Harmonization of Laboratory Indicators, 09 03-2017

Most of Medical labs are having KPIs to monitor their performance and enhance process improvement. This presentation discusses in short the IFCC attempts to reach a consensus and harmonize medical labs quality indicators.

1. Harmonization of
Laboratory Indicators
Ola H. Elgaddar
MD, PhD, MBA, CPHQ, LSSGB
Lecturer of Chemical Pathology
Medical Research Institute
Alexandria University
[email protected]

6. Sources of Medical Errors
ØAvailabledatausedtofocusonmedication
relatederrors
ØHowever,inrecentyears,largescale
surveyshavedemonstratedthatdiagnostic
errorsareacommonoccurrenceincluding
errorsrelatedtolaboratorytesting

8. Quality Indicators (QIs) …... Why?
ØAssessandmonitorthequalitysystemof
thelab….......
ØPromotesandencouragesinvestigations
whenerrorsoccur….....

9. Quality Indicators (QIs) …... Why?
ØIdentifystrategiesandproceduresfor
improvement
ØEvaluatelabperformanceinrelationto
theState-of-the-Art(i.e.benchmarking)

10. Quality Indicators (QIs) …... Why?
ØAccordingtotheISO15189:2012,
clinicallaboratoriesshouldidentifycritical
TTPactivitiesandimplementQIsinorder
tohighlightandmonitorerrorswhenthey
occur.

12. Harmonization
Harmonization,inmusic,isthe
implementationofharmony,usuallyby
usingchords,includingharmonizedscales

13. Harmonization –Lab Medicine
Accordingtoapatient-centered
viewpoint,harmonizationisthatthe
informationshouldbecomparable
irrespectiveofthemeasurement
procedureusedandwhereand/or
whenameasurementismade.

14. Provision of an accurate
and actionable
laboratory information

15. Harmonization –Lab Medicine
SCOPE=TTP
ØTestsandtestprofilesrequest
ØAnalyticalprocessesandmethods
ØTerminology
ØUnits
ØReportformats
ØReferenceintervals
ØDecisionlimits

16. Back to
Are they harmonized??

17. Unfortunately,thereisnoconsensus
oncommonQIscoveringthewhole
TTP,northereisanagreementon
commonterminologyortargets!

18. IdentifyingasuitableState-of-the-Art
ischallenging,becauseitcallsforthe
knowledgeoferrorratesmeasuredin
avarietyoflaboratoriesthroughout
theworldthatdifferintheir
organizationand management,
context,andpopulationserved

19. TheWorkingGroup“LaboratoryErrorsand
PatientSafety”(WG-LEPS)oftheIFCChas,
since2008,implementedaprojectaimedat
definingacommonModelofQIs(MQI),a
harmonizedmethodfordatacollection,
managedasanEx QualityAssurance
Program(EQAP)inwhichconfidentialityis
guaranteed

21. PreliminaryMQIthatwastestedunderreal
conditionsbyinvolvinglaboratoriesbetween2008
&2013,thenthemainfindingswerediscussedin
theConsensusConferenceheldinPaduain2013

22. Theachievedpreliminaryconsensuson
terminology,rationale,purpose and
proceduresofdatacollectionresultedina
preliminarysetofreviewedandapproved
qualityindicatorsissuedaftertheConsensus
Conference,andusedsince2014

23. AnewMQIhasbeen
issued afterthe
ConsensusConference
ofPadua2016,that
includes:
Ø53measurementsto
monitor
Ø27QIs
ØExplanatorynotes
ØApriorityindexhas
beenassignedto
eachqualityindicator
(“1”isthehigher
priority;“4”thelower)

24. Indicators and measurements
ØDifferentmeasuresareoftenrequiredto
ensurethatanindicatorisappropriately
monitored.
ØItisadvisabletosplitanindicatorinto
differentmeasuresinordertoconsider
alltheeventscausingaspecificerror,
andtobenchmarkdataenteredby
differentlaboratoriestoavoidmisleading
comparisons(Ex:Inandoutpatients)

25. AlllaboratoriescanusethenewMQI,availableinthewebsite,
since2017.Thelaboratoryresultsarecollectedonthe
specifically-developedwebsite(www.ifcc-mqi.com)and
managedwithinanEQAPthroughwhichlaboratoryresultsare
evaluatedincomparisontotheresultsofallparticipating
laboratories.

26. Inordertoencouragelaboratoriesto
participateintheproject,theyarenot
compelledtouseallQIsproposedinthe
modelandtheycan,atleastatthebeginning,
selectthemostappropriateQIs(chosenfrom
thosewith“priority1”assigned)andthen,they
mayeventuallyintroduceandusefurtherQIs.

27. Aconfidentialreportisperiodicallyissuedforeach
labcontainingthefollowinginformationforeachQI:
-Laboratoryresult;
-Sigmavalue
-Trendofthelaboratoryresultsandofthesigma
values,overtime;
-Distributionoffrequencyoflaboratoryresultsand
ofthesigmavalues.

32. Statistical data of QIs collected in the 2014,
2015 and 2016 (6 months)

33. QIs most widely used:
ØPre-analyticalphase:a)unsuitable
samplesandb)misidentifiederrors
ØAnalyticalphase:a)unacceptable
performanceinPTandb)testswith
inappropriateIQCperformance
ØPost-analyticalphase:a)incorrect
reportsissuedandb)inappropriateTAT

34. QIs most widely used:
ForQIsofOutcomeMeasuresandSupport
Processes,allindicatorsproposedinMQI
appeartobeusedinasimilarfashion,but
onlybyasmallnumberoflaboratories.

35. Most reported difficulties:
ØInadequateparticipationinQIdata
collectionbymostlabs,attributingthisto
the‘excessive’numberofQIsincludedin
theMQI
ØDifficultiesindatacollection,especially
whenautomatedcollectionisunavailable.

36. Most reported difficulties:
ØDifficultyinmeetingthedeadlinefor
collectingandenteringdataintheMQI-
dedicatedwebsite.Laboratoriesaremore
inclinedundertaketheretrospective
collectionofdata,withtrans-mission
delayedbymonthsor,inex cases,a
year.