Following inspection failures, 2 mammography centers have 2 different outcomes
The FDA’s Center for Devices and Radiological Health (CDRH) has updated the status of two previously disaccredited mammography operations, rehabilitating the reputation of one while showing the other in limbo.
The restored center, Elliott Breast Clinic of Baton Rouge, La., had failed an annual MQSA inspection in March 2021.
The deficiency owed to the clinic’s lack of documentation to show an interpreting physician was qualified for the job.
As a result, the center had to inform recent patients and referrers of the problem by sending out a standardized Patient and Referring Healthcare Provider Notification (PPN).
The Elliott clinic completed all its assigned corrective actions, including the PPN, and was cleared to resume mammography services as of last October.
Full FDA notice here.
The facility whose doors are still shut, Watson Imaging Center in St. Louis, is evidently out of business by its own hand.
FDA says it notified the center its corrective actions and PPN were accepted as complete, but Watson Imaging did not reapply for accreditation.
Consonant with that status report, a popup message on the center’s website as of Aug. 8 says it closed last Dec. 30.
Detailed FDA notice here.
Supplying background on MQSA, the FDA says it compiles and makes available to physicians and the general public information “that is useful in evaluating the performance of mammography facilities.”
More:
As of October 2010, the FDA posts individual notices following completion of the adverse actions taken against facilities. This information is useful in evaluating the performance of mammography facilities nationwide and assists providers and patients in making informed decisions. For additional information, please see the Reports (MQSA) webpage.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.