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 (% of facilities with highest level findings) L 1 L 2L 3No Finding FY952.619.847.430.0 FY961.512.442.243.7 FY970.912.430.755.8 FY981.118.721.658.4 FY991.623.516.258.5 FY003.932.610.353.0 FY01*3.528.010.158.2 (to 7/31/01)

7. Inspection Findings by Level - FY 95 to FY 01 (% of facilities 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 2L 3No Finding FY99 (total)1.623.516.258.5 FY99 (I)0.918.918.361.7 (Q1-Q3) FY99 (F)3.636.810.149.2 (Q4)

11. % of Facilities w/L1 Findings - FY 99 --- FY 99 total (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 00 total (3.9%)

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

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

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

19. Facilities with Level 1 Findings Recent Results (10/1/00 - 7/2/01) Number % L1 Findings (facilities cited)2453.5 Processor or Phantom QC1592.3 Results Communication570.8 Initial Qualifications - Any Personnel 340.5 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 QC86212.6 L2 Requirements - Any Personnel6028.8 Med. Reports w/o Results/ID4676.8 Med. Outcomes Audit System2273.3 Survey Rep. & MEE2994.4 No S.O.P. Consumer Complaints1992.9 No S.O.P. Infection Control1101.6 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