News | Mammography | March 25, 2020

MQSA Inspection Information Related to COVID-19

The FDA has received numerous inquiries about COVID-19 and its increasing impact on mammography facilities, and is providing information about common scenarios that may arise due to the evolving COVID-19 situation in the United States

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March 25, 2020 — The Division of Mammography Quality Standards (DMQS) has received numerous inquiries regarding COVID-19 and its increasing impact on mammography facilities. The FDA has temporarily postponed domestic inspections including ones performed under contract with its state regulatory partners. The FDA press release can be found here. As such, DMQS is providing appropriate regulatory flexibility and posting the following information regarding common scenarios that may arise due to the evolving COVID-19 situation in the United States.

Facilities that choose to close

Facilities that choose to cease operations due to the coronavirus should document the period in which they are not performing mammography and ensure all required quality control testing is performed prior to resuming operations. This includes the annual medical physicist survey or other quality assurance duties which may have been required during the closure period.

Facilities that cannot schedule an annual medical physicist survey due to circumstances out of their control

If the medical physicist cannot travel to the facility to conduct the annual survey due to coronavirus travel restrictions or other circumstances out of their control, the facility should contact the FDA or State Certifying Agency to request an extension of the annual medical physicist survey if it will be conducted beyond 14 months. Extension requests should be submitted in writing and received prior to the date that marks the 14th month since the last annual survey. Additional instructions for the extension process can be found here.

Facilities that continue to operate and have non-compliance citations that are due to circumstances out of their control

For any circumstance due to coronavirus which the facility cannot control and that could lead to non-compliance citations, the facility should be prepared to provide detailed documentation. Examples may include (1) the failure of mammography personnel to meet the continuing education requirement due to cancellation of courses/meetings due to coronavirus; and (2) the failure to meet certain aspects of EQUIP due to staffing absences related to coronavirus.

DMQS will continue to monitor the situation and will issue other communications should the need arise. For any other inquiries, please contact the MQSA Hotline at 1-800-838-7715 or [email protected].