A New Era in Quality Control: Developing an IQCP for Your Laboratory

A New Era in Quality Control: Developing an IQCP for Your Laboratory Gerald A. Capraro, Ph.D., D(ABMM) Medical Director, Clinical Microbiology & Diagnostic Virology Laboratories LSU Health Sciences Center Shreveport September 17, 2015 gcapra@lsuhsc.edu

I have no relevant disclosures.

Objectives: At the conclusion of this lecture, the attendee will be able to: 1. Compare and contrast the current Equivalent Quality Control (EQC) strategy and the new Individualized Quality Control Plan (IQCP) 2. Describe the three components of an IQCP 3. Design an IQCP implementation strategy for his/her own laboratory

New Individualized Quality Control Plan (IQCP) EQC Use if manufacturer QC less rigid than regulation IQCP Use if manufacturer QC less rigid than regulation Transitional Updated Solution (2016) Standardized Rigid Analytic Requires internal QC Decreases external QC Customizable Flexible Pre Post Analytic Does not require internal QC May/may not decrease QC Replaces current EQC language in CLIA regulations as of January 1, 2016

Mandatory or Voluntary? IQCP is voluntary for laboratories Current CLIA control default regulations continue to be in effect: Pos & Neg QC each test day for qualitative tests 2 levels of QC each test day for quantitative tests EQC (based on using internal controls; weekly QC; shipment/lot QC; etc.) will be discontinued and will no longer be an acceptable QC option under CLIA in January 2016 The laboratory must choose to: follow CLIA default QC regulations, OR develop an IQCP

3 Components of IQCP 1. Risk Assessment Collect Data identify potential sources of error/failures in pre-analytical, analytical, and post-analytical phases of laboratory testing Assess the frequency of occurrence of the error and the potential harm from the error 2. Quality Control Plan Defines the mechanisms in place for detecting, controlling, or preventing errors Defines the QC acceptability criteria 3. Quality Assessment Designed to monitor the effectiveness of the QCP

Risk Assessment Identify the sources of potential failures and errors associated with the test system Evaluate the frequency of failures/errors Evaluate the impact due to failures/errors

Risk Assessment CMS-defined Risk Assessment Components Specimen Patient preparation, collection, labeling, storage preservation, stability, transportation, processing, acceptability, referral Test System Inadequate sampling, clot detection, detecting interfering substances, calibration issues, mechanical/electronic failure, optics, pipettors, bar code readers, function checks, built-in controls, external controls, temperature monitors/controllers, software/hardware, transmission of data to LIS, result reporting Reagent Shipping/receiving, storage, expiration dates, preparation Environment Temperature, airflow/ventilation, light intensity, humidity, altitude, dust, water, utilities, space Testing Personnel Training, competency, education, experience, staffing

Risk Assessment The resulting Risk Assessment is then used to develop the Quality Control Plan (How you will control for these risks)

Quality Control Plan A document/process/plan that describes the practices, resources, and procedures used to control the quality of a test system. Control all phases of testing specimen collection performance result reporting Must monitor the accuracy and precision of test performance Include the number, type, and frequency of QC Define criteria for acceptability of QC

Quality Assessment The laboratory must establish a review system for the on-going monitoring of the effectiveness of their QCP. The monitoring should include all 5 Risk Assessment Components (part of our RA): specimens, test system, reagents, environment, testing personnel When the laboratory discovers a testing process failure or error it must: conduct and document an investigation to identify the cause of the failure/error, determine its impact or harm, and

Implementation of IQCP Until December 31, 2015: Laboratories may use CLIA QC regulations (QC each day of testing), EQC, or IQCP By January 1, 2016: Laboratories must follow CLIA QC regulations (QC each day of testing) or IQCP* (no more EQC) All new and existing test systems must be in compliance *NOTE: Your IQCP must include testing of QC at least as stringent as recommended by the manufacturer.

Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System

Risk Assessment Collect Information Manufacturer instructions Look specifically at the Limitations section to identify possible risks. Note manufacturer recommended QC (IQCP may not include QC that is less than that recommended by the manufacturer). Include a copy of your manufacturer s instructions in your IQCP materials. Manufacturer performance data Look for any risks associated with this system that have been identified in the manufacturer s performance data. Include copy in your IQCP materials. Literature published on assay Look for any risks/concerns associated with this system that have been identified in the literature. Include copies of pertinent articles in your IQCP materials. Accreditation/Regulatory requirements Ensure that your IQCP will be in compliance with any accreditation or regulatory requirements. Include copies of these requirements in your IQCP materials. Individual laboratory data available Review your verification (initial and any subsequent studies) and historical QC data to help define your IQCP. Include these data in your IQCP materials, or identify where this data can be found in the laboratory.

Historical data - Summary Historical Quality Review: QC data for the past 32 months (1/1/13-8/31/15) was reviewed. Testing was performed as outlined in the Clostridium difficile Quik Chek Complete Rapid Membrane Enzyme Immunoassay procedure found in the Bacteriology Test Manual. Our data showed: 0 occurrence of random QC errors involving the internal built in procedural controls that are a part of each test device. The appearance of the blue control dots on each test device confirms that the sample and reagents were added correctly, that the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. 0 occurrence of potential system QC errors that required corrective action involving external quality control testing.

Risk Assessment Conduct RA Identify where along the testing process risk/errors might occur. Determine the frequency of the error and the potential impact if an error would occur. Must include pre-analytical, analytical, and post-analytical areas of laboratory testing. Must include the 5 Risk Assessment Components (CMS): 1. Specimen 2. Testing Personnel 3. Reagent 4. Environment 5. Test System

Risk Evaluation For Severity of harm to the patient: Negligible: Inconvenience or temporary discomfort Minor: Temporary injury; not requiring medical intervention Serious: Impairment/injury requiring medical intervention Critical: Permanent impairment or life-threatening injury Catastrophic: results in patient death For Frequency of occurrence: Frequent: once per week Probable: once per month Occasional: once per year Remote: once every few years Improbable: once in the life of the system All risks need to have control measures in place.

Risk Assessment Conduct RA Identify where along the testing process risk/errors might occur. Determine the frequency of the error and the potential impact if an error would occur. Must include pre-analytical, analytical, and post-analytical areas of laboratory testing. Must include the 5 Risk Assessment Components (CMS): 1. Specimen 2. Testing Personnel 3. Reagent 4. Environment 5. Test System

Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System

Quality Control Plan (QCP) Identify Measures to Control/Reduce Risk Build tables to include all of the risks identified in your risk assessment. Determine the frequency and impact for each risk identified. Indicate the measures you have in place to reduce/control these risks/errors. Include where to find these measures in your procedures, reports, logs, etc. Must also include: QC Testing frequency, amount, type Criteria for QC acceptability At least as stringent as the manufacturer s instructions May also include electronic QC, procedural QC, training, competency assessment, etc.

1$$$Specimen$X$$$PreXAnalytical$ 1$ SPECIMEN FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ PreviousTesting Within7Days Frequent Negligible Repeattestingiscontraindicated; Thistestisnotatestof cure; Specimensarerejectedwith documentationrecordedafter physician/designeenotification. Followtestingprotocol andguidelinesinprocedure Clostridium+difficileEIA TestProcedure BacteriologyTestManua SpecimenRejectionLog ProblemLogBook Unacceptable/Suboptima SpecimenProcedure LabGeneralP&IManua Collection/ Container Frequent Negligible Minor Specimensimproperlycollectedin preservativeswillcause invalidtestresults. Specimensreceivedthatarein preservatives(formalinorpva)are rejectedwithdocumentationrecorded afterphysician/designeenotification. Followtestingprotocol andguidelinesinprocedureand AlerePackageInsert(PI) Clostridium+difficileEIA TestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Unacceptable/Suboptimal SpecimenProcedure LabGeneralP&IManual SpecimenRejectionLog Specimen Transport Frequent Negligible Minor Specimensreceivedthataretooold willcauseinvalidtestresults. Specimensreceivedthatareover24 hoursoldarerejectedwith documentationrecordedafter physician/designeenotification. Followtestingprotocol andguidelinesinprocedureandpi Clostridium+difficileEIATest Procedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Unacceptable/Suboptimal SpecimenProcedure LabGeneralP&IManual SpecimenRejectionLog

2$$$Testing$Personnel$X$$$Analytical$ 2$$$TESTING$ PERSONNEL FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Personnel Qualifications Remote Minor Serious Onlylicensedandcertifiedstaffare hiredforpatienttestingandallowed toperformmoderatetohigh complexitytestsperclia. UHJobDescriptions UHHumanResources NewEmployee Orientation StaffingPolicy LabGeneralP&IManua Training Remote Minor Serious Newoperatorsaretrainedand deemedcompetentbefore beingreleasedtoperform andreportpatienttesting. Annuallyalloperatorsmustcomplete acompetencyassessmenttocontinue totestandreportpatientspecimens. SOPandPIareavailable atalltimestostaff. Operatorstestproficiencytesting samplesonarotationalbasis. CompetencyAssessment AdministrativeandSafety ProceduresManual Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook CAPProficiencyTesting MicroPTBook CompetencyAssessment Guidelines LabGeneralP&IManual ColorVisionRecords CompetencyBook

2$$$TESTING$ PERSONNEL FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Personnel Errors Probable Minor Serious Allerrorsareproperlydocumented withphysician/designee notificationpersop. Allpersonnelerrorsare distributedweeklybythelis departmentandreviewed withstaffanddocumented. CorrectiveActionReport QualityAssessmentPlan AdministrativeandSafety ProceduresManual SeparateandDistribute CorrectedResultsLog LISClerical ProcedureManual PolicyforCorrectedor ErroneousResults LISPolicyand InformationManual CorrectedResultsLog Competency Probable Minor Serious Annuallyalloperatorsmustcomplete acompetencyassessmenttocontinue totestandreportpatientspecimens Operatorstestproficiencytesting samplesonarotationalbasis. CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook CAPProficiencyTesting MicroPTBook

2$$$TESTING$ FREQUENCY$OF$ PERSONNEL OCCURRENCE$ SEVERITY$OF$$ HARM$ QualityControl Remote Minor Serious Proficiency Testing Remote Negligible MEASURES$TO$$ CONTROL$/REDUCE$RISK$ Eachtestdevicehasabuiltin proceduralinternal controlthatis recordedwitheachtestrun. Notestresultsarereported outwithoutverifyingthat theinternalcontrolisvalid. InvalidinternalQCtestsarerepeated andasupervisorisnotified DocumentedinternalQCtest resultsandexternaltesting QCare monitoredweeklyandmonthly. Newlotsandshipmentsaretested withexternalcontrolstoverify accuracybeforebeingused toreportoutpatientresults. Operatorstestproficiencytesting samplesonarotationalbasis. Allstaffreadandsignoff onptsamplecritiques. RELEVANT$ SOP$ Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook QualityControl Procedure QualityAssurance ProceduresManual C.+difficileQCBook MicroPTPolicy CAPProficiencyTesting MicroPTBook

3$$$REAGENT$ FREQUENCY$OF$ INTEGRITY OCCURRENCE$ 3$$$Reagent$ $Analytical$ SEVERITY$OF$$ HARM$ Storage Remote Serious ExpirationDate Remote Serious MEASURES$TO$$ CONTROL$/REDUCE$RISK$ Kitsarestoredatthespecified temperatureaccordingtothe manufacturer sprecautions inthepackageinsert. Stafftrainedtostoresuppliesatthe properstoragetemperature Refrigeratortemperaturemonitored anddocumentedondailylog. Expirationdatesofallsupplies receivedarerecordeduponreceipt inordertopreventanexpired kitbeingputintoinventory. Stafftrainedtocheckkitandreagent expirationdatebeforeuse. Theexpirationdateisdocumented witheachtestruninordertoprevent incorrectresultsbeingreported. Staffbiweeklychecks expirationdateofallsupplies. RELEVANT$ SOP$ Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook QualityControl Procedure QualityAssurance ProceduresManual TemperatureLogBook Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Schedulefor QualityControl QualityControlProcedure QualityAssurance ProceduresManual BiweeklyInventoryBook CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook

5$$$$$$$$TEST$ SYSTEM FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Internal procedural control Improbable Minor Serious Testdeviceshaveabuiltininternal controlthatconfirmsthatthesample andreagentswereaddedcorrectly, thatthereagentswereactiveatthe timeofperformingtheassay,andthat thesamplemigratedproperlythrough themembranedevice. Italso confirmsthereactivityoftheother reagentsassociatedwiththeassay. Builtincontrolareaandlinewill detectreagentdeterioration Weeklypos/negexternalQCcontrols checkforkitreagentreactivity Kitsarenotusedpasttheexpiration dateofthekitand/orreagents Lotandexpirationdatesarerecorded witheachtestrun. Stafftrainedtocheckkitandreagent expirationdatesbeforeuse. Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook C.+difficileQCBook BiweeklyInventoryLog CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook

6$$$$$$$$TEST$ RESULT FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ DataEntryintoLIS Probable Minor Serious Staffaretrainedtorecordresultsinto thedirectexamlogbookas wellasinthelis. Resultsarerecordedinorderto reduceclericalerrorswhilemanually enteringresultsintothelis. Resultsareinterpretedperthe manufacturer s packageinsert andthetestprocedure. Dataentryerrorsarecorrectedper policywithphysician/designee notificationdocumented. Allpersonnelerrorsare distributedweeklybythelis departmentandreviewed withstaffanddocumented. Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook CompetencyAssessment CorrectiveActionReport QualityAssessmentPlan AdministrativeandSafety ProceduresManual SeparateandDistribute CorrectedResultsLog LISClerical ProcedureManual PolicyforCorrectedor ErroneousResults LISPolicyand InformationManual DirectExamBook CompetencyBook CorrectedResultsLog

6$$$$$$$$TEST$ RESULT FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ CriticalValue Reporting Probable Minor Serious Staffaretrainedtonotifythe physician/designeeonall positivetestresults. Staffaretrainedtonotify InfectionControlonallinpatient positivetestresults. Allphonenotificationsarehighlighted toprintoutonthelab sdaily criticalvaluereport CompetencyAssessment Contactand NotificationGuides AdministrativeandSafety ProceduresManual SignificantFindingsBook Clinician Complaints Occasional Serious Allcliniciancomplaints/concernsare investigatedandfollowedupon regardingdelayedresults,testing errors,andtestingprotocols Newriskswillbeincorporatedinto QCPplanasappropriate QualityAssessmentPlan AdministrativeandSafety ProceduresManual ComplaintForm MicroFormsManual $ $

Based on our: Risk Assessment Quality Control Program Overall Laboratory Quality Assessment program The QCP for our C. difficile EIA System will consist of adhering to the instructions in the C. difficile EIA SOP and recording results in the C. difficile QC Log Book QC will consist of: Testing the internal procedural control on each run. Testing positive and negative external controls on each new lot or shipment (based on review of historical QC data). QC Acceptability Criteria is defined in SOP Quality Control Procedure located in the Quality Assurance Procedures Manual found online on the MCN Healthcare website lsuhsc.ellucid.com.

Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System

Quality Assessment Develop a Post-Implementation Monitoring Process that will allow you to know when a process is in need of review/revision. These may include the periodic review and monitoring of the following (not limited to these): Specimen collection/transportation, etc. protocols Staff training Competency assessment Proficiency testing Quality Control/Instrument function results Unexpected Errors Laboratory error investigation/remediation Complaint investigation/remediation Pre-analytical Analytical Post-analytical

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