standards for quality assurance in colposcopy · 3.1.10 changes to service capacity, capability or...

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


Thelaboratorywillhaveaqualitymanagementsystem(QMS)inplaceasrequiredby the appropriate, local accreditation standards.


ThelaboratorywillhaveadesignatedpersonresponsibleforqualitymanagementwhowillliaisewithCervicalChecktoresolveanyqualityissuesthatmayarise.


AnyqualityissuesraisedthroughtheQMSinrelationtothecervicalscreeninglaboratoryservicemustbenotifiedtoCervicalCheck.


4

3.1.3 Health and safety compliance


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


InrelationtotheprovisionofservicestotheNationalScreeningService(NSS),alldataprotectionrequirements(storage,access,security,confidentialityanddatatransfer)willbecompliantwiththeGeneralDataProtectionRegulation.LaboratorieswillcomplywithallrequestsfordataorreportsbyIrishhealthagenciesandauthorities,subjecttotheconditionsimposedbyGDPR,ortheappropriatedataprotectionagencyoperationalinthecountryoforiginofthelaboratory concerned.


AVirtualPrivateNetwork(VPN)mustbeinstalledbetweenthelaboratoryandtheprogrammeoperationsofficeforthesecureexchangeofelectronicdata.Whereservicesareprovidedintwoseparatelaboratoryorganisations,aVPNmustbeinstalledbetweenthetwolaboratoriesforthesecureexchangeofelectronicdata.

3.1.5 Laboratory information management system


Avalidatedandverifiedlaboratoryinformationmanagementsystem(LIMS)willbeoperated in the laboratory.


TheLIMSwillbeinasecurefacilitywiththeprovisionforadequateback-uparrangements.


AccesstotheLIMSwillbebysecureprivilegelevelaccesscontrol.


TheLIMSwillbecapableofgeneratingperiodicqualitymetricsandauditreturnstoCervicalCheckandtoCervicalCheckrequirements.

QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices

5


TheLIMSwillbecapableofrecordingtheminimumdatasetfromtheCervicalChecklaboratoryrequestform.

Itisdesirablethatlaboratoriesarecapableofreceivingorderselectronicallyandissuingresultselectronicallytoandfromorderingdoctorsorclinics,accordingtoaspecifiedmessagingstandard.ElectroniclaboratoryorderformatisHL-7basedandconformstotheLaboratoryordermessagespecificationsoftheHealthInformationandQualityAuthority(HIQA)currentGPMessagingStandard.HL-7basedordersandresultsuseHealthlink’sMessageBrokerSystem.Thephysicalformforelectronicordersincludesabarcode,whichlaboratoriesshallbeabletoscanandextracttheincludeddetailsforautomatic import into their data entry system.


TheLIMSwillbecapableofrecordingtestresultsincludingaprimaryHPVscreeningtestresultincombinationwithasecondarytriagetestresult(s)whereapplicableandgeneratingasinglemanagementrecommendationforthecombinedresult(s).Inthecaseoflaboratoriesondifferentsitesitwillbetheresponsibilityofthecytologyservicetoauthorisethefinalreport.


TheLIMSwillbecapableofrecordingtheidentityofthereportingscreeners,pathologist(s) and the authorising virology technologist.


InadditiontheLIMSwill:

• Linkmultipletestresultsforthesamepatient.

• Provideeasyaccesstodetailsaboutpreviouscervicalscreeninghistoryforthepatient.

• Provideamechanismforascertainingandrecordingclinicaloutcomeafterscreening tests and diagnostic/ treatment procedures.

• ProvidethedatanecessaryforevaluationoftheCervicalCheckprogramme.


TheLIMSwillbecapableofextractingandtransferringnecessarydatatotheprogrammeintherequiredformatasperCervicalCheckspecifications(notificationandresultfiles).Thelaboratorywillalsoreceiveinformationfromtheprogrammeinspecifiedformatsandtransferittoitsinformationsystems(errorandhistory/eligibilityfiles).


Thelaboratorywillhavethecapabilitytoexchangeelectroniccommunicationsbetweenstaffmembersandprogrammestaffthroughsecureprotocols(e.g.secure email).


6

3.1.6 Telephone support


LaboratoriesmustprovideFreephonetelephoneaccess(forcallsmadefromIreland)tolaboratorystaffduringnormalbusinesshours(GMT)forregisteredsampletakersandNSSstaffforqueriesandfollow-up.

3.1.7 Other laboratories


Laboratory(ies)willmakerelevantclinicalinformationandfollow-updataavailableto other laboratories providing services to CervicalCheck.

3.1.8 Segregation, identification and traceability of programme samples


AllworkcarriedoutinrelationtotheprovisionoflaboratoryservicestotheNSSwillbeclearlydistinguishablefromtheworkcarriedoutforotherclientsofthelaboratory,beginningwithreceiptofsamples,throughoutthescreeningandresultingprocesses,toreporting,laterinvestigationsandreviews,aswellasstorage and archiving.

3.1.9 Health agencies and authorities


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


Anychangesthatimpactonorcouldhaveanimpactonanyaspectoflaboratoryservices, including laboratory accreditation status, processes, system procedures, analysisandreporting,mustbeagreedwithCervicalCheck.AnychangeswillbeadvisedinadvanceinwritingandmustbeapprovedbeforeimplementationbyCervicalCheck.


7

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.


NetworkedlaboratorysolutionsinthecontextofcervicalscreeningservicesmustbesupportedbycloselyalignedQMS,LIMSanddocumentmanagementsystems.

Note: All screening should take place at the minimum number of laboratory sites possible.


Amedicallyqualifiedconsultantpathologistmusttakeresponsibilityfortheissueofallcervicalscreeningtestresults.

• Atleast2medicallyqualifiedconsultantpathologistswhoactivelypracticeincervicalcytologymustbeinvolvedintheprovisionofaCervicalCheckcervicalscreening service.

• Theconsultantpathologistsmustpractiseincervicalcytologywithinthelaboratorynetworkwherescreeningofcervicalcytologysamplesisundertaken.

• Oneconsultantpathologistisalwaysavailabletoprovidedirectiontostaff.

• Theconsultantsmustbefullyintegratedintotheworkingofthedepartment(s)andbeavailableduringnormallaboratoryopeninghoursforstafftoconsultwithor vice versa.

3.2.1 Contracting arrangements between NSS and screening laboratory(ies)


Laboratoriesmustadheretothetermsofanycontract/ServiceLevelAgreement(SLA)orMemorandumofUnderstanding(MOU)betweentheNSSandthelaboratory.


8

3.2.2 Service level agreement/ Memorandum of Understanding / Contract for virology services


CervicalcytologylaboratoriesmusthaveanSLA(s)/MOU/contractinplaceforvirologyservicesifprovidedbyathirdpartytospecifytheservicesrequired.


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


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.


9

• Thatinternalqualitycontrol(IQC)andqualityassurancemustbecarriedoutinaccordancewithnationalguidance.

• Howfinalresultswillbeauthorisedandprovidedtocytology.

• TheexpectedturnaroundtimeofsamplesforhrHPVtestingtomakesurethereiscompliancewiththeoverallCervicalCheckturnaroundstandard.

• Stepsinvolvedinthespecimenpathwayandareasofresponsibilityforcytologyand virology.

• ThebusinesscontinuityplanningforthehrHPVtestingservice.

• Thearrangementsforpatientconfidentialitytraining.

• Thearrangementsforhealthandsafety.

• Thecompliancewithstafftrainingandcompetencyassessments.

• TherequirementstoprovideperformancedatatotheCervicalCheckprogramme.

• Therequirementstoattendmeetingstodiscussperformanceoranyserviceissues or changes.

3.2.4 Contract for service advisors


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


Laboratoryservicesmustnotbeoutsourcedwithoutfullandcomprehensivediscussion,planningandwrittenapprovalfromCervicalCheck.


10

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.


Scientific,medicalandnon-medicalstaffmustbequalifiedforthepositionstheyholdaccordingtonationalrequirementstopractice.Staffmustberegisteredwiththeappropriateregulatoryboardaccordingtonationalrequirementstopractice(eg.CORUinIreland).


Laboratoriesmusthaveanorganisationchartthatidentifiestheindividual(s)withinthedepartmentwhois/areresponsibleforeachelement.Theremustbeagreementonprocessesandinteractionswhichsetclearexpectationsforeffectiveworking.

3.3.2 The role of the lead pathologist for cervical cytology triage


Theleadpathologistforcervicalcytologytriagemust:

• Beaconsultantcellularpathologistregisteredwiththeappropriatenationalprofessionalandregulatorybody.

• Haveanominateddeputymedicalpathologist.

• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesthecervicalcytology service.

• ReportcervicalcytologyandsatisfyCervicalCheckstandardsinrelationtocervical screening.

• Haveajobdescriptionwhichtakesaccountofthisroleanditstimecommitment.

• HavesatisfactoryandappropriateparticipationinanappropriateContinuingProfessionalDevelopment(CPD)scheme(forexample,RCPath).

• ParticipatesatisfactorilyinanaccreditedExternalQualityAssessment(EQA)SchemeforGynaecologicalCytopathology.


11

• 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.


12

3.3.3 The role of the consultant cytopathologist


Theconsultantpathologistforcervicalcytologytriagemust:

• Beaconsultantcellularpathologistregisteredwiththeappropriatenationalprofessionalandregulatorybody.

• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesthecervicalcytology service.



• HavesatisfactoryandappropriateparticipationinanappropriateCPDscheme(e.g. RCPath).

• ParticipatesatisfactorilyinanaccreditedEQASchemeforGynaecologicalCytopathology.

• Beavailabletothedepartment/networkonadailybasisasfaraspracticallypossible(or,ifnot,thenominatedalternatemustbe).

• Supportassessingtheoverallqualityofthelaboratoryscreeningservice.TakeoverallresponsibilityforthequalityofreportsissuedonbehalfofCervicalCheck.


• AttendcervicalscreeningMDTmeetings,ormakesurethatalaboratoryrepresentative (other consultant or consultant BMS) is present, to discuss appropriate cases.


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.


13

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.


TheconsultantBMSforcervicalcytologytriagemust:

• BeaconsultantBMSregisteredwiththeappropriatenationalprofessionalandregulatory body.

• Beemployedinalaboratoryorlaboratorynetworkwhichprovidesacervicalcytology service.



• HavesatisfactoryandappropriateparticipationinanappropriateCPDscheme(e.g. IBMS/RCPath).

• ParticipatesatisfactorilyinanaccreditedEQASchemeforgynaecologicalcytopathology.

• Beavailabletothedepartment/networkonadailybasisasfaraspracticallypossible(or,ifnot,thenominatedresponsiblepersonmustbeavailable).

• Supportqualityassessmentandimprovementofthelaboratoryscreeningservice.

• Ensure,withtheleadmedicalscientistandcellularcytologylaboratorymanager,thatthelaboratoryfollowsallnationalguidancerelatedtocervicalscreening.


• AttendcervicalscreeningMDTmeetings-ormakesurethatalaboratoryrepresentative (other consultant or consultant BMS) is present, to discuss appropriate cases.


• Attendinternalandexternalcervicalscreeningmeetingsasrequired-ormakesurethataalternateispresentwheretheperformanceoftheservicewillbemonitored and local issues discussed.


14

3.3.5 The role of the lead medical scientist /laboratory manager for cervical cytology triage


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.


15

3.3.6 The role of the cervical cytotechnologist/medical scientist

Acervicalcytotechnologistisatrainedindividualemployedtoundertakethecytologicalexaminationofcervical cytology samples.


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


ThoseundertakingscreeningshouldNOTbeemployedonalessthanhalftimebasis.


Updatetrainingmustbeprovidedonaminimum2yearlybasis.


16


ScreenersidentifiedaspersistentlynotdetectingabnormalcytologymustberemovedfromCervicalCheckcytologyscreening.Followingsuspensionfromscreening,returntonormal,unsupervisedscreeningshouldonlybewhereupdatereskillingtraininghasbeensuccessfullycompletedinthelast2yearsandafteranagreedperiodofdoublescreening(atleast200cases,followedby50%doublescreeningfornext100slides)andcarefulmonitoring8.Ifanyhighgradecasesareundetectedduringthissupervisedperiodthenaperiodoffurtherre-educationmonitoringmustbeinstigated.Anysuspensionfromscreeningmustberecordedinwritinginthescreener’strainingfile.


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.


17

3.3.8 The role of the lead virologist for hrHPV testing


Theleadvirologistmust:

• Beaconsultantvirologist(medicalorclinicalscientist),registeredwiththeappropriatenationalprofessionalandregulatorybody.

• Haveanominateddeputyvirologist.

• BeemployedinorhaveacontractwithalaboratorywhichprovidesanaccreditedhrHPVtestingservice.ThislaboratorymusthaveanSLAorMOUifappropriatewiththelaboratoryprovidingcytologyservicestotheprogramme.

• EnsurethemolecularlabhasdetailedSOPS(inconjunctionwiththecytologylaboratory) to record the end to end cervical screening test protocols to CervicalCheck standards or recommendations.


• HavesatisfactoryparticipationintheCPDschemefortheirprofessionalbody.

• WorkwiththeleadpathologisttoassuretheoverallqualityofthehrHPVtestingservice.

• Ensure,alongwiththeleadscientist,thatalllaboratorystaffarequalifiedfortheirroles.


• 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.


18 QualityAssuranceinLaboratoriesProvidingHPVTesting,CytologyandHistopathologyServices

3.3.9 The role of the lead scientist/medical scientist for hrHPV testing


Theleadscientist/medicalscientistmust:

• Beemployedinorhaveacontractwithalaboratorywhichprovidesanaccredited hrHPV testing service to CervicalCheck.


• Beregisteredwiththeappropriatenationalandregulatorybody,ifapplicable.

• Workcollaborativelywiththemedicalconsultants,andlaboratorymanagerstomonitorandmaintainahighqualitylaboratorycervicalscreeningservice.

• SupportallaspectsofdeliveryofthehrHPVservice.

• Haveexperienceofleadingandtroubleshootingahigh-throughputmoleculardiagnostic service.

• ProvideanhrHPVtestingserviceinlinewiththeappropriateaccreditationstandards e.g. CAP, ISO 15189.

• Overseethedevelopmentandreviewoflaboratorypoliciesandprocedures.

• EnsurethatthelaboratoryfollowsCervicalCheckguidanceinrelationtoallaspectsofcervicalscreening.


• Ensurethatallscientificandlaboratorysupportstaffhavetheappropriatequalifications,trainingandregistrationwhereappropriate.

• MakesurethereiscompliancewithCervicalCheckcriteriafortheassessmentandimplementationofnewormodifiedtechniquesrelevanttotheHPVservice.

• Providemoleculardiagnosticstrainingandsupport.

• Ensurethatthecompetenceofalllaboratorystaffismonitored,maintainedandevidenced.NotifyCervicalCheckofanyinstancewherethereareissueswithstaffcompetenceandremovethestaffmemberfromCervicalCheckworkloaduntiltheissueissatisfactorilyresolved.

• HavesatisfactoryparticipationintheCPDschemeappropriatefortheirprofessionalbody.


3.3.10 The role of the virology scientist/ medical scientist for hrHPV testing


Thevirologyscientist/medicalscientistforhrHPVtestingmust:

• Beemployedinorhaveacontractwithalaboratorywhichprovidesanaccredited hrHPV testing service to CervicalCheck.


• Beregisteredwiththeappropriatenationalandregulatorybody,ifapplicable.

• Workcollaborativelywiththemedicalconsultantsandlaboratorymanagerstomaintainahighqualitylaboratorycervicalscreeningservice.

• SupportallaspectsofdeliveryofthehrHPVservice.

• Becapableoftroubleshootingahigh-throughputmoleculardiagnosticservice.

• ProvideanhrHPVtestingserviceinlinewiththeappropriateaccreditationstandards e.g. CAP, ISO 15189.

• FollowCervicalCheckguidanceinrelationtoallaspectsofcervicalscreening.


• FollowCervicalCheckcriteriafortheassessmentandimplementationofnewormodifiedtechniquesrelevanttotheHPVservice.

• Providemoleculardiagnosticstrainingandsupport.

• HavesatisfactoryparticipationintheCPDschemeappropriatefortheirprofessionalbody.

3.3.11 Proficiency and competency of virology staff


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.


3.3.12 Locum staff


Locumstaffmust:


• 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


SOPsmustbeinplaceforhandlingCervicalChecksamples.Sampleacceptancemust adhere to the HPV Primary Screening Eligibility Framework/Reference Guide for GPs and Clinics (see Appendix 4).


Laboratorieswillacceptordersviapostaldeliveryandviaelectroniclaboratoryorderswhereapplicable(followedbythereceiptofthephysicalsampleandform).Forelectronicordersthelaboratorywillbecapableofextractingbar-codedinformation.


ThelaboratorymustonlyacceptprogrammesamplesfromdoctorsorclinicsthatarenotifiedtothelaboratorybyCervicalCheck.


Onlythosesamplesaccompaniedbyacurrent,approvedversionoftheCervicalCheckcervicalscreeningformwillbeaccepted.


Onlythosesamplesinclusiveofinformedconsentwillbeaccepted.


3.4.2 Specimen reception


Allformsmustbedate-stampeduponreceiptanddateofreceiptmustbecaptured on the LIMS.


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.


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.


SamplesnotifiedasineligiblebytheProgrammeforscreeningwillnotbetested.


Wheresamplesareunsuitablefortestingareportmaybegenerated.Unsuitablespecimenswillbetrackedusingthelaboratoriesnon-conformancelog.


Followingacceptanceofthesampleandformforprocessing,bothwillbelabelledwithauniqueidentificationnumber(laboratoryaccessionnumber).Theuniquelaboratoryaccessionnumberforthesamplemustremainthesameregardlessoftest.

22

3.4.3 Data entry


DataentryofthedetailsrecordedonCervicalCheckformsaccompanyingsubmittedsamplevialsmustconformtoCervicalCheckdatacapturerequirements.AlldatarelevanttocervicalscreeningrecordedontheCervicalScreeningFormbythesampletakerwillbeenteredontotheLIMS.


Asecondpersonverificationofallrelevantdataenteredfromtheformontothecomputersystemwillbecarriedoutanddeemedtobecorrectbeforethesampleisauthorisedforfurtherprocessing.


Samples must be assigned to the correct clinically responsible doctor or clinic as perthereceivedform.


CervicalCheckmusthaveaccesstoHPVcervicalscreeningrequest/orderformsreceivedbythelaboratoryinelectronicformatandindexedbylaboratoryaccession number.

Standard 3-1 Cervicalscreeningsamplesmustbenotifiedpromptly to CervicalCheck once they are accessioned on the LIMS.

Target

95%within48hours,minimum80%by17:00GMTnextworkingday.


23

3.5 Sample processing and analysis

3.5.1 Molecular hrHPV testing


HPVtestingserviceswillbeprovidedinadedicatedlaboratoryareaorfacility.Allareaswillbeclean,well-lit,temperaturemonitoredandwell-ventilated.


Laboratories must use those hrHPV assays approved by CervicalCheck. ModificationstoexistingassaysmustbenotifiedinwritingandCervicalCheckapproval sought prior to implementation by the laboratory.


Processors used in either the molecular HPV testing or cytology preparation areamustbemaintainedonlybylaboratorystaffwhohavebeentrainedbythemanufacturerorindividualsdesignatedbythemanufacturer.


Handlingprocedureswillensurearobust“chainofcustody”acrossallphasesofthelaboratoryprocess,includingspecimenreceipt,HPVdetection(pre-analyticsandanalytics),documentationandstorage.Anaudittrailwillbeinplaceforsample processing.


Laboratorieswillverifyeachnewreagentbatchand/ornewreagentlotnumberpriortouse,usingadefinedanddocumentedprocedure.Theremustbesufficientdocumentationexplainingthecriteriaforacceptance.Thisensuresconsistencyofperformancebetweenbatchesandthatthechangeinreagenthashadnoimpactonthequalityoftheexamination.


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.


LaboratoriesmustcarryoutIQAanddocumentthefindings.



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.


In-housevalidationandverificationofassaysmustbecarriedoutpriortotheintroductionofanyCervicalCheckapprovedHPVassay.

Thelaboratorymustusetheappropriatecontrolandmonitoringprocedurestomanageassayrun“drift”inadditiontothemanufacturerkitcontrols.


Manufacturers’controlsmustconformtoproductkitinsertfortheassayconcerned.


IQCmustbeperformedatsufficientintervalstoassureresultintegrityandreducetheriskofretestingintheeventofafailure.Evidenceofsamemustbeavailable.Ifinternalqualitycontrolsarepreparedbythelab,internaldocumentationrelatingtotheirpreparationmustbeinplace.Anychangetoanewcontrolshouldbeplannedandcotestedwiththeexistingcontroltofacilitatevalidationpriortointroduction.


Tomonitorforlongtermdeviations,acontrolchart,registeringeachvalueobtainedineachbatch,ismandatory.Thisallowseasyidentificationoftrendsinqualitycontroldata,andidentificationofbothsystematicandrandomerrors.Aprocedureoutliningrejectionrulesandimmediateflaggingofrejectioneventsmustbe in place. Associated corrective actions should also be clearly documented.

Otheraspectsimportantforqualitymonitoringincludetheassessmentofpositivityratesandquantificationofthenumberofsampleswithvaluesclosetothecutoff,andthosethatrequirerepeatfortechnicalreasons.Checksontheinternalreproducibilityoftheassaycanprovideinsightintothelongitudinalperformance.


Laboratories must monitor and document invalid (indeterminate) sample rates, byreasonappropriatetotheHPVassayplatform.Anincreaseinratesaboveexpectedshouldtriggerfurtherlabinvestigationandcorrectiveactiontakenasappropriate.


LaboratoriesmustundertakeyearlyverificationofHPVassays.ReportsforverificationshouldincorporateareviewofIQCandEQAperformanceaswellasasummaryofanyoperationalormanufactureissuesthathaveariseninthetimeperiodconcerned.Laboratoriesmustclearlystatethemethodofverificationandcriteriaforacceptableperformance.

25

3.5.1.3 EQA of molecular primary HPV testing


AlllaboratoriesprovidingHPVtestingmustparticipate,andshowadequateperformance,inanapprovedEQAscheme.Ideally,thelaboratoryshouldalsoparticipateinaregularprogrammeofinter-laboratorycomparison(ILC).


EQAsampleswillbeanalysedaspartoftheroutinelaboratoryassayrun,bypersonnelwhoroutinelytestpatientsamples.TheEQAsamplesshouldbesubjecttothesameprimarymethodsasforpatientsamplestomimicroutinelaboratorytestingconditionsasfaraspossible.


EQAperformancewillbeevaluatedonanongoingbasis,withpromptcorrectiveactiontakenforunacceptableresults.TheEQAperformanceandanycorrectiveaction(s)undertakenwillbefullydocumentedandrecordedinthelaboratoryannualmanagementreview.


NomorethantworepeattestswillbeperformedonfailedsamplesincludingthosewhereclotsaredetectedbeforereportingashrHPVindeterminate.

3.5.2 Cytology triage


Liquid-basedcytology(LBC)ismandatory.Liquid-basedspecimensmustbeprocessedaccordingtothemanufacturer’sinstructions.


SlideswillbestainedusingthePapanicolaoustain(originalormodified).Thesamples should have a cover slip that covers all the cellular material.


Slidelabelsshouldincludepatientsurnameandforenameorfirstinitialofforenameinadditiontotheaccessionnumber.Wherethelaboratoryusesautomatedprocessorswhichreadandtransfertheuniquelaboratoryaccessionnumber (via barcode) onto the slide, it may not be possible to include all three identifiersonthesampleslide.



3.5.2.1 Staining


ThelaboratorymustparticipateinanappropriateEQAschemeforstainingknownas“TechnicalEQA”.


Internaltechnicalqualityassurancechecksmustbecarriedoutroutinelyincludingqualityofstainingandqualityofpreparation.Theresultsofthesechecksshouldbeavailableforreviewandshouldspecifyindividualprocessorsifmultipleprocessors are used.

3.5.2.2 Microscopy

ThecytologicalexaminationisafullmanualscreenofacervicalcytologysamplefollowingapositivehrHPVtest.TheThinPrepImagingSystem(TIS)hasnotbeenevaluated11foruseinasettingwheretheprimaryscreeningtestisahrHPVtestandisnotcurrentlyapprovedforuseinclinicalpracticebyCervicalCheck.


Equipment(microscopes,multi-headedmicroscopes,digitalimagingsystems)mustbeavailableandconfiguredtotheergonomicstandardsformicroscopywork.


Onlyapprovedprotocolswillbeused,approvalmustbesoughtpriortoimplementation.

Note: TIS may be used for IQC screening in a HPV primary cytology triage programme.


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.


ScreenersandpathologistsmustregisterwithCervicalCheckandsubmittheirassignednumberstoCervicalCheckintheresultsfile.


Everyonewhoexpressesanopiniononaslidemusthavetheiropinionrecordedinaretrievablemanner.ScreenerswillrecordtheirresultsindependentlyontheLIMS.

27


Cytologyreportingmustbecontrolledandmonitoredcarefullytomanageanyovercall/ bias due to a positive HPV primary screen.


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.


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.



3.5.2.3 Laboratory internal quality assurance of cytology triage


Accuracyofscreeningmustbemonitoredandmanagedwithapprovedprotocolsandproceduresfordefininganddealingwithpoorperformance.


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.


3.5.2.3.1Rapidreview/preview

Rapidreview12isoneoftheapprovedmethodsforroutinequalitycontrolofcervicalcytology.Rapidreviewisaswiftre-examinationofallcervicalcytologysamplesidentifiedasnegativeorinadequateattheinitialcytologicalexamination,aspartofthequalitycontrolprocess.Thecytologysamplesarenotfullyscreened.Rapidpreview12isanalternativeapprovedmethodforroutinequalitycontrolincervicalcytology.Rapidpreviewisperformedmicroscopicallyinexactlythesamewayasrapidreviewandisundertakenpriortotheinitialfullcytologicalexaminationoftheslide.Allcytologyslidesaresubjecttorapidpreviewnotjustthoseclassifiedasnegativeorinadequate.Thecytologysamplesarenotfullyscreened.

Asecondfullscreencanalsobeemployedasamethodforroutinequalitycontrolincervicalcytology.Afullscreeninvolvesthefullreviewofallmaterialontheslide.


Rapidreview/previewmust:

• Onlybecarriedoutbyqualifiedmembersofstaffwhoaremeetingcompetencystandards.

• Therapidreviewermustbeadifferentindividualfromthepersonundertakingthefullscreen.

• Individualsmustundergotraininginrapidreview/previewpriortoundertakingthisactivityandshowcompetencyinthistechnique.

• Arapidreview/previewmusttakeatleast60seconds.

• Ifadiscrepancyisidentifiedduringrapidreview/followingrapidpreviewthenthismustberecordedandpassedtoastaffmemberresponsibleforchecking.

• Rapidreview/previewdatamustberecordedtoallowforindividualscreeningnumbers and sensitivities to be calculated.

• Themethodofrapidreview/previewmustberegularlyauditedwithinthelaboratorytovalidateitseffectiveness.

30

3.5.2.4 Checking of abnormal cases

“Checkers”areexperiencedstaffwithvariedrolesandresponsibilitieswithinthecervicalscreeninglaboratory.Aswellasundertakinginitialcytologicalexaminationofslides,anexperiencedcytotechnologistcan,dependingonrequirements,performasecondexaminationofaslideinitiallydeemedpotentiallyabnormal(checking)ofabnormalcytologysamples.


• “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


Laboratorieswillcarryoutadditionalauditsinaccordancewithdepartmentalannual plans.

3.5.4 Amended result following discussion at multi-disciplinary meeting


WhereascreeningreportischangedfollowingreviewataMDTmeetingthetreatingclinicianandNSSmustbenotifiedofthischange.


31

3.5.5 External quality assessment


Laboratories must participate in the relevant accredited interpretive and technical nationalEQAschemes.


All individuals reporting cervical cytology must participate in and demonstrate acceptableperformanceintheinterpretiveEQAscheme.


ThelaboratoryshouldalsoparticipateinanapprovedEQAschemeforthepreparationandstainingofcervicalLBCsamples.


EQAresultsmustbeevaluatedbythelaboratoryonanongoingbasis,withpromptanddocumentedcorrectiveactiontakenforunacceptableresults.

3.6 Reporting and classification of cervical screening samples HPVresultsmaybebatchauthorisedwithinthevirologylaboratorytoforwardtocytologyfortriageofHPVdetectedresultsandapplicationofmanagementrecommendationpriortofinalauthorisation.

3.6.1 HPV results


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


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.



3.6.2.1 Adequacy of cervical cytology samples


LaboratoriesmustfollowBethesdaandNHSguidanceonadequacyof5,000wellpreserved cells13,14Wherecellcountingisperformed,themethodforcountingmust be incorporated into laboratory SOPs.

3.6.2.2 Reporting multiple diagnoses


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.


Thelaboratorymusthaveasystemtomaintaintheidentificationofbothcervicalsamples by accession numbers.

Thesamplereportmustidentifywhichcervixitrelatesto.

33

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


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.


TheCervicalCheckcytologyresultfilewillbereportedwiththedetailandintheformatspecifiedbyCervicalCheck.


ThescreeninghistoryofthewomanprovidedbythesampletakerviathecervicalscreeningformandfromtheCSR(wheresuchhistoryisavailable)mustbereferredtoandtakenintoaccountduringtheresultsprocess.


Anindependentcheckofthecaseresultandmanagementcodewillbeinplace,prior to report authorisation.


Everyresultwillbeappropriatelyauthorisedbeforerelease.Theresponsibleauthoriserwillbeidentifiable.Abnormalcytologyresultswillonlybereportedbyapathologist.


Results,onceauthorisedandreleased,willbeissuedintheagreedsummaryformatassoonaspossiblebyelectronicmeanstoCervicalCheck.


ThecontentsoftheresultsreporttoorderingdoctorsandclinicsmustbeinaccordancewiththeguidelinesoutlinedinCervicalCheckProgrammeguidelines.


Results, once authorised and released, must be issued promptly to the ordering doctor or clinic.




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.


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.


LaboratoriesarerequiredtoprovideCervicalCheckaccesstomaterialsincludinglogsandrecords,onrequest.

3.9 Protocol for multi-disciplinary team meetings Laboratorieswillprovidefacilities,participationandsupportforMDTmeetingsheldinprogrammecolposcopy services.

LaboratoriesareencouragedtoincorporateMDTmeetingsintotheinternalcontinuingeducationofscientificstaff.

CytologylaboratorieswillretrieveslidesordigitalimagesforcasesnotifiedforreviewatMDTmeetingsonrequest,andprovidethemwithin10workingdays.

35

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.


Acompleteandaccuratereportcontainingprescribedqualitymetricsmustbeprovidedatdefinedintervals(combinedHPVandcytologyreturn)asspecifiedbyCervicalChecktoallowcomparisonsagainstnationalstandardsandotherqualityindicators.Theidentifierassignedtoeachindividualscreenerandcytopathologistwillbethesamefordifferentmetricsofthereportandoversuccessivereportingperiods.

Note: Laboratories must have the ability to separate CervicalCheck workload from other workloads for statistical and monitoring purposes.


Performancemeasuresmustbecontinuouslymonitoredbythelaboratory.Failuretomeetthemmustalwaystriggerfurtherinvestigationandresultinappropriatedocumentedactiontakenwhennecessary.


Laboratoriesmusthavesystemsinplacewhereperformancedataisregularlyreviewedatdepartmentalandlaboratory/hospitalgovernancemeetings.


WhereperformancefallsoutsidetheindicatedrangesthismustbediscussedatCervicalCheckoperationalmanagementmeetings.InconjunctionwiththeCervicalCheckLaboratoryCoordinationteam,thelaboratorywillcooperateininvestigatingtheissueandprovideevidencetosupporttheexplanationforthisperformance.Thisexplanationmightnotnecessarilyberelatedtoreportingpractice,however,ifarootcauseisidentified,preventativeandreportingpracticesmustbeaddressedimmediately.PersistentoutliersagainstperformancestandardswillbeinvestigatedwithintheCervicalCheckgovernanceandqualitystructures.



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.


Nationalguidanceformanagingsafetyconcerns,safetyincidentsandseriousincidentsintheHSEmustbeadheredtoforservicesthatmaybeinvolvedinidentifyingormanagingascreeningincident.

3.14 Business planning and service continuity QR208. Quality requirement

Thelaboratoryservicemusthaveacontingencyplaninplacetomakesurethereisresilienceandcontinuityofservicewhenfacedwithdisruptiveeventssuchasequipmentfailureanddowntime,prolongedlossofpowerorITsystemsorflood/firedamagetothelaboratory.


Theremustbeaformalrecordwhichidentifiesthemainrisks,howtheywouldbemitigatedandhowthelaboratorywouldrecoverfromamajorincidentorfault.


Individualswithservicecriticalskillsetsmustalsobeidentifiedandsystemsputinplacetomakesurethereiscontinuityofserviceineventoftheirprolongedabsence.


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.


Histopathologistsmustremainabreastofcurrentandemerginginterpretationguidelines.



3.15.1 Quality requirements and standards

Ensuringqualityassuranceinservicedeliverycomprisescompliancewithbothqualityrequirementsandqualitystandards.

3.15.1.1 Accreditation

TheINABisthesolenationalaccreditationbodyformedicallaboratoriesintheRepublicofIreland.IrishlaboratoriesmusthaveorberegisteredforaccreditationtotheISO15189:2012Medical laboratories - requirements for quality and competence6.


LaboratoriesprovidingservicesforCervicalCheckthatareoutsideoftheEuropeanUnionmusthaveorberegisteredforaccreditationtotheappropriatestandardswithinthecountryoforiginofthecontractedlaboratory.

3.15.1.2 Changes to service capacity, capability or conformance to quality assurance standards


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


Allcervicalhistologysampleswillbeprocessedinthemannerappropriateforanexternally assessed and accredited histopathology laboratory.


AdiscrepancyhandlingandresolutionprocesswillbeinplacetomanagealldiscrepancieswithCervicalChecksamplesreceived.

3.15.3.1 Data entry and notification to CervicalCheck

RelevantclinicaldetailsrecordedontheCervicalHistologyFormwillberecordedontheLIMS.NotificationandresultfilesshouldbesenttoCervicalCheckinadefinedformatatspecifiedintervals.AperiodicreconciliationoffilessentandreceivedshouldbeinplacebetweenCervicalCheckandthelaboratory.


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.


40

3.15.5 Proficiency and competency of staff

3.15.5.1 Staff qualifications and competencies


Scientific,medicalandnon-medicalstaffwillbequalifiedforthepositionstheyholdaccordingtonationalrequirementstopractice.


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.


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.


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.


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.


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.



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


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


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.


LaboratoriesmusthavetheabilitytoseparateCervicalCheckworkloadfromotherworkload(s)forstatisticalandmonitoringpurposes.

Theidentifierassignedtoanindividualpathologistwillbethesamefordifferentsectionsofthereportand over successive reporting periods.



3.15.10.4 Quality metrics improvement

Laboratorieswillundertakeappropriateandtimelymeasurestoaddressperformanceissuesthatimpactonqualitymetricsandresultingvaluesoutsideoflaboratory,nationaland/orinternationalnorms.

Sub-optimalperformanceidentifiedbytheproviderlaboratoryintheHisto1returnwillrequireaddressinginlinewiththeofficiallyapprovedguidanceoftheappropriateprofessionalbody.SuchperformanceissuesshouldbenotifiedimmediatelytotheNSSandevidenceofcorrectiveactionincludingretraining,ifapplicable,willbesoughtbytheNSS.

3.15.10.5 Quality assurance visits


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


https://www.gov.uk/government/publications/cervical-screening-laboratory-hpv-testing-and-cytology-se

https://www.gov.uk/government/publications/cervical-screening-laboratory-hpv-testing-and-cytology-se

https://www.gov.uk/government/publications/cervical-screening-primary-hpv-screening-implementation

https://www.gov.uk/government/publications/cervical-screening-primary-hpv-screening-implementation

https://www.gov.uk/government/publications/cervical-screening-cytology-reporting-failsafe

https://www.gov.uk/government/publications/cervical-screening-cytology-reporting-failsafe

https://www.gov.uk/government/publications/cervical-screening-pathway-for-acceptance-of-new-hpv-test

https://www.gov.uk/government/publications/cervical-screening-pathway-for-acceptance-of-new-hpv-test

https://www.gov.uk/government/publications/cervical-screening-laboratory-testing-for-human-papilloma



48

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


https://www.journalslibrary.nihr.ac.uk/hta/hta19220#/abstract

49

Appendix 1Cervical screening results and recommendations table


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.


51

Appendix 3HPV primary screening algorithm


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


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

standards for quality assurance in colposcopy · 3.1.10 changes to service capacity, capability or...

Documents