Should a certified facility that is not currently performing mammography be inspected?
Yes. In keeping with the intent of the regulations, once a facility is certified, that facility must maintain its certified status by:
- having an annual physics survey performed (and mammography equipment evaluations, when applicable),
- undergoing periodic audits and reviews by its accreditation body,
- permitting an annual MQSA inspection,
- paying an inspection fee, and
- correcting any deficiencies found during inspections.
Should a certified facility choose not to meet these requirements, it must relinquish its certified status. This means the facility must notify its accreditation body and the FDA (Facility Hotline Number: (800) 838-7715, MQSAhotline@hcmsllc.com Address: MQSA Hotline, P.O. Box 6057, Columbia, MD 21045-6057) or the Certifying State as soon as possible. Once the facility’s certified status has been relinquished, it cannot display the MQSA certificate and cannot lawfully perform mammography.
Should the facility decide to perform mammography services in the future, it must proceed through the accreditation process again. 21 C.F.R. 900.11.