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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
USER GUIDEScore-TB packageBuilding Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA MethodologyVersion 1.5 – July 2020
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ContentsContents 2
Acronyms & Abbreviations 3
Acknowledgements 4
1. Guidance to readers 4
Background 4
Target audience 5
2. Overview 6
3. User Guide 7
3.1Requiredassessorcompetencyprofile 7
3.2Schedulingandperformingassessments 7
3.3TheSLIPTAchecklist(Version2:2015) 9
3.4TheTBLabQualityScorecards 9
3.4.1Useofthescorecards 9
3.4.2Scoring 10
3.4.3InformationonthespecificTBLabQualityScorecards 10
3.5 Reporting the assessment 31
References 32
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Acronyms & AbbreviationsASLM
BSC
BSL
CDC
DST
EQA
FIND
GLI
GLI tool
ICMR
ISO
LF-LAM
LJ
LMIC
LPA
LQSI tool
MTB
NA
NTM
NTP
NTRL
PT
QMS
RIF
RCF
SR
PPE
QC
SLIPTA
SLMTA
SOP
TAT
TB
TB SLMTA
TB-LAMP
USAID
WHOZN
AfricanSocietyforLaboratoryMedicine
BiologicalSafetyCabinet
BiosafetyLevel
UnitedStatesCentersforDiseaseControlandPrevention
DrugSusceptibilityTesting
ExternalQualityAssessment
FoundationforInnovativeNewDiagnostics
GlobalLaboratoryInitiative
GlobalLaboratoryInitiativeStepwiseProcessTowardsTBLaboratoryAccreditation
IndiaCouncilforMedicalResearch
InternationalOrganizationforStandardization
LateralFlowUrineLipoarabinomannanAssay
Löwenstein-Jensen
Low-andMiddle-IncomeCountries
Line-probeAssay
LaboratoryQualityStepwiseImplementationtool
Mycobacteriumtuberculosis
NotApplicable
NontuberculousMycobacteria
NationalTuberculosisProgram
NationalTuberculosisReferenceLaboratory
ProficiencyTesting
QualityManagementSystem
Rifampicin
RelativeCentrifugalForce
Substrate Reagent
PersonalProtectiveEquipment
QualityControl
StepwiseLaboratory(Quality)ImprovementProcessTowardsAccreditation
StrengtheningLaboratoryManagementTowardsAccreditation
StandardOperatingProcedure
Turnaround Time
Tuberculosis
SLMTAadaptedforTBlaboratories
TBLoop-MediatedIsothermalAmplification
UnitedStatesAgencyforInternationalDevelopment
WorldHealthOrganization
Ziehl-Neelsen
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
AcknowledgementsThedevelopmentoftheScore-TBPackagewasledbyFINDwithcontributionsfromAndreTrollipandHeidiAlbert(FIND)andTjeerdDatemaandLindaOskam(DATOS).TheTBLabQualityScorecardsdrawfromanumberofexistingtools,includingCDCLaboratoryAssessmentofAntimicrobialResistanceTestingCapacitychecklist,IndiaCouncilforMedicalResearch(ICMR)TBChecklist,the World Health Organization (WHO) Regional Office for Africa's SLIPTAchecklistandFIND’sTBLaboratoryQualityManagementSystemsTowardsAccreditationHarmonizedChecklist.
1. Guidance to readersThisuserguideinstructsassessorsonhowtousetheScore-TBPackagefortuberculosis(TB)laboratoryassessment.Chapter2startswithanexplanationofthestructureandcontentsoftheScore-TBPackage.Chapter3proceedswithabriefexplanationofhowtoscheduleandperformassessmentsandhowtousetheindividualTBLabQualityScorecardsoftheScore-TBPackage.Thechapterendswithinstructionsonhowtoreportassessmentfindings.
Important:WeassumethatassessorsarelaboratoryexpertswithexperienceinTBtestingandinLaboratoryQualityManagement.Therefore,thisuserguidedoesnotprovidedetailedinformationonspecificTBtests.Instead,foreachTBtest,chapter3providesreferencestoguidanceandreferencematerialsdevelopedbypartners(includingtheGlobalLaboratoryInitiative(GLI),WorldHealthOrganization(WHO),andtheUnitedStatesAgencyforInternationalDevelopment(USAID)ChallengeTBproject)thatprovideessentialbackgroundinformationforassessors.Specifictechnicalinformationisalsoprovidedinthescorecardsthemselves.ItisassumedthatassessorsusingtheScore-TBPackagearealreadycertifiedandcompetentinconductinglaboratoryassessmentsandthattheycomplywiththerequiredassessorcompetencyprofiledescribedinsection3.1.
Background
Despitethefactthatlaboratoryresultsinfluence70%ofmedicaldiagnoses,laboratoryservicesinlow-andmiddle-incomecountries(LMICs)havelongbeenaneglectedcomponentofhealthcaresystems[1–7].TBlaboratories,whichareanessentialcomponentinallstagesoftheTBcarecascade,arenoexception[8].Akeyinterventiontostrengthenlaboratoryservicesistheimplementationofaqualitymanagementsystem(QMS)[9–11].AQMSisdefinedbytheInternationalOrganizationforStandardization(ISO)asthe“managementsystemtodirectandcontrolanorganizationwithregardtoquality”[12,13].Henceitisthesystem(“thesetofinterrelatedorinteractingelements”[13])aimedatimplementingandoperationalizingqualitymanagementinanorganization.StandardizationoftestingthroughimplementationofaQMShasbeenshowntoimprovethequalityoftestingbyreducingtestingerrors[14].
Severaltoolsandinitiativestoassistlaboratoriesimplementqualityimprovementactivitieshavebeendeveloped.OneofthemostsuccessfulapproachestoQMSimprovementistheStrengtheningLaboratoryManagementtowardAccreditation(SLMTA)approach,firstdescribedbyYaoetal.[15].TheSLMTAapproachisoftenusedinconjunctionwiththeStepwiseLaboratoryImprovementProcessTowardsAccreditation(SLIPTA)checklist[16].TheSLIPTAchecklistwasdevelopedbythe WHORegionalOfficeforAfricaandpartnersin2010inrecognitionofthegapbetweenthecurrentstateoflaboratoryqualityandtherequirementsoftheISO15189:2007standard[17].In2015,theSLIPTAchecklistwasadaptedtoincorporatetherequirementsoftheISO15189:2012standardandbecameknownas‘SLIPTAv2:2015’[18].
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
TheFoundationforInnovativeNewDiagnostics(FIND)hasreportedonthedevelopmentofaTBlaboratory-specificapproachcalledTBStrengtheningLaboratoryManagementtowardAccreditation(TBSLMTA)[19].TheprogramisbasedontheexistingsuccessfulSLMTAapproachandutilizedarevisedchecklist(TBHarmonizedChecklist)basedonSLIPTA,butincorporatingsomeelementsfromtheGLItoolwithafocusonthetechnicalsideofTBlaboratorytesting.
In2019,anadditionaltechnicalrevisionwasmadetotheTBSLMTAHarmonizedChecklisttoincludeTBtestingmethodsnotincludedinpreviousrevisions.ThecurrentmajorrevisionconcernstheincorporationoftheTBSLMTAHarmonizedChecklistintothe‘Score-TBPackage’,whichalsoincludesanelectronicversionofthechecklistreferredtoasthe‘e-tool’.Thee-toolsubstantiallyincreasesuser-friendlinessandreducestheriskforerrorsbyautomatingthecalculationofassessmentscoresandpresentingtheseinareportingworksheettovisualizestrengthsandweaknessesofalaboratory’sQMS(theSLIPTAscore)andTB testing methods.
Target audience
TheScore-TBPackageisintendedtoinformMinistriesofHealthofficials,healthfacility-andlaboratorymanagers,donors,implementingpartners,qualityassurancepersonnel,programmanagersandsupervisorystaffatnational,regionalandfacilitylevelonrequirementsfordeliveringquality-assuredlaboratorytestingforTBandensuringeffectiveuseoflaboratoryresourcesaswellasdataforpatientmanagementandsurveillanceinLMIC.
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2. OverviewTheScore-TBPackageconsistsofthefollowingcomponents:
1. The User Guide2.TheTBLabQualityScorecards,consistingofthefollowingscorecards:
1. Generalprocedures ThisscorecardincludesquestionsthatarenotrelatedtoonespecificTBtestbutarerelevantforaTBlaboratory.Thisscorecardshouldalwaysbecompletedforeachassessment.
2. Smear microscopy Containsquestionspecificforsmearmicroscopy(lightmicroscopyand/orfluorescencemicroscopy),onlyapplicabletolaboratoriesthatperformthistest.
3. TBculturefordetectionandidentificationofmycobacteria ContainsquestionsspecificforTBculture,onlyapplicabletolaboratoriesthatperformthistest.
4. PhenotypicDrugSusceptibilityTesting(DST) ContainsquestionsspecificforDST,onlyapplicabletolaboratoriesthatperformthistest.
5. XpertMTB/RIF ContainsquestionsspecificforXpertMTB/RIFandXpertMTB/RIFUltratesting,onlyapplicabletolaboratoriesthatperformthistest.
6. LateralFlowUrineLipoarabinomannanAssay(LF-LAM) ContainsquestionsspecificfortheLF-LAMtest,onlyapplicabletolaboratoriesthatperform this test.
7. Loop-MediatedIsothermalAmplification(TB-LAMP) ContainsquestionsspecificfortheTB-LAMPtest,onlyapplicabletolaboratoriesthatperform this test.
8. LineProbeAssay(LPA) ContainsquestionsspecificforLPA,onlyapplicabletolaboratoriesthatperformthistest.
9. TrueNat ContainsquestionsspecificfortheTruenattest,onlyapplicabletolaboratoriesthatperform this test.
3. The SLIPTA checklist
InthehardcopyversionoftheTBscorecards,referencestoSLIPTAchecklistquestionsaregiven.Inthee-tool,theTBscorecardquestionsareincorporatedintheSLIPTAchecklist,meaningthatthescoresontheTBscorecardquestionsareincorporatedinthecalculationoftheSLIPTAscore.
Additional resources:
1.WHOSLIPTAChecklistVersion2:2015
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
3. User Guide ThischapterexplainshowtoscheduleandperformassessmentsusingtheScore-TBPackageandhowtousetheTBLabQualityScorecards,andhowtocalculateandreportassessmentfindings.Inaddition,referencestoessentialguidanceandreferencematerialsdevelopedbypartnersareprovidedforeach scorecard. 3.1 Required assessor competency profile
Assessmentsareobjectivemeasurestoinvestigatecompliancewithstandardsand/orregulations.AssessmentsconductedusingtheScore-TBPackageshouldyielddetailedinformationonaTBlaboratory’squalityingeneral,andthecorrectconductofspecificTBdiagnostictests.Itisthereforeessentialthatassessorsarecompetentandfamiliarwithallthedetailsof,andrecommendationsrelatedto,theTBtestshe/sheisgoingtoassess.Therefore,theassessmentsusingtheScore-TBpackageshouldonly be conducted by SLIPTA certified assessorswho,inaddition,are:
• FamiliarwithTBlaboratorypractice• Wellversedin,andknowledgeableof,thedetailsrelatedtothespecificTBtestsincludedinthe Score-TBPackage.
3.2 Scheduling and performing assessments
Assessmentsareaneffectivemeansto:1)determineiftheTBlaboratoryisprovidingaccurateandreliableresultsforTB;2)determineiftheTBlaboratoryandclinicalsitesarewell-managedandlaboratoryresultsarebeingreportedandusedeffectivelyforclinicalmanagementandsurveillance;and3)identifyareasforimprovement. Thescorecardscanbeusedinseveralways:
1. FortheassessmentofaTBlaboratory,theTBLabQualityScorecardscanbeusedwithorwithouttheSLIPTAchecklistaswillbefurtherexplainedbelow.
2. Assessorsmayelecttoconducttheassessmentusingpaper-basedscorecardswithlaterentryofdataintothee-toolforscorecalculation,analysis,andreporting,ortheymayenterdatadirectlyintothee-toolatthetimeoftheassessment1.Itisstronglyrecommendedtousethee-toolforscorecalculation(seebelow).
3. AssessorsmayelecttoperformtheSLIPTAassessmentfirstandthentheTBassessment,orviceversa.4. Itisrecommendedthataminimumoftwoassessorsperformtheassessment,wherebyoneasksthequestionsandthesecondpersonrecordstheanswers.
5. Theassessorsshouldallowapproximately6hourstocompletetheGeneralProcedures-scorecardandapproximately1-2hourstocompleteeachtestspecificscorecard.
6. Theassessorshouldallowapproximately1.5daystocompletetheSLIPTAchecklist.7. Assessorsshoulddiscussaccessingdatawiththelaboratorypriortoperformingtheassessment.Laboratoriesshouldalsoberequestedtoprovidekeyqualitydocuments(suchasSOPs,qualitymanual,biosafetymanual,etc.)andquantitativedatainadvanceoftheassessmentforreviewbytheleadassessor.Ifthelaboratoryisunabletoprovidedocumentationanddatainadvance,assessorsshouldscheduleadditionaltimetoreviewdocumentationon-site.Alternatively,anadditionalassessorcanbetaskedwithdocumentreview,whiletheotherassessor(s)assessthetechnicalaspectsofthelaboratory.
8. Laboratoriesshouldberequestedtoprovidekeyqualityindicatordata(seesection11ofeachscorecard).
1Fullinstructionsonuseofthee-toolareprovidedwithinthee-toolitself.Informationanddatacollectedinthepaper-basedscorecardsande-toolarethesame.
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9. Assessorsshouldnotethatwhenplanningassessmentsofmultiplelaboratories,thelengthofthevisitswillvarybaseduponfourmainfactors:
I. Numberoflaboratoriestobeassessed.II. Sizeofthelaboratoriestobeassessed.III. Testmenu/diagnosticspectrumofthelaboratoriestobeassessed.IV.Numberofassessorsontheassessmentteam.V. Logistics and transportation considerations.
Duringtheassessment,assessorsshould: • Explainatthestartoftheassessmentthescopeoftheassessment,theassessmentmethod,andensurethatstaffarecomfortabletocontributetotheassessmentbymakingthemunderstandthatthisisnotapersonalcompetencyassessmentbut,instead,anassessmentofthelaboratoryprocesses,andthattheassessmentisnotintendedtoleadtodisciplinarymeasuresagainstindividualsbuttoimprovethefunctioningofthelaboratoryasawhole.
• Aggregatedataand/orreviewexistingqualityindicatordatatodeterminethenumberoftestsbymethodtype,aswellasthenumberofpositiveresults,DSToutcomesandnumberofnegativeorcontaminatedcultures(whereapplicable).
• Reviewlaboratoryanddocumentstotriangulatefindingsandverifythatpolicies,manuals,StandardOperatingProcedures(SOPs)andotherdocumentationarecomplete,current,accurate,and annuallyreviewed.
• ReviewrecordsandotherrelevantdocumentstoverifythatTBpoliciesarebeingfollowed.• Observelaboratoryoperationstoensure:
− aboratorytestingfollowswrittenpoliciesandproceduresinpre-analytic,analyticandpost-analyticphasesoflaboratorytestingforTB.
− laboratoryproceduresareappropriateforthetestingperformed. − deficienciesandnon-conformitiesidentifiedareadequatelyinvestigatedandresolvedwithintheestablishedtimeframe.
• Askopen-endedquestionstoclarifydocumentationseenandobservationsmade.Askquestionslike,“showmehow…”or“tellmeabout…”Itisoftennotnecessarytoaskallthechecklistquestionsverbatim.Anexperiencedassessorcanoftenanswermultiplechecklistquestionsatthesametimethroughopen-endedquestions.
• Followapatientspecimenthroughthelaboratoryfromcollectionthroughregistration,preparation,analyzing,resultverification,reporting,printing,andpost-analytichandlingandstoringsamplestodeterminethestrengthoflaboratorysystemsandoperations.
• Checkwhetherproficiencytesting(PT)resultsarereviewedandcorrectiveactiontakenasrequired.• Evaluatethequalityandefficiencyofsupportingworkareas(e.g.,samplecollection,dataregistrationandreception)andstaff(messengers,drivers,cleanersandIT)andoversightcommitteessuchastheHospitalmanagementandtheNationalTBProgram.
• Modelpropersafetypracticesandtakenecessarysafetyprecautionsduringtheassessment.E.g.:weartheproperPersonalProtectiveEquipment(PPE)(gown,gloves,mask).
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
3.3 The SLIPTA checklist (Version 2:2015)
TheTBLabQualityScorecardsaredesignedtobeusedinconjunctionwiththeSLIPTAchecklist(Version2:2015).TheSLIPTAchecklistwasdevelopedbyWHO Regional Office for Africa,incollaborationwiththeAfricanSocietyforLaboratoryMedicine(ASLM),U.S.CentersforDiseaseControlandPrevention(CDC)andhostcountries.Theobjectiveofthechecklististoprovideaframeworkforimprovingqualityof(public)healthlaboratoriesindevelopingcountriestoachievetherequirementsoftheISO15189standard.Sinceitsinceptionin2008,theSLIPTAchecklisthasundergoneonerevisionin2015.ThecurrentSLIPTAchecklist(v2)canbedownloadedfromhttp://apps.who.int/iris/handle/10665/204423.
ItisbeyondthescopeofthisuserguidetoprovideinstructionsontheuseoftheSLIPTAchecklist.TheSLIPTAchecklistitselfcontainsinstructionsforitsuse(seePartIIoftheSLIPTAchecklist)andfurtherinstructionsareprovidedintheSLIPTAGuidewhichcanbedownloadedathttp://www.who.int/tb/laboratory/afro-slipta-checklist-guidance.pdf.ComprehensivetrainingforSLIPTAauditorsisprovidedbyASLM(http://www.aslm.org/what-we-do/slipta/).
3.4 The TB Lab Quality Scorecards
TheTBLabQualityScorecardsareavailableinhard-copyandelectronic(e-tool)formats.Thee-toolalsocontainsadigitalversionoftheSLIPTAchecklist,wherebytheTBLabQualityScorecardsaremergedwiththeSLIPTAchecklisttoenablecalculationofone,overall,TB-SLIPTAscoreforthelaboratory.
3.4.1 Use of the scorecardsItisstronglyrecommendedtousethee-toolinsteadofthepaper-basedscorecardsforscorecalculationbecausethee-toolenablesautomaticcalculationofscoreswhereaswiththepaper-basedscorecardsthisneedstobedonemanually,whichismorepronetoerrors.Anotheradvantageofusingthee-toolisthatitdirectlyvisualizesthescoringandtheprogresssincethepreviousassessment,ifapplicable.Thepaper-basedscorecardscouldbeconvenientforuseduringtheassessmenttonotefindingsontheprintedscorecardswithtranscriptionintothee-tooldirectlyfollowingtheassessment.Notethat,ifobservingTBtestingintheBiosafetyLevel(BSL)3facility,paper-basedscorecardsshouldbeusedandtheuseofelectronicdevicesbeavoidedforsafetyreasons.
TheTBLabQualityScorecardscanbeusedintwowayswhenusingthee-tool:
1. OnecouldassessthecorrectimplementationandoperationofspecificTBtests,usingtheGeneralProcedures-scorecardincombinationwiththerespectivescorecardsforthetestsasstand-alonescorecards.Thee-toolwillcalculateascoreforthescorecardsthathavebeencompleted.
2. OnecouldusetheTBLabQualityScorecardsaspartofacomprehensiveSLIPTAassessmenttoverifycorrectimplementationofSLIPTArequirements,withaspecificfocusonTBtesting.Thee-toolwillcalculatescoresforeachscorecardbutwillalsocalculateone,overall,SLIPTAscore.
Inanassessment,theGeneralprocedures-scorecardshouldalwaysbeused.ThisscorecardcontainsquestionstoassessTB-specificlaboratoryprocessesunrelatedtospecificTBlaboratorytests.Subsequently,dependingonthetestmenuofthelaboratory,theassessor(s)mayuseoneormoretechnicalscorecardstoassesstechnicalcomplianceofspecificlaboratorytests.Forexample:
• Ifalaboratoryonlyperformssmearmicroscopy,thislaboratoryshouldbeassessedwiththeGeneralprocedures-scorecardandtheSmearmicroscopyscorecard.
• Ifalaboratoryperformssmearmicroscopy,culture,DSTandLF-LAM,thislaboratoryshouldbeassessedwiththeGeneralprocedures-scorecardandthescorecardsforsmearmicroscopy,culture,DSTandLF-LAM.
Inthee-tool,onthe‘SetAuditScope’-tab,theassessorcanindicatewhichtestsareperformed.Basedontheselection,thee-toolwillprovidealistoflinkstoscorecardsthatshouldbeusedfortheassessment.
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3.4.2 ScoringTheTBLabQualityScorecardsusethesamescoringsystemastheSLIPTAchecklist.Eachscorecardquestionhasbeenawardedapointvalueof2,3,or5points—basedonrelativeimportanceand/orcomplexity.Responsestoallquestionsareratedas,“yes”,“partial”,or“no”.Questionsansweredwith“yes”receivethecorrespondingpointvalue(2,3,or5points).Forquestionswithsubquestionsor“ticklists”,allsubquestionsmustbeansweredwith“yes”toreceivethemaximumnumberofpoints. • Questionsmarked“partial”receive1point.• Questionsmarked“no”receive0points.• Whenmarking“partial”or“no”,notesshouldbewritteninthecommentsfieldtoexplainwhytherequirementwasnotfulfilled.
• Whenquestionconsistsofsubquestions,theoverallanswercanonlybe“yes”ifallsubquestionsareansweredwith“yes”.
Whereachecklistquestiondoesnotapply,thisshouldbeindicatedas“NA”.Inthiscase,thequestiondoesnotcountforthecalculationoftheoverallscore.Thee-toolautomaticallyomitsquestionsansweredwithNAfromthecalculationoftheoverallscore.Itisthereforerecommendedtousethee-tooltocalculatethescores.Ifthepaper-basedscorecardsareusedinsteadofthee-tool,theassessorshoulddothiscalculationmanually.Inthiscase,theassessorshouldcalculatethesumoftotalpossiblepointsthatcanbescoredwithallquestionsansweredwith“NA”andsubtractthatfromthetotalnumberofpointsthatcanbescoredfortheoverallsection.Thispreventsthatlaboratoriesforwhichcertainquestionsarenotapplicable,areneverabletoreachthemaximumscore.
Example: During an assessment, question 11.2 of the General Procedures-scorecard: “Are aggregate reports shared periodically with clinicians/NTP/NTRL (as applicable)?” is answered with ‘NA’. The total number of points that can be scored with this question is 2. The total number of points that can be scored in the General Procedures-scorecard is 72. But because this question is answered with ‘NA’, the two points for this question should be subtracted from the total number of points that can be scored in the General Procedures-scorecard, which, hence, becomes 70.
3.4.3 Information on the specific TB Lab Quality ScorecardsBelow,detailedguidanceisprovidedoncompletingeachTBLabQualityScorecard,startingwiththeGeneralProcedures-scorecard,followedbythetest-specificscorecards.Thescorecards(withorwithoutSLIPTA)canalsobeusedforinternalandexternalaudits.
Scorecard structure
Allscorecardshavethesamestructure,consistingofthreeparts:
• Score• PartA:Generalinformation• PartB:Technicalinformation
Scoresummarizesthescoresfortheassessment.This section should only be completed if the assessor uses the paper-based scorecards without the e-tool as the e-tool calculates the scores automatically.
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Ifcompletingthissection,assessorsshouldnotethedateofthecurrentassessmentandthedateofthepreviousassessment,ifany.Thetotalpointsscoredforeachscorecardsectionshouldbetranscribedtotheplaceprovidedandthepercentageforeachsectioncalculated(pointsofsectiondividedbytotalpointsexpressedasapercentage).Notethatsomequestionsmaynotbeapplicablewhichthenaffectstheoveralltotalofthechecklist–assessorsshouldreplacethedenominatorandcalculatescorebasedonthepercentageaccordingly,asexplainedinparagraph3.3.2.Onceallthesectionsarecompleted,thetotalscoreandtotalpercentagecanbecalculated.Starsaresubsequentlyawardedbasedonthefollowingthresholds:
• Nostars:<55%• 1star:55%-64%• 2stars:65%-74%• 3stars:75%-84%• 4stars:85%-94%• 5stars:≥95%
Ifapreviousassessmenthasbeenperformed,assessorsshouldreviewthescoresandnotewhetherthelaboratoryhasimprovedsincethelastassessment.Improvementsandprogress(orlackthereof)towardsmeetinglaboratoryassessmentobjectivesshouldbereviewedwithlaboratorymanagement(see3.4Reportingtheassessment).
Part A: General informationiscompulsoryforallassessments.ThesectionisusedtocollectgeneralinformationabouttheTBlaboratoryandprovidestheassessorthecontextforperformingtheassessment.ThissectionismostelaborateintheGeneralProcedures-scorecardwhereasitisonlyminorinthetest-specificscorecards.Thesectionisbestcompletedbythefacilitymanager(orequivalent)beforethestartoftheassessmentandverifiedatthestartoftheassessmentatthelaboratory.
Part B: Technical information, isthemostelaboratepartofthescorecards.Inallscorecards,PartBstartswithasectioncapturingquantitativedataonspecificaspects,suchasequipmentavailability,functioning,servicingandmaintenance,thenumberoftestsperformed,stratifiedinseveralcategories,thereportingmethodologyusedbythelaboratory,etc.Itisstronglyrecommendedtoaskthelaboratorytocompletethesectionitselfpriortotheassessment,afterwhichtheassessorsverifycorrectcompletionofthissectionatthestartoftheassessment.Thisisrecommendedbecausethecollectionofquantitativedatawillrequiretimethatmightnotbeavailableduringtheassessment.
TheremainderofPartBconsistsof‘closed’/multiple-choicequestions.Thesameoutlineisusedforallscorecards,followingtheSLIPTAchecklist.ThequestionsineachsectionsupplementthequestionsoftheSLIPTAchecklistandshouldbeaskedinconjunctionwiththequestionsfromtheSLIPTAchecklist.Thequestionscoverthefollowingtopics:
• Section1:Documents&Records Questionscoverdocumentationrelatedtopolicies,processes,clientinstructions,andrecordingandreportingmechanismsspecificforTBtesting.Documentscanberequestedandreviewedpriortotheassessment.TheanswersarebestverifiedtogetherwiththeLaboratoryManagerand/orthepersonresponsibleforthedocumentcontrolsystem.QuestionsrelatedtoSection2arepresentin allscorecards.
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• Section2:ManagementReviews QuestionscoverthereportingoflaboratoryfindingsandqualityindicatorsatanaggregatedleveltodecisionmakerssuchasNTPandNTRL.Documentssuchasyearlyreportscanberequestedandreviewedpriortotheassessment.TheanswersarebestverifiedtogetherwiththeLaboratoryManager.QuestionsrelatedtoSection2areonlypresentintheGeneralProcedures-scorecard.
• Section3:Organization&Personnel QuestionscovertrainingofstaffandstafffollowingproceduresasdescribedintherelevantSOPs.Trainingrecords,competencyassessmentreportsanddutyrosterscanberequestedandreviewedbeforehandandverifiedwiththeLaboratoryManagerand/orHRManager.WhetherstafffollowsproceduresshouldbeobservedatthebenchanddirectlyobservedwiththeSOP.Randomlychoosea fewtechniquestoobserve.QuestionsrelatedtoSection3areonlypresentintheGeneral Procedures-scorecard.
• Section4:ClientManagement&CustomerService Questionscoverinstructionsforsamplecollectionofsputumsamplesaswellasextra-pulmonarysamplesandfeedbacktocliniciansaftertesting.InstructiondocumentssuchastheCustomerHandbookcanberequestedandreviewedbeforehand,feedbacktoclinicianscanbediscussedwiththeLaboratoryManagerormicrobiologist/pathologistandproofshouldberequested.Questionsrelatedtosection4arepresentinallscorecards.
• Section5:Equipment Equipmentquestionscovertheuseofverifiedandvalidatedmethods2,installation,location,andmaintenanceofequipment.ThesecanbebestdiscussedwiththeEquipmentOfficer(technicalaspects)andtheQualityOfficer(verificationandvalidationaspects).Randomlychooseafewtechniquestoobserve.QuestionsrelatedtoSection5areonlypresentintheGeneralProcedures-scorecard.
• Section6:EvaluationandAudits QuestionscoverregularinternalandexternalauditingoftheTBlaboratory(separatelyoraspartoflargeraudits)andfollowupofresultingrecommendationsandactionplans.ThesecanbebestdiscussedwiththeQualityOfficer.Documentationforfollowupofactionsshouldbereviewed.QuestionsrelatedtoSection6areonlypresentintheGeneralProcedures-scorecard.
• Section7:Purchasing&Inventory Questionsarerelatedtotheuseofcorrectspecificationsandthecorrectstorageofreagentsandsupplies.ThesecanbebestdiscussedwiththeStockOfficer.Visitthestorageareaandobserveafewreagentsandsuppliescriticaltocorrectperformance.Checkstorageconditionsandexpirationdates.QuestionsrelatedtoSection7arepresentinallscorecards.
2Themainobjectiveofvalidationandverificationistodemonstratethatanexaminationprocedureisfit-for-purpose(JLabPrecisMed2017;2:58).Useofnon-validated/non-verifiedexaminationproceduresarenotuncommoninthelaboratory.Whenusedwithoutmodification,avalidatedexaminationprocedureshallbe**verified**,whilstnon-standardmethods,homebrewmethods,validatedmethodswhichhavebeenmodifiedorarebeingusedoutsidetheirintendedscopeshallbe**validated**.
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
• Section8:ProcessControl Processcontrolisthemostextensivesectioninallscorecards.Questionsarerelatedtothecorrectperformanceofthetestingprocedure,qualitycontrol,qualityassuranceandexternalquality3. DocumentsrelatedtoEQAscorescanberequestedandreviewedbeforehandanddiscussedwiththeLaboratoryManagerand/orQualityOfficer.Executionoftestsincludingqualitycontrolsshouldbeobservedatthebenchandintheresultsrecordingledger.
• Section9:InformationManagement Questionscovertherecordingandreportingofindividualtestresults.Thesecanbebestdiscussedandverifiedwiththepersonresponsibleforreportsubmission.Thecorrectregistrationofresultscanbebestcheckedforcomplextestresult(forexampleDSTorLPA)astranscriptionerrorsmaybemostprevalent.QuestionsrelatedtoSection9areonlypresentintheGeneralProcedures-scorecard.
• Section10:IdentificationofNonconformities,CorrectiveandPreventiveActions Questionsarerelatedtotheidentificationanddocumentationofnon-conformities,theiranalysis10 andcorrectiveactions.ThesequestionscanbebestdiscussedwiththeQualityOfficer.Documentsdescribingnon-conformities,theiranalysisandcorrectionshouldbereviewed.QuestionsrelatedtoSection10areonlypresentintheGeneralProcedures-scorecard.
• Section11:Occurrence/IncidentManagement&ProcessImprovement Questionsarerelatedtothecollectionandreportingofperformanceindicators.DocumentscanberequestedandreviewedbeforehandandarebestdiscussedandverifiedwiththeLaboratoryManagerand/orpersonresponsiblefordatamanagement.QuestionsrelatedtoSection11arepresentin allscorecards.
• Section12:FacilitiesandBiosafety Questionscoverthesafeperformanceoftestingandwastemanagement.ThesecanbebestdiscussedwiththeSafetyOfficerandobservedatthebench.QuestionsrelatedtoSection10areonlypresentintheGeneralProcedures-scorecard.
Notallscorecardscontainquestionsforeachsection.Forexample:Section2:ManagementReviews,onlycontainsquestionsintheGeneralProcedures-scorecard.Inthetest-specificscorecardstherearenoquestionsrelatedtomanagementreviews.
3QualityControl:theactivitiesundertakenduringthetestingproceduretoensurethatresultsarereliable(ingeneral:positiveandnegativecontrols).QualityAssurance:theactivitiesundertakenbeforetestingtoensurethatresultsarereliable(suchastrainedstaff,highqualitymaterialsandequipment,presenceofdocumentssuchasSOPs).ExternalQualityAssessment:proficiencytesting,blindedretestingand/orinspectionvisitsbyanexternalentitytoassessthereliabilityoflaboratorytestresults.4RootCauseAnalysisaimsatidentifyingtheunderlyingproblemcausingthenon-conformity.EstablishedtechniquesaretheIshikawaDiagram(https://en.wikipedia.org/wiki/Ishikawa_diagram)andtheFiveTimesWhymethod(https://en.wikipedia.org/wiki/Five_whys).
14
Information on completing the General Procedures-scorecard
PartA:GeneralInformation
ThissectionismoreelaborateintheGeneralProcedures-scorecardcomparedtootherscorecards.Asexplainedabove,thissectioncapturestheinformationtoprovidethecontextagainstwhichtheassessmentisconducted.Theassessorwillfillhis/hernameandaffiliationsandthenameanddetailsofthelaboratorybeingassessed.Toanswerthequestion“DoestheTBlaboratorymeetminimumspaceandinfrastructurerequirements?”,theassessormayrefertotheGLIMycobacteriologyLaboratoryManual,chapter4,section4.15.
PartB:Technicalinformation
IntheGeneralProcedures-scorecardtwoquestionshavebeenincludedthatcapturequantitative/descriptivedata:
• QuestionGAisintendedtogetanoverviewoftheavailableequipmentandthestateofmaintenance/calibration.Assessorsshouldnotewhethertheequipmentisinworkingorder,thefunctionalityofequipmentregularlychecked;theequipmentregularlyservicedbyaqualifiedservicetechnicianandwhethertheequipmentisregularlymaintainedaccordingtothemanufacturer’srecommendations.Ifmolecularmethodsarebeingused,theassessorshouldreviewtheSOPtodeterminetherequirementsandlisttheseunder“otherequipment”.AssessorsmayneedtoreviewtheSOPorequipment“BookofLife”todeterminespecificsregardingmaintenance,servicingetc.forspecializedmolecularsystems.
• QuestionGBismeanttoprovideinsightintothereportingprocessforthedifferentlaboratorytests.
TheremainderofpartBintheGeneralProcedures-scorecardconsistsofclosed/multiplechoicequestions.IntheGeneralProcedures-scorecardthesequestionsarenotspecifictoanylaboratorytests.Instead,theyarerelatedtosupportprocessofthelaboratory.
IntheGeneralProcedures-scorecard,questionsareincludedinalltwelvesections.Mostquestionsareself-explicatory.However,ifadditionalinformationisneeded,thebelowresourcescanbeconsulted.
5GLIMycobacteriologyLaboratoryManual:http://www.stoptb.org/wg/gli/assets/documents/gli_mycobacteriology_lab_manual_web.pdf
15
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Resource Description
General information
GLIMycobacteriologyLaboratoryManual
Acomprehensivelaboratorymanualthatstandardizeskeylaboratoryprocedures.
GLIPracticalGuidetoTBLaboratory Strengthening
PracticalguidanceonimplementationofWHOrecommendationsandinternationalbestpracticesforTBlaboratorystrengthening.
GLIModelTBDiagnosticAlgorithms
Thishandbookprovides4modelalgorithmsthatgraphicallydepictthemostup-to-dateWHOrecommendationsonuseofTBdiagnostics.ThealgorithmsfollowtheprinciplesoftheEndTBStrategytoprovideuniversalaccesstorapidtestingforMycobacterium tuberculosiscomplexbacteriaandDST,andincludetheuseofXpertMTB/RIF,lineprobeassaysfor2ndlinedrugs,theLF-LAMassayandtheTB-LAMPtest,togetherwithconventionaltoolsincludingmicroscopyandphenotypiccultureandDST.
WHODefinitionsandreportingframeworkfortuberculosis
WHOstandardizeddefinitionsandreportingstructuresforTB.
General information
WHOLaboratoryQualityManagementSystemHandbook
HandbookforunderstandingthestructureandrequirementsofalaboratoryQMSbasedoninternationalstandards.
WHOLaboratoryQualityManagementSystemtrainingtoolkit
TrainingmaterialsforunderstandingthestructureandrequirementsofalaboratoryQMSbasedoninternationalstandards.
WHOLaboratoryQualityStepwiseImplementation(LQSI)tool
TheLQSItoolprovidesaroadmapforstepwiseimplementationofalaboratoryQMSbasedoninternationalstandardsfor(public)healthlaboratories.
ISO15189QualityManagementSystemImplementationLookBeforeYouLeap–BestPracticeGuidanceDocument
ThisguidancedocumentisdesignedtoprovidepublicTBlaboratorieswithbestpracticeswhenembarkingonimplementingaQMSandseekingISO15189accreditation.
GLIStepwiseProcessTowardsTB Laboratory Accreditation (‘GLItool’)
ThistoolprovidesaroadmapforstepwiseimplementationofalaboratoryQMSbasedoninternationalstandardsforTBlaboratories.
GLIStandardOperatingProceduresfortheTBLaboratory
TemplatesofSOPsfortheTBlaboratory.
Specimen referral and transport
GLI Guide to TB Specimen ReferralSystemsandIntegratedNetworks
Thisguidedescribesthevariousphasestocreateandstrengthenspecimenreferralsystems,essentialcomponentsinvolvedinreferral,aswellasotherconsiderationsforTBprogrammeandlaboratorymanagers,MinistryofHealthofficials,andotherstakeholdersacrossdiseaseprogrammes.Inadditiontodescribingtransportmechanismsandequipmentrequiredtomovespecimensinasafemanner,thisguidealsoprovidesinformationonlogistics,resultsreporting,datamanagement,monitoringandevaluation,andstandardoperatingproceduresthatwillfacilitateandimprovespecimenreferralsystems
16
Resource Description
Biosafety
GLILaboratorySafetyHandbook
TheLaboratorySafetyhandbookisapracticalguideforlaboratorystaff.TheHandbookusessimpletextandclearillustrationstoassistlaboratorystaffinunderstandingtheimportantsafetyissuesinvolvedinperformingcultureandDST.TheTBLaboratorySafetyhandbookshouldbeusedtogetherwiththeWHOTuberculosisLaboratoryBiosafetyManual.
WHOTBLaboratoryBiosafetyManual
ThismanualprovidesinformationandexplanationonbiosafetyrequirementsfortheTBlaboratorycontext.
WHOLaboratoryBiosafetyManual
Thismanualprovidesinformationandexplanationonbiosafetyrequirementsformedicallaboratories.
Other
TBfacts.org ThiswebsiteisausefulresourceprovidinginformationonTBingeneralandforTBlaboratorytestingspecifically.
GLIresourcecenters:• Guidanceandtools• Training packages• SOPs
ProvidesmanyadditionalresourcesforTBlaboratorypractice.
ChallengeTBtools,guidelinesandmanuals
ProvidesmanyadditionalresourcesforTBlaboratorypractice.
WHOpublicationsontuberculosis
ProvidesmanyadditionalresourcesrelatedtoTBdetection,diagnosis,treatment,and care.
17
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the Smear Microscopy Scorecard
PartA:GeneralInformation
PartAoftheSmearMicroscopyScorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBstartswithatabletocollectinformationonthenumberofsmearmicroscopytestsfordiagnosisandfollow-upperformedinthelastyear.Datashouldbestratifiedbythenumberofsamplesreceivedandrejected,andthenumberofscantypositive,positiveandnegativeresultsperquarter.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillnotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.
• Section1:Documents&Records Containingquestionsaboutdocumentationofsmearmicroscopy-specificprocedures.
• Section4:ClientManagement&CustomerService Containingaquestionrelatedtoprovisionofinformationandinstructionstoclientsoninterpretationofsmearmicroscopyresults.AquestionfocusingoncorrectcollectionofsputumsamplesisincludedintheGeneralProcedures-scorecard.
• Section7:Purchasing&Inventory Containingaquestiononstorageofreagentsneededformicroscopy.
• Section8:ProcessControl Thissectionismostelaborateasitinvestigatestechnicaldetailsforcorrectexecutionofsmearmicroscopy(usefulresourcesareprovidedbelow).
• Section11: Containsaquestionrelatedtosmearmicroscopy-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutthesmearmicroscopyprocedure.
18
Resource Description
Smear microscopy procedure
MovieonAuraminestaining DemonstrationofAuraminestaining.
MovieonZiehlNeelsenstaining
DemonstrationofZiehl-Neelsenstaining.
Handbook:LaboratoryDiagnosisofTBbySputumMicroscopy
Apracticalguidetoassistlaboratorystaffinunderstandingtheimportantissuesinvolvedinconductingsputumsmearmicroscopy.
GLIMycobacteriologyLaboratoryManual
Detailedinformationonsamplepreparationandstaining,andsmearexamination(chapters7,8and9,respectively).
UNIONTrainingPackageonAcid-FastDirectSmearMicroscopy
Onlinetrainingpackageondirectsmearmicroscopy.
GLIStandardOperatingProceduresfortheTBLaboratory
TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforsmearmicroscopy.
Biosafety
GLILaboratorySafetyHandbook
Includesinformationonbiosafetyspecificallyforsmearmicroscopy.
WHOTBLaboratoryBiosafetyManual
Includesinformationonbiosafetyspecificallyforsmearmicroscopy.
Other
TBfacts.org ThiswebsiteisausefulresourceprovidinginformationonTBingeneralandforTBlaboratorytestingspecifically,includingsmearmicroscopy.
19
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the scorecard for TB culture for detection and identification of mycobacteria
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBstartswithatabletocollectinformationonthenumberofsolidandliquidculturetestsperformedinthelastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillnotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.
Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records Containingquestionsaboutdocumentationofculture-specificprocedures.
• Section4:ClientManagement&CustomerService Containingaquestionrelatedtoprovisionofinformationandinstructionstoclientsoninterpretationofcultureresults.
• Section7:Purchasing&Inventory Containingaquestiononstorageofreagentsneededforsolidandliquidcultureandidentificationtests.
• Section8:ProcessControl ThissectionismostelaborateandinvestigatestechnicaldetailsforcorrectexecutionofTBculture.Thesectionisdividedintothefollowingsegments:qualitycontrol,decontamination,liquidcultureprocedure,solidcultureprocedure,andMTBidentificationprocedure.
• Section11: Containsaquestionrelatedtoculture-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationabouttheTBcultureprocedures.
20
Resource Description
Culture procedures
GLIMycobacteriologyLaboratoryManual
Providesdetailedinformationonliquidandsolidcultureprocedures(chapters10and11,respectively).
GLI Training Package on CultureinSolidandLiquidMedia
Zippedfile(311MB)withtrainingmaterials.
GLIStandardOperatingProceduresfortheTBLaboratory
TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforTBculture.
TBfacts.org InformationonTBculture.
Biosafety
GLILaboratorySafetyHandbook
IncludesinformationonbiosafetyspecificallyforTBculture.
WHOTBLaboratoryBiosafetyManual
IncludesinformationonbiosafetyspecificallyforTBculture.
21
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the scorecard for Phenotypic Drug Susceptibility Testing (DST)
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBofthisscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.
Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofDST-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofDSTresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofantibioticsandmedianeededforDST.
• Section8:ProcessControl ThissectionismostelaborateandinvestigatestechnicaldetailsforcorrectexecutionofDST,includingqualitycontrol.
• Section11: ContainsaquestionrelatedtoDST-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutthephenotypicDSTprocedure.
22
Resource Description
DST procedures
WHOTechnicalmanualfordrugsusceptibilitytestingofmedicinesusedinthetreatmentoftuberculosis
ThistechnicalmanualfocusesontheavailableDSTmethodsforbothfirst-andsecond-lineanti-TBagents.Culture-basedphenotypicDSTmethodsforcertainanti-TBmedicinesarereliableandreproducible,butthesemethodsaretime-consuming,requiresophisticatedlaboratoryinfrastructure,qualifiedstaffandstrictqualitycontrol.OnlyindirectDSTproceduresforanti-TBmedicinesareincludedinthisdocument.ThemethodsdescribedareLJ,7H10and7H11agarandMGIT.
GLIMycobacteriologyLaboratoryManual
ProvidesdetailedinformationonDSTusingMGIT(chapter12).
GLITrainingPackageonDSTbyPhenotypicandMolecularMethods
Zippedfile(34MB)withtrainingmaterialsonDST.
TBCAREICompleteCultureandDSTPackage
Thispackage(140MB)containsstandardizedtrainingmaterialsoncultureandDSTtechniques.
GLIStandardOperatingProceduresfortheTBLaboratory
TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforTBcultureandDST.
TB-CAREIStandardOperatingProceduresforCultureDSTandMolecularResistance Testing
ThispackageoffilescontainsnewSOPtemplatesonGeneXpert,MGIT960,DSTSolidandLPA.
TBfacts.org InformationonTBDST.
Biosafety
GLILaboratorySafetyHandbook
IncludesinformationonbiosafetyspecificallyforTBcultureandDST.
WHOTBLaboratoryBiosafetyManual
IncludesinformationonbiosafetyspecificallyforTBcultureandDST.
23
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the Xpert MTB/RIF Scorecard
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBoftheXpertMTB/RIFScorecard(includingXpertMTB/RIFUltra)startswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.TheScoreTB-PackageadherestotheXpertreportingsystemrecommendedbyWHO6 and updated by GLI7. It is recommended toaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.AnadditionalquestionisincludedtocollectinformationabouttheGeneXpertequipmentavailability,functionality,andmaintenance. Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofGeneXpert-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofGeneXpertresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofGeneXpertcartridges.
• Section8:ProcessControl ContainingquestionsontechnicalaspectsofGeneXperttesting,includingqualitycontrol.
• Section11: ContainsaquestionrelatedtoGeneXpert-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutGeneXpertMTB/RIFandMTB/RIFUltratesting.
6WHODefinitionsandReportingFrameworkforTuberculosis–2013revision:https://www.who.int/tb/publications/definitions/en/7GLIPlanningforcountrytransitiontoXpertMTB/RIFUltraCartridges:http://www.stoptb.org/wg/gli/assets/documents/gli_ultra.pdf
24
Resource Description
GeneXpert procedure
MovieonGeneXperttestingprocedure
TrainingvideoonconductingtheGeneXpertMTB/RIFtest.
GLITrainingPackageonDSTbyPhenotypicandMolecularMethods
Zippedfile(34MB)withtrainingmaterialsonDST.
ImplementingaQualityAssuranceSystemforXpertMTB/RIFTesting
Thispracticalguide,andaccompanyingshortguide,provideusefulinformationandtoolstoestablishingandimplementingaqualityassurance(QA)systemfortheXpertMTB/RIFtestacrossthediagnosticnetwork.
GeneXpertTrainingMaterialswithGuides(2015)
ThisisafulltrainingpackagewithguidestosupporttheuseofXpertMTB/RIF(84Mb).
StandardOperatingProceduresforCultureDSTandMolecularResistanceTesting
Thiszippedpackageoffiles(1.8MB)containsnewstandardoperatingproceduresonGeneXpert,MGIT960,DSTSolidandLPA.
TBfacts.org InformationontheGeneXpertforTBtesting.
TBonline.info InformationontheGeneXpertforTBtesting.
Biosafety
GLILaboratorySafetyHandbook
IncludesinformationonbiosafetyspecificallyforGeneXpert.
WHOTBLaboratoryBiosafetyManual
IncludesinformationonbiosafetyspecificallyforGeneXpert.
Other
GLIPlanningforcountrytransitiontoXpertMTB/RIFUltraCartridges
ThisguideprovidespracticalguidancetodevelopanactionableimplementationplantosmoothlytransitiontouseofXpertMTB/RIFUltracartridges,ensuringuninterruptedserviceandavoidingcartridgewastage.
25
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the Loop-Mediated Isothermal Amplification (TB-LAMP) scorecard
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBoftheTB-LAMPscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.AnadditionalquestionisincludedtocollectinformationabouttheTB-LAMPequipmentavailability,functionality,andmaintenance. Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofTB-LAMP-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofTB-LAMPresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofTB-LAMPreagents.
• Section8:ProcessControl ContainingquestionsontechnicalaspectsofTB-LAMPtesting,includingqualitycontrol,DNAextractionandMTBCdetection.
• Section11:Occurrence/IncidenceManagement&ProcessImprovement ContainsaquestionrelatedtoTB-LAMP-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutTB-LAMPtesting.
26
Resource Description
TB-LAMP procedure
MovieonTB_LAMP Thisshort,animatedvideoshowsthebackground,themostimportantstepsaswellastheadvantagesoftheTB-LAMP.
LAMP-tutorial Shorttutorial(movie)ontheLAMPprinciple.
WHOFactsheetonTB-LAMP ShortdescriptionoftheTB-LAMPassayandWHOrecommendations.
TB-LAMPflyer InformationontheTB-LAMPassayprovidedbyitsmanufacturer.
GLITB-LAMPinformationnote
GLIPracticalconsiderationontheimplementationofTB-LAMP.
Other
WHOPolicyguidanceonTB-LAMP
PolicyguidanceontheuseofTB-LAMPforthediagnosisofpulmonaryTB.
27
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Information on completing the Lateral Flow Urine Lipoarabinomannan Assay (LF-LAM) scorecard
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBoftheLF-LAMscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.
Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofLF-LAM-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofLF-LAMresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofLF-LAMtests.
• Section8:ProcessControl ContainingquestionsontechnicalaspectsofLF-LAMtesting,includingqualitycontrol.
• Section11:Occurrence/IncidenceManagement&ProcessImprovement ContainsaquestionrelatedtoLF-LAM-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutLF-LAMtesting.
Resource Description
LF-LAM procedure
MovieonLF-LAM AshortmovieonhowtodotheFujifilmSILVAMPTBLAMtest.
GLILF-LAMinformationnote GLIPracticalinformationontheLF-LAMtest.
Other
WHOPolicyupdateonLF-LAM
Background,justificationandobjectivesfortherevisionofWHOpolicyonLF-LAM.
28
Information on completing the Line Probe Assay (LPA) scorecard
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBoftheLPAscorecardstartswiththecollectionofquantitativedataonthenumberoftests(categorizedbyMTBDRplusandMTBDRsl,andCM)performedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.AnadditionalquestionisincludedtocollectinformationabouttheLPAequipmentavailability,functionality,andmaintenance. Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofLPA-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofLPAresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofLPAtestreagents.
• Section8:ProcessControl ContainingquestionsontechnicalaspectsofLPAtesting,includingqualitycontrol,extraction,amplificationanddetection.
• Section11:Occurrence/IncidenceManagement&ProcessImprovement ContainsaquestionrelatedtoLPA-specificqualityindicators
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutLPAtesting.
29
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
Resource Description
LPA procedure
MovieonLPA DemonstrationofLPA(directdetectionofMTBandresistancetoisoniazidandrifampicin)insputum.
GLI guide on LPA interpretation and reporting
Interpretationandreportingguideforlaboratorystaffandclinicians.
TBfacts.org InformationontheLPAforTBtesting.
StandardOperatingProceduresforCultureDSTandMolecularResistanceTesting
Thiszippedpackageoffiles(1.8MB)containsnewSOPsonGeneXpert,MGIT960,DSTSolidandLPA.
GLITrainingPackageonDSTbyPhenotypicandMolecularMethods
Zippedfile(34MB)withtrainingmaterialsonDST.
Other
GLILaboratorySafetyHandbook
IncludesinformationonbiosafetyspecificallyforLPA.
Other
WHOPolicyupdateonLPA Policyupdateontheuseofmolecularlineprobeassaysforthedetectionofresistancetoisoniazidandrifampicin.
WHOPolicyupdateonLPAforsecondlineanti-TBdrugs
Policyupdateontheuseofmolecularlineprobeassaysforthedetectionofresistancetosecondlineanti-TBdrugs.
30
Information on completing the Truenat scorecard
PartA:GeneralInformation
Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).
PartB:Technicalinformation
PartBoftheTruenatscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.AnadditionalquestionisincludedtocollectinformationabouttheTruenatequipmentavailability,functionality,andmaintenance. Theremainderofthisscorecardcontainsquestionsrelatedto:
• Section1:Documents&Records ContainingquestionsaboutdocumentationofTruenat-specificprocedures.
• Section4:ClientManagement&CustomerService ContainingonequestionaskingaboutprovisionofinformationoncorrectinterpretationofTruenatresultstolaboratoryclients.
• Section7:Purchasing&Inventory ContainingaquestiononstorageofTruenatreagents.
• Section8:ProcessControl ContainingquestionsontechnicalaspectsofTruenattesting,includingqualitycontrol.
• Section11:Occurrence/IncidenceManagement&ProcessImprovement ContainsaquestionrelatedtoTruenat-specificqualityindicators.
Mostquestionsareself-explicatoryandassessorscomplyingwiththeassessorprofiledescribedinsection3.4shouldbeabletoanswerthem.Below,severalusefulresourcesarelistedthatprovideessential(technical)informationaboutTruenattesting.
Resource Description
Truenat procedure
AnnouncementofWHOensorsementoftheTruenatassay
AnnouncementthatWHOhasendorsedtheTruenatassayforinitialdiagnosisofTBanddetectionofrifampicinresistance.
WHORapidCommunication:Molecularassaysasinitialtestsforthediagnosisoftuberculosisandrifampicinresistance
ThisdocumentaimstoinformnationalTBprogrammesandotherstakeholdersaboutthekeyimplicationsofthelatestevidenceontheuseofspecificmolecularassays,includingTruenat,asinitialdiagnostictestsofpulmonaryandextrapulmonaryTBandRR-TB,inadultsandchildren.
StopTB Partnership PracticalconsiderationsforimplementationofTruenat
ProvidespracticalconsiderationsforimplementationofTruenat,includingthetestprocedureandoperationalconsiderations.
TBfacts.org InformationontheTruenatassayforTBtesting.
31
Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
3.5 Reporting the assessment
Duringtheassessment:
1. FillintheGeneralProcedures-scorecardandthetest-specificscorecardsforallTBtestsperformedinthelaboratory.Dothiseitherusingthepaper-basedversionorinsertanswersandfindingsdirectlyintothee-tool(exceptwhenobservingTBtestingintheBSL3facilitywheretheuseofelectronicdevicesshouldbeavoidedforsafetyreasons,seesection3.4.1).
2. Optional:fillintheSLIPTAchecklist
Attheendoftheassessment,theassessormust: 3. Transcribeallscoresfromthepaper-basedversionsintothee-tool(ifapplicable).4. Thee-toolwillautomaticallycalculatethescoreandthenumberofstarsforeachoftheTBLabQualityScorecards(see“TBsummaryreport”worksheet). IftheSLIPTAchecklisthasalsobeencompletedthee-toolwillautomaticallycalculatetheSLIPTAscore,incorporatingthescoresontheTBLabQualityScorecards. NOTE:Calculatingthescorebyhandisextremelycomplexduetothepossibilityofnotapplicable-answersthatinfluencethetotalnumberofpointsthatcanbescored(seesection3.3.2).Calculatingthescorebyhandisthuspronetoerrors.Wethereforestronglyrecommendusingthee-tooltocalculatethescore.Anotheradvantageofusingthee-toolisthatitdirectlyvisualizesthescoringandtheprogresssincethepreviousassessment,ifapplicable.
5. Identifyrecommendationsforimprovement(forquestionswith“No”and“Partial”answers),andreportthesetothelaboratoryduringthemeetingwiththelaboratorymanagement(point6)andinthefinalreport(point7).
6. Wherepossible,theassessorshouldsupporttheirfindingswithtoolsandguidancematerialsasreferredinsection3.3.3tohelpthelaboratoryaddresstheareasforimprovement.Assessorsareresponsibleforensuringthattheresourcessuppliedtothelaboratoryaremostcurrent. Meetwiththelaboratorystaffandmanagementandcommunicatetheoverallfindingsoftheassessment.TheassessorshouldusetheformatsuggestedintheSLIPTAchecklist(Summary).i.e.reportnotedcommendations,notedchallengesandrecommendations.Wherepossible,theassessorshouldsupportthecommendations&challengeswithexamplesfromtheassessment.TheassessorcanalsopresentthenumberofstarsscoredontheTBLabQualityScorecardsandtheSLIPTAchecklist,ifapplicable(seepoint4).
Aftertheassessment:
7. Withintwoweeksaftertheassessment,theassessormustsubmitafinalreporttothelaboratory.ThereportshouldincludeacopyofthecompletedTBLabQualityScorecards(andSLIPTAchecklistifapplicable)aswellastheobservedchallengesandrecommendations.
Thelistofrecommendationsforimprovementshouldbecommunicatedintheformofnonconformitiesandmustbegradedasmajororminor:
• Majornonconformitiesarethosenon-conformitiesthatdirectlyinfluencethequalityoftheworkperformedandthereforerequireurgentaction.
• Minornonconformitiesarethosethatmayindirectlycompromisequalityoftheworkperformedandshouldbeaddressedaftermajornonconformitieshavebeenresolved.
Furthertothisitisadvisabletoprioritizetherecommendationstoassistthelaboratorywithimplementing/improvingitsQMSinalogicalandrationalway.
Thelaboratoryisresponsibleforaddressingthenonconformitiesthroughitsowncorrectiveactionsystem.Supporttothelaboratorytoaddressnonconformitiesisbeyondthescopeoftheassessmentbutcanbeprovidedintheformofamentorprogram.
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Tuberculosis Technical Scorecard Building Quality-Assured Tuberculosis Testing and Management Capacity Utilizing SLIPTA Methodology Version 1.5 – July 2020
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