( 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 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 .
For all dental offices All dental offices are impacted by the following changes :
• Radiation-producing machines must be registered with DEP within 30 days of acquisition . In addition , DEP must be notified in writing with 30 days of any changes to the name , address or individual responsible for a radiation source . Individuals must maintain a written inventory including the type and location of all radiation producing devices .
• Frequency of Continuing Education ( CE ):
- “ High Risk ” procedures require CE at least every 2 years ( Dental offices with CBCT machines )
- “ Low Risk ” procedures require CE at least every 4 years ( All other dental offices )
• Quality Assurance programs must address diagnostic reference levels and image quality / artifact . For CT images , each study must be checked , and if artifact is present the registrant must take corrective action .
• Quality Assurance documents , including CE records , must be retained for 5 years .
DEP regulations regarding Radiological Health can be found in 25 PA . Code , Chapters 215-221 . If you have additional questions , please contact Kathleen Bumpers kek @ padental . org .
SEPTEMBER / OCTOBER 2021 | PENNSYLVANIA DENTAL JOURNAL 25