§ 228.76. Spot checks.
Spot checks shall be performed on systems subject to this subchapter during full calibrations and thereafter once in each calendar month. The spot checks shall meet the following requirements:
(1) The procedures shall be in writing and developed by a qualified expert for radiation therapy calibrations.
(2) If a qualified expert does not perform the spot check measurements, the results of the spot check measurements shall be reviewed by a qualified expert within 15 days of the completion of the spot check.
(3) The measurements taken during spot checks shall demonstrate the degree of consistency of the operating characteristics which can affect the radiation output of the system or the radiation delivered to a patient during a therapy procedure.
(4) The spot-check procedures shall specify the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the full calibration.
(5) If a spot check indicates a change in the operating characteristics of a system, as specified in the qualified experts spot-check procedures, the system shall be recalibrated as required in § 228.75 (relating to calibrations).
(6) Records of spot-check measurements performed under this section shall be maintained by the licensee for 5 years after completion of the spot-check measurements and necessary corrective actions.
(7) Spot check measurements shall be performed using a dosimetry system that has been calibrated in accordance with § 228.75(c). Alternatively, a dosimetry system used solely for spot check measurements may be calibrated by direct intercomparison with a system that has been calibrated in accordance with § 228.75(c). This alternative calibration method shall have been performed within the previous year and after a servicing that may have affected the system calibration.
The provisions of this § 228.76 adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (249370) to (249371).
DETERMINATION OF COMPETENCE
The licensee shall ensure training on the subjects listed in Appendix A has been conducted. The individual shall be trained and competent in the general operation of the radiation therapy equipment and its functions, and in the following subject areas, as applicable to the procedures performed and the specific equipment utilized:
(1) Basic properties of radiation.
(2) Units of measurement.
(3) Sources of radiation exposure.
(4) Methods of radiation protection.
(5) Biological effects of radiation exposure.
(6) Medical accelerator operation.
(7) Treatment planning and execution.
(8) Patient positioning and protection.
(9) Operating and emergency procedures.
(10) Quality assurance.
The provisions of this Appendix A adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3823. Immediately preceeding text appears at serial pages (249371) to (249372).
This appendix cited in 25 Pa. Code § 228.35 (relating to operating procedures).
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