The falsified records include processor quality control testing, phantom image quality control testing, or both. In addition, the FDA has discovered cases of technologists who falsified registration cards from the American Registry of Radiologic Technologists (ARRT).
"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 said.
All mammography facilities are responsible for ensuring that staff meets the following requirements:
- Keeping personnel records: Records should be maintained to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists, or medical physicists.
- Keeping quality assurance records: The lead interpreting physician, quality control technologist, and medical physicist should 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.
Mammography facilities should not depend on one person to ensure compliance with Mammography Quality Standards Act (MQSA) standards, the agency said. At least three people, if not more, are responsible for quality control oversight.
"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," the FDA wrote.
FDA meeting to address radiation-reduction initiative, February 25, 2010
FDA staff says agency may need new device powers, February 22, 2010
FDA launches initiative to rein in medical radiation, February 9, 2010
U.S. FDA names permanent chief of devices unit, January 21, 2010
FDA releases new mammo standard, December 11, 2009
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