MQSA Facility Certification

1. MQSA FacilityCertification Joanne Choy Certification Coordinator DMQRP/FDA

2. Facility Certification • To legally perform mammography, a facility must be certified and display their certificate prominently at the facility • FDA issues certification upon notification by an accreditation body (AB) that a mammography facility is accredited

3. Accreditation Bodies (AB) American College of Radiology (ACR) The States of Arkansas, California, Iowa and Texas

4. Certificate Types • Provisional • 90-Day Extension • Provisional Reinstatement • Full

5. Provisional Certificate First time applicant for accreditation All materials have been submitted and accepted by the AB for review Enables the facility to perform mammography and obtain clinical images needed to complete accreditation valid for up to 6 months

6. 90-Day Extension Certificate Facility must be in a Provisional or Provisional Reinstatement Status Accreditation process cannot be completed before expiration Facility applies to their AB for the extension AB forwards their recommendation to FDA

7. 90-Day Extension Certificate • FDA considers the following • Evidence of a significant adverse impact on access to mammography in the community or geographical area • Facility compliance with AB timeframe requirements • Denial of the extension • Facility must cease performing mammography upon certificate expiration • Apply and receive a reinstatement in order to continue performing mammography

8. Provisional Re-instatement Certificate Full certificate expired/about to expire Submitted application, but testing materials not received Had a failure/deficiency OR Didn’t adhere to time constraints Must receive AB approval of the submitted corrective action plan valid for up to 6 months

9. Full Certificate Facility accreditation standards met under a provisional certificate OR Facility reaccreditation process completed (full to full) valid for up to 3 years

10. Certification/Accreditation Procedures • AB’s electronically notify the certifiers (FDA, States of Iowa and Illinois) of a facility’s status via data transmissions • Data updates the Certification and Accreditation Support System (CASS) • Data is uploaded by ACR 3 times a week • Other AB’s enter data online directly into CASS

11. Certification/Accreditation Procedures • Data generates the appropriate certificate • Certificate sent by certification contractor and includes a cover letter and fact sheet • Facilities no longer need to return their certificates to FDA (expired certificates may not be displayed)

12. Interim Notice Administrative action covering the time between certification approval and facility receipt of a certificate Borrows time from certificate Carries full weight of a certificate Faxed after AB email notification to FDA Valid for up to 45 days

13. AB Recommendations for Interim Notices • Issued to Fully Certified Facilities approaching expiration of current certificate • Facility Applies to their AB • AB forwards recommendation to FDA • FDA issues a final decision after considering the following: • Facility accreditation history • Valid for up to 45 days

14. Inspector Responsibilities • Perform annual inspection of fully certified facilities within 12 months of certification • Verify the billing address with the facility at the time of the annual inspection • Update the MPRIS Inspection Report with billing address changes

15. Web-based CASS • Inspector Access to CASS @ - http://mpris.cdrh.fda.gov:90/ • Request CASS access via http://computersupport@cdrh.fda.gov • Available Reports • Specified Facility • Facility Counts • Facility Listing by State • Facility Search

16. Facility Hotline • Phone: 1-800-838-7715 • FAX: 1-410-290-6351 • Address: Mammography Quality Assurance Program Food and Drug Administration P.O. Box 6057 Columbia, MD 21045-6057

17. Inspector Hotline • Phone: 301-827-6287 • E-mail: Helpdesk@cdrh.fda.gov