G ove r n men t Re lat ions
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 qualified medical physicist
(QMP) or qualified expert (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 source-image receptor
distance (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 quality
control (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:
(c) CBCT systems are exempt for 221.202(a) (relating to equipment
requirements).
A quality assurance phantom should have been supplied when
the CBCT unit was installed. If a phantom was not supplied, please
contact your manufacturer. For offices with CBCT machines,
you may wish to reference the Conference of Radiation Control
Program Director’s (CRCPD) white paper: Cone Beam Computed
Tomography for Dental Applications for additional guidance.
All dental offices
• Regulations previously required that radiation-producing
machines be registered with DEP within 30 days of
acquisition. In addition, regulations now require that DEP be
notified in writing within 30 days of any changes to the name,
address, or owner/individual responsible for the radiation
source. Individuals must also maintain a written inventory
including (at a minimum) the type and location of all
radiation-producing devices. (Chapter 216.2)
• Continuing education requirements for X-ray equipment
operators have been further defined. Offices that conduct
“high-risk” procedures (dental offices with CBCT machines)
will be required to complete continuing education at least
every 2 years. All other offices are considered “low-risk” and
will be required to complete continuing education at least
every 4 years. Any continuing education is still required to
address radiation safety, biological effects, quality assurance
and quality control. (Chapter 221.11)
• Quality assurance programs are now required to address
diagnostic reference levels, and image quality and artifacts.
For CT images, each study must be checked. If artifact is
present, the registrant must take corrective action. Quality
assurance documents, along with CE documents, must be
retained for inspection by DEP for 5 years. Previously
documents were only required to be retained for 3 years.
(Chapter 221.11)
DEP regulations can be found in 25 PA. Code, Chapters 215-221.
(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.
JU LY/AU G U ST 2019 | P EN N SYLVAN IA DEN TAL JOURNAL
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