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  L1 & L2 FINDINGS - The last two years  PROGRAMS UNDERWAY

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

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

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

Inspection Findings by Level - FY 95 to FY 01 (% of facilities with highest level findings) L 1 L 2L 3No Finding FY FY FY FY FY FY FY01* (to 7/31/01)

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

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

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

% of Facilities w/Highest Finding Levels FY 99 L 1 L 2L 3No Finding FY99 (total) FY99 (I) (Q1-Q3) FY99 (F) (Q4)

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

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

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

Number of Potential Findings

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

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

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

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

Facilities with Level 1 Findings Recent Results (10/1/00 - 7/2/01) Number % L1 Findings (facilities cited) Processor or Phantom QC Results Communication570.8 Initial Qualifications - Any Personnel Other< 9< 0.1 No Valid Certificate Unaccredited Unit in Use for => 1y Phantom score Underprocessing (STEP test) No Survey for 2 years

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

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

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

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