LAWSUITS NEWS & LEGAL INFORMATION
FDA Issues Warning For Mammograms at Boston Diagnostic Imaging in Florida
Washington, DC: The Food and Drug Administration (FDA) is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms.
The American College of Radiology (ACR) conducted a clinical image review of mammograms performed by Boston Diagnostic Imaging between May 13, 2013, and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility' accreditation renewal application. The ACR revoked the facility' application for mammography accreditation effective July 29, 2015. The FDA suspended the facility' Mammography Quality Standards Act (MQSA) certificate on August 13, 2015, and directed the facility to cease performing mammography.
On August 13, 2015, the FDA directed the facility to notify all patients who received mammograms at Boston Diagnostic Imaging any time on or after May 13, 2013, and their referring health care providers, about the problems with the mammography quality at the facility. 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 MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up. Patients have the right to request their mammogram and copies of their medical reports from Boston Diagnostic Imaging.
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 suspension of its MQSA certificate.
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The American College of Radiology (ACR) conducted a clinical image review of mammograms performed by Boston Diagnostic Imaging between May 13, 2013, and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility' accreditation renewal application. The ACR revoked the facility' application for mammography accreditation effective July 29, 2015. The FDA suspended the facility' Mammography Quality Standards Act (MQSA) certificate on August 13, 2015, and directed the facility to cease performing mammography.
On August 13, 2015, the FDA directed the facility to notify all patients who received mammograms at Boston Diagnostic Imaging any time on or after May 13, 2013, and their referring health care providers, about the problems with the mammography quality at the facility. 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 MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up. Patients have the right to request their mammogram and copies of their medical reports from Boston Diagnostic Imaging.
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 suspension of its MQSA certificate.
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