FDA Warns of Mammography Quality Issues at California Facility

April 30, 2015 — The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Coastal Diagnostic Center in Pismo Beach, California, on or after Feb. 24, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up.

The FDA became aware of problems following an American College of Radiology (ACR) clinical image review of mammograms performed at the facility between Feb. 24, 2013, and Feb. 24, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility’s accreditation renewal application. The ACR revoked the facility’s accreditation effective April 10, 2015.

On April 24, the FDA required the facility to notify all patients who received mammograms at Coastal Diagnostic Center during the specified period, and their referring healthcare providers, about the problems with the mammography quality at the facility.

Under the MQSA of 1992, 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 standards for mammography quality under the Act. The facility may no longer legally perform mammography at this time due to the revocation of its accreditation by the ACR and its MQSA certification being no longer in effect.

The FDA recommends the following actions:

• If you have had a more recent mammogram at a MQSA-certified facility since then, you should follow the recommendations from that facility.
• If you have not had a mammogram at an MQSA-certified facility since then, follow these guidelines:
  • Talk with your healthcare provider as soon as possible about the need for a follow-up exam
  • If your healthcare provider recommends a repeat mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy.

For more information: www.fda.gov