Or. Admin. R. 333-535-0110

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-535-0110 - Surgical Facilities

A surgical unit shall consist of but not be limited to facilities as follows for exclusive use of the surgery department, unless otherwise noted:

(1) The number of operating rooms and recovery beds and the sizes of the service areas shall be based on the expected surgical workload. The surgical suite shall be located and arranged to prevent non-related traffic through the suite. Also see OAR 333-535-0300 for mechanical rules and 333-535-0310 for electrical rules which apply;

(2) Certain rules of this section differ dependent upon the type of surgical procedures performed. These are classified as one of the following three categories:

(a) Unrestricted areas for Minor Surgical and Diagnostic Procedures: Unrestricted areas include a central control point established to monitor the entrance of patients, personnel, and materials. Street clothes are permitted in this area and traffic is not limited. Minor procedures are those that conform to the criteria listed in paragraphs (2)(a)(A) through (D) of this rule based on an assessment of the patient. These procedures are non-invasive and require no general anesthetic.

(A) Anesthesia is limited to local anesthesia or conscious sedation;

(B) Procedure time (duration) is less than two hours;

(C) Procedure is non-invasive with low risk for infection; and

(D) Patient assessment indicates no special risks for cardiorespiratory complications.

(b) Semi-restricted areas include the following:

(A) The peripheral support areas of the surgical suite, and storage areas for clean and sterile supplies, work areas for storage and processing of instruments, and corridors leading to the restricted areas of the surgical suites; and

(B) Traffic in this area is limited to authorized personnel and patients. Personnel are required to wear surgical attire and cover all head and facial hair.

(c) Restricted areas for Major Surgical and Diagnostic Procedures are those which exceed the criteria described for Minor Surgical and Diagnostic Procedures in OAR 333-535-0110(2)(a). Restricted areas include the following:

(A) The operating and procedure rooms, the clean core, and scrub sink areas.

(B) Where surgical attire, hair coverings, and masks are required due to the presence of open sterile supplies, scrubbed people or similar circumstances.

(3) Operating Rooms:

(a) One or more operating rooms shall be provided. Each operating room shall provide a system for emergency communication with the surgical control station which can be operated without use of the hands, but which is not foot operated. No plumbing fixtures or open drains shall be provided in operating rooms except as stipulated in subsection (3)(d). Each operating room shall have a minimum clear area as follows:

(A) Existing operating rooms shall have not less than 360 square feet exclusive of fixed cabinets and built-in shelves. The minimum dimension shall be 18 feet between fixed cabinets and built-in shelves. At least one image reader shall also be provided.

(B) In new construction, operating rooms shall have a minimum clear area of 400 square feet exclusive of fixed or wall-mounted cabinets and built-in shelves, with a minimum of 20 feet clear dimension between fixed cabinets and built-in shelves. At least one image reader shall also be provided.

(b) Operating room(s) for orthopedic surgery, when provided, shall in addition to meeting subsection (a) of this section, have enclosed storage space for splints and traction equipment. Storage may be outside the operating room but must be located for convenient access. If plaster of paris is used for cast work, also provide a plaster sink outside the operating room, but within the operating suite.

(c) Operating rooms for cardiovascular surgery, when provided, shall provide appropriate plumbing connections in both the cardiovascular operating room and pump room and shall in addition to meeting subsection (a) of this section, provide a minimum clear area as follows:

(A) Existing facilities shall have not less than 400 square feet exclusive of fixed cabinets and built-in shelves with a minimum of 20 feet clear dimension between fixed cabinets and built-in shelves; and

(B) In new construction, rooms for cardiovascular, orthopedic, neurological, and other special procedures or combination of procedures such as cardiac catheterization lab and surgery that require additional personnel or large equipment shall have, in addition to the above requirements for general operating rooms, a minimum clear area of 600 square feet with a minimum room dimension of 20 feet clear dimension exclusive of fixed or wall-mounted cabinets and built-in shelves.

(d) Operating rooms for surgical cystoscopic and surgical endoscopic procedures and operating rooms dedicated to eye surgery, when provided, shall meet requirements of subsection (a) of this section, but clear area of the room shall be as follows:

(A) Existing facilities shall have not less than a minimum of 250 square feet exclusive of fixed cabinets and built-in shelves.

(B) In new construction, rooms for surgical cystoscopic and other endourologic procedures shall have a minimum clear area of 350 square feet exclusive of fixed or wall-mounted cabinets and built-in shelves, with a minimum of 15 feet clear dimension between fixed cabinets and built-in shelves. If cystoscopy rooms are used for procedures other than cystoscopy, provisions must be made to allow cleaning and sealing of any floor drains, and such procedures must be included in the hospital's written infection control policy.

(e) Operating rooms for minor surgical procedures, as defined in section (2) of this rule, shall meet requirements of subsection (a) of this section, except that clear area of the room shall be a minimum of 200 square feet exclusive of fixed cabinets and built-in shelves and minimum dimensions do not apply. Film illuminators are required only if procedures involve the use of X-rays.

(f) Despite requirements under subsections (a) through (e) of this section, needs for some procedures may require additional clear operating room space, and special plumbing and mechanical features. Such specialized operating rooms are not addressed by subsections (a) through (e) of this section, and are the responsibility of the hospital and their design consultants.

(4) Service areas: Services, except the enclosed soiled utility room mentioned in subsection (f) of this section and the housekeeping closet in subsection (q) of this section, may be shared with obstetrical facilities if the Functional Program and project design reflect this concept. Service areas, when shared with delivery rooms, shall be arranged to avoid the need for patients or staff to pass between the operating room and the delivery room areas. (See also obstetrical rules under OAR 333-535-0120.) The following services shall be provided:

(a) Control station located to permit visual observation of all traffic into and within the suite;

(b) Administrative and administrative support space in accord with the hospital's program needs;

(c) Sterilizing facility(ies) with high speed autoclave(s) for emergency use. Other facilities for processing and sterilizing reusable instruments may be located in another hospital department such as Central Services. Immediate access to sterilizing facilities is not required where only disposable supplies, instruments and equipment are used. Sterilization equipment shall conform to the Oregon Boiler and Pressure Vessel Specialty Code, ORS 480.525(1)(e);

(d) Medication storage and distribution facilities. Provisions shall be made for storage and preparation of medications administered to patients. A refrigerator and storage system meeting the requirements of Oregon Board of Pharmacy rules, OAR chapter 855, division 41 shall be provided. A hand-washing station shall be provided in or accessible to each area or room;

(e) Scrub facilities. For major surgical procedures, two scrub facilities shall be provided near the entrance to each operating room. Two scrub positions may serve two operating rooms if both are located adjacent to the entrance of each operating room. For minor surgical procedures, a scrub sink or a hand-washing station shall be provided in or accessible to each room. This sink shall be equipped with fittings usable without the use of hands;

(f) Soiled utility room. An enclosed soiled utility room for the exclusive use of the surgical suite staff or soiled holding room that is part of a system within the building for the collection and disposal of soiled material shall be provided. The soiled utility room shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand-washing, waste receptacle, and linen receptacle. When a soiled holding room is used, the clinical sink and work counter may be omitted from that room. (Also see subsection (g) of this section for fluid waste disposal facilities.) Soiled utility or holding areas shall not have direct connection with operating rooms or other sterile activities. The maximum travel distance to soiled utility or holding rooms shall be not more than six rooms or 180 feet;

(g) Fluid waste disposal facilities. These shall be located convenient to, but not connected with, the operating rooms. A clinical sink or equivalent equipment in a soiled utility room or in a soiled holding room would meet this standard if convenient for use. When the surgical program does not include procedures with substantial liquid or solid wastes (for example, minor eye surgery), a clinical sink is not required;

(h) Clean utility room or a clean supply room. A clean utility room is required when clean materials are assembled within the surgical suite prior to use. A clean utility room shall contain work counter, a hand-washing station, and space for clean and sterile supplies. If the Functional Program defines a system for the storage and distribution of clean and sterile supplies in a clean supply room, the counter and sink may be omitted. The clean workroom or supply room may be shared with the delivery suite when provisions for joint use are included in the hospital's infection control policy and arrangement allows for direct access from both surgery and delivery suites. (See also obstetrical rules under OAR 333-535-0120.);

(i) Medical gas storage facilities. Storage of bulk medical gases shall be provided outside or inside the facility. Provisions shall be made for additional separate storage of reserve gas cylinders to complete at least one day's procedures. Storage facilities shall be in compliance with National Fire Protection Association (NFPA) 99;

(j) Anesthesia workroom. Inhalation anesthesia workroom for cleaning, testing, and storing anesthesia equipment shall contain a work counter and sink. Provisions shall be made for separated storage of clean and holding of soiled items. When facilities for cleaning and testing are available elsewhere in the building or the surgical program does not involve substantial anesthesia, a separate utility room is not required;

(k) Anesthesia storage. Anesthesia storage facilities shall be provided for anesthesia-related materials stored within the surgery suite;

(l) Equipment storage room(s) for equipment and supplies used in surgical suite. Ten percent of the surgical suite shall be devoted to equipment storage space. See OAR 333-535-0270 for storage requirements;

(m) Staff clothing change areas. Appropriate areas shall be provided for male and female personnel including orderlies, technicians, nurses and doctors working within the surgical suite. Each area shall contain lockers, showers, toilets, hand-washing stations, and space for donning scrub attire. In surgical suites providing general anesthesia and invasive surgical procedures, these areas shall be arranged to encourage a traffic pattern so that personnel entering from outside the surgical suite can change and move directly into the surgical suite. Showers are not required in suites limited to minor procedures;

(n) Pre-surgical waiting area. In facilities with two or more operating rooms, a room or separate area shall be provided to accommodate stretcher patients waiting for surgery. This may be adjoining the post anesthesia recovery area and be serviced by the same staff nurse when feasible. The area shall be located to allow for nursing supervision and emergency communications;

(o) Storage areas for portable equipment used in surgery, such as portable X-ray unit, stretchers, fracture tables, warming devices or auxiliary lamps. These areas shall not infringe on the width of exit corridors;

(p) Lounge, toilet facilities, and dictation and report preparation space for surgical staff. These facilities shall be provided in hospitals having three or more operating rooms and shall be located to permit use without leaving the surgical suite. A toilet room shall be provided near the recovery room(s);

(q) Housekeeping closet. A closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the surgical suite;

(r) For major procedures, an area for preparation and examination of frozen sections. This may be part of the general laboratory if the system and procedures provide immediate results that will not unnecessarily delay the completion of surgery;

(s) Ice machine to supply ice for patient use and treatments;

(t) Provisions for refrigerated blood bank storage when major procedures are included; and

(u) Post anesthesia care unit for major surgical procedures. Each recovery unit shall be designed to provide:

(A) A medication distribution station, hand-washing stations (at a rate of one sink per four beds), nurses' station with charting facilities and clinical sink. Provisions for bedpan cleaning, storage space for stretchers, supplies and equipment shall be closely available.

(B) Clearance space of at least 5 feet between patient beds and 4 feet between sides of beds and adjacent walls.

(C) Patient privacy such as cubicle curtains.

(D) Provisions shall be made for isolation of infectious patients, although a separate isolation room is not mandated. At least one door to a recovery unit shall access directly from the surgical suite without crossing uncontrolled common hospital corridors. Separate and additional recovery space may be necessary to accommodate surgical outpatients, where applicable but is not required.

(5) Separate Hospital Licensed Outpatient Surgical Facilities. The following additional features shall be provided when an outpatient surgical facility is outside the inpatient hospital building or remote from the inpatient suite:

(a) Visual privacy shall be provided for registration, preparation, examination and recovery. Audible privacy shall be provided during registration;

(b) Provisions shall be made for patient examination, interview, testing and preparation prior to surgery;

(c) Outpatient surgical facilities not part of an inpatient hospital structure shall meet the requirements of the Oregon Structural Specialty Code and the NFPA 101 and 99; and

(d) Outpatient surgery change areas. If the Functional Program defines an outpatient surgery component as part of the inpatient surgical suite, facilities shall be provided where outpatients may change from street clothing into hospital gowns and be prepared for surgery. This would include facilities for waiting, storage of clothing, toilets, and space for gowning. Separate clothes changing areas are not required when sufficient pre-operative holding cubicles are available;

(e) Phase 1 recovery. If the facility provides outpatient surgery, rooms or cubicles for postanesthesia care and recovery shall be provided. At least 3 feet shall be provided at each side of each bed or recovery lounge chair and at the foot of each bed as needed for circulation of staff and gurneys and wheelchairs. Recovery spaces shall be observable from a nursing station. Provide hand wash stations at a rate of one sink per six recovery beds; and

(f) Phase 2 recovery spaces. Dedicated recovery spaces or a dedicated recovery lounge shall be provided in facilities where the surgical program includes patients who do not require postanesthesia recovery or who have completed postanesthesia recovery, but need additional time for observation by staff prior to leaving the facility. Access to toilet facilities shall be provided.

(g) Administrative and public areas. The following shall be provided:

(A) A patient and visitor waiting room or area and information and reception desk or counter;

(B) Public telephone or other phone(s) usable by patients and visitors;

(C) Space(s) for private interviews relating to social services, credit and admission;

(D) Office space(s) for business transactions, records, and administrative and professional staff, and space and equipment for medical records dictating, recording and retrieving. These shall be separate from public and patient areas with provisions for confidentiality of records;

(E) Secure storage for staff clothing and personal effects; and

(F) General storage for administrative supplies.

(6) Dental operations: Dental surgery facilities not part of a multi-specialty surgical unit shall meet the requirements of sections (1) through (4) of this rule. Operating rooms dedicated to dental surgery shall also conform to the following:

(a) Operating rooms used for invasive maxillofacial and reconstructive dental procedures with general anesthesia shall meet the rules of an operating room for major surgical procedures, except that room size shall be a minimum of 250 square feet; and

(b) Operating rooms for extractions and minor operative procedures within limited anesthesia or conscious sedation shall provide a minimum of 132 square feet of clear space and include the following features:

(A) Four feet or more of clear space at one side of the dental chair and a clear access route for a stretcher or gurney; and

(B) Mechanical and electrical features of a minor surgical procedure room according to OAR 333-535-0300 and 333-535-0310.

Or. Admin. R. 333-535-0110

HB 183, f. & ef. 5-26-66; HB 209, f. 12-18-68; HD 7-1979, f. & ef. 7-17-79; HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0200(11); HD 21-1987, f. & ef. 11-13-87; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-074-0255; HD 21-1993, f. & cert. ef. 10-28-93; HD 2-2000, f. & cert. ef. 2-15-00; PH 14-2005, f. 8-10-05, cert. ef. 8-15-05; PH 10-2009, f. & cert. ef. 10-1-09; PH 7-2016, f. & cert. ef. 2/24/2016; PH 18-2019, repeal filed 10/01/2019, effective 1/1/2020

Publications: Publications referenced are available from the agency.

Statutory/Other Authority: ORS 441.025 & 441.060

Statutes/Other Implemented: ORS 441.025 & 441.060