Meaningful Metrics Scorecard Sampling Pilot

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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CDRH Strategic Plan 2000 - 2005

MEANINGFUL METRICS SCORECARD SAMPLING PILOT

George Koustenis
Debra Adams
Phil Frappaolo
Don Marlowe
Larry Kessler

PURPOSE OF PILOT

To Determine if We Can Utilize a Representative Sample of the ~3000 Class I and Class II Exempt Facilities of Interest to Maximize Field and HQ Resources in Adhering to Mandates

SAMPLE PARAMETERS

From the Field
History
Class III
18 Percent OAI

DRAWING THE SAMPLE

Create Master List
Random Number Generator
Sample Without Replacement
Proportional to District Breakdown

STATISTICAL ISSUES

N = 80
Alpha = .05
Beta = .1
Power = 90%

PRIMARY RESULTS BASED ON FIELD REPORTS

ACTION	FREQUENCY	PERCENT
NAI	43	53.75
VAI	27	33.75
OAI	10	12.50

Class I Top Ten Industry Scorecard Deficiencies N = 83

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PRACTICAL RESULTS

WHAT DOES IT MEAN?
WHAT CAN WE SAY AND NOT SAY ABOUT THE DATA?

NEXT STEPS

WORKING WITH FIELD AS A TEAM
FURTHER SAMPLES AS A TEST
IMPLEMENTATION OF SAMPLING FOR THE FUTURE

THANKS - GREAT JOB

END OF PILOT & DATA COLLECTION!!

Q&A

Return to Strategic Planning Page

Updated February 11, 2004

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