Mammography Accreditation and MQSA Certification

1. Mammography Accreditation and MQSA Certification www.acr.org

2. Introduction www.acr.org

3. History • 1987 – ACR’s voluntary Mammo Accreditation Program • 1992 – President Bush signs the Mammography Quality Standards Act • 1994 – FDA’s Interim Rules requires all mammo facilities in the US to be accredited, certified and inspected; QC regs mirror the ACR requirements • 1999 – FDA’s Final Rules went into effect with new detailed requirements, including direct patient notification www.acr.org

4. Why ACR Accreditation? • Validation of quality • Peer process • Judy Destouet, M.D. – current chair, Committee on Mammography Accreditation • Educational process • MQSA requires accreditation for all mammo facilities (screening and diagnostic) • Patient confidence • Facilities meet the highest standards of their profession www.acr.org

5. How Can ACR Accreditation Help You and Your Practice? • ACR coordinates members’ review and comment of proposed FDA regs and guidance • Sent to FDA from ACR, a professional society of over 30,000 • Practice support materials develop by radiologists, medical physicists and technologists • Mammography QC Manual, BI-RADS, Standards • Many other resources www.acr.org

6. Study Guide www.acr.org

7. 1. We just moved one of our 2 accredited mammography units to our new free-standing clinic. After my physicist does her Equipment Evaluation survey and everything passes, we can use it to examine patients. TRUE or FALSE www.acr.org

8. Facility Requirements Under MQSA DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration21 CFR Part 900Quality Mammography Standards AGENCY: Food and Drug Administration, HHS. ACTION: Final ruleAs Amended by Federal Register Notice 10/22/98, 4/15/99, 6/17/99 DATES: This regulation is effective April 28, 1999; except Sec. 900.12(b)(8)(i), (e)(4)(iii)(B),(e)(5)(i)(B) which become effective October 28, 2002. • Before operation • Just starting out: 6-month provisional MQSA certificate • After accreditation: 3-year full certificate • Mammo facilities must be • Accredited • Certified • Inspected • Complementary www.acr.org

9. 2. It is the responsibility of the _____ to ensure that the facility applies for and completes accreditation renewal before MQSA certificate expiration. • A. Accrediting body • B. Certifying body • State inspectors • D. Facility www.acr.org

10. When Do the MQSA Certificate and Accreditation Expire? • ACR expiration dates on certificate and unit label • Against the law to perform mammo without a current MQSA certificate • Medicare will not reimburse under expired certificate www.acr.org

11. Meet All Application Deadlines • Renewal notices sent out 8 months prior to accreditation expiration • ACR must receive the complete entry application within 6 months prior to expiration • You have 45 calendar days to return completed testing to ACR • This guarantees completion of the review process before accreditation expiration www.acr.org

12. 3. In order to pass ACR accreditation, a facility must perform and document that they pass all of the QC tests outlined in the 1999 ACR Mammography QC Manual. TRUE or FALSE www.acr.org

13. 1999 ACR Quality Control Manual • Aid for meeting FDA rules • Consistent with MQSA requirements • Additional recommendationsfor further quality improvement • Meeting ACR recommendations not required for accreditation www.acr.org

14. 4. The ACR staff employees 25 full-time clinical image reviewers and 15 phantom image reviewers at their Reston, VA office to ensure quick turn around of your accreditation images. TRUE or FALSE www.acr.org

15. ACR Image Reviewers • 85 radiologists and 35 medical physicists qualified under MQSA • In clinical (or physics) practice across the US • Board certified • 5+ years of experience in accreditation modality • Participate in formal training program • May not review images from the same state www.acr.org

16. 5. Your phantom image fails if the medical physicist reviewer can’t see the following • A. 5 largest fibers (after artifact subtraction) • B. 4 largest speck groups (after artifact subtraction) • C. 3 largest masses (after artifact subtraction) • Fewer than 5 dust artifacts • E. C and D www.acr.org

17. Tips for Submitting Phantom Images & Dosimeter • Make test shot without dosimeter • Don’t cover fibers, specks, masses (or pink block) with dosimeter or disk www.acr.org

18. Phantom Image Quality Evaluation • In order to pass must see • 4 largest fibers • 3 largest speck groups • 3 largest masses • Background density measurement www.acr.org

19. Phantom Image Quality Evaluation • Phantom Image Reviewers use same criteria in ACR QC Manual • Subtract artifacts if they appear • Fiber-like • Speck-like • Mass-like www.acr.org

20. 6. ACR radiologist reviewers assume that clinical images submitted for accreditation are • A. Examples of your facility’s best work • B. Examples of your facility’s typical work • C. Benign cases • Reviewed by your facility’s mammography QC technologist • E. A and C www.acr.org

21. Follow Instructions Submitting Clinical Images • Examples of facility’s best work • Supervising radiologist should review & approve images • Submit “negative” images • BI-RADS assessment category 1 (“nothing to comment on…breasts are symmetrical…no masses, architectural disturbances or suspicious calcifications”) • ACR will accept BI-RADS assessment category 2 (“benign”) with prior approval & report • Do NOT use models or volunteers www.acr.org

22. 7. The radiologist reviewers will not review clinical images submitted for accreditation that are not adequately fatty or dense. TRUE or FALSE www.acr.org

23. Different Breast Densities (BI-RADS) Present Different Imaging Challenges Comp Cat 2 25-50% glandular Comp Cat 1 <25% glandular Fatty Comp Cat 3 51-75% glandular Comp Cat 4 >75% glandular Dense www.acr.org

24. 8. The major reason for failure of ACR accreditation is • A. Excessive patient dose • B. Poor phantom image quality • Poor clinical image quality • Processor QC (more than 3 data points outside of control limits without corrective action) www.acr.org

25. Clinical Image Quality Evaluated in Eight Categories • Review evaluation criteria in “Clinical Image Evaluation” section of 1999 QC Manual before submitting images • (*Primary reason for accreditation failure) • Positioning* • Compression • Exposure level • Contrast • Sharpness • Noise • Artifacts • Exam ID www.acr.org

26. 1999 ACR Mammo QC Manual: Clinical Image Evaluation • ACR Criteria for evaluating quality • Guide for technical assessment of clinical images by radiologist • Under MQSA radiologist must provide feedback to technologist • Examples of poor and good clinical image Underexposed Properly Exposed www.acr.org

27. 9. Your facility does not pass accreditation after the initial application. (The clinical images were not acceptable.) You must immediately cease performing mammography. TRUE or FALSE www.acr.org

28. Accreditation Attempts

29. ACR Mammography Accreditation Program Pass Rates – 1st Attempt www.acr.org

30. Reasons for Failures – 1st Attempt www.acr.org

31. 10. Your accredited facility just installed a new unit. You must ___ before you examine patients with that unit • Have you medical physicist conduct an Equipment Evaluation on the unit • Correct all problems identified during the Equipment Evaluation • C. Send ACR the accreditation application and Equipment Evaluation results for the new unit • D. All of the above www.acr.org

32. Equipment Evaluations for New Units • Must be done by qualified medical physicist • This “acceptance test” evaluates different features in addition to those tested as part of the medical physicist’s annual QC survey • Must be done (& all problems fixed) before equipment used on patients • Must be submitted to ACR during initial application of new (or used) mammo unit www.acr.org

33. Equipment Evaluations and Accreditation (New) • Physicist can no longer tell facility that everything is OK and they may now use the new unit on patients • Facility must also send ACR the medical physicist’s Equipment Evaluation results showing that everything passes before the facility may use the new unit on patients • Required by FDA • Effective February 15, 2003 www.acr.org

34. New Facilities • Before beginning mammography (including “applications” training) • Send in Entry App, fees and Equipment Evaluation Pass/Fail results to ACR (new!) • All FDA-required tests must be done and pass • Must receive 6-month provisional MQSA certificate (or interim notice) www.acr.org

35. New Facilities • ACR reviews and approves complete application and Equipment Evaluation and notifies FDA (or state certifier) • FDA (or state certifier) sends 6-mo provisional MQSA certificate to facility • Not more than 4 days from the time facility submits required documentation to ACR • Recommend scheduling Equipment Evaluation 1 week before examining patients www.acr.org

36. Accredited Facilities Installing New Units • Application depends on time left on MQSA certificate • >13 mo – complete New Unit Addendum (mid-cycle) application for new unit at reduced fee • After approval, new unit has same expiration as other units • <13 mo – all units must go through Renewal at usual fee • Saves facility time and dollars • New expiration date is old expiration date + 3 years www.acr.org

37. Accredited Facilities Installing New Units • May not use new unit for mammography until • All FDA-required Equipment Evaluation tests are done and pass • Facility sends in application, fees and Equipment Evaluation Pass/Fail results to ACR (new!) • Facility does not have to wait for a response from ACR to use for mammography • With a current MQSA certificate www.acr.org

38. Equipment Evaluations for New Units (New) • A rapid ACR review is essential for facilities • Only summaries are required, BUT medical physicists must use ACR summary forms (sent with application materials; also download from www.acr.org) • MQSA Requirements for Mammography Equipment (checklist) • Medical Physicist’s QC Test Summary form • Different formats (even if they contain all the necessary information) will delay review www.acr.org

39. Download Forms from ACR Website 900.12(b) www.acr.org

40. Different Form for Screen-Film and Digital 900.12(e) www.acr.org

41. One More Thing • Equipment Evaluation • Not required to complete “Evaluation of Site’s Technologist QC Program” part of QC Test Summary at this time, BUT • 45 days later when facility submits Full Application or Testing Materials • ACR will request full Annual Survey report • “Evaluation of Site’s Technologist QC Program” must be completed for new unit • Medical physicist may perform this evaluation by mail, fax, etc., but must do it www.acr.org

42. Full-Field Digital Mammography (FFDM) Accreditation www.acr.org

43. FDA Approval of FFDM • Fischer Senoscan approved September 25, 2001 • Lorad Selenia Amorphous Selenium Direct-Capture System approved October 2, 2002 • GE Senographe 2000D approved January 28, 2000 • Soft copy interpretation for GE approved November 16, 2000 www.acr.org

44. FFDM Under MQSA • At the time of approval, ACR did not have an accreditation program for full-field digital • Not sufficient clinical experience to develop relevant QC or performance standards • All other ACR accreditation programs developed after modality has been around for a while • MQSA Catch 22 • In order to perform mammography, facilities must certified • Facilities must be accredited before they can be certified www.acr.org

45. FFDM Accreditation Module • Subcommittee on Full-field Digital Mammography Accreditation, Chaired by Martin Yaffe, Ph.D. • Developed (and tested) revised accreditation testing protocols and forms • Conducted module pilot test in early 2001 • At the time, GE was only FDA-approved FFDM unit www.acr.org

46. FDA Approved ACR to Accredit GE Senographe 2000D • On December 18, 2002 • Effective February 15, 2003 www.acr.org

47. Accreditation Process for GE FFDM • General process is identical to screen-film • Facilities will be able to have “stand-alone” digital systems (no screen-film required) www.acr.org

48. Facilities with FDA-Approved Units • Currently over 280 GE FFDM units approved by FDA at over 260 facilities • ACR will phase in accreditation of these systems • ACR will contact these FFDM facilities and let them know what to do • ACR does not need to review these units’ Equipment Evaluations (already reviewed by FDA) www.acr.org

49. ACR’s Phase-In Plan

50. Facilities Installing New GE FFDM Units • Contact the ACR ASAP for appropriate accreditation materials • Do not contact FDA www.acr.org