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Standards forQuality Assurance in Cervical ScreeningQuality Assurance in Laboratories Providing HPV Testing, Cytology and Histopathology Services
Quality Assurance in Laboratories Providing HPV Testing, Cytology and Histopathology Services
Introduction 2
Section A: Screening laboratories (primary hrHPV testing and cytology triage) 3
3.1 Laboratory organisation 3
3.2 Clinical governance 7
3.3 Laboratorypersonnel(rolesandresponsibilitiesandstaffqualifications) 10
3.4 Sampleacceptance,receptionanddataentry 20
3.5 Sample processing and analysis 23
3.6 Reportingandclassificationofcervicalscreeningsamples 31
3.7 Managementofwomen 33
3.8 Storage and archiving 34
3.9 Protocolformulti-disciplinaryteammeetings 34
3.10 Qualitymetricsandperformancemonitoring 35
3.11 Qualityassurancevisits 36
3.12 Auditofinvasivecervicalcancers 36
3.13 Risk and incident management 36
3.14 Business planning and service continuity 36
Section B: Histopathology 37
3.15 CervicalCheckrequirementsforhistopathology 37
3.16 References 47
Appendix 1 – Cervical screening results and recommendations table 49
Appendix2– Managementrecommendationtable 50
Appendix 3 – HPV primary screening algorithm 51
Appendix4– HPVprimaryscreening:eligibilityframework 52
March 2020
1QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
Introduction
Since2015,thehighriskHPV(hrHPV)testhasbeenperformedoncervicalscreeningsamplestakeninCervicalCheckthatarecytologicallyclassifiedaslowgradeabnormalities(hrHPVtriage),andincolposcopyclinicsformanagementofuncertainty(MUCH)orfollowingtreatmentasatestoftreatment(hrHPVToC–testofcure).
IntheprimaryHPVcervicalscreeningpathway,cytologyisusedasatriagetestinwomenwherehrHPVisdetectedtodeterminewhetherimmediatereferraltocolposcopyisrequired.Anyabnormalcytologyresultsleadtocolposcopyreferral;aqueryglandularneoplasia(non-cervical)resultwillnormallybereferredforagynaecologicalopinion.
Thisdocumentreplaceschapters4,5,and7ofthesecondeditionofGuidelines for Quality Assurance in Cervical Screeningpublishedin2014inreadinessforhighriskhumanpapillomavirus(hrHPV)tobeintroducedastheprimaryscreeningtestforCervicalCheck-theNationalCervicalScreeningProgramme.Thedocumentisorganisedintotwosections,SectionAcoversscreeninglaboratoryrequirementsandstandards(CytologyandHPV)andSectionBcoversdiagnostictestingrequirements(histopathology).
PrimaryhrHPVtestingisamajorundertakingthatimpactsuponallelementsofthecervicalscreeningprogramme(CSP)andrequiressignificantserviceredesignacrosstheentirescreeningpathway.ManychangeswilloccurbecauseofprimaryhrHPVscreeningimplementation,andcomprehensiveHPVvaccinationwillresultinaprogressivereductionintheprevalenceofcervicalneoplasia.
CervicalCheckhasreviewedbestpracticeguidelines1,2,3andadoptedstandardswhichwillbereferencedthroughoutthisdocument.CervicalCheckhasapprovedanumberoftheavailablehrHPVtestsforusewithappropriateliquidbasedcytologysamples4.Thedocumentisbasedonthevalidationexercisescarried out on hrHPV tests by Public Health England (PHE)5andprovidesguidanceforlaboratoriesonHPVcervicalscreeningqualitycontrolandassurance.
ThisguidancewasdevelopedbytheCervicalCheckLaboratoryAdvisoryGroup(LAG)andbasedonbestevidencewhereavailableorrecommendedbestpractice.TheLAGisasub-groupoftheCervicalCheckClinicalAdvisoryGroupandfunctionstoprovideclinicallaboratoryadvicetoCervicalCheck.ThegroupcontainsmemberswhoareexperiencedprofessionalsinthefieldsofHPVprimary screening, cytopathology and histopathology.
Ensuring quality assurance in service delivery comprises compliance with both quality requirements and quality standards. Quality standards are those with a measurable level of performance and associated target for achievement. Where no target is provided these are considered quality requirements that the service provider must fulfil. These requirements are identified with a “must” or “will” statement.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices2
Section A Screening laboratories (primary hrHPV testing and cytology triage)3.1 Laboratory organisation
3.1.1 Compliance and assurance framework
TheIrishNationalAccreditationBoard(INAB)isthesolenationalaccreditationbodyformedicallaboratoriesintheRepublicofIreland.
QR83. Quality requirement
ScreeninglaboratoriesmusthaveaccreditationtotheISO15189:2012Medical laboratories - requirements for quality and competence6. Laboratories providing servicesforCervicalCheckthatareoutsideoftheEuropeanUnionmusthaveaccreditationtotheappropriatestandardswithinthecountryoforiginofthecontractedlaboratory.ThescopeofthelaboratoryaccreditationmustincludeHPV/ cytology testing as applicable.
3.1.2 Quality management system
QR84. Quality requirement
Thelaboratorywillhaveaqualitymanagementsystem(QMS)inplaceasrequiredby the appropriate, local accreditation standards.
QR85. Quality requirement
ThelaboratorywillhaveadesignatedpersonresponsibleforqualitymanagementwhowillliaisewithCervicalChecktoresolveanyqualityissuesthatmayarise.
QR86. Quality requirement
AnyqualityissuesraisedthroughtheQMSinrelationtothecervicalscreeninglaboratoryservicemustbenotifiedtoCervicalCheck.
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3.1.3 Health and safety compliance
QR87. Quality requirement
Thelaboratoryshallbecompliantwithallnationallegalandstatutoryhealthandsafetyrequirements.
Note: The Clinical and Laboratory Standards Institute (CLSI) document ‘MM3-A2-Molecular Diagnostics Methods for Infectious Diseases; Approved Guideline-Current Edition7’ is the reference document recommended for HPV testing.
3.1.4 Data protection
QR88. Quality requirement
InrelationtotheprovisionofservicestotheNationalScreeningService(NSS),alldataprotectionrequirements(storage,access,security,confidentialityanddatatransfer)willbecompliantwiththeGeneralDataProtectionRegulation.LaboratorieswillcomplywithallrequestsfordataorreportsbyIrishhealthagenciesandauthorities,subjecttotheconditionsimposedbyGDPR,ortheappropriatedataprotectionagencyoperationalinthecountryoforiginofthelaboratory concerned.
QR89. Quality requirement
AVirtualPrivateNetwork(VPN)mustbeinstalledbetweenthelaboratoryandtheprogrammeoperationsofficeforthesecureexchangeofelectronicdata.Whereservicesareprovidedintwoseparatelaboratoryorganisations,aVPNmustbeinstalledbetweenthetwolaboratoriesforthesecureexchangeofelectronicdata.
3.1.5 Laboratory information management system
QR90. Quality requirement
Avalidatedandverifiedlaboratoryinformationmanagementsystem(LIMS)willbeoperated in the laboratory.
QR91. Quality requirement
TheLIMSwillbeinasecurefacilitywiththeprovisionforadequateback-uparrangements.
QR92. Quality requirement
AccesstotheLIMSwillbebysecureprivilegelevelaccesscontrol.
QR93. Quality requirement
TheLIMSwillbecapableofgeneratingperiodicqualitymetricsandauditreturnstoCervicalCheckandtoCervicalCheckrequirements.
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QR94. Quality requirement
TheLIMSwillbecapableofrecordingtheminimumdatasetfromtheCervicalChecklaboratoryrequestform.
Itisdesirablethatlaboratoriesarecapableofreceivingorderselectronicallyandissuingresultselectronicallytoandfromorderingdoctorsorclinics,accordingtoaspecifiedmessagingstandard.ElectroniclaboratoryorderformatisHL-7basedandconformstotheLaboratoryordermessagespecificationsoftheHealthInformationandQualityAuthority(HIQA)currentGPMessagingStandard.HL-7basedordersandresultsuseHealthlink’sMessageBrokerSystem.Thephysicalformforelectronicordersincludesabarcode,whichlaboratoriesshallbeabletoscanandextracttheincludeddetailsforautomatic import into their data entry system.
QR95. Quality requirement
TheLIMSwillbecapableofrecordingtestresultsincludingaprimaryHPVscreeningtestresultincombinationwithasecondarytriagetestresult(s)whereapplicableandgeneratingasinglemanagementrecommendationforthecombinedresult(s).Inthecaseoflaboratoriesondifferentsitesitwillbetheresponsibilityofthecytologyservicetoauthorisethefinalreport.
QR96. Quality requirement
TheLIMSwillbecapableofrecordingtheidentityofthereportingscreeners,pathologist(s) and the authorising virology technologist.
QR97. Quality requirement
InadditiontheLIMSwill:
• Linkmultipletestresultsforthesamepatient.
• Provideeasyaccesstodetailsaboutpreviouscervicalscreeninghistoryforthepatient.
• Provideamechanismforascertainingandrecordingclinicaloutcomeafterscreening tests and diagnostic/ treatment procedures.
• ProvidethedatanecessaryforevaluationoftheCervicalCheckprogramme.
QR98. Quality requirement
TheLIMSwillbecapableofextractingandtransferringnecessarydatatotheprogrammeintherequiredformatasperCervicalCheckspecifications(notificationandresultfiles).Thelaboratorywillalsoreceiveinformationfromtheprogrammeinspecifiedformatsandtransferittoitsinformationsystems(errorandhistory/eligibilityfiles).
QR99. Quality requirement
Thelaboratorywillhavethecapabilitytoexchangeelectroniccommunicationsbetweenstaffmembersandprogrammestaffthroughsecureprotocols(e.g.secure email).
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3.1.6 Telephone support
QR100. Quality requirement
LaboratoriesmustprovideFreephonetelephoneaccess(forcallsmadefromIreland)tolaboratorystaffduringnormalbusinesshours(GMT)forregisteredsampletakersandNSSstaffforqueriesandfollow-up.
3.1.7 Other laboratories
QR101. Quality requirement
Laboratory(ies)willmakerelevantclinicalinformationandfollow-updataavailableto other laboratories providing services to CervicalCheck.
3.1.8 Segregation, identification and traceability of programme samples
QR102. Quality requirement
AllworkcarriedoutinrelationtotheprovisionoflaboratoryservicestotheNSSwillbeclearlydistinguishablefromtheworkcarriedoutforotherclientsofthelaboratory,beginningwithreceiptofsamples,throughoutthescreeningandresultingprocesses,toreporting,laterinvestigationsandreviews,aswellasstorage and archiving.
3.1.9 Health agencies and authorities
QR103. Quality requirement
LaboratoriesengagedbyCervicalCheckwillcomplywithallrequestsfordataorreportsbyIrishhealthagenciesandauthorities,includingtheDepartmentofHealthandtheNationalCancerRegistryIreland(NCRI).Allrequestsfordatafromother health agencies and authorities must come to and be processed through CervicalCheck.
3.1.10 Changes to service capacity, capability or conformance to quality assurance standards
QR104. Quality requirement
Anychangesthatimpactonorcouldhaveanimpactonanyaspectoflaboratoryservices, including laboratory accreditation status, processes, system procedures, analysisandreporting,mustbeagreedwithCervicalCheck.AnychangeswillbeadvisedinadvanceinwritingandmustbeapprovedbeforeimplementationbyCervicalCheck.
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3.2 Clinical governance
TheHealthServiceExecutive(HSE)isaccountableforcontinuouslyimprovingthequalityofitsservicetosafeguardhighstandardsofcarebycreatinganenvironmentinwhichclinicalexcellencewillflourish.
Clinicalgovernanceencompassesqualityassurance,qualityimprovementandriskandincidentmanagementwhicharecorefunctionsofalaboratoryscreeningservice.
Clinical governance for CervicalCheck screening samples is the responsibility of the cytopathology service under the lead pathologist.
QR105. Quality requirement
NetworkedlaboratorysolutionsinthecontextofcervicalscreeningservicesmustbesupportedbycloselyalignedQMS,LIMSanddocumentmanagementsystems.
Note: All screening should take place at the minimum number of laboratory sites possible.
QR106. Quality requirement
Amedicallyqualifiedconsultantpathologistmusttakeresponsibilityfortheissueofallcervicalscreeningtestresults.
• Atleast2medicallyqualifiedconsultantpathologistswhoactivelypracticeincervicalcytologymustbeinvolvedintheprovisionofaCervicalCheckcervicalscreening service.
• Theconsultantpathologistsmustpractiseincervicalcytologywithinthelaboratorynetworkwherescreeningofcervicalcytologysamplesisundertaken.
• Oneconsultantpathologistisalwaysavailabletoprovidedirectiontostaff.
• Theconsultantsmustbefullyintegratedintotheworkingofthedepartment(s)andbeavailableduringnormallaboratoryopeninghoursforstafftoconsultwithor vice versa.
3.2.1 Contracting arrangements between NSS and screening laboratory(ies)
QR107. Quality requirement
Laboratoriesmustadheretothetermsofanycontract/ServiceLevelAgreement(SLA)orMemorandumofUnderstanding(MOU)betweentheNSSandthelaboratory.
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3.2.2 Service level agreement/ Memorandum of Understanding / Contract for virology services
QR108. Quality requirement
CervicalcytologylaboratoriesmusthaveanSLA(s)/MOU/contractinplaceforvirologyservicesifprovidedbyathirdpartytospecifytheservicesrequired.
QR109. Quality requirement
Molecular HPV testing services must be provided by a legally recognised organisationasmustthecervicalcytologyservice,althoughnotnecessarilywithinthesamedepartmentorthesameorganisation.Thecytologyandvirologyleadsmustsetclearlydefinedparametersforcollaborativeworkingandagreeprocessesandinteractionstodemonstrateregularengagementforthedurationofthecontract/ agreement.
3.2.3 Service level agreement/ Memorandum of Understanding / Contract for virology support within the cytology department
QR110. Quality requirement
A cytology service undertaking hrHPV testing must have appropriate consultant virologistsupport,documentedinanSLA/MOU,asappropriate.TheSLA/MOUshouldmakesurethatvirologysupportisavailabletothecytologyservicewhenrequired.
Asaminimum,theSLA/MOUmustspecifythefollowing:
• Theorganisationsordepartmentstheagreementisbetween.
• Thetenurefortheservice.
• Theexpectedlevelofactivity.
• Thearrangementsformodificationstotheagreement.
• Theservicebeingprovided.
• Thecostoftheservice.
• Thepaymentterms.
• Thelegalissues,forexample,penaltyclausesforunderperforming.
• Therequirementforthelaboratorytobeaccreditedtotheappropriatestandardse.g.CollegeofAmericanPathologists(CAP),ISO15189.
• Therequirementtonotifythepartnerserviceofanychangetoitsaccreditationstatus.
• ThehrHPVtestingplatformthatwillbeused.
• Thearrangementsfortransportofsamplestovirology.
• HowsampleswillbetestedincludingafullyintegratedelectronicLIMStoCervicalChecklinkandGDPR.
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• Thatinternalqualitycontrol(IQC)andqualityassurancemustbecarriedoutinaccordancewithnationalguidance.
• Howfinalresultswillbeauthorisedandprovidedtocytology.
• TheexpectedturnaroundtimeofsamplesforhrHPVtestingtomakesurethereiscompliancewiththeoverallCervicalCheckturnaroundstandard.
• Stepsinvolvedinthespecimenpathwayandareasofresponsibilityforcytologyand virology.
• ThebusinesscontinuityplanningforthehrHPVtestingservice.
• Thearrangementsforpatientconfidentialitytraining.
• Thearrangementsforhealthandsafety.
• Thecompliancewithstafftrainingandcompetencyassessments.
• TherequirementstoprovideperformancedatatotheCervicalCheckprogramme.
• Therequirementstoattendmeetingstodiscussperformanceoranyserviceissues or changes.
3.2.4 Contract for service advisors
QR111. Quality requirement
A consultant virologist or lead scientist appointed to provide external advisory servicestoacytologylaboratorymustholdacontractwiththehostprovider.
As a minimum the contract must state:
• Thecontractingorganisationasalegalentity.
• Theprofessionalregistrationrequirements.
• Thedutiesofthecontractedappointee.
• Thereportingandaccountabilityarrangements.
• Thearrangementsforappraisalandperformancedevelopment.
• Thearrangementsforanyperformancerequirements.
3.2.5 Outsourcing laboratory services
QR112. Quality requirement
Laboratoryservicesmustnotbeoutsourcedwithoutfullandcomprehensivediscussion,planningandwrittenapprovalfromCervicalCheck.
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3.3 Laboratory personnel (roles and responsibilities and staff qualifications)
3.3.1 Service leads and staff roles and responsibilities
Serviceleadshavespecificresponsibilityforclinicalgovernanceandaredirectlyaccountableforthequalityoftheirownworkandthatoftheirdepartmentalteams.Theentirescreeningpathway,includingassociatedfollowupservices,mustbefunctionalandsafe.
Theteammustincorporatepersonnelwithmolecularbiologytrainingandskills,knowledgeoftheinstrumentationandsoftwareinuse,knowledgeofthescreeningprogramme,capacitytoorganisetheworkwithlargenumbersofsamples,problemsolvingabilityandalsotheskillstoenableinteractionwithexternalindividualswhichservethescreeningprogramme.
QR113. Quality requirement
Scientific,medicalandnon-medicalstaffmustbequalifiedforthepositionstheyholdaccordingtonationalrequirementstopractice.Staffmustberegisteredwiththeappropriateregulatoryboardaccordingtonationalrequirementstopractice(eg.CORUinIreland).
QR114. Quality requirement
Laboratoriesmusthaveanorganisationchartthatidentifiestheindividual(s)withinthedepartmentwhois/areresponsibleforeachelement.Theremustbeagreementonprocessesandinteractionswhichsetclearexpectationsforeffectiveworking.
3.3.2 The role of the lead pathologist for cervical cytology triage
QR115. Quality requirement
Theleadpathologistforcervicalcytologytriagemust:
• Beaconsultantcellularpathologistregisteredwiththeappropriatenationalprofessionalandregulatorybody.
• Haveanominateddeputymedicalpathologist.
• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesthecervicalcytology service.
• ReportcervicalcytologyandsatisfyCervicalCheckstandardsinrelationtocervical screening.
• Haveajobdescriptionwhichtakesaccountofthisroleanditstimecommitment.
• HavesatisfactoryandappropriateparticipationinanappropriateContinuingProfessionalDevelopment(CPD)scheme(forexample,RCPath).
• ParticipatesatisfactorilyinanaccreditedExternalQualityAssessment(EQA)SchemeforGynaecologicalCytopathology.
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• Beavailabletothedepartment/networkonadailybasisasfaraspracticallypossible(or,ifnot,thenominateddeputymustbe).
• Supportassessingtheoverallqualityofthelaboratoryscreeningservice.TakeoverallresponsibilityforthequalityofreportsincludingHPVresultsissuedforCervicalCheck.
• Ensure,alongwiththeleadscientist,thatalllaboratorystaffarequalifiedfortheirroles.
• Ensure,withtheleadmedicalscientistandcellularcytologylaboratorymanager,thatthelaboratoryfollowsallnationalguidancerelatedtocervicalscreening.
• Adviseontheimplementationofnewguidanceormonitoringofnewstandardsas communicated by CervicalCheck.
• AttendcervicalscreeningMulti-DisciplinaryTeam(MDT)meetings,ormakesure that a laboratory representative (other consultant or consultant biomedical scientist (BMS)) is present, to discuss appropriate cases.
• Ensurethat100%ofMDTmeetingsareattendedbyasuitablyqualifiedperson.
• Beresponsibleformakingsurethenecessarypathologyinputismadeforcervicalcancerreviews.
• Adviseandparticipateinauditforthecervicalscreeningprogramme.
• Attendinternalandexternalcervicalscreeningmeetings-ormakesurethatadeputyispresentwheretheperformanceoftheservicewillbemonitoredandlocal issues discussed.
• Signoffscreeningstatisticalreportsandotherdatareturnsandauditsasrequired.
• Betheprimarymedicalcontactwithinthedepartmentforcervicalcytologytriagematters.
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3.3.3 The role of the consultant cytopathologist
QR116. Quality requirement
Theconsultantpathologistforcervicalcytologytriagemust:
• Beaconsultantcellularpathologistregisteredwiththeappropriatenationalprofessionalandregulatorybody.
• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesthecervicalcytology service.
• ReportcervicalcytologyandsatisfyCervicalCheckstandardsinrelationtocervical screening.
• Haveajobdescriptionwhichtakesaccountofthisroleanditstimecommitment.
• HavesatisfactoryandappropriateparticipationinanappropriateCPDscheme(e.g. RCPath).
• ParticipatesatisfactorilyinanaccreditedEQASchemeforGynaecologicalCytopathology.
• Beavailabletothedepartment/networkonadailybasisasfaraspracticallypossible(or,ifnot,thenominatedalternatemustbe).
• Supportassessingtheoverallqualityofthelaboratoryscreeningservice.TakeoverallresponsibilityforthequalityofreportsissuedonbehalfofCervicalCheck.
• Adviseontheimplementationofnewguidanceormonitoringofnewstandardsas communicated by CervicalCheck.
• AttendcervicalscreeningMDTmeetings,ormakesurethatalaboratoryrepresentative (other consultant or consultant BMS) is present, to discuss appropriate cases.
• Adviseandparticipateinauditforthecervicalscreeningprogramme.
Note: Pathologists - if there is an absence from work for a period exceeding six months then the individual must undertake a short period of retraining consisting of double screening a minimum of 150 cases with 95 per cent sensitivity for HSIL and have successfully participated in the most recent round of EQA slides/proficiency testing.
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3.3.4 The role of the consultant biomedical scientist (currently only applicable to referral laboratories based in the UK)
TheconsultantBMSisanon-medicalindividualwhoisqualifiedtoDiplomateoftheRCPathorequivalent(diplomaofadvancedpractice-cervicalcytology,InstituteofBiomedicalSciences(IBMS)/RCPathconjointexaminationboard)orrecognisedequivalent.
QR117. Quality requirement
TheconsultantBMSforcervicalcytologytriagemust:
• BeaconsultantBMSregisteredwiththeappropriatenationalprofessionalandregulatory body.
• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesacervicalcytology service.
• ReportcervicalcytologyandsatisfyCervicalCheckstandardsinrelationtocervical screening.
• Haveajobdescriptionwhichtakesaccountofthisroleanditstimecommitment.
• HavesatisfactoryandappropriateparticipationinanappropriateCPDscheme(e.g. IBMS/RCPath).
• ParticipatesatisfactorilyinanaccreditedEQASchemeforgynaecologicalcytopathology.
• Beavailabletothedepartment/networkonadailybasisasfaraspracticallypossible(or,ifnot,thenominatedresponsiblepersonmustbeavailable).
• Supportqualityassessmentandimprovementofthelaboratoryscreeningservice.
• Ensure,withtheleadmedicalscientistandcellularcytologylaboratorymanager,thatthelaboratoryfollowsallnationalguidancerelatedtocervicalscreening.
• Adviseontheimplementationofnewguidanceormonitoringofnewstandardsas communicated by CervicalCheck.
• AttendcervicalscreeningMDTmeetings-ormakesurethatalaboratoryrepresentative (other consultant or consultant BMS) is present, to discuss appropriate cases.
• Adviseandparticipateinauditforthecervicalscreeningprogramme.
• Attendinternalandexternalcervicalscreeningmeetingsasrequired-ormakesurethataalternateispresentwheretheperformanceoftheservicewillbemonitored and local issues discussed.
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3.3.5 The role of the lead medical scientist /laboratory manager for cervical cytology triage
QR118. Quality requirement
Theleadscientistforcervicalcytologytriagemust:
• Beemployedinacytologylaboratorywhichprovidesacervicalscreeningservice to CervicalCheck.
• Beappropriatelyqualifiedandcompetenttocarryouttherole.Wheretheroleinvolvescervicalcytology,onlyreportnegativeorinadequatecytologysamplesthatarepositiveforhrHPVandthathaveundergoneaninitialandqualityassurance screen.
• Beregisteredwiththeappropriateregulatorybody,ifapplicable.
• Haveanominateddeputy.
• Workcollaborativelywiththemedical/non-medicalconsultantsandlaboratorymanagerstomonitorandmaintainahighqualitylaboratorycervicalscreeningservice.
• Haveexperienceofleadingaclinicallaboratoryservice.
• Overseethedevelopmentandreviewoflaboratorypoliciesandprocedures.
• Ensurethatthecervicalscreeninglaboratoryservicesareinlinewithappropriatelaboratory accreditation standards such as CAP, ISO 15189.
• Ensurethecytologylabhasdetailedstandardoperatingprocedures(SOPs)(inconjunctionwiththemolecularlaboratory)torecordtheendtoendcervicalscreening test protocols to CervicalCheck standards or recommendations.
• EnsurethatthelaboratoryfollowsCervicalCheckguidanceinrelationtoallaspectsofcervicalscreening.
• Supporttheimplementationofnewguidanceormonitoringofnewstandardsaspublished by CervicalCheck or other relevant bodies as appropriate.
• Ensurethatallscientificandlaboratorysupportstaffhavetheappropriatequalifications,trainingandregistrationwhereappropriate.
• Ensurethatthecompetenceofalllaboratorystaffismonitored,maintainedandevidenced.
• NotifyCervicalCheckofanyinstancewherethereareissueswithstaffcompetenceandremovethestaffmemberfromCervicalCheckworkloaduntiltheissueissatisfactorilyresolved.
• HavesatisfactoryparticipationintheCPDschemeappropriatetotheirprofessionalpractice.
Note: If there is an absence from cervical screening work for a period exceeding three months then the individual must undertake a formal period of retraining. If absent for more than six months, then, external training may be required.
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3.3.6 The role of the cervical cytotechnologist/medical scientist
Acervicalcytotechnologistisatrainedindividualemployedtoundertakethecytologicalexaminationofcervical cytology samples.
QR119. Quality requirement
Thecervicalcytotechnologist/medicalscientistforcervicalcytologytriagemust:
• Beemployedinacytologylaboratorywhichprovidesacervicalscreeningservice to CervicalCheck.
• Beappropriatelyqualifiedandcompetenttocarryouttherole.
• Beregisteredwiththeappropriateregulatorybody,ifapplicable.
• Havesuccessfullycompletedanapprovedtrainingprogramme.
• OnlysignoutandreportnegativeorinadequatecytologysamplesthatarepositiveforhrHPVandthathaveundergoneaninitialandqualityassurancescreen.
• Participateintheprimary,doubleandrapidscreeningofcervicalsamples.
• Maintaintheircompetencethroughparticipationinproficiencytestingschemes,recognisedcervicalcytopathologyEQAschemesandin-housetraining,asappropriate.
• HavesatisfactoryparticipationintheCPDappropriatetotheirprofessionalpractice.
Note: If there is an absence from work for a period exceeding three months then the individual should undertake a formal period of retraining. If absent for more than six months, then, external training may be required.
3.3.7 Proficiency and competency of cytology staff
QR120. Quality requirement
ThoseundertakingscreeningshouldNOTbeemployedonalessthanhalftimebasis.
QR121. Quality requirement
Updatetrainingmustbeprovidedonaminimum2yearlybasis.
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QR122. Quality requirement
ScreenersidentifiedaspersistentlynotdetectingabnormalcytologymustberemovedfromCervicalCheckcytologyscreening.Followingsuspensionfromscreening,returntonormal,unsupervisedscreeningshouldonlybewhereupdatereskillingtraininghasbeensuccessfullycompletedinthelast2yearsandafteranagreedperiodofdoublescreening(atleast200cases,followedby50%doublescreeningfornext100slides)andcarefulmonitoring8.Ifanyhighgradecasesareundetectedduringthissupervisedperiodthenaperiodoffurtherre-educationmonitoringmustbeinstigated.Anysuspensionfromscreeningmustberecordedinwritinginthescreener’strainingfile.
QR123. Quality requirement
Therewillbeprotocolsandpracticesinoperationtodemonstrateasystemofbothinternalandexternalcontinuingeducationforscientificandmedicalstaffreporting CervicalCheck cases.
Note: Internal continuing education may comprise some or all of the following:
• Discussion of difficult/review cases between cytotechnologists, medical scientists and/or cytopathologists. Laboratories should have a multi-headed microscope for this purpose.
• Provision of up-to-date cytology textbooks and/or electronic material for consultation in the cytopathology laboratory.
• Access to one or more of the cytology journals.
External continuing education may comprise some or all of the following:
• Attending workshops and symposia.
• Attendance at regular update courses.
• Regional inter-laboratory slide review sessions.
• Participation in proficiency testing.
• Teaching cytotechnology students and pathology trainees.
• Independent study contributions to laboratory handbooks or work in committees of the relevant medical and/or professional societies.
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3.3.8 The role of the lead virologist for hrHPV testing
QR124. Quality requirement
Theleadvirologistmust:
• Beaconsultantvirologist(medicalorclinicalscientist),registeredwiththeappropriatenationalprofessionalandregulatorybody.
• Haveanominateddeputyvirologist.
• BeemployedinorhaveacontractwithalaboratorywhichprovidesanaccreditedhrHPVtestingservice.ThislaboratorymusthaveanSLAorMOUifappropriatewiththelaboratoryprovidingcytologyservicestotheprogramme.
• EnsurethemolecularlabhasdetailedSOPS(inconjunctionwiththecytologylaboratory) to record the end to end cervical screening test protocols to CervicalCheck standards or recommendations.
• Haveajobdescriptionwhichtakesaccountofthisroleanditstimecommitment.
• HavesatisfactoryparticipationintheCPDschemefortheirprofessionalbody.
• WorkwiththeleadpathologisttoassuretheoverallqualityofthehrHPVtestingservice.
• Ensure,alongwiththeleadscientist,thatalllaboratorystaffarequalifiedfortheirroles.
• Adviseontheimplementationofnewguidanceormonitoringofnewstandardsas communicated by CervicalCheck.
• SignoffscreeningstatisticalreportsandotherdatareturnsandauditsasrequiredthatrelatetohrHPVtesting.
• AdvisetheleadscientistforhrHPVonparticipationinanationalEQAschemeforhrHPVtesting,internalqualitycontrolmonitoringandinternalqualityassurance(IQA)procedures.
• AdviseoncompliancewithCervicalCheckcriteriafortheassessmentandimplementationofnewormodifiedtechniquesrelevanttothehrHPVservice.
• Beavailableforadviceonadailybasis,ormakesurethereissupportfromthenominated deputy.
• Adviseontheimplementationofnewguidanceormonitoringofnewstandardsas published by CervicalCheck, RCPath or other relevant bodies.
• AttendcervicalscreeningMDTmeetingswhereappropriate,orensurethatadeputy provides cover.
• Adviseonauditforthelocalcervicalscreeningprogrammerelevanttotheroleinthe programme.
• ReceiveminutesofCervicalCheckmeetings,asappropriate,wheretheperformanceoftheserviceismonitoredandprogrammeissuesdiscussed.
• ContributewherenecessarytoanyqualityreportsgiventotheCervicalCheckprogramme, local cervical screening business or governance meeting and contribute to any annual reports relating to the service.
• BetheprimarycontactwithinthelaboratoryserviceforhrHPVclinicalmatters.
• EnsureallauthorisedreportstransfersuccessfullytothecytologyLIMS.
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3.3.9 The role of the lead scientist/medical scientist for hrHPV testing
QR125. Quality requirement
Theleadscientist/medicalscientistmust:
• Beemployedinorhaveacontractwithalaboratorywhichprovidesanaccredited hrHPV testing service to CervicalCheck.
• Beappropriatelyqualifiedandcompetenttocarryouttherole.
• Beregisteredwiththeappropriatenationalandregulatorybody,ifapplicable.
• Workcollaborativelywiththemedicalconsultants,andlaboratorymanagerstomonitorandmaintainahighqualitylaboratorycervicalscreeningservice.
• SupportallaspectsofdeliveryofthehrHPVservice.
• Haveexperienceofleadingandtroubleshootingahigh-throughputmoleculardiagnostic service.
• ProvideanhrHPVtestingserviceinlinewiththeappropriateaccreditationstandards e.g. CAP, ISO 15189.
• Overseethedevelopmentandreviewoflaboratorypoliciesandprocedures.
• EnsurethatthelaboratoryfollowsCervicalCheckguidanceinrelationtoallaspectsofcervicalscreening.
• Supporttheimplementationofnewguidanceormonitoringofnewstandardsaspublished by CervicalCheck or other relevant bodies as appropriate.
• Ensurethatallscientificandlaboratorysupportstaffhavetheappropriatequalifications,trainingandregistrationwhereappropriate.
• MakesurethereiscompliancewithCervicalCheckcriteriafortheassessmentandimplementationofnewormodifiedtechniquesrelevanttotheHPVservice.
• Providemoleculardiagnosticstrainingandsupport.
• Ensurethatthecompetenceofalllaboratorystaffismonitored,maintainedandevidenced.NotifyCervicalCheckofanyinstancewherethereareissueswithstaffcompetenceandremovethestaffmemberfromCervicalCheckworkloaduntiltheissueissatisfactorilyresolved.
• HavesatisfactoryparticipationintheCPDschemeappropriatefortheirprofessionalbody.
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3.3.10 The role of the virology scientist/ medical scientist for hrHPV testing
QR126. Quality requirement
Thevirologyscientist/medicalscientistforhrHPVtestingmust:
• Beemployedinorhaveacontractwithalaboratorywhichprovidesanaccredited hrHPV testing service to CervicalCheck.
• Beappropriatelyqualifiedandcompetenttocarryouttherole.
• Beregisteredwiththeappropriatenationalandregulatorybody,ifapplicable.
• Workcollaborativelywiththemedicalconsultantsandlaboratorymanagerstomaintainahighqualitylaboratorycervicalscreeningservice.
• SupportallaspectsofdeliveryofthehrHPVservice.
• Becapableoftroubleshootingahigh-throughputmoleculardiagnosticservice.
• ProvideanhrHPVtestingserviceinlinewiththeappropriateaccreditationstandards e.g. CAP, ISO 15189.
• FollowCervicalCheckguidanceinrelationtoallaspectsofcervicalscreening.
• Supporttheimplementationofnewguidanceormonitoringofnewstandardsaspublished by CervicalCheck or other relevant bodies as appropriate.
• FollowCervicalCheckcriteriafortheassessmentandimplementationofnewormodifiedtechniquesrelevanttotheHPVservice.
• Providemoleculardiagnosticstrainingandsupport.
• HavesatisfactoryparticipationintheCPDschemeappropriatefortheirprofessionalbody.
3.3.11 Proficiency and competency of virology staff
QR127. Quality requirement
TherewillbeprotocolsandpracticesinoperationtodemonstrateasystemofbothinternalandexternalcontinuingeducationforscientificandmedicalstaffreportingCervicalCheck cases.
Note: Internal continuing education may comprise some or all of the following:
• Discussion of difficult cases.
• Provision of up-to-date textbooks and/or electronic material for consultation in the virology laboratory.
• Access to one or more of the virology journals.
External continuing education may comprise some or all of the following:
• Attending workshops and symposia.
• Attendance at courses.
• Regional inter-laboratory QA sessions.
• Teaching.
• Independent study contributions to laboratory handbooks or work in committees of the relevant medical and/or professional societies.
20 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.3.12 Locum staff
QR128. Quality requirement
Locumstaffmust:
• Beappropriatelyqualifiedandcompetenttocarryouttherole.
• Beregisteredwithappropriatenationalregulatorybodies.
• MeettherequirementsandstandardsoftheCervicalCheckcervicalscreeningprogramme.
• MeetthetrainingandupdaterequirementsoftheCervicalCheckcervicalscreening programme.
• Routinelyparticipateinanappropriateandvalidated/accreditedEQAscheme.
Note: The service provider is responsible for making sure these requirements are included in any contract.
3.4 Sample acceptance, reception and data entryThecytologylaboratoryhasoverallresponsibilityforacceptanceandreceptionofCervicalCheckscreening samples.
3.4.1 Sample acceptance
QR129. Quality requirement
SOPsmustbeinplaceforhandlingCervicalChecksamples.Sampleacceptancemust adhere to the HPV Primary Screening Eligibility Framework/Reference Guide for GPs and Clinics (see Appendix 4).
QR130. Quality requirement
Laboratorieswillacceptordersviapostaldeliveryandviaelectroniclaboratoryorderswhereapplicable(followedbythereceiptofthephysicalsampleandform).Forelectronicordersthelaboratorywillbecapableofextractingbar-codedinformation.
QR131. Quality requirement
ThelaboratorymustonlyacceptprogrammesamplesfromdoctorsorclinicsthatarenotifiedtothelaboratorybyCervicalCheck.
QR132. Quality requirement
Onlythosesamplesaccompaniedbyacurrent,approvedversionoftheCervicalCheckcervicalscreeningformwillbeaccepted.
QR133. Quality requirement
Onlythosesamplesinclusiveofinformedconsentwillbeaccepted.
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3.4.2 Specimen reception
QR134. Quality requirement
Allformsmustbedate-stampeduponreceiptanddateofreceiptmustbecaptured on the LIMS.
QR135. Quality requirement
Samplevialswillbecheckedforleaksanddamageandmatchedtotheaccompanyingformspriortolabelling.Toensurearobust‘chainofcustody’withinthelaboratory,cross-checkingofaminimumofthreepatientidentifiersmustbeperformed.
Note: If the testing procedure requires pre-aliquoting from the LBC vial then a second person verification should be in place to ensure a robust ’chain of custody’. For an automated aliquoting process a single step verification is required.
QR136. Quality requirement
A documented discrepancy handling and resolution process must be in place to managealldiscrepanciesforCervicalChecksamplesreceived.DiscrepancieswillberecordedandthelogwillbemadeavailabletoCervicalCheckspecification.
Note: The CervicalCheck guidance document “Discrepancy Handling and Resolution Guidance for Laboratories participating in the CervicalCheck Screening Programme9” is available for laboratories contracted to the programme and must be adhered to.
Samples returned to ordering sample takers or clinics must be traceable.
QR137. Quality requirement
SamplesnotifiedasineligiblebytheProgrammeforscreeningwillnotbetested.
QR138. Quality requirement
Wheresamplesareunsuitablefortestingareportmaybegenerated.Unsuitablespecimenswillbetrackedusingthelaboratoriesnon-conformancelog.
QR139. Quality requirement
Followingacceptanceofthesampleandformforprocessing,bothwillbelabelledwithauniqueidentificationnumber(laboratoryaccessionnumber).Theuniquelaboratoryaccessionnumberforthesamplemustremainthesameregardlessoftest.
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3.4.3 Data entry
QR140. Quality requirement
DataentryofthedetailsrecordedonCervicalCheckformsaccompanyingsubmittedsamplevialsmustconformtoCervicalCheckdatacapturerequirements.AlldatarelevanttocervicalscreeningrecordedontheCervicalScreeningFormbythesampletakerwillbeenteredontotheLIMS.
QR141. Quality requirement
Asecondpersonverificationofallrelevantdataenteredfromtheformontothecomputersystemwillbecarriedoutanddeemedtobecorrectbeforethesampleisauthorisedforfurtherprocessing.
QR142. Quality requirement
Samples must be assigned to the correct clinically responsible doctor or clinic as perthereceivedform.
QR143. Quality requirement
CervicalCheckmusthaveaccesstoHPVcervicalscreeningrequest/orderformsreceivedbythelaboratoryinelectronicformatandindexedbylaboratoryaccession number.
Standard 3-1 Cervicalscreeningsamplesmustbenotifiedpromptly to CervicalCheck once they are accessioned on the LIMS.
Target
95%within48hours,minimum80%by17:00GMTnextworkingday.
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3.5 Sample processing and analysis
3.5.1 Molecular hrHPV testing
QR144. Quality requirement
HPVtestingserviceswillbeprovidedinadedicatedlaboratoryareaorfacility.Allareaswillbeclean,well-lit,temperaturemonitoredandwell-ventilated.
QR145. Quality requirement
Laboratories must use those hrHPV assays approved by CervicalCheck. ModificationstoexistingassaysmustbenotifiedinwritingandCervicalCheckapproval sought prior to implementation by the laboratory.
QR146. Quality requirement
Processors used in either the molecular HPV testing or cytology preparation areamustbemaintainedonlybylaboratorystaffwhohavebeentrainedbythemanufacturerorindividualsdesignatedbythemanufacturer.
QR147. Quality requirement
Handlingprocedureswillensurearobust“chainofcustody”acrossallphasesofthelaboratoryprocess,includingspecimenreceipt,HPVdetection(pre-analyticsandanalytics),documentationandstorage.Anaudittrailwillbeinplaceforsample processing.
QR148. Quality requirement
Laboratorieswillverifyeachnewreagentbatchand/ornewreagentlotnumberpriortouse,usingadefinedanddocumentedprocedure.Theremustbesufficientdocumentationexplainingthecriteriaforacceptance.Thisensuresconsistencyofperformancebetweenbatchesandthatthechangeinreagenthashadnoimpactonthequalityoftheexamination.
QR149. Quality requirement
Processingofsampleswillbecarriedoutaccordingtoinstrumentusermanualsandassayspecificpackageinserts.UserIDshouldbetraceableforallactivitiesperformedontheplatformandforeachstepoftheHPVtestingprocess.
Note: For comprehensive guidance regarding request form/vial discrepancy handling, please refer to the SOP on discrepancy handling9.
3.5.1 Molecular hrHPV testing
IQAmustbecarriedouttomonitorallspecimenprocessingactivitiesthroughthelaboratory,startingfromreceptionandendinginthedispatchofthefinalreport.IQAmeasuresmustalsoassessthereproducibilityofthelaboratorysampleprocessingandHPVtestingtechniques.
QR150. Quality requirement
LaboratoriesmustcarryoutIQAanddocumentthefindings.
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24 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.5.1.2 Laboratory internal quality control (assay) of molecular primary HPV testing
LaboratoriesperforminghrHPVtestingfortheCervicalCheckcervicalscreeningprogrammeshouldrefertotheNationalHealthServiceCervicalScreeningProgramme(NHSCSP)documentLaboratory Quality and Assurance for human papillomavirus testing10.ItprovidesguidanceonIQCandIQAproceduresandtheirmonitoring,plusEQA.
TheguidancewascommissionedbyPHEandCervicalCheckrecognisethatalthoughtheguidancereferscontinuallytoISO15189:2012standards,itisimperativethatlaboratoriesmustoperatetotheNHSCSPdocumentasaminimum,alongwithanyfurtherqualitystandardsdictatedbytheexternalaccrediting body appropriate to that laboratory such as CAP, CLIA etc.
QR151. Quality requirement
In-housevalidationandverificationofassaysmustbecarriedoutpriortotheintroductionofanyCervicalCheckapprovedHPVassay.
Thelaboratorymustusetheappropriatecontrolandmonitoringprocedurestomanageassayrun“drift”inadditiontothemanufacturerkitcontrols.
QR152. Quality requirement
Manufacturers’controlsmustconformtoproductkitinsertfortheassayconcerned.
QR153. Quality requirement
IQCmustbeperformedatsufficientintervalstoassureresultintegrityandreducetheriskofretestingintheeventofafailure.Evidenceofsamemustbeavailable.Ifinternalqualitycontrolsarepreparedbythelab,internaldocumentationrelatingtotheirpreparationmustbeinplace.Anychangetoanewcontrolshouldbeplannedandcotestedwiththeexistingcontroltofacilitatevalidationpriortointroduction.
QR154. Quality requirement
Tomonitorforlongtermdeviations,acontrolchart,registeringeachvalueobtainedineachbatch,ismandatory.Thisallowseasyidentificationoftrendsinqualitycontroldata,andidentificationofbothsystematicandrandomerrors.Aprocedureoutliningrejectionrulesandimmediateflaggingofrejectioneventsmustbe in place. Associated corrective actions should also be clearly documented.
Otheraspectsimportantforqualitymonitoringincludetheassessmentofpositivityratesandquantificationofthenumberofsampleswithvaluesclosetothecutoff,andthosethatrequirerepeatfortechnicalreasons.Checksontheinternalreproducibilityoftheassaycanprovideinsightintothelongitudinalperformance.
QR155. Quality requirement
Laboratories must monitor and document invalid (indeterminate) sample rates, byreasonappropriatetotheHPVassayplatform.Anincreaseinratesaboveexpectedshouldtriggerfurtherlabinvestigationandcorrectiveactiontakenasappropriate.
QR156. Quality requirement
LaboratoriesmustundertakeyearlyverificationofHPVassays.ReportsforverificationshouldincorporateareviewofIQCandEQAperformanceaswellasasummaryofanyoperationalormanufactureissuesthathaveariseninthetimeperiodconcerned.Laboratoriesmustclearlystatethemethodofverificationandcriteriaforacceptableperformance.
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3.5.1.3 EQA of molecular primary HPV testing
QR157. Quality requirement
AlllaboratoriesprovidingHPVtestingmustparticipate,andshowadequateperformance,inanapprovedEQAscheme.Ideally,thelaboratoryshouldalsoparticipateinaregularprogrammeofinter-laboratorycomparison(ILC).
QR158. Quality requirement
EQAsampleswillbeanalysedaspartoftheroutinelaboratoryassayrun,bypersonnelwhoroutinelytestpatientsamples.TheEQAsamplesshouldbesubjecttothesameprimarymethodsasforpatientsamplestomimicroutinelaboratorytestingconditionsasfaraspossible.
QR159. Quality requirement
EQAperformancewillbeevaluatedonanongoingbasis,withpromptcorrectiveactiontakenforunacceptableresults.TheEQAperformanceandanycorrectiveaction(s)undertakenwillbefullydocumentedandrecordedinthelaboratoryannualmanagementreview.
QR160. Quality requirement
NomorethantworepeattestswillbeperformedonfailedsamplesincludingthosewhereclotsaredetectedbeforereportingashrHPVindeterminate.
3.5.2 Cytology triage
QR161. Quality requirement
Liquid-basedcytology(LBC)ismandatory.Liquid-basedspecimensmustbeprocessedaccordingtothemanufacturer’sinstructions.
QR162. Quality requirement
SlideswillbestainedusingthePapanicolaoustain(originalormodified).Thesamples should have a cover slip that covers all the cellular material.
QR163. Quality requirement
Slidelabelsshouldincludepatientsurnameandforenameorfirstinitialofforenameinadditiontotheaccessionnumber.Wherethelaboratoryusesautomatedprocessorswhichreadandtransfertheuniquelaboratoryaccessionnumber (via barcode) onto the slide, it may not be possible to include all three identifiersonthesampleslide.
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3.5.2.1 Staining
QR164. Quality requirement
ThelaboratorymustparticipateinanappropriateEQAschemeforstainingknownas“TechnicalEQA”.
QR165. Quality requirement
Internaltechnicalqualityassurancechecksmustbecarriedoutroutinelyincludingqualityofstainingandqualityofpreparation.Theresultsofthesechecksshouldbeavailableforreviewandshouldspecifyindividualprocessorsifmultipleprocessors are used.
3.5.2.2 Microscopy
ThecytologicalexaminationisafullmanualscreenofacervicalcytologysamplefollowingapositivehrHPVtest.TheThinPrepImagingSystem(TIS)hasnotbeenevaluated11foruseinasettingwheretheprimaryscreeningtestisahrHPVtestandisnotcurrentlyapprovedforuseinclinicalpracticebyCervicalCheck.
QR166. Quality requirement
Equipment(microscopes,multi-headedmicroscopes,digitalimagingsystems)mustbeavailableandconfiguredtotheergonomicstandardsformicroscopywork.
QR167. Quality requirement
Onlyapprovedprotocolswillbeused,approvalmustbesoughtpriortoimplementation.
Note: TIS may be used for IQC screening in a HPV primary cytology triage programme.
QR168. Quality requirement
Priortotheassessmentofthesample,thepatient’sscreeninghistorywillberetrievedfromthelocallaboratoryfilesand/ortheCervicalCheckscreeningdatabaseandbemadeavailabletothescientificstaffscreeningthesample.
Note: Within 48 hours of receipt of sample notification, CervicalCheck will transmit an electronic file or record containing all previous screening history for the woman known to the programme for samples that are to be processed by the laboratory.
QR169. Quality requirement
ScreenersandpathologistsmustregisterwithCervicalCheckandsubmittheirassignednumberstoCervicalCheckintheresultsfile.
QR170. Quality requirement
Everyonewhoexpressesanopiniononaslidemusthavetheiropinionrecordedinaretrievablemanner.ScreenerswillrecordtheirresultsindependentlyontheLIMS.
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QR171. Quality requirement
Cytologyreportingmustbecontrolledandmonitoredcarefullytomanageanyovercall/ bias due to a positive HPV primary screen.
QR172. Quality requirement
Screenersmustoverlapfieldsbyatleast30percent.
Note: Screening should be carried out using a x10 objective, but in particularly crowded or difficult samples, it may be safer to slow down considerably or screen using a x20 objective.
Standard 3-2 Lead medical scientist, cytology manager, supervisory scientificstaff:iftheroleinvolvescervicalscreeningthenaminimumnumber(1,000)ofcaseswillbescreened.
Standard 3-3 Inordertomaintainproficiency,aminimumnumber(1,000)ofcytology screens per year must be screened per screener.
Target
Cytology screening should be limited to 6 hourswithina24hour period.
Standard 3-4 Inordertomaintainquality,accuracyandsafetyinthescreeningprocess,themaximumtimespentonfullmanualscreeningofLBCslidesmustnotbeexceeded.
Target
Noindividualtorapid screen more than50casesin the allocated screening time.
QR173. Quality requirement
Theremustbeabreakfromcontinuousscreeningofatleast30minutes’durationinthescreeningday(ideallyshouldbetakenawayfromthescreeningroom).Regularmicro-breaksofseveralsecondsmustbetakenevery10to15minutes.
Note: The other duties required of cervical cytotechnologists may serve as breaks from microscopy.
Standard 3-5 Weeklyworkloadmustnotexceed6consecutivedaysina7day period.
Standard 3-6 Pathologistproficiency:Tomaintainamedicalconsultant’sdiagnostic skill in cervical cytopathology, a minimum number (750)ofcaseswillbereviewed.
Standard 3-7 Multi-DisciplinaryMeetings:AleadcytopathologistreportingCervicalCheckworkloadwillparticipateinregularMDTmeetings.
Target
50%minimum,90%achievable.
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28 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.5.2.3 Laboratory internal quality assurance of cytology triage
QR174. Quality requirement
Accuracyofscreeningmustbemonitoredandmanagedwithapprovedprotocolsandproceduresfordefininganddealingwithpoorperformance.
QR175. Quality requirement
IQAofcytologyscreeningmustbemonitoredby:
• Re-screeningofslidesinitiallyjudgedduringprimaryscreeningasnegativeorinadequatetodetectfalsepositives/negativesandtodeterminesensitivityandspecificityrates.
• Monitoringscreeningdetectionandreportingratesbymeasuringthepercentagesofthemaintypesofcytologicalfindings(highgrade,lowgrade,inadequate,negative)detectedbyindividualscreenersandcytopathologists,andincomparisonwiththelaboratoryasawhole,theprogrammeandnationalstandards.
• Performanceevaluationstoidentifythosewithdeficienciesinknowledgeandskillswhowouldbenefitfromamoredirectededucationalprogramme.
• Correlationofcytologywithclinical/histologicaloutcomes.
• CorrelationofcytologywithHPVtestingforsampletestsreportedasASCUS.
• MonitoringandanalysisofqualitymetricsasrequestedbyCervicalCheck.
Note: Internal laboratory quality assurance may be undertaken by the use of full re-screen, rapid review or rapid preview re-screening of cytology samples.
29QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.5.2.3.1Rapidreview/preview
Rapidreview12isoneoftheapprovedmethodsforroutinequalitycontrolofcervicalcytology.Rapidreviewisaswiftre-examinationofallcervicalcytologysamplesidentifiedasnegativeorinadequateattheinitialcytologicalexamination,aspartofthequalitycontrolprocess.Thecytologysamplesarenotfullyscreened.Rapidpreview12isanalternativeapprovedmethodforroutinequalitycontrolincervicalcytology.Rapidpreviewisperformedmicroscopicallyinexactlythesamewayasrapidreviewandisundertakenpriortotheinitialfullcytologicalexaminationoftheslide.Allcytologyslidesaresubjecttorapidpreviewnotjustthoseclassifiedasnegativeorinadequate.Thecytologysamplesarenotfullyscreened.
Asecondfullscreencanalsobeemployedasamethodforroutinequalitycontrolincervicalcytology.Afullscreeninvolvesthefullreviewofallmaterialontheslide.
QR176. Quality requirement
Rapidreview/previewmust:
• Onlybecarriedoutbyqualifiedmembersofstaffwhoaremeetingcompetencystandards.
• Therapidreviewermustbeadifferentindividualfromthepersonundertakingthefullscreen.
• Individualsmustundergotraininginrapidreview/previewpriortoundertakingthisactivityandshowcompetencyinthistechnique.
• Arapidreview/previewmusttakeatleast60seconds.
• Ifadiscrepancyisidentifiedduringrapidreview/followingrapidpreviewthenthismustberecordedandpassedtoastaffmemberresponsibleforchecking.
• Rapidreview/previewdatamustberecordedtoallowforindividualscreeningnumbers and sensitivities to be calculated.
• Themethodofrapidreview/previewmustberegularlyauditedwithinthelaboratorytovalidateitseffectiveness.
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3.5.2.4 Checking of abnormal cases
“Checkers”areexperiencedstaffwithvariedrolesandresponsibilitieswithinthecervicalscreeninglaboratory.Aswellasundertakinginitialcytologicalexaminationofslides,anexperiencedcytotechnologistcan,dependingonrequirements,performasecondexaminationofaslideinitiallydeemedpotentiallyabnormal(checking)ofabnormalcytologysamples.
QR177. Quality requirement
• “Checkers”musthaveaminimumoffiveyears’experienceincervicalscreeningand meet the appropriate competency standards.
• WherethecheckerhasalreadyundertakenprimaryorrapidscreeninginthatworkingdayasuitablebreakMUSTbetakenbeforeproceedingtocheckingofslides.
• Incaseswheretheprimaryscreenerhasindicatedthattheysuspectthesampleis demonstrating high grade dyskaryosis or glandular neoplasia and the checker considersthetesttobenegativeorinadequatetheslidemustbepassedtoasecondchecker/consultanttospotreviewtheslidebeforeallowingittobereported.
• Individualcheckerreferralratesmustbecalculatedandcomparedtotheoveralllaboratory average.
• Thepercentageofslidesreferredasabnormal,butfinallyreportedasnegativeshouldbemonitoredandcomparedacrossindividualcheckerstoidentifyinconsistenciesinabnormalreferralrates.
3.5.3 Audit
QR178. Quality requirement
Laboratorieswillcarryoutadditionalauditsinaccordancewithdepartmentalannual plans.
3.5.4 Amended result following discussion at multi-disciplinary meeting
QR179. Quality requirement
WhereascreeningreportischangedfollowingreviewataMDTmeetingthetreatingclinicianandNSSmustbenotifiedofthischange.
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3.5.5 External quality assessment
QR180. Quality requirement
Laboratories must participate in the relevant accredited interpretive and technical nationalEQAschemes.
QR181. Quality requirement
All individuals reporting cervical cytology must participate in and demonstrate acceptableperformanceintheinterpretiveEQAscheme.
QR182. Quality requirement
ThelaboratoryshouldalsoparticipateinanapprovedEQAschemeforthepreparationandstainingofcervicalLBCsamples.
QR183. Quality requirement
EQAresultsmustbeevaluatedbythelaboratoryonanongoingbasis,withpromptanddocumentedcorrectiveactiontakenforunacceptableresults.
3.6 Reporting and classification of cervical screening samples HPVresultsmaybebatchauthorisedwithinthevirologylaboratorytoforwardtocytologyfortriageofHPVdetectedresultsandapplicationofmanagementrecommendationpriortofinalauthorisation.
3.6.1 HPV results
QR184. Quality requirement
HPV test results must adhere to CervicalCheck test results and management recommendation protocols (see Appendices 1 and 2).
3.6.2 Cytology classification and reporting codes
QR185. Quality requirement
ThereportingclassificationforCervicalChecksamplesistheBethesdasystem13 and this must be incorporated into laboratory SOPs.
Note: Appendix 1 details the cytology classification and cytology reporting codes which are used in routine reporting practice on hrHPV positive samples.
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3.6.2.1 Adequacy of cervical cytology samples
QR186. Quality requirement
LaboratoriesmustfollowBethesdaandNHSguidanceonadequacyof5,000wellpreserved cells13,14Wherecellcountingisperformed,themethodforcountingmust be incorporated into laboratory SOPs.
3.6.2.2 Reporting multiple diagnoses
QR187. Quality requirement
Wherecervicalabnormalitiesco-existwithnon-cervicalglandularneoplasiathecervicallesionmustbereportedtothescreeningprogramme.Thereporttotheclinician must contain both results.
Note: Where there is uncertainty in reporting cervical pathology the most severe interpretation should be captured and reported on.
3.6.2.3 Women with 2 cervices
Multiplereportscanalsobepossibleinacasewhereawomanhas2cervices.Thelaboratoryshouldreceiveseparatesampleslabelledtoidentifywhichcervixtheyhavecomefrom.
QR188. Quality requirement
Thelaboratorymusthaveasystemtomaintaintheidentificationofbothcervicalsamples by accession numbers.
Thesamplereportmustidentifywhichcervixitrelatesto.
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3.7 Management of women Note: refer to Appendix 1: Cervical screening results and recommendations table; Appendix 2: Management recommendation table and Appendix 3: HPV primary screening algorithm.
3.7.1 Reporting of cervical screening samples
QR189. Quality requirement
TheCervicalCheckHPVresultfilewillbereportedintheformatspecifiedbyCervicalCheck.Generally,thedetailsrequiredinclude:HPVtestmethodology,HPVtestresult,subtypestestedandreferencerange.
Note: All women with a negative hrHPV result will not have cytology performed. Samples from women testing positive for hrHPV must undergo cytology triage.
QR190. Quality requirement
TheCervicalCheckcytologyresultfilewillbereportedwiththedetailandintheformatspecifiedbyCervicalCheck.
QR191. Quality requirement
ThescreeninghistoryofthewomanprovidedbythesampletakerviathecervicalscreeningformandfromtheCSR(wheresuchhistoryisavailable)mustbereferredtoandtakenintoaccountduringtheresultsprocess.
QR192. Quality requirement
Anindependentcheckofthecaseresultandmanagementcodewillbeinplace,prior to report authorisation.
QR193. Quality requirement
Everyresultwillbeappropriatelyauthorisedbeforerelease.Theresponsibleauthoriserwillbeidentifiable.Abnormalcytologyresultswillonlybereportedbyapathologist.
QR194. Quality requirement
Results,onceauthorisedandreleased,willbeissuedintheagreedsummaryformatassoonaspossiblebyelectronicmeanstoCervicalCheck.
QR195. Quality requirement
ThecontentsoftheresultsreporttoorderingdoctorsandclinicsmustbeinaccordancewiththeguidelinesoutlinedinCervicalCheckProgrammeguidelines.
QR196. Quality requirement
Results, once authorised and released, must be issued promptly to the ordering doctor or clinic.
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34 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
QR197. Quality requirement
Resultsreportswillbeissuedtothecorrectorderingdoctororclinic.Documentedprocessesarerequiredtoensurethatresultsaresenttothecorrectdoctor.Foreverysamplereceivedtherewillbeareporttransmitted.
Note: It is desirable that where possible all results reports be issued to ordering doctors or clinics and CervicalCheck in full electronic format via a nominated telecommunications pathway. The electronic format for results is HL-7 based and conforms to the laboratory result message specifications of HIQA’s GP Messaging Standard.
QR198. Quality requirement
Laboratorieswillhaveproceduresinplacetomanageandrespondtorequestsforamending management recommendations, and provide replacement reports to doctors/clinicswherenecessary.Amendedresults,onceauthorisedandreleased,mustadheretothesamestandardsandtargetsastheoriginalreport.Thisalsoappliestorescreeningrequests.
Standard 3-8 Cervical screening results must be authorised, released and transmittedtoCervicalCheckwithinthetargetturnaroundtimefromsamplevalidationbytheprogramme.
Target
95%within10workingdays.
3.8 Storage and archivingQR199. Quality requirement
SecurearchivingofCervicalScreeningForms,samples,slidesandwrittenand/orcomputerisedreportsisrequiredforspecificretentionperiodsasoutlinedintheRCPath guidelines on specimen retention15. Vials must be stored until samples are finallyauthorised.
QR200. Quality requirement
LaboratoriesarerequiredtoprovideCervicalCheckaccesstomaterialsincludinglogsandrecords,onrequest.
3.9 Protocol for multi-disciplinary team meetings Laboratorieswillprovidefacilities,participationandsupportforMDTmeetingsheldinprogrammecolposcopy services.
LaboratoriesareencouragedtoincorporateMDTmeetingsintotheinternalcontinuingeducationofscientificstaff.
CytologylaboratorieswillretrieveslidesordigitalimagesforcasesnotifiedforreviewatMDTmeetingsonrequest,andprovidethemwithin10workingdays.
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3.10 Quality metrics and performance monitoring Thelaboratoriesmustprovideaservicesatisfyingtherequirementsofthenationalprogrammestandards.Whilethesestandardsaimtoensureasafeandeffectiveprogramme,theydonotguaranteesatisfactoryperformance.
Thestandardsassessthescreeningprocessandallowforcontinuousimprovement.Performanceoutsidetheindicatedrangemustbeexaminedandcorrectedwherenecessary.
Note: The expected reported ranges are calculated from the 5th to the 95th percentile from the previous year’s NHS CSP statistical KC61 returns. For high grade results ASC-H is included in the overall rate but atypical glandular cells are excluded.
QR201. Quality requirement
Acompleteandaccuratereportcontainingprescribedqualitymetricsmustbeprovidedatdefinedintervals(combinedHPVandcytologyreturn)asspecifiedbyCervicalChecktoallowcomparisonsagainstnationalstandardsandotherqualityindicators.Theidentifierassignedtoeachindividualscreenerandcytopathologistwillbethesamefordifferentmetricsofthereportandoversuccessivereportingperiods.
Note: Laboratories must have the ability to separate CervicalCheck workload from other workloads for statistical and monitoring purposes.
QR202. Quality requirement
Performancemeasuresmustbecontinuouslymonitoredbythelaboratory.Failuretomeetthemmustalwaystriggerfurtherinvestigationandresultinappropriatedocumentedactiontakenwhennecessary.
QR203. Quality requirement
Laboratoriesmusthavesystemsinplacewhereperformancedataisregularlyreviewedatdepartmentalandlaboratory/hospitalgovernancemeetings.
QR204. Quality requirement
WhereperformancefallsoutsidetheindicatedrangesthismustbediscussedatCervicalCheckoperationalmanagementmeetings.InconjunctionwiththeCervicalCheckLaboratoryCoordinationteam,thelaboratorywillcooperateininvestigatingtheissueandprovideevidencetosupporttheexplanationforthisperformance.Thisexplanationmightnotnecessarilyberelatedtoreportingpractice,however,ifarootcauseisidentified,preventativeandreportingpracticesmustbeaddressedimmediately.PersistentoutliersagainstperformancestandardswillbeinvestigatedwithintheCervicalCheckgovernanceandqualitystructures.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
36 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.11 Quality assurance visitsQR205. Quality requirement
Laboratorieswillaccommodateon-sitevisitsbyNSS-designatedpersonnelforqualitymonitoring,auditandassurancepurposes,providingaccesstopersonnel,resources, processes, documentation and results.
3.12 Audit of invasive cervical cancers QR206. Quality requirement
Placeholderstandard:TobeupdatedoncetheExpertReferenceGrouponClinicalAuditofIntervalCancerintheScreeningPopulationpublishesitsreportandrecommendations.
3.13 Risk and incident management Errorscan,andwill,happen.Someerrorswillberelativelyminorbutotherscanbeserious.
QR207. Quality requirement
Nationalguidanceformanagingsafetyconcerns,safetyincidentsandseriousincidentsintheHSEmustbeadheredtoforservicesthatmaybeinvolvedinidentifyingormanagingascreeningincident.
3.14 Business planning and service continuity QR208. Quality requirement
Thelaboratoryservicemusthaveacontingencyplaninplacetomakesurethereisresilienceandcontinuityofservicewhenfacedwithdisruptiveeventssuchasequipmentfailureanddowntime,prolongedlossofpowerorITsystemsorflood/firedamagetothelaboratory.
QR209. Quality requirement
Theremustbeaformalrecordwhichidentifiesthemainrisks,howtheywouldbemitigatedandhowthelaboratorywouldrecoverfromamajorincidentorfault.
QR210. Quality requirement
Individualswithservicecriticalskillsetsmustalsobeidentifiedandsystemsputinplacetomakesurethereiscontinuityofserviceineventoftheirprolongedabsence.
QR211. Quality requirement
AllagreementswithexternalagenciestomaintainserviceresiliencemustbeclearlydocumentedinaformaldocumentsuchasaSLAorMOU.Formalagreementsmustclearlyidentifyindividualresponsibilities.Allagreementsmustmeet the CAP/ ISO 15189 standards or the accreditation standards appropriate to thecountryoforiginofthelaboratory.
37
Section B Histopathology3.15 CervicalCheck requirements for histopathologyHrHPV testing and cervical cytology triage currently represents the primary screening method. Colposcopylocatesthemostabnormalareasofthecervix.Histopathologyprovidesthefinaldiagnosisofcervicalneoplasia,formingthebasisforwhichtreatmentisplanned.Histopathologydiagnosesincludethepresenceorabsenceofhighorlowgradenon-invasivesquamouslesions,highgradeglandularabnormalities(highgradecervicalglandularintraepithelialneoplasia(CGIN)/adenocarcinoma-in-situ)aswellasdetailsofanyinvasivecancerpresent.
HistopathologyisthesourceofdiagnosticdatastoredattheNCRIandusedfortheevaluationofscreeningprogrammes.Itservesasthe‘goldstandard’forqualitycontrolofcytologyandcolposcopyalbeitthatitissubjecttosimilarissuesofreproducibilityandsubjectivityascytologicandcolposcopicanalyses.
Asincytopathology,thesamplepathwayforhistopathologycanbesubdividedintothreekeystages:
1. Pre-analytical - sample taking, sample transport and receipt of sample in the laboratory Accuratehistopathologicaldiagnosisoftissuespecimensdependsonadequatequalitysamples,obtainedbycolposcopicallydirectedpunchbiopsies(withendocervicalcurettage,ifnecessary,LargeLoopExcisionoftheTransformationZone(LLETZ)orknifeconeexcision).
2. Analytical - sample processing and interpretation Accuratehistopathologicaldiagnosisfurtherdependsonappropriatemacroscopicdescription,technicalprocessing,microscopicinterpretationandqualitymanagementcorrelatingcytologicalandhistopathological diagnoses.
3. Post-analytical - report generation It is important to recognise that the interpretative reports provided in histopathology and cytopathology aretheopinionofthereportingpathologists.Thereisthereforeasubjectiveelementinthecontentofanyreport.Somediagnosesrequirethecombinedinputofacolposcopist,cytologistandhistopathologist.Thereareavarietyofreasonswhyclinicalappearances,cytology,biopsyandexcisionresultsmayappeardiscrepant.MDTmeetingscanoftenresolvesuchdiscrepancies.Ifacolposcopistisunsureofthesignificanceormeaningofareportorfeelsthatareportisincorrect,theyshouldcontacttheissuinglaboratory or reporting pathologist.
QR212. Quality requirement
Histopathologistsmustremainabreastofcurrentandemerginginterpretationguidelines.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
38 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.15.1 Quality requirements and standards
Ensuringqualityassuranceinservicedeliverycomprisescompliancewithbothqualityrequirementsandqualitystandards.
3.15.1.1 Accreditation
TheINABisthesolenationalaccreditationbodyformedicallaboratoriesintheRepublicofIreland.IrishlaboratoriesmusthaveorberegisteredforaccreditationtotheISO15189:2012Medical laboratories - requirements for quality and competence6.
QR213. Quality requirement
LaboratoriesprovidingservicesforCervicalCheckthatareoutsideoftheEuropeanUnionmusthaveorberegisteredforaccreditationtotheappropriatestandardswithinthecountryoforiginofthecontractedlaboratory.
3.15.1.2 Changes to service capacity, capability or conformance to quality assurance standards
QR214. Quality requirement
Anychangesthathaveorcouldhaveanimpactonanyaspectofthelaboratoryservices, including standards and guidelines, laboratory accreditation status, processes, system procedures, analysis, and reporting should be immediately advised to CervicalCheck.
3.15.2 Organisational requirements
3.15.2.1 Health agencies and authorities
LaboratorieswillcomplywithallrequestsfordataorreportsbyIrishhealthagenciesandauthorities,subjecttotheconditionsimposedbyGDPR,ortheappropriatedataprotectionagencyoperationalinthecountryoforiginofthelaboratoryconcerned.
3.15.2.2 Laboratory facilities
Alllaboratorieswillprovideappropriatefacilities.Thesewillincludeappropriateareasforsamplereception, specimen dissection, processing, reporting, typing and authorisation.
3.15.3 Specimen reception
SOPswillbeinplaceforhandlingCervicalChecksamples.Forthepurposesofdatacapture,samplesoriginatingfromCervicalCheckcolposcopyservicesmustbesegregatedfromsamplesfromothersources.Thismaybeviatheprogramme’sCervicalHistologyForm(whereapplicable)orbyanaccreditedlaboratoryformwheretheoriginofasampleisclearlyidentifiable.Thewoman’sconsentshouldbeincorporatedintotheprocessesforsampledatacaptureanddataexchange.
39
QR215. Quality requirement
Allcervicalhistologysampleswillbeprocessedinthemannerappropriateforanexternally assessed and accredited histopathology laboratory.
QR216. Quality requirement
AdiscrepancyhandlingandresolutionprocesswillbeinplacetomanagealldiscrepancieswithCervicalChecksamplesreceived.
3.15.3.1 Data entry and notification to CervicalCheck
RelevantclinicaldetailsrecordedontheCervicalHistologyFormwillberecordedontheLIMS.NotificationandresultfilesshouldbesenttoCervicalCheckinadefinedformatatspecifiedintervals.AperiodicreconciliationoffilessentandreceivedshouldbeinplacebetweenCervicalCheckandthelaboratory.
QR217. Quality requirement
AstandardSNOMED16 biopsy and result code dictionary approved by CervicalCheckmustbeusedandappliedbyeithercodingonlyfortheworstdegreeofdysplasiaorcodingmultiplepathologiesseparately.
3.15.4 Specimen dissection and assessment
Specimendescriptionandsamplingwillbedoneinsuchawayastofacilitatemicroscopicreportingandpathological staging.
3.15.4.1 Sample ‘chain of custody’
Handlingprocedureswillensurearobust‘chainofcustody’throughoutthespecimenpathway.Theappropriateprofessionalstandardsandguidance(e.g.RCPathandNHSCSP)mustbeadheredto.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
40
3.15.5 Proficiency and competency of staff
3.15.5.1 Staff qualifications and competencies
QR218. Quality requirement
Scientific,medicalandnon-medicalstaffwillbequalifiedforthepositionstheyholdaccordingtonationalrequirementstopractice.
QR219. Quality requirement
Thehistopathologylaboratorywillbeledbyamedicallyqualifiedconsultantwhoworksinthatdisciplineonaregularbasis.AllsampleswillbereportedbyamedicallyqualifiedconsultantorappropriatelyqualifiedandexperiencedconsultantBMSintheUK.
Therewillbealeadmedicalscientistwhoisresponsiblefortheday-to-daymanagementofthedepartmentandwhohasresponsibilityforsupervisionofnon-medicalstaff.
3.15.5.2 All staff
Allstaffwillbecompetenttocarryouttheirroles.Competencywillbemaintainedbyregulartrainingandeducation.Trainingandcompetencyrecordsshouldberetainedandavailableforreview.
3.15.5.3 Continuing education
Continuingeducationwillbefacilitatedwithevidenceofinternalandexternaleducationalactivities.
3.15.5.4 Pathologists
Allpathologistswillparticipateincontinuingmedicaleducation(CME)asrequiredbyPart11oftheMedical Practitioners (Amendment) Act 2017 – Maintenance of Professional Competence. Consultant BiomedicalScientistswillparticipateinanapprovedCPDscheme.
3.15.5.5 Lead medical scientist, manager and supervisory scientific staff
Theleadmedicalscientistwillberesponsibleformaintainingahighqualityservice.Sufficientsupervisoryscientificstaffwillbeavailabletoprovidesatisfactorysupervisionforthetraining,servicedevelopmentandqualitycontrolofstaffoutput.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
41
3.15.6 Microscopy and reporting of results
Pathologistsmusthaveaccesstorelevantresourcestofacilitateaccuratediagnosisincludingtheappropriate immunohistochemistry.
TherelevantRCPathDataset(currentlyHistological Reporting of Cervical Neoplasia (3rd edition), 201117) canbeusedasareportingguide.DiagnosticterminologyshouldincludetermsusedinthecurrentWorld Health Organisation (WHO) Classification of Tumours of the Female Reproductive Organs18.
QR220. Quality requirement
All histopathology reports must be authorised by a consultant pathologist/consultantbiomedicalscientistwhereapplicable(electronicand/ormanual).
AllhistopathologicalresultsmustbeenteredontoaLIMStoallowqualityassessment.Amendedreportsandsupplementaryreportswillbeauditable.
Themicroscopicdiagnosiswillrecordallgradesofsquamousand/orglandularintra-epithelialneoplasia,andinvasivelesions.Thedescriptionofalesionwillnoteifanorientatedspecimenhasbeensubmitted.Anyinvasivelesionsareclassifiedandgradedaccordingtonationalprotocolsandguidelines.
Whereanexcisionprocedurehasbeenundertaken,wherepossiblethemicroscopicreportwillindicatewhetherornotthesquamousorglandularlesionhasbeencompletelyexcised.
WhenabiopsyfailstorevealthesourceoftheabnormalcellsinanLBCslide,itisimportanttodifferentiatebetweenabiopsythatistechnicallyadequatebutfailstoidentifyalesion,andabiopsythatistechnicallyinadequate.
Allreportswillbecoded(usingapprovedSNOMEDnomenclature16)toallowdatacollection.
3.15.6.1 Authorisation of results
Everyresultwillbeappropriatelyauthorisedbeforerelease.Everyreportshouldbecheckedforinconsistenciesbeforeauthorisation.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
42
3.15.6.2 Recording of results
Resultsdetailswillincludeatleast:
• Patientidentificationdata.
• Nameandaddressofthelaboratory.
• Nameofrequestingphysician.
• LaboratoryIDnumber.
• Dateofspecimenprocurement(specimendate).
• Dateofarrivalofthespecimeninthelaboratory.
• Sampletype.
• Anatomicalsiteoforigin.
• Relevantclinicaldetails.
Standard 3-9 Theresultsofthelaboratoryexaminationwillbepresentedinaccordancewiththecurrentstandardclassificationsystemanddataformat,includingajudgmentofthequalityandadequacyofthehistopathologicalslide(ifnecessary),dateofauthorisationofthefinalreportandnameofpathologistwhohasevaluatedthesample.
3.15.6.3 Turnaround time
Thisisdefinedasthetimetakenbetweenthereportingofhistologyresultsrelatingtothespecimenandthedateofarrivalofthespecimenintothelaboratory.
Standard 3-10 >90%ofsampleswillbereportedwithin4weeksofthewoman’sattendance
Note: Biopsies are regarded as small specimens (<3 blocks). LLETZ, cone, trachelectomy, hysterectomy are deemed to be large specimens.
Target
Small specimen: minimum80%within10days.Large specimen: minimum80%within14days.
3.15.6.4 Results reporting
Standard 3-11 Laboratorymanagementwillensurethathistologyresults,once authorised and released, must be issued promptly to the ordering doctor or clinic.
Target
100%tobereceivedwithin5daysofreportbeing authorised.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
43
3.15.6.5 Delivery of results reports to ordering doctors or clinics
Resultsreportswillbeissuedtothecorrectorderingdoctororclinic.Thelaboratorywillensurethatanappropriatedeliverymechanismisinplaceforthesereports.
3.15.6.6 Review requests and amended reports
Laboratorieswillhaveproceduresinplacetomanageandrespondtorequestsforsecondopinionsandto issue amended or addendum reports as necessary. Additional or amended reports, once authorised and released, must adhere to the same standards and targets.
3.15.7 Storage and archiving
Standard 3-12 Administration,archivinganddisposalprocedureswillcomplywithaccreditationstandards and national and regional legislation, including that relating to confidentialityanddatasecurityofpersonalhealthinformationanddisposalofhazardousmedicalwasteorchemicals.
Securearchivingofcervicalhistologyforms,blocks,slidesandwrittenand/orcomputerisedreportsisrequiredforspecificretentionperiodsasdefinedinthelatestStorageandRetentionofsamplesguidanceoftheRoyalCollegeofPathologistsoftheUnitedKingdom15.
Note 1: Cervical histology forms may be in paper format or in their electronic equivalent, as per local accredited practice.
Note 2: All slides/blocks will be stored in conditions adequate for preservation.
Note 3: Records will be stored to allow prompt retrieval if required.
3.15.7.1 Retention and disposal of specimens
Logsofspecimensretainedordisposedofwillbemaintained.Sampleswillnotbedisposedofpriortofinalreportauthorisationbythepathologist.Retentionofspecimenswillcomplywithrelevantlegislation15.
3.15.7.2 Access to materials
LaboratoriesarerequiredtoprovideCervicalCheckaccesstomaterialsincludingslidesandrecordsonrequest.
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44 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.15.8 Multi-disciplinary team meetings
ThereareawidevarietyofreasonsforcasestobeincludedinMDTmeetings.Casesdiscussedmustincludereporteddiscrepanciesbetweencytology,histologyandclinicalappearances.
3.15.8.1 Participation in multi-disciplinary meetings
HistopathologistsareintegralparticipantsinMDTmeetings.MDTmeetingsareconvenedbyandorganisedbyprogrammecolposcopyservices.Thelocations,timingandfrequencyofMDTmeetingsmayvaryfromtimetotimebutreasonablenoticewillbeprovidedbythecolposcopyservicetothelaboratory.Whileclinicalteamsareprimarilyresponsibleforcaseselection,laboratoriesareencouragedtosubmitcasesfordiscussion.MDTmeetingsandcasesrequirepreparation.
3.15.8.2 Protocol for MDT meetings
Participation,includingasignedrecordofpersonnelattendingandoperationaldecisions,willberecordedbyapersonnominatedbytheprogramme.Participantsmustbesubjecttoconfidentialityanddataprotectionrequirements.LaboratoriesareencouragedtoincorporateMDTmeetingsintotheinternalcontinuingeducationofscientificstaffwithinthelaboratory.
3.15.9 Audit of invasive cervical cancers
QR221. Quality requirement
Placeholderstandard:TobeupdatedoncetheExpertReferenceGrouponClinicalAuditofIntervalCancerintheScreeningPopulationpublishesitsreportand recommendations.
3.15.9.1 Review of histology slides
Theprocessesaroundthereviewofhistologyslidesarebeingreconsideredforupdatingatthecurrenttimeandwillbedocumentedsubsequenttotheapprovaloftherevisedprocess.
3.15.9.2 Independent third-party review
Laboratorieswillprovideallcasematerialwhererequestedforcasesidentifiedaswarrantingindependentthird-partyreviewbytheprocessforcervicalcancerreview.
45
3.15.10 Quality assurance and continuous improvement
3.15.10.1 External quality assurance
QR222. Quality requirement
Laboratorieswillparticipate,andshowadequateperformance,inaccreditedEQAschemesforhistopathologyandfortechnicalquality.
3.15.10.2 Internal quality control
IQCofmicroscopicdiagnosisshouldbeanintegralpartofhistopathologyreportingpractices.Thiscanbeachievedbyavarietyofactivities,including:
• Monitoringhistopathologydetectionandreportingrates.
• Correlationofcytologywithclinical/histologicaloutcome.
• ParticipationinregularMDTmeetingsincludingslidereview.
3.15.10.3 Quality metrics
Acompleteandaccuratereport(Histo1)containingprescribedqualitymetricswillbeprovidedatregularintervalstoCervicalCheck.Completedataatleastquarterly,tobereceivedbyCervicalCheckwithinonemonthofquarter-end.
ThequalitymetricsrequiredaredetailedinthecurrentversionoftheCervicalCheck‘Histo1Report’.Theyincludemeasureswhichshouldbereadilyavailablefromthelaboratory’sinternalqualitycontrolprocessesandarebasedonqualityassurancemetricsspecifiedbytheappropriateprofessionalbodiesconcerned.Qualitymetricsinclude,amongstothers,detailsof:
• Workload.
• Cytological/histologicalcorrelationandfollow-up(whereavailable).
• Retrospectivereview.
• MDTmeetings.
• EQA.
• Turnaroundtimes.
QR223. Quality requirement
LaboratoriesmusthavetheabilitytoseparateCervicalCheckworkloadfromotherworkload(s)forstatisticalandmonitoringpurposes.
Theidentifierassignedtoanindividualpathologistwillbethesamefordifferentsectionsofthereportand over successive reporting periods.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
46 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
3.15.10.4 Quality metrics improvement
Laboratorieswillundertakeappropriateandtimelymeasurestoaddressperformanceissuesthatimpactonqualitymetricsandresultingvaluesoutsideoflaboratory,nationaland/orinternationalnorms.
Sub-optimalperformanceidentifiedbytheproviderlaboratoryintheHisto1returnwillrequireaddressinginlinewiththeofficiallyapprovedguidanceoftheappropriateprofessionalbody.SuchperformanceissuesshouldbenotifiedimmediatelytotheNSSandevidenceofcorrectiveactionincludingretraining,ifapplicable,willbesoughtbytheNSS.
3.15.10.5 Quality assurance visits
QR224. Quality requirement
Laboratorieswillaccommodateon-sitevisitsbyNSS-designatedpersonnelforqualitymonitoring,auditandassurancepurposesandprovideaccesstopersonnel, resources, processes, documentation and results.
47
3.16 References 1 NHSCervicalScreeningProgramme:laboratoryHPVtestingandcytologyservices.Recording
andreportingrequirementsforlaboratoriesinaccordancewiththeprimaryhighriskhumanpapillomavirus(hrHPV)screeningpathway.Published20thSeptember,2019. https://www.gov.uk/government/publications/cervical-screening-laboratory-hpv-testing-and-cytology-services
2 NHSCervicalScreeningProgramme:PrimaryHPVscreeningimplementation.InformationtoaidlocalprovidersoftheNHSCervicalScreeningProgrammeinimplementinghigh-riskhumanpapillomavirus(hrHPV)testing.Published31stJanuary,2019. https://www.gov.uk/government/publications/cervical-screening-primary-hpv-screening-implementation
3 NHSCervicalScreeningProgramme:Cytologyreportingfailsafe.GuidelinescoveringprimaryHPVandprimarycytologyscreeningpathways,toavoidandmanageerrors(ormissedscreens)duringthecervicalscreeningprocess.Updated19thJuly,2019.https://www.gov.uk/government/publications/cervical-screening-cytology-reporting-failsafe
4 NationalScreeningService:CervicalCheckHPVPrimaryScreening-HrHPVacceptabletests.ReleasedJuly2019.
5 NHSCervicalScreeningProgramme-Cervicalscreening:pathwayforacceptanceofnewHPVtests.Published5thJuly,2019. https://www.gov.uk/government/publications/cervical-screening-pathway-for-acceptance-of-new-hpv-tests
6 Medicallaboratories-Requirementsforqualityandcompetence(ISO15189:2012)BSENISO15189:2012
7 Day,S;Jackson,CL;Nolte,FS;Tezack-Fragale,Z.MolecularDiagnosticMethodsforInfectiousDiseases.MM03–3rdEdition,February2015.
8 CS-SOP-LAB3MonitoringcytologylabsagainstQAGuidelinesforCervicalScreening
9 CS-PUB-LAB-7SamplesReceipt-Discrepancyhandlingandresolution
10 NHSCervicalScreeningProgramme:laboratoryqualitycontrolandassuranceforhumanpapillomavirustesting.Updated25thJuly,2019. https://www.gov.uk/government/publications/cervical-screening-laboratory-testing-for-human-papillomavirus/nhs-cervical-screening-programme-laboratory-quality-control-and-assurance-for-human-papillomavirus-testing
11 PalmerT,NicollS,McKeanM,ParkA,BishopD,BakerLandImrieJ.ProspectiveparallelrandomizedtrialoftheMultiCyte™ThinPrep®imagingsystem:theScottishexperience.Cytopathology2013;24:235–245
12 DuddingN,HewerE,LancuckiL.Rapidscreening:acomparativestudy.Cytopathology2001;12:235–248
13 NayarRandWilburDC.ThePapTestandBethesda2014.ActaCytologica2015;59:121–132.DOI:10.1159/000381842
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14 Astudyofcellularcountingtodetermineminimumthresholdsforadequacyforliquid-basedcervicalcytologyusingasurveyandcountingprotocol.HealthTechnologyAssessment2015;19: https://www.journalslibrary.nihr.ac.uk/hta/hta19220#/abstract
15 TheRoyalCollegeofPathologistsandtheInstituteofBiomedicalScience.Theretentionandstorageofpathologicalrecordsandspecimens(5thedition). https://www.rcpath.org/uploads/assets/049ea966-df5c-4a9f-9353ba24a69bb808/The-retention-and-storage-of-pathological-records-and-specimens-5th-edition.pdf
16 SNOMED-CT.SystemisedNomenclatureofMedicine–ClinicalTerms.SNOMEDInternational.http://www.snomed.org/snomed-ct/software-tools
17 Datasetforhistologicalreportingofcervicalneoplasia(3rdedition)April2011.RoyalCollegeofPathologistsdocumentG071. https://www.rcpath.org/uploads/assets/eb26fb88-3db6-417b-97ee6338ef54dc79/g071cervicaldatasetapril11.pdf
18 Kurman,Robert&Carcangiu,M.L.&Herrington,C.S.&Young,R.H..(2014).WHOClassificationofTumoursofFemaleReproductiveOrgans.Lyon:IARCPress. https://www.researchgate.net/publication/302563285_WHO_Classification_of_Tumours_of_Female_Reproductive_Organs
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Appendix 1Cervical screening results and recommendations table
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
Cer
vica
l Scr
eeni
ng re
sults
and
reco
mm
enda
tions
tabl
e
HPV
Tes
t Res
ult
Cyt
olog
y Pa
ttern
(w
here
app
licab
le)
Cod
eM
anag
emen
t R
ecom
men
datio
nR
atio
nale
/ Rec
omm
enda
tion
Not
Det
ecte
d/
Neg
ativ
eN
/AR
1Sc
reen
ing
com
plet
edW
oman
is a
ged
61 o
r ove
r at d
ate
of te
st O
R po
st h
yste
rect
omy
and
no re
quire
men
t for
incr
ease
d su
rvei
llanc
eR
3I y
ear r
ecal
lif
HIV
+. O
r as
per c
olpo
scop
y di
scha
rge
if re
com
men
ded
incr
ease
d su
rvei
llanc
e (in
crea
sed
surv
eilla
nce
= m
ore
than
on
e an
nual
test
requ
ired
post
col
posc
opy
disc
harg
e &
disc
harg
e da
te is
afte
r HPV
prim
ary
scre
enin
g im
plem
enta
tion
date
)R
2a3
year
reca
llIf
aged
bet
wee
n 25
and
29
year
s (in
clud
es w
omen
dis
char
ged
for o
ne te
st in
12
mon
ths
post
dis
char
ge).
R2b
5 ye
ar re
call
If ag
ed 3
0 - 6
0 ye
ars
at te
st d
ate.
Inde
term
inat
e H
PV re
sult
N/A
R6
3 m
onth
repe
atFi
rst o
r sec
ond
inde
term
inat
e sc
reen
ing
test
resu
ltR
7Re
fer t
o co
lpos
copy
3 co
nsec
utiv
e in
dete
rmin
ate
scre
enin
g te
st re
sults
Any
3 sc
reen
ing
test
resu
lts th
at a
re n
ot n
orm
al in
pre
viou
s 10
yea
rs &
wom
an h
as n
ot h
ad c
olpo
scop
yTe
st n
ot
Proc
esse
dN
/AR
63
mon
th re
peat
Repe
at 3
mon
ths
Dete
cted
/ Po
sitiv
eP1
(Uns
atis
fact
ory)
R6
3 m
onth
repe
atRe
peat
3 m
onth
sP2
(No
abno
rmal
ity
dete
cted
)R
31
year
re-c
all
Firs
t HPV
pos
itive
and
cyt
olog
y N
AD, r
epea
t scr
eeni
ng te
st in
1 y
ear
R7
Refe
r to
colp
osco
pySe
cond
con
secu
tive
HPV
pos
itive
and
cyt
olog
y N
AD (d
isre
gard
inte
rven
ing
inde
term
inat
e or
uns
atis
fact
ory
resu
lts),
refe
r to
colp
osco
pyAn
y H
PV p
ositi
ve te
st fo
r wom
an w
ith H
IV, r
efer
to c
olpo
scop
yAn
y H
PV p
ositi
ve a
nd in
crea
sed
surv
eilla
nce
(incr
ease
d su
rvei
llanc
e =
mor
e th
an o
ne a
nnua
l tes
t req
uire
d po
st
colp
osco
py d
isch
arge
& d
isch
arge
dat
e is
afte
r HPV
prim
ary
scre
enin
g im
plem
enta
tion
date
)P3
a+ (A
SCU
S or
w
orse
)R
7Re
fer t
o co
lpos
copy
Any
HPV
pos
itive
resu
lt w
ith a
bnor
mal
cyt
olog
y, re
fer t
o co
lpos
copy
NO
TE:
Whe
re c
ervi
x is
sus
pici
ous
for i
nvas
ive
dise
ase,
refe
r for
urg
ent c
olpo
scop
y, do
not
take
scr
eeni
ng te
st.
Whe
n cu
rrent
clin
ical
det
ails
reco
rd P
ost C
oita
l Ble
edin
g (P
CB)
/inte
rmen
stru
al b
leed
ing(
IMB)
/ Pos
t-Men
opau
sal (
PMB)
Ble
edin
g it
is re
com
men
ded
to re
fer f
or g
ynae
colo
gica
l ass
essm
ent.
Whe
re th
ere
is a
cyt
olog
y re
sult:
If th
ere
are
endo
met
rial c
ells
pre
sent
out
of c
ycle
for a
wom
an o
ver 4
0 ye
ars
it is
reco
mm
ende
d to
refe
r for
gyn
aeco
logi
cal a
sses
smen
t.
CS/PUB/LAB-2 Rev. 10
00/5
5/95
/00/
14/1
9/60
Result Recommendation
HPVNotDetected
R1 Womanisaged61orolderatdateoftest,nofurtherscreeningrequired
R1 Nofurtherscreeningposthysterectomyunlessrecommendedbycolposcopy or oncology
R2a Ifthewomanisbetween25and29years–repeatin3years(includeswomendischargedfor1testin12monthspostdischarge)fromcolposcopy
R2b Ifthewomanis30–60years(atdateoftest)–repeatin5years
R3 PatientswhoareHIVpositive
R3 Ifrecommendedincreasedsurveillancepostcolposcopy(>1testrequiredpostdischarge&dischargedateisafterHPVprimaryscreeningimplementationdate)
HPVDetected R7 IfcytologytriageresultisASCUSorworse-refertocolposcopy–anytest
R6 Firstscreeningtestwithcytologytriagetestresultofunsatisfactory–repeatinthree months
R3 FirstscreeningtestwithcytologytriagetestresultofNoabnormalitydetected–repeat test in 12 months
R7 SecondconsecutivescreeningtestwithcytologytriagetestresultofNoabnormalitydetected(disregardinterveningindeterminateorunsatisfactoryresults)–refertocolposcopy
R7 IfHIV+ve-refertocolposcopy
R7 Ifdischargedforincreasedsurveillance(>1testrequiredpostdischarge)–referto colposcopy
HPV indeterminate result
R6 Ifthisisthefirstorsecondindeterminatescreeningtestresult–repeatnoearlierthan 3 months
R7 Ifthisisthethirdconsecutiveindeterminatescreeningtestresult–refertocolposcopy
R7 Ifthewomanhashadanythreescreeningtestresultsthatarenotnormalintheprevious10yearsandhasnothadacolposcopy–refertocolposcopy
Testnotprocessed
R6 Repeat no earlier than three months
Whereacytologyresultispresent:
Endometrialcellsinawomanover40(outofcycle) Referforgynaecologicalassessment.
Clinicaldetailsofabnormalbleeding(PCB/IMB/PMB) Referforgynaecologicalassessment.
Note:wherethecervixissuspiciousforthepresenceofcancerascreeningtestshouldnotbetaken,insteadanurgentreferralshouldbemadetothecolposcopyservice.Adetaileddescriptionofthecervixshouldbeprovidedonthereferralform.
50
Appendix 2 Management recommendation table Itisimportanttonotethatforwomenpost-colposcopy,theHPVresultsupersedestheoriginaldischargerecommendationfromcolposcopy.
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
51
Appendix 3HPV primary screening algorithm
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
Routine recall
Routine recall
3-year recall (25 to 29)
5-year recall (≥ 30)
3-year recall (25 to 29)
5-year recall (≥ 30)
HR-HPVnegative
HR-HPVnegative
Referral colposcopy
Referral colposcopy
Cytology ASCUS+
Cytology ASCUS+
HPV primary screening 25 to 65
Routine & early recall
12-month repeat
Cytology triage
Referral colposcopy
Cytology NAD
Cytology NAD
HR-HPVpositive
The agreed HPV Primary Screening algorithm comprises the following key steps:• ActiveinviteandrecallforallwomenresidentinIrelandwithintheagerangeof25-65• WomenwhotestnegativeforHPVarereturnedtoroutinerecall• 3yearrecallforwomenages25-29• 5yearrecallforwomenaged>=30• Atfirsttest:Womenwhotestpositiveforanyofthe14oncogenicHPVvariantsandwhoarecytologynegative,willbetestedagainin12monthstime.
• Atfirsttest:Womenwhotestpositiveforanyofthe14oncogenicHPVvariantsandwhoarecytologyASCUS+willbereferredtocolposcopy.
• Onrepeattestingafter12months,allwomenwhotestpositiveforanyofthe14oncogenicHPVvariantswillbereferredtocolposcopy;regardlessofcytology.
• HR-HPVpositivereferstoHPVpositivityforanyofthe14high-risk./oncogenicHPVsub-types=16,18,31,33,35,39,45,51,52,56,58,59,66and68.
CS/
PUB/
PM-1
4 Re
v 1
HPV Primary Screening Algorithm
HR-HPVpositive
Cytology triage
52
Appendix 4HPV primary screening: eligibility framework
QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices
HPV
Prim
ary
Scre
enin
g: E
ligib
ility
Fra
mew
ork
/ Ref
eren
ce G
uide
for G
Ps a
nd C
linic
sPl
ease
not
e, th
roug
hout
this
docu
men
t, w
here
we
refe
r to
‘wom
en’,
we
mea
n ‘w
omen
, or p
eopl
e w
ith a
cer
vix’.
A. W
omen
– s
tand
ard
elig
ible
pop
ulat
ion
i.e. w
omen
age
d 25
to 6
5 ye
ars
who
hav
e a
cerv
ical
scr
eeni
ng re
quire
men
tG
P / C
linic
Pay
men
tW
omen
age
d 25
to 2
9 ye
ars:
Rout
ine
Scre
enin
g:Ev
ery
3 ye
ars
for w
omen
with
neg
ativ
e H
PV te
st re
sults
.Ye
s if
inte
rval
ob
serv
ed
Wom
en a
ged
30 y
ears
or o
lder
:Ro
utin
e Sc
reen
ing:
Ever
y 5
year
s fo
r wom
en w
ith n
egat
ive
HPV
test
resu
lts.
Wom
en a
ged
25 y
ears
or o
lder
:12
mon
th re
peat
:1-
year
repe
at fo
llow
ing
posi
tive
HPV
test
with
tria
ge n
egat
ive
(NAD
cyt
olog
y).
3 m
onth
repe
at:
Uns
atis
fact
ory
resu
lt or
exp
ired
sam
ple
/ via
lW
omen
age
d ov
er 6
5Sc
reen
ing
com
plet
ed:
No
furth
er p
rogr
amm
e sc
reen
ing
follo
win
g 1
(one
) neg
ativ
e H
PV te
st re
sult.
B. W
omen
– s
peci
al c
ircum
stan
ces
GP
/ Clin
ic P
aym
ent
Wom
en:
● po
st-c
olpo
scop
y sc
reen
ing
test
s●
Firs
t scr
eeni
ng te
st a
s pe
r col
posc
opy
disc
harg
e re
com
men
datio
n, th
erea
fter a
s pe
r scr
eeni
ng te
st re
com
men
datio
n.
Yes
if
inte
rval
and
crit
eria
ob
serv
ed
Wom
en:
● po
st-to
tal h
yste
rect
omy
●
Wom
en w
ith n
o C
IN a
t hys
tere
ctom
y: n
o fu
rther
scr
eeni
ng is
requ
ired.
● W
omen
with
com
plet
ely
exci
sed
CIN
at h
yste
rect
omy:
follo
w u
p is
und
erta
ken
by th
e tre
atin
g cl
inic
ian
in li
ne w
ith
colp
osco
py m
anag
emen
t pro
toco
ls
● If
hist
olog
y is
unk
now
n: N
o fu
rther
pro
gram
me
scre
enin
g fo
llow
ing
1 (o
ne) n
egat
ive
HPV
test
resu
lt.W
omen
:●
with
HIV
infe
ctio
n (c
oded
‘CD4
i’)●
Wom
en a
re e
ligib
le fo
r pro
gram
me
scre
enin
g fro
m th
e tim
e of
thei
r HIV
dia
gnos
is.
● C
ervi
cal s
cree
ning
sho
uld
be p
erfo
rmed
with
in o
ne y
ear o
f HIV
dia
gnos
is.
● An
nual
scr
eeni
ng fo
r wom
en w
ith n
egat
ive
HPV
test
resu
lts.
●Afterfi
rstp
ositiveHPV
result,wom
enwillbe
referre
dtocolpo
scop
y.
If w
oman
is u
nder
25
or
ove
r 65
year
s G
P/C
linic
mus
t se
ek p
aym
ent f
rom
C
ervi
calC
heck
06
1 40
6500
ad
min
@ce
rvic
alch
eck.
ieW
omen
:●
with
rena
l fai
lure
requ
iring
dia
lysi
s●
abou
t to
unde
rgo
rena
l tra
nspl
ant
● po
st o
rgan
tran
spla
nt●
unde
rgoi
ng p
re-o
rgan
tran
spla
nt w
orku
p
● Sc
reen
ing
test
requ
ired
at o
r sho
rtly
afte
r dia
gnos
is o
f ren
al fa
ilure
. ●
Wom
en a
bout
to u
nder
go o
rgan
tran
spla
ntat
ion
shou
ld h
ave
had
a ce
rvic
al s
cree
ning
test
per
form
ed w
ithin
1 y
ear.
●
Furth
er m
anag
emen
t of t
hese
coh
orts
is g
over
ned
by th
e st
anda
rd H
PV s
cree
ning
alg
orith
m.
Wom
en:
● Po
st p
elvi
c ra
diot
hera
py fo
r cer
vica
l, bl
adde
r, re
ctal
and
oth
er p
elvi
c ca
ncer
s●
Con
geni
tal a
bsen
ce o
f the
cer
vix
● C
ervi
cal s
cree
ning
not
reco
mm
ende
d.
Not
App
licab
le
Elig
ibili
ty c
heck
Che
ck w
oman
’s n
ext t
est d
ue d
ate
ww
w.c
ervi
calc
heck
.ie
Not
esG
P / C
linic
Pay
men
t1.
W
omen
age
d le
ss th
an 2
5 ye
ars
who
hav
e ne
ver h
ad a
cer
vica
l scr
eeni
ng te
st o
r hav
e ha
d a
prev
ious
neg
ativ
e te
st re
sult.
Not
elig
ible
. No
paym
ent
2.
Wom
en n
ot y
et d
ue a
rout
ine
or s
urve
illanc
e sc
reen
ing
test
.N
ot e
ligib
le. N
o pa
ymen
t3.
W
omen
age
d 65
yea
rs o
r old
er (w
ith n
o re
quire
men
t for
incr
ease
d su
rvei
llanc
e)N
ot e
ligib
le. N
o pa
ymen
t4.
W
omen
age
d un
der 2
5 ye
ars
with
pre
viou
s (n
on-C
ervi
calC
heck
) scr
eeni
ng te
st re
sult
that
is n
ot n
orm
al re
quiri
ng a
repe
at te
st.
Not
elig
ible
. No
paym
ent
5.
Wom
en o
ver 2
5 w
ith p
revi
ous
Cer
vica
lChe
ck n
orm
al re
sult
and
subs
eque
nt n
on-C
ervi
calC
heck
test
requ
iring
a re
peat
test
.N
ot e
ligib
le. N
o pa
ymen
t6.
W
omen
ove
r 25
to 6
5 ye
ars
rece
ivin
g lo
ng-te
rm im
mun
o-su
ppre
ssan
t med
icat
ion
or a
ttend
ing
DES
clin
ic.
Stan
dard
HPV
scr
eeni
ng a
lgor
ithm
app
lies.
CS/SPP/PM-9 Rev 8
53QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServicesCS/PUB/Q-8Rev2