USER GUIDE Score-TB package Find-TB...checklist (TB Harmonized Checklist) based on SLIPTA, but incorporating some elements from the GLI tool with a focus on the technical side of TB

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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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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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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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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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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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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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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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• 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).

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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


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


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


Information on completing the Smear Microscopy Scorecard


PartAoftheSmearMicroscopyScorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).


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


Smear microscopy procedure

MovieonAuraminestaining DemonstrationofAuraminestaining.

MovieonZiehlNeelsenstaining

DemonstrationofZiehl-Neelsenstaining.

Handbook:LaboratoryDiagnosisofTBbySputumMicroscopy

Apracticalguidetoassistlaboratorystaffinunderstandingtheimportantissuesinvolvedinconductingsputumsmearmicroscopy.


Detailedinformationonsamplepreparationandstaining,andsmearexamination(chapters7,8and9,respectively).

UNIONTrainingPackageonAcid-FastDirectSmearMicroscopy

Onlinetrainingpackageondirectsmearmicroscopy.


TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforsmearmicroscopy.

Biosafety


Includesinformationonbiosafetyspecificallyforsmearmicroscopy.


Includesinformationonbiosafetyspecificallyforsmearmicroscopy.

Other

TBfacts.org ThiswebsiteisausefulresourceprovidinginformationonTBingeneralandforTBlaboratorytestingspecifically,includingsmearmicroscopy.

19


Information on completing the scorecard for TB culture for detection and identification of mycobacteria


Similartootherscorecards,partAofthisscorecardislimitedtoaddingdetailsaboutthisassessment(incl.nameandaffiliationoftheassessorandthelaboratorybeingassessed,andinformationaboutthepreviousassessment,ifany).


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


Culture procedures


Providesdetailedinformationonliquidandsolidcultureprocedures(chapters10and11,respectively).

GLI Training Package on CultureinSolidandLiquidMedia

Zippedfile(311MB)withtrainingmaterials.


TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforTBculture.

TBfacts.org InformationonTBculture.

Biosafety


IncludesinformationonbiosafetyspecificallyforTBculture.


IncludesinformationonbiosafetyspecificallyforTBculture.

21


Information on completing the scorecard for Phenotypic Drug Susceptibility Testing (DST)




PartBofthisscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.


• 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


DST procedures

WHOTechnicalmanualfordrugsusceptibilitytestingofmedicinesusedinthetreatmentoftuberculosis

ThistechnicalmanualfocusesontheavailableDSTmethodsforbothfirst-andsecond-lineanti-TBagents.Culture-basedphenotypicDSTmethodsforcertainanti-TBmedicinesarereliableandreproducible,butthesemethodsaretime-consuming,requiresophisticatedlaboratoryinfrastructure,qualifiedstaffandstrictqualitycontrol.OnlyindirectDSTproceduresforanti-TBmedicinesareincludedinthisdocument.ThemethodsdescribedareLJ,7H10and7H11agarandMGIT.


ProvidesdetailedinformationonDSTusingMGIT(chapter12).

GLITrainingPackageonDSTbyPhenotypicandMolecularMethods

Zippedfile(34MB)withtrainingmaterialsonDST.

TBCAREICompleteCultureandDSTPackage

Thispackage(140MB)containsstandardizedtrainingmaterialsoncultureandDSTtechniques.


TemplatesofSOPsfortheTBlaboratory,includingSOPtemplatesforTBcultureandDST.

TB-CAREIStandardOperatingProceduresforCultureDSTandMolecularResistance Testing

ThispackageoffilescontainsnewSOPtemplatesonGeneXpert,MGIT960,DSTSolidandLPA.

TBfacts.org InformationonTBDST.

Biosafety


IncludesinformationonbiosafetyspecificallyforTBcultureandDST.


IncludesinformationonbiosafetyspecificallyforTBcultureandDST.

23


Information on completing the Xpert MTB/RIF Scorecard




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


GeneXpert procedure

MovieonGeneXperttestingprocedure

TrainingvideoonconductingtheGeneXpertMTB/RIFtest.



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


IncludesinformationonbiosafetyspecificallyforGeneXpert.


IncludesinformationonbiosafetyspecificallyforGeneXpert.

Other

GLIPlanningforcountrytransitiontoXpertMTB/RIFUltraCartridges

ThisguideprovidespracticalguidancetodevelopanactionableimplementationplantosmoothlytransitiontouseofXpertMTB/RIFUltracartridges,ensuringuninterruptedserviceandavoidingcartridgewastage.

25


Information on completing the Loop-Mediated Isothermal Amplification (TB-LAMP) scorecard




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


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


Information on completing the Lateral Flow Urine Lipoarabinomannan Assay (LF-LAM) scorecard




PartBoftheLF-LAMscorecardstartswiththecollectionofquantitativedataonthenumberoftestsperformedlastyear,stratifiedbyoutcome.Itisrecommendedtoaskthelaboratorytocompletethistableinadvanceandverifytheinformationduringtheassessment,astherewillbenotbesufficienttimeavailableduringtheassessmentforcompletionofthistable.


• 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.


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




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



LPA procedure

MovieonLPA DemonstrationofLPA(directdetectionofMTBandresistancetoisoniazidandrifampicin)insputum.

GLI guide on LPA interpretation and reporting

Interpretationandreportingguideforlaboratorystaffandclinicians.

TBfacts.org InformationontheLPAforTBtesting.

StandardOperatingProceduresforCultureDSTandMolecularResistanceTesting

Thiszippedpackageoffiles(1.8MB)containsnewSOPsonGeneXpert,MGIT960,DSTSolidandLPA.



Other


IncludesinformationonbiosafetyspecificallyforLPA.

Other

WHOPolicyupdateonLPA Policyupdateontheuseofmolecularlineprobeassaysforthedetectionofresistancetoisoniazidandrifampicin.

WHOPolicyupdateonLPAforsecondlineanti-TBdrugs

Policyupdateontheuseofmolecularlineprobeassaysforthedetectionofresistancetosecondlineanti-TBdrugs.

30

Information on completing the Truenat scorecard




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.


Truenat procedure

AnnouncementofWHOensorsementoftheTruenatassay

AnnouncementthatWHOhasendorsedtheTruenatassayforinitialdiagnosisofTBanddetectionofrifampicinresistance.

WHORapidCommunication:Molecularassaysasinitialtestsforthediagnosisoftuberculosisandrifampicinresistance

ThisdocumentaimstoinformnationalTBprogrammesandotherstakeholdersaboutthekeyimplicationsofthelatestevidenceontheuseofspecificmolecularassays,includingTruenat,asinitialdiagnostictestsofpulmonaryandextrapulmonaryTBandRR-TB,inadultsandchildren.

StopTB Partnership PracticalconsiderationsforimplementationofTruenat

ProvidespracticalconsiderationsforimplementationofTruenat,includingthetestprocedureandoperationalconsiderations.

TBfacts.org InformationontheTruenatassayforTBtesting.

31


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.

32


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13. ISO9000:2005Qualitymanagementsystems-Fundamentalsandvocabulary.Geneva:InternationalOrganizationforStandardization;2005.

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