A Quality System Approach To POCT - Whitehat

Point-of-Care TestingCharacteristicsA broad based process.Unrestricted to location,personnel or test menu.A collective, multidisciplinaryeffort.Simple to use technologyPotentially low volumetesting

POCT versus Central Lab TestingCentral LabPOCTTesting personnelPathologists,, PhDs,Med. LabTechnologistsNurses, other caregiversPrimary duties Laboratory testing Patient careKnows laboratory testing Extensive MinimalUnderstands instrument’squality checksExtensiveMinimalCan interpret QC data Yes Probably notSkills to resolve problems,troubleshootingYesRecognizes quality testing Yes Not necessarilyNo

Potential Analytes for POCTBilirubinBlood GasesBUNCardiac MarkersCBCChloesterol/TrigsDrugsFecal Occult BloodGastric Occult BloodGlucoseGram StainsHgB/HctHgB A1CInfectious DiseasesLactateNa, K, Ca ++ , Cl, Mg ++O 2 SatPlatelet FunctionPregnancyPT/PTT/ACTUrinarymicroalbumin/creatinineUrinalysis/Specific Gravity

Point-of-Care Tests (POCT) NOT considered laboratory testing– Breath alcohol– Continuous glucose monitors– Pulse oximeters– Transcutaneous bilirubinometers– Ex vivo ABG– Biosensor Technologies (monitors)

Trends in Healthcare ProvisionPOCTLaboratoryHomePrimaryCareCentreCommunityTreatmentCentreLocalHospitalReferral/SpecialistHospital

The Truth about POCT POCT introduces an additional technology– Different precision– Biases– Unique interferences POCT results do not necessarily agree with corelaboratory results Quality concerns if manufacturers instructionsand controls are not performed as required Additional testing is ordered when POCT resultsdo not match core lab results or questions aboutthe quality of results present

Growth in POCT2008 Worldwide IVD Market -$42.1 Billion (46B in 2010)2008 Worldwide POCT Market -$13.1 Billion (31%)2010 Worldwide ProfessionalPOCT Market - $4 Billion ~10-12% annual growth

Moderators of POCT Growth Quality Assurance Quality Control - Matrix/Electronic Regulatory Requirements Record Keeping/Data Management Finances

What is Quality Laboratory– Delivery of test results within a specific timeframe with specifiedprecision and accuracy Physician– Reliable test results that meet medical needs PatientTHE CORRECT RESULT, ONTHE CORRECT PATIENT,REPORTED IN THE CORRECTTIMEFRAME TO EFFECTPATIENT MANAGEMENT– A test that tells the physician what is wrong Manufacturer– Stable test systems which perform within required accuracy andprecision specifications

Quality Issues There is no “perfect” device, otherwise we wouldall be using it. Any device can and will fail under the rightconditions. Any discussion of risk must start with what cango wrong with a test (errors). Laboratory tests are not foolproof.

Quality SystemOrganizational structure, resources, policies,processes and procedures needed to implementquality management(ISO, NCCLS)In other words… all activities which contribute to qualityof testing, directly or indirectly.

Quality AssuranceAll planned and systematicactions necessary to provideadequate confidence that goodsor services will satisfy thecustomer’s needs.

POC Testing Knowledge FlowHealth CareProviderDeterminesNeed for DataData entryinto LISSampleObtainedSample ProcessedAt POCSampleReceived &Processed inLabSampleTransportedTo Satellite Lab

POCT Quality Assurance DilemmaDue to the rapid availability of resultswith POCT, data can often be seenand acted upon prior to any QAchecks or other external mechanismsfor assuring test results can be appliedto these systems.

What is RiskCombination of the probability ofoccurrence of harm and the severity ofthat harm (ISO/IEC Guide 51).

Risk AcceptabilitySeverity of HarmProbability of Harm Negligible Minor Serious Critical CatastrophicFrequent unacceptable unacceptable unacceptable unacceptable unacceptableProbable acceptable unacceptable unacceptable unacceptable unacceptableOccasional acceptable acceptable acceptable unacceptable unacceptableRemote acceptable acceptable acceptable acceptable unacceptableImprobable acceptable acceptable acceptable acceptable acceptableCLSI. Laboratory Quality Control Based on RiskManagement; Approved Guideline. EP23-A.Wayne, PA: Clinical and Laboratory StandardsInstitute; 2011.

Quality Control Operational techniques and activities usedto fulfill requirements for quality (ISO) Internal quality control (IQC) – set ofprocedures for continuously assessinglaboratory work and the emergent results;immediate effect, should actually controlrelease of results (WHO, 1981)

Process to Develop and Maintain (CQI)a Quality Control Plan (QCP)MEASURING SYSTEMINFORMATIONMedicalRequirements forthe Test ResultsRegulatory andAccreditationRequirementsMeasuring System Information● Provided by the Manufacturer● Obtained by the LaboratoryInformation AboutHealth Care andTest Site SettingPROCESSRisk AssessmentCorrectiveandPreventiveAction andContinualImprovementOUTPUTQuality Control PlanPROCESSPostimplementation MonitoringCLSI. Laboratory Quality Control Based on Risk Management;Approved Guideline. EP23-A. Wayne, PA: Clinical andLaboratory Standards Institute; 2011.

Key Processes in the LaboratoryPath of WorkflowPreexamination(Preanalytical)Processes• Examinationordering• Sample collection andlabeling• Sample transport• Sample receipt andaccessioning• Preexaminationsample processingExamination(Analytical)Processes• Examination• Results review andfollow-up• Medical reviewPostexamination(Postanalytical)Processes• Results reporting• Results archiving• Sample archiving• Charging forexaminations, whereapplicableCLSI. Laboratory Documents: Development and Control;Approved Guideline—Fifth Edition. GP02-A5. Wayne, PA: Clinicaland Laboratory Standards Institute; 2006.

Quality System HierarchyTQMQualityManagementQuality SystemsQuality AssuranceQuality Control

POCT as a TQM Project Multidisciplinary team approach Looking at entire system, rather thanindividual performance On-going evaluation & refinement(CQI) Cost savings Improvement in delivery of criticallaboratory services

Quality Management System ModelLaboratory’s Path of WorklowPreanalytical Analytical PostanalyticalQSEs encompass the entire path

Quality Service Essentials (QSEs)Facilities&SafetyDocuments&RecordsEquipmentCustomerServiceInformationManagementProcessControlQualitySystemProcessImprovementAssessmentsExternal &InternalOrganizationPersonnelPurchasing&InventoryOccurrenceManagement

Quality Service Essentials (QSEs)EquipmentProcessImprovementFacilities&SafetyTheLabOrganizationCustomerServiceMeasurmentOccurrenceManagementPersonnelPurchasing&InventoryDocuments&RecordsAssessmentsExternal & InternalTheWorkProcessControlInformationManagement

Quality of Health Care in U.S. Institute of Medicine– Medical errors cause 44,000 to 98,000 deaths eachyear» Equivalent to 200 deaths each day in airline crashes» Fifth leading cause of death in U.S.Ahead of diabetes, breast cancer, HIV» Lab testing certainly contributes to deathsLab is looking for built-in safeguards to preventerrorsTo Err is Human: Building a Safer Health System.Washington, DC, National Academy Press; 2000

Laboratory TestingPotential Sources of ErrorspatientTransmitresultRecordresultPreparerequestformPhlebotomydoctorReportresultTransportsampleValidateresultQualitycontrolAnalysesamplePreparesampleRegistersample

Sources of Testing Error1997 2007Preanalytical 68% 62%Analytical 13% 15%Postanalytical 19% 23%Plebani M, Carraro P, Clin Chem 1997;43:1348-1351Carraro P, Plebani M, Clin Chem 2007;53;1338-1342

Potential Impact of POCT onLaboratory ErrorsPre-AnalyticalPatient IdentificationSpecimen IdentificationImproper result validation (QC)Post-AnalyticalRoutingExcessive turn-around timeAnalyticalMethod CalibrationInterferencesResults out of measurement rangeQuality Assessment (EQA/PT)

Fishbone Diagram of PotentialFailure Modes1Samples2Operator4Laboratory EnvironmentSample Integrity- Lipemia- Hemolysis- Interfering subtances- Clotting- Incorrect tubeSample Presentation- Bubbles- Inadequate volumeIdentify Potential HazardsOperator Capacity- Training- CompetencyReagent Degradation- Shipping- Storage- Used past expiration- PreparationQuality Control Material Degradation- Shipping- Storage- Used past expiration- PreparationOperator staffing- Short staffing- Correct staffing3ReagentsAtmospheric Environment- Dust- Temperature- HumidityCalibrator Degradation- Shipping- Storage- Used past expiration- PreparationUtility Environment- Electrical- Water quality- Pressure5MeasuringSystemInstrument Failure- Software failure- Optics drift- Electronic instabilityIncorrect Test ResultInadequate Instrument Maintenance- Dirty optics- Contamination- ScratchesCLSI. Laboratory Quality Control Based on Risk Management;Approved Guideline. EP23-A. Wayne, PA: Clinical andLaboratory Standards Institute; 2011.

Sources of Quality Errors in POCTPostanalytical3%Analytical65%Preanalytical32%N = 225

POCT Quality Errors by TestTest Type # of Tests # of defects % of defectsBlood gas/electrolytes 22,687 119 0.52Blood gas/electrolytes/troponin I5,809 10 0.17Pregnancy 8,879 14 0.158Glucose 30,389 71 0.02Drugs of Abuse 247 1 0.4Hb A1c 1,236 8 0.65Urinalysis 64,370 2 0.003Blood Ketones 1,087 0 0O’Kane M, et al, Clin Chem 2011;57:1267-1271

Impact of POCT ErrorsScoreAcutaln (%)Potentialn (%)1 116 (51.2) 6 (2.7)2 109 (48.4) 175 (77.8)3 0 (0) 3 (1.3)4 0 (0) 33 (14.7)5 0 (0) 8(3.6)

POCT & Patient Safety:Quality Testing Criteria Correct test ordered Correct patient Correct time for collection Correct specimen and processing Correct (accurate) test result Correct patient record Correct clinical interpretation of POCT result(s) Correct and timely clinical response

Best Practices for Glucose POCT Positive Patient ID- two identifiers Operator Certification Regular Calibration & QC Use Fresh Reagents Prevent Reagent Contamination Prevent Substance Interference Prevent Blood Sampling Errors

Evolution of POCTManualAutomationA process or system operating automaticallyAutonomationIntelligent automation – detects single defective operation andautomatically stopsEhrmeyer S, Lassig R. Clin Chem Lab Med 2007;45(6):766-773

Managing Sources of POCT ErrorsDesigned out of the productTested forWarned about

Evolution of Glucose POCTTechnologyManual Testing Incorrect sample amount Incorrect reagent amount Incorrect mixing Wrong position of testingdevice Wrong wait time Color blindness

Evolution of Glucose POCTTechnologyManual Methods1 st /2 nd Generation Instruments Wipe/Wipeless technology Operator ID / Patient ID Reduced operatorintervention Operator prompts Check on reagent viability QC lock-outs Rudimentary DataManagement

Evolution of Glucose POCTTechnologyManual Tests1 st /2 nd Generation InstrumentsCurrent Technology Electrochemical Technology Ability to use universalspecimen types Extended linearity Minimally Invasive Technology(

Patient/Sample Identifcation Pre-barcodedarterial syringe forpositive patientidentification Establishes andMaintains SampleID throughouttesting process

Preanalytical Error Reduction Reduced Analytical Risks– Glucose-specific strip technology– Individually foil wrapped and bar-codedstrips –» reduces risk of contamination» assure fresh reagents for each test» only approved lots can be used Reduced Risk of Sampling Errors– Test begins when adequate sample isdetected, reducing risk of short-samplingand over-sampling errors

Unit use and POCT devices It is often suggested that QC has no rolein a unit use device because…– QC of a single unit (good or bad result) doesnot inform about other units [same argumentwould apply to non POCT analyzers in mainlab that use discrete (unit use) reagent packs]– IMS fulfills QC role in unit use devices Unit use and continuous flow systemsare not that different

Characteristics of Unit-Use Test The container where the test is performed isalways discarded after each test. Reagents, calibrators, and wash solutionsare typically segregated as one test. Thereis no interaction of reagents, calibrators, andwash solutions from test to test.

Nature of QC Procedures Use of electronic checks, including anyinstrument software features that serve aserror detection or prevention mechanisms Use and number of surrogate samples,where appropriate, to be included as part ofthe QC procedure Testing of controls that are engineered intothe test system

Centrifugal Analyzer – IntegratedSurogate Controls

Integrated Surrogate ControlQuantitative Immunochromatography

Surrogate QC doesn’t detectall errors

Non-Surrogate Sample QCIncludes all forms of quality control other than themeasurement of a surrogate sample, usuallyintegrated into the device– electronic QC (which simulates signalselectronically), ex. i-STAT– automated procedural controls (which ensure thatcertain steps of the procedure occur appropriately),ex. Immunochromatography test kits– automated internal quality controls (which may, forexample, ensure the quality of a raw signal), ex.– diagnostic pattern recognition systems, ex. GEM iQM

Immunochromatography – UrineDipstick

Blood Gas Analyzer - IMSContinuously monitors all criticalcomponents of blood gas testing in real timeto assure accurate resultsAutomatically assures that each test meetsdemanding quality specificationsImmediately detects, corrects and documentserrorsEliminates labor and material costsassociated with traditional QCAssures that optimal quality controlprotocols are followed at all times,regardless of operator training

Internal monitoring systems(IMS)IMS are a collection of hardware andsoftware that detect errors and prevent theeffect of the error from occurring– Example: Noise in the signal of a patientsample is detected, the result is flagged and notreportedIMS are not new – although alwaysimproved, they have been in systems forover 30 years

Internal monitoring systems Internal monitoring systems don’tdetect all errors, because– Complexity of instrument systemsprevents perfect failure mode models– There is management pressure to releasenew products quickly– There is insufficient knowledge to“design things right the first time”

Non-Surrogate QC and QCSurrogate andNon-Surrogate QC are not completelyredundant do not detect allerrorsSurrogate QCNon SurrogateQC

Thinking in the POCT BoxIncorrectIdentificationSampleHandling/TransportEquipmentMalfunctionImproperDataEntryInsufficientSamplePre Analytical62%Analytical15%Post Analytical23%ReportingorAnalysisIncorrectSampleSampleConditionSample Mix-Ups/InterferencesDelayedTurn-aroundTimeAs autononmation reduces errors in the box,further reductions must occur outside the box.

Thinking Outside the POCT BoxPre-pre: Phsician must consider» What POCT is available?» What POCT will best serve the patient?» Will an immediate answer improve the patient’soutcome? Post-post: Is the Physician?» Receptive to using an immediate POCT result» Able to interpret result in the patient’s context» Amenable to initiating an immediate response

Critical Factors in QC Decisions QC must be able to detect mistakes to enableimmediate correction Risks and costs must be weighed QC is only one part of the quality control plan / qualitymanagement system Not all laboratories have the same competencies andorganization Science and common sense must converge

Quality Control Plan Summarizes the potential errors for a device and how the lab willaddress them. Can be high level or very detailed - depends on the device, thelaboratory, and the clinical application and can vary from lab to lab. Is scientifically based. It depends on the extent to which thedevice’s features or actions achieve their intended purpose and thelaboratory’s expectations for ensuring quality test results. Once implemented, is monitored for effectiveness and may bemodified to maintain risk at a clinically acceptable level.

The Problem with Pedestals

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