Or. Admin. Code § 333-535-0105

Current through Register Vol. 63, No. 10, October 1, 2024

Section 333-535-0105 - Radiation Oncology Facility or Department

All radiation oncology installations must comply with provisions of the 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.

(1) Treatment Rooms:

(a) Rooms and control areas shall be provided as necessary to accommodate the radiation oncology Functional Program. Equipment manufacturers' recommendations should be sought and followed. Any radiotherapeutic (i.e. cobalt, linear accelerators, high dose rate after loading, etc.) treatment room shall be sized in accordance with manufacturers' recommended standards and shall accommodate a stretcher;

(b) Control areas shall have visual and audio contact with the patient in the treatment room as appropriate to the radiation protection needs of the equipment;

(c) If invasive procedures take place in the treatment room, the room must also meet the rules for surgery facilities, OAR 333-535-0110; and

(d) Hyperthermia room, when provided, shall be of adequate size to accommodate equipment, stretcher, and a hand-washing station. This may be combined with an examination room.

(2) Treatment Support Areas:

(a) Simulator room and control area shall be sized to accommodate equipment and stretcher per the manufacturers' recommendations. A hand-washing station shall be provided within the room.

(b) The control area shall have visual and audio contact with the simulator room.

(c) Darkroom or film processing area shall be convenient to the treatment room(s) and simulator area, and shall include a utility sink in or convenient to this area. Film storage for unprocessed film shall be provided.

(d) Block fabrication, when provided, shall have seamless flooring and integral coved base. Non-porous counter tops shall have backsplash, and a hand-washing station shall be provided. Exhaust hoods shall be provided.

(e) Treatment planning, if provided, shall be sized to accommodate manufacturers' dosimetry system requirements.

(3) Hot lab, if provided, shall include the following features:

(a) Seamless flooring and integral coved base.

(b) Non-porous counter tops with backsplash.

(c) Adequate storage and work area for multiple types of radioactive material, with adequate shielding and security including additional support areas for cobalt room for hot lab storage.

(d) A hand-washing station shall be accessible. If located in the hot lab, the sink must have a filtration trap. Refer to OAR 333-535-0300(5)(e)(G) for mechanical requirements.

(e) If radiopharmaceutical preparation is performed on site, an area adequate to house a radiopharmacy shall be provided with appropriate shielding.

(A) Space requirements shall include the following:

(i) Adequate space for storage of radionuclides, chemicals for preparation, dose calibrators, a film file area, and record-keeping;

(ii) If pre-prepared materials are used, storage and calculation area may be considerably smaller than that for on site preparation; and

(iii) Space shall be adequately provided for dose calibration, quality assurance, and record-keeping.

(B) Radiation protection requirements. The area may still require shielding from other portions of the facility.

(C) Construction requirements shall include the following:

(i) Floors and walls constructed of materials that are easy to decontaminate;

(ii) Vents and traps for radioactive gases shall be provided if such are used; and

(iii) Hoods for pharmaceutical preparation shall be in accordance with mechanical requirements of OAR 333-535-0300 and other applicable standards.

(f) Nuclear Waste Disposal. See Code of Federal Regulations (CFR), Title X, parts 20 and 35, concerning the handling and disposal of nuclear materials in health care facilities.

(4) Patient Support Areas: These areas shall include, but not be limited to:

(a) Examination rooms equipped with a hand-washing station. At least one examination room shall accommodate stretcher patients;

(b) Patient reception and waiting area. The waiting area shall be out of traffic, under staff control, and both shall have seating capacity in accordance with anticipated needs. If the suite is routinely used for outpatients and inpatients at the same time, separate waiting areas shall be provided with screening for visual privacy between the waiting areas;

(c) Patient toilet rooms. Toilet rooms shall be provided accessible to the waiting rooms and shall be equipped with an emergency call station; and

(d) Patient dressing rooms. Dressing rooms shall be provided in accordance with the anticipated needs, shall be accessible to the waiting areas with the provision for safe storage of valuables and clothing. At least one space shall be large enough for staff-assisted dressing.

(5) General Support Areas: These areas shall include, but not be limited to:

(a) Clean storage. Provisions shall be made for the storage of clean supplies and linens, in or closely available to the department;

(b) Soiled holding area. Provisions shall be made for handling and separately holding contaminated items. If toxic chemicals are used, exhaust shall be provided. Whenever soiled items are handled, a hand-washing station shall be provided;

(c) Housekeeping closet shall be equipped with service sink or floor receptor. The closet shall be large enough for equipment or supplies storage;

(d) Staff facilities. Toilets shall be convenient for staff use. Staff lounge with lockers is required if not available elsewhere; and

(e) Film and radiation oncology patient record file area.

Or. Admin. Code § 333-535-0105

OHD 2-2000, f. & cert. ef. 2-15-00; 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