Under the final MQSA regulations, each certified mammography facility must utilize the services of a qualified medical physicist to survey the facility's equipment and to oversee the equipment-related quality control (QC) program used by the facility and perform mammography equipment evaluations (MEE) on x-ray units and image processors, whenever such evaluations are necessary. For example, the facility is required to have any equipment that is new to the facility, has been reassembled due to a move or transfer, or has undergone any major repair (including component replacement), evaluated by a medical physicist.
It is the facility's responsibility to see that these evaluations are performed by a qualified medical physicist, that reports are complete, and that any issues are addressed in a timely manner. It is the facility who will receive citations for any violations identified during an inspection.
Before medical physicists can independently conduct either the annual survey and/or the MEE, they must meet the initial qualifications and the continuing education and experience requirements. The facility must retain the initial qualification and the continuing experience and continuing education documentation provided by the medical physicist for review by the inspector at the time of the MQSA inspection.
The physicist's annual survey must include several baseline items and specific annual QC tests related to the equipment evaluation and the medical physicist must send the annual survey report to the facility within 30 days of the survey date, as well as notify the facility immediately of any test failures or problems. During MQSA inspections, inspectors routinely review certain aspects of the annual survey and/or MEE reports.
Note that for Full Field Digital Mammography units and Digital Breast Tomosynthesis units, the QC tests and quality assurance program must be substantially the same as the one specified by the image receptor manufacturer.
A complete Physicist's Survey report or MEE report includes these basic components:
- A clearly identified date of the survey or MEE.
- The name(s) and signature of the medical physicist performing or supervising the survey or MEE, as well as the name of any other individual(s) participating in the survey
- A summary of the required QC test results in pass/fail designations and the results of all tests conducted, including the numerical values when called for and a summary of any recommendations and/or corrective actions for which facilities must have supporting documentation (i.e. service reports) to demonstrate that corrective actions were performed in a timely manner.
- A summary of the evaluation of the facility's QC testing (other than annual) with any recommendations for necessary improvements and/or corrective actions, as needed.
- A written justification from the medical physicist for any omitted tests, deviations, or unusual circumstances in which he/she used professional judgment.
Remember, it is the FACILITY'S responsibility to review and ensure the medical physicist survey and/or MEE report is complete and contains the above elements. A survey report and MEE should document the serial numbers of the mammography equipment currently in use and that all QC tests have passed the medical physicist's evaluation, as well as note any corrective action recommendations made by the medical physicist.