FDA is aware of several cases where radiologic technologists at mammography facilities falsified QC records (processor QC testing, phantom image QC testing, or both), and other technologists who falsified registration cards from the American Registry of Radiologic Technologists (ARRT) (see Mammography Facility Adverse Event and Action Reports for more information). While the vast majority of technologists are honest professionals who provide a vital service to patients, these few individuals may put patients and facilities at risk.
All mammography facilities are responsible for assuring that all personnel meet the requirements under 21 CFR 900.12(a). Under 21 CFR 900.12(a)(4), it states:
Retention of personnel records. Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors at the time of inspection. Facilities should not discard records of personnel no longer employed by them until the next annual inspection has been completed and FDA has determined that the facility complies with the MQSA personnel requirements.
Since ARRT registration has an expiration date, each technologist should have an up-to-date registration card. We recommend that facilities check all original personnel documentation at the time of employment and periodically to assure that their personnel meet the initial and continuing requirements. For requirements like ARRT registration that expires, facilities may wish to maintain a list of personnel with the expiration dates of their credentials. To assist facilities, the ARRT maintains the following Directory Search on its web site:
Facilities may use this directory to verify current registrations for their personnel.
Regarding the equipment quality assurance (QA) requirements, 21 CFR 900.12(d)(2) states:
(2) Quality assurance records. The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection and employee qualifications to meet assigned quality assurance tasks are properly maintained and updated. These quality control records shall be kept for each test specified in paragraphs (e) and (f) of this section until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.
Relying on a single individual at a facility to assure compliance with MQSA for QA and other requirements may put a facility at risk. The requirement above indicates that QA oversight is the responsibility of, at a minimum, the three individuals mentioned above and possibly others. Facility management should ensure the involvement of all of the responsible parties in the review of QC records and the oversight of the QA program, particularly the lead interpreting physician.
It is always better to admit mistakes rather than compound the problems by engaging in illegal behavior that could result in a criminal prosecution, loss of certification, and loss of employment.