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OVERVIEW OF MQSA INSPECTION FINDINGS

OVERVIEW OF MQSA INSPECTION FINDINGS. 8/22/01 Walid G. Mourad, Ph.D., CSO Inspection Support Branch DMQRP/OHIP/CDRH/FDA. OVERVIEW OF MQSA INSPECTION FINDINGS. BACKGROUND FINDING LEVEL DISTRIBUTION - Historical Perspective INSPECTION FINDINGS - Final Regulations

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OVERVIEW OF MQSA INSPECTION FINDINGS

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  1. OVERVIEW OF MQSA INSPECTION FINDINGS 8/22/01 Walid G. Mourad, Ph.D., CSO Inspection Support Branch DMQRP/OHIP/CDRH/FDA

  2. OVERVIEW OF MQSA INSPECTION FINDINGS • BACKGROUND • FINDING LEVEL DISTRIBUTION - Historical Perspective • INSPECTION FINDINGS - Final Regulations • L1 & L2 FINDINGS - The last two years • PROGRAMS UNDERWAY

  3. BACKGROUND • MQSA (10/92) • Interim Regulations (10/94) • Final Regulations (published 10/97, effective 4/99) • MQSRA (10/98) • Lay summary to all women • Release of original mammogram • Demonstration Program – Inspection Frequency

  4. Inspection Scope • Equipment performance including dose, phantom image, processing, & darkroom fog • Quality assurance & quality control test records (including survey report & mammography equipment evaluations) • Consumer complaint mechanism • Personnel qualifications • Medical reports and lay summaries • Medical outcomes audit

  5. MQSA Finding Levels • Level 1 • Serious - Warning Letter within 15 days & subsequent facility response within 15 days • Level 2 • Moderate - 30 day response • Level 3 • Minor - Follow up at next inspection

  6. Inspection Findings by Level - FY 95 to FY 01 (% offacilities with highest level findings) L 1 L 2 L 3 No Finding FY95 2.6 19.8 47.4 30.0 FY96 1.5 12.4 42.2 43.7 FY97 0.9 12.4 30.7 55.8 FY98 1.1 18.7 21.6 58.4 FY99 1.6 23.5 16.2 58.5 FY00 3.9 32.6 10.3 53.0 FY01* 3.5 28.0 10.1 58.2 (to 7/31/01)

  7. Inspection Findings by Level - FY 95 to FY 01 (% offacilities with highest level findings) * FY to 7/31/01

  8. % of Facilities w/L1 Findings - FY95-FY01 * (to 7/31)

  9. % of Facilities w/L2 Findings - FY95-FY01 * (to 7/31)

  10. % of Facilities w/Highest Finding Levels FY 99 L 1 L 2 L 3 No Finding FY99 (total) 1.6 23.5 16.2 58.5 FY99 (I) 0.9 18.9 18.3 61.7 (Q1-Q3) FY99 (F) 3.6 36.8 10.1 49.2 (Q4)

  11. % of Facilities w/L1 Findings - FY 99 --- FY 99total (1.6%)

  12. Inspection Findings Under the Final Regulations • Level Changes & Consequences • L 1 & L 2 Findings ~ Two Year Results • Future Trend

  13. Final Regulations - Perspective For the final regulations, FDA: • Added new requirements  new findings at all levels • Elevated several L3 & L2 findings • Deleted several L3 findings As a result… • L3 findings decreased • L2 & L1 findings increased

  14. Number of Potential Findings

  15. % of Facilities w/L1 Findings FY 00 --- FY 00total (3.9%)

  16. % of Facilities w/L2 Findings FY 00 --- FY 00total (32.6%)

  17. % of Facilities w/L1 Finding FY 01 * (to 7/31) --- FYTD 01total (3.5%)

  18. % of Facilities w/L2 Findings FY 01 * (to 7/31) --- FY 00total (28%)

  19. Facilities with Level 1 FindingsRecent Results (10/1/00 - 7/2/01) Number % L1 Findings (facilities cited) 2453.5 Processor or Phantom QC 159 2.3 Results Communication 57 0.8 Initial Qualifications - Any Personnel 34 0.5 Other < 9 < 0.1 No Valid Certificate Unaccredited Unit in Use for => 1y Phantom score Underprocessing (STEP test) No Survey for 2 years

  20. Facilities with Level 2 Findings (as highest)Recent Results (10/1/00 - 7/2/01) Number % L2 Findings (facilities cited) 189927.6 Processor or Phantom QC 862 12.6 L2 Requirements - Any Personnel 602 8.8 Med. Reports w/o Results/ID 467 6.8 Med. Outcomes Audit System 227 3.3 Survey Rep. & MEE 299 4.4 No S.O.P. Consumer Complaints 199 2.9 No S.O.P. Infection Control 110 1.6 Other < 45 < 0.7 Unaccredited Unit in Use for < 1y Phantom score Underprocessing (STEP test)

  21. FUTURE TREND Based on experience to date, we believe that in the foreseeable future (~ 1 year) … • % Facilities with L1citations < 2.5 • % Facilities with L2 citations < 25.0 • % Facilities with L3 citations < 10.0

  22. PROGRAMS UNDERWAY • Demonstration Program • Scheduled to start May 2002 • About 300 eligible facilities (14 states) in the pool • ~ 150 will be inspected once in 2 years • New Mammographic Modality – FFDM • Currently only GE’s Senographe 2000D (since 6/00) - others expected in the near future • Small number of facilities & units • 8 hours training in FFDM are the only citations implemented to date

  23. ...for more Information on MQSA • MQSA Internet home page: http://www.fda.gov/cdrh/mammography • MQSA facility hotline: 1-800-838-7715 • (DSMA) Facts on Demand: 1-800-899-0381

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