§ 228.35. Operating procedures.
(a) Accelerators, when not in operation, shall be secured to prevent unauthorized use.
(b) An interlock may not be used to turn off the accelerator beam except in an emergency or for testing the interlock.
(c) Each safety and warning device, except interlocks, shall be checked at least every 3 months for proper functioning and shall be repaired as necessary. Interlocks shall be checked at least annually. Results of these checks and records of repairs shall be maintained for 5 years at the accelerator facility for inspection by the Department.
(d) In the event of a malfunction of a safety or warning device, the accelerator may not be operated unless appropriate interim precautions are instituted to provide equivalent protection.
(e) If it is necessary to intentionally bypass a safety interlock system or component thereof, the action shall be the following:
(1) Authorized in writing by the radiation safety officer.
(2) Recorded in a permanent log and a notice posted at the accelerator operator’s position.
(3) Terminated as soon as possible.
(f) A copy of the current operating and emergency procedures shall be maintained in the accelerator operator area.
(g) For accelerators used in the healing arts, operating procedures shall meet the following requirements:
(1) No individual other than the patient is in the treatment room during treatment of a patient.
(2) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used.
(3) The system may not be used in the administration of radiation therapy unless the requirements of this chapter have been met.
(4) A medical reportable event for radiation-producing machine therapy, as defined in § 219.3 (relating to definitions), shall be reported as required under § 219.228 (relating to reports of medical reportable events for radiation-producing machine therapy).
(5) An individual who operates an accelerator system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions shall include, but not be limited to, items included in Appendix A (relating to determination of competence). There shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
(h) An individual who operates an accelerator system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions must include items included in Appendix A (relating to determination of competence) for medical accelerator operations, as well as basic radiation protection for nonmedical accelerator operations. There shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
Source The provisions of this § 228.35 adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823; amended October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791. Immediately preceding text appears at serial pages (304583) to (304584).
Cross References This section cited in 25 Pa. Code § 228.39 (relating to records).
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