FDA: Mammogram Issues Associated with Big Sky Diagnostic Imaging, LLC ‏

Mammogram-Issues-Associated-with-Big-Sky-Diagnostic-ImagingThe U.S. Food and Drug Administration (FDA) indicated that it became aware of quality issues tied to mammograms performed at Big Sky Diagnostic Imaging, LLC, in Butte, Montana.

The agency collaborated with the American College of Radiology (ACR) when a routine review of a sample of mammograms was conducted. The mammograms were performed by Big Sky Diagnostic Imaging, LLC and included images taken between November 20, 2011 and November 20, 2013.

Results from the review included poor quality mammograms. The FDA said that while these findings do not indicate that examination results were inaccurate, it does mean that patients should talk to their health care providers to determine if their mammograms must be repeated. The FDA indicated that it will keep monitoring the issue.

Under federal law—the Mammography Quality Standards Act (MQSA)—the FDA mandates that every mammography facility must meet certain baseline quality standards and must also receive certification to legally operate in the United States.

These standards for mammography quality were not met by Big Sky Diagnostic Imaging, LLC, according to the agency. In fact, effective February 6, 2014, the facility is not performing mammograms. The ACR revoked Big Sky Diagnostic Imaging, LLC’s accreditation; the facility’s MQSA certificate is now invalid.

For patients who received a mammogram at Big Sky Diagnostic Imaging, LLC after November 19, 2011, the FDA recommends:

  • If a patient has undergone another mammogram at another MQSA-certified facility since November 19, 2011, the patient should follow the recommendations from that facility.
  • If a patient has not undergone a mammogram at another MQSA-certified facility since November 19, 2011, then the following guidelines should be followed:
    • The patient should speak with her/his current health care provider as soon as possible concerning the need for a follow-up exam.
    • If the patient’s health care provider recommends another mammogram, the follow-up mammogram should be conducted at an MQSA-certified facility to ensure quality and accuracy. A database of MQSA-certified facilities is available online.
    • If the patient’s health insurance will not pay for a repeat mammogram, the National Cancer Institute’s (NCI) information service, toll-free, at 1-800-422-6237, provides a listing of MQSA-certified facilities that provide free or low-cost mammograms.
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