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. For details, see Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections.
Accordingly, 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.
All facility personnel (updated 4/27/2020):
Facility personnel, even if they are furloughed or working less than full-time, are encouraged to continue to meet the MQSA requirements for continuing education and continuing experience, if feasible under current circumstances. For example, it may be possible for all personnel to obtain continuing education by reviewing journal articles, and through on-line training providers that grant Continuing Education Units (CEUs) or Continuing Medical Education credits (CMEs) for completed training activities. For interpreting physicians, it may be possible to obtain continuing experience through multi-reading of previously interpreted examinations, where he/she did not perform the initial interpretation of the exam.
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 continue to operate but at a reduced volume, a modified scope of practice, or reduced personnel (updated 4/27/2020):
Facilities that continue to operate but change their scope of practice or their volume of examinations (e.g., performing only diagnostic mammograms but deferring screening mammograms), and/or reduce the number of personnel who are actively performing mammography, should document the nature of the change(s) to their practice and the period in which they are performing mammography with this altered scope.
For each of the facility’s personnel who are subject to the MQSA quality standards for mammography personnel (interpreting physicians, radiologic technologists, and medical physicists), facilities should also document the status of each individual (e.g., practicing full-time, practicing two days per week, furloughed, etc.) and the period that each individual is in this status.
Facilities who continue to use the mammography equipment on an intermittent basis over the four-month extension of the annual survey requirement (addressed below) should continue to report any equipment-related QC testing failures and/or concerning trends to the medical physicist for review and evaluation.
Facilities that cannot schedule an annual medical physicist survey due to circumstances out of their control (updated 4/27/2020):
For mammography facilities for which the annual medical physicist survey falls within the time period January 2020 through August 2020: Due to the evolving COVID-19 impact on travel and facility operations, the FDA intends to automatically grant a four-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 the 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 July 16, 2020. Due to the FDA four-month extension, the facility would not be considered noncompliant for exceeding the FDA’s recommended 14-month timeframe since the date of the previous annual survey if the survey was completed by July 16, 2020.
The 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.
