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CDCLaboratoryStandards

LaboratoryQualityAssuranceandStandardization
Programs
Morethanabillionlaboratoryteststhatidentifyandmeasure
chemicals,suchasleadorcholesterol,areperformedeachyear
intheUnitedStates.Suchtestresultshaveasignificantinfluence
onmedicaldecisions.
Giventheimportanceoflaboratorytestresults,theCentersfor
DiseaseControlandPrevention's(CDC)NationalCenterfor
EnvironmentalHealthhasprogramstohelpassurethequalityof
thesedatasopatientsandhealthcareproviders(aswellas
researchersandpublichealthofficials)canbeconfidentthat
laboratorytestresultstheyreceiveareaccurate.TheseCDC
programsfocusspecificallyonlaboratoryteststhatarerelatedto
chronicdiseases,newbornscreeningdisorders,nutritionalstatus,andenvironmentalexposures.

QualityAssurance
LaboratoryQualityAssurance(QA)encompassesarangeofactivitiesthatenablelaboratoriesto
achieveandmaintainhighlevelsofaccuracyandproficiencydespitechangesintestmethodsand
thevolumeofspecimenstested.AgoodQAsystemdoesthesefourthings:
establishesstandardoperatingprocedures(SOPs)foreachstepofthelaboratorytesting
process,rangingfromspecimenhandlingtoinstrumentperformancevalidation
definesadministrativerequirements,suchasmandatoryrecordkeeping,dataevaluation,and
internalauditstomonitoradherencetoSOPs
specifiescorrectiveactions,documentation,andthepersonsresponsibleforcarryingout
correctiveactionswhenproblemsareidentifiedand
sustainshighqualityemployeeperformance.

LaboratoryStandardization
LaboratoryStandardizationisachievedwhentestresultswiththesamehighlevelsofaccuracy
andprecisioncanbereproducedacrossmeasurementsystems,laboratories,andovertime.
Standardizationdependsonarigorousprocessusing:
referencematerialasampleoftheanalytewithapreciselyknowncomposition,whichcan
beusedtocalibratelaboratoryinstrumentsandvalidatetestprotocols
areferencemeasurementprocedure(RMP)the"goldstandard"measurementsystemfora
particularanalyteand
secondarymeasurementproceduresvalidatedusingreferencematerialandRMP.These
proceduresmaybelesssophisticatedthantheRMP,buttheyareusuallymoreeasily
implementedbyalargernumberoflaboratories.
Wellexecutedstandardizationprogramsgreatlyimprovethequalityoflaboratorymeasurements
thatareusedtodetectsignsofillnessesandtoguideinterventionstopreventortreatillnesses.
http://www.cdc.gov/labstandards/

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CDCLaboratoryStandards

Standardizationalsoensurestheproductionofcredibleandcomparabledataacrosslaboratories
aboontoepidemiologistsandresearcherswhomayneedtopooldatafrommultiplesources.
CDCofferscustomizedQAandstandardizationprogramstohelplaboratoriesimprovethequality
andreliabilityoftheirmeasurementprocedures.ThespecificCDCservicesthatareofferedare:
Referencematerials
Proficiencytesting
Training
Guidelines
Consultations
EachCDClaboratoryQAandstandardizationprogramisvoluntaryandmostarefreeofcharge.
Pagelastreviewed:TuesdayJuly292014
Pagelastupdated:TuesdayJuly292014
Contentsource:CentersforDiseaseControlandPrevention

CentersforDiseaseControlandPrevention1600CliftonRoadAtlanta,GA30329
4027,USA
800CDCINFO(8002324636)TTY:(888)2326348ContactCDCINFO

http://www.cdc.gov/labstandards/

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