§ 221.64. CBCT.
(a) The following radiation measurements shall be evaluated annually and as soon as practical after a component repair or change which, in the opinion of the QMP or QE, may affect the performance of the CBCT unit:
(1) Beam alignment. The X-ray field in the plane of the image receptor may not exceed beyond the edge of the image receptor by more than 2% of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, the center of the X-ray field must be aligned with the center of the image receptor to within 2% of the SID.
(2) A performance evaluation shall be performed by or under the direct supervision of a QMP or QE. The evaluation shall follow nationally-recognized standards and tolerances or those recommended by the manufacturer. The evaluation shall be performed within 30 days of initial installation, at intervals not to exceed 14 months, and within 30 days after any change or replacement of components which could cause a change in the radiation output or image quality.
(3) The registrant shall document and implement QC guidelines in accordance with nationally-recognized guidelines.
(4) The registrant shall document and implement a policy addressing deviations from established protocols.
(5) In addition to the requirements of § 221.16 (relating to training, competency and continuing education), the CBCT X-ray system shall only be operated by an individual who has been specifically trained in its operation.
(6) The facility shall maintain documentation of the established standards and tolerances and testing results for 5 years for inspection by the Department.
(b) The CBCT operator shall have instructions on all of the following:
(1) Performing routine QC, including the use of the CBCT phantom.
(2) A schedule of routine QC appropriate for the system.
(3) Allowable variations set by the QMP, if required, for the indicated parameters.
(4) The results of at least the most recent routine QC completed on the system.
(c) CBCT systems are exempt from § 221.202(a) (relating to equipment requirements).
The provisions of this § 221.64 issued under sections 301 and 302 of the Radiation Protection Act (35 P.S. § § 7110.301 and 7110.302); and section 1920-A of the Administrative Code (71 P.S. § 510.20).
The provisions of this § 221.64 adopted October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791.
This section cited in 25 Pa. Code § 221.63 (relating to therapy imaging guidance systems).
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