Date Issued: March 30, 2021
The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Tennessee Women’s Care P.C., located in Nashville, Tennessee, on or after November 1, 2019, about possible problems with the quality of their mammograms.
Recommendations for Patients and Caregivers
- If you have had a more recent mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after November 1, 2019, follow the recommendations from that facility.
- If you have not had a mammogram at a different MQSA-certified facility on or after November 1, 2019, follow these guidelines:
- Consider asking for your mammogram and copies of your medical reports from Tennessee Women’s Care, P.C., and have your mammogram reviewed at another MQSA-certified facility to decide if a repeat mammogram or more medical follow-up is needed. As a patient, you or your representatives have the right to ask for your mammograms and copies of your medical reports.
- A database of facilities can be found online, or you can call the National Cancer Institute's information telephone number at 1-800-422-6237 to find a MQSA-certified facility in your area.
A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary screening method for detecting breast cancer in its earliest, most treatable stages.
Summary of Problem or Scope
The FDA became aware of problems associated with the quality of mammograms performed at:
Tennessee Women’s Care, P.C.
2011 Murphy Ave.
Nashville, TN 37203
The facility’s annual MQSA inspection indicated that required quality control tests were not performed from November 1, 2019 through August 17, 2020. As a result, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA, and whether there was a need to notify affected patients.
The American College of Radiology (ACR), at the request of the FDA, contacted the facility to request the clinical images and documentation needed to conduct the AMR of mammograms performed at Tennessee Women’s Care, P.C. The facility did not comply with the ACR’s request, and as a result, on December 28, 2020, the ACR revoked the facility’s accreditation. On December 30, 2020, the FDA placed the facility's MQSA certificate in a "no longer in effect" status.
Under the MQSA, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet the standards for mammography quality under the MQSA. This facility may not legally perform mammography at this time as it does not have an active MQSA certificate.
The FDA will continue to monitor this issue and keep the public informed as new information becomes available. At this time, the FDA recommends that patients contact Tennessee Women’s Care, P.C. to gain access to their medical records.
If you have questions about this communication, please contact the Mammography Quality Standards Act Hotline by phone: 1-800-838-7715, email: [email protected] or fax: 1-443-285-0689.