OVERVIEW OF MQSA INSPECTION FINDINGS

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OVERVIEW OF MQSA INSPECTION FINDINGS

• 8/22/01
• Walid G. Mourad, Ph.D., CSO
• Inspection Support Branch
• DMQRP/OHIP/CDRH/FDA

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OVERVIEW OF MQSA INSPECTION FINDINGS

• BACKGROUND
• FINDING LEVEL DISTRIBUTION - Historical
  Perspective
• INSPECTION FINDINGS - Final Regulations
• L1 L2 FINDINGS - The last two years
• PROGRAMS UNDERWAY

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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

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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

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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

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Inspection Findings by Level - FY 95 to FY 01
( of facilities 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)

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Inspection Findings by Level - FY 95 to FY 01
( of facilities with highest level findings)
FY to 7/31/01
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of Facilities w/L1 Findings - FY95-FY01
(to 7/31)
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of Facilities w/L2 Findings - FY95-FY01
(to 7/31)
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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)

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of Facilities w/L1 Findings - FY 99
--- FY 99 total (1.6)
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Inspection Findings Under the Final Regulations

• Level Changes Consequences
• L 1 L 2 Findings Two Year Results
• Future Trend

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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

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Number of Potential Findings
15
of Facilities w/L1 Findings FY 00
--- FY 00 total (3.9)
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of Facilities w/L2 Findings FY 00
--- FY 00 total (32.6)
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of Facilities w/L1 Finding FY 01
(to 7/31)
--- FYTD 01 total (3.5)
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of Facilities w/L2 Findings FY 01
(to 7/31)
--- FY 00 total (28)
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Facilities with Level 1 Findings Recent Results
(10/1/00 - 7/2/01)

• Number
• L1 Findings (facilities cited) 245 3.5
• Processor or Phantom QC 159 2.3
• Results Communication 57 0.8
• Initial Qualifications - Any Personnel 34 0.5
• Other lt 9 lt 0.1
• No Valid Certificate
• Unaccredited Unit in Use for gt 1y
• Phantom score
• Underprocessing (STEP test)
• No Survey for 2 years

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Facilities with Level 2 Findings (as highest)
Recent Results (10/1/00 - 7/2/01)

• Number
• L2 Findings (facilities cited) 1899 27.6
• 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 lt 45 lt 0.7
• Unaccredited Unit in Use for lt 1y
• Phantom score
• Underprocessing (STEP test)

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FUTURE TREND

• Based on experience to date, we believe that in
  the foreseeable future ( 1 year)
• Facilities with L1citations lt 2.5
• Facilities with L2 citations lt 25.0
• Facilities with L3 citations lt 10.0

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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 GEs 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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...for more Information on MQSA

• MQSA Internet home page
• http//www.fda.gov/cdrh/mammography
• MQSA facility hotline [phone]
• (DSMA) Facts on Demand 1-800-899-0381