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MQSA Facility Certification. Joanne Choy Certification Coordinator DMQRP/FDA. Facility Certification. To legally perform mammography, a facility must be certified and display their certificate prominently at the facility

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mqsa facility certification

MQSA FacilityCertification

Joanne Choy

Certification Coordinator


facility certification
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
accreditation bodies ab

Accreditation Bodies (AB)

American College of Radiology (ACR)

The States of Arkansas, California, Iowa and Texas

certificate types
Certificate Types
  • Provisional
  • 90-Day Extension
  • Provisional Reinstatement
  • Full
provisional certificate

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

90 day extension certificate

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

90 day extension certificate1
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
provisional re instatement certificate

Provisional Re-instatement Certificate

Full certificate expired/about to expire

Submitted application, but testing materials not received

Had a failure/deficiency


Didn’t adhere to time constraints

Must receive AB approval of the submitted corrective action plan

valid for up to 6 months

full certificate

Full Certificate

Facility accreditation standards met under a provisional certificate


Facility reaccreditation process completed

(full to full)

valid for up to 3 years

certification accreditation procedures
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
certification accreditation procedures1
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)
interim notice

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

ab recommendations for interim notices
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
inspector responsibilities
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
web based cass
Web-based CASS
  • Inspector Access to CASS @ -
  • Request CASS access via
  • Available Reports
    • Specified Facility
    • Facility Counts
    • Facility Listing by State
    • Facility Search
facility hotline
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

inspector hotline
Inspector Hotline
  • Phone: 301-827-6287
  • E-mail: