poct: building and managing a top-notch program a top-notch program sharon s. ehrmeyer, ph.d....

POCT: POCT: Building and ManagingBuilding and Managing a Top-Notch Programa Top-Notch Program

SHARON S. EHRMEYER, Ph.D.SHARON S. EHRMEYER, Ph.D.MEDICAL SCHOOLMEDICAL SCHOOL

Department of Pathology and Laboratory MedicineDepartment of Pathology and Laboratory Medicine

UNIVERSITY OF WISCONSINUNIVERSITY OF WISCONSIN

MADISON, WIMADISON, WI

POCT -- Where are we now?POCT -- Where are we now?

Two US hospital surveys, one in 1999 Two US hospital surveys, one in 1999 (510) and one in 2001 (584)*(510) and one in 2001 (584)*– Tracked POCT in hospitalsTracked POCT in hospitals– Provided information to manufacturers, Provided information to manufacturers,

healthcare providers, and testing siteshealthcare providers, and testing sites

* - US Hospitals POCT Survey, Enterprise Analysis * - US Hospitals POCT Survey, Enterprise Analysis

Corp (EAC), Stamford, ConnecticutCorp (EAC), Stamford, Connecticut

POCT -- Where are we now?POCT -- Where are we now?

Instrument category Instrument category % (584) % (584) hospitals using POCThospitals using POCT – Blood glucose meters Blood glucose meters 100%100%– CoagulationCoagulation 62%62%– Blood gas/electrolytesBlood gas/electrolytes 50%50%– Chemistry (other)Chemistry (other) 36%36%– HematologyHematology 28%28%– Urine chemistryUrine chemistry 15%15%– CardiacCardiac markersmarkers 4%4%

* - US Hospitals POCT Survey, Enterprise Analysis * - US Hospitals POCT Survey, Enterprise Analysis Corp (EAC), Stamford, ConnecticutCorp (EAC), Stamford, Connecticut

POCT GrowthPOCT Growth Predicted - growth rate will double in next 5 Predicted - growth rate will double in next 5

yearsyears– Now 1 in 4 tests performed at POCNow 1 in 4 tests performed at POC– May represent 40% of “laboratory” tests in futureMay represent 40% of “laboratory” tests in future

Current POCT market is estimated at $4.9 Current POCT market is estimated at $4.9 billionbillion– Expected to double within next 5 – 10 yearsExpected to double within next 5 – 10 years– 414 of 584 hospitals anticipate purchasing POCT 414 of 584 hospitals anticipate purchasing POCT

instruments before June 2002instruments before June 2002

* - US Hospitals POCT Survey, Enterprise* - US Hospitals POCT Survey, Enterprise

POCT – BenefitsPOCT – Benefits

Improved turn around times (TAT) Improved turn around times (TAT) – Quicker interventionQuicker intervention– Better treatmentBetter treatment– Improved patient outcomesImproved patient outcomes

ConvenienceConvenience– PatientPatient– PhysicianPhysician

Potential Potential for decreased costsfor decreased costs– Reduced cost for episode of careReduced cost for episode of care

POCT -- What about cost?POCT -- What about cost?

Be careful with any POCT comparisonsBe careful with any POCT comparisons

POCTPOCT Concerns Concerns

Oversight and QualityOversight and Quality

Each addressed through:Each addressed through:

Structure, Leadership and Structure, Leadership and Managing the ProcessManaging the Process

POCT: StructurePOCT: Structure

Provides:Provides:

Authority, responsibility,Authority, responsibility,

and accountability for POCTand accountability for POCT

Administrative StructureAdministrative Structure Situational-specificSituational-specific

– Design for local needsDesign for local needs Should be reality driven, not “perception” Should be reality driven, not “perception”

drivendriven Includes “players/parties” involved in POCTIncludes “players/parties” involved in POCT

– Hospital and laboratory administrationHospital and laboratory administration– Medical staffMedical staff– NursingNursing– PharmacyPharmacy– PurchasingPurchasing– Information ServicesInformation Services– Risk managementRisk management– etc., etc.etc., etc.

Administrative OversightAdministrative Oversight Determines appropriateness of POCT Determines appropriateness of POCT

– For a given site, test, and patientFor a given site, test, and patient cost vs benefitscost vs benefits influence on length of stay (LOS)influence on length of stay (LOS)

Assures appropriate selection of testing procedure / Assures appropriate selection of testing procedure / instrumentinstrument– Assists in evaluation of technologyAssists in evaluation of technology

Assures training of testing personnelAssures training of testing personnel– Makes recommendations on who will testMakes recommendations on who will test– Advises senior management of status/changesAdvises senior management of status/changes– Builds bridges with all involvedBuilds bridges with all involved

Administrative OversightAdministrative Oversight

Assures regulations are metAssures regulations are met– Determines needed policies and proceduresDetermines needed policies and procedures– DocumentationDocumentation– QC/QAQC/QA

Provides oversight for getting the “job” Provides oversight for getting the “job” done rightdone right– Advise senior management of status/changesAdvise senior management of status/changes– Build bridges with all involvedBuild bridges with all involved

Administrative OversightAdministrative Oversight

AuthorityAuthority– Make and enforce policyMake and enforce policy– Assign responsibilityAssign responsibility– Make decisionsMake decisions– Problem solveProblem solve– Provide administrative supportProvide administrative support

POCT OversightPOCT Oversight

Authority assures a team effortAuthority assures a team effort

Clinicians define the medical situations Clinicians define the medical situations where POCT is appropriatewhere POCT is appropriate

Laboratory focuses on good POCT resultsLaboratory focuses on good POCT results Nursing and other health professionals strive Nursing and other health professionals strive

for good patient carefor good patient care

Oversight - LeadershipOversight - Leadership

LeadershipLeadership

Pick the Pick the rightright coordinator coordinator

POCT OversightPOCT Oversight

Final OutcomeFinal Outcome

Right testRight testRight resultRight result

Right patientRight patientRight timeRight time

Right recordRight record

POCTPOCT Concerns Concerns

QualityQuality

Quality of Health Care in U.S.Quality of Health Care in U.S.

Institute of Medicine*Institute of Medicine*– Medical errors cause 44,000 to 98,000 Medical errors cause 44,000 to 98,000

deaths each yeardeaths each year Equivalent to 200 deaths each day in airline Equivalent to 200 deaths each day in airline

crashescrashes Fifth leading cause of death in U.S.Fifth leading cause of death in U.S.

– Ahead of diabetes, breast cancer, HIVAhead of diabetes, breast cancer, HIV Lab testing certainly contributes to deathsLab testing certainly contributes to deaths

– Lab is looking for built-in safeguards to Lab is looking for built-in safeguards to prevent errorsprevent errors

*To Err is Human: Building a Safer Health System. Washington, DC, National Academy Press; 2000

Errors in perspective (per Errors in perspective (per 101066))

Airline passenger fatalities 0.2

Deaths due to general anesthesia 2-5

Viral transmissions from blood transfusions29

Deaths/accidents due to

defective Firestone tires 300

Lost bags of airplane passengers 5000

Lab errors 10000-30000

Arch Pathol Lab Med 123:761, 1999

Quality POCT ResultsQuality POCT Results - a major - a major concern!concern!

Must focus on reducing medical Must focus on reducing medical errorserrors

Patients deserve qualityPatients deserve quality POC needs to generate quality POC needs to generate quality

resultsresults– Yet, non-laboratorians often do the testingYet, non-laboratorians often do the testing

IOM - Why Testing FailsIOM - Why Testing Fails

Human errorHuman error Lack of documentationLack of documentation Lack of test managementLack of test management

Error ReductionError Reduction

Prevention of human error will fuel the next Prevention of human error will fuel the next wave of significant change in medical carewave of significant change in medical care– Data management and QC processes are key to Data management and QC processes are key to

error preventionerror prevention– Error prevention will result in both better patient Error prevention will result in both better patient

safety and decreased costssafety and decreased costs– Goals of regulations are to reduce/eliminate errorsGoals of regulations are to reduce/eliminate errors– Error prevention cannot be achieved without Error prevention cannot be achieved without

participation from industry (manufacturers)participation from industry (manufacturers)

In U.S.: CLIA sets minimum testing standardsIn U.S.: CLIA sets minimum testing standards

Intent of Regulations is reduce/eliminate Intent of Regulations is reduce/eliminate errorserrors

Quality ControlQuality Control PersonnelPersonnel Proficiency testing (external assessment)Proficiency testing (external assessment) Quality AssuranceQuality Assurance InspectionInspection

POCT ConcernsPOCT Concerns

Regulatory complianceRegulatory compliance– Will POCT meet regulatory Will POCT meet regulatory

requirement?requirement?– Will POCT be acceptable to the Will POCT be acceptable to the

central laboratory?central laboratory?

POCT – Users’ Major Compliance POCT – Users’ Major Compliance ConcernsConcerns

QCQC– Performance; remedial actions;documentationPerformance; remedial actions;documentation

Operator certificationOperator certification– Authorized operators; recertification when requiredAuthorized operators; recertification when required

Lack of identificationLack of identification– Operator; patientOperator; patient

Appropriate documentation in patient recordsAppropriate documentation in patient records– Patient results in a timely mannerPatient results in a timely manner– Audit trail to link patient result with analyst, instrument, QC, Audit trail to link patient result with analyst, instrument, QC,

time, datetime, date DocumentationDocumentation

– Method verification, reagent validation, proficiency testing, Method verification, reagent validation, proficiency testing, etc.etc.

– http://www.advanceforal.com/asp/spotanswer.asphttp://www.advanceforal.com/asp/spotanswer.asp

Top POCT Deficiencies – 5 Cincinnati HospitalsTop POCT Deficiencies – 5 Cincinnati Hospitals

Following manufacturer’s instructions Following manufacturer’s instructions Documentation of patient results in patient Documentation of patient results in patient

recordrecord Patient identificationPatient identification Operator identificationOperator identification Failure to do QCFailure to do QC Failure to respond to out-of-control situationsFailure to respond to out-of-control situations Unauthorized testerUnauthorized tester Using outdated/expired reagentsUsing outdated/expired reagents Failure to observe safety requirementsFailure to observe safety requirements

Barbara Goldsmith, 2001Barbara Goldsmith, 2001

POCT: OversightPOCT: Oversight

Centralize decisions allows for:Centralize decisions allows for:– Appropriate POCT instrument Appropriate POCT instrument

selectionselection Built-in safeguardsBuilt-in safeguards Quality assured resultsQuality assured results DocumentationDocumentation

POCT 2003 & BeyondPOCT 2003 & Beyond

Consider the environmentConsider the environment Select the appropriate Select the appropriate

instruments/methodsinstruments/methods Proactively manage the processProactively manage the process

POCT versus Central Lab TestingPOCT versus Central Lab TestingCentral LabCentral Lab POCTPOCT

Testing personnelTesting personnel Pathologists,, Pathologists,, PhDs, Med. Lab PhDs, Med. Lab TechnologistsTechnologists

Nurses, other Nurses, other care giverscare givers

Primary duties Primary duties Laboratory Laboratory testingtesting

Patient carePatient care

Knows laboratory testingKnows laboratory testing ExtensiveExtensive MinimalMinimal

Understands instrument’s Understands instrument’s quality checksquality checks

ExtensiveExtensive MinimalMinimal

Can interpret QC dataCan interpret QC data YesYes Probably notProbably not

Skills to resolve problems, Skills to resolve problems, troubleshootingtroubleshooting

YesYes NoNo

Recognizes quality testingRecognizes quality testing YesYes Not necessarilyNot necessarily

POCT EnvironmentPOCT Environment

Nurses are patient Nurses are patient caregiverscaregivers

Nurses are very competentNurses are very competent Nurses are very busyNurses are very busy Nurses’ perspective must be Nurses’ perspective must be

considered when selecting considered when selecting POCT instruments:POCT instruments:– Quality POCT to better treat Quality POCT to better treat

patientspatients– Easy and trouble free POCTEasy and trouble free POCT

POCT instrument selection criteria POCT instrument selection criteria

Testing needs (menu)Testing needs (menu)– Many “instruments” or just oneMany “instruments” or just one– Space limitations / portability needsSpace limitations / portability needs– Reagents and storage requirementsReagents and storage requirements– Test volume; Sample volumeTest volume; Sample volume

Accuracy and precisionAccuracy and precision Measurement rangeMeasurement range CostsCosts ReliabilityReliability Manufacturer supportManufacturer support

POCT instrument selection POCT instrument selection criteriacriteria

To prevent human errors, To prevent human errors, need:need:

Embed operating rules Embed operating rules – Impossible not to follow manufacturer’s Impossible not to follow manufacturer’s

testing instructionstesting instructions Patient IDPatient ID No sample preparationNo sample preparation

– Easy sample applicationEasy sample application

Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315


To prevent human errors, need:To prevent human errors, need:

Operator ID requiredOperator ID required– Trained and competent operators onlyTrained and competent operators only

Operator lockoutOperator lockout

Preventative maintenance done automatically Preventative maintenance done automatically No expired/deteriorated reagents allowedNo expired/deteriorated reagents allowed Automatic assured calibrationAutomatic assured calibration



To prevent human errors, need:To prevent human errors, need:

Assured quality of test resultsAssured quality of test results– Automatic QC and data evaluationAutomatic QC and data evaluation

Result withheld when QC failsResult withheld when QC fails

– Automatic monitoring of instrument functionsAutomatic monitoring of instrument functions– Automatic error detection and correctionAutomatic error detection and correction

Instrument shutdown when correction is not Instrument shutdown when correction is not possiblepossible

– Tracking of errorsTracking of errors



To prevent human errors, To prevent human errors, need:need:

Automatic data capture Automatic data capture (documentation)(documentation)– Patient results in patient recordPatient results in patient record– Instrument checksInstrument checks– Regulatory / legal informationRegulatory / legal information


Instrumentation 2003Instrumentation 2003

2003 instrument philosophy2003 instrument philosophy Coca Cola anyone?Coca Cola anyone?

Put sample in; get quality resultPut sample in; get quality result Quality control/quality assuranceQuality control/quality assurance

Not my problem; don’t bother me; just do Not my problem; don’t bother me; just do itit

Documentation/ConnectivityDocumentation/Connectivity Automatic; don’t bother me; just do itAutomatic; don’t bother me; just do it

Instrumentation 2003Instrumentation 2003

Accurate and preciseAccurate and precise Easy to operate – foolproofEasy to operate – foolproof

– Built-in safeguards Built-in safeguards Minimum (no) maintenanceMinimum (no) maintenance 24/7 availability; instant results24/7 availability; instant results Readily accessible to all care providersReadily accessible to all care providers Quality control – don’t bother me; just do itQuality control – don’t bother me; just do it Quality assurance – not my problemQuality assurance – not my problem Data capture – automaticData capture – automatic Result in patient record -- automaticResult in patient record -- automatic

Instrumentation 2003 & BeyondInstrumentation 2003 & Beyond Automatic self-calibrationAutomatic self-calibration

– On-board calibrator materialsOn-board calibrator materials

Automatic QCAutomatic QC– On-board QC materialsOn-board QC materials– Automatic QC interpretationAutomatic QC interpretation

Guaranteed quality resultsGuaranteed quality results– Withhold “bad” resultsWithhold “bad” results

ConnectivityConnectivity– Paperless systemPaperless system– From order to report to billingFrom order to report to billing

Regulations are no problemRegulations are no problem– Requirements met; data assessed; documentation inspector-Requirements met; data assessed; documentation inspector-

readyready

Connectivity – Solves many POCT problems

Benefits of connectivityBenefits of connectivity

Increased surveillanceIncreased surveillance– Patient results, QC, QA, analystPatient results, QC, QA, analyst– Alerts supervisor to problemsAlerts supervisor to problems

Reduced data handlingReduced data handling– Less chance for transcription errorsLess chance for transcription errors

Full data record for traceabilityFull data record for traceability– Links patient result, instrument, analyst, QCLinks patient result, instrument, analyst, QC– Patient results in patient recordPatient results in patient record

Cost savingsCost savings– Fewer repeatsFewer repeats– Only authorized testingOnly authorized testing

Where are we now?Where are we now?

Documentation*Documentation*– Estimated that only 15% of POCT results get Estimated that only 15% of POCT results get

into patient record (US)into patient record (US)

* - * - US Hospitals POCT Survey, Enterprise Analysis US Hospitals POCT Survey, Enterprise Analysis Corp (EAC) Corp (EAC)

POCT oversightPOCT oversight

Pick the right instrumentPick the right instrument

Selecting “right” instrument Selecting “right” instrument eliminates problemseliminates problems

Following manufacturer’s instructionsFollowing manufacturer’s instructions Documentation of patient results in patient Documentation of patient results in patient

recordrecord Patient identificationPatient identification Operator identificationOperator identification Failure to do QCFailure to do QC Failure to respond to out-of-control situationsFailure to respond to out-of-control situations Unauthorized testerUnauthorized tester Using outdated/expired reagentsUsing outdated/expired reagents Failure to observe safety requirementsFailure to observe safety requirements

Barbara Goldsmith, 2000Barbara Goldsmith, 2000

ManagementManagement

It is all about management, only It is all about management, only managementmanagement

Features and benefits exist only in Features and benefits exist only in the context of customers’ the context of customers’ situationssituations

Take a quality systems approachTake a quality systems approach

Error Error SourceSource

Ross and BooneRoss and Boone11 Plebani et al.Plebani et al.22

Pre-analyticalPre-analytical

46%46% 68%68%

AnalyticalAnalytical 7%7% 13%13%

Post-analyticalPost-analytical 47%47% 19%19%

1 – Ross and Boone, Inst. of Critical Issues in Health Lab Practices, DuPont Press, 19911 – Ross and Boone, Inst. of Critical Issues in Health Lab Practices, DuPont Press, 1991

22 -- Plebani and Carraro. Clin Chem 43:1348, 1997Plebani and Carraro. Clin Chem 43:1348, 1997

Total Analytical Error Total Analytical Error DistributionDistribution

Error managementError managementQuality systemQuality system

NCCLS Document EP18

“Quality Management (System*) for Unit-use Testing”

Error managementError managementQuality systemQuality system

Quality systems approach to identify Quality systems approach to identify potential error sourcespotential error sources– pre-analytical, analytical and post pre-analytical, analytical and post

analytical analytical Identify strategies to eliminate/reduce Identify strategies to eliminate/reduce

errors errors – Differs for different test systemsDiffers for different test systems

Design a quality system for all of POCT, Design a quality system for all of POCT, not just analytical phasenot just analytical phase

EP18

Sources of errorSources of errorPOCTPOCT

Pre-analyticalPre-analytical– patient identificationpatient identification– specimen collectionspecimen collection

arterial versus venousarterial versus venous fasting versus non-fastingfasting versus non-fasting wrong anticoagulantwrong anticoagulant contamination from intravenous fluids, cleansing contamination from intravenous fluids, cleansing

agentsagents inadequate amount collectedinadequate amount collected hemolysishemolysis

– delay in sample analysisdelay in sample analysis– etc., etc., etc.etc., etc., etc.


AnalyticalAnalytical– sample inadequately mixedsample inadequately mixed– introduction of air bubblesintroduction of air bubbles– adverse reaction conditionsadverse reaction conditions

temperature, humidity, power, barometric pressure, temperature, humidity, power, barometric pressure, altitudealtitude

– outdated reagentsoutdated reagents– deterioration of reagentsdeterioration of reagents– instrument failureinstrument failure– QC out of acceptable limitsQC out of acceptable limits– inadequate maintenanceinadequate maintenance– etc., etc., etc.etc., etc., etc.


Post-analyticalPost-analytical– incorrect reading of resultsincorrect reading of results– outlier, nonsense resultoutlier, nonsense result– result does not correlate with patient’s result does not correlate with patient’s

conditioncondition– result outside of linear limitsresult outside of linear limits– non-recognition of interferencesnon-recognition of interferences– no result recordedno result recorded– result recorded in wrong patient chartresult recorded in wrong patient chart– etc., etc., etc.etc., etc., etc.

EP18PEP18PBasic premiseBasic premise

Errors impacting results vary with the test Errors impacting results vary with the test devicedevice– a single quality regimen cannot cover all devices a single quality regimen cannot cover all devices

Partnership between users and Partnership between users and manufacturersmanufacturers– device’s design should eliminate/minimize device’s design should eliminate/minimize

sources of errorsources of error manufacturer identifies what device does in terms of manufacturer identifies what device does in terms of

detecting / preventing these errorsdetecting / preventing these errors manufacturer discloses errors NOT detectedmanufacturer discloses errors NOT detected

– POCT incorporates manufacturer’s approaches POCT incorporates manufacturer’s approaches and develops additional practices to and develops additional practices to detect/minimize errors that remaindetect/minimize errors that remain

EP18 (quality tool) error EP18 (quality tool) error matrixmatrix

Pre-analyticalPre-analytical

Potential source of Potential source of error error (critical points)(critical points)

Device Device capabilities capabilities (function (function checks, EQC, checks, EQC, etc.)etc.)

Liquid QCLiquid QC Frequency Frequency of checksof checks

Training/Training/Policies/Policies/MaintenanceMaintenance

Patient IDPatient ID

Collection techniqueCollection technique

HemolysisHemolysis

Time of collectionTime of collection

Interfering substancesInterfering substances


AnalyticalAnalytical





Reaction temperatureReaction temperature

Sample volumeSample volume

Reagent storageReagent storage

Reagent failureReagent failure

Poor precisionPoor precision


Post-analyticalPost-analytical





Nonsense resultNonsense result

Result outside of Result outside of reportable rangereportable range

No result recordedNo result recorded

Incorrect information Incorrect information recordedrecorded

A real-world example for using EP18A real-world example for using EP18

The Biosite Triage® Cardiac System

Triage® Cardiac SystemPre-analyticalPre-analytical



Liquid QCLiquid QC Frequency Frequency of checks*of checks*


Patient IDPatient ID XX Each patientEach patient XX

Patient infoPatient info XX

Specimen Specimen collectioncollection

XX

Wrong sampleWrong sample XX

Triage® Cardiac SystemAnalyticalAnalytical

* M = with each measurement

Potential source Potential source of error of error (critical points)(critical points)




Cartridge integrityCartridge integrity XX MM XX

Authorized Authorized operatoroperator

XX

Sample Sample applicationapplication

XX XX MM XX

PrecisionPrecision XX XX MM

InaccuracyInaccuracy XX XX MM

Meter statusMeter status XX MM XX

Triage® Cardiac SystemPost-analyticalPost-analytical





Interpretation of QCInterpretation of QC XX MM XX

Outlier recognized and Outlier recognized and markedmarked XX MM XX

Critical value Critical value recognizedrecognized XX MM XX

Result in patient chartResult in patient chart X X (connectivity)(connectivity)

XX

Results uploaded to Results uploaded to data management data management systemsystem

XX XX

* M = with each measurement

Error management Error management Quality System EP18Quality System EP18

Users mustUsers must– identify relevant sources of erroridentify relevant sources of error– develop strategies to ensure quality test develop strategies to ensure quality test

resultsresults ToolsTools

– manufacturer’s approachesmanufacturer’s approaches– additional protocols (QC and QA practices)additional protocols (QC and QA practices)

trainingtraining protocols—policies and proceduresprotocols—policies and procedures

What Defines Quality for Patient What Defines Quality for Patient Testing?Testing?

Right testRight test Right timeRight time Right patientRight patient Right specimenRight specimen Right (accurate) resultRight (accurate) result Leading to the right therapeutic Leading to the right therapeutic

actionaction

poct: building and managing a top-notch program a top-notch program sharon s. ehrmeyer, ph.d....

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poct concerns quality

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administrative oversight

appropriateness of poct