Mqsa facility certification
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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

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Mqsa facility certification

MQSA FacilityCertification

Joanne Choy

Certification Coordinator

DMQRP/FDA


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

OR

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

OR

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 @ - http://mpris.cdrh.fda.gov:90/

  • Request CASS access via http:[email protected]

  • 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: [email protected]


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