mqsa facility certification joanne choy certification coordinator dmqrp/fda
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MQSA FacilityMQSA FacilityCertificationCertification
Joanne ChoyJoanne Choy
Certification CoordinatorCertification Coordinator
DMQRP/FDA DMQRP/FDA
Facility CertificationFacility Certification
To legally perform mammography, To legally perform mammography, a facility must be certified and a facility must be certified and display their certificate display their certificate prominently at the facilityprominently at the facility
FDA issues certification upon FDA issues certification upon notification by an accreditation notification by an accreditation body (AB) that a mammography body (AB) that a mammography facility is accreditedfacility is accredited
Accreditation Bodies (AB)Accreditation Bodies (AB)
American College of Radiology American College of Radiology (ACR)(ACR)The States of Arkansas, The States of Arkansas, California, Iowa and TexasCalifornia, Iowa and Texas
Certificate TypesCertificate Types
ProvisionalProvisional90-Day Extension90-Day ExtensionProvisional Provisional ReinstatementReinstatement
FullFull
Provisional CertificateProvisional Certificate
First time applicant for accreditationFirst time applicant for accreditation
All materials have been submitted All materials have been submitted and accepted by the AB for reviewand accepted by the AB for review
Enables the facility to perform Enables the facility to perform mammography and obtain clinical mammography and obtain clinical
images needed to complete images needed to complete accreditationaccreditation
valid for up to 6 monthsvalid for up to 6 months
90-Day Extension 90-Day Extension CertificateCertificate
Facility must be in a Provisional or Facility must be in a Provisional or Provisional Reinstatement StatusProvisional Reinstatement Status
Accreditation process cannot be Accreditation process cannot be completed before expirationcompleted before expiration
Facility applies to their AB for the Facility applies to their AB for the extension extension
AB forwards their recommendation to AB forwards their recommendation to FDAFDA
90-Day Extension 90-Day Extension CertificateCertificate
FDA considers the followingFDA considers the following– Evidence of a significant adverse impact on Evidence of a significant adverse impact on
access to mammography in the community access to mammography in the community or geographical areaor geographical area
– Facility compliance with AB timeframe Facility compliance with AB timeframe requirementsrequirements
Denial of the extension Denial of the extension – Facility must cease performing Facility must cease performing
mammography upon certificate expirationmammography upon certificate expiration– Apply and receive a reinstatement in order Apply and receive a reinstatement in order
to continue performing mammographyto continue performing mammography
Provisional Provisional Re-instatement Re-instatement
CertificateCertificateFull certificate expired/about to expire Full certificate expired/about to expire
Submitted application, but testing Submitted application, but testing materials not receivedmaterials not received
Had a failure/deficiencyHad a failure/deficiencyOROR
Didn’t adhere to time constraintsDidn’t adhere to time constraintsMust receive AB approval of the Must receive AB approval of the submitted corrective action plan submitted corrective action plan
valid for up to 6 monthsvalid for up to 6 months
Full CertificateFull CertificateFacility accreditation Facility accreditation standards met under a standards met under a provisional certificateprovisional certificate
OROR
Facility Facility reaccreditation reaccreditation
process completedprocess completed
(full to full)(full to full)
valid for up to 3 yearsvalid for up to 3 years
Certification/Certification/Accreditation Accreditation ProceduresProcedures
AB’s electronically notify the AB’s electronically notify the certifiers (FDA, States of Iowa and certifiers (FDA, States of Iowa and Illinois) of a facility’s status via data Illinois) of a facility’s status via data transmissionstransmissions
Data updates the Certification and Data updates the Certification and Accreditation Support System (CASS)Accreditation Support System (CASS)– Data is uploaded by ACR 3 times a week Data is uploaded by ACR 3 times a week – Other AB’s enter data online directly Other AB’s enter data online directly
into CASSinto CASS
Certification/Certification/Accreditation Accreditation ProceduresProcedures
Data generates the appropriate Data generates the appropriate certificatecertificate
Certificate sent by certification Certificate sent by certification contractor and includes a cover contractor and includes a cover letter and fact sheet letter and fact sheet
Facilities Facilities no longerno longer need to return need to return their certificates to FDA (expired their certificates to FDA (expired certificates may not be displayed)certificates may not be displayed)
Interim NoticeInterim Notice
Administrative action covering the Administrative action covering the time between certification approval time between certification approval and facility receipt of a certificateand facility receipt of a certificate
Borrows time from certificateBorrows time from certificateCarries full weight of a certificateCarries full weight of a certificate
Faxed after AB email notification to Faxed after AB email notification to FDA FDA
Valid for up to 45 daysValid for up to 45 days
AB Recommendations AB Recommendations for Interim Noticesfor Interim Notices
Issued to Fully Certified Facilities Issued to Fully Certified Facilities approaching expiration of current approaching expiration of current certificatecertificate
Facility Applies to their ABFacility Applies to their AB AB forwards recommendation to FDAAB forwards recommendation to FDA FDA issues a final decision after FDA issues a final decision after
considering the following:considering the following:– Facility accreditation historyFacility accreditation history
Valid for up to 45 daysValid for up to 45 days
Inspector Inspector ResponsibilitiesResponsibilities
Perform annual inspection of fully Perform annual inspection of fully certified facilities within 12 months certified facilities within 12 months of certificationof certification
Verify the billing address with the Verify the billing address with the facility at the time of the annual facility at the time of the annual inspectioninspection
Update the MPRIS Inspection Report Update the MPRIS Inspection Report with billing address changeswith billing address changes
Web-based CASSWeb-based CASS Inspector Access to CASS @ Inspector Access to CASS @ - -
http://mpris.cdrh.fda.gov:90/http://mpris.cdrh.fda.gov:90/ Request CASS access via Request CASS access via
http://[email protected]://[email protected] Available Reports Available Reports
– Specified FacilitySpecified Facility– Facility CountsFacility Counts– Facility Listing by StateFacility Listing by State– Facility SearchFacility Search
Facility HotlineFacility Hotline
Phone: 1-800-838-7715Phone: 1-800-838-7715 FAX: 1-410-290-6351FAX: 1-410-290-6351 Address: Mammography Quality Address: Mammography Quality
Assurance ProgramAssurance Program
Food and Drug Food and Drug AdministrationAdministration
P.O. Box 6057P.O. Box 6057
Columbia, MD 21045-6057Columbia, MD 21045-6057
Inspector HotlineInspector Hotline
Phone: 301-827-6287Phone: 301-827-6287 E-mail: [email protected]: [email protected]