Presentation on theme: "Luann Ochs, MS Senior Vice President – Operations"— Presentation transcript:
1The New EP23 ‒ Laboratory Quality Control Based on Risk Management, Approved Guideline Luann Ochs, MSSenior Vice President – OperationsClinical and Laboratory Standards Institute
2Objectives Describe the various types of control processes. Identify CLSI document EP23-A as a resource for developing a laboratory quality control (QC) plan based on risk management.Review key aspects of risk management.
3Today’s Quality Control AdvantagesQC monitors the end product (result) of the entire test system.QC has target values: if assay recovers target, then everything is assumed stable (instrument, reagent, operator, sample).DisadvantagesWhen a problem is detected, one must go back and reanalyze patients since last “good” QC.If results are released, then results may need to be corrected.For Point of Care devices, does traditional QC work for every test?Need to get to fully automated analyzers that eliminate errors up frontUntil that time, need a robust QC plan (QCP)3
4Types of Quality Control “On-Board” or Analyzer QC – built-in device controls or system checksInternal QC – laboratory-analyzed surrogate sample controlsExternal QC – blind proficiency surveyOther types of QC – control processes either engineered by a manufacturer or enacted by a laboratory to ensure result reliability4
6Quality Control Limitations No single QC procedure can cover all devices, because the devices may differ.QC practices developed over the years have provided laboratories with some degree of assurance that results are valid.Newer devices have built-in electronic controls, and “on-board” chemical and biological controls.QC information from the manufacturer increases the user’s understanding of device’s overall quality assurance requirements.6
7The Quality Control Toolbox Every QC tool has its strengths and weaknesses (there is no perfect QC tool).Implement a combination of tools in order to properly control a test.EP23 explains the strengths and weaknesses of the different QC processes, and helps the laboratory determine the right combination of tools: The Right QC
8CLSI Document EP23Laboratory Quality Control Based on Risk Management; Approved GuidelineJames H. Nichols, PhD, DABCC, FACB, Chairholder of the document development committeeEP23 describes good laboratory practice for developing a QCP based on the manufacturer’s risk mitigation information, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting.8
9The ScenarioCLSI document EP23 provides guidance on developing an appropriate QCP that will:Save time and money.Use electronic and/or integrated QC features.Use other sources of QC information.Conform to one’s laboratory and clinical use of the test.
10Post-implementation Monitoring Developing a QCPMEASURING SYSTEM INFORMATIONMedicalRequirements forthe Test ResultsRegulatory andAccreditationRequirementsTest System Information- Provided by the Manufacturer- Obtained by the LaboratoryInformation AboutHealth Care andTest Site SettingPROCESSRisk AssessmentOUTPUTQuality Control PlanPROCESSPost-implementation Monitoring
11Measuring System Information Gather information from several sources:Medical requirements for the test resultsAllowable performance specifications via physiciansRegulatory and accreditation requirementsClinical Laboratory Improvement AmendmentsTest/test system informationUser’s manual, reagent package insert, literaturePrior laboratory dataHealth care and testing site settingsTemperature conditions, operator training programs
12Developing a Process Map Break down all phases of the test/test system into steps, so that weak points can be identified.Each step can be analyzed to find potential failure modes that could present significant risk to patients.Process can then be further analyzed to see if controls can be put into place to avoid the failures.
14Developing a Process Map (cont’d) Compile this information.A process map or a fishbone diagram is one example.
15The Risk AssessmentOnce the process map is created, examine it for places where errors could occur.Five major areas:SamplesOperatorReagentsLaboratory environmentMeasuring system
16Key Process StepsPREPARATIONPre-analyticalPre-examinationTESTINGAnalyticalExaminationRESULT REPORTINGPost-analyticalPost-examinationThink about what steps can be taken to reduce errors “unrelated” to the actual testing of the sample.
17Perform the Risk Assessment Identify the potential failures and their causes.Review the process map, fishbone diagram, manufacturer’s instructions, etc.Assess each potential failure.Where a failure could occur, add an element to the QCP that will reduce the possibility of that failure, making residual risk acceptable.For some types of failures, the manufacturer’s information may already have a quality check in place.
18Perform the Risk Assessment “Risk Assessment” and “Risk Management” are formal terms for what you’re already doing.
19Risk DefinitionRisk – the chance of suffering or encountering harm or loss (Webster's Dictionary and Thesaurus. Ashland, OH: Landall, Inc.; 1993).Risk, can be estimated through a combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).Risk, essentially is the potential for an error to occur that could lead to patient/staff harm.19
20Life is a Continual Risk Assessment You assess risk every day,all the time, usually without even thinking about it.
22Assess the Risk of Harm Due to Failures Defective IVD: HazardIncorrect ordelayedtest result:HazardIncorrect ordelayedmedicaltreatment:HazardousSituationInjury or death:Harm
23Perform the Risk Assessment (cont’d) Construct a table; see which types of errors are detected and which ones are not.If not detected, it must be included in the QCP.For each possible failure, assess the likelihood of that failure occurring, and the severity of consequences if it occurs.Do this for each identified failure.Use all of the information gathered in order to make these assessments.
25Frequency (1 – 5) Example (Sometimes called “Probability”) Common TermsRatingExample (ISO 14971)Practical ExampleFrequent5≥ 1/1,000More than 1x/weekProbable4< 1/1,000 and ≥1/10,000Once every few monthsOccasional3< 1/10,000 and ≥1/100,000Once a yearRemote2< 1/100,000 and ≥1/1,000,000Once every few yearsImprobable1< 1/1,000,000 and ≥10,000,000Unlikely to ever happenThe laboratory must decide – and it may be different for different tests!
26Severity (1 – 5) Example Common Terms Rating Possible Description (ISO 14971)Catastrophic5Results in patient deathCritical4Results in permanent injury of life-threatening injurySerious3Results in injury or impairment requiring professional medical interventionMinor2Results in temporary injury or impairment not requiring professional medical interventionNegligible1Inconvenience or temporary discomfort
27Detectability (1 – 5)What is the likelihood that the control process detects or prevents the failure?Common TermsRatingExampleLow5Control is ineffective4Control less likely to detect the failure3Control may or may not detect the failure2Control almost always detects the failureHigh1Control can detect the failure
29Criticality Multiply Frequency x Severity x Detectability Example: Probable (4) x Catastrophic (5) x High likelihood to detect failure (1) = 20CriticalityResultLow<10Mid10 – 20High>20Higher criticality numbers must have quality control actions in place.
30Assemble the Quality Control Plan Use the information gathered earlier to assess all of the identified risks and their control measures.Construct the QCP.Include each of the identified QCP actions in the QCP.
31Monitor QCP for Effectiveness Verify that the QCP that is put in place actually worksContinue to monitor errors and control failures.If an error occurs:Take the appropriate corrective action.Investigate the cause of the error.Once the cause is understood, evaluate whether any changes need to be made in the QCP.
32Monitor QCP for Effectiveness (cont’d) Review any complaints that the laboratory receives from health care providers.These complaints may include pointing out another source of QC “failure” that must be addressed.For patient safety, the QCP should be reviewed and monitored on an ongoing basis to ensure that the QCP is optimal.
33Summary A QCP is necessary for result quality, and each QCP is unique. A QCP is the industry standard. It depends upon the extent to which the device’s features achieve their intended purpose in union with the laboratory’s expectation for ensuring quality results.Once implemented, the QCP is monitored for effectiveness and modified as needed to maintain risk at a clinically acceptable level.
34EP23 Companion Products www.clsi.org Implementation WorkbookRisk Assessment WorksheetPlus – More fully worked examples coming soon