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James O. Westgard University of Wisconsin Medical School Westgard QC, Inc. Madison, WI www.westgard.com
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Objectives
Review principles of industrial risk analysis Identify priorities when applying risk analysis for analytical quality management in medical labs Assess importance of method validation for dealing with safety characteristics Assess importance of Statistical QC for providing known detection capabilities Recognize the advantages of integrating SQC procedures and Risk Analysis control mechanisms in a QC Plan
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Oct 25, 2011: CLSI EP23A Risk Analysis and The Right QC!
The Right QC is what I always do! Why would I do the wrong QC?
(a) Laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytical process. (b) must establish the number, type, and frequency of testing control materials (c 1) The control procedures must detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance; (c 2) Monitor over time the accuracy and precision of test performance
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Manufacturers
ISO 15198 CLSI EP18
CLSI EP22
CLSI C24
CLSI EP23
ISO 22367
Laboratories
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Combine factors
Industry calculates Risk Priority Number Risk = OCC * DET * SEV = RPN Healthcare often use Risk Matrix
SEVERITY - Provide instructions for safe use and precautions for use errors
IVD medical devices have performance characteristics that determine the accuracy of examination results. Failure to meet the performance characteristics required for a specific medical use could result in a hazardous situation that should be evaluated for risk to patients.
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Safety Characteristics performance characteristics that determine the accuracy of IVD devices - precision, trueness or bias, analytical specificity, quantitation limit, etc.
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Estimating the severity of harm requires an understanding of the medical use of the IVD examination results, the analytical performance requirements for each application and the extent to which medical decisions are based on IVD examination results. For this reason, qualified medical input to the risk estimation process is essential.
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Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance (CLIA 493.1256) Perform corrective actions to recover before reporting of test results Provide information for safe use
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For existing IVD medical devices, conventional statistical quality control procedures (e.g., as described in CLSI C24) are considered adequate unless evidence from risk-monitoring activities indicates [other] quality control procedures are essential for maintaining risk at an acceptable level. In that case, the quality control procedures shall be validated.
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3.65
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4.65
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5.65 P fr P ed N R /2of3 /R /3 /6 3s 2s 4s 1s x 0.07 0.07 6 1 1 /2 /R /4 3s 2s 4s 1s 0.03 0.03 4 1 1 2.5s 0.04 0.04 4 1 12.5s 0.03 0.03 13s /22s /R4s 0.01 13s 0.00 1 3.5s 0.00 1 3s 0.00 0.01 0.00 0.00 0.00 2 2 2 2 1 1 1 1 1 1
2.65
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2.0
3.0
4.0
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Expected Events
What changes or failures might occur? What is the probability of failure? What is the severity of harm from a failure? What control mechanisms can be implemented to detect failures?
Unexpected Events
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Quality Control Plan a document that describes the practices, resources, and sequences of specified activities to control the quality of a particular measuring system or test process to ensure requirements for its intended use are met
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Example QC Plan
QCPlan
Analyst/operatorcontrols
StandardOperatingProcedure YearlySOPreview Operatortraining Operatorchecklists Systemmaintenance Operatorcompetency Everyoperator Daily Manuf.Schedule Yearly Manuf. Manuf. Manuf. Manuf./Reg. Startup+Monitor Calibration 3/year Eachsample Directorreview Supervisorreview Supervisorreview Manuf.Repair Retrain Manuf.Instructions Manuf.Instructions Supervisorreview TSguidelines TSguidelines CAplan Repeattest No No No No No No No No No No No Yes 22
Frequency
Recovery
Disclosure
Builtinanalyzercontrols
Electronicchecks Functiontests Processtests Calibrationchecks Manuf.Instructions Samplecondition
Stablecontrolmaterials
StatisticalQC Truenesscontrol PeriodicEQA,PT
Patientdataanalysis
Implausiblevalues
Risk combination of the probability of occurrence of harm and the severity of that harm
OCC - Probability of occurrence of harm is not the same as probability of occurrence of a failure
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What is Occurrence when observe 1 hemolyzed sample per day? Does it make any difference if the lab workload/day is 10 or 1000 samples?
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1 failure with a sample 1 failure with an analytic run 1 failure per shift 1 failure per day 1 failure per bottle of reagent 1 failure per lot of reagent 1 failure per calibration 1 failure per calibration cycle 1 failure per proficiency testing event
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Occurrence 1/What?
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CLSI guidelines simplify risk analysis, but also make it qualitative, subjective, even arbitrary
Laboratories must prioritize activities for defining quality requirements, validating method performance, and selecting SQC procedures to provide a safety net for catching errors
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Risk analysis should be integrated into existing error framework for managing analytical quality of testing processes Development of Analytic QC Plan should complement Statistical QC by adding control mechanisms for specific failure modes
Traditional Statistical QC
QC1 QC2
SQC
QC7
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Laboratory may change these processes more readily than changing analytic processes
Thats my diagnosis!
Dr. Parvin, what do you think? Whats the probability of occurrence of harm?