OVERVIEW OF MQSA INSPECTION FINDINGS 8/22/01 Walid G. Mourad, Ph.D., CSO Inspection Support Branch...
-
Upload
kate-northrup -
Category
Documents
-
view
239 -
download
0
Transcript of OVERVIEW OF MQSA INSPECTION FINDINGS 8/22/01 Walid G. Mourad, Ph.D., CSO Inspection Support Branch...
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 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)
Inspection Findings by Level - FY 95 to FY 01
(% of facilities with highest level findings)
0.0
10.0
20.0
30.0
40.0
50.0
60.0
95 96 97 98 99 00 01*
Level 1
Level 2
Level 3
No Findings
* FY to 7/31/01
% 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)
% of Facilities w/L1 Findings - FY 99
012345
Q1-99 (I) Q2-99 (I) Q3-99 (I) Q4-99 (f)--- 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
% of Facilities w/L2 Findings FY 00
0
5
10
15
20
25
30
35
Q1-00 Q2-00 Q3-00 Q4-00
--- FY 00 total (32.6%)
% of Facilities w/L1 Finding FY 01
--- FYTD 01 total (3.5%)
012345
Q1-01 Q2-01 Q3-01 Q4-01** (to 7/31)
% of Facilities w/L2 Findings FY 01
05
101520253035
Q1-01 Q2-01 Q3-01 Q4-01*
--- 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) 245 3.5
Processor or Phantom QC 159 2.3
Results Communication 57 0.8
Initial Qualifications - Any Personnel 34 0.5
Other < 9 < 0.1No 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) 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 < 45 < 0.7Unaccredited 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