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U.S. Department of Health and Human Services

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What are 45 day interim notices and interim accreditation and when are they used?

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When a facility’s MQSA certificate has expired or is about to expire, FDA or the Certifying State may, under certain conditions, issue a 45 day interim notice that allows the facility to continue to perform mammography. FDA or a Certifying State may issue a 45 day interim notice to a mammography facility under the following circumstances:

1) REACCREDITATION COMPLETION DELAY: In cases where there has been a delay in the AB reaching a final reaccreditation decision, FDA or the Certifying State may issue a 45 day interim notice to a facility. This allows the facility to continue to perform mammography after its MQSA certificate has expired. In order for a facility to be eligible to receive an interim notice, the facility needs to been granted interim accreditation by its AB. Interim accreditation is a temporary accreditation granted by the AB. The AB may grant an interim accreditation for up to 45 days if additional time is needed to complete the reaccreditation process.

A facility should submit its request for interim accreditation to its AB. The AB will apply its established criteria for interim accreditation and issue a decision regarding the request. If the interim accreditation request is approved by the AB, the AB will notify FDA or the Certifying State to fax the facility an interim notice (an MQSA certificate is not issued in this situation). Upon receipt of the interim notice, the facility may perform or continue to perform mammography for up to 45 days. If full accreditation does not occur during this time period, the facility should contact the AB to discuss reinstatement. A facility whose interim notice has expired is considered no longer certified and must not perform mammography.

If the AB does not grant the facility’s request for interim accreditation, the facility may apply for reinstatement in accordance with its AB’s policies. Once the current MQSA certificate and interim notice expire, a facility is considered no longer certified and must not perform mammography.

2) CERTIFICATE DELAY: If the AB has already made a positive accreditation decision, FDA or the Certifying State may fax the facility a copy of its MQSA certificate or issue an interim notice in order to allow the facility to perform mammography while awaiting receipt of the original MQSA certificate as described below.

Facilities Waiting for Receipt of their Provisional ( 6 month) MQSA Certificate (New Facilities)

When the AB accepts the facility’s application for review, the AB will notify FDA or the Certifying State. The Certifying Agency will fax the facility an MQSA provisional certificate or a 45 day interim notice allowing it to begin performing mammography as soon as possible. The facility cannot perform mammography until it receives either of these documents. Facilities with questions about their accreditation/certification status should first contact their AB to see if their application has been accepted and if the Certifying Agency has been notified. If the facility still has not received its MQSA certificate or interim notice, the facility should contact FDA or the Certifying State. FDA may be contacted by fax at 1-410-290-6351 or by phone at 1-800-838-7715. Contact the Certifying State if your MQSA certificate is issued by the State.

Facilities Waiting for Receipt of their Full (3 year), Reinstatement, or 90 Day Extension MQSA Certificates

 Upon AB notification to FDA or the Certifying State that a facility has successfully completed the accreditation process, the Certifying Agency will mail the facility an original MQSA certificate. Because there may be a delay in receipt of the MQSA certificate, the AB may request the Certifying Agency to fax the facility a 45 day interim notice or photocopy of the MQSA certificate allowing continued mammography performance in cases where the facility’s MQSA certificate has or is about to expire. Upon receipt of the interim notice or MQSA certificate, the facility may perform or continue to perform mammography. A facility that has questions about its accreditation status should contact its AB.

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