(a)

1. (1) The surgical suite shall be located and arranged to preclude unrelated traffic through the suite.
2. (2) The surgical suite shall be designed in accordance with NFPA 99 except that, within suites, mixed facilities as defined in the code shall not be allowed.
3. (3) The suite or suites shall provide the following elements.

(b) General operating room or rooms.

1. (1) At least one (1) general operating room shall be provided for every fifty (50) beds or major fraction thereof up to two hundred (200) beds.
2. (2) Over two hundred (200) beds, additional operating room needs shall be based on the projected surgical workload.

3. (3) In new construction, each room shall have a minimum clear area of four hundred square feet (400 sq. ft.) exclusive of fixed or wall-mounted cabinets and built-in shelves, with a:

   1. (A) Minimum of twenty feet (20’) clear dimension between fixed cabinets and built-in shelves; and
   2. (B) System for emergency communication with the surgical suite control station.
4. (4) X-ray film illuminators for handling at least four (4) films simultaneously shall also be provided.
5. (5) In renovation projects, every effort shall be made to meet the floor space requirements indicated above.
6. (6) In no event shall the clear floor area be less than three hundred sixty square feet (360 sq. ft.) with a minimum dimension of eighteen feet (18’).

(c) Specialty operating rooms for cardiovascular, orthopedic, neurological, and other procedures that require additional personnel and/or large equipment.

1. (1) When included, this room shall have in addition to the above requirements for general operating rooms a minimum clear area of six hundred square feet (600 sq. ft.) with a minimum of twenty feet (20’) clear dimension exclusive of fixed or wall-mounted cabinets and built-in shelves.
2. (2) When open-heart surgery is performed, an additional room in the restricted area of the surgical suite shall be designated as a pump room where extracorporeal pump or pumps, supplies, and accessories are stored and serviced.
3. (3) When complex orthopedic and neurosurgical surgery is performed, additional rooms shall be in the restricted area of the surgical suite that shall be designated as equipment storage rooms for the large equipment used to support these procedures.
4. (4) Appropriate plumbing, medical gases, and electrical connections shall be provided in the pump storage room.
5. (5) When included, a room for orthopedic surgery shall, in addition to the above, have enclosed storage space for splints and traction equipment.
6. (6) Storage outside the operating room shall be conveniently located.
7. (7) If a sink is used for the disposal of casting material, an appropriate trap shall be provided.
8. (8) In renovation projects, every effort shall be made to meet the floor space requirements indicated above.
9. (9) In no event shall the clear floor area be less than four hundred square feet (400 sq. ft.), except orthopedic procedures shall be three hundred sixty square feet (360 sq. ft.) with a minimum dimension of eighteen feet (18’).

(d) Room or rooms for surgical cystoscopic and endo-urologic procedures.

1. (1) When provided and/or required by the written functional program, the cystoscopic and endo-urologic procedures room or rooms shall follow these requirements.
2. (2) A scrub sink or large lavatory shall be provided within or adjoining the cystoscopy room.
3. (3) In new construction, these rooms shall have a minimum clear area of three hundred fifty square feet (350 sq. ft.) exclusive of fixed or wall-mounted cabinets and built-in shelves, with a minimum of fifteen feet (15’) clear dimension between fixed cabinets and built-in shelves.
4. (4) Additional clear space may be required by the functional program to accommodate special functions in one (1) or more of these rooms.
5. (5) An emergency communications system shall connect with the surgical suite control station.
6. (6) Facilities for the disposal of liquid wastes shall be provided.

7. (7) If a floor drain is installed to provide for disposal of liquid wastes, it shall be completely insulated from ground by means of:

   1. (A) An insulating-type floor drain; and
   2. (B) Nonconductive waste connections.
8. (8) The drain shall also be provided with a flushing device.
9. (9) X-ray viewing capability to accommodate at least four (4) films simultaneously shall be provided.
10. (10) In renovation projects, every effort shall be made to meet the clear floor space requirements indicated above for construction.
11. (11) In no event shall the clear floor space be less than two hundred fifty square feet (250 sq. ft.).

(e) Endoscopy.

1. (1) The endoscopy suite may be divided into three (3) major functional areas:

   1. (A) The procedure room or rooms;
   2. (B) The instrument processing room or rooms; and
   3. (C) The patient holding/preparation and recovery room or area.

2. (2) Note.

   1. (A) When invasive procedures are to be performed in this unit on persons who are known or suspected of having airborne infectious diseases, these procedures should not be performed in the operating suite.
   2. (B) These procedures shall be performed in a:

(i) Room meeting airborne infections isolation ventilation requirements; or

1. (ii) Space using local exhaust ventilation.

   1. (C) Procedures room or rooms.

      1. (i) Each procedure room shall have a minimum clear area of two hundred square feet (200 sq. ft.) (fifteen and fifty-eight hundredths square meters (15.58 sq. m.)) exclusive of fixed cabinets and built-in shelves.
      2. (ii) A freestanding handwashing fixture with hands-free controls shall be available in the suite.
      3. (iii) Refer to Table 10 of Appendix A for medical gas station outlets.
      4. (iv) Floor covering shall be monolithic and joint-free.
      5. (v) A system for emergency communication shall be provided.
      6. (vi) Procedure rooms shall be designed for visual and acoustical privacy for the patient.

   2. (D) Instrument processing room or rooms.

      1. (i)

(b) (b) In an optimal situation, cleaning room or rooms shall be located between two (2) procedure rooms.

1. (c) (c) However, one (1) processing room may serve multiple procedure rooms.

   1. (d) (d) Size of the cleaning room or rooms is dictated by the amount of equipment to be processed.

(f) (f) The clean equipment rooms, including storage, should protect the equipment from contamination.

1. (ii) The decontamination room shall be equipped with the following:

(b) (b) One (1) freestanding handwashing fixture;

1. (c) (c) Work counter space or spaces;

   1. (d) (d) Space and plumbing fixtures for automatic endoscope cleaners, sonic processor, and flash sterilizers, where required;

(e)

1. (1) (e)(1) Ventilation system.
2. (2) (2) Negative pressure shall be maintained and a minimum of ten (10) air changes per hour shall be maintained.
3. (3) (3) A hood is recommended over the work counter.
4. (4) (4) All air shall be exhausted to the outside to avoid recirculation within the facility;

(g) (g) Floor covering shall be monolithic and joint-free.

1. (E) Patient holding/prep/recovery area. The following elements shall be provided in this area:

   1. (i) Each patient cubicle shall be equipped with oxygen and suction outlets;

      1. (ii) Cubicle curtains for patient privacy;
      2. (iii) Medication preparation and storage with handwashing stations;
      3. (iv) Toilet facilities (may be accessible from patient holding or directly from procedure room or rooms, or both);
      4. (v) Change areas and storage for patients’ personal effects;
      5. (vi) Nurses’ reception and charting area with visualization of patients;
      6. (vii) Clean utility room or area; and
      7. (viii) Environmental services closet.

(f) Service areas.

1. (1) Individual rooms shall be provided when so noted, otherwise, alcoves or other open spaces that shall not interfere with traffic may be used.
2. (2) Services, except the soiled workroom and the janitor’s closet, may be shared with and organized as part of the obstetrical facilities if the approved functional program reflects this sharing concept.
3. (3) Service areas shall be arranged to avoid direct traffic between the operating and delivery suites.

4. (4) The following areas shall be provided:

   1. (A) Control station located to permit visual surveillance of all traffic that enters the operating suite;

   2. (B)

      1. (i) A supervisor’s office or station.
      2. (ii) The number of offices, stations, and teaching areas in the surgical suite shall depend upon the functional program;

   3. (C)

      1. (i) Sterilizing facilities conveniently located to serve all operating rooms.
      2. (ii) The sterilizing facility shall have:

(b) (b) A handwashing sink.

1. (iii) When the functional program indicates that adequate provisions have been made for replacement of sterile instruments during surgery, sterilization facilities in the surgical suite shall not be required;

   1. (D)

      1. (i) Medication distribution.
      2. (ii) Provisions shall be made for storage and distribution of medications.
      3. (iii) This may be done from a medication preparation room or unit, from a self- contained medication dispensing unit, or by another system approved by the Department of Health.
      4. (iv) If used, a medication preparation room or unit shall be under visual control of nursing staff.
      5. (v) It shall contain a work counter, sink, refrigerator, and double-locked storage for controlled substances with convenient access to handwashing stations provided.
      6. (vi) Each blood bank refrigerator shall be on an emergency power circuit;

   2. (E)

      1. (i) Scrub facilities.
      2. (ii)

(b) (b) However, two (2) scrub stations may serve two (2) operating rooms if the scrub stations are located adjacent to the entrance of each operating room.

1. (iii) Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel or supply carts.

   1. (iv) In new construction, view windows at scrub stations permitting observation of room interiors shall be provided.

      1. (v) The scrub sinks shall be recessed into an alcove out of the main traffic areas.
      2. (vi) Equipment and supplies for timed scrub technique shall be available at each scrub sink with manual and/or automatic two-way controls;

   2. (F)

      1. (i) Soiled workroom.
      2. (ii) An enclosed soiled workroom, or soiled-holding room that is part of a system for the collection and disposal of soiled material, for the exclusive use of the surgical suite shall be provided.
      3. (iii) It shall be located in the restricted area.
      4. (iv) The soiled workroom shall contain:

(b) (b) A work counter;

1. (c) (c) A handwashing fixture; and

   1. (d) (d) Space for waste receptacles and soiled linen receptacles.

      1. (v) Rooms used only for temporary holding of soiled material may omit the flushing-rim clinical sink and work counters.
      2. (vi) However, if the flushing-rim clinical sink is omitted, other provisions for disposal of liquid waste shall be provided.
      3. (vii) This room shall not have direct connection with:

(b) (b) Other sterile activity rooms.

1. (viii) Soiled and clean work or holding rooms shall be separated;

   1. (G)

      1. (i) Clean workroom or a clean supply room.
      2. (ii) A clean workroom is required when clean materials are assembled within the surgical suite prior to use, or following the decontamination cycle;
      3. (iii) It shall contain:

(b) (b) A handwashing fixture;

1. (c) (c) Storage for clean supplies; and

   1. (d) (d) Space to package reusable items;

      1. (iv) The storage for sterile supplies shall be separated from this space.
      2. (v) If 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 handwashing fixture may be omitted.
      3. (vi) Storage space for sterile and clean supplies shall be adequate for the functional plan.
      4. (vii) The space shall be:

(b) (b) Free from cross-traffic;

1. (H)

   1. (i) The location of sterilization for surgical instruments and the direction of flow from the decontamination location to the sterile location shall be addressed by the written functional program.

      1. (ii) An operating room suite design with a sterile core shall provide for no cross-traffic of staff and supplies from the decontaminated/soiled areas to the sterile/clean areas.
      2. (iii)

(b) (b) This room shall have no direct opening into an operating room;

1. (I) Anesthesia storage shall be provided in accordance with NFPA 99;

   1. (J)

      1. (i) Medical gas storage facilities.
      2. (ii) Main storage of medical gases may be outside or inside the facility in accordance with NFPA 99.
      3. (iii) Provision shall be made for additional separate storage of reserve gas cylinders necessary to complete at least one (1) day’s procedures;

   2. (K) An anesthesia workroom for testing and storing anesthesia equipment shall contain:

      1. (i) A work counter;
      2. (ii) A sink; and
      3. (iii) Racks for cylinders;

   3. (L)

      1. (i) Equipment storage room or rooms for equipment and supplies used in the surgical suite.
      2. (ii) Each surgical suite shall provide sufficient storage area to keep the exit access corridor free of equipment and supplies, but not less than one hundred fifty square feet (150 sq. ft.) or fifty square feet (50 sq. ft.) per OR, whichever is greater;

   4. (M)

      1. (i) Staff dressing room.
      2. (ii) Appropriate room or rooms shall be provided for males and females working within the surgical suite.
      3. (iii) The room or rooms shall contain:

(b) (b) Showers;

1. (c) (c) Toilets;

   1. (d) (d) Lavatories equipped for handwashing; and

(e) (e) Space for donning scrub suits and boots.

1. (iv) This room or these rooms shall be arranged to provide a one-way traffic pattern so personnel entering from outside the surgical suite can:

(b) (b) Shower;

1. (c) (c) Gown; and

   1. (d) (d) Move directly into the surgical suite;
   2. (N) Stretcher storage area out of direct line of traffic;

   3. (O)

      1. (i) Staff lounge and toilet facilities.
      2. (ii) Separate or combined lounges for males and females shall be provided.
      3. (iii) A lounge or lounges shall be located to:

(b) (b) Provide convenient access to the recovery room;

1. (P)

   1. (i) Dictation and report preparation area.

      1. (ii) This may be accessible from the lounge area;

   2. (Q)

      1. (i) Phase II recovery.
      2. (ii) Where outpatient surgeries are to be part of the surgical suite, and where outpatients receive Class B or Class C sedation, a second Phase II or step-down recovery room shall be provided.
      3. (iii) The room shall contain:

(b) (b) A nurse station with charting facilities;

1. (c) (c) A clinical sink;

   1. (d) (d) Provision for bedpan cleaning; and

(e) (e) Storage space for supplies and equipment.

1. (iv) In addition, the design shall provide a minimum of fifty square feet (50 sq. ft.) for each patient in a lounge chair with space for:

(b) (b) Clearance of four feet (4’) between the:

1. (1) (1) Sides of the lounge chairs; and

2. (2) (2) Foot of the lounge chairs.

   1. (v) Provisions shall be made for the isolation of infectious patients.

      1. (vi) Provisions for patient privacy, such as cubicle curtains, shall be made.
      2. (vii) In new construction, at least one (1) door shall access the PACU without crossing unrestricted corridors of the hospital.
      3. (viii) A patient toilet shall be provided with direct access to the Phase II recovery unit for the exclusive use of patients.
      4. (ix) A staff toilet shall be provided with direct access to the working area to maintain staff availability to patients;
   2. (R) Handwashing stations with hands-free operable controls shall be available with at least one (1) for every four (4) lounge chairs, uniformly distributed to provide equal access from each patient bed;

   3. (S)

      1. (i) Change areas for outpatients and same-day admissions.
      2. (ii) If the functional program defines outpatient surgery as part of the surgical suite, a separate area shall be provided where outpatients may:

(b) (b) Be prepared for surgery.

1. (iii) This would include a:

(b) (b) Locker or lockers;

1. (c) (c) Toilet or toilets; and

   1. (d) (d) Clothing change or gowning area.

      1. (iv) Changing may also be accommodated in a private holding room or cubicle;

   2. (T) Provisions shall be made for:

      1. (i) Patient examination;
      2. (ii) Interviews;
      3. (iii) Preparation;
      4. (iv) Testing; and
      5. (v) Obtaining vital signs of patients for outpatient surgery;

   3. (U)

      1. (i) Patient holding area.
      2. (ii) In facilities with two (2) or more operating rooms, an area shall be provided to accommodate stretcher patients waiting for surgery.
      3. (iii) This holding area shall be under the visual control of the nursing staff;

   4. (V)

      1. (i) Storage areas for portable X-ray equipment, stretchers, fracture tables, warming devices, auxiliary lamps, etc.
      2. (ii) These areas shall be out of corridors and traffic;
   5. (W) Emergency equipment storage under direct control of the nursing staff and not obstructing the corridor;

   6. (X)

      1. (i) Environmental services closet.
      2. (ii) See 20 CAR § 41-168, physical facilities — cleaning and sanitizing carts, employee facilities, and environmental closets, for detailed requirements;

   7. (Y)

      1. (i) Area for preparation and examination of frozen sections.
      2. (ii) This may be part of the general laboratory if immediate results are obtainable without unnecessary delay in the completion of surgery;

   8. (Z)

      1. (i) Ice machine.
      2. (ii) An ice machine shall be provided to provide ice for treatments and patient use.
      3. (iii) Ice intended for human consumption shall be from self-dispensing icemakers;

   9. (AA)

      1. (i) A waiting room with toilets, telephones, and drinking fountains conveniently located.
      2. (ii) The toilet room shall contain handwashing stations.
      3. (iii) If outpatients, as defined by the written functional program, are required to wait in this area then a separate area shall be provided.
      4. (iv) Provisions shall be made for:

(b) (b) Interviews;

1. (c) (c) Testing; and

   1. (d) (d) Obtaining vital signs.

      1. (v) A separate area shall be provided where outpatients may change from street clothing into hospital gowns; and

   2. (BB)

      1. (i) Ethylene oxide sterilization facilities.
      2. (ii) Where ethylene oxide is used for sterilization, provisions shall be made for complete exhaust of gases to the exterior.
      3. (iii) When the door is opened, arrangement shall ensure that gases are pulled away from the operator.
      4. (iv) Provisions shall be made for appropriate aeration of supplies.
      5. (v) Aeration cabinets shall be vented to the outside.
      6. (vi) Where aeration cabinets are not used in ethylene oxide processing, provision for isolated area mechanically vented to the outside for aeration, United States Occupational Safety and Health Administration standards shall be met.

(g) Preoperative patient holding area or areas.

1. (1) In facilities with two (2) or more operating rooms, areas shall be provided to accommodate stretcher patients as well as sitting space for ambulatory patients not requiring stretchers.

2. (2) These areas:

   1. (A) Shall be under the direct visual control of the nursing staff; and
   2. (B) May be part of the recovery suite to achieve maximum flexibility in managing surgical caseloads.

3. (3) Each stretcher station shall:

   1. (A) Be a minimum of eighty square feet (80 sq. ft.); and

   2. (B) Have a minimum clearance of four feet (4’) on the:

      1. (i) Sides of the stretchers; and
      2. (ii) Foot of the stretcher.
4. (4) Provisions shall be made for the isolation of infectious patients.
5. (5) Provisions for patient privacy, such as cubicle curtains, shall be made.

(h) Postanesthetic care units (PACUs).

1. (1)

   1. (A) Each PACU shall contain:

      1. (i) A medication station;
      2. (ii) Handwashing stations;
      3. (iii) A nurse station with charting facilities;
      4. (iv) A clinical sink;
      5. (v) Provisions for bedpan cleaning; and
      6. (vi) Storage space for:

(b) (b) Supplies; and

1. (c) (c) Equipment.

   1. (B) Additionally, the design shall provide a minimum of eighty square feet (80 sq. ft.) for each patient bed with a space for:

      1. (i) Additional equipment described in the functional program; and
      2. (ii) Clearance of at least:

(b) (b) Four feet (4’) between patient bedsides and adjacent walls.

1. (C) Provisions shall be made for the isolation of infectious patients.

   1. (D) Provisions for patient privacy, such as cubicle curtains, shall be made.
   2. (E) In new construction, at least one (1) door to the recovery room shall access directly from the surgical suite without crossing public hospital corridors.

2. (2)

   1. (A) An airborne infection isolation room is not required in a PACU.
   2. (B) Provision for the recovery of a potentially infectious patient with an airborne infection shall be determined by the infection prevention and control risk assessment.
3. (3) A staff toilet shall be located within the working area to maintain staff availability to patients.
4. (4) Handwashing stations with hands-free operable controls shall be available with at least one (1) for every four (4) beds, uniformly distributed to provide equal access from each patient bed.