Or. Admin. Code § 333-535-0100

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-535-0100 - Imaging Facilities

(1) General: Imaging facilities are those which provide fluoroscopy, radiography, mammography, tomography, computerized tomography scanning, ultrasound, magnetic resonance, angiography, and other similar techniques. Room layouts, including clearances, must meet equipment manufacturers' minimum recommendations.

(2) Radiation Protection: All imaging facilities and radiation producing equipment installations must comply with Oregon Health Authority, Public Health Division, Regulations for Control of Radiation, OAR 333-100 through 123, and be licensed by Radiation Protection Services of the Division.

(a) Where protected alcoves with view windows are required, a minimum of 1 foot 6 inches between the view window and the outside partition edge shall be provided.

(3) Angiography. The following shall be provided:

(a) Procedure rooms shall be a minimum of 400 square feet in size exclusive of fixed cabinets and built-in shelves;

(b) A control room shall be provided to house associated staff and equipment. A view window shall be provided to permit full view of the patient;

(c) Area for image reading;

(d) A scrub sink, as referenced in OAR 333-535-0260, located outside the staff entry to the procedure room shall be provided for staff use;

(e) Facilities shall be available for patients waiting on stretchers that are out of the line of traffic;

(f) Storage for equipment; and

(g) Facilities shall be available within the facility for extended post-procedure observation of outpatients.

(4) Cardiac Catheterization Lab. Facilities for cardiac catheterization may be combined with the imaging department or be part of the surgery suite. If provided, cardiac catheterization lab facilities shall meet the rules for angiography rooms under section (3) above. The following additional requirements shall be provided:

(a) A separate scheduling and staff work space, cardiologist's office and staff toilet shall be provided when the facilities are located outside the imaging suite; and

(b) There shall be access to a clean assembly/workroom with Hi-vacuum or gravity steam sterilizers and sterilization equipment to accommodate heat sensitive equipment.

(c) Electrophysiology labs. If electrophysiology labs are also provided in accordance with the approved Functional Program, these labs may be located within the catheterization suite or located in a separate functional area proximate to the cardiac care unit.

(d) For Cardiac Catheterization Lab combined with Surgery refer to OAR 333-535-0110 to be used in conjunction with this section.

(5) Computerized Tomography (CT) Scanning. The following shall be provided:

(a) Procedure rooms shall be configured to accommodate equipment in accordance with the equipment manufacturers' recommendations;

(b) When required by the Functional Program, control room(s) shall be located to allow for film processing and designed to accommodate the computer and other controls for the equipment. When viewing of patients is required, a window shall be provided to permit full view of the patient; and

(c) A conveniently available patient toilet.

(6) Diagnostic X-ray (Radiography). The following shall be provided:

(a) Radiography room(s), sized to accommodate the Functional Program;

(b) Each X-ray room shall include a shielded control alcove designed to provide a full view of the patient when the table is in the tilt position or the chest X-ray is being utilized. For mammography machines with built-in shielding for the operator, the alcove may be omitted when approved by the Oregon Health Authority, Public Health Division, Radiation Protection Services; and

(c) Rooms primarily utilized for fluoroscopy shall have direct access to a toilet room.

(7) Magnetic Resonance Imaging (MRI). The following shall be provided:

(a) MRI procedure room(s) to accommodate the Functional Program and meet equipment manufacturers' recommendations;

(b) Secure storage for patient belongings;

(c) A control room with full view of the MRI;

(d) A computer room as needed to support the specific equipment installation;

(e) Cryogen storage when service to replenish supplies is not otherwise available;

(f) Power conditioning and voltage regulation equipment as well as direct current (DC) when required by the equipment manufacturer;

(g) Magnetic shielding and radio frequency shielding when required by the equipment manufacturer;

(h) Patient holding area convenient to the MRI unit and large enough to accommodate stretchers;

(i) Venting of cryogen exhaust to the outside; and

(j) Signage shall be provided for the purpose of limiting ferrous material.

(8) Ultrasound. The following shall be provided:

(a) Procedure room(s) meeting equipment manufacturers' minimum room size and configuration recommendations; and

(b) A patient toilet room shall be accessible to every three procedure rooms without traveling through public areas.

(9) Nuclear medicine. The nuclear medicine area shall include the following: (See also, OAR 333-535-0105(3))

(a) Space requirements. Space shall be adequate to permit entry of stretchers and beds and able to accommodate imaging equipment, electronic consoles, and if present, computer terminals;

(b) Hand-washing stations provided within each procedure room;

(c) Dose administration area(s) as specified by the Functional Program shall be provided near the preparation area. The area shall provide for visual privacy from other areas due to long periods for dose effects, as well as features for comfortable seating, varied lighting, and entertainment; and

(d) Positron Emission Tomography (PET). When provided, in addition to the nuclear medicine requirements, PET facilities shall be in accordance with the Functional Program, including the following:

(A) Laboratory and equipment space shall be provided as follows:

(i) Scanner room should be not less than 300 square feet and space for the cyclotron room should be not less than 225 square feet with 16 square feet of space safe for storage of parts that may require cool-down periods of one year or more;

(ii) Both hot (radioactive) labs and cold labs, each requiring a minimum of 250 square feet. Blood labs having a minimum of 80 square feet;

(iii) Patient holding areas capable of accommodating a minimum of two stretchers; and

(iv) Gas storage areas large enough to accommodate sufficient bottles of gas piped individually to the cyclotron or the lab.

(B) Construction requirements capable of providing protection from the high radiation generated from the cyclotron shall be provided.

(C) Ventilation adequate for the occupancy shall be provided as follows:

(i) Compressed air, or equivalent, shall be provided to pressurize a water circulation system;

(ii) Special ventilation systems together with monitors, sensors, and alarm systems shall be provided to vent gases and chemicals; and

(iii) Regarding heating, ventilating, and air-conditioning systems, the highest pressure shall be in the coldest (radiation) areas and the exhaust shall be in the hottest (radiation) areas. (Redundancy may be important.)

(D) A redundant plumbing system connected to a holding tank shall be required to prevent accidental leakage of contaminated water into the regular plumbing system.

(10) Support Spaces. The following spaces shall be common to the imaging department and shall be minimum requirements unless stated otherwise:

(a) Patient waiting areas shall provide seating capacity in accordance with the Functional Program;

(b) Control desk and reception area;

(c) Patient holding area under staff control, designed to accommodate inpatients on stretchers or beds and outpatients, that is not in the path of traffic. This area may be shared with the dose administration area and patient waiting areas provided there is visual privacy between the areas;

(d) Patient toilet room with hand-washing station shall be provided and reserved for nuclear medicine patients convenient to waiting and procedure rooms and directly accessible from each fluoroscopy room;

(e) Patient dressing rooms. Dressing rooms with convenient access to waiting areas and procedure rooms shall include a seat or bench, a mirror, and provisions for hanging patient's clothing and securing valuables;

(f) Access to staff toilet, lounge and locker facilities which shall be within or closely available to the department;

(g) Film storage facilities for active and inactive files under departmental administrative control shall be provided to properly secure and protect film against loss or damage. This storage is permitted to be off site;

(h) Storage for unexposed film;

(i) Contrast media preparation area with sink, counter and storage to allow mixing of contrast media. Where prepared media is used, this area may be omitted and storage shall be provided for the prepared media;

(j) A darkroom shall be provided for film processing unless the processing equipment does not require a darkroom for loading and transfer;

(k) If automatic film processors are used, a receptacle of adequate size with hot and cold water for cleaning processor racks shall be provided;

(l) Quality control room. An area or room for immediate viewing of film after processing shall be provided unless other viewing facilities are immediately available;

(m) Housekeeping facilities, including a service sink or floor receptacle and storage for cleaning equipment and supplies;

(n) A hand-washing station shall be provided in each procedure room unless it is used only for routine diagnostic screening such as for chest X-rays and where the patient is not physically handled by the staff. A hand-washing station shall be provided convenient to MRI, CT and ultrasound rooms, but it need not be within the room;

(o) Clean storage area. Provisions shall be made for storage of clean supplies and linens (See OAR 333-535-0260 for clean storage details and definitions);

(p) Soiled holding area. Provisions shall be made for a separated holding area for soiled materials, linens and trash. Hand-washing facilities shall be closely available. If cleaning and disinfecting of equipment occurs within the imaging department, a counter, sink, hand-wash station and exhaust ventilation shall be provided (See OAR 333-535-0260 for clean storage details and definitions);

(q) Provisions shall be made for locked storage of medications and drugs when the program includes their use; and

(r) When the Functional Program requires a centralized computer area, it shall be a separate room with access terminals available within the imaging rooms.

Or. Admin. Code § 333-535-0100

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(10); HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-074-0250; 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 18-2019, repeal filed 10/01/2019, effective 1/1/2020

Statutory/Other Authority: ORS 441.060

Statutes/Other Implemented: ORS 441.060