The U.S. Food and Drug Administration (FDA) has announced the conclusion of a Mammography Facility Adverse Event and Action Report that resulted in the removal of accreditation of a Missouri mammogram clinic. The August 5 report stated that Watson Imaging Center in St. Louis, MO is unaccredited and does not have a valid Mammography Quality Standards Act (MQSA) certificate.
Under the MQSA program, the FDA compiles information used to evaluate facilities that perform mammograms and makes the information available to physicians and the general public. Since 2010, the FDA has made individual reports after completing any adverse actions taken against mammogram facilities in order to allow providers and patients to make informed decisions about where they want to receive their mammogram.
The report on the Watson Imaging Center states that on May 5, 2021, the facility was subjected to an Additional Mammography Review (AMR) by their accreditation group, the American College of Radiology (ACR), based on some red flags and deficiencies noted during a routine Validation Image Check (VIC). VICs are periodic reviews of images produced and analyzed by the facility to help the accreditation group determine if a facility meets minimum image quality standards over the course of the three-year accreditation cycle.
On June 22, 2021, the ACR alerted the Watson Imaging Center that it had found that 14 of 30 clinical cases submitted did not meet the clinical evaluation standards and that Watson Imaging Center had failed its AMR. The ACR noted that some of the deficiencies observed in the AMR were severe. Along with failing Watson Imaging Center, the ACR also announced its intent to revoke the facility’s accreditation. After a short period in which Watson attempted to appeal the decision, the ACR revoked the facility’s accreditation on July 8, 2021.
After reviewing the reports submitted by the ACR, the FDA upheld the revocation, determining that Watson Imaging Center posed “a serious risk to human health” and on July 9, 2021, it removed the facility’s MQSA certification. The FDA noted that the facility could have its MQSA certification returned if it complied with the FDA’s requirements. The agency also demanded that Watson issue a Patient and Referring Healthcare Provider Notification to alert all patients who received mammograms from Watson between May 5, 2019, and July 9, 2021, as well as their health care providers about the facility’s quality issues.
Since these actions were taken, Watson Imaging Center has not reapplied for accreditation and therefore does not have a valid MQSA certificate. At this time, the facility is legally prohibited from performing any mammograms.