gital Mammography Ac.pptVIP

2002 NMQAAC ACR Full-Field Digital Mammography Accreditation -2002 Update Last Year at This Time The Full-Field Digital Accreditation (FFDM) Module was complete and was mid-way through ACR leadership approval We had hoped for final ACR approval by end of Sept 2001 Module was manufacturer-specific (first GE) Exposure control mechanisms are different Due to FDA regs, required QC is different Since Then In early October, ACR sent the FFDM Module documents to the Executive Committee of the ACR’s Board of Chancellors and the FDA for review In Mid-October, FFDM Module approved by the Executive Committee of the ACR’s Board of Chancellors In mid November, FDA instructed ACR to submit a formal application for approval of the FFDM Accreditation Module (to include the same requirements addresses as part of ACR accreditation body application approved by the FDA on December 20, 2000.) Formal Application Submission At the beginning of July 2002, ACR submitted a complete formal FFDM Accreditation Module application to FDA At the end of July, after initial review of the application, FDA advised ACR that the information provided with the alternative standard request was insufficient In early August, the digital subcommittee collected additional data to supplement the alternative standard request The revision to the alternative standard request is currently under internal review prior to re-submission to FDA Proposed Accreditation Process for Full-Field Digital Mammography General Process Will Not Differ Paperwork will depend on time left on facility’s certification and accreditation 13 months – all units must go through early renewal at usual fee 13 months – the FFDM unit must complete “mid-cycle” accreditation at a reduced fee Facilities will be able to have “stand-alone” digital systems (no screen-film required) Clinical Image Quality Evaluation Will Not Differ Images must be submitted on hard copy Eight attributes evaluated the same as screen-film Positioning Compression Ex