bottom shelf shall be closed in and sealed tight for ease of cleaning.

(ii) Windows. Operable windows and doors not equipped with automatic closing devices shall be equipped with insect screens.

(iii) Food processing areas. Food processing areas in the central dietary kitchen shall have ceiling heights not less than nine feet. Ceiling-mounted equipment shall be supported from rigid structures located above the finished ceiling.

(iv) Mirrors. Mirrors shall not be installed at hand washing fixtures in the food preparation areas.

(B) Finishes.

(i) Flooring. Floors in areas used for food preparation, food assembly, soiled and clean ware cleaning shall be water-resistant and grease-proof. Floor surfaces, including tile joints, shall be resistant to food acids.

(ii) Wall bases. Wall bases in food preparation, food assembly, soiled and clean ware cleaning, and other areas that are frequently subject to wet cleaning methods shall be made integral and coved with the floor, tightly sealed to the wall, constructed without voids that can harbor insects, retain dirt particles, and be impervious to water.

(iii) Wall construction, finishes, and trim. In the dietary and food preparation areas, the wall construction, finishes, and trim, including the joints between the walls and the floors, shall be free of voids, cracks, and crevices.

(iv) Food preparation and food assembly area ceiling. The ceiling in food preparation and food assembly areas shall be washable as required by §511.162(d)(2)(B)(vi)(II) of this subchapter.

(v) Soiled and clean ware cleaning area ceiling. The ceiling in the soiled and clean ware cleaning area shall be of the monolithic type as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical Requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Exhaust hood requirements. Exhaust hoods handling grease-laden vapors in food preparation centers shall comply with National Fire Protection Association 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, 2011 edition. All hoods over cooking ranges shall be equipped with grease filters, fire extinguishing systems, and heat-actuated fan controls. Clean out openings shall be provided every 20 feet and at any changes in direction in the horizontal exhaust duct systems serving these hoods. (Horizontal runs of ducts serving range hoods should be kept to a minimum.)

(B) Air change standards. When air change standards in Table 3 of §511.169(c) of this subchapter do not provide sufficient air for proper operation of exhaust hoods (when in use), supplementary filtered make-up air shall be provided in these rooms to maintain the required airflow direction and exhaust velocity. Make-up systems for hoods shall be arranged to minimize "short circuiting" of air and to avoid reduction in air velocity at the point of contaminant capture.

(C) Air handling units. Air handling units serving the dietary suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall be in accordance with §511.162(d)(4) of this subchapter and this paragraph.

(A) Grease trap location. The kitchen grease traps shall be located and arranged to permit easy access without the need to enter food preparation or storage areas. Grease traps shall be of capacity required and shall be accessible from outside of the building without need to interrupt any services.

(B) Grease traps or grease interceptors. Grease traps or grease interceptors shall be located outside the food preparation area and shall comply with the requirements in the National Association of Plumbing-Heating-Cooling Contractors (PHCC), National Standard Plumbing Code, 2000 edition.

(C) Plumbing fixtures. The material used for plumbing fixtures shall be nonabsorptive and acid-resistant.

(D) Water spouts. Water spouts used at lavatories and sinks shall have clearances adequate to avoid contaminating utensils and containers.

(E) Food handler hand washing fixtures. Hand washing fixtures used by food handlers shall be trimmed with valves that can be operated without hands. Single lever or wrist blade devices may be used. Blade handles used for this purpose shall not be less than four inches in length.

(F) Drainage and waste piping. Drainage and waste piping shall not be installed within the ceiling or installed in an exposed location in food preparation centers, food serving facilities and food storage areas unless precautions are taken to protect the space below from leakage and condensation from necessary overhead piping. Any required secondary protection shall be labeled, "code required secondary drain system" every 20 feet in a highly visible print or label.

(G) Plumbing lines. No plumbing lines may be exposed overhead or on walls where possible leaks would create a potential for food contamination.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) Exhaust hoods. Exhaust hoods shall have an indicator light indicating that the exhaust fan is in operation.

(B) Electrical circuits. The electrical circuit or circuits to equipment in wet areas shall be provided with five milliampere GFCI.

(e) Emergency suite. This subsection applies to all LSRHs included under the LSRH license.

(1) Architectural requirements.

(A) Emergency treatment area.

(i) Emergency treatment room. An LSRH shall provide at least one emergency treatment room and facilities to handle emergencies. The room and facilities shall meet the following requirements.

(I) Single patient room area requirements. The emergency treatment room for a single patient shall have a minimum clear floor area of 120 square feet exclusive of fixed and movable cabinets and shelves. The minimum clear room dimension exclusive of fixed cabinets and built-in shelves shall be 10 feet. The emergency treatment room shall contain cabinets, medication storage, work counter, examination light, and a hand washing fixture with hands-free operable controls.

(II) Multiple-patient room area requirements. When a multiple-patient station emergency treatment room is provided, the clearance between the side of a gurney and a wall or partition shall be a minimum of four feet. The clearance between the sides of gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurney shall not be less than seven feet for single load area or room or ten feet for double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The multiple-patient station emergency treatment room shall contain cabinets, medication storage, work counter, examination light, and a hand washing fixture with hands-free operable controls. The fixed and movable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(III) Hand washing fixtures. One hand washing fixture with hands-free operable controls shall be provided for each gurney location. One hand washing fixture may serve two gurneys if distributed appropriately between the two.

(IV) Storage space. Storage space shall be provided within the room or suite and be under staff control for general medical-surgical emergency supplies and medications. Adequate space shall be provided for emergency equipment such as emergency treatment trays, ventilator, defibrillator, splints, cardiac monitor, etc.

(V) Medication preparation storage. Locked storage space shall be provided for drugs and an area for preparation of medication with a work counter, refrigerator, and hand washing fixture with hands-free operable controls.

(VI) Stretcher and wheelchair storage. An alcove shall be provided for stretcher and wheelchair storage. The storage shall be located out of the line of traffic.

(VII) Patient toilet room. At least one patient toilet room shall be provided and shall be convenient to treatment rooms, examination rooms, and holding rooms, and a hand washing fixture with hands-free operable controls.

(VIII) Emergency entry signage. An emergency sign shall be provided at the entry from the public roads or streets serving the site. The emergency sign at the entry to the site shall be illuminated and connected to the emergency essential electrical system. Additional signs on-site may be required to direct patients to the emergency treatment area entrance when the emergency treatment area is not visible from the site entry. The letters on the entry sign shall be red with a contrasting background, all capitalized, at least eight inches in height, and an arrow indicating direction.

(IX) Entrances. Separate ambulance and pedestrian entrances at grade level shall be well-illuminated, identified by signs, and protected from inclement weather. The ambulance entry shall have a drive under canopy for protection from inclement weather. The emergency access to permit discharge of patients from automobile and ambulances shall be paved. Parking shall be provided near and convenient to the pedestrian entrance.

(X) Control station. A registration, reception, discharge or control station shall be located to permit staff observation and control of access to treatment rooms, pedestrian and ambulance entrances, and public waiting areas. When a dedicated triage space is provided, it shall include a counter with a hand washing fixture with hands-free operable controls.

(XI) Public waiting room. A public waiting room shall be provided.

(XII) Public facilities. Toilet facilities, public telephone, and drinking fountain shall be provided for the exclusive use of the waiting room.

(XIII) Diagnostic radiographic (X-ray) room. Imaging facilities for diagnostic services shall be readily available to the emergency suite. If a separate radiographic (X-ray) room is installed within the emergency suite, it shall comply with the requirements in subsection (j)(1)(A) of this section. When the diagnostic X-ray room is exclusively used for the emergency treatment area, the dressing rooms may be omitted.

(XIV) Laboratory unit. Laboratory services shall be made available to the emergency suite. If a separate laboratory workroom is installed within the emergency suite, it shall comply with the requirements in subsection (k)(1)(C)(i) of this section. All laboratory services provided on site or by contractual arrangement shall comply with §511.45 of this chapter (relating to Laboratory Services).

(XV) Medical staff work area and charting areas. A medical staff work area and charting area shall be provided. The area may be combined with the reception and control area.

(XVI) Clean storage room. A clean storage room shall be provided for clean supplies, linens, and medications as needed. A hand washing fixture shall be provided with hands-free operable controls.

(XVII) Soiled workroom. The workroom shall contain a work counter, a clinical sink or equivalent flushing type fixture, hand washing fixture with hands-free operable controls, waste receptacles, and soiled linen receptacles.

(XVIII) Housekeeping room. The housekeeping room shall contain a floor receptor or service sink, storage space for housekeeping supplies and equipment, and be located within the suite. When automatic film processors are used, a receptacle of adequate size with hot and cold water for cleaning the processor racks shall be provided.

(XIX) Staff toilets. Toilets may be outside the suite but shall be convenient for staff use and include hand washing fixtures with hands-free operable controls. When a department has four or more treatment or examination rooms, toilet facilities shall be in the suite.

(ii) Other rooms. If an LSRH provides one or more of the following rooms, the room shall meet the applicable requirements in this clause.

(I) Examination room. When provided, the examination room for a single patient shall have a minimum clear floor area of 100 square feet exclusive of fixed and movable cabinets and shelves. The minimum clear room dimension exclusive of fixed cabinets and built-in shelves shall be nine feet. The examination room shall contain cabinets, medication storage, work counter, examination light, and a hand washing fixture with hands-free operable controls.

(II) Multi-bed examination room. When a multiple-patient station examination room is provided, the clearance between the side of the gurney and a wall or partition shall be a minimum of three feet. The clearance between sides of the gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurney shall not be less than seven feet for single load area or room or ten feet for double load area or room. Four feet of the passage space at the foot of the bed may be shared between two gurneys. The multiple-patient station examination room shall contain cabinets, work counters, and a hand washing fixture with hands-free operable controls. One hand washing fixture shall be provided for every four gurneys or fraction thereof. Fixtures shall be uniformly distributed. The fixed and moveable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(III) Isolation room. The need for an airborne infection isolation room in the emergency suite shall be determined by the LSRH and the infection risk assessment. When an LSRH provides treatment rooms to perform procedures on persons who are known or suspected of having an airborne infectious disease, these procedures shall be performed in a designated treatment room meeting airborne infection isolation ventilation requirements. The isolation room shall have functional space in accordance with clause (i)(I) of this subparagraph, and meet the ventilation requirements contained in Table 3 of §511.169(c) of this subchapter.

(IV) Secured holding room. When provided, this room shall be constructed to allow for security, patient and staff safety, patient observation, and sound mitigation. The secure holding room shall have a minimum clear floor area of 100 square feet exclusive of fixed cabinets. The minimum clear room dimension exclusive of fixed cabinets shall be 10 feet.

(V) Orthopedic and cast room. When provided, the room may be in a separate room or in the trauma room. The room shall contain a work counter, storage for splints and orthopedic supplies, traction hooks, medication storage, examination light, and a hand washing fixture with hands-free operable controls. When a cast room is provided it shall be equipped with hand washing facilities, plaster sink, storage, and other provisions required for cast procedures.

(VI) Film processing room. When a radiographic (X-ray) room is provided, a darkroom for processing film shall be provided unless the processing equipment does not require a darkroom for loading and transfer. When daylight processing is used, the darkroom may be minimal for emergency and special uses. Film processing shall be located convenient to the darkroom.

(VII) Decontamination room. When provided, a decontamination room shall have an exterior entry point and as far as practical from any other entry point to the emergency treatment area. The internal door from the decontamination room shall open directly to the corridor into the emergency treatment area. The door shall swing into the room and be lockable against ingress from the corridor. The room shall have a minimum clear floor area of at least 80 square feet and a hand washing fixture with hands-free operable controls.

(B) Holding or observation room area.

(i) Location. When a holding or observation room or area is provided within or adjacent to the emergency suite, it shall comply with the following.

(I) Single occupancy room area. A single occupancy holding or observation room shall have a minimum clear area of 100 square feet exclusive of fixed and movable cabinets and shelves. The holding or observation room shall contain a work counter and hand washing fixture with hands-free operable controls.

(II) Single occupancy room location. The single occupancy holding or observation room shall be near the nurse station and near a patient toilet room that contains a hand washing fixture with hands-free operable controls.

(III) Multiple occupancy room area. In a multiple occupancy holding or observation room or area, the clearance between the side of the gurney and a wall or partition shall be at least three feet. The clearance between sides of the gurneys shall be at least six feet. The minimum distance at the foot of the gurney shall not be less than seven feet for a single load area or room or ten feet for a double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The multiple occupancy holding or observation room or area shall contain cabinets, work counters, and a hand washing fixture with hands-free operable controls. One hand washing fixture shall be provided for every four holding or observation gurneys or fraction thereof. Fixtures shall be uniformly distributed. The fixed and moveable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(IV) Toilet room. In a multiple occupancy holding or observation room or area, a patient toilet room with a hand washing fixture with hands-free operable controls shall be provided within the room or area.

(ii) Multiple occupancy room location. When a multiple occupancy holding or observation room is not within or adjacent to the emergency suite, the following additional spaces shall be provided:

(I) a stretcher and wheelchair storage alcove, that shall be located out of the line of traffic;

(II) a clean storage room for clean supplies, linen and medication as needed that is located within or adjacent to the holding or observation room and contains a hand washing fixture with hands-free operable controls;

(III) a soiled workroom located within or adjacent to the holding or observation room and contains a work counter, a clinical sink or equivalent flushing type fixture, hand washing fixture with hands-free operable controls, waste receptacles, and soiled linen receptacles; and

(IV) a housekeeping room located within or near the holding or observation room and contains a floor receptor or service sink and storage space for housekeeping supplies and equipment.

(C) Trauma center. When provided, a trauma center shall comply with subparagraph (B) of this paragraph and the following requirements.

(i) Trauma room. At least one trauma room shall be provided with 250 square feet of clear floor area exclusive of aisles and fixed and moveable cabinets and shelves. The minimum clear dimension between fixed cabinets and built-in shelves shall be 12 feet. The trauma room shall contain a work counter, cabinets, medication storage, and examination light.

(ii) Multiple-station trauma room. When multiple-patient stations are provided, the clearance between the head of the gurney to the wall or partition shall be at least three feet. The clearance between the side of a gurney and a wall or partition shall be at least six feet. The clearance between the sides of gurneys shall be at least twelve feet. The minimum distance at the foot of the gurney shall not be less than seven feet for a single load area or room or ten feet for a double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The multiple-station trauma room shall contain cabinets, medication storage, work counter, examination light, and scrub sink with hands-free operable controls. The fixed and moveable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(iii) Scrub facilities. A scrub station shall be located at the entrance to each trauma room either inside or outside of the room. One scrub station may serve two trauma gurneys. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts. The scrub sinks shall be recessed out of the main line of traffic.

(iv) Doorways. All doorways openings from the ambulance entrance to the trauma room shall be at least five feet wide.

(D) Emergency clinic. When an emergency clinic (that may also be referred to as "urgent care," "fast track," "express care," "minor care," etc.) is provided, the clinic shall be separate and distinct from the emergency treatment area and trauma center and shall meet all the requirements of subparagraph (A) of this paragraph. All facilities required by subparagraph (A) of this paragraph may be shared with the emergency treatment area and trauma center except for the emergency treatment room. An emergency treatment room in the emergency clinic shall not be less than 100 square feet. An emergency exam room in the emergency clinic shall not be less than 80 square feet.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Area. Trauma rooms shall have ceiling heights not less than nine feet.

(ii) Fixtures. The decontamination room shall be equipped with two hand-held showerheads with temperature controls and a dedicated holding tank with a floor drain.

(B) Finishes.

(i) Flooring. Flooring used in a trauma room, treatment room, examination room, holding area, and soiled workroom shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter. Seamless type flooring is not required in the examination room in the emergency clinic.

(ii) Ceiling. Ceilings in soiled workrooms, isolation rooms, and trauma rooms shall be of the monolithic type as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(iii) Surfaces. The decontamination room floor shall be self-coved to a height of six inches. The room shall have all smooth, nonporous, scrubbable, nonabsorbent and nonperforated surfaces.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Duct linings. Duct linings exposed to air movement shall not be used in ducts serving any trauma rooms, treatment rooms, examination rooms, holding areas, and clean room. This requirement shall not apply to mixing boxes and acoustical traps that have special coverings over such lining.

(B) Air supply. When a trauma room is provided under paragraph (1)(C)(i) of this subsection, the air supply for the trauma or surgical room shall be from ceiling outlets that are as near the work centers as possible, and a minimum of two low return inlets shall be located diagonally opposite from one another.

(C) Return air inlets. Return air inlets shall be not lower than four inches nor higher than 12 inches from floor level.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) Medical gas systems. Medical gas systems shall be provided in accordance with §511.162(d)(4)(A)(iii) of this subchapter.

(B) Ice machine. An ice machine shall be provided for therapeutic purposes and shall be located in the clean utility room. A self-dispensing ice machine shall be provided for ice for human consumption.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) General.

(i) Examination room electrical receptacles. Each treatment and examination room in the emergency treatment area and trauma center shall have at least six duplex electrical receptacles located convenient to the head of each patient station.

(ii) Emergency clinic suite electrical receptacles. Each treatment and examination room in the emergency clinic suite shall have a minimum of four duplex electrical receptacles located convenient to the head of each patient station.

(iii) Work counter electrical receptacles. Each work counter and table shall have access to at least one duplex receptacle connected to the critical branch of the emergency electrical system.

(iv) Film illuminators. The LSRH shall provide X-ray film illuminators for handling at least four films simultaneously in all treatment, examination, and trauma rooms in the emergency treatment area. When the entire emergency treatment area is provided with digital imaging, at least two X-ray film illuminators shall be provided within a central location within the emergency treatment area.

(B) Nurses calling systems. The nurse call system shall comply with §511.162(d)(5)(L) of this subchapter and Table 7 of §511.169(g) of this subchapter.

(f) Employees suite.

(1) Architectural requirements.

(A) Compliance. Architectural requirements shall comply with §511.162(d)(1) of this subchapter and this paragraph.

(B) Lockers, lounges, toilets, and showers. Lockers, lounges, toilets, and showers shall be provided within the LSRH for employees and volunteers. These facilities are in addition to, and separate from, those required for the medical staff and the public.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this chapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(g) Engineering suite and equipment areas.

(1) Architectural requirements. Architectural requirements comply with §511.162(d)(1) of this subchapter and this paragraph.

(A) General. The following facilities shall be provided:

(i) an engineer's office with file space and provisions for protected storage of facility drawings, records, manuals, etc.;

(ii) a general maintenance shop or shops for repair and maintenance;

(iii) a separate room for building maintenance supplies and equipment, and storage of bulk solvents and flammable liquids shall be in a separate building and not within the LSRH building;

(iv) a medical equipment room that includes provisions for the storage, repair, and testing of electronic and other medical equipment;

(v) a separate room or building for yard maintenance equipment and supplies. When a separate room is within the physical plant the room shall be located so that equipment may be moved directly to the exterior. Yard equipment or vehicles using flammable liquid fuels shall not be stored or housed within the LSRH building; and

(vi) sufficient space in all mechanical and electrical equipment rooms for proper maintenance of equipment. Provisions shall also be made for removal and replacement of equipment.

(B) Additional areas or rooms. Additional areas or rooms for mechanical, and electrical equipment shall be provided within the physical plant or installed in separate buildings or weatherproof enclosures with the following exceptions.

(i) An area shall be provided for cooling towers and heat rejection equipment when such equipment is used.

(ii) An area for the medical gas park and equipment shall be provided. For smaller medical gas systems, the equipment may be housed in a room within the physical plant in accordance with National Fire Protection Association 99, Standard for Health Care Facilities, 2012 edition (NFPA 99), Chapters 4 and 8.

(iii) When provided, compactors, dumpsters, and incinerators shall be located in an area remote from public entrances.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(h) General storage. A general storage room shall be provided at least equal to five percent of the total area of the patient care units.

(i) Hyperbaric suite.

(1) Architectural requirements. When a hyperbaric suite is provided, it shall meet the requirements of NFPA 99 Chapter 20, and NFPA 101 Chapter 18.

(A) Hyperbaric chamber clearances. Multiple occupancy chambers (Class A) shall comply with NFPA 99 Chapter 20. The minimum clearances for individual (Class B) hyperbaric chambers and the side of a chamber and a wall or partition shall be at least three feet. The clearance between sides of chambers shall be at least six feet. The minimum distance at the chamber entry shall not be less than seven feet for a single load area or room or ten feet for a double load area or room. Four feet of the passage space at the chamber entry may be shared between two chambers. The chamber room shall contain cabinets, medication storage, work counter and a hand washing fixture with hands-free operable controls. The fixed and movable cabinets and shelves shall not encroach upon the chamber clear floor space or area.

(B) Service areas. The following minimum service areas and facilities shall be provided convenient to the hyperbaric chamber suite.

(i) Patient waiting area. The area shall be out of traffic, under staff control, and shall have seating capacity in accordance with the LSRH's functional program. Patient waiting areas are not required where two or fewer individual hyperbaric chamber units are provided.

(ii) Control desk and reception area. A control desk and reception area shall be provided.

(iii) Holding area. A holding area under staff control shall accommodate patients on stretchers or beds. Stretcher patients shall be out of the direct line of normal traffic. The patient holding area is not required where two or fewer individual hyperbaric chamber units are provided.

(iv) Patient toilet rooms. Toilet rooms shall be provided with hand washing fixtures with hands-free operable controls and with direct access from the hyperbaric suite.

(v) Patient dressing room. A dressing room for outpatients shall be provided and shall include a seat or bench, mirror, and provisions for hanging patients' clothing and for securing valuables. At least one dressing room shall be provided to accommodate wheelchair patients.

(vi) Staff facilities. Toilets with hand washing fixtures with hands-free operable controls may be outside the suite but shall be convenient for staff use. These facilities may be shared with an adjacent suite.

(vii) Consultation room. An appropriate consultation room for individual consultation with referring clinicians shall be provided for outpatients. This room may be shared with an adjacent suite.

(viii) Storage space. A clean storage space shall be provided for clean supplies and linens. The space shall contain a hand washing fixture with hands-free operable controls. The storage room may be shared with another department if convenient to both.

(ix) Soiled holding room. A soiled holding room shall be provided with waste receptacles and soiled linen receptacles. This room may be shared with an adjacent suite.

(x) Hand washing. A lavatory equipped for hand washing with hands-free operable controls shall be located in the room where the hyperbaric chambers are located.

(xi) Housekeeping room. The housekeeping room shall contain a floor receptor or service sink, storage space for housekeeping supplies and equipment, and be located nearby.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) Grounding of hyperbaric chambers shall be connected only to the equipment ground in accordance with NFPA 99 §3-3.2.1.2, and National Fire Protection Association 70, National Electrical Code, 2011 edition (NFPA 70) Article 250 (A)-(C), and Article 517.

(B) Additional grounds such as earth or driven grounds shall not be permitted.

(C) The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(j) Imaging suite.

(1) Architectural requirements.

(A) General. An LSRH shall have a diagnostic radiographic (X-ray) room convenient to emergency suites, and where provided surgery suites.

(i) Room size. All diagnostic imaging room sizes shall be in compliance with the manufacturer's recommendations for the specific equipment. Clearance and unobstructed space shall not be less than three feet around the diagnostic equipment.

(ii) Radiation protection. When radiation protection is required for any diagnostic imaging room, a medical physicist licensed under the Texas Occupations Code Chapter 602 (relating to Medical Physicists), shall specify the type, location, and amount of radiation protection to be installed for the layout and equipment selections.

(iii) Shielded control. Each room where radiation protection is required shall include a shielded control alcove. The control alcove shall be provided with a view window designed to permit full view of the examination table and the patient at all times.

(iv) Warning signs. Warning signs capable of indicating that the equipment is in use shall be provided.

(v) Ventilation requirements. Diagnostic and procedure room intended for patients with airborne infectious diseases shall meet the ventilation requirements as contained in Table 3 of §511.169(c) of this subchapter.

(B) Diagnostic X-ray and radiographic and fluoroscopy (R&F) rooms. X-ray and R&F rooms shall comply with the manufacturer's recommendations for the specific equipment. Clearance and unobstructed space shall not be less than three feet around the diagnostic equipment.

(i) Control alcove. A control alcove shall be provided with a view window designed to provide full view of the patient at all times.

(ii) Toilet room. A toilet room shall be provided including a hand washing fixture with hands-free operable controls and have direct access to each R&F room and a corridor.

(C) Noninvasive angiography imaging room. When noninvasive angiography imaging is provided, the room shall have a minimum clear floor area of 250 square feet exclusive of built-in shelves or cabinets. Clearance and unobstructed space shall not be less than three feet around the diagnostic equipment.

(i) Control alcove. A control alcove shall be provided with a view window designed to provide full view of the patient at all times.

(ii) Viewing room or area. A viewing room or area shall be provided and shall be at least 10 feet in length. The viewing room or area may be provided in combination with the control room.

(iii) Scrub sink. A scrub sink shall be near the entrance to each angiographic room and shall be recessed out of the main traffic areas or corridor. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts.

(iv) Storage space. Storage space for portable equipment and supplies shall be provided.

(D) Computerized tomography (CT) scanning. When CT services are provided, the CT room's size shall comply with the manufacturer's recommendations and shall contain the following.

(i) Control room. A control room shall be provided with a view window permitting view of the patient. The control room shall be located to allow convenient film processing.

(ii) Patient toilet room. A patient toilet shall be provided conveniently to the procedure room. When directly accessible to the scan room, the toilet shall be arranged so that a patient may leave the toilet room without having to reenter the scan room. The toilet room shall have a hand washing fixture with hands-free operable controls.

(E) Mammography. When mammography services are provided, the room shall have a minimum clear floor area of 100 square feet exclusive of built-in shelves or cabinets.

(i) Control alcove. A control alcove shall be provided with a view window designed to provide full view of the patient at all times.

(ii) Built-in shielding. When mammography machines with built-in shielding for the operator are provided, the alcove is not required when approved by a medical physicist licensed under Texas Occupations Code Chapter 602.

(F) Magnetic resonance imaging (MRI). When MRI services are provided, the room shall be of sufficient size to house equipment but no less than 325 square feet of clear floor area exclusive of built-in shelves or cabinets.

(i) Control alcove. A control alcove shall be provided with a view window designed to provide full view of the patient at all times.

(ii) Computer room. A separate computer room shall be provided to accommodate the equipment.

(iii) Cryogen storage requirements. When cryogen is provided, a storage room or closet shall have a minimum clear floor area of 50 square feet for two large dewars of cryogen. A storage room or closet is required in areas where service to replenish supplies is not readily available.

(iv) Darkroom. When a darkroom is provided, the room shall be located near the required control room and shall be outside the 10-gauss field.

(v) Spectroscopy. When spectroscopy is provided, caution should be exercised in locating it in relation to the magnetic fringe fields.

(vi) Magnetic shielding. Magnetic shielding may be required to restrict the magnetic field plot. Radio frequency shielding is required to attenuate stray radio frequencies.

(vii) Patient holding area. A patient holding area shall be provided and shall be located near the MRI unit and be large enough to accommodate stretchers.

(viii) Hand washing fixture. A hand washing fixture with hands-free controls shall be provided near the entrance to the MRI room and shall be recessed out of the main traffic areas or corridor.

(ix) 3T magnetic strength MRI. A 3T or larger magnetic strength MRI shall be secured behind locked doors. The patient and staff entrance to the MRI shall have a traffic pattern from the waiting, dressing, holding and work areas through a lockable control station before entering the MRI. At no time shall patients or nonpatients be allowed to enter this restricted area without MRI staff present when the magnet is active.

(G) Ultrasound room. When ultrasound services are provided, the room's size shall comply with the manufacturer's recommendations. A patient toilet room shall be provided convenient to the procedure room and a corridor. The toilet room shall have a hand washing fixture with hands-free operable controls.

(H) Cardiac catheterization laboratory. The cardiac catheterization laboratory is normally a separate suite, but may be within the imaging suite. If provided, a cardiac catheterization laboratory shall comply with the requirements of subsection (w)(1)(C) of this section.

(I) Service areas. The following common service areas shall be provided.

(i) Patient waiting area. The area shall be out of traffic and under direct staff visual control.

(ii) Control desk and reception area. A control desk and reception area shall be provided.

(iii) Holding area. The holding area shall be out of direct traffic patterns and under visual control by staff. At least one stretcher station shall be provided for each three diagnostic and procedure rooms or fraction thereof. The minimum clear floor space in the holding area shall be 80 square feet exclusive of aisles and fixed and moveable cabinets and shelves. The area shall contain cabinets, a work counter, and a hand washing fixture with hands-free operable controls. The holding area may be reduced to 50 square feet exclusive of aisles and fixed and moveable cabinets and shelves for mammography, bone density, and other similar procedures.

(iv) Post-procedure observation room. When invasive diagnostic X-ray services are provided with anesthesia, a room for extended post-procedure observation of patients shall be provided. The minimum clear floor space for the observation space shall be 100 square feet exclusive of aisles and fixed and moveable cabinets and shelves. The room shall contain cabinets, a work counter, and a hand washing fixture with hands-free operable controls.

(v) Patient toilet rooms. A toilet room with hand washing facilities shall be located convenient to the waiting area.

(vi) Patient dressing rooms or cubicles. Dressing rooms or cubicles shall be convenient to the waiting areas and X-ray rooms. Each room shall include a seat or bench, mirror, and provisions for hanging patients' clothing and for securing valuables. At least one dressing room shall be provided to accommodate wheelchair patients.

(vii) Hand washing facilities. A hand washing fixture with hands-free controls shall be provided in or near the entrance to each diagnostic and procedure room unless noted otherwise. When a hand washing fixture is provided in the room, the fixture shall be located near the entrance to the room or near the staff entrance. When a hand washing fixture is located outside the room, the fixture shall be recessed in the egress corridor and located within five feet of the entrance to the room. Hand washing facilities shall be arranged to minimize any incidental splatter on nearby personnel or equipment.

(viii) Staff facilities. Toilets may be outside the suite and may be shared with other departments but shall be convenient for staff use. When four or more diagnostic or procedure imaging rooms are provided, a staff toilet is required with a hand washing fixture with hands-free controls.

(ix) X-ray film illuminator viewers. When all the diagnostic and imaging procedures are provided with digital imaging, two mounted X-ray film illuminator viewers shall be provided in the central viewing area or room.

(x) Contrast media preparation. This room shall include a work counter, a sink with hands-free operable controls, and storage. One preparation room may serve any number of rooms. When prepared media is used, this area is not required, but storage shall be provided for the media.

(xi) Film processing room. A darkroom shall be provided for processing film unless the processing equipment normally used does not require a darkroom for loading and transfer. When daylight processing is used, the darkroom may be minimal for emergency and special uses. Film processing shall be located convenient to the procedure rooms and to the quality control area.

(xii) Quality control area or room. An area or room for film viewing shall be located near the film processor. All view boxes shall be illuminated to provide light of the same color value and intensity.

(xiii) Film storage (active). When X-ray film is used, it shall be stored in a room with a cabinet or shelves for filing patient film for immediate retrieval.

(xiv) Film storage (inactive). When X-ray film is used, a room for inactive film storage shall be provided. It may be outside the imaging suite, but must be under the administrative control of imaging suite personnel and be properly secured to protect films against loss or damage.

(xv) Storage for unexposed film. When X-ray film is used, storage facilities for unexposed film shall include protection of film against exposure or damage.

(xvi) Storage of cellulose nitrate film. When used, cellulose nitrate film shall be stored in accordance with the requirements of National Fire Protection Association 40, Standard for the Storage and Handling of Cellulose Nitrate Motion Picture Film, 2011 edition.

(xvii) Additional spaces. When four or more diagnostic or procedure rooms are provided in the LSRH, the following shall be required:

(I) an office for radiologists and assistants;

(II) clerical office spaces, as necessary for the functional program;

(III) consultation area or room;

(IV) medication station. Storage and preparation of medication shall be done from a room, alcove area, or from a self-contained dispensing unit but must be under visual control of nursing staff. A work counter, hand washing fixture with hands-free operable controls, refrigerator, and double-locked storage for controlled substances shall be provided. Standard cup-sinks are not acceptable for hand washing;

(V) clean storage room. Clean storage room shall be provided for clean supplies and linens. A hand washing fixture shall be provided with hands-free operable controls. When conveniently located, the clean storage room may be shared with another department; and

(VI) soiled workroom. The soiled workroom shall not have direct connection to the diagnostic and procedure rooms. The room shall contain a clinical sink or equivalent flushing type fixture, work counter, hand washing fixture with hands-free operable controls, waste receptacle, and soiled linen receptacle. When contaminated soiled material or fluid waste is not handled, only a soiled holding room shall be required.

(xviii) Housekeeping room. The room may serve multiple departments when conveniently located.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Radiation protection. Radiation protection shall be designed, tested, and approved by a medical physicist licensed under Texas Occupations Code Chapter 602.

(I) Room shielding. Room shielding calculations for linear accelerators, teletherapy units and remote control brachytherapy units must be submitted to the Department of State Health Services Radiation Control Program (RC) for approval prior to use. Shielding in diagnostic radiographic rooms will be reviewed by RC inspectors, in the field, subsequent to use. Any changes in design or shielding that affects radiation exposure levels adjacent to those rooms requires prior approval by RC.

(II) Facility design and environmental controls. Facility design and environmental controls associated with licensable quantities of radioactive material in laboratories, imaging rooms, or both shall be approved by RC prior to licensed authorizations.

(ii) Protected alcoves. Where protected alcoves with view windows are required, provide a minimum of one foot six inches from the edge where the glazing and the frame connect and the outside partition edge.

(iii) Ceilings. Imaging procedure rooms shall have ceiling heights not less than nine feet. Ceilings containing ceiling-mounted equipment shall be of sufficient height to accommodate the equipment of fixtures and their normal movement.

(B) Finishes.

(i) Flooring. Flooring used in contrast media preparation and soiled workroom shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Ceilings. A lay-in type ceiling is acceptable for the diagnostic and procedure rooms.

(3) Mechanical Requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Cryogen gas venting and exhaust. The cryogen gas venting from the MRI unit shall be exhausted to the exterior. When a cryogen storage room is provided to replenish supplies, the storage room shall be vented and exhausted to the exterior.

(B) Air conditioning. Self-contained air conditioning to supplement the cooling capacity in computer rooms is permitted.

(C) Air handling units. Air handling units serving the imaging suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph. When automatic film processors are used, a receptacle of adequate size with hot and cold water for cleaning the processor racks shall be provided.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) General.

(i) Each imaging procedure room shall have at least four duplex electrical receptacles.

(ii) A special grounding system in areas such as imaging procedures rooms where a patient may be treated with an internal probe or catheter shall comply with NFPA 99 Chapter 9 and NFPA 70 Article 517.

(iii) General lighting with at least one light fixture powered from a normal circuit shall be provided in imaging procedures rooms in addition to special lighting units at the procedure or diagnostic tables.

(B) Nurses calling system. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(k) Laboratory suite.

(1) Architectural requirements.

(A) General.

(i) Laboratory facilities. Laboratory facilities and services shall be provided by the LSRH such as hematology, clinical chemistry, urinalysis, cytology, anatomic pathology, immunohematology, microbiology, bacteriology and others.

(ii) Code requirements. Each laboratory unit shall meet the requirements of NFPA 99 Chapter 11 (relating to Laboratories), and NFPA 101 Chapter 18 (relating to New Health Care Occupancies).

(B) Minimum laboratory facilities. When laboratory services are provided off site by contract, the following minimum facilities shall be provided within the LSRH.

(i) Laboratory work room. The laboratory workroom shall include a counter and a sink with hands-free operable controls.

(ii) General storage. Cabinets or closets shall be provided for supplies and equipment used in obtaining samples for testing. A refrigerator or other similar equipment shall be provided for specimen storage waiting for transfer to off-site testing.

(iii) Blood storage facilities. Refrigerated blood storage facilities for transfusions shall be provided. The blood storage refrigerator shall be equipped with temperature monitoring and alarm signals.

(iv) Specimen collection facilities. A blood collection area shall be provided with a counter, space for seating, and hand washing fixture with hands-free operable controls. A toilet and lavatory with hands-free operable controls shall be provided for specimen collection. This facility may be outside the laboratory suite if conveniently located.

(C) On-site laboratory facilities. When the LSRH provides on-site laboratory services, the following facilities shall be provided in addition to the requirements in subparagraphs (A) and (B) of this paragraph.

(i) Laboratory workroom. The laboratory work room shall include a counter, space appropriately designed for laboratory equipment and a sink with hands-free operable controls.

(ii) General storage. Storage, including refrigeration for reagents, standards, supplies, and stained specimen microscope slides, etc. shall be provided. Separate facilities shall be provided for such incompatible materials as acids and bases, and vented storage shall be provided for volatile solvents.

(iii) Chemical safety facilities. When chemical safety is a requirement, provisions shall be made for an emergency shower and eye flushing devices.

(iv) Flammable liquids. When flammable or combustible liquids are used, the liquids shall be stored in approved containers, in accordance with National Fire Protection Association 30, Flammable and Combustible Liquids Code, 2012 edition.

(v) Radioactive materials. When radioactive materials are employed, storage facilities shall be provided.

(D) Bone marrow laboratory. A cryopreservation laboratory and a human leukocyte antigen laboratory shall be provided in hospitals providing bone marrow transplantation services.

(E) Service areas and facilities. The following service areas and facilities shall be provided.

(i) Hand washing facilities. Each laboratory room or work area shall be provided with a hand washing fixture with hands-free operable controls.

(ii) Office spaces. The scope of laboratory services shall determine the size and quantity for administrative areas including offices as well as space for clerical work, filing, and record maintenance. At a minimum, an office space shall be provided for the use of the laboratory service director.

(iii) Staff facilities. Lounge, locker, and toilet facilities shall be conveniently located for male and female laboratory staff. These may be outside the laboratory area and shared with other departments.

(iv) Housekeeping room. A housekeeping room shall be located within the suite or conveniently located nearby.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter. Floors in laboratories shall comply with the requirements of §511.162(d)(2)(B)(iii) of this subchapter except that carpet flooring shall not be used.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Air recirculation. No air from the laboratory areas shall be recirculated to other parts of the LSRH. Recirculation of air within the laboratory suite is allowed.

(B) Laboratory hoods. When laboratory hoods are provided, they shall meet the following general requirements.

(i) Face velocity. The average face velocity of each exhaust hood shall be at least 75 feet per minute.

(ii) Exhaust system. The exhaust shall be connected to an exhaust system to the exterior that is separate from the building exhaust system. Biological safety cabinets with HEPA filters and alarms to alert staff do not have to be exhausted to the exterior. If the air changes for biological safety cabinets as provided in Table 3 of §511.169(c) of this subchapter do not provide sufficient air for proper operation of the safety cabinets (when in use), supplementary make-up air (filtered and preheated) shall be provided around these units to maintain the required airflow direction and exhaust velocity. Make-up air system for safety cabinets shall be arranged to minimize "short circuiting" of air and to avoid reduction in air velocity at the point of contaminant capture.

(iii) Exhaust fan. The exhaust fan shall be located at the discharge end of the system.

(iv) Exhaust duct system. The exhaust duct system shall be of noncombustible and corrosion- resistant material.

(v) Fume hoods. Where fume hoods are used, the design should consider the placement and types of air distribution devices to avoid the disturbance of a uniform velocity across the face of the hood.

(C) Special laboratory hoods. When special laboratory hoods are provided, they shall meet the following special standards for these types of hoods.

(i) Associated equipment. Fume hoods, and their associated equipment in the air stream, intended for use with perchloric acid and other strong oxidants, shall be constructed of stainless steel or other material consistent with special exposures, and be provided with a water wash and drain system to permit periodic flushing of duct and hood. Electrical equipment intended for installation within such ducts shall be designed and constructed to resist penetration by water. Duct systems serving these hoods shall be constructed of acid-resistant stainless steel for at least 10 feet from the hood. Lubricants and seals shall not contain organic materials. When perchloric acid or other strong oxidants are only transferred from one container to another, standard laboratory fume hoods and the associated equipment may be used in lieu of stainless steel construction.

(ii) Infectious or radioactive material laboratory hoods. Each laboratory hood used to process infectious or radioactive materials shall have a minimum face velocity of 90-110 feet per minute and be connected to an independent exhaust system, with suitable pressure-independent air modulating devices and alarms to alert staff of fan shutdown or loss of airflow. Each hood shall also have filters with a 99.97 percent efficiency (based on the dioctyl-phthalate (DOP) test method) in the exhaust stream, and be designed and equipped to permit the safe removal, disposal, and replacement of contaminated filters. Filters shall be as close to the hood as practical to minimize duct contamination.

(iii) Radioactive isotope hoods. Fume hoods intended for use with radioactive isotopes shall be constructed of stainless steel or other material suitable for the particular exposure and shall comply with National Fire Protection Association 801, Standard for Facilities Handling Radioactive Materials, 2003 edition and NFPA 99 §11.3.5.

(iv) Air modulating devices. Each laboratory hood shall have a suitable pressure-independent air modulating device and alarm to alert staff of fan shutdown or loss of airflow. The alarm shall be audible within the laboratory and at a 24-hour manned location.

(D) Filtration requirements. Filtration requirements for air handling units serving the laboratory suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter.

(E) Duct linings. Duct linings exposed to air movement shall not be used in ducts serving any laboratory room and clean room unless terminal filters of at least 80 percent efficiency are installed downstream of linings. This requirement shall not apply to mixing boxes and acoustical traps that have special coverings over such lining.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) General.

(i) Faucet spouts. Faucet spouts at lavatories and sinks shall have clearances adequate to avoid contaminating utensils and the contents of beakers, test tubes, etc.

(ii) Sink drain lines. Drain lines from sinks used for acid waste disposal shall be made of acid-resistant material.

(iii) Other drain lines. Drain lines serving some types of automatic blood-cell counters must be of carefully selected material that will eliminate potential for undesirable chemical reactions, explosions, or both between sodium azide wastes and copper, lead, brass, and solder, etc.

(B) Medical gas systems. When provided, medical gas systems shall comply with §511.162(d)(4)(A)(iii) and (iv) of this subchapter. The number of outlets in the laboratory for vacuum, gases, and air shall be determined by the LSRH's functional program requirements.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(A) Blood storage refrigerator alarm. The blood storage refrigerator shall have an alarm device to indicate a temperature increase or malfunction and indicate an audible warning at a 24-hour manned location.

(B) Blood storage refrigerator connection. The blood storage refrigerator shall be connected to the critical branch of the emergency essential electrical system.

(C) Exhaust hoods. All exhausts hoods shall be connected to the emergency essential electrical system.

(l) Laundry suite. Laundry facilities shall be provided on site or off site. On-site laundry services may be within the LSRH or in a separate building on-site. The laundry facilities shall be separated from a patient treatment room, patient examination room, and a patient diagnostic room, or areas of food preparation and storage, and areas in which clean supplies and equipment are stored.

(1) Architectural requirements.

(A) When laundry service is provided on site, it shall comply with the following.

(i) Soiled and clean linen processing room. Soiled and clean linen processing rooms shall be provided. When the soiled and clean linen processing are combined in a single room, each process shall be physically separated within the room.

(ii) Hand washing facilities. Adequate hand washing facilities shall be provided in both the soiled and clean processing areas.

(iii) Receiving, holding, and sorting room. A receiving, holding, and sorting room for control and distribution of soiled linen shall be provided. This area may be combined with the soiled linens processing room. Discharge from soiled linen chutes may be received in the soiled room or area or in a separate dedicated room.

(iv) Laundry processing room. A laundry processing room shall be provided with a commercial washer and dryer capable of processing at least a seven-day laundry supply within the regular scheduled work week.

(v) Clean linen processing room. A clean linen processing room or area shall be provided with folding counters or tables. This area shall have provisions for inspections, folding, packing, and mending of linen.

(vi) Storage room. A holding room or area for storage and issuing of clean linen shall be provided but may be combined with clean linen processing room.

(vii) Storage space. Storage space and cabinets for soaps, stain removers, and other laundry processing agents shall be located in the soiled and clean processing room or areas.

(viii) Laundry equipment. Laundry equipment shall be arranged so that the processing of laundry is an orderly work flow from soiled to clean operations. Cross-traffic shall be held to a minimum to prevent contamination.

(B) Off-site laundry. When laundry service is provided off site, the following minimum requirements shall be provided on site:

(i) a service entrance that shall have a drive under canopy for protection from inclement weather, for loading and unloading of linen;

(ii) a control station for pickup and receiving. This may be a room at the common loading dock, in the soiled linen holding room, or the central clean linen storage room;

(iii) a soiled linen holding room; and

(iv) a central clean linen storage and issuing room in addition to linen storage required at the individual patient units.

(C) Required areas or rooms. The following areas or rooms shall be provided regardless of delivery type of laundry service:

(i) office space for the director of laundry services;

(ii) cart storage rooms for clean and soiled linen. The cart storage areas may be provided within the clean and soiled rooms. Carts may not be parked or stored in the egress corridor;

(iii) cart sanitizing facilities that comply with subsection (b) of this section;

(iv) staff toilet in the laundry suite or convenient for staff use and with a hand washing fixture with hands-free operable controls;

(v) lockers for staff use may be in laundry suite or part of a central locker room when convenient to the laundry; and

(vi) housekeeping room within the laundry suite or available nearby.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter.

(3) Mechanical Requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Ventilation system. The ventilation system shall include adequate intake, filtration, exchange rate, and exhaust in accordance with Table 3 and Table 4 of §511.169(c) and (d) of this subchapter, respectively.

(B) Filtration. Filtration requirements for air handling units serving the laundry suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter.

(C) Air flow. Direction of air flow of the HVAC systems shall be from clean to soiled areas.

(D) Soiled processing ventilation. The ventilation system for soiled processing area shall have negative air pressure while the clean processing area shall have positive pressure.

(E) Lint interceptors. Lint interceptors shall be located outside the laundry area. Drainage piping that serves laundry equipment shall employ suds-control features.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(m) Medical records suite.

(1) Architectural requirements. The following rooms, areas, or offices shall be provided in the medical records suite:

(A) medical records administrator or technician office;

(B) review and dictating rooms or spaces;

(C) work area that includes provisions for sorting, recording, scanning, or microfilming records; and

(D) file room. When nondigital files are stored on site, the room shall be considered as hazardous. The construction protection for the storage room or area shall comply with Chapter 18 of NFPA 101 §18.3.2.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(n) Mental health and chemical dependency treatment.

(1) General requirements. Areas that a patient receiving mental health or chemical dependency services at the LSRH may occupy shall comply with the requirements in this subsection.

(2) Details and finishes.

(A) Details.

(i) Security. The type and degree of security and patient safety required in the suite shall be determined by LSRH administration and described in the LSRH's functional program narrative, unless stated otherwise within these rules.

(ii) Visibility. All areas where a person receiving mental health services is located in the LSRH, including entrances to patient care rooms, shall be visible from the nurse station. Observation by video cameras of seclusion rooms, entrances, hallways, and activity areas shall be acceptable.

(iii) Fasteners. All exposed and accessible fasteners shall be tamper-resistant.

(iv) Hardware. Suitable hardware shall be provided on doors to toilet rooms so that access to these rooms can be controlled by staff. Hardware shall be utilized that is appropriate to prevent patient injury.

(v) Breakaway fixtures. Only breakaway or collapsible clothes bars in wardrobes, lockers, and closets and shower curtain rods shall be permitted in areas that a patient receiving mental health or chemical dependency treatment services may occupy in the LSRH.

(vi) Hangers. Wire coat hangers shall not be permitted in the suite.

(vii) Special hardware. Special fixtures, hardware, and tamper-proof screws are required throughout the suite.

(viii) Grab bars. Horizontal grab bars shall be constructed to prevent looping or tying of cords, ropes, etc.

(ix) Safety glazing. Where glass fragments may create a hazard, safety glazing or other appropriate security features shall be incorporated.

(B) Finishes. Patient sleeping rooms, patient toilet rooms and seclusion rooms shall have monolithic ceilings and bonded walls for patient safety and security measures. The ceiling in the soiled workroom shall be monolithic type as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall be in accordance with 25 TAC §133.163(t)(3) and this paragraph. Special consideration shall be given to the type of heating and cooling units, ventilation outlets, and appurtenance installed in patient-occupied areas of mental health nursing units. The following shall apply:

(A) All air grilles and diffusers shall be of a type that prevents the insertion of foreign objects.

(B) All convector or HVAC enclosures exposed in the room shall be constructed with rounded corners and shall have enclosures fastened with tamper-resistant fasteners.

(C) HVAC equipment shall be of a type that minimizes the need for maintenance within the room.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall be in accordance with 25 TAC §133.163(t)(4) and this paragraph.

(A) Piping systems.

(i) Medical gas. Piped medical gas systems are not required.

(ii) Sprinklers and showerheads. Only tamper-proof sprinkler and tamper-proof showerheads from which it is not possible to suspend any objects shall be installed.

(B) Plumbing fixtures.

(i) Faucet controls. Faucet controls shall not be equipped with handles that may be easily broken off.

(ii) Bedpan washers. Bedpan washers are not allowed in patient bathrooms or toilet rooms.

(5) Electrical requirements. Electrical requirements shall be in accordance with 25 TAC §133.163(t)(5) and this paragraph.

(A) Nurse call. A nurse call system shall comply with the requirements of §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter. Pull cords shall not exceed 18 inches in length, and provisions shall be made to permit removal of call buttons and use of blank plates as required for security.

(B) Each patient room shall have duplex grounded receptacles. There shall be one receptacle at each side of the head of each bed and one on every other wall. Receptacles in areas intended for mental health and chemical dependency patients of all ages shall be protected by GFCI breakers installed in distribution panel enclosures serving the unit.

(C) Fifteen-ampere and 20-ampere, 125-volt receptacles intended to supply patient care areas shall be tamper-resistant as permitted by NFPA 70, §517-18, or shall be protected by GFCI breakers. A tamper-resistant receptacle is one that is constructed to limit improper access to its energized contacts.

(o) Morgue.

(1) Architectural requirements.

(A) General. When a morgue or body-holding room is provided, it shall be located to avoid the need for transporting bodies of deceased patients through public areas. A body-holding room shall be provided.

(B) Autopsy performed within LSRH. When autopsies are performed within the LSRH, the following rooms, areas, and equipment shall be provided.

(i) Facilities. Refrigerated facilities shall be provided for body-holding.

(ii) Room requirements. The autopsy room shall contain work counters, hand washing facilities with hands-free operable controls, autopsy table and storage space for supplies, equipment and specimens.

(iii) Sink. A deep sink shall be provided for washing specimens.

(iv) Change area. A clothing change area shall be provided with shower, toilet, hand washing facilities and lockers.

(C) Service areas. The following service areas shall be provided:

(i) a pathologist office;

(ii) staff toilets may be outside the suite but be convenient for staff use with a hand washing fixture with hands-free operable controls; and

(iii) a housekeeping room that meets the requirements of §511.162(d)(2)(A)(xxviii) of this subchapter shall be provided for the exclusive use of the morgue when autopsies are performed.

(D) Minimum requirements. If autopsies are performed outside the LSRH, a well-ventilated, temperature-controlled, nonrefrigerated body-holding room shall be provided.

(2) Details and finishes. Details and finishes shall be in accordance with §511.162(d)(2) of this subchapter and this paragraph.

(A) Flooring used in the autopsy room shall be the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(B) Ceilings in the autopsy rooms shall be monolithic as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall be in accordance with §511.162(d)(3) of this subchapter and this paragraph.

(A) The autopsy room shall be equipped with low exhaust grilles.

(B) The body-holding room shall be ventilated in accordance with Table 3 of §511.169(c) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall be in accordance with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall be in accordance with §511.162(d)(5) of this subchapter and this paragraph. Refrigerators for body-holding in the autopsy room shall be connected to the equipment branch of the essential electrical distribution system.

(p) Nuclear medicine suite.

(1) Architectural requirements.

(A) General. When nuclear medicine services are provided, the facilities may be in a separate suite or combined with an imaging suite.

(i) Radiation protection. When nuclear medicine requires radiation protection, a medical physicist licensed under Texas Occupations Code Chapter 602 shall specify the type, location, and amount of radiation protection to be installed for the layout, equipment selections and storage, handling and disposal of radioactive material.

(ii) Room size. The nuclear medicine room shall be sufficiently sized to house all fixed and moveable equipment and allow a minimum of three feet of clear and unobstructed working space on all sides of equipment accessible to staff and patient.

(B) Radioisotope room (Hot lab). When radiopharmaceutical preparation is performed on site, the room shall include sufficient space for equipment, storage of radionuclides, chemicals for preparation, dose calibrators, and record keeping. When preprepared materials are used, storage and calculation area may be smaller than for on-site preparation.

(i) Radiation shielding. The room and isotope handling areas within the room shall have appropriate radiation shielding.

(ii) Radioisotope storage. There shall be a shielded area or enclosed shielded cabinet for long-term storage of decaying radioisotopes.

(iii) Hood exhaust. When venting of radioactive gases is required, a hood shall exhaust to the exterior.

(C) Positron emission tomography (PET). When PET services are provided, scanner and cyclotron rooms shall be in compliance with the manufacturer's recommendations and provide a minimum of three feet of clear and unobstructed working space on all sides of equipment accessible to staff and patient.

(i) Control alcove. A control alcove shall be provided with a view window permitting view of the patient.

(ii) Equipment area. An equipment area large enough to contain necessary electronic and electrical gear shall be provided.

(iii) Dose administration room. A dose administration room with radiation shielding shall be located near the treatment room. Patients in route to procedure rooms shall not pass through public corridors and waiting rooms after injection with radioisotope.

(iv) Patient toilet. A patient toilet with radiation shielding shall be provided with or adjacent to the dose administration room. The patient toilet room shall contain a hand washing fixture with hands-free operable controls.

(D) Service areas.

(i) Patient waiting area. The area shall be out of traffic and under direct staff visual control.

(ii) Control desk and reception area. A control desk and reception area shall be provided.

(iii) Dictation and report preparation area. The dictation and report preparation area may be incorporated with the control station.

(iv) Holding area. The holding area shall be under direct staff control, out of the direct line of traffic, and have space for stretchers. The holding area shall accommodate two stretchers for the first procedure room with one additional station for each additional procedure room.

(v) Patient toilet facilities. A toilet room with a hand washing fixture with hands-free operable controls shall be provided convenient to the waiting room and procedure room.

(vi) Staff toilet facilities. Toilets and hand washing fixtures with hands-free operable controls may be outside the suite but shall be convenient for staff use.

(vii) Patient dressing rooms or cubicles. Dressing rooms or cubicles shall be provided convenient to the waiting areas and procedure rooms. Each room or cubicle shall include a seat or bench, mirror, and provisions for hanging patients' clothing and for securing valuables. At least one dressing room shall be provided to accommodate patients using wheelchairs.

(viii) Exam rooms. When examination rooms are provided, each room shall have a minimum of 100 square feet of clear floor area exclusive of built-in shelves or cabinets. Each exam room shall be equipped with a work counter and a hand washing fixture with hands-free operable controls.

(ix) Dose administration area. When a dose administration area is provided, the area shall be located near the preparation area and include visual privacy for the patients.

(x) Computer control area or room. Computer control area shall be located within or adjacent to the treatment room or rooms. When a centralized computer area is provided, it shall be a separate room with access terminals available within the treatment rooms.

(xi) Film processing room. A darkroom shall be provided for film processing unless the processing equipment normally used does not require a darkroom for loading and transfer. When daylight processing is used, the darkroom may be minimal for emergency and special uses. Film processing shall be located convenient to the treatment room or rooms and to the quality control area.

(xii) Quality control area or room. A quality control area shall include view boxes illuminated with light of the same color value and intensity.

(xiii) Film storage room (active). A room with cabinet or shelves for filing patient film for immediate retrieval shall be provided.

(xiv) Film storage room (inactive). A room for inactive film storage may be located outside the nuclear medicine suite, but must be under the administrative control of nuclear medicine personnel and properly secured to protect films against loss or damage.

(xv) Digital imaging. If digital imaging is utilized throughout the suite, the darkroom film processing area and film viewers is not required.

(xvi) Storage for unexposed film. Storage facilities for unexposed film shall include protection of film against exposure or damage.

(xvii) Offices for physicians, oncologist, physicists, and assistants. Offices shall include provisions for individual consultation, viewing, and charting of film.

(xviii) Clerical office spaces. Clerical office spaces shall be provided.

(xix) Consultation room. A consultation room shall be provided.

(xx) Clean storage room. A clean storage room shall be provided for clean supplies and linens. A hand washing fixture shall be provided with hands-free operable controls. When conveniently located, the clean storage room may be shared with another department.

(xxi) Soiled workroom. The soiled workroom shall not have direct connection to the nuclear medicine procedure or diagnostic rooms or sterile activity rooms. The room shall contain a clinical sink or equivalent flushing type fixture, work counter, hand washing fixture with hands-free operable controls, waste receptacle, and soiled linen receptacle. When contaminated soiled material or fluid waste is not handled, only a soiled holding room is required.

(xxii) Housekeeping room. The housekeeping room shall be located within the suite.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Radiation protection. Radiation protection shall be designed, tested and approved by a medical physicist licensed under Texas Occupations Code Chapter 602.

(I) Room shielding. Room shielding calculations for the stipulated rooms within the nuclear medicine suite must be submitted to the Department of State Health Services Radiation Control Program (RC) for approval prior to use. Shielding in diagnostic radiographic rooms will be reviewed by RC inspectors, in the field, subsequent to use. Any changes in design or shielding that affects radiation exposure levels adjacent to those rooms requires prior approval by RC.

(II) Facility design and environmental controls associated with licensable quantities of radioactive material in laboratories or procedure rooms must be approved by RC prior to licensed authorizations.

(ii) The nuclear medicine treatment rooms shall have ceiling heights not less than nine feet. Ceilings containing ceiling-mounted equipment shall be of sufficient height to accommodate the equipment of fixtures and their normal movement.

(B) Finishes.

(i) Flooring. Flooring used in the nuclear medicine procedure room, any work or treatment areas where radioactive material is handled, and soiled workroom shall be of the seamless monolithic type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Ceiling. Ceilings in radiopharmacy, hot laboratory, and soiled workrooms shall be monolithic as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Radiopharmaceutical preparations. When radiopharmaceutical preparations are performed, vents and traps for radioactive gases shall be provided.

(B) Direction of air flow of the HVAC system shall be from nonradioactive spaces into the radioactive spaces. A minimum of two return air inlets located diagonally opposite from one another and near floor level shall be provided.

(C) In the PET suite, special ventilation systems together with monitors, sensors, and alarm systems shall be required to vent gases and chemicals. The ventilation shall be directly to the exterior.

(D) Filtration requirements for air handling units serving the nuclear medicine suite shall be equipped with filters having efficiencies equal to, or greater than specified in Table 4 of §511.169(d) of this subchapter.

(E) Where fume hoods are used, the design should consider the placement and types of air distribution devices to avoid the disturbance of a uniform velocity across the face of the hood. Fume hoods shall be exhausted directly to the exterior.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) General.

(i) Nuclear medicine procedure room. Each nuclear medicine procedure room shall have at least four duplex electrical hospital grade receptacles.

(ii) Nuclear medicine procedures rooms shall have general lighting in addition to that provided by special lighting units at the procedure tables.

(B) Nurses calling systems. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(q) Nursing unit. The requirements in this subsection apply to nursing units in LSRHs. Architectural requirements shall comply with §511.162(d)(1) of this subchapter and this subsection.

(1) Accessibility requirements. At least 10 percent of each patient room type, isolation room, bathing units and toilets in medical/surgical, intermediate care, universal care, antepartum, postpartum, mental health, chemical dependency, and pediatric nursing units and all public and common use areas shall be designed and constructed to be Americans with Disabilities Act (ADA) accessible. These requirements shall apply in all new construction and when an existing nursing unit or a portion thereof is converted from one service to another (e.g., mental health care to medical or surgical nursing care).

(2) Patient room suites. A patient room suite shall consist of the patient room and a bathroom. Patient room suites shall comply with the following requirements.

(A) Maximum patient room capacity. The maximum patient room capacity shall be two patients. In existing facilities where renovation work is undertaken and the present capacity is more than two patients, the maximum room capacity shall be no more than the present capacity with a maximum of four patients.

(B) Single-patient station room. In a single-patient station room, the minimum clear floor area shall be 120 square feet.

(C) Multi (two)-patient station room. The clearance between the side of a station and a wall or partition shall be a minimum of three feet. The clearance between sides of stations shall be a minimum of five feet. The minimum distance at the foot of the station shall not be less than four feet for a single load area or room or seven feet for a double load area or room. Four feet of the passage space at the foot of the station may be shared between two stations.

(D) Multi (two)-station accessible patient room. The clearance between the side of a station and a wall or partition shall be a minimum of five feet. The clearance between sides of stations shall be a minimum of four feet. The minimum distance at the foot of the station shall not be less than four feet for a single load area or room or seven feet for a double load area or room. Four feet of the passage space at the foot of the station may be shared between two stations.

(E) Arrangement of patient rooms. Minor encroachments including columns and wall hung lavatories that do not interfere with functions may be ignored when determining space requirements for patient rooms.

(i) Clear floor space. Required clear floor space in patient rooms shall be exclusive of toilet rooms, closets, lockers, built-in cabinets, wardrobes, alcoves, or vestibules.

(ii) Visual privacy. Visual privacy shall be provided each patient in multi-station room. Design for privacy shall not restrict independent patient access to the corridor, lavatory, or bathroom.

(F) Patient bathroom. Each patient shall have access to a bathroom without having to enter the general corridor area. Each bathroom shall contain a toilet with bed pan washers, hand washing fixture with hands-free operable controls, bathing facilities, and storage shelf or cabinet and serve not more than two patient rooms. Hand washing facilities shall be located in the patient room and in the patient bathroom. The hand washing fixture in the room shall be located outside of the patient's cubicle curtain in multi-station patient room.

(G) Patient storage. Each patient shall have a separate wardrobe, locker, or closet that is suitable for hanging full-length garments and for storing personal effects. A minimum of 12 lineal inches of hanging space shall be provided per patient.

(3) Airborne infection isolation suites. Where provided, a minimum of one isolation room shall be designated for pediatric patient care. Each airborne infection isolation suite shall consist of a work area, a patient room, and a patient bathroom.

(A) The work area may be a separately enclosed anteroom or a vestibule that is open to and is located immediately inside the door to the patient room. It shall have facilities for hand washing, gowning, and storage of clean and soiled materials. One enclosed anteroom may serve multiple isolation rooms.

(B) Each patient room shall have a clear floor area of 120 square feet exclusive of the work area and shall contain only one patient station. A patient bathroom shall be provided in accordance with paragraph (2)(F) of this subsection.

(C) At least one airborne infection isolation suite with an enclosed anteroom shall be provided.

(D) A door from an anteroom to an airborne infection isolation room and a door from an egress corridor into an anteroom shall be provided with a self-closing device. When an isolation room does not have an anteroom, the door from the egress corridor into the isolation room shall be provided with a self-closing device. When sliding doors are used in isolation rooms and in surgical suite post-anesthesia care units, the self-closing device may not be required as long as assurances of negative air pressure are met when sliding doors are opened.

(E) Pressure differential monitors or air flow devices shall be installed outside the isolation room and anteroom. Devices shall be installed in corridors, passageways, etc.

(F) Where a special assisted bathing facility is provided, it shall meet the requirements of this paragraph. including space for attendant, for patients on stretchers, carts, and wheelchairs. This may be on another floor if convenient for use. The central bathing room shall contain a bathtub that is accessible to a patient using a wheelchair or a shower that can accommodate a gurney. The room shall have space for drying and dressing and be provided with a hand washing fixture with hands-free operable controls and a toilet with three feet of clear space on sides and front of the water closet; The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(r) LSRH-based outpatient suite.

(1) Architectural requirements.

(A) Site, administration and public areas. The following areas shall be provided.

(i) Public waiting area. Toilet facilities, public telephone, and drinking fountain shall be provided. When pediatric services are provided, pediatric and adult patients waiting areas shall be separate.

(ii) Control station. A control station shall be located to permit staff observation of waiting area and control of access to LSRH-based outpatient clinical rooms.

(iii) Wheelchair storage alcove. The alcove provided for wheelchair storage shall be located out of line of traffic.

(iv) Interview space. Interview spaces shall be provided for social services, credit, and admissions. Provisions shall be made for privacy and dignity of the patient during interview, LSRH-based outpatient clinical services.

(v) Office. At least one office shall be provided for business transaction, records, and administrative and professional staff.

(B) LSRH-based outpatient room. The room shall have a minimum clear floor area of 100 square feet exclusive of fixed cabinets and shelves. Each examination room shall contain a work counter, cabinets, examination light and hand washing fixture with hands-free operable controls. A clearance of three feet shall be provided at each side and the foot of the examination table.

(C) Service areas. The following service areas and facilities shall be provided within the outpatient suite unless noted otherwise.

(i) Nurse stations. The nurse station shall contain a work counter, communication system, space for supplies, and provisions for charting.

(ii) Hand washing fixtures. Hand washing fixtures with hands-free operable controls shall be available at all patient care areas.

(iii) Patient toilet rooms. A toilet room shall be conveniently located to treatment rooms, examination rooms, and diagnostic rooms and shall include hand washing fixtures with hands-free operable controls.

(iv) Staff toilet facilities. Toilet rooms equipped with hand washing fixtures with hands-free operable controls shall be provided for the exclusive staff use. Toilet facilities may be provided in conjunction with the staff lounge.

(v) Staff lounge. A staff lounge with separate male and female staff clothing change rooms and toilets with hand washing fixtures with hands-free operable controls shall be provided in an LSRH having a total of six or more LSRH-based outpatient clinical rooms.

(vi) Medication station. Storage and distribution of medication may be done from a medicine preparation room, medicine alcove area, or from a self-contained medicine dispensing unit but must be under visual control of nursing staff. A work counter, a hand washing fixture with hands-free operable controls, refrigerator, and double-locked storage for controlled substances shall be provided. Standard cup-sinks provided in many self-contained units are not acceptable for hand washing. The medication station may be shared with the clean workroom.

(vii) Dictation and report preparation area. This area may be accessible from the lounge.

(viii) Cast room. When a cast room is provided, it shall be equipped with hand washing facilities, plaster sink, storage, and other provisions required for cast procedures.

(ix) Wheelchair and stretcher storage. Wheelchair and stretcher storage space or alcove shall be provided and located out of direct line of traffic.

(x) Storage. Storage facilities shall be provided for office supplies, sterile supplies, pharmaceutical supplies, splints and other orthopedic supplies, and housekeeping supplies and equipment.

(xi) Ice machine. A self-dispensing ice machine shall be provided.

(xii) Clean workroom. A clean workroom or clean supply room shall be provided.

(xiii) Storage room. A storage room for the outpatient services shall be provided at least equal to five percent of the total area of the outpatient suite. This required storage room area may be combined with general stores.

(xiv) Soiled workroom. A soiled workroom shall be provided. It shall not have direct access to any patient treatment, examination, diagnostic rooms, or sterile rooms. The room shall contain a clinical sink or equivalent flushing rim fixture, work counter, hand washing fixture with hands-free operable controls, waste receptacle, and linen receptacle.

(xv) Housekeeping room. The housekeeping room shall be located within the suite.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph. Treatment rooms shall be provided with seamless flooring in accordance with requirements contained in §511.162(d)(2)(B)(iii)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph. Filtration requirements for air handling units serving the outpatient and surgical suite shall be equipped with filters having efficiencies equal to, or greater than specified for patient care areas in Table 4 of §511.169(d) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph. Sinks used for the disposal of plaster of paris shall have a plaster trap.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(s) Pharmacy suite.

(1) Architectural requirements.

(A) General. The pharmacy room or suite shall be located for convenient access, staff control, and security for drugs and personnel.

(B) Dispensing area. The pharmacy room or suite shall include the following functional spaces and facilities:

(i) area for pickup, receiving, reviewing and recording;

(ii) extemporaneous compounding area with sufficient counter space for drug preparation and sink with hands-free operable controls;

(iii) work counter space for automated and manual dispensing activities;

(iv) storage or areas for temporary storage, exchange, and restocking of carts; and

(v) security provisions for drugs and personnel in the dispensing counter area.

(C) Manufacturing. The pharmacy room or suite shall provide the following functional spaces and facilities for the manufacturing area:

(i) bulk compounding area with work space and counters; and

(ii) area for packaging, labeling and quality control.

(D) Storage. The following spaces shall be provided in cabinets, shelves, or separate rooms or closets:

(i) space for bulk storage, active storage, and refrigerated storage;

(ii) storage in a fire safety cabinet or storage room that is constructed under the requirements for protection from hazardous areas in accordance with NFPA 101 Chapter 12, for alcohol or other volatile fluids, when used;

(iii) storage in a secure vault, safe, or double locking wall cabinet for narcotics and controlled drugs; and

(iv) storage space for general supplies and equipment not in use.

(E) Intravenous (IV) solutions area. When IV solutions are prepared in a pharmacy, a sterile work area shall be provided and be in compliance with 22 TAC §291.133 (relating to Pharmacies Compounding Sterile Preparations) and the United States Pharmacopeia Chapter 797, Pharmaceutical Compounding-Sterile Preparations.

(i) IV work area components. The IV work area shall consist of a preparation room, hood room and, if provided, a separate chemo-hood room. Access to the preparation room shall be through the pharmacy only, access to the hood room or chemo-hood room shall be through the preparation room only.

(ii) Preparation room components. The preparation room shall contain a work counter, gowning area, and shelving.

(iii) Hand washing fixtures. A hand washing fixture with hands-free operable controls shall be in the preparation room and within five feet of each entrance to the hood room or chemo-hood room. Hand washing fixtures and floor drains are not allowed inside the hood room or chemo-hood room.

(iv) Laminar-flow hoods/work stations. Laminar-flow hoods/work stations shall be located inside the hood room.

(F) Compounding aseptic isolator (CAI). When a CAI is used for compounding in lieu of the IV solutions area, it may be done within the pharmacy provided it complies with the following.

(i) CAI requirements. The CAI shall provide isolation from the room and maintain the International Organization for Standardization (ISO) Class 5 (100 particles greater than or equal to 0.5 microns per cubic foot) levels during dynamic operating conditions including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations.

(ii) Particle counts. The particle counts sampled shall be six to 12 inches upstream of the critical exposure site within the CAI and maintain ISO Class 5 levels during compounding operations.

(iii) CAI documentation. The pharmacy shall obtain documentation from the manufacturer that the CAI will meet this standard when located in worse than ISO Class 7 (10,000 particles greater than or equal to 0.5 microns per cubic foot environments).

(G) Administrative areas. The following functional spaces and facilities shall be included for the administrative areas:

(i) office area for the chief pharmacist and any other offices areas required for records, reports, accounting activities, and patients profiles;

(ii) poison control center with storage facilities for reaction data and drug information centers; and

(iii) a room or area for counseling and instruction when individual medication pick-up is available for inpatients or outpatients.

(H) Satellite pharmacy facilities. When provided, the room shall include a work counter, a sink with hands-free operable controls, storage facilities, and refrigerator for medications. As applicable, items required in subparagraphs (B) and (C) of this paragraph may be incorporated into the satellite pharmacy.

(I) Service areas and facilities. The following service areas and facilities shall be provided.

(i) Hand washing facilities. A hand washing fixture with hands-free operable controls shall be located in each room where open medication is handled except for IV prepared chemo-hood rooms.

(ii) Staff facilities. Toilet rooms with hand washing fixture with hands-free operable controls may be outside the suite but shall be convenient for staff use.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Flooring. Flooring in the IV solutions area for the preparation room, hood room and chemo-hood room shall be seamless and coved to the wall.

(B) Ceilings. IV solutions area ceiling and wall finishes for the preparation room, hood room and chemo-hood room shall be interlocking monolithic panels and sealed together or monolithic epoxy-painted gypsum board. The ceiling shall be coved to the wall.

(C) Sealing requirements. All penetrations in the walls and ceilings shall be sealed.

(D) Door requirements. The door from hood room shall swing into the preparation room. The door from preparation room shall swing into the chemo room. The door from preparation room shall swing into pharmacy.

(3) Mechanical Requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Laminar-flow system. When IV solutions are prepared, the required laminar-flow system shall include a nonhygroscopic filter rated at 99.97 percent (HEPA). A pressure gauge shall be installed for detection of filter leaks or defects.

(B) Fume hoods for chemotherapy. When fume hoods are used for chemotherapy, the air and fumes shall be exhausted directly to the exterior. The hood exhaust shall not use the building exhaust system. When more than one fume hood is in the same hood room and the work stations face each other, at least six feet must separate work area openings.

(C) General fume hood requirements. When fume hoods are used, the design should consider the placement and types of air distribution devices to avoid the disturbance of a uniform velocity across the face of the hood.

(D) Filtration. All air entering the IV solutions area for the preparation room, hood room and chemo-hood room shall be HEPA filtered.

(E) Air pressure. In the IV solutions area the air pressure in the preparation room shall be positive to the pharmacy, the hood room shall be positive to the preparation room, and the chemo-hood room shall be negative to the preparation room.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) Material used for plumbing fixtures shall be nonabsorptive and acid-resistant.

(B) Water spouts used at lavatories and sinks shall have clearances adequate to avoid contaminating utensils and the contents of carafes, etc.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) Under-counter receptacles. Under-counter receptacles and conduits shall be arranged (raised) to not interfere with cleaning of the floor below or of the equipment.

(B) Exhaust hoods. Exhaust hoods shall have an indicator light indicating that the exhaust fan is in operation.

(C) Electrical circuits. Electrical circuits to equipment in wet areas shall be provided with five milliampere GFCI.

(t) Radiotherapy suite. When radiotherapy services are provided, the suite may contain equipment for electron beam therapy, radiation therapy, or both. The following facilities shall be provided.

(1) Architectural requirements.

(A) Radiation protection. Cobalt, linear accelerators, and simulation rooms require radiation protection. A medical physicist licensed under Texas Occupations Code Chapter 602, shall specify the type, location, and amount of radiation protection to be installed for the layout and equipment selections. Room layouts and construction shall prevent the escape of radioactive particles. Openings into the room, including doors, ductwork, vents, and electrical raceways and conduits, shall be baffled to prevent direct exposure to other areas of the facility.

(B) Room size. Cobalt, linear accelerator, and simulator rooms shall be sized in accordance with the installed equipment requirements, patient access on a stretcher, medical staff access to the equipment and patient, and access for servicing the equipment.

(C) Mold room. When a mold room is provided, it shall contain a ventilation hood exhausted to the exterior and a hand washing fixture with hands-free operable controls.

(D) Block room. A block room with storage for the linear accelerator may be combined with the mold room.

(E) Hot laboratory. A hot laboratory in support of cobalt therapy shall be provided.

(F) Service areas. The following service areas shall be provided unless these are accessible from other departments such as imaging or outpatient areas:

(i) a stretcher hold area adjacent to the treatment rooms, screened for privacy, and combined with a seating area for outpatients;

(ii) exam rooms for each treatment room shall be at least 100 square feet and shall be provided with hand washing facilities;

(iii) a patient gowning area with provisions for safe storage of valuables and clothing. At least one space shall be sized to allow for staff-assisted dressing;

(iv) convenient access to a housekeeping room;

(v) film file area;

(vi) film storage area for unprocessed film; and

(vii) a radioisotope decay room, that may be combined with the hot lab.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Radiation protection. Radiation protection shall be designed, tested, and approved by a medical physicist licensed under the Texas Occupations Code Chapter 602.

(ii) Room shielding. Room shielding calculations for linear accelerators, cobalt, and simulation rooms shall be submitted to the Department of State Health Services Radiation Control Program (RC) for approval prior to use. Shielding in diagnostic radiographic rooms will be reviewed by inspectors, in the field, subsequent to use. Any changes in design or shielding that affects radiation exposure levels adjacent to those rooms requires prior approval by RC.

(iii) Ceiling heights. The cobalt, simulation, and linear accelerator rooms shall have ceiling heights not less than nine feet. Ceilings containing ceiling-mounted equipment shall be of sufficient height to accommodate the equipment of fixtures and their normal movement.

(iv) Ceiling-mounted equipment. Properly designed rigid support structures for ceiling-mounted equipment shall be located above the finished ceiling.

(B) Finishes.

(i) Flooring. Flooring in the soiled workroom and any work or treatment areas in the radiotherapy suite where radioactive materials are handled shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Walls. Walls shall be constructed of materials that are easily decontaminated from accidental radioactive spills and finished in accordance with §511.162(d)(2)(B)(iv) of this subchapter.

(iii) Ceilings. Ceilings in the hot laboratory and soiled workroom shall be monolithic as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Fume hoods. Where fume hoods are used, the design should consider the placement and types of air distribution devices to avoid the disturbance of a uniform velocity across the face of the hood.

(B) Radioactive material fume hoods. Each hood used to process radioactive materials shall have a minimum face velocity of 90-110 feet per minute, be connected to an independent exhaust system, with suitable pressure-independent air modulating devices and alarms to alert staff of fan shutdown or loss of airflow. Each hood shall also have filters with a 99.97 percent efficiency (based on the dioctyl-phthalate (DOP) test method) in the exhaust stream, and be designed and equipped to permit the safe removal, disposal, and replacement of contaminated filters. Filters shall be as close to the hood as practical to minimize duct contamination.

(4) Plumbing fixtures and piping systems. Piping systems and plumbing fixtures shall comply with the requirements of §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Each radiotherapy suite shall comply with the requirements of §511.162(d)(5) of this subchapter and this paragraph.

(A) Radiotherapy procedure room. Each radiotherapy procedure room shall have at least four electrical receptacles.

(B) Ground fault circuit. Ground fault circuit interrupters shall not be used in radiotherapy procedure rooms.

(C) Nurses calling system. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(u) Rehabilitation therapy suite. Rehabilitation therapy may include one or more categories of services. Where two or more rehabilitation services are provided, the services may share common areas when appropriate.

(1) Architectural requirements.

(A) Occupational therapy. When occupational therapy services are provided, the following rooms or areas shall be included:

(i) an activity area with work areas, counters and a hand washing fixture with hands-free operable controls. Work areas and counters shall be suitable for wheel chairs;

(ii) an area for teaching daily living activities with space for a bed, kitchen counter with appliances and sink, bathroom, and a table and chair. The daily living activities area may be combined with the activity area;

(iii) an office for the occupational therapist; and

(iv) a storage room for supplies and equipment.

(B) Physical therapy. When physical therapy services are provided, the following rooms or areas shall be included.

(i) Provisions shall be made for thermotherapy, diathermy, ultrasonics, and hydrotherapy when required by the LSRH's functional program.

(ii) Treatment areas shall be provided with at least 70 square feet of clear floor area for each patient station, exclusive of four foot aisle space. Privacy screens or curtains shall be provided at each treatment station.

(iii) A hand washing fixture with hands-free operable controls shall be provided in each treatment room or space. One hand washing fixture may serve up to four patient stations when cubicles or open room concepts are used and when the fixture is conveniently located.

(iv) An area shall be provided for exercise and may be combined with treatment areas in open plan concepts.

(v) An office shall be provided for the physical therapist.

(vi) Separate storage shall be provided for soiled linen, towels, and supplies.

(vii) A storage area or room for equipment, clean linen, and supplies shall be provided.

(viii) When outpatient physical therapy services are provided, the suite shall have as a minimum patient dressing areas, showers and lockers. These shall be accessible and usable by people with disabilities.

(C) Prosthetics and orthotics. When prosthetics and orthotics services are provided, the following rooms or areas shall be included:

(i) work space with counters and shelves for technicians;

(ii) a treatment space for evaluating and fitting with privacy screens or curtains; and

(iii) a storage area or room for equipment and supplies.

(D) Speech and hearing. When speech and hearing services are provided, the following rooms or areas shall be included:

(i) a space for evaluating and treatment with privacy screens or curtains; and

(ii) a storage area or room for equipment and supplies.

(E) Service areas. The following areas or items shall be provided in a rehabilitation therapy suite, but may be shared when multiple rehabilitation services are offered:

(i) patient waiting area out of traffic with space for wheelchairs;

(ii) patient toilet facilities containing hand washing fixtures, with hands-free operable controls;

(iii) reception and control stations shall be located to provide supervision of activities areas. The control station may be combined with office and clerical spaces;

(iv) office and clerical space;

(v) wheelchair and stretcher storage room or alcove that shall be in addition to other storage requirements;

(vi) lockable closets, lockers or cabinets for securing staff personal effects;

(vii) staff toilets may be outside the suite but shall be convenient for staff use and contain hand washing fixtures with hands-free operable controls;

(viii) soiled holding room; and

(ix) housekeeping room with service sink, conveniently accessible.

(2) Details and finishes.

(A) Details. Details shall comply with §511.162(d)(2)(A) of this subchapter.

(B) Finishes. Finishes shall comply with §511.162(d)(2)(B) of this subchapter and this paragraph.

(i) Flooring in a treatment room and soiled workroom shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Wall finishes shall comply with the requirements of §511.162(d)(2)(B)(iv) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph. Air handling units serving the rehabilitation therapy suite shall be equipped with filters having efficiencies equal to, or greater than specified for patient care areas in Table 4 of §511.169(d) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(v) Respiratory therapy suite. The type and extent of respiratory therapy services vary greatly in each LSRH.

(1) Architectural requirements.

(A) Respiratory therapy suite. When respiratory services are provided from a centralized area, the following rooms or areas shall be included:

(i) an office for the respiratory therapist;

(ii) office and clerical space with provision for filing and retrieval of patient records;

(iii) receiving/decontamination workroom with work counter or table, a deep sink, and a hand washing fixture with hands-free operable controls;

(iv) a storage room for clean and sterile supplies that is separate from the receiving/decontamination workroom;

(v) when a blood gas analyzer is provided, it shall be located in a room and contain a counter and hand washing sink;

(vi) when a portable blood gas analyzer is used, it may be used in rooms that have a work counter and hand washing facilities with hands-free operable controls and storage of the unit may occur in an alcove or equipment storage room;

(vii) patient waiting area with space for wheelchairs;

(viii) reception and control station with visual control of waiting and activities areas;

(ix) patient toilet facilities that include hand washing fixtures with hands-free operable controls;

(x) office and clerical space; and

(xi) consultation/education room.

(B) Cough-inducing and aerosol-generating procedures. All cough-inducing procedures performed on patients who may have infectious Mycobacterium tuberculosis shall be performed in rooms, booths or special enclosures using local exhaust ventilation devices with HEPA filters located at the discharge end and exhaust directly to the outside.

(C) Service areas. The following areas and facilities shall be provided for the respiratory therapy suite but may be shared with other departments when conveniently located:

(i) wheelchair and stretcher storage room or alcove that is in addition to other storage requirements;

(ii) lockable closets, lockers or cabinets for securing staff personal effects;

(iii) staff toilets that include a hand washing fixture with hands-free operable controls. Staff toilets may be located outside suite if location is near and convenient; and

(iv) the housekeeping room shall be located within the suite or nearby, and shall contain a service sink and storage space for housekeeping supplies and equipment.

(2) Details and finishes.

(A) Details. Details shall comply with §511.162(d)(2)(A) of this subchapter.

(B) Finishes. Finishes shall comply with §511.162(d)(2)(B) of this subchapter and this paragraph.

(i) Flooring. Flooring in a decontamination room shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Wall finishes. Wall finishes shall comply with the requirements of §511.162(d)(2)(B)(iv) of this subchapter.

(iii) Ceilings. Ceilings shall comply with §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter.

(w) Special procedure suite.

(1) Architectural requirements.

(A) General. When special procedures such as endoscopy, bronchoscopy, and cardiac catheterization and other similar special procedures are provided, procedure rooms may be in a separate suite or may be part of the surgical suite.

(i) When special procedure rooms are part of the surgical suite and noninvasive procedures are performed, these rooms are not required to be part of the sterile environment.

(ii) Nonsurgical or noninvasive procedure rooms shall have a minimum clear floor area of 250 square feet, and a minimum clear dimension between fixed cabinets and built-in shelves shall be 14 feet.

(iii) A hand washing fixture or a scrub sink with hands-free controls shall be located within five feet of the entrance to each nonsurgical procedure room either in the room or outside. Hand washing facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts and recessed out of the main traffic areas.

(iv) When general anesthesia or inhalation anesthetizing agents are used during special procedures, these rooms shall comply with the detail, finish, mechanical and electrical requirements for an operating room contained in subsection (x) of this section.

(B) Special procedure room. Special procedure rooms for surgical cystoscopic and other endourologic procedures.

(i) Room area. The procedure room shall have a minimum clear floor area of 350 square feet exclusive of fixed cabinets and shelves. The minimum clear dimension between fixed cabinets and built-in shelves shall be 15 feet.

(ii) Room design. Procedure rooms shall be designed for visual and acoustical privacy for the patient.

(iii) Scrub station. One scrub station shall be located within five feet of the outside entrance of each special procedure surgical room. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel, medical equipment, or supply carts. The scrub sinks shall be recessed out of the main traffic areas. The scrub sink shall be located off the restricted areas of the special procedure surgical procedure rooms. Scrub sinks or sinks shall not be located inside the sterile area.

(iv) Changing rooms. Appropriately sized areas shall be provided for male and female changing rooms within the special procedure 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 or changing rooms shall be provided for male and female staff. The shower and toilet room may be unisex. These areas shall be arranged to provide a traffic pattern so that personnel entering from outside the special procedure surgical suite can shower, change, and move into the restricted portions of special procedure surgical suite.

(C) Catheterization laboratory. A catheterization procedure room may be in a separate suite, part of a special procedure suite, surgical suite, or in the imaging suite. The following items and facilities shall be provided.

(i) The room shall be located in an area restricted to authorized personnel.

(ii) The procedure room shall be a minimum of 400 square feet of clear floor area exclusive of fixed and movable cabinets and shelves. The minimum clear dimension between fixed cabinets and built-in shelves shall be 18 feet.

(iii) A control room shall have a view window that permits complete observation of the patient from the control console. The control room shall be large enough to contain the efficient functioning of the X-ray and image recording equipment.

(iv) An area for viewing images and film file room shall be provided. When digital imaging is provided throughout the suite, at least two X-ray film illuminators shall be provided within a central location within the catheterization laboratory and the film file room is not required.

(v) An equipment room large enough to contain X-ray transformers, power modules, and necessary electronics and electrical gear shall be provided.

(vi) Appropriately sized areas shall be provided for male and female changing rooms within the catheterization laboratory 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 or changing rooms shall be provided for male and female staff. The shower and toilet rooms may be unisex. These areas shall be arranged to provide a traffic pattern so that personnel entering from outside the catheterization laboratory can shower, change, and move into the restricted portions of catheterization laboratory.

(vii) One scrub station shall be located within five feet of the outside entrance of each cardiac catheterization laboratory procedure room. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel, medical equipment, or supply carts. The scrub sinks shall be recessed out of the main traffic areas. The scrub sink shall be located off the restricted areas of the cardiac catheterization laboratory. Scrub sinks or sinks shall not be located inside the sterile area.

(viii) Sterilizing facilities for immediate or emergency use shall be provided unless instruments are all disposable. A work space and hand washing fixture with hands-free operable controls shall be included.

(D) Patient holding and preparation area. In suites with two or more special procedure rooms, a patient holding and preparation area shall be provided to accommodate ambulatory and stretcher patients and meet the following requirements:

(i) two-stretcher stations shall be provided for first procedure room with one additional station for each additional procedure room;

(ii) the minimum clear floor space in a private holding and preparation room shall be 100 square feet exclusive of toilet room, built-in cabinets, work counter, alcove, or vestibules. A hand washing fixture with hands-free operable controls shall be provided. A minimum of 10 feet width shall be provided for the head wall;

(iii) in a multiple-station holding and preparation area, the clearance between the side of a gurney and a wall or partition shall be a minimum of three feet. The clearance between sides of gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurney shall not be less than seven feet for single load area or room or ten feet for double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The fixed and moveable cabinets and shelves shall not encroach upon the gurney clear floor space or area;

(iv) a control station and charting area arranged to permit staff visual observation of holding and preparation area;

(v) a work counter and a hand washing fixture with hands-free operable controls for every four gurneys located in the preparation area; and

(vi) cubicle curtains at each station for patient privacy.

(E) Recovery room or area. In suites with two or more special procedure rooms, a recovery room or area shall be provided to accommodate ambulatory and stretcher patients and meet the following requirements:

(i) a minimum of one patient recovery station shall be provided for each special procedure room;

(ii) in a single patient recovery room, there shall be a minimum clear area of 130 square feet exclusive of aisles and fixed and moveable cabinets and selves. A minimum of 10 feet width shall be provided for the head wall. The room shall contain cabinets, work counter, and a hand washing fixture with hands-free operable controls. The fixed and movable cabinets and shelves shall not encroach upon the gurney clear floor space or area;

(iii) when multiple-gurney recovery patient stations are provided, the clearance between side of gurney and a wall or partition shall be a minimum of four feet. The clearance between sides of gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurneys shall not be less than eight feet for single load area or room or twelve feet for double load area or room. Four feet of passage space requirement at the foot of the gurney may be shared between two gurneys. The multiple-gurney recovery patient station shall contain cabinets, medication storage, and work counter. The fixed and movable cabinets and shelves shall not encroach upon the gurney clear floor space or area. One hand washing fixture with hands-free operable controls shall be provided for every four stations or fraction thereof;

(iv) a nurse station with a hand washing fixture with hands-free operable controls and charting area shall be provided and arranged to provide visual observation of recovery room area;

(v) a staff toilet room with a hand washing fixture with hands-free operable controls shall be provided and located within the working area to maintain staff availability to patients;

(vi) cubicle curtains shall be provided at each station for patient privacy; and

(vii) the recovery room or area may be within the patient holding area.

(F) Instrument processing room. When instruments and equipment are processed, cleaned and disinfected within the suite, dedicated rooms shall be provided. The room may serve multiple procedure rooms. The following rooms shall be included.

(i) A decontamination room shall be provided and equipped with work counters, two sinks remote from each other and a hand washing fixture with hands-free operable controls. One of the sinks shall be utility type.

(ii) A clean room shall be provided and the process of cleaning the instruments or equipment shall flow from the contaminated area to the clean area, and finally, to storage. The room shall include a work counter and a hand washing sink fixture with hands-free operable controls. Instruments and equipment shall be protected from contamination.

(iii) When endoscopy scope wash rooms are provided, cleaning, washing and drying may occur in the same room. The room shall contain two sinks.

(G) Service areas. The following services shall be provided for all types of special procedure rooms unless noted otherwise.

(i) Control station. In facilities with two or more special procedure rooms in a suite, a nurse station shall be provided and located to permit visual surveillance of all traffic that enters the special procedure rooms suite.

(ii) Dictation and report preparation area. This area may be incorporated with the control station.

(iii) Medication station. Provision shall be made for the storage and distribution of medication to be administered to patients. This may be done from a medicine preparation room, medicine alcove area or from a self-contained medicine dispensing unit. The medicine preparation room, medicine alcove area or self-contained medicine dispensing unit shall be under visual control of nursing staff. A work counter, hand washing fixture with hands-free operable controls, refrigerator, and double-locked storage for controlled substances shall be provided. Standard cup-sinks provided in many self-contained units are not acceptable for hand washing. The medication station may be shared with the clean work room.

(iv) Patient toilet room. A toilet room shall be conveniently located to special procedure rooms and patient changing areas and shall include hand washing fixtures with hands-free operable controls.

(v) Staff toilet facilities. Facilities shall be provided for exclusive staff use and include a hand washing fixture with hands-free operable controls. The toilet may be accessible from a staff lounge, when a staff lounge is provided.

(vi) Storage. A storage room shall be provided for equipment and supplies used in the special procedure suite. Each special procedure suite shall provide at least 150 square feet of storage area or 50 square feet per procedure room, whichever is greater.

(vii) Wheelchair and stretcher storage. A wheelchair and stretcher storage space or alcove shall be provided and located out of direct line of traffic.

(viii) Staff storage. Storage space for employees' personal effects shall be provided.

(ix) Ice machine. An ice machine shall be provided.

(x) Clean storage room. A clean storage room shall be provided for clean supplies and linens. A hand washing fixture shall be provided with hands-free operable controls.

(xi) Soiled workroom. The soiled workroom shall not have direct connection to the special procedure or diagnostic rooms or other sterile or clean activity rooms. The room shall contain a clinical sink or equivalent flushing type fixture, work counter, hand washing fixture with hands-free operable controls, waste receptacle, and linen receptacle.

(xii) Housekeeping room. A housekeeping room shall be provided for the exclusive use of the special procedure suite. It shall be directly accessible from the suite and shall contain a floor receptor or service sink and storage for supplies and housekeeping equipment.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details. Special procedure rooms shall have ceiling heights not less than nine feet.

(B) Finishes.

(i) Flooring. Flooring used in special procedure rooms, decontamination room, and in the soiled workroom shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Ceilings. Ceiling finishes in special surgical procedure rooms and isolation rooms, soiled workroom and sterile processing rooms shall be monolithic as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(iii) Nonsurgical special procedure room ceilings. A lay-in type ceiling is acceptable in nonsurgical special procedure rooms.

(iv) Nonsurgical or noninvasive cauterization lab ceilings. A nonsurgical or noninvasive catheterization lab shall have a washable ceiling.

(3) Mechanical Requirements. Mechanical requirements comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Air supply. Air supply for the special procedure rooms shall be from ceiling outlets that are as near the work centers as possible. At least two low return inlets shall be located diagonally opposite from one another.

(B) Return air inlets. Return air inlets shall be not lower than four inches nor higher than 12 inches from floor level.

(C) Smoke removal system. Smoke removal systems shall be provided in accordance with §511.162(d)(3)(D)(iv)(II) of this subchapter, for special procedure rooms that have piped-in nitrous oxide medical gas or where anesthesia is administered to patients.

(D) Ventilation. The decontamination room shall meet the ventilation requirements that are contained in Table 3 of §511.169(c) of this subchapter.

(E) Temperature and humidity indicating devices. Each special procedure room and recovery room shall have wall-mounted temperature and humidity indicating devices.

(F) Airborne infection ventilation. When patients with airborne infectious disease are treated, the room shall meet requirements for airborne infection ventilation for patient care areas in accordance with Table 3 of §511.169(c) of this subchapter.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) Drainage and waste piping shall not be installed within the ceiling or installed in an exposed location in special procedure rooms and sterile processing rooms unless precautions are taken to protect the space below from leakage and condensation from necessary overhead piping. Any required secondary protection shall be labeled, "code required secondary drain system" every 20 feet in a highly visible print or label.

(B) A medical gas system shall be provided in accordance with §511.162(d)(4)(A)(iii) and (iv), and Table 6 of §511.169(f) of this subchapter.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) General.

(i) X-ray film illuminators. X-ray film illuminators for handling at least four films simultaneously shall be provided in a central location. When the entire special procedure suite is provided with digital imaging system capabilities, at least two X-ray film illuminators viewers shall be provided.

(ii) Electrical receptacles. Each special procedure room shall have at least six duplex electrical hospital grade receptacles.

(iii) Additional receptacles. In locations where mobile X-ray, laser, or other equipment requiring special electrical configuration is used, the additional receptacles shall be distinctively marked for the special use.

(iv) GFCIs. The electrical circuits to equipment in wet areas shall be provided with GFCIs. GFCI circuits shall not be used in special procedure rooms. When ground fault circuit interrupters are used in critical areas, provisions shall be made to ensure that other essential equipment is not affected by activation of one interrupter.

(v) Special grounding system. Special grounding system in areas such as special procedure rooms where a patient may be treated with an internal probe or catheter the ground system shall comply with NFPA 99 Chapter 10 and NFPA 70 Article 517.

(vi) Lighting. Special procedures rooms shall have general lighting in addition to that provided by special lighting units at the procedure tables.

(B) Nurses calling system. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(x) Surgical suite.

(1) Architectural requirements.

(A) General.

(i) Waiting room. A public waiting room shall be provided.

(ii) Toilet facilities. Toilet facilities, public telephone, and drinking fountains shall be provided within or nearby.

(iii) Unrelated traffic. The surgical suite shall be located and arranged to preclude unrelated traffic through the suite.

(B) General operating room. At least one operating room shall be provided and shall have a minimum clear floor area of 400 square feet exclusive of fixed and movable cabinets and shelves. The minimum clear dimension between fixed cabinets and built-in shelves shall be 20 feet. There shall be no direct access between operating rooms.

(C) Operating rooms for cardiovascular, orthopedic, neurological, and other special surgical procedures that require additional personnel and large equipment.

(i) When provided, these rooms shall have a minimum clear floor area of 600 square feet, with a minimum of 20 feet clear dimension exclusive of fixed or wall-mounted cabinets and built-in shelves.

(ii) An additional room shall be provided in the restricted area of the surgical suite, preferably adjoining this operating room, where extra corporeal pumps, supplies and accessories can be stored and serviced.

(iii) When complex orthopedic surgery and neurosurgery are performed, additional rooms shall be provided in the restricted area of the surgical suite, preferably adjoining the specialty operating rooms, for storage of equipment used during these procedures.

(D) Preoperative patient holding areas or rooms. In facilities with two or more operating rooms, a patient holding area or rooms shall be provided. The preoperative patient holding area may be used for secondary recovery. The area shall meet the following requirements.

(i) Clear floor space for private preoperative holding room. The minimum clear floor space in a private preoperative holding 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.

(ii) Clear floor space for multiple-patient station preoperative holding area. In a multiple-patient station preoperative holding area, the clearance between the side of a gurney and a wall or partition shall be a minimum of three feet. The clearance between sides of gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurney shall not be less than seven feet for single load area or room or ten feet for double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The fixed and moveable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(iii) Control station. A control station and charting area shall be provided and arranged to permit staff visual observation of holding and preparation area.

(iv) Work counter. A work counter with hand washing fixture with hands-free operable controls shall be provided and located in the preparation area.

(v) Cubicle curtains. Cubicle curtains shall be provided at each station for patient privacy.

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

(E) Post-anesthesia care units.

(i) Post-anesthesia care units (PACU) requirements. PACUs for surgical patients shall contain a medication distribution station, nurse station with charting facilities, clinical sink provisions for bedpan cleaning, and storage space for stretchers, supplies, and equipment. The nurse station shall be arranged to permit the staff to have full visual control of the PACU area.

(ii) Patient station. At least one and a half patient stations per operating room shall be provided for post-anesthesia care or fraction thereof. At least two stations shall be provided when there is only one operating room.

(iii) Private recovery room clear floor area. The minimum clear floor space in a private recovery room shall be 130 square feet exclusive of aisles and fixed and moveable cabinets and selves. A minimum of 10 feet width shall be provided for the head wall. The room shall contain cabinets, work counter, and hand washing fixture with hands-free operable controls. The fixed and movable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(iv) Multiple-gurney recovery patient station area. In multiple-gurney recovery patient stations, the clearance between the side of gurney and a wall or partition shall be a minimum of five feet. The clearance between sides of gurneys shall be a minimum of six feet. The minimum distance at the foot of the gurney shall not be less than eight feet for single load area or room or twelve feet for double load area or room. Four feet of the passage space at the foot of the gurney may be shared between two gurneys. The multi-gurney recovery patient station shall contain cabinets, medication storage, and work counter. The fixed and movable cabinets and shelves shall not encroach upon the gurney clear floor space or area.

(v) Cubicle curtains. Cubicle curtains shall be provided for patient privacy.

(vi) Doors. At least one door to the PACU room shall be within the surgical suite.

(vii) Staff toilets. Staff toilet facilities and a hand washing fixture with hands-free operable controls shall be located within or immediately adjacent to the PACU.

(viii) One hand washing fixture 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.

(F) Separation of recovery patients. Provisions shall be made for separating all patients subject to general anesthesia from those who did not receive general anesthesia. This requirement may be satisfied by providing separate recovery rooms, cubicles, secondary recovery rooms, or scheduling of procedures.

(G) Service areas. Services, except for the enclosed soiled workroom and the housekeeping room, may be shared with the obstetrical facilities if the LSRH's functional program reflects this concept. Service areas, when shared with delivery rooms, shall be designed to avoid the passing of patients or staff between the operating room and the delivery room areas.

(i) Control station. A control station located to permit visual surveillance of all traffic entering the surgical suite shall be provided.

(ii) Office. A supervisor's office or station shall be provided.

(iii) Scrub facilities. Two scrub stations shall be located in the restricted corridor within five feet of the entrance of each operating room. Two scrub stations may serve two operating rooms if the scrub stations are located adjacent to the entrance of both operating rooms. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel, medical equipment, or supply carts. Viewing panels shall be provided for observation of the surgical room interior. The scrub sinks shall be recessed out of the main traffic areas. The alcove shall be located within the restricted areas of the surgical suite. Scrub sinks shall not be located inside the sterile area.

(iv) Substerile facilities. Sterilizing facilities located conveniently to the operating rooms for immediate or emergency use with work counter shall be provided.

(v) Anesthesia workroom. The anesthesia workroom shall contain a work counter, sink with hands-free operable controls, and storage space for medical gas cylinders and other anesthesia equipment.

(vi) Medication station. Storage and distribution of medication may be done from a medicine preparation room, medicine alcove area, or from a self-contained medicine dispensing unit but must be under visual control of nursing staff. A work counter, hand washing fixture with hands-free operable controls, refrigerator, and double-locked storage for controlled substances shall be provided. Standard cup-sinks provided in many self-contained units are not acceptable for hand washing. The medication station may be shared with the clean work room.

(vii) General storage room. At least 50 square feet per operating room is required for general storage space. The minimum requirement for three operating rooms or less is 150 square feet. This storage room is exclusive of soiled holding, sterile supplies, clean storage, drug storage, locker rooms, and storage alcoves.

(viii) Orthopedic surgery storage. Splints and traction equipment shall be stored in an enclosed storage room. Storage shall be outside the operating room but must be conveniently located.

(ix) Storage alcove. An alcove or alcoves located out of the direct line of traffic shall be provided for the storage of stretchers, portable X-ray equipment, fracture tables, warming devices, auxiliary lamps, etc.

(x) Surgical suite staff clothing change 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 changing rooms shall be provided for male and female staff. The shower and toilet room or rooms 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.

(xi) Lounge. A lounge shall be provided in an LSRH with three or more operating rooms. The lounge shall permit staff use without leaving the surgical suite and may be accessed from the clothing changing rooms. The 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.

(xii) Staff toilet facilities. Toilet facilities located in the surgical suite for exclusive staff use shall be provided and contain a hand washing fixture with hands-free operable controls. The toilet room may be accessible from a staff lounge, when provided.

(xiii) Dictation and report preparation area. This may be accessible from the lounge area.

(xiv) Cast room. When a cast room is provided, it shall be equipped with hand washing facilities, plaster sink, storage, and other provisions required for cast procedures. This room may be located in the emergency room.

(xv) Ice machines. An ice machine shall be provided for therapeutic purposes. A self-dispensing ice machine shall be provided for human consumption.

(xvi) Clean workroom or clean supply room. A clean workroom is required when clean materials are assembled within the surgical suite prior to use or following the decontamination cycle. It shall contain a work counter, a hand washing fixture with hands-free operable controls, storage facilities for clean supplies, and a space to package reusable items. The storage for sterile supplies must be in a separate room. When the room is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and hand washing fixture are not required.

(xvii) Sterile core. When a surgical suite contains a sterile core, it shall be free of any cross-traffic of staff and supplies from the soiled or decontaminated areas to the sterile or clean areas. The use of facilities outside the operating room for soiled or decontaminated processing, clean assembly and sterile processing shall be designed to move the flow of goods and personnel from dirty to clean without compromising universal precautions or aseptic techniques in both departments.

(xviii) Soiled workroom. The soiled workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, hand washing fixture with hands-free operable controls, waste receptacle, and linen receptacle. The clinical sink and work counter may be eliminated if the room is used only for temporary holding of soiled material and cleaning of equipment and instruments and sterilization is provided outside the surgical suite. Provisions shall be made for the disposal of liquid waste. The soiled workroom shall be provided for the exclusive use of the surgical suite, shall be located in the restricted area of the surgical suite, and shall not have direct connection with operating rooms, delivery rooms, or other sterile activity rooms.

(xix) Housekeeping room. A housekeeping room containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided for the exclusive use of the surgical suite and shall be directly accessible from the surgical suite.

(2) Details and finishes. Details and finishes shall comply with §511.162(d)(2) of this subchapter and this paragraph.

(A) Details.

(i) Ceiling height. Operating rooms shall have ceiling heights not less than nine feet.

(ii) Noise minimization. Recreation rooms, exercise rooms, equipment rooms, and similar spaces where impact noises may be generated shall not be located directly over operating suites, unless special provisions are made to minimize such noise.

(B) Finishes.

(i) Flooring. Flooring within operating rooms, soiled workrooms and sterile processing rooms shall be of the seamless type as required by §511.162(d)(2)(B)(iii)(III) of this subchapter.

(ii) Walls. Walls in operating rooms, special procedures rooms, and soiled workrooms shall comply with the requirements of §511.162(d)(2)(B)(iv)(II) of this subchapter.

(iii) Ceilings. Ceilings in operating rooms, isolation rooms, soiled workroom, and sterile processing rooms shall be monolithic as required by §511.162(d)(2)(B)(vi)(III) of this subchapter.

(3) Mechanical requirements. Mechanical requirements shall comply with §511.162(d)(3) of this subchapter and this paragraph.

(A) Air supply for the operating rooms shall be from ceiling outlets near the center of the work area to efficiently control air movement. At least two return air inlets located diagonally opposite from one another and near floor level shall be provided. Design should consider turbulence and other factors of air movement to minimize airborne particulate matter. Where extraordinary procedures require special designs, the installation shall be reviewed on a case-by-case basis.

(B) Smoke removal systems shall be provided in accordance with §511.162(d)(3)(D)(iv)(II) of this subchapter.

(C) The ventilation system for anesthesia storage rooms and medical gases storage shall conform to the requirements of Chapter 5, NFPA 99 §5.1.3.3.3.

(D) Each operating room, PACU, and recovery room shall be provided with conveniently mounted temperature and humidity indicating devices.

(4) Piping systems and plumbing fixtures. Piping systems and plumbing fixtures shall comply with §511.162(d)(4) of this subchapter and this paragraph.

(A) General.

(i) Drainage and waste piping shall not be installed above or below ceilings in operating rooms, and sterile processing rooms unless precautions are taken to protect the space below from leakage and condensation from necessary overhead piping. Any required secondary protection shall be labeled, "code required secondary drain system" every 20 feet in a highly visible print or label.

(ii) Floor drains shall not be installed in operating rooms. Flushing rim type floor drains may be installed in cystoscopic operating rooms. If a floor drain is installed in cystoscopy, it shall contain a nonsplash, horizontal-flow flushing bowl beneath the drain plate.

(iii) Sinks used for the disposal of plaster of paris shall have plaster trap.

(B) Medical gas systems. Medical gas systems and outlets that comply with §511.162(d)(4)(A)(iii) and Table 6 of §511.169(f) of this subchapter shall be provided.

(5) Electrical requirements. Electrical requirements shall comply with §511.162(d)(5) of this subchapter and this paragraph.

(A) General.

(i) X-ray film illuminators for handling at least four films simultaneously shall be provided in each operating room. When the entire surgical suite is provided with digital imaging system capabilities, at least two X-ray film illuminator viewers shall be provided. The film illuminators shall be mounted within the central area of the suite.

(ii) Each operating room shall have at least eight duplex electrical hospital grade receptacles of which three shall be located convenient to the head of the procedure table. Each PACU recovery station shall have at least seven receptacles at the head of each patient station.

(iii) Special grounding system for critical care areas such as operating rooms, and special procedure rooms where patients are subjected to invasive procedures and connected to line-operated, electromedical devices shall comply with NFPA 99 Chapter 9 and NFPA 70 Article 517.

(iv) Operating rooms and special procedure rooms shall have general lighting in addition to that provided by special lighting units at the surgical tables. Each fixed special lighting unit at the operating or delivery table shall be connected to an independent circuit powered by the critical branch of the essential electrical system. Portable units may share circuits. At least one general lighting fixture shall be served from a normal branch panel.

(v) Operating rooms shall be provided with one or more battery-powered emergency lighting units as required by NFPA 99 §13.4.1.2.6(E).

(vi) Operating rooms shall be provided with at least one receptacle powered from a normal power panel. Receptacle shall be labeled, "Normal power receptacle, use only in the event of loss of critical system."

(B) Nurses calling system. The nurse call shall comply with §511.162(d)(5)(L) and Table 7 of §511.169(g) of this subchapter.

(y) Labor, Delivery, and Recovery (LDR).

(1) When provided, each LDR room shall have controlled access and shall be located so that a patient may be transported to the caesarean section operating room without the need to pass through other functional areas.

(2) Each LDR room shall be designed for single occupancy and have a minimum clear floor area of 200 square feet exclusive of the infant resuscitation area, built-in shelves or cabinets, alcove, vestibule or other adjoining rooms. The minimum clear room dimension shall not be less than 11 feet.

(3) A hand washing fixture with hands-free operable controls shall be provided in each LDR room.

(4) Each LDR shall have direct access to and exclusive use of a bathroom with a shower, or tub with shower, hand washing fixture with hands-free operable controls and a toilet.

Source Note: The provisions of this §511.163 adopted to be effective October 5, 2023, 48 TexReg 5668