Current through Register Vol. 54, No. 52, December 28, 2024
(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).
This section cited in 25 Pa. Code §
221.63 (relating to therapy
imaging guidance systems).
