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:
Due to the evolving COVID-19 impact on travel and facility operations, mammography facilities for which the annual medical physicist survey falls within the time period, January 2020 to June 2020, FDA intends to automatically grant a two-month extension (from the FDA recommended 14-month timeframe) for the facility to complete the annual survey. A request for an extension does not need to be filed with FDA.
As an example, for a facility that received its last annual medical physicist survey on January 16, 2019, based on current FDA recommendations, the current survey was due anytime during the period January 16, 2020 to March 16, 2020. The FDA extension would allow the annual survey to be performed as late as May 16, 2020. Due to the FDA two-month extension, the facility would not be considered noncompliant for exceeding FDA’s recommended 14-month timeframe since the date of the previous annual survey, if the survey was completed by May 16, 2020.
FDA will continue to monitor this situation and revise this policy as appropriate.
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 MQSAhotline@versatechinc.com.
