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Revised:04/06/2006CollegeofAmericanPathologistsRevised:04/06/2006FLOWCYTOMETRYThisCollegeofAmericanPathologistsCAPLaboratoryAccreditationProgramLAPChecklistisprovidedasaMicrosoft®Word2000electronicfileforconvenien__andforeducationalpurposes.Itrepresentsthefully-approvedversionforuseintheLAPasofthedategivenintheheader.NewerapprovedversionsofthisChecklist__ybefoundviatheInternetattheCAPWebsitehttp://___.cap.org/apps/docs/laboratory_accreditation/checklists/checklistftp.htmlhttp://___.cap.org/apps/docs/laboratory_accreditation/checklists/checklistftp.htmlforbothviewinganddownloadtoyourcomputer.IfyouarecurrentlyenrolledintheCAPLAPandarepreparingforaninspectionpleasenote:TheChecklistsundergofrequentrevisionandthecontents__yh__echangedafteryoure__iveyourinspectionpacket.IfaChecklisthasbeenupdatedsin__re__ivingyourpacketyouwillbeinspectedbasedupontheCheckliststhatwere__iledtoyouinyourapplicationorreapplicationpacket.ForquestionsabouttheuseofChecklistsintheinspectionpro__sspleasee-__iltheCAPataccred@cap.orgorcall800323-4040ext.
6065.Suggestionsforcontentimprovementshouldbesentbye-__iltoLAPataccred@cap.org.Allchecklistsare©2006CollegeofAmericanPathologists.Allrightsreserved.OUTLINESUM__RYOFCHANGESINSPECTIONTECHNIQUES–KEYPOINTSINTRODUCTIONPROFICIENCYTESTINGQUALITY__NAGEMENTANDQUALITYCONTROLGENERALISSUESPRO__DURE__NUALSPECIMENCOLLECTIONANDHANDLINGREAGENTSCONTROLSANDSTANDARDSINSTRUMENTSANDEQUIPMENTFlowCytometersTemperature-DependentEquipmentThermometers__ntrifugesPRO__DURESANDTESTSYSTEMSIMMUNOPHENOTYPINGBloodLymphocyteSubsetEnumerationCD34Stem__llEnumerationLeukemiaandLympho__DNACONTENTAND__LLCYCLE____YSISPERSONNELPHYSICALFACILITIESLABORATORYSAFETYINSPECTIONTECHNIQUES–KEYPOINTSINTRODUCTIONPROFICIENCYTESTINGQUALITY__NAGEMENTANDQUALITYCONTROLGENERALISSUESPRO__DURE__NUALSPECIMENCOLLECTIONANDHANDLINGREAGENTSCONTROLSANDSTANDARDSINSTRUMENTSANDEQUIPMENTFlowCytometersTemperature-DependentEquipmentThermometers__ntrifugesPRO__DURESANDTESTSYSTEMSIMMUNOPHENOTYPINGBloodLymphocyteSubsetEnumerationCD34Stem__llEnumerationLeukemiaandLympho__DNACONTENTAND__LLCYCLE____YSISPERSONNELPHYSICALFACILITIESLABORATORYSAFETYSUM__RYOFCHANGESFLOWCYTOMETRYChecklist4/6/2006EditionThefollowingquestionsh__ebeenaddedrevisedordeletedinthiseditionofthechecklistorinthetwoeditionsimmediatelyprevioustothisone.Ifthischecklistwascreatedforareapplicationon-siteinspectionorself-evaluationithasbeencustomizedbasedonthelaboratorysactivitymenu.Thelistingbelowiscomprehensive;thereforesomeofthequestionsincluded__ynotappearinthecustomizedchecklist.Suchquestionsarenotapplicabletothetestingperformedbythelaboratory.Note:Forrevisedchecklistquestionsacomparisonofthepreviousandcurrenttext__ybefoundontheCAPwebsite.ClickonLaboratoryAccreditationChecklistsandthenclickthecolumn__rkedChangesfortheparticularchecklistofinterest.NEWChecklistQuestionsQuestionEffectiveDateFLO.1354004/06/2006FLO.1677004/06/2006FLO.2373704/06/2006FLO.2447504/06/2006FLO.3055704/06/2006REVISEDChecklistQuestionsQuestionEffectiveDateFLO.2100004/06/2006FLO.2392510/06/2005FLO.1015012/29/2004FLO.1018012/29/2004DELETEDChecklistQuestionsQuestionEffectiveDateFLO.2015004/06/2006FLO.5050010/06/2005FLO.6000012/29/2004ThechecklistsusedinconnectionwiththeinspectionoflaboratoriesbytheCommissiononLaboratoryAccreditation“CLA”oftheCollegeofAmericanPathologistsh__ebeencreatedbytheCollegeandarecopyrightedworksoftheCollege.TheCollegehasauthorizedcopyinganduseofthechecklistsbyCollegeinspectorsinconductinglaboratoryinspectionsfortheCLAandbylaboratoriesthatarepreparingforsuchinspections.Ex__ptaspermittedbysection107oftheCopyrightAct17U.S.C.sec.107anyotheruseofthechecklistsconstitutesinfringementoftheCollege’scopyrightsinthechecklists.TheCollegewilltakeappropriatelegalactiontoprotectthesecopyrights.IMPORTANT:ThecontentsoftheLaboratoryGeneralChecklistareapplicabletotheFlowCytometrysectionofthelaboratory.****************************************************************INSPECTIONTECHNIQUES–KEYPOINTS****************************************************************I.READ–OBSERVE–ASK–thethreemethodsofelicitinginfor__tionduringtheinspectionpro__ss.Thesethreemethods__ybeusedthroughoutthedayinnoparticularorder.Plantheinspectioninawaythatallowsadequatetimeforallthreecomponents.READ=ReviewofRecordsandDocumentsDocumentreviewverifiesthatpro__duresand__nualsarecompletecurrent__ailabletostaffaccurateandreviewedanddescribegoodlaboratorypracti__.__kenotesofanyquestionsyou__yh__eorpro__ssesyouwouldliketoobserveasyoureadthedocumentation.OBSERVE–ASK=DirectObservationandAskingQuestionsObservingandaskingquestionsaccomplishthefollowing:
1.Verifiesthattheactualpracti____tchesthewrittenpolicyorpro__dure
2.Ensuresthatthelaboratorypro__ssesareappropriateforthetestingperformed
3.EnsuresthatoutcomesforanyproblemareassuchasPTfailuresandissues/problemsidentifiedthroughthequality__nagementpro__ssh__ebeenadequatelyinvestigatedandresolved
4.Ensuresthatpreviouslyciteddeficienciesh__ebeencorrectedUsethefollowingtechniques:Observelaboratorypracti__s–lookatwhatthelaboratoryisactuallydoing.Comparethewrittenpolicy/pro__duretowhatyouactuallyobserveinthelaboratorytoensurethewrittenpolicy/pro__dureaccuratelyreflectslaboratorypracti__.Noteifpracti__deviatesfromthedocumentedpolicies/pro__dures.Askopenendedprobingquestions–thesearestartingpointsthatwillallowyoutoobtainlargeamountsofinfor__tionandhelpyouclarifyyourunderstandingofthedocumentationyou’veseenandobservationsyou’ve__de.Thiseliminatestheneedtoaskeverysinglechecklistquestionasthedialoguebetweenyouandthelaboratory__yaddressmultiplechecklistquestions.Askopen-endedquestionsthatstartwithphrasessuchas“showmehow…”or“____meabout…”or“whatwouldyoudoif…”.Byaskingquestionsthatareopen-endedorbyposingahypotheticalproblemyouwill__oid“cookbook”answers.Forexampleask“Couldyoushowmethespecimentransportpolicyandshowmehowyouensureoptimumspecimenquality”Thiswillhelpyoutodeterminehowwellthetechnicalstaffistrainedwhetherornottheyareadheringtothelab’spro__duresandpoliciesandgiveyouafeelforthegenerallevelofperfor__n__ofthelaboratory.Askfollow-upquestionsforclarification.Generallyitisbestnottoaskthechecklistquestionsverbatim.Forexampleinsteadofaskingthechecklistquestion“Istheredocumentationofcorrectiveactionwhencontrolresultsex__eddefinedtoleran__limits”ask“WhatwouldyoudoiftheSDorCVdoublesonemonth”Afollow-upprobingquestioncouldbe“WhatwouldyoudoifyouwereunabletofindacauseforthechangeinSDorCV”II.EvaluateSelectedSpecimensandTestsinDetailFortheLaboratoryGeneralChecklist:Followaspecimenthroughthelaboratory.ByfollowingaspecimenfromcollectiontotestresultyoucancovermultiplechecklistquestionsintheLaboratoryGeneralchecklist:questionsonthespecimencollection__nual;phlebotomy;verbalorders;identificationofpatientsandspecimens;ac__ssioning;andresultreportingincludingappropriatereferen__rangesretentionoftestrecords__intainingconfidentialityofpatientdataandproperhandlingofcriticalvaluesandrevisionstoreports.Fortheindividuallaboratorysections:Consultthelaboratory’sactivitymenuandfocusonteststhatpotentiallyh__ethegreatestimpactonpatientcare.ExamplesofsuchtestsincludeHIVantibo___shepatitisBsu_____antigenurinedrugsofabusequantitativebeta-hCGculturesofbloodorCSFacid-fastculturesprothrombintimeandINRreportingandcompatibilitytestingandunexpectedantibodydetection.Otherpotentiallyhigh-impacttests__ybeidentifiedbylookingatveryhighorlowvolumetestsintheparticularlaboratoryorproblemsidentifiedbyreviewingtheVariantProficiencyTestingPerfor__n__Report.Toevaluatepre____yticandpost____yticissues:Choosearepresentativespecimenand“followthespecimenthroughthelaboratoryorsectionofthelaboratoryreviewingappropriaterecordsinthepre____yticandpost____yticcategories.Toevaluate____yticpro__sses:Choose2or3____ytesandperformacomprehensivereviewofrecordsincludingpro__dure__nualsqualitycontrolandproficiencytestingrecordsinstrument__intenan__recordsandmethodperfor__n__validationsforthelast2yearsselectingtimeframesatthebeginningmid-pointandendofthistimeframe.Compareinstrumentprint-outstopatientreportsandproficiencytestingresultstoensureaccuratedataentry.Ifproblemsareidentifiedchooseadditionaltestsormonthstoreview.III.Verifythatproficiencytestingproblemh__ebeenresolved:Fromtheinspector’spacketreviewtheVariantPTPerfor__n__Reportthatidentifiesby____yteallofthePTscoresbelow100%.CorrelateanyPTproblemstoQCor__intenan__recordsfromthesametimeperiod.Bethoroughwhenreviewingtheserepresentativerecordsselectingdatafromthebeginningmiddleandendoftheperiodsin__thelaston-siteinspection.IV.Reviewcorrectionofpreviousdeficiencies:Reviewthelistofdeficienciesfromthepreviouson-siteinspectionprovidedintheinspector’spacket.Ensurethattheyh__ebeenappropriatelyaddressed.*****************************************************************************INTRODUCTION*****************************************************************************Inspectorsofaflowcytometrylaboratoryshouldbepathologistsclinicalscientistsormedicaltechnologistswhoareactivelyinvolvedwithorh__eextensivere__ntexperien__inthepracti__offlowcytometryandareknowledgeableaboutcurrentCAPChecklistandCLIA-88requirements.Inspectorspreferablyshouldh__eparticipatedinare__ntCAPInspectorTrainingactivity.Inspectorsshouldtothegreatestextentpossiblebepeersofthelaboratorybeinginspected.*****************************************************************************PROFICIENCYTESTING*******************************************************************************REVISED**12/29/2004FLO.10150PhaseIIN/AYESNOIsthelaboratoryenrolledintheappropriaterequiredCAPSurveysorCAP‑approvedalternativeproficiencytestingPTprogramappropriateforthepatient/clienttestingperformedNOTE:Thelistof____ytesforwhichCAPrequiresproficiencytestingis__ailableontheCAPwebsite[http://___.cap.org/apps/docs/laboratory_accreditation/checklists/checklist_referen___links.dochttp://___.cap.org/apps/docs/laboratory_accreditation/checklists/checklist_referen___links.doc]orbyphoning800-323-4040or847-832-7000option
1.Thelaboratory’sparticipationinproficiencytestingmustincludeall____ytesonthislistforwhichitperformspatienttesting.Participationinproficiencytesting__ybethroughCAPSurveysoraCAP-approvedproficiencytestingprovider.Laboratorieswillnotbepenalizediftheyareunabletoenrollinanoversubscribedprogram.Ifunabletoenrollhoweverthelaboratorymustimplementanalternativeasses__entpro__durefortheaffected____ytes.Forregulated____ytesiftheCAPandCAP-approvedalternativePTprogramsareoversubscribedCMSrequiresthelaboratorytoattempttoenrollinanotherCMS-approvedPTprogram.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7146[42CFR
493.801];2BrandoBSom__rugaE.Nationwidequalitycontroltrialonlymphocyteimmunophenotypingandflowcytometerperfor__n__inItaly.Cytometry.1993;14:294‑306;3HomburgerHAetal.Asses__entofinterlaboratoryvariabilityofimmunophenotyping:resultsoftheCollegeofAmericanPathologistsflowcytometrysurvey.AnnNYAcadSci.1993;677:43‑52;4GoguelAFetal.Interlaboratoryqualityasses__entoflymphocytephenotyping.Etalonorme1990‑1992surveys.Biol__ll.1993;78:79‑84;5WestgardJOetal.Laboratoryprecisionperfor__n__.Stateoftheartversusoperatingspecificationsthatassurethe____yticalqualityrequiredbyclinicallaboratoryimprovementamendmentsproficiencytesting.ArchPatholLabMed.1996;120:621‑625;6NCCLSContinuousqualityimprovement:essential__nagementapproachesandtheiruseinproficiencytesting;proposedguidelineGP22‑P.WaynePA:NCCLS1997;7RosnerEetal.Asses__entoftheimpactofaCD4+T-__lltestinglaboratoryimprovementprogram.ArchPatholLabMed.1998;122:512-519;8CollegeofAmericanPathologistsCommissiononLaboratoryAccreditation.Standardsforlaboratoryaccreditation;standardIII.NorthfieldIL:CAP1998;9ReillyJTBarnettD.UKNEQASforleukocyteimmunophenotyping:thefirst10years.JClinPathol.2001;54:508-
511.**REVISED**12/29/2004FLO.10180PhaseIIN/AYESNOFortestsforwhichCAPdoesnotrequirePTdoesthelaboratoryatleastsemiannually1participateinexternalPTor2exerciseanalternativeperfor__n__asses__entsystemfordeterminingthereliabilityof____ytictestingNOTE:Appropriatealternativeperfor__n__asses__entpro__dures__yinclude:splitsample____ysiswithreferen__orotherlaboratoriessplitsampleswithanestablishedin-housemethodassayed__terialregionalpoolsclinicalvalidationbychartrevieworothersuitableanddocumentedmeans.Itistheresponsibilityofthelaboratorydirectortodefinesuchalternativeperfor__n__asses__entpro__duresasapplicableinaccordan__withgoodclinicalandscientificlaboratorypracti__.Participationinungraded/educationalproficiencytestingprogramsalsosatisfiesthischecklistquestion.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7184[42CFR
493.1236c1];2ShahangianSetal.Asystemtomonitoraportionofthetotaltestingpro__ssinmedicalclinicsandlaboratories.Feasibilityofasplit-specimendesign.ArchPatholLabMed.1998;122:503-
511.FLO.10210PhaseIIN/AYESNODoesthelaboratoryintegrateallproficiencysurveysamplesintotheroutinelaboratoryworkloadasmuchaspossibleandarethosesamples____yzedbypersonnelwhoroutinelytestpatientsamplesusingthesamepri__rymethodsystemsasforpatientsamplesNOTE:Replicate____ysisofproficiencysamplesisac__ptableonlyifpatientspecimensareroutinely____yzedinthesame__nner.Ifthelaboratoryusesmultiplemethodsforan____ytethesesamplesshouldbe____yzedbythepri__rymethod.Theremustnotbeanyinterlaboratorycommunicationonproficiencytestingdatabeforeresultsreporting.Theeducationalpurposesofproficiencytestingarebestservedbyarotationthatallowsalltechnologiststobeinvolvedintheproficiencytestingprogram.Recordsofthesestu___smustbekeptandcanbeanimportantpartofthecompetencyandcontinuingeducationdocumentationinthepersonnelfilesoftheindividuals.Whenexternalproficiencytesting__terialsarenot__ailablethesemi-annualalternativeperfor__n__asses__entpro__ssshouldalsobeintegratedwithintheroutineworkload.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7146[42CFR
493.801b];2ShahangianSetal.Towardopti__lPTuse.MedLabObserv.2000;324:32-
43.FLO.10260PhaseIIN/AYESNOIsthereeviden__ofevaluationandifindicatedcorrectiveactiontakeninresponseto“unac__ptable”resultsontheproficiencytestingreportsandresultsofthealternativeperfor__n__asses__entsystemNOTE:Theevaluationmustdocumentthespecificreasonsfortheunac__ptableresultsandactionstakentoredu__thelikelihoodofrecurren__.Thismustbedonewithinonemonthafterthelaboratoryre__ivesitsproficiencytestingevaluation.Alsothelaboratorymustreviewitsresultsandinstitutecorrectiveactionasappropriateforchallengesthatwereintendedtobegradedbutforwhichnogradewasre__ivedforexamplebecausethelaboratorydidnotsubmititsresultsusedtheincorrectmethodcodeorbecauseoflackofconsensus.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7173[42CFR
493.1407e4iv];2NCCLS.UsingproficiencytestingPTtoimprovetheclinicallaboratory;approvedguidelineGP27‑A.WaynePA:NCCLS1998;3ShahangianSetal.Towardopti__lPTuse.MedLabObserv.2000;324:32-
43.FLO.10310PhaseIIN/AYESNOIstheredocumentedeviden__ofongoingevaluationbythelaboratorydirectorordesigneeoftheproficiencytestingandalternativeperfor__n__asses__entresultsCOMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7173[42CFR
493.1407e4iii];2NCCLS.UsingproficiencytestingPTtoimprovetheclinicallaboratory;approvedguidelineGP27‑A.WaynePA:NCCLS
1998.**NEW**04/06/2006FLO.13540PhaseIIN/AYESNOIsthereapolicythatprohibitsinterlaboratorycommunicationaboutproficiencytestingsamplesuntilafterthedeadlineforsubmissionofdatatotheproficiencytestingproviderCOMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7146[42CFR
493.801b3];2BierigJR.ComparingPTresultscanputalab’sCLIAli__nseontheline.NorthfieldIL:CollegeofAmericanPathologistsCAPToday.2002;162:84-
87.**NEW**04/06/2006FLO.16770PhaseIIN/AYESNOIsthereapolicythatprohibitsreferralofproficiencytestingspecimenstoanotherlaboratoryNOTE:UnderCLIA-88regulationsthereisastrictprohibitionagainstreferringproficiencytestingspecimenstoanotherlaboratory.Inotherwordsthelaboratory__ynotreferaproficiencytestingspecimentoalaboratorywithadifferentCLIAnumberevenifthesecondlaboratoryisinthesamehealthcaresystem.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:[42CFR
493.801b4].*****************************************************************************QUALITY__NAGEMENTANDQUALITYCONTROL*****************************************************************************-----------------------------------------------------------------GENERALISSUES-----------------------------------------------------------------FLO.20000PhaseIIN/AYESNODoestheflowcytometrylaboratoryh__eawrittenquality__nagement/qualitycontrolQM/QCprogramNOTE:TheQM/QCprogramintheflowcytometrylaboratorymustbeclearlydefinedanddocumented.Theprogrammustensurequalitythroughoutthepre____ytic____yticandpost-____yticreportingphasesoftestingincludingpatientidentificationandpreparation;specimencollectionidentificationpreservationtransportationandpro__ssing;andaccuratetimelyresultreporting.Theprogrammustbecapableofdetectingproblemsinthelaboratory’ssystemsandidentifyingopportunitiesforsystemimprovement.Thelaboratorymustbeabletodevelopplansofcorrective/preventiveactionbasedondatafromitsQMsystem.AllQMquestionsintheLaboratoryGeneralChecklistpertaintotheflowcytometrylaboratory.COMMENTARY:N/AREFEREN__S:1DHautcourtJL.Qualitycontrolpro__duresforflowcytometricapplicationsinthehe__tologylaboratory.He__tol__llTher.1996;38:467-470;2Grata__JWetal.Qualitycontrolofflowcytometricimmunophenotypingofhae__tological__lignancies.ClinLabHaem.1999;21:155-
160.FLO.20010PhaseIIN/AYESNOIsthereadocumentedpro__duredescribingmethodsforpatientidentificationpatientpreparationspecimencollectionandlabelingspecimenpreservationandconditionsfortransportationandstoragebeforetestingconsistentwithgoodlaboratorypracti__COMMENTARY:N/AFLO.20020PhaseIIN/AYESNOIsthereeviden__ofongoingevaluationofinstrument__intenan__andfunctiontemperatureetc.forallpro__duresasrequiredCOMMENTARY:N/AFLO.20050PhaseIIN/AYESNOIstheredocumentationofcorrectiveactiontakenwhenvaluesforinstrumentfunctiontemperatureetc.ex__eddefinedtoleran__limitsCOMMENTARY:Theremustbeeviden__ofdocumentationofcorrectiveactionstakenwheninstrumentfunctiontemperatureetc.ex__eddefinedtoleran__limits.FLO.20100PhaseIIN/AYESNOIsthereadocumentedsysteminoperationtodetectandcorrectsignificantclericaland____yticalerrorsandunusuallaboratoryresultsinatimely__nnerNOTE:Thelaboratorymusth__eadocumentedsysteminoperationtodetectandcorrectsignificantclericaland____yticalerrorsandunusuallaboratoryresults.Onecommonmethodisreviewofresultsbyaqualifiedpersontechnologistsupervisorpathologistbeforereleasefromthelaboratorybutthereisnorequirementforsupervisoryreviewofallreporteddata.Theselectiveuseofdeltachecksalso__ybeusefulindetectingclericalerrorsinconsecutivesamplesfromthesamepatient/client.Incomputerizedlaboratoriesthereshouldbeauto__tictrapsforimprobableresults.Thesystemfordetectingclericalerrorssignificant____yticalerrorsandunusuallaboratoryresultsmustprovidefortimelycorrectionoferrorsi.e.beforeresultsbecome__ailableforclinicaldecision__king.Forsuspectederrorsdetectedbytheenduserafterreportingcorrectionsmustbepromptly__deifsucherrorsareconfirmedbythelaboratory.Eachpro__duremustincludealistingofcommonsituationsthat__ycause____yticallyinaccurateresultstogetherwithadefinedprotocolfordealingwithsuch____yticerrorsorinterferen__s.This__yrequirealternatetestingmethods;insomesituationsit__ynotbepossibletoreportresultsforsomeorallofthetestsrequested.TheintentofthisrequirementisNOTtorequireverificationofallresultsoutsidethereferen__nor__lrange.COMMENTARY:N/AFLO.20200PhaseIIN/AYESNOIntheabsen__ofon‑sitesupervisorsaretheresultsoftestsperformedbypersonnelreviewedbythelaboratorydirectororgeneralsupervisorwithin24hoursNOTE:TheCAPdoesNOTrequiresupervisoryreviewofalltestresultsbeforeorafterreportingtopatientrecords.RatherthisquestionisintendedtoaddressonlythatsituationdefinedunderCLIA‑88forhighcomplexitytestingperformedbytrainedhighschoolgraduatesqualifiedunder42CFR
493.14__b5whenaqualifiedgeneralsupervisorisnotpresent.COMMENTARY:Intheabsen__ofon‑sitesupervisorstheresultsoftestsperformedbypersonnelmustbereviewedbythelaboratorydirectororgeneralsupervisorwithin24hours.TheCAPdoesNOTrequiresupervisoryreviewofalltestresultsbeforeorafterreportingtopatientrecords.RatherthisquestionisintendedtoaddressonlythatsituationdefinedunderCLIA‑88forhighcomplexitytestingperformedbytrainedhighschoolgraduatesqualifiedunder42CFR
493.14__b5whenaqualifiedgeneralsupervisorisnotpresent.REFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7182[42CFR
493.1463a3and42CFR
493.1463c]:7183[42CFR
493.14__b1and42CFR
493.14__b5].-----------------------------------------------------------------PRO__DURE__NUAL-----------------------------------------------------------------Thepro__dure__nualshouldbeusedbypersonnelattheworkbenchandshouldinclude:testprincipleclinicalsignifican__specimentyperequiredreagentstestcalibrationqualitycontrolpro__duralstepscalculationsreferen__intervalsandinterpretationofresults.The__nualshouldaddressrelevantpre-____yticandpost-____yticconsiderationsaswellasthe____yticactivitiesofthelaboratory.Thespecificstyleandfor__tofpro__dure__nualsareatthediscretionofthelaboratorydirector.Theinspectionteamshouldreviewthepro__dure__nualindetailtounderstandthelaboratorysstandardoperatingpro__duresensurethatallsignificantinfor__tionandinstructionsareincludedandthatactualpracti____tchesthecontentsofthepro__dure__nuals.**REVISED**04/06/2006FLO.21000PhaseIIN/AYESNOIsacompletepro__dure__nual__ailableattheworkbenchorintheworkareaNOTE1:Theuseofinsertsprovidedby__nufacturersisnotac__ptableinpla__ofapro__dure__nual.Howeversuchinserts__ybeusedaspartofapro__dureiftheinsertaccuratelyandpreciselydescribesthepro__dureasperformedinthelaboratory.Anyvariationfromthisprintedpro__duremustbedetailedinthepro__dure__nual.Inallcasesappropriatereviewsmustoccur.NOTE2:A__nufacturerspro__dure__nualforaninstrument/reagentsystem__ybeac__ptableasacomponentoftheoveralldepartmentpro__dures.Anymodificationtoordeviationfromthepro__dure__nualmustbeclearlydocumented.NOTE3:Cardfilesorsimilarsystemsthatsum__rizekeyinfor__tionareac__ptableforuseasquickreferen__attheworkbenchprovidedthat:a.Acomplete__nualis__ailableforreferen__b.Thecardfileorsimilarsystemcorrespondstothecomplete__nualandissu__ecttodocumentcontrolNOTE4:Electronic__nualsarefullyac__ptable.Thereisnorequirementforpapercopiestobe__ailablefortheroutineoperationofthelaboratorysolongastheelectronicversionsarereadily__ailabletoallpersonnel.Howeverpro__duresmustbe__ailabletolaboratorypersonnelwhentheelectronicversionsareinac__ssiblee.g.duringlaboratoryinfor__tionsystemornetworkdowntime;thusthelaboratorymust__intaineitherpapercopiesorelectroniccopiesonCDorothermediathatcanbeac__ssedviadesignatedcomputers.Currentpapercopiesofelectronicallystoredpro__duresshouldbe__ailableatthetimeoftheCAPinspectionorrapidlygeneratedattherequestoftheInspector.Electronicversionsofpro__duresmustbesu__ectedtoproperdocumentcontroli.e.onlyauthorizedpersons__y__kechangeschangesaredated/signed__nualorelectronicandthereisdocumentationofannualreview.Documentationofreviewofelectronicpro__dures__ybeaccomplishedbyincludingstatementssuchas“reviewedby[nameofreviewer]on[dateofreview]”intheelectronicrecord.Alternativelypaperreviewsheets__ybeusedtodocumentreviewofelectronicpro__dures.DocumentationofreviewbyasecureelectronicsignatureisNOTrequired.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1251];2vanLeeuwenAM.6Stepstobuildinganefficiencytool.Advan__/Lab.1999:86:88-91;3BorkowskiAetal.Intranet-basedqualityimprovementdocumentationattheVeteransAffairs__rylandhealthcaresystem.Mod.Pathol.2001;14:1-5;4NCCLS.Clinicallaboratorytechnicalpro__dure__nuals-fourthedition;approvedguidelineGP2‑A
4.WaynePA:NCCLS
2002.FLO.21100PhaseIIN/AYESNOIstheredocumentationofatleastannualreviewofallpoliciesandpro__duresintheflowcytometrylaboratorysectionbythecurrentlaboratorydirectorordesigneeNOTE:Thedirectormustensurethatthecollectionofpoliciesandtechnicalprotocolsiscompletecurrentandhasbeenthoroughlyreviewedbyaknowledgeableperson.Technicalapproachesmustbescientificallyvalidandclinicallyrelevant.Tominimizetheburdenonthelaboratoryandreviewersitissuggestedthataschedulebedevelopedwherebyroughly1/12ofallpro__duresarereviewedmonthly.Paper/electronicsignaturereviewmustbeatthelevelofeachpro__dureorasmultiplesignaturesonalistingofnamedpro__dures.AsinglesignatureonaTitlePageorIndexofallpro__duresisnotsufficientdocumentationthateachpro__durehasbeencarefullyreviewed.Signatureorinitialsoneachpageofapro__dureisnotrequired.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7173[42CFR
493.1407e13];2BorkowskiAetal.Intranet-basedqualityimprovementdocumentationattheVeteransAffairs__rylandhealthcaresystem.Mod.Pathol.2001;14:1-
5.FLO.21125PhaseIIN/AYESNODoesthedirectorordesigneereviewandapproveallnewpoliciesandpro__duresaswellassubstantialchangestoexistingdocumentsbeforeimplementationNOTE:Currentpracti__must__tchthepolicyandpro__duredocuments.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1251d].FLO.21150PhaseIIN/AYESNODoesthelaboratoryh__easystemdocumentingthatallpersonnelareknowledgeableaboutthecontentsofpro__dure__nualsrelevanttothescopeoftheirtestingactivitiesNOTE:Theformofthissystemisatthediscretionofthelaboratorydirector.Thereisnospecificrequirementforannualpro__duresign-offbytestingpersonnel.COMMENTARY:N/AFLO.21210PhaseIIN/AYESNOIfthereisachangeindirectorshipdoesthenewdirectorensureoverareasonableperiodoftimethatlaboratorypro__duresarewell‑documentedandundergoatleastannualreviewCOMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1251d].FLO.21220PhaseIIN/AYESNOWhenapro__dureisdiscontinuedisapaperorelectroniccopy__intainedforatleast2yearsrecordinginitialdateofuseandretirementdateCOMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1105a2].----------------------------------------------------------------SPECIMENCOLLECTIONANDHANDLING-----------------------------------------------------------------FLO.22000PhaseIIN/AYESNOArepro__duresadequatetoverifysampleidentityandintegrityincludesspecimensofbloodbodyfluidsandtissuesCOMMENTARY:N/AFLO.22050PhaseIIN/AYESNOAretheredocumentedcriteriafortherejectionofunac__ptablespecimensorthespecialhandlingofsub‑opti__lspecimensNOTE:Thisquestiondoesnotimplythatallsubopti__lspecimensarediscardedornot____yzedbutratherthatthelaboratoryshouldh__eapolicyfordealingwithsuchspecimens.Laboratoriesshouldbealerttosubopti__lspecimenconditionssuchashemolysislipemiaorclottingandthesespecimenconditionsshouldbenotedonthereport.Specimensexhibitingextremesoftheseconditionswheretheaccuracyoftestresultsissignificantlyaffectedshouldberejected.Thelaboratory__ywishtorecordthatadialoguewasheldwiththephysicianwhensuchoccurs.COMMENTARY:N/AREFEREN__S:1DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7183[42CFR
493.1249aandb];2NationalInstituteforAllergyandInfectiousDiseases/DivisionofAIDSguidelinesforflowcytometricimmunophenotypingversion
1.0Jan1993sec
1.
06.FLO.22100PhaseIIN/AYESNOIsthedispositionofallunac__ptablespecimensdocumentedinthepatientreportand/orquality__nagementrecordsNOTE:Thisinfor__tionisessentialtoproperpatienttest__nagementandtothelaboratoryquality__nagementprogram.COMMENTARY:N/A-----------------------------------------------------------------REAGENTS-----------------------------------------------------------------Thelaboratoryhastheresponsibilityforensuringthatallreagentscalibratorsandcontrolswhetherpurchasedorpreparedbythelaboratoryareappropriatelyreactive.Theverificationofreagentperfor__n__isrequiredandmustbedocumented.Anyofseveralmethods__ybeappropriatesuchasdirect____ysiswithreferen____terialsparalleltestingofoldvs.newreagentsandcheckingagainstroutinecontrols.Theintentofthequestionsisfornewreagentstobecheckedbyanappropriatemethodandtheresultsrecordedbeforepatientresultsarereported.Whereindividuallypackagedreagents/kitsareusedthereshouldbecriteriaestablishedformonitoringreagentqualityandstabilitybasedonvolumeofusageandstoragerequirements.Pro__ssingofperiodicwetcontrolstovalidatereagentqualityandoperatortechniqueisatypicalcomponentofsuchasystem.FLO.23000PhaseIIN/AYESNOArereagentscalibrators__llularcontrolsandsolutionsproperlylabeledasapplicableandappropriatewiththefollowingelements
1.Contentandquantitycon__ntrationortiter
2.Storagerequirements
3.Datepreparedorreconstitutedbylaboratory
4.ExpirationdateNOTE:Theaboveelements__yberecordedinalogpaperorelectronicratherthanonthecontainersthemselvesprovidingthatallcontainersareidentifiedsoastobetra__abletotheappropriatedatainthelog.Whileusefulforinventory__nagementlabelingwithdatere__ivedisnotroutinelyrequired.Thereisnorequirementtoroutinelylabelindividualcontainerswithdateopened;howeveranewexpirationdatemustberecordedifopeningthecontainerchangestheexpirationdatestoragerequirementetc.Theinspectorwilldescribespecificissuesofnon-complian__intheInspectorsSum__tionReport.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1252c].FLO.23050PhaseIIN/AYESNOAreallreagentsusedwithintheirindicatedexpirationdateCOMMENTARY:Reagentsmustnotbeusedbeyondtheirstatedorassignedexpirationdate.REFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1252d].FLO.23100PhaseIIN/AYESNOArereagentsstoredasrecommendedbythe__nufacturerCOMMENTARY:Reagentsmustbestoredasrecommendedbythe__nufacturertopreventenviro__entally‑indu__dalterationsthatcouldaffecttestperfor__n__.Ifambienttemperatureisindicatedtheremustbedocumentationthatthedefinedambienttemperatureis__intainedandcorrectiveactionistakenwhentoleran__limitsareex__eded.FLO.23150PhaseIIN/AYESNOArenewreagentlotsand/orshipmentscheckedagainstoldreagentlotsorwithsuitablereferen____terialbeforeorconcurrentlywithbeingpla__dinservi__NOTE:Thepurposeistodeterminethatthenewlotorshipmentoftestreagentgivesaclinicallycomparableresulttotheoldreagent.This__ybeaccomplishedbycomparingtheresultsoftheoldandnewreagenttestedinparallelonthesamefreshcontrolpatientornor__lortestingjustthenewreagentonastandardizedcontrolwithdefinedmeanandreferen__range.Thisdoesnotimplytheneedtocomparethenewreagentlottoanegativecontrol.COMMENTARY:N/AFLO.23250PhaseIIN/AYESNOAretherecommendationsofthe__nufacturerfortheproperuseofreagentsandcontrolsinkitpro__duresfollowedNOTE:Variationsmustbedocumentedbyappropriatetesting.COMMENTARY:Commercialreagentsandcontrolsshouldbeusedinaccordan__withthe__nufacturersdirections.Ifalternativepro__duresareusedthemethodaccuracymustbeevaluatedanddocumentedtojustifythechange.REFEREN__:Caldwell__.____yte-specificreagentsintheflowcytometrylaboratory.ArchPatholLabMed.1998;122:861-
864.FLO.23300PhaseIIN/AYESNOIftherearemultiplecomponentsofareagentkitdoesthelaboratoryonlyusewithin‑kitlotcomponentsofreagentsunlessotherwisespecifiedbythe__nufacturerCOMMENTARY:Iftherearemultiplecomponentsofareagentkitthelaboratorymustusecomponentsofreagentkitsonlywithotherkitsthatareinthesamelotnumberunlessotherwisespecifiedbythe__nufactureroraccuracy/equivalencyisverifiedbythelaboratory.REFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7164[42CFR
493.1252d].FLO.23675PhaseIIN/AYESNOIfpatienttestingisperformedusingClassI____yte-specificreagentsASR’sobtainedorpurchasedfromanoutsidevendordoesthepatientreportincludethedisclaimerrequiredbyfederalregulationsNOTE:ASR’sareantibo___sbothpolyclonalandmonoclonalspecificre__ptorproteinsligandsnucleicacidsequen__sandsimilarreagentswhichthroughspecificbindingorchemicalreactionwithsubstan__sinaspecimenareintendedforuseinadiagnosticapplicationforidentificationandquantificationofanindividualchemicalsubstan__orligandinbiologicalspecimens.AnASRistheactiveingre___ntofanin-house-developedtestsystem.Thischecklistquestioncon__rnsClassIASR’s.ClassIASR’sarenotsu__ecttopreclearan__bytheU.S.FoodandDrugAdministrationFDAortospecialcontrolsbyFDA.MostASR’sareClassI.Ex__ptionsincludethoseusedbybloodbankstoscreenforinfectiousdiseasesClassIIorIIIorusedtodiagnose__rtaincontagiousdiseasese.g.HIVinfectionandtuberculosisclassIII.IfthelaboratoryperformspatienttestingusingClassIASR’sfederalregulationsrequirethatthefollowingdisclaimeraccompanythetestresultonthepatientreport:Thistestwasdevelopedanditsperfor__n__characteristicsdeterminedbylaboratoryname.IthasnotbeenclearedorapprovedbytheU.S.FoodandDrugAdministration.TheCAPrecommendsadditionallanguagesuchasTheFDAhasdeterminedthatsuchclearan__orapprovalisnotne__ssary.Thistestisusedforclinicalpurposes.Itshouldnotberegardedasinvestigationalorforresearch.Thislaboratoryis__rtifiedundertheClinicalLaboratoryImprovementAmendmentsof1988CLIA-88asqualifiedtoperformhighcomplexityclinicallaboratorytesting.Thedisclaimerisnotrequiredfortestsusingreagentsthataresoldinkitformwithother__terialsoraninstrumentnorreagentssoldwithinstructionsforuse.Thelaboratorymustestablishtheperfor__n__characteristicsoftestsusingClassIASR’s.COMMENTARY:IfthelaboratoryperformspatienttestingusingClassIASR’sfederalregulationsrequirethatthefollowingstatementaccompanythetestresultonthepatientreport:Thistestwasdevelopedanditsperfor__n__characteristicsdeterminedbylaboratoryname.IthasnotbeenclearedorapprovedbytheU.S.FoodandDrugAdministration.TheCAPrecommendsadditionallanguagesuchasTheFDAhasdeterminedthatsuchclearan__orapprovalisnotne__ssary.Thistestisusedforclinicalpurposes.Itshouldnotberegardedasinvestigationalorforresearch.Thislaboratoryis__rtifiedundertheClinicalLaboratoryImprovementAmendmentsof1988CLIA-88asqualifiedtoperformhighcomplexityclinicallaboratorytesting.REFEREN__S:1DepartmentofHealthandHu__nServi__sFoodandDrugAdministration.Medicaldevi__s;classification/reclassification;restricteddevi__s;____ytespecificreagents.Finalrule.FedRegister.1997Nov21;62243[21CFR809and864];2Caldwell__.____yte-specificreagentsintheflowcytometrylaboratory.ArchPatholLabMed.1998;122:861-864;3Graziano.Disclaimernowneededfor____yte-specificreagents.CAPToday.1998;1211:5-11;4U.S.DepartmentofHealthandHu__nServi__sFoodandDrugAdministration.____yteSpecificReagents;__allEntityComplian__Guidan__.http://___.fda.gov/cdrh/oivd/guidan__/
1205.htmlhttp://___.fda.gov./cdrh/oivd/guidan__/
1205.htmlFebruary262003;5ShapiroJDandPrebulaRJ.FDA’sRegulationof____yte-SpecificReagents.MedicalDevi__linkFebruary
2003.http://___.devi__link.com/mddi/archive/03/02/
018.htmlhttp://___.devi__link.com/mddi/archive/03/02/
018.html.-----------------------------------------------------------------CONTROLSANDSTANDARDS-----------------------------------------------------------------Controlsaresamplesthatactassurrogatesforpatientspecimens.Theyareperiodicallypro__ssedlikeapatientsampletomonitortheongoingperfor__n__oftheentire____yticpro__ss.Mostquantitativetestsaretraditionallymonitoredwith2levelsofliquidcontrol__terialpro__duralcontrol.Thisisdoneatafrequencywithinwhichtheaccuracyandprecisionofthemeasuringsystemisexpectedtobestablebasedupon__nufacturersrecommendationsbutatleasteachdaythatpatienttestingisperformed.Thedailyuseoftwolevelsofliquidcontrol__yNOTberequiredfor__rtaintestsystemswherethedailyuseofinstrumentand/orelectroniccontrolsisdemonstrablysufficienttovalidatethatcalibrationstatusis__intainedwithinac__ptablelimits.Thedailyuseof2levelsofinstrumentand/orelectroniccontrolsastheonlyQCsystemisac__ptableonlyforu__odifiedtestsystemsclearedbytheFDAandclassifiedunderCLIA‑88aswaivedormoderatecomplexity.Thelaboratoryisexpectedtoprovidedocumentationofitsvalidationofallinstrument‑reagentsystemsforwhichdailycontrolsarelimitedtoinstrumentand/orelectroniccontrolsandtheinspectorwillreviewthesedatatoassesstheadequacyoftheQCsystem.ThisdocumentationmustincludetheFederalcomplexityclassificationofthetestingsystemANDdatashowingthatcalibrationstatusismonitored.**NEW**04/06/2006FLO.23737PhaseIIN/AYESNOIstheperfor__n__ofreagentsandstainingpro__duresverifiedperiodicallybytheuseofpositivecontrolsNOTE:ForsingleplatformmeasurementsofCD4+lymphocyteandCD34+stem__llcon__ntrationstwolevelsofcontrolareneededseethenextchecklistquestionbelow.Thesour__typeofpositivecontrolsandtheirfrequencyofevaluationwillvarybytheparticularflowcytometricapplication.Thefrequencyshouldbe:1eachdayof____ysisforlymphocytesubsetandCD34+stem__llmeasurementsregardlessofwhetherone-ortwo-platformmethodsareused;and2atleastmonthlyforleukemia/lympho__immunophenotyping.Thesour__ofcontrol__terialshouldbe1externalpositivecontrolse.g.nor__lorcommercialcontrolsforlymphocytesubsetCD34+stem__llquantitationsandleukemia/lympho__samples;or2internalpositivecontrolsonlyforleukemia/lympho__samples.Suchinternalcontrol__llsarethevariablenumbersofresidualnor__l__llsinthepatientssample.Liketheexternalcontrolstheremustbewrittenguidelinesdefiningo__ectivecriteriaforac__ptableperfor__n__oftheinternalcontrolsandwrittendocumentationoftheevaluationoftheactualperiodicperfor__n__.COMMENTARY:N/AFLO.23800PhaseIIN/AYESNOForQUANTITATIVEtestse.g.CD4+CD34+__llcon__ntrationsareatleast2levelsofpositive__llularcontrols____yzedatleastdailyoreachtimetheflowcytometerisrestartedtoverifytheperfor__n__ofreagentspreparationmethodsstainingpro__duresandtheinstrumentNOTE:Oneofthelevelsofthesecontrolsshouldbeatornearclinicaldecisionlevelse.g.lowCD
34.ExampleswouldbealowCD4+lymphcountof200__ll/uLinaHIV+individualora5–20CD34+stem__lls/uLcon__ntrationintheperipheralbloodofanindividualbeingrea___dforperipheralstem__llpheresis.Whencommercialcontrolsarenot__ailablethenthelaboratorydirectormustimplementanequivalentpro__duretomeetthetwo-levelrequirement.Thisalternativemustbedeemedac__ptablebythelaboratoryinspectionteamthroughLAP.Controltestingisnotne__ssaryondayswhenpatienttestingisnotperformed.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.1992Feb28:7146[42CFR
493.801].**REVISED**10/06/2005FLO.23925PhaseIIN/AYESNOHasastatisticallyvalidtargetmeanandrangebeenestablishedorverifiedforeachlotofcontrol__terialNOTE:Forunassayedcontrolsthelaboratorymustestablishavalidac__ptablerangebyrepetitive____ysisinrunsthatincludepreviouslytestedcontrol__terial.Forassayedcontrolsthelaboratorymustverifytherecoveryrangessuppliedbythe__nufacturer.COMMENTARY:N/AFLO.24100PhaseIIN/AYESNOArethererecordstoreflecttheresultsofallcontrolpro__duresCOMMENTARY:Resultsofcontrolsmustberecordedroutinelyforeachbatchoftests.FLO.24230PhaseIIN/AYESNOIstheredocumentedeviden__ofcorrectiveactiontakenwhenqualitycontrolresultsex__eddefinedtoleran__limitsCOMMENTARY:Whenqualitycontroldataex__eddefinedtoleran__limitscorrectiveactiontakenmustbedocumenteddescribingthecoursetakenandresultsofthecorrectiveaction.FLO.24250PhaseIIN/AYESNOArecontrolspecimenstestedinthesame__nnerandbythesamepersonnelaspatientsamplesNOTE:Itisimplicitinqualitycontrolthatcontrolspecimensaretestedinthesame__nneraspatientspecimens.MoreoverQCspecimensmustbe____yzedbypersonnelwhoroutinelyperformpatienttesting-thisdoesnotimplythateachoperatormustperformQCdailysolongaseachinstrumentand/ortestsystemhasQCperformedatrequiredfrequenciesandall____ystsparticipateinQConaregularbasis.Totheextentpossibleallstepsofthetestingpro__ssmustbecontrolledrecognizingthatpre‑____yticandpost‑____yticvariables__ydifferfromthoseencounteredwithpatients.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7166[42CFR
493.1256d8].FLO.24300PhaseIIN/AYESNOAretheresultsofcontrolsverifiedforac__ptabilitybeforereportingresultsCOMMENTARY:Controlsmustbereviewedbeforereportingpatientresults.Itisimplicitinqualitycontrolthatpatienttestresultswillnotbereportedwhencontrolsdonotyieldunac__ptableresults.REFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.Clinicallaboratoryimprovementamendmentsof1988;finalrule.FedRegister.2003Jan24:7166[42CFR
493.1256f].**NEW**04/06/2006FLO.24475PhaseIIN/AYESNOArequalitycontroldatareviewedandassessedatleastmonthlybythelaboratorydirectorordesigneeCOMMENTARY:N/AFLO.24650PhaseIIN/AYESNOIfthelaboratoryhasmorethanonemethodforperformingtestsforagiven____ytearetheycheckedagainsteachotheratleasttwi__ayearforcorrelationofpatientresultsNOTE:Thisincludessameordifferentinstrument__kes/models.Thiscomparisonmustincludeallinstruments.Theuseoffreshbloodsamplesratherthansimplystabilizedcommercialcontrolswithpotential__trixeffectsisimportanttodirectlyaddresstheissueofwhetherapatientsampleyieldsthesameresultsonallofthelaboratorysinstruments.Statisticalagreementofcommercialcontrol__terialsacrossinstrumentsdoesnotguaranteecomparabilityofpatientspecimenresults.Incaseswhenpre-____yticalstabilityofpatientspecimensisalimitingfactoralternativeprotocolsbasedonQCorreferen____terials__ybene__ssarybutthe__terialsusedshouldbevalidatedtoh__ethesameresponseasfreshhu__nsamplesfortheinstruments/methodsinvolved.COMMENTARY:N/AREFEREN__:DepartmentofHealthandHu__nServi__s__ntersforMedicareandMedicaidServi__s.MedicareMedicaidandCLIAprograms;CLIAfeecollection;correctionandfinalrule.FedRegister.2003Jan24:5236[42CFR
1998.FLO.25200PhaseIIN/AYESNOAreinstructionsprovidedforminortroubleshootingandrepairsofinstrumentssuchas__nufacturersservi____nualCOMMENTARY:Servi____nualsorinstructionsforminortroubleshootingmustbe__ailablefor__jorinstruments.FLO.25250PhaseIIN/AYESNOAreinstrument__intenan__servi__andrepairrecordsorcopiespromptly__ailabletoandusablebythetechnicalstaffoperatingtheequipmentNOTE:Theeffectiveutilizationofinstrumentsbythetechnicalstaffdependsupontheprompt__ailabilityof__intenan__repairandservi__documentationcopiesareac__ptable.Laboratorypersonnelareresponsibleforthereliabilityandproperfunctionoftheirinstrumentsandmusth__eac__sstothisinfor__tion.Off‑sitestoragesuchaswith__ntralizedmedical__intenan__orcomputerfilesisnotprecludediftheinspectorissatisfiedthattherecordscanbepromptlyretrieved.COMMENTARY:N/AFLO.25300PhaseIIN/AYESNOArerecordsof__intenan__keptandreviewedperiodicallybytheflowcytometrytechnicalsupervisorCOMMENTARY:Recordsof__intenan__mustbekeptandreviewedperiodicallybytheflowcytometrytechnicalsupervisor.FLO.30250PhaseIIN/AYESNOAreappropriatestandardsforeachfluorochromee.g.fluores__ntbeadsruneachdaythattheinstrumentisusedaspartofthecalibrationpro__ss;andaretheresultsrecordedforqualitycontrolpurposesCOMMENTARY:Appropriatestandardsforeachfluorochromemustberuneachdaytheinstrumentisusedandtheresultsrecordedforqualitycontrolpurposes.Thesestepsarene__ssarytooptimizetheflowsystemandtheopticsoftheinstrument.REFEREN__:NCCLS.Clinicalapplicationsofflowcytometry:qualityassuran__andimmunophenotypingoflymphocytes;approvedguidelineH42-A.WaynePA:NCCLS
1998.FLO.30260PhaseIIN/AYESNOArepro__duresestablishedfordeterminingappropriatecolorcompensationsettingsCOMMENTARY:Fortwoormorecolor____ysistheremustbeapro__duretoensurethat__llsco-labeledwithmorethanonefluores__ntreagentcanbeaccuratelydistinguishedfrom__llslabeledonlywithonereagent.__llsstainedwithmutuallyexclusiveantibo___sbearingtherelevantfluorochromesaretheproperreferen____terialforestablishingappropriatecompensationsettings.REFEREN__:NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS
1.Waterbaths
2.Incubatorswheretemperaturecontrolisne__ssaryforapro__dure
3.RefrigeratorsandfreezersNOTE:Temperature-dependentequipmentcontainingreagentsandpatientspecimensmustbemonitoreddailyasequipmentfailurescouldaffectaccuracyofpatienttestresults.Itemssuchaswaterbathsandheatblocksusedforpro__duresneedonlybecheckedondaysofpatienttesting.TheInspectormustprovidespecificdetailsofanydeficienciesinPartBDeficiencySum__ryoftheInspectorsSum__tionReport.COMMENTARY:Temperaturesmustbecheckedandrecordedappropriatelyforeachofthefollowingtypesofequipment.
1.Waterbaths
2.Incubatorswheretemperaturecontrolisne__ssaryforapro__dure
1998.FLO.30450PhaseIIN/AYESNOArespecimensstoredappropriatelyafterinitialpro__ssingCOMMENTARY:Specimensmustbestoredappropriatelyafterinitialpro__ssing.Asoneexampleparafor__ldehyde
0.5%fixationofstained__llspreserves__llularintegrityandfluores__n__forupto5days.Cautionmustbeexercisedinutilizingthispro__dureasfluores__n____ybediminishedwithsomereagentsandcytometers.REFEREN__S:1AmericanSocietyforMicrobiology.__nualofclinicalimmunology4thed.WashingtonDC:A__1992:940;2NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS
1998.FLO.30460PhaseIIN/AYESNOAreappropriategatingtechniquesusedtoselectthe__llpopulationfor____ysisNOTE:This__yinvolveacombinationoflightscatterand/orfluores__n__measurements.Thisisparticularlyimportantifthe__llsamplesh__ealowlymphocytecountand/orarelativelyhighmonocyte‑granulocytecount.COMMENTARY:Gatingtechniquesmustbeusedtoselectthe__llpopulationfor____ysis.Examplesincludelymphocytegatessetusinglinearforwardanglelightscatterand90-degreesidescatteror__ybevalidatedusingCD45‑FITCandCD14‑PEmonoclonalantibo___s.REFEREN__:NationalInstituteforAllergyandInfectiousDiseases/DivisionofAIDSguidelinesforflowcytometricimmunophenotypingver
1.0Jan
1993.FLO.30470PhaseIIN/AYESNOAreresultsoflymphocytesubset____ysiscorrectedforgatepurityasappropriateCOMMENTARY:When5%non‑lymphocyteeventsareincludedinagateresultsmustbecorrectedfortheproportionofcontaminating__lls.OnemethoduseslowsidescatterandbrightCD45fluores__n__foridentificationoflymphocyteswhereanassumptionis__dethattheonly__llsmeetingthiscriteriaarelymphocytesandthereforethelymphocytepurityofthegateiscloseto100%.Othermethods__yalsobeappropriateandmustbedocumented.REFEREN__S:1NationalInstituteforAllergyandInfectiousDiseases/DivisionofAIDS.Revised3colorsupplementtoflowcytometryguidelinessec
5.02;2NCCLS.Clinicalapplicationsofflowcytometry:qualityassuran__andimmunophenotypingoflymphocytes;approvedguidelineH42-A.WaynePA:NCCLS
1998.FLO.30480PhaseIIN/AYESNOIsthereapro__duretoset__rkerscursorstodistinguishfluores__n__negativeandfluores__n__positive__llpopulationsCOMMENTARY:Eachlaboratorymusth__easetofo__ectivecriteriatodefinetheappropriatepla__mentof__rkerscursorstodelineatethepopulationofinterest.Isotypiccontrols__ynotbene__ssaryinallcasesandcursorsettingsfortheisotypecontrol__ynotbeappropriateforall__rkers.Cursorsettingsmustbedeterminedbasedonthefluores__n__patternsfromthenegativeandpositivepopulationsforCD3CD4andCD
8.REFEREN__S:1NationalInstituteofAllergyandInfectiousDiseases/DivisionofAIDSflowcytometryguidelinessec
3.09Band
5.03A;2SreenanJJetal.Theuseofisotypiccontrolantibo___sinthe____ysisofCD3+andCD3+CD4+lymphocytesubsetsbyflowcytometry.Aretheyreallyne__ssaryArchPatholLabMed.1997;121:118-
121.FLO.30500PhaseIIN/AYESNOAretheresultsof____ysesofpatientsspecimensreviewedbythelaboratorydirectorordesigneeandarecommentstocliniciansreportedwhenne__ssarytofacilitateinterpretationoftheresultsCOMMENTARY:Qualityassuran__ofthereportingoflaboratoryresultsrequiresthattheresultsbereviewedbyqualifiedpersonnellaboratorydirectorordesigneeandresultsclearlycommunicatedtoclinicians.FLO.30550PhaseIIN/AYESNODoesthereportincludeanestablishedorverifiedreferen__intervalforbloodlymphocytesubsetsappropriatefortheageofthepatientCOMMENTARY:Age‑and___‑specificreferen__intervalsnor__lvaluesmustbedeterminedbylaboratoryiffeasible.Ifthisisnotpossibleorpracticalthenthelaboratoryshouldcarefullyevaluatetheuseofpublisheddataforitsownreferen__intervalsandretaindocumentationofthisevaluation.REFEREN__S:1KnightJA.Laboratoryissuesregardinggeriatricpatients.LabMed.1997;28:458-461;2NCCLS.Howtodefineanddeterminereferen__intervalsintheclinicallaboratory;approvedguidelineC28‑A
2.WaynePA:NCCLS
1998.FLO.30564PhaseIN/AYESNOIsthereapro__dureinpla__todocumentCD34__llularviabilitywhereapplicableNOTE:Viabilitytestingisnotne__ssaryonperipheralbloodorapheresisspecimensthatarestainedand____yzedwithin4hoursofdrawingharvesting.Cordbloodbone__rrowandsamplesmorethanfourhoursoldshouldh__etotal__llularviabilityevaluatedasaminimumbydyeexclusion.____ysesontheseoldersamplesarepossibleifthelaboratoryhasverifiedtheabsen__ofclinicallysignificantdifferen__sinCD34+__llsbetweenthefreshandagedspecimens.Theviabilitydye7-aminoactinomycin-D7-AADhasbeenreportedtoprovideex__llentresultsinthis____ysis.ApheresissamplesrepresentaspecificsubsetandaredealtwithinFL
0.
30571.COMMENTARY:N/AREFEREN__S:1OwensMLokenM.Peripheralbloodstem__llquantitationInFlowCytometryPrinciplesforClinicalLaboratoryPracti__.NewYorkNY:Wiley-Liss1995:111-127;2KeeneyM.etal.SingleplatformflowcytometryabsoluteCD34+__llcountsbasedontheISHAGEguidelines.Cytometry.1998;34:61-70;3HublWetal.Measurementofabsolutecon__ntrationandviabilityofCD34+__llsincordbloodandcordbloodproductsusingfluores__ntbeadsandcyaninenucleicaciddyes.Cytometry.1998;34:121-127;4Grata__Jetal.FlowcytometricenumerationofCD34+he__topoieticstemandprogenitor__lls.Cytometry.1998;34:128-
142.FLO.30571PhaseIN/AYESNOForapheresissamplesstoredmorethan4hoursisanaliquotoftheproducttakenimmediatelybeforepro__ssingforfreezingautologousdonorsorinfusionallogeneicdonorsNOTE:Forapheresissamplesstoredformorethan4hoursbeforeCD34__ll____ysisanaliquotoftheproductshouldbetakenandtestedforCD34+__llnumbersandviabilityimmediatelybeforeinfusionorpro__ssingforfreezing.Theviabilityasses__entmustbeperformedusingaflowcytometricmethodwiththeviabilitydyeincludedinthesametubewiththeCD34andCD45monoclonalantibo___sforaprecisedeterminationofCD34+__llviabilityseereferen__stoFLO.
30564.Asacorollaryesti__tesoftotal__llularviabilityforexampletrypanblueexclusion__ynotbeusedasanalternativeasthey__yoveresti__tetheviabilityofthemuch__allerandmorefragileCD34stem__llpopulation.Whenforclinicalreasonsitisne__ssarytoperformCD34__ll____ysisonspecimensstoredformorethan4hoursthereportshouldindicatethenumberofhourswhichpassedpriorto____ysisofthespecimenandastatementthatalthoughlaboratoryviabilitytestingisaofreflectiontheabilityofCD34__llstosurviveandproliferateinvivothefunction/engraftmentofCD34__lls____yzedmorethan4hoursafterbeingremovedfromthedonorislesspredictablethanthose____yzedwithin4hours.COMMENTARY:N/AFLO.30578PhaseIIN/AYESNOAreappropriatelyconjugatedClassIIorClassIIIanti-CD34monoclonalantibo___susedCOMMENTARY:ClassIreagentsarenotrecommended.ClassIIreagentsconjugatedtoFITCarenotrecommended.FLO.30585PhaseIIN/AYESNOAreastatisticallyvalidnumberofCD34+eventscollectedtoensureclinicallyrelevantprecisionandaccuracyNOTE:The__ximumcoefficientofvariationforCD34+__llcountsshouldbe10%.Toachievethisprecisionaminimumof100CD34+eventsshouldbecountedasrecommendedbytheISHAGEguidelinesandEuropeanWorkingGrouponClinical__ll____ysis.IftheCD34+__llcountinasampleis
1998.FLO.30640PhaseIIN/AYESNODoesthelaboratoryuseantibo___sappropriatefortheclinicalsituationNOTE:TheInspectorshouldexamineseveralreportsandhistogramsofleukemiasand/orlympho__sthath__ebeenre__ntly____yzedbythelaboratory.COMMENTARY:Thepanelofmonoclonalantibo___semployedmustbesufficientlycomprehensivetoaddresstheclinicalproblemunderconsideration.Knowledgeoftheclinicalsituationand/orthemorphologicappearan__oftheabnor__l__lls__yhelptoguideantibodyselection.Becauseantibo___svaryintheirdegreeoflineagespecificityandbecause__nyleukemiaslackoneormoreantigensexpectedtobepresentonnor__l__llsofaparticularlineageitisrecommendedthata__rtaindegreeofredundancybebuiltintoapanelusedforleukemiaphenotyping.REFEREN__S:1NCCLS.Immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS1998;2RimszaLMetal.Thepresen__ofCD34+__llclusterspredictsimpendingrelapseinchildrenwithacutelymphoblasticleukemiare__iving__intenan__chemotherapy.AmJClinPathol.1998;110:313-320;3SiebertJDetal.Flowcytometryutilityinsubtypingcomponentsofcompositeandsequentiallympho__s.AmJClinPathol.1998;110:536;4KampalathBetal.CD19onT__llsinfollicularlymphocyticleukemia/__alllymphocyticlympho__andT-__ll-richB-__lllympho__:anenig__.AmJClinPathol.1998;110:536;5KrasinskasAMetal.TheusefulnessofCD64othermonocyte-associatedantigensandCD45gatinginthesubclassificationofacutemyeloidleukemiaswithmonocyticdifferentiation.AmJClinPathol.1998;110:797-
805.FLO.30670PhaseIIN/AYESNOAre__llcon__ntrationsadjustedforopti__lantibodystainingCOMMENTARY:Eachlaboratorymusth__eapro__duretoidentifyspecimenswithabnor__l__llcountsandadjustcon__ntrationsforopti__lantibodystaining.REFEREN__:NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS
1998.FLO.30720PhaseIIN/AYESNOAremethodsestablishedtoensurethatimmunoglobulinstainingisintrinsicandnotextrinsiccytophilicNOTE:Thequestionisdirectedtowardsensuringthattheimmunoglobulinlightchain____ysisincludesonlylightchainsynthesizedbyB__llsintrinsiclightchain.__ny__lltypeswillbindserumimmunoglobulinnonspecificallyviaFcre__ptorsincludingB__lls.ToensurethatimmunoglobulinstainingdetectedbyflowcytometryisintrinsiconB__llsratherthancytophilicapan-B__ll__rkere.g.CD19CD20__ybeincludedinthesametubeasoneorbothanti-lightchainreagents.Theinclusionofbothlambdaandkappalightchainreagentsinthesametubeallowsacleardelineationofnon-specificbindingevenonB__lls.COMMENTARY:N/AREFEREN__:NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS
1998.FLO.30730PhaseIIN/AYESNOAretherepro__duresestablishedfordistinguishingabnor__l__llsofinterestfromnor__l__llsbasedontheirlightscatterandfluores__n__propertiesCOMMENTARY:Generallybothneoplasticandnon‑neoplastic__llsareacquiredinanygateusedforacquisition.Attemptsmustbe__detodistinguishthematthetimeof____ysis.Appropriatepro__duresincludeusefluores__ntantibo___sfluores__ntdyeslightscattermeasurementsoranycombinationthereoftoselectouttherelevant__llsubpopulationforfurther____ysis.Morphologicevaluationisalsoavaluableparametertoimprove____ysis.REFEREN__S:1MuirheadKAetal.Methodologicalconsiderationsforimplementationoflymphocytesubset____ysisinaclinicalreferen__laboratory.AnnNYAcadSci.1986;468:113-127;2AmericanSocietyforMicrobiology.__nualofclinicalimmunology4thed.WashingtonDC:A__1992;3SunTetal.Gatingstrategyforimmunophenotypingofleukemiaandlympho__.AmJClinPathol.1997;108:152-157;4NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43‑A.WaynePA:NCCLS1998;5__conWRSalhanyKE.T-__llsubset____ysisofperipheralT-__lllympho__sbyparaffinsectionimmunohistologyandcorrelationofCD4/CD8resultswithflowcytometry.AmJClinPathol.1998;109:610-617;6DunphyCH.Combiningmorphologyandflowcytometricimmunophenotypingtoevaluatebone__rrowspecimensforB-__ll__lignantneopla__s.AmJClinPathol.1998;109:625-
630.FLO.30760PhaseIIN/AYESNOIsthereapro__duretodistinguishfluores__n__‑negativeandfluores__n__‑positive__llpopulationsNOTE:Thisdoesnotimplythataseparatenegativecontrolsamplemustberun.Itispossibletocoordinatepanelsofmonoclonalantibo___stocomparethebindingofmonoclonalantibo___softhesamesubclassthattypicallyh__emutuallyexclusivepatternsofreactivityofsubsetsofhe__topoietic__lls.Inthiswaytestantibo___s__yalsodoubleascontrolreagents.COMMENTARY:Theremustbeapro__duretodistinguishfluores__n__‑negativeandfluores__n__‑positive__llpopulations.Testantibo___s__ydoubleascontrolreagents.Howevertheremustbepro__duresinpla__tocomparedisplaysoftestdatatosimilardisplaysofdesignatedcontrols.Itispossibletocoordinatepanelsofmonoclonalantibo___stocomparethebindingofmonoclonalantibo___softhesamesubclassthattypicallyh__emutuallyexclusivepatternsofreactivityofsubsetsofhe__topoietic__lls.Inthiswaytestantibo___s__yalsodoubleascontrolreagents.REFEREN__:NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS
1998.FLO.30790PhaseIIN/AYESNODoesthefinalreportincludeinfor__tionabouttheimmunophenotypeoftheabnor__l__llsifidentifiedandcommentsne__ssarytofacilitatetheinterpretationNOTE:Clinicalinfor__tionand__ailablepathologic__terialshouldbereviewedtoselectappropriateantibo___sand__oidperformingflowcytometryonnor__ltissues.Ideallydirectmorphologiccorrelationshouldbedone.Suchreviewisappropriateforbone__rrowsamplessolidtissuesandbloodincaseofsuspectedlymphoproliferativedisorders.Incasesinvolvingleukemiaandlympho__phenotypingcorrelationshouldbe__debetweentheimmunologicandpathologicresults.Theflowhistogramsratherthanjusttheper__ntageofpositive__llsshouldbereviewedbythelaboratorydirectorindifficultcases.Thepeakchannelandshapesofthecurves__ybehelpfulinidentifyingclonalpopulations.COMMENTARY:Thefinalreportmustincludeinfor__tionabouttheimmunophenotypeoftheabnor__l__llsifidentifiedandcommentsne__ssarytofacilitatetheinterpretation.REFEREN__S:1NCCLS.Clinicalapplicationsofflowcytometry:immunophenotypingofleukemic__lls;approvedguidelineH43-A.WaynePA:NCCLS1998;2NguyenANDetal.Arelationaldatabasefordiagnosisofhe__topoieticneopla__susingimmunophenotypingbyflowcytometry.AmJClinPathol.2000;113:95-
106.-----------------------------------------------------------------DNACONTENTAND__LLCYCLE____YSIS-----------------------------------------------------------------FLO.31000PhaseIIN/AYESNOAretheremethodstoensurethatspecimenspro__ssedforDNAcontentand__llcycle____ysiscontainneoplastic__llsofinterestNOTE:Thisgenerallyrequiresmicroscopicexaminationofthespecimenbyananatomicorclinicalpathologist.COMMENTARY:Itiscriticalthatspecimenssubmittedforflowcytometric____ysisarerepresentativesamplesoftheneoplasticdisorderbeingcharacterized.Inspecimensinwhichnopopulationofabnor__lDNAcontentisdetecteditisespeciallyimportanttodemonstratethatneoplastic__llsarepresentinthesamplerunthroughtheflowcytometer.Thisgenerallyrequiresmicroscopicevaluationofthespecimenbyananatomicorclinicalpathologist.FLO.31010PhaseIIN/AYESNOAretheremethodsinpla__toaccountfor__llulardebrisandaggregatesCOMMENTARY:__llulardebriscanaffectmeasurementsofS-phasefractionandaggregatescanalterploidyasses__ents;theseneedtobeexcludedfromconsideration.DNA____ysissoftwareprogramsgenerallyprovideoptionsfordebrissubtractionanddoubletdiscrimination.Eachlaboratoryshouldincorporatesuchmethodsintotheirpro__dures.Confir__tionwithfluores__ntmicroscopicexaminationofthestainednuclearsuspension__yprovideadditionaldocumentationof__llularaggregates.FLO.31020PhaseIIN/AYESNOArecriteriaestablishedfordeterminingac__ptablelinearityforDNAcontentmeasurementusing__llsorparticlesofknownrelativefluores__n__COMMENTARY:Criteriamustbeestablishedfordeterminingac__ptablelinearityforDNAcontentusing__llsorparticlesofknownrelativefluores__n__.FLO.31050PhaseIIN/AYESNOArethestainingand____yticalpro__duresdescribedinthepro__dure__nualbaseduponestablishedmethodologyreferen__citedCOMMENTARY:__nydifferentvariablesneedtobecontrolledtoensureproperstoichiometryofdyebindingtoDNA.Thereforeitisessentialthatpro__duresadoptedbyalaboratoryarebasedonpublishedwork.FLO.31100PhaseIIN/AYESNODoesspecimentreatmentwithnucleicaciddyeincludetreatmentwithRNAseifthedyeisnotspecificforDNACOMMENTARY:__rtaindyesusedtostainfixed__llse.g.ethidiumandpropidiumiodidebindtoRNA.PriortreatmentwithRNAseeliminatesartifactualbroadeningoftheDNAcontentdistributionsthatwouldresultfromfluores__n__ofcomplexesofthedyewithRNA.REFEREN__:ShapiroHA.Practicalflowcytometry.NewYorkNY:AlanR.Liss
1985.FLO.31150PhaseIN/AYESNOAretheredocumentedcriteriathatspecifythetypeofneopla__sac__ptableforDNA____ysisCOMMENTARY:Thereshouldbedocumentedcriteriathatspecifythetypeofneopla__sthatshouldbe____yzedforDNAcontent.Thelaboratoryshouldshoweviden__thatitrestricts____ysistothoseneopla__sforwhichtheliteraturesupportssignificantindependentprognosticsignifican__forDNAploidyand/orS‑phase____ysis.REFEREN__S:1DNAcytometryconsensusconferen__.Cytometry.1993;14:471-500;2HensonDetal.CollegeofAmericanPathologistsConferen__XXVIonclinicalrelevan__ofprognostic__rkersinsolidtumors.Sum__ry.ArchPatholLabMed.1995;119:1109-
1112.FLO.31200PhaseIIN/AYESNOAretheredocumentedcriteriaforac__ptabilityofhistogramsforinterpretationCOMMENTARY:Theremustbedocumentedcriteriafortheac__ptabilityofhistogramsforinterpretation.FLO.31250PhaseIIN/AYESNOAretheredocumentedcriteriaforspecimenrejectionforDNAcontent____ysisCOMMENTARY:Theremustbedocumentedcriteriathatdefinewhenspecimensarenotac__ptableforDNAcontent____ysis.FLO.31300PhaseIIN/AYESNOHasthecon__ntrationofnucleicacid‑specificdyebeendeterminedtobeasaturatingcon__ntrationNOTE:Standardtechniquesuseanex__sscon__ntrationoffluorochromesin__con__ntrationsbelowsaturationwill__kethe__llsappearhypoploid.COMMENTARY:Thecon__ntrationofnucleicacid‑specificdyemustbedeterminedtobeasaturatingcon__ntration.Standardtechniquesuseanex__sscon__ntrationoffluorochromesin__con__ntrationsbelowsaturationwill__kethe__llsappearhypoploid.REFEREN__:ShapiroHA.Practicalflowcytometry.NewYorkNY:AlanR.Liss
1985.FLO.31350PhaseIIN/AYESNOArecontrol__llsofknownDNAcontentrunwitheachspecimenorbatchofspecimenstoestablishanac__ptableCVfortheG0/G1peakandtodeterminetheDNAindexCOMMENTARY:Control__llsofknownDNAcontentmustalwaysbeusedwhendeterminingtheDNAindexofanunknown__llpopulation.Repetitive____ysisofthereferen____llsallowsreferen__intervalstobeestablishedtodetermineanac__ptablerangeofresults.ThiscanbeusedasacontrolforDNAstainingandinstrumentalparametersusedinthe____ysis.REFEREN__S:1Hidde__nnWetal.ConventiononnomenclatureforDNAcytometry.Cytometry.1984;5:445-446;2NCCLS.Laboratorystatistics–standarddeviation;areport.WaynePA:NCCLS
1995.FLO.___00PhaseIIN/AYESNOAre____yticalcriteriaestablishedforidentificationofananeuploid__llpopulationinthetestspecimenNOTE:Aninternationalworkshoprecommendedthat__llsornucleishouldbetermedash__inganabnor__lDNAstemlineorDNAaneuploidywhenatleasttwoseparateG0/G1peaksaredemonstrated.COMMENTARY:TheabilitytodetectDNAaneuploidybyflowcytometricmeasurementdependsupontheresolutionoftheDNAmeasurementsusuallyassessedbythecoefficientofvariationCVofthepeaks.CVsshouldbereportedforallclinicalstu___s.TherangeofCVsishighlydependentonthetissuetypeandthewayitisprepared.Histogramsobservedforclinicalspecimensoftenrepresentcomplexoverlappingpatternsbecausemosttumorspecimenscontainamixtureoftumor__llsstro__l__llsandinflam__tory__lls.____ysisofcontrol__llsisne__ssarytoestablishtheCVforanor__ldiploidG0/G1peak.PeriodicreviewoftheCVsforcontrol__llsisne__ssarytoensureadequatefunctioningofthe____yticpro__dure.REFEREN__S:1Hidde__nnWetal.ConventiononnomenclatureforDNAcytometry.Cytometry.1984;5:445-446;2CoonJSetal.Advan__sinflowcytometryfordiagnosticpathology.LabInvest.1987;57:453-
479.FLO.___50PhaseIIN/AYESNOAretheresultsof____ysesofpatientsspecimensreviewedbythelaboratorydirectorordesigneeandarecommentstocliniciansreportedwhenne__ssarytofacilitateinterpretationoftheresultsCOMMENTARY:Reportsfor____ysesofpatientsspecimensmustbereviewedbythelaboratorydirectorordesigneetoensurethatinterpretationofthedatabylaboratorypersonnelisaccurate.Commentsaboutthedata__yberequiredtoenablecorrectinterpretationofthemedicalsignifican__ofthedata.REFEREN__:CoonJSetal.Advan__sinflowcytometryfordiagnosticpathology.LabInvest.1987;57:453-
479.*****************************************************************************PERSONNEL*****************************************************************************FLO.40000PhaseIIN/AYESNODoesthepersoninchargeoftechnicaloperationsinflowcytometryh__eeducationequivalenttothatofanMTASCPandatleastoneyearsexperien__inflowcytometryunderaqualifieddirectorCOMMENTARY:N/A*****************************************************************************PHYSICALFACILITIES*****************************************************************************Sufficientspa__andutilitiesneedtobeprovidedfortheoverallworkloadoftheflowcytometrysectionandtomeetallsafetyrequirementsFLO.50000PhaseIN/AYESNOIsthereadequatespa__foradministrativefunctionsCOMMENTARY:Additionalspa__shouldbeprovidedforadministrativefunctions.FLO.50050PhaseIN/AYESNOIsthereadequatespa__forclericalworkCOMMENTARY:Additionalspa__shouldbeprovidedforclericalwork.FLO.50100PhaseIN/AYESNOIsthereadequatespa__fortechnicalworkbenchspa__COMMENTARY:Additionalspa__shouldbeprovidedfortechnicalworkbenchspa__.FLO.50150PhaseIN/AYESNOIsthereadequatespa__forinstrumentsCOMMENTARY:Additionalspa__shouldbeprovidedforinstruments.FLO.50200PhaseIN/AYESNOIsthereadequatespa__forshelfstorageCOMMENTARY:Additionalspa__shouldbeprovidedforshelfstorage.FLO.50250PhaseIN/AYESNOIsthereadequaterefrigerator/freezerstoragespa__COMMENTARY:Additionalspa__shouldbeprovidedforrefrigerated/frozenstorage.FLO.50300PhaseIN/AYESNOIsthe__ailablespa__efficientlyutilizedCOMMENTARY:Theexistingspa__shouldbeusedmoreefficiently.FLO.50350PhaseIIN/AYESNOIssufficientspa____ailablesothatthereisnocompromiseofthequalityofworkincludingqualitycontrolactivitiesorsafetyofpersonnelCOMMENTARY:N/AFLO.50400PhaseIN/AYESNOArefloorsandbenchescleanfreeofclutterandwell‑__intainedCOMMENTARY:Floorsandbenchesshouldnotbeclutteredorotherwisedeteriorated.Bettercleaningand/or__intenan__pro__duresshouldbeimplemented.FLO.50450PhaseIN/AYESNOArewatertapssinksanddrainsadequateCOMMENTARY:Watertapssinksanddrainsshouldbeimprovedtosupportthetypesofpro__duresandworkloadofthelaboratory.FLO.50550PhaseIN/AYESNOAreelectricaloutletsadequateCOMMENTARY:Electricaloutletsshouldbeimprovedtosupportthetypesofpro__duresandworkloadofthelaboratory.FLO.50600PhaseIN/AYESNOIsventilationadequateCOMMENTARY:Ventilationshouldbeimprovedtosupportthetypesofpro__duresandworkloadofthelaboratory.FLO.50650PhaseIN/AYESNOIslightingadequateNOTE:Directsunlightshouldbe__oidedbecauseofitsextremevariabilityandtheneedforlowlightlevelsne__ssarytoobservevariouscomputerconsolesetc.Lightingcontrolshouldbesectionalizedsogenerallevelsofilluminationcanbecontrolledinareasoftheroomifdesired.COMMENTARY:Lightingshouldbeimproved.REFEREN__:CollegeofAmericanPathologists.Medicallaboratoryplanninganddesign.NorthfieldIL:CAP
1986.FLO.50700PhaseIN/AYESNOIstemperature/humiditycontroladequateCOMMENTARY:Temperature/humiditycontrolshouldbeimprovedtosupportthetypesofpro__duresandworkloadofthelaboratory.FLO.50750PhaseIN/AYESNOAretelephonesconvenientlylocatedandarecallseasilytransferredCOMMENTARY:Telephonesnumberand/orlocationshouldbeimprovedtosupportthetypesofpro__duresandworkloadofthelaboratory.*****************************************************************************LABORATORYSAFETY*****************************************************************************TheinspectorshouldreviewrelevantquestionsfromtheSafetysectionoftheLaboratoryGeneralchecklisttoassurethattheflowcytometrylaboratoryisincomplian__.PleaseelaborateuponthelocationandthedetailsofeachdeficiencyintheInspectorsSum__tionReport.FLO.50850PhaseIIN/AYESNODothepro__dure__nualscontaininfor__tionforsafehandlingofclinicalsamplesandinstrumentswithregardtoinfectiousbiohazardriskscryogenicsubstan__scarcinogenicdyesandlasersCOMMENTARY:N/AFLOWCYTOMETRYPage2of48。