MQSA Facility Certification Joanne Choy Certification Coordinator DMQRP/FDA

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

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

Certificate Types n Provisional n 90-Day Extension n Provisional Reinstatement n Full

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

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

90-Day Extension Certificate n 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 n Denial of the extension –Facility must cease performing mammography upon certificate expiration –Apply and receive a reinstatement in order to continue performing mammography

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

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

Certification/Accreditation Procedures n AB’s electronically notify the certifiers (FDA, States of Iowa and Illinois) of a facility’s status via data transmissions n 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

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

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

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

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

Web-based CASS Inspector Access to - Inspector Access to - Request CASS access via Request CASS access via n Available Reports –Specified Facility –Facility Counts –Facility Listing by State –Facility Search

Facility Hotline n Phone: n FAX: n Address: Mammography Quality Assurance Program Food and Drug Administration P.O. Box 6057 Columbia, MD

Inspector Hotline n Phone: n