NASHVILLE, TN (WSMV) – According to the U.S. Food & Drug Administration, a medical group practice in Nashville may have problems with mammography regulations.
The FDA announced that they are alerting patients who had mammograms at Tennessee Women’s Care P.C. in Nashville on or after November 1, 2019.
In the notice on the FDA’s website, the department said they became aware of problems associated with the quality of mammograms performed at Tennessee Women’s Care, P.C, located on 2011 Murphy Avenue, Suite 201.
According to the FDA, 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.
At the request of the FDA, the American College of Radiology (ACR) 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. 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 On December 30, 2020, the FDA placed the facility’s MQSA certificate in a “no longer in effect” status.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 said they require all mammography facilities to meet specific baseline quality standards and be certified to operate in the United States legally. This facility did not meet the criteria 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 says they will continue monitoring the issue and keeping the public informed as new information becomes available. The FDA recommends that patients contact Tennessee Women’s Care P.C. to gain access to their medical records.
Tennessee Women’s Care released a statement on the recent FDA press release.
News 4 previously reported on customers dealing with multiple issues regarding refunds at Tennessee Women’s Care.
<a href=”https://www.wsmv.com/call_4_action/it-s-not-your-money-to-keep-mother-upset-over-health-care-provider-not-refunding/article_ae7a0d9a-f6ac-11e9-8198-8f3714ce5459.html” target=”_blank”>”It’s not your money to keep” Mother upset over health care provider not refunding her nearly $2,000</a>
<a href=”https://www.wsmv.com/call_4_action/father-plans-to-sue-tennessee-women-s-care-over-billing-refund-issues/article_967f068c-ff5d-11e9-ac2a-5b174045de55.html” target=”_blank”>Father plans to sue Tennessee Women’s Care over billing, refund issues</a>
News4 reached out to Tennessee Women’s Care P.C. for a response to the FDA’s memo. We are waiting to hear back.
The FDC says if you have any questions, please contact Mammography Quality Standards Act Hotline by phone <a href=”http://call%20to%201-800-838-7715″ target=”_blank”>1-800-838-7715</a>, email: <a href=”mailto:MQSAhotline@versatechinc.com”>MQSAhotline@versatechinc.com</a> or fax: 1-443-285-0689. For the FDA’s full article, <a href=”https://www.fda.gov/medical-devices/safety-communications/mammography-problems-tennessee-womens-care-pc-nashville-tn-fda-safety-communication” target=”_blank”>click here</a>.