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
POCT instrument selection POCT instrument selection criteriacriteria
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
Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315
POCT instrument selection POCT instrument selection criteriacriteria
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
Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315
POCT instrument selection POCT instrument selection criteriacriteria
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
Kost, GJ, Arch Pathol Lab Med. (2001) 125:1307–1315
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.
Sources of errorSources of errorPOCTPOCT
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.
Sources of errorSources of errorPOCTPOCT
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
EP18 (quality tool) error EP18 (quality tool) error matrixmatrix
AnalyticalAnalytical
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
Reaction temperatureReaction temperature
Sample volumeSample volume
Reagent storageReagent storage
Reagent failureReagent failure
Poor precisionPoor precision
EP18 (quality tool) error EP18 (quality tool) error matrixmatrix
Post-analyticalPost-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
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
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 checks*of checks*
Training/Training/Policies/Policies/MaintenanceMaintenance
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)
Device Device capabilities capabilities (function (function checks, EQC, checks, EQC, etc.)etc.)
Liquid QCLiquid QC Frequency Frequency of checks*of checks*
Training/Training/Policies/Policies/MaintenanceMaintenance
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
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 checks*of checks*
Training/Training/Policies/Policies/MaintenanceMaintenance
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