Radiation-Emitting Products

A mammography facility has contacted our accreditation body (AB) and wants to switch from its current AB. What procedures should the ABs follow to ensure a smooth transition?

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The following procedures should be followed to process a facility’s request to change ABs.

1. When a facility notifies its current AB that it wants to change ABs, the current AB should make no change in the facility status until it has been notified that the new AB has received and accepted an application for accreditation from the facility.

2. Upon receipt and acceptance of an application for accreditation from a facility intending to change accreditation bodies, the new AB should notify by e-mail both FDA (and the State Certifying Agency where applicable) and the previous AB.

Note 1: If a facility notifies the new AB that it wants to change its accreditation to it but does NOT send an acceptable application for accreditation, the new AB should not send any notification to either FDA (and the State Certifying Agency where applicable) or the previous AB and should not make any changes to its database.
Note 2: Prior to transmitting updates to the facility's accreditation history, the new AB should review the history in FDA’s certification/accreditation support system (CASS) database and avoid reusing unit #s (unless the update pertains to an existing unit). This ensures retention of unit accreditation history of all units accredited by both AB's.

3. Upon receipt of the AB’s notification, FDA will switch the facility’s affiliation in the CASS database so that CASS will only accept data for the facility from the new body, and not accept data from the previous AB.

4. To preclude FDA from receiving a status change report before the facility affiliation is manually changed, both ABs should wait two business days after the notification of acceptance of an application before transmitting updated facility records to FDA. The previous AB need not transmit any further records for the facility. The new AB should only transmit additional records when there is a change in the facility’s status.

Change of accreditation body subsequent to denial or expiration of accreditation:

A facility that has been denied accreditation, or has allowed its accreditation to lapse, may have to provisionally reinstate before it can continue performing mammography. Provisional reinstatement involves submission and completion of a corrective action plan that is acceptable to the AB, and in some cases FDA or the State Certifying Agency. Corrective action plan requirements are no less stringent for a facility that decides to change ABs while seeking provisional reinstatement. The new AB should request the facility provide a complete accreditation and certification history when applying for provisional reinstatement. It is essential that the new AB be fully aware of the issues that made provisional reinstatement necessary.

In such cases, in addition to the accreditation history provided by the facility, the new AB should contact the previous AB by e-mail, with a copy to the FDA accreditation liaison officer (and State Certifying Agency where applicable), and request a complete history of the facility’s prior accreditation or attempts at accreditation. The previous AB should provide such history, including pertinent information about any failure or revocation of accreditation.

The new AB, in consultation with FDA through the AB liaison officer (or State Certifying Agency where applicable), when appropriate, should then request a corrective action plan from the facility in accordance with the AB’s policies.

Accreditation body of record:

When switching ABs, which AB is the facility’s AB of record may be ambiguous if the change is not made subsequent to a denial or expiration of accreditation. The facility’s full certificate will usually remain in effect until it expires. The full certificate is predicated upon accreditation by the previous accreditation body. Unless such accreditation was revoked for cause, FDA would not usually make a determination that a facility’s certificate should be terminated.

However, once the CASS affiliation has been changed, only the new AB is able to change facility status information in CASS. It is therefore incumbent on the new AB to ensure that FDA (and the State Certifying Agency, where applicable) is notified of any change in the accreditation status of the facility. This includes submitting or having the facility submit a request for an interim notice when necessary, and determining when such a notice is appropriate in accordance with the FDA’s (or the State Certifying Agency’s) and the AB’s policy. When a facility has not completed renewal of accreditation before its certificate has expired, and the issuance of an interim notice is not appropriate, the new AB should make a determination concerning provisional reinstatement of the facility in accordance with its policies.

 

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Page Last Updated: 06/11/2014
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