FDA accuses techs of falsifying mammo quality control records
“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,” the agency wrote.
According to the FDA, mammography facilities are responsible for assuring that personnel meet the requirements under 21 CFR 900.12(a), which states:
- Retention of personnel records: Facilities shall maintain records to document the qualifications of personnel who worked at the facility as interpreting physicians, radiologic technologists or medical physicists. The records must be available for review by the Mammography Quality Standards Act (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.
- Quality assurance records: The lead interpreting physician, QC technologist and medical physicist shall ensure that records concerning mammography technique and procedures, QC (including monitoring data, problems detected by analysis of those 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. The QC records shall be kept for each test specified in paragraphs and 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.
Since ARRT registration has an expiration date, each technologist should have an up-to-date registration card, according to the agency. The FDA also recommended 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.
According to the FDA, relying on a single individual at a facility to assure compliance with MQSA for quality assurance (QA) and other requirements may put a facility at risk. The requirements above indicate 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.
The agency concluded that “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.”