Facilities that choose to close should note the period they stopped performing mammography, the FDA said in an update. Upon reopening, facilities must perform quality control testing, including completing an annual medical physicist survey.
Facilities that stay open should alert the FDA about any potential noncompliance citations due to COVID-19-related circumstances they can't control. These circumstances could include, for example, mammography personnel being unable to meet continuing education requirements due to canceled conferences or the site being unable to meet inspection program aspects because of quarantined staff.
Further, open facilities with an upcoming Mammography Quality Standards Act (MQSA) inspection but limited resources due to the novel coronavirus outbreak should inform their inspector as soon as possible. The FDA stated it is working with facilities to reschedule inspections on a case-by-case basis.
Facilities that cannot have their annual survey due to a medical physicist's restrictions should contact the FDA or state certifying agency for an extension. Extensions must be submitted in writing and received within 14 months of a facility's last survey, the FDA noted in the guidance.
In states that restrict inspector travel or duties, state managers should notify their radiological health and MQSA representatives if they can't perform their obligated duties due to quarantines of inspectors, inability to gain access to facilities, or as a result of restricted travel. The FDA said it intends to work with each individual state on an action plan once normal operations resume.
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