Appendix 3 - UKCRC Tissue Directory and Coordination Centre · Does the policy ensure that bona...
34
16 Appendix 3 Biobank self-assessment form. This form should be read alongside the Confederation of Cancer Biobank’s general standard (http://ccb.ncri.org.uk/wp-content/uploads/2014/03/Biobank-quality-standard-Version-1.pdf). It is intended for use by biobanks wishing to assess their activities against the requirements of the biobank standard and is used for self-assessment prior to a peer review audit. 10 Using HTA scoring system; 1=non-compliant or not applicable, 2= some progress towards compliance, 3=compliant with regard to most important features, 4=fully compliant Domain Comment Self - score 10 Quality management system General requirements How does the biobank ensure that its quality management system complies with the requirements of the standard? What evidence is available to demonstrate the biobank’s efforts to continually improve the effectiveness of its quality management system? Quality Manual and Quality Policy Does the biobank have a quality manual that provides an overview of the biobank's quality management system? Does this overview include or show where to find: • the quality policy? • a description of the quality management system? • a description of the organisational structure and governance arrangements? • a description of the roles and responsibilities of laboratory management? • a description of the documentation that supports the quality management system? Are biobank personnel familiar with the quality management system, the contents of the quality manual and all procedures relevant to their work? Does the biobank take a systematic approach to the improvement of quality? Best practice: Does the quality policy set out the biobank's commitment to defining the quality of its products and services, and to meeting those quality parameters?
Transcript of Appendix 3 - UKCRC Tissue Directory and Coordination Centre · Does the policy ensure that bona...
16
Appendix3Biobankself-assessmentform.
ThisformshouldbereadalongsidetheConfederationofCancerBiobank’sgeneralstandard(http://ccb.ncri.org.uk/wp-content/uploads/2014/03/Biobank-quality-standard-Version-1.pdf).Itisintendedforusebybiobankswishingtoassesstheiractivitiesagainsttherequirementsofthebiobankstandardandisusedforself-assessmentpriortoapeerreviewaudit.
10UsingHTAscoringsystem;1=non-compliantornotapplicable,2=someprogresstowardscompliance,3=compliantwithregardtomostimportantfeatures,4=fullycompliant
Domain Comment Self-score10
QualitymanagementsystemGeneralrequirementsHowdoesthebiobankensurethatitsqualitymanagementsystemcomplieswiththerequirementsofthestandard?Whatevidenceisavailabletodemonstratethebiobank’seffortstocontinuallyimprovetheeffectivenessofitsqualitymanagementsystem?
QualityManualandQualityPolicyDoesthebiobankhaveaqualitymanualthatprovidesanoverviewofthebiobank'squalitymanagementsystem?Doesthisoverviewincludeorshowwheretofind:
• thequalitypolicy?
• adescriptionofthequalitymanagementsystem?
• adescriptionoftheorganisationalstructureandgovernancearrangements?
• adescriptionoftherolesandresponsibilitiesoflaboratorymanagement?
• adescriptionofthedocumentationthatsupportsthequalitymanagementsystem?
Arebiobankpersonnelfamiliarwiththequalitymanagementsystem,thecontentsofthequalitymanualandallproceduresrelevanttotheirwork?Doesthebiobanktakeasystematicapproachtotheimprovementofquality?
Bestpractice:Doesthequalitypolicysetoutthebiobank'scommitmenttodefiningthequalityofitsproductsandservices,andtomeetingthosequalityparameters?
17
DocumentationrequirementsAretheredocumentedpoliciesandprocedurescoveringallaspectsofactivityrelatingtothebiobank,includingbutnotlimitedtoconsent,collection,storageandreleaseoftissueanddata,themanagementofthebiobankanditsadherencetoapplicablequalityandregulatorystandards?Doesthebiobankmaintainrecordswhichprovideevidencethatitsactivitiesarebeingperformedincompliancewiththerequirementsofthequalitymanagementsystem?
DocumentcontrolHasthebiobankestablishedandmaintainedaproceduretocontrolalldocumentsthatformpartofitsqualitymanagementsystem(internallygeneratedorfromexternalsources)suchasregulations,standardsandmethodsaswellasproformas,drawings,software,specifications,instructionsandmanuals?Isthereamasterlistshowingalldocumentscurrentlyapprovedforuseandtheirlocationorauthorisedholder?Aredocumentsapprovedbyauthorisedpersonnelpriortoissue?Aredocumentsandtheprocedurestheydescribereviewedregularly?Dodocumentscontainauniqueidentifier,activationdate,reviewdate,versionnumber,totalnumberofpagesandnameoftheapprover?Aredocumentslegible,readilyidentifiableandavailableatthepointofuse?Doestheprocedurefordocumentcontrolensurethattheauthorisedholderorlocationofeachcontrolledcopyisknownatalltimes?Aresupercededversionsofdocumentsarchivedandcopiesremovedpromptlyfromcirculationsothatstaffmembershaveaccesstothelatestversionofdocumentsonly?Arearchiveddocumentsmarkedasobsoletetopreventtheiraccidentaluse?
BestPractice:Areallbiobankdocumentsidentifiedwiththedocumenttitle,author,owner,approver,dateactivated,versionnumber,and,forpaper-basedsystems,copynumber?Iseachpagenumberedandthetotalnumberofpagesshownortheendofthedocumentidentified?
18
DocumentreviewandrevisionIsthereadocumentedprocedureandschedulefordocumentreviewand,ifnecessary,revision?Aredocumentrevisionsapprovedbyauthorisedpersonnelpriortoissue?Isconsiderationgiventotheneedforadditionaltrainingwhenimplementingdocumentchanges?Arestaffnotifiedwheneveranewversionofadocumentisissued?
BestPractice:Arechangestodocumentsapprovedbytheoriginaldocumentapproverortheirnominateddeputy?Isadescriptionofthechangesmadeincludedinthereviseddocument?Areallbiobankdocumentsidentifiedwithinadocumentcontroldatabaseorlogwhichtracksdifferentversionsofthedocumentwithdatesofactivationandwithdrawalandabriefdescriptionofthereasonanewversionwasissued?
DocumentretentionHasthebiobankmanagementdeterminedtheappropriateretentiontimesandmethodofdestructionfordocumentsremovedfromcurrentuse?
ControlofrecordsIsthereadocumentedrecordmanagementsystemthatspecifieswhatdataistoberecorded,whereitistoberecorded,howlongitistoberetainedandhowitistobedisposedof(ifappropriate)inlightofrelevantdataprotectionlaws?Areallrecordslegibleandstoredinanenvironmentthatmaintainstheirlegibility?Areallrecordskeptsecureandisconfidentialitymaintained?Doesthebiobankhaveprocedurestoprotectand,ifheldelectronically,backuprecords?Dotheseprocedurespreventunauthorisedaccesstooramendmentofrecords?Areallpaperrecordssignedanddatedbythepersoncreatingtherecordatthetimeitismade?Isanequivalentsystemimplementedforelectronicrecords,enablingthepersoncreatingtherecordtobetracedandthedateandtimeofcreationoftherecordtoberecorded?Ifchangestorecordsarepermitted,doanychangesmadeensurethattheoriginalrecordremainslegible?Areallchangestopaperrecordsdatedandsignedbythepersonmakingthechangeatthetimethechangeismade?Areequivalentmeasurestakenforrecordsstoredelectronically?
BestPractice:
19
Doesthebiobank'squalitymanuallistalldatatypesandspecifywhereeachdatatypeshouldberecorded,togetherwitharecordretentionperiodand,ifappropriate,thedisposalroute?Arebiobankdatageneratedduringthesampleconservationprocessandqualityassessmentsretainedforaperiodofnotlessthan10yearsfromtheexpirationdateoftheproductstowhichthedatarelates,or,ifthereisnoexpirationdate,fromthedateoffinalproductdistribution?Isthereanaudittrailshowinganychangestoelectronicrecords,whomadethechangesandthedateandtimeofsuchchanges?ChangecontrolIsthereasystematicapproachtochangecontrol?Dodocumentedprocedure(s)existforcreation,review,amendmentanddeletionoftechniquesandprocedures?Ifnewtechniquesorproceduresarebeingconsidered,orexistingonesrevised,isthereadocumentedprocedurefortheassessment,recordingandmitigationofthepotentialandactualimpactofchanges?Isconsiderationgiventothepotentialneedforvalidationandtheprovisionofadditionaltrainingtoallthoseaffectedbythechanges?
BestPractice:Doesthechangecontrolsystemincorporatetherequirementtoundertakeanassessmentoftherisksassociatedwithchange,tovalidatefullyanynewtechniquesandproceduresbeforetheyareintroducedandtomonitorthepotentialcumulativeeffectsofmultipleminorchanges?
ManagementresponsibilityandgovernanceDoesthebiobankhaveadocumentedgovernancepolicythathasbeenagreedbyrelevantstakeholdersandoutlinesthegovernanceofthebiobank?Doesthispolicycover:
• Whohaslegalresponsibilityforthebiobank?
• Whohasoversightofthebiobankandresponsibilityforitsorganisationandpolicies?
• Whoisresponsibleforitsdaytodayoperation?
• Howresponsibilityisdelegated?
• Howtheconsent,collectionandreleaseoftissueisgovernedincludingreferencetoitsaccesspolicyandarrangementsforensuringethicalapprovalofresearch?
• Thestandardstowhichthebiobankwilladhere?
• Therequirementforthebiobanktomaintain
20
ResearchTissueBankethicalapprovalstatus?
• Therequirementforthebiobanktoholdanappropriatelicencetostoretissueforresearch(whererelevant)?
• Therequirementtoprotecttheprivacyofdonorsandmaintaintheirdataconfidentially?
• TherequirementtoprotectanyIPrightsaccruingtothebiobankoritsstakeholders?
BestPractice:Ifthebiobankisdiseasespecific,aredonorsorothersaffectedbythediseaseabletoinfluencetheoperationofthebiobank?Ifthebiobankisnotdiseasespecificdoesitallowadvocatesofthoseonwhomthebiobankreliesfortissueand/orthoseitaimsultimatelytobenefittoinfluencetheoperationofthebiobank?Aretheprocessestoallowdonorinvolvement,andtheinputexpectedfromthedonorsdocumented?DoesthegovernancedocumentgrantultimateresponsibilityforthebiobanktoonegroupsuchasaTissueBankExecutiveCommitteewhichconsistsofappropriatelyqualifiedandexperiencedpersonnel?Doesgenericethicalapprovalandeachdonor’sconsentextendtothecollectionandreleaseofallrelevantmaterialsandassociateddataaccordingtodocumentedcriteria?
OrganisationalstructureIsthereanorganisationalplanthatdefinestheorganisationandmanagementofthebiobank,itsplaceinanyhostorganisationanditsrelationshiptoanypartnerorganisations?Doestheorganisationalplanincludetheresponsibilities,authorityandinterrelationshipsofallorganisationsinvolved?Isthereadocumentedorganisationalchartdetailingrelationshipsandresponsibilities/dutiesofallbiobankpersonnel(whetheremployeddirectlybythebiobankorbyahostorpartnerorganisation)?
Bestpractice:DoestheQualityManualhaveasectiondescribingtheorganisationalstructureandinterrelationshipsofthebiobankanditshost,andarediagramsandtablesusedtoprovideclarity?
ManagementcommitteesArebiobankstakeholders,includingresearchers,donorsandlayrepresentatives,involvedinthebiobank’ssteering,managementandaccesscommittees?
21
Bestpractice:Isthereatleastonedonor/layrepresentativememberofthesteering,managementandaccesscommittees?Istheroleofthelaypersonclearlydefinedandcommunicated,withtrainingprovidedtotheindividual(s)?
LicencesandlegalrequirementsDoesthebiobankoperateandprovideevidencethattheyareoperatingwithinthelegalparametersofthecountryinwhichtheyarebased,holdingallnecessarylicencesandapprovals?DoesthebiobankcomplywithallrelevantregulatoryCodesofPractice,forexampletheHTA’sCodesofPracticeonconsentanddisposaloftissue?
Bestpractice:IsaHumanTissueCoordinator(howevernamed)nominatedtooverseeadherencetolicenceandregulatoryrequirements?Arecurrentreferencecodesforallappropriateregulatorypermissions(forexampleHumanTissueAuthority(HTA)andResearchEthicsCommittees(RECs))includedinbiobankcommunicationsandaretheyeasilyidentifiableonthebiobankwebsite?
EthicalapprovalsDoesthebiobankmaintainappropriateandcurrentethicalapprovalsfortissueanddatastorage/useforresearch,encompassingproceduresfordataandsamplecollection,storage,releaseanddisposal?Doesthebiobankproduceanannualreportofitsactivitiestosatisfytherequirementsofitsethicalapproval?Aretheaccesspolicy,proceduresanddecision-makingprocessoutlinedinthebiobank’sresearchethicsprotocol?Doestheauditregimeninplaceforthebiobankincludescrutinyofcompliancewiththeethicalapprovalsthatgovernitsoperations?
AccesstotissueanddataDoesthebiobankhavedocumentedaccesspoliciesandprocedures?Istheaccesspolicyclearlystatedandreferencedinallofthebiobank'sdonor-facingandclient-facing?Doesthepolicyensurethatbonafideresearchersinanysectorcanbegrantedaccesstosamplesanddata?Doesthebiobankensurethatoperationalpoliciesdonotprecludeinvolvementbyanyindividualorgroup,orclearlyjustifywhyexclusivepoliciesexist?Doresearchershavetoapplyinwritingforaccesstosamplesandassociateddatafromthebiobank?Areguidelinesforresearchers/applicantsavailable?Dosuch
22
guidelinesexplainclearlytheapplicationsubmissionprocess,applicationreviewprocess,timetoreviewandnotificationofoutcome?Iseachrequestaccompaniedbyalaysummaryoftheresearchanditssamplerequirements?Areallapplicationsfullyreviewedbyatissueaccesscommitteeforscientificmeritandimpactoftheresearchinthewidercontextofresearchintherelevantfield?Areguidelinesforapplicationreviewersavailable?Dosuchguidelinesexplainclearlythedetailoftheapplicationreviewprocess,scoringsystemandallpossibleoutcomes?Ifthereiscompetitionforscarcesamples,aresamplesprovidedtotheprojectwithgreatestscientificmeritasjudgedbytheaccesscommittee?Isfeedbackprovidedtoallresearchapplicants(whethersuccessfulorunsuccessful)whohavesubmittedanapplicationtoaccesssamplesfromthebiobank?Areunsuccessfulapplicantsabletoappealthedecision?Bestpractice:Areresearchersrequiredtoprovidefeedbacktothebiobankonprogressofthestudy,samplequality,findingsandpublications?Areresearchersrequiredtoreturntheirresearchresultstothebiobanktoenrichthedataassociatedwiththesamples?Areresearchersrequiredtoacknowledgethebiobankasthesourceofthesamplesusedintheirresearch?Isinformationaboutthesamplesanddataheld,andtheprocedurewhenapplyingforaccesstothem,availableonlinewithoutregistration?
AccessreviewDoesthebiobankreview,atleastannually,thenumberandnatureofsamplesaccruedbalancedagainstthosereleasedforresearch?Ifacollectionorsub-collectionisdeterminedtobeinappropriatelyunderused,isthereamechanismforpromptinvestigationanddecisiononthevalueofcontinuedaccrualincludingareviewofthebiobank’saccesspolicy?
MaterialanddatatransferagreementsDomaterialanddatatransferagreements(MTAs)formacontractgoverningtherightsandobligationsofthebiobankandtherecipientofsamplesandassociateddata?AreMTAsdrawnupandsignedbythebiobankandtheirclientsbeforeanysamplesordataarereleasedtotheclient?
Bestpractice:DoMTAsspecifytheclient'sresponsibilitiesinrespectof:
23
• Obtainingethicalapprovalfortheplannedwork?
• Complyingwithanyrestrictionsontheuseofthesamples?
• Returningsurplussampleand/orderivedmaterialstothebiobank(ifrequiredbythebiobank)?
• Maintainingthesecurityandtraceabilityofthesampleswhentheyareissuedtothem?
• Complyingwithinstructionsfordisposalofthesamples?
• Complyingwithobligationstothebiobankinregardstointellectualproperty,provisionofdatageneratedtothebiobank,co-authorshipand/oracknowledgementofthebiobankinpublications?
• Providingperiodicreportstothebiobank
DoesthebiobankseeklegaladviceforstatingtheappropriaterightsandobligationsintheMTA/contractforbiobankshostedbylargerinstitutions?HealthandSafetyDoesthebiobankcomplywithallapplicablehealthandsafetylegislationandgoodpractice?Doesthebiobankoperateaccordingtodocumentedhealth&safetypolicyandprocedures?
CommunicationwithstakeholdersArepoliciesgoverningthebiobanktransparent?Arethereeffectivelinesofcommunicationamongstakeholders?
Bestpractice:Priortotheinitiationofcollection,didstakeholders,includingpotentialdonors,theirrepresentatives,researchersandotherpotentialclients,discusscommunicationstrategiestopromotetransparencyandtrust?Hasthebiobankdevelopedclearguidanceastowhatservicesareprovided,thecostsfortheprovisionofthoseservices,andthehoursduringwhichservicesareavailable?Iscontactinformationreadilyavailabletostakeholders?
InternalcommunicationAreeffectiveproceduresforthedisseminationofinformationtostaffimplementedandistheireffectivenessreviewedperiodically?Arethereregularmeetingsforexchangeofinformationbetweenallmembersofthebiobankstaffandmanagement?Arerecordsofthesemeetingskeptanddisseminatedtostaffandotherstakeholders?
24
Bestpractice:Dostaffandmanagementmeetingstakeplacenotlessthaneverythreemonths?
ExternalcommunicationDoesthebiobankpromotegoodcommunicationwithexternalstakeholders,includingfunders,donorsandresearchers,ensuringtheyareregularlyinformedaboutitsactivities,plansanddevelopments?Doallstakeholdershavetheopportunitytoshapethebiobank’sdirectionandcontributetoitsdevelopment?
Bestpractice:Doesthebiobankprovidestakeholderswithinformationabouttheuseofitssamplesanddata?Doesthisfeedbackinclude:
• Thenumberofsamplesused?
• Thepurposeoftheiruse?
• Thenumberofprojectssupported?
• Theoutcomeofresearch(inbroadterms)includinganypublications?
ExternalstaffDoesthebiobankengagewithstaffofpartnerorganisationsinvolvedinthecollection,transportandprocessingoftissueforresearchtoensuremutualunderstandingofclinicalandbiobankingmattersrelatingtoclinicalsamples?Doesthisengagementincludemedical,nursing,alliedprofessionalandadministrativestaff,includingtrainees,andincludingSurgeryandPathology?Doesthebiobankengagewithresearcherstoensuremutualunderstandingofthepossibleusesandlimitationstotheuseofavailabletissueforresearch?Doesthebiobankensurethatitunderstandsresearchers’needswithrespecttotypesandformatsoftissueandassociateddata,ensuringthatitwillbesuitabletosupportresearchusingemergingtechnologies?
Bestpractice:DoPathologystaffcontributingtoR&Dhavethisintheirjobplansascoreactivity?Isthereregularpathologyinputintoeducationandtrainingforbiobankstaff,andviceversa?Doesthebiobankhavearegularprogrammeofactivitiesand/orotherevents/publicationsaimedspecificallyatengaginghospitalstaff,withfeedback?Isthereinputintothedesignanddeliveryoftheseactivities,eventsandpublicationsbyhospitalstaffgroupsanddonorrepresentatives?
25
PatientsanddonorsDoesthebiobankpromotebiobankingtopotentialdonorsandtheirfamiliesaspartofawiderdonorengagementprogramme?Aredonorviewssoughtonbiobankactivitiesonaregularbasis?Isthereactiveandongoinginvolvementofdonor/layrepresentativestoprovideinputintothepromotionalandoperationalactivitiesofthebiobank?Aredonorrepresentative/laymembersinvolvedinthedesignandanalysisofthebiobank’sfeedbackmechanisms?Doesthebiobankhaveamechanisminplacetoseekdonors’viewsonsensitiveissuesandfeedbacktodonorstheresultsoftheseconsultations?Doesthebiobankhaveamechanisminplacetoseekdonor/layinputintoanyinformationproducedfordonors?Arethegeneralresultsofresearchundertakenwithsamplesfromthebiobankcommunicatedtointeresteddonors?
Bestpractice:Arethegeneralresultsofresearchundertakenwithsamplesfromthebiobankpublished(forexampleonthebiobank’swebsite)?Isnon-useofsamplesacomponentofdiscussion/informationsharingwithdonorsassociatedwiththebiobank?
ReturnofresearchresultsorincidentalfindingstodonorsDoesthebiobankhaveaclearlydefined,justifiedpolicyand,wherenecessary,processforthemanagementofclinicallyrelevantresearchresultsandincidentalfindings?Isthispolicyfullyandclearlydescribedtothedonorduringtheconsentprocess(priortoconsentbeinggiven)byanappropriateperson?Ifthepolicypermitsthereturnofresearchresultsorincidentalfindings,isthedonor’sconsenttobere-contactedsoughtandthisinformationloggedinaccordancewiththesectiononsampletraceability?Isfeedbackgivenonlytodonorsand/ordonors’familieswhohaveconsentedtobere-contactedforthispurpose?Isfeedbackgivenbytrained,qualifiedpersonnelwhounderstandtheimplicationsoftheresultsforthedonorand/ortheirfamily?Ifsampleshavebeencollectedwithoutthedonorbeinginformedaboutcommunicationofclinicallyrelevantfindings,oriftheiropinionisnotrecorded,hasthebiobankconsultedalocalethicscommitteeforadviceonthebestcourseofactionshouldaclinicallyrelevantfindingarise?
Bestpractice:Isafeedbackpathwaydefined,resourcedandtested(ifthebiobank’spolicypermitsfeedbackofresults)?
26
CommunicationwithresearchersDoesthebiobankhaveamethodforpublicisingitsexistenceandthetypesandnumbersofsamplesheldwithinit?Isthebiobankreadilyvisibletoresearchersasaresourceforsamples,withlocal,regionaland/ornationalvisibilityinformatsappropriateforthescopeofcollection(s)?IsthebiobankshownontheNCRI’sweb-basedportal(See:http://biosampledirectory.ncri.org.uk/)?
Bestpractice:Doesthebiobankhaveanindependentpresenceontheweb?Arethebiobank’sholdingssearchableviaweb-basedsampledirectoryportal(s)?
StakeholderfeedbackDoesthebiobankhaveadocumentedpolicydescribinghowitwillseekandrespondtofeedbackregardingitsoperation,performanceandquality?Isthereadocumentedprocedureforassessingclientsatisfaction?
Bestpractice:Doesthestakeholderfeedbackpolicy:
• outlineproceduresforactivelyseekingfeedback?
• outlineproceduresforimprovingthebiobankinresponsetofeedback?
• ensurethatimprovementsarehighlightedtothoseusingthebiobank?
• ensurethatthosegivingthefeedbackreceivearesponseoutliningwhatthebiobankwilldo/hasdoneinresponsetothefeedback?
Complaints,anomaliesandnon-conformitiesComplaintsIsthereadocumentedprocedureshowinghowthebiobankwillreceive,assessandrespondinatimelyfashiontocomplaintsfromdonors,prospectivedonorsandclients?Doesthebiobankrecordallcomplaintsandacknowledgethemassoonaspossiblebythemostappropriatemethod?Arerecordskeptofresponses/solutionsandaretheserecordsreviewed?Doesthebiobankinvestigateallcomplaintssoastoidentifytherootcauseandimplementanynecessarycorrectiveactions?
27
Bestpractice:Hasthebiobankdevelopedaclearcomplaintsprocedureandmadethisavailabletoallstakeholders?Arethecommunicationmethodsavailableforcomplaintsappropriateforalllikelycomplainants?Onreceivingacomplaint,doesthebiobankacknowledgeitandcommunicatethisbythesamemeansasthecomplaintwasinitiallymade?Isthecomplaintprocedureclearlycommunicatedtothecomplainantatthisstage?Isthecomplaintlogged,togetherwiththeresultsofanyinvestigationandaclearlystatedoutcome?Isthecomplainantmadeawareoftheresultsofanyinvestigationandtheultimateoutcome?Isthereanyappealsprocess?Isthecomplaintsprocedurereferencedinallofthebiobank'sdonor-facingandclient-facingmedia?
Anomaliesandnon-conformitiesDoesadocumentedprocedureexistforrecording,investigating,reportingandreviewinganomaliesandnon-conformities?Isanybreachofprotocolloggedinsuchawaythatitisflaggedwheneveranaffectedsampleisrequested?Dorecordsdetaileachevent?Aredecisionsmadepromptlyastowhatcorrectiveaction(s)shallbetakentopreventinappropriateuseofcompromisedsamplesandtosuggestcorrectiveandpreventiveactiontoavoidrecurrence?
Bestpractice:Dotheprocedure(s)forloggingadverseeventsandnon-conformitiesincludeariskassessmentofhowthateventmightinfluencetheintegrityofthesampleandthetypeofanalysisthismightaffect?Isthecategoryofriskrecordedforeachsampleaffectedsothatitisflaggedwheneverthesampleisrequested?Aremeetingsheldasrequiredtodiscusscomplaints,anomaliesandnon-conformitiessoastoidentifytrendsandsuggestbroadercorrectiveorpreventivemeasures?
CorrectiveandpreventiveactionsDoesthebiobankoperatedocumentedprocedure(s)forimplementingcorrectiveandpreventiveactions?Dosuchproceduresensurethatsuchactionsareimplementedinatimelymannerandincludetherequirementtoensurethattheactionstakenaddresstherootcauseoftheproblemorpotentialproblem?Dotheproceduresincludeanassessmentoftheeffectivenessofcorrectiveandpreventiveactions?
28
AuditandreviewofbiobankactivitiesInternalandexternalauditDoesthebiobankoperateadocumentedprocedureforsubmittingallaspectsofitsoperationstohorizontalandvertical,internalandexternalaudits,inaccordancewithapredeterminedschedule,todemonstratethatitsoperationscontinuetocomplywiththerequirementsofitsmanagementsystemandthisstandard?Doestheauditsystemcoverallaspectsofthebiobank’smanagementsystem?Areallauditorstrainedandcompetentinauditing?Areinternalauditorsclearlydefinedintheorganogram,showinghowtheywillbeassignedtaskssothattheyarenotauditingtheirownpractice?Iftheauditfindingscastdoubtonanyaspectofthebiobank’soperations,doesthebiobanktaketimelycorrectiveactions?Areauditrecordsmaintained,showingtheareaaudited,auditfindingsandanycorrectiveactionsarisingfromthem?Doesthebiobankassessandrecordtheeffectivenessofanycorrectiveactionsimplemented?
ManagementreviewDoesthebiobank’stopmanagementreviewthequalitymanagementsystematleastannually?Doesthisreviewincludeacomprehensivereviewofthequalitymanagementsystemanditscontinuedsuitabilityandeffectiveness?Areanynecessarychangesorimprovementsintroducedusingthebiobank’schangecontrolprocedure?Arethefindingsfrommanagementreviewsandtheactionsthatarisefromthemrecorded?Areactionsdischargedwithinanappropriateandagreedtimescale?
BiobanksustainabilityDoesthebiobankhaveadocumentedstrategytosafeguarditscontinuedfinancialviabilityfortheexpectedlifetimeofthesamplestorageandhandlingactivities?Doesthebiobankmaintainalegacyplanforitsownholdings,incasethefutureofthebiobankisthreatened?Areplansreviewedperiodicallyandamendedasneeded?
Bestpractice:Hasthebiobankdevelopedabreakdownofthecostsassociatedwiththecollection,storageanddistributionofsamplessuchthattheannualheadlinecostsfor(a)maintainingand(b)adding
29
tothebiobankareknown?Canthebiobankdistinguishwithinitsbudgets,(1)thecostsrequiredtocontinuecollectinganddistributingand(2)thoserequiredforcontinuedmaintenanceanddistributionofthecurrentcollection?Ifthebiobankisfundedpredominatelyfromonesource,hasariskassessmentandcontingencyplanbeendevelopedagainstthelossofthatfunder?Hasthebiobankdevelopedaprotocolforthetransferofsamplestoanotherbiobankshoulditfailtocontinuetobefinanciallyviableorneedtotransferitsholdingsforanyotherreason?Hasthisprotocolbeendevelopedincoordinationwithanappropriateethicscommitteeandwithlayinput?Riskassessmentandcontingencyplanning.Hasthebiobankperformedadocumentedassessmentoftheriskstoitsbusiness,operationsandproducts,covering:
• Riskstothemanagementandoperationofthebiobankandthesamplesanddataitholds?
• Minimisationandmitigationofthoserisks?
• Contingencyplans,includinganemergencyprocedure,abusinesscontinuityplanandadisasterrecoveryplan?
• Rolesandresponsibilitiesofkeystaffinimplementingthecontingencyplans?
• Riskassessmentanddetailedplansforbiobanklegacyinshort,mediumandlongterm,addressingpersonnel,premisesandtechnology?
Aretheriskassessmentandcontingencyplansreviewedregularlyandamendedasneeded?Doesthebiobankhavedocumentedproceduresforassessingtheimpactofunplannedeventsonitsoperationsandthesamplesanddataitholds?
Bestpractice:Doesthebiobank,ortheorganisationofwhichitisapart,maintaindetailedplansandstandardoperatingproceduresforimplementationincaseofanemergency?Arestaffawareoftheseplansandprocedures?Iseachpotentialriskdocumented,showinghowhighorlowtheriskis,theconsequence(s)ofthatriskoccurring,theactionstakentomitigatetheriskandtheremedy/actionstobetakenshouldthatriskoccur?Doplansincludeinstructionsforcontactingkeypersonnelout-of-hours?
30
StaffRolesandresponsibilitiesIseachrolewithinthebiobankdescribedinajobdescriptionandpersonspecification?Arethequalificationsandcompetenciesrequiredforeachroledefined,andcommunicated?Arethereclearreportinglinesandaccountability,documentedlevelsofauthorityandresponsibilityassociatedwitheachrole,asystemofstaffappraisal,andtraininganddevelopmentofstaff?Arestaffmembersperformingspecificroleswithinthebiobankqualifiedonthebasisofappropriatetraining,experienceand/ordemonstratedskills,asappropriate?Doesthebiobankshallhaveadirector(howevernamed)withoverallresponsibilityformanagementofthebiobank?Isthedirectorqualifiedbytrainingandexperiencetodirectandmanagethescopeofactivitiesconductedbythebiobank?Hasapersonresponsibleforqualityassurancemanagementbeenidentified?Ifthisindividualhasotherroles,aretheyindependentofbiobankservicestheyareresponsibleforqualityassuring?
Training,competenceandstaffdevelopmentDoesthebiobankmaintainadocumentedtrainingprocedurethatincludes:
• Anew-starterinductionprocedure
• Trainingstaffinskillsspecifictotheirjobaccordingtodocumentedprotocols
• Assessmentofstaffcompetenceagainstdocumentedcriteria
• Recordingofstafftrainingandcompetence,withsign-off
• Assessmentoftheneedforand,ifnecessary,implementationofstafftrainingandcompetencyassessmentbeforetheintroductionofnewtechnologiesorpractices
• Adocumentedprocedureforstaffappraisal,withannualreviewoftrainingneeds,includingaprocedureformanagersandtheirstafftoreviewcontinuingprofessionaldevelopmentneedsandpersonaldevelopmentplans.
31
• Experiencedindividualsdesignatedtoberesponsiblefordeliveringtrainingandappraisal.
• Clearline-managementofbiobankpersonnel.
• Mechanisminplacetopromotestaffdevelopmentandprogression.
Inthecaseofabiobankstoringsamplesaspartofaclinicaltrial,arestaffrecruitedwithcertifiedGCP-Ltrainingorissuchtrainingprovidedbeforestaffmembersbeginworkwithanytrialmaterial?AreallstaffwhowillworkinthelaboratoryorstoragefacilitywherethetrialsamplesareprocessedorstoredtrainedintheGCP-Lrequirementsspecificforthattrial?IsGCP-Ltrainingrepeatedatleastonceevery2yearsinordertokeepabreastoflatestlegislationrelatingtoclinicaltrials?IstheGCP-Ltrainingandinductioncertifiedandrecordedintheindividual’strainingrecord?Bestpractice:Isabespoketrainingprogrammecreatedforeverymemberofstaffatthetimetheyareappointedanddoesthistrainingprogrammeserveasastructurefortheemployee'strainingthroughouttheirdeploymentinthebiobank?Arebiobankstaffmemberswithaclinicaland/orscientificroleencouragedtoundertakecontinuingprofessionaldevelopment(CPD)?Isstafftrainingmanagedinastructuredway?Istrainingdeliveredbyappropriatelyexperienced,authorisedindividuals?Isthereacorporatesystemofstaffappraisallinkedtopersonaldevelopmentplansandcontinuingprofessionaldevelopment?Istheappraisalsystemdeliveredbysuitablytrainedstaff?Doappraisalmeetingstakeplaceannually,withfollow-upmeetingssixmonthslaterandregularreviews?Isjobprogressionpossibleandencouraged?Areopportunitiesprovidedtomentorjuniormembersofstaffsotheycantakeonnewrolesasandwhenadditional(oftensenior)positionsbecomeavailable?Doesthebiobank,regardlessofinvolvementwithclinicaltrials,providebasicGCP-Ltraining?Areallsamplestreatedasiftheycouldbeusedtoinfluencetrialoutcomemeasures(i.e.withfullaudittrails)?AreallGCP-Ltrainingcoursesusedaccreditedandareonlinecoursesusedonlyasatemporarymeasure?
32
Isfacetofacetrainingcarriedoutassoonaspossibleevenifanonlinecourseiscompleted?
ProfessionalbehaviourArebiobankstaffmemberswhohaveaccesstodonoridentitiesand/ordonoridentifiabledataboundbyaprofessionalcodeofpracticethatincludesstandardsofethicalbehaviour?Dostaffmeettherequirementsoftheirhostinstitution(s)inrespectofholdinghonorarycontracts,orequivalent,governingtheiraccesstopatient-identifiabledata?
Bestpractice:DoPersonspecificationsforrolesthatinvolveaccesstodonoridentitiesand/ordonoridentifiabledataincludearequirementthatthepost-holderisregisteredwithaCouncilforHealthcareRegulatoryExcellence-monitoredregulator(suchastheGeneralMedicalCouncilorHealth&CareProfessionsCouncil)or,forstaffwhoarenoteligibleforregistrationwithastatutoryregulator,withtheVoluntaryRegistrationCounciloranequivalentnon-statutoryregulatorybody?
IndirectlymanagedstaffAretherequirementsofthisstandardappliedtostaffofotherorganisations,suchasahostorganisationoraffiliatedorganisation,iftheycarryoutworkonbehalfofthebiobank?DoesthebiobankensurethatindirectlymanagedstaffmembersareclearabouttheirbiobankrolesasdistinctfromotherNHSorservice/researchrolestheymayhave?Areindirectlymanagedstaffsupervisedbyappropriateperson(s)withinthebiobankforthepartoftheirworktheycarryoutonbehalfofthebiobank?
FacilitiesSuitabilityofpremisesAretheaccommodationandenvironmentwithinwhichthebiobankoperatesadequateandsuitableforitsoperations?Doareasusedforstorageofhumantissueordata,foruseinresearch,provideanenvironmentthatissafeforbiobankstaffandpreservestheintegrityofthetissueanddata?Isthebiobankkeptcleanandtidywithvisibleevidenceofgoodhousekeeping?
Bestpractice:Isthereadocumentedassessmentofthefacilities’“fitnessforpurpose”?Dothefacilitiesallowforthecompletionandstorageofaccompanyingpaperworkandelectronicdata?Isthesuitabilityofthefacilitiesreviewedregularly?
33
AccesstofacilitiesIsthereadocumentedproceduretorestrictaccesstocriticalsystems,equipmentandfacilitiestoauthorisedpersonnelonly?Arevisitorstoareascontainingcriticalsystems,equipmentandfacilitiesaccompaniedbyauthorisedpersonnelatalltimes?Doesthebiobankimplementappropriatesafeguardstopreventunauthorisedaccesstoorremovalofsamplesoraccesstoelectronicdataorpaperrecords?Canthebiobankdemonstratethatsamplesanddataareheldsecurelyinsuchawayastopreventunauthorisedaccessbothduringandoutsidenormalworkinghours?
Bestpractice:Arebankedsamplesandrecordscontainingconfidentialinformationhousedwithinrestrictedareas?Arerestrictedareasopenonlytobiobankstaff,withaccesslimited,forexample,bytheuseofelectronicpasscardsorbylockandkey?Whereitisnotpossibletohouseconfidentialdataorbankedsamplesinanareathatisonlyaccessiblebybiobankstaffmembers,issuchmaterialheldundertwoseparatelockingsystems(e.g.apermanentlylockedcupboardorlockedfreezerlocatedinsidearoomorlaboratorythatisitselflockedwhennoauthorisedpersonnelarepresent)?
EquipmentSelectionandqualificationHasthebiobankimplementedasystematicprocedureforidentifyingcriticalequipmentandensuringthatdocumentaryand/orpracticalevidenceisinplacetoverifythatequipmentadequatelymeetstheneedsofthebiobankand,whereappropriate,equipmentismaintainedandvalidated?
Bestpractice:Isequipmentvalidatedbeforeitisfirstused?
Calibration,maintenanceandservicingHasthebiobankdocumenteditsproceduresandschedulesfortheregularcleaning,maintenance,servicing,qualityassurance,validation,calibrationandmonitoringofequipment?Arerecordsmaintainedofallcleaning,maintenance,servicing,qualityassurance,validation,calibrationandmonitoringofequipment?Hasthebiobankundertakenanassessmentofthecontrolmeasuresnecessarytoreducethelikelihoodoffailuresincriticalequipment?Aretheredocumentedproceduresfordealingwithequipmentfaultsandbreakdowns?Dotheseproceduresincludeanassessmentoftheimpactofthefaultorbreakdownonthesamplesheldbythebiobank?
34
Isdefectiveequipmentremovedfromuseuntilithasbeenrepairedorreplacedand,ifnecessary,re-validated?Arerecordsmaintainedofallequipmentfaultsandbreakdownsandhowtheyareresolved?Bestpractice:Isthereacapitalassetregisterorequipmentdatabasewhichisusedtorecordthecleaning,maintenance,servicing,fault,repairandmonitoringeventsforallcriticalequipment?
TemperaturecontrolledequipmentAreallrefrigeratorsandfreezerslocatedinairconditionedroom(s)withcontrolledroomtemperature?Areallrefrigerators,freezersandliquidnitrogen(LN2)storageunitswithautomaticfillingsystemsconnectedtothe“essential”powersupplycircuitand/orback-upgenerator?Istheeffectivenessofallmonitoringandback-upsystems,suchastheoperationofalarmsandback-upgenerators,testedtoadefinedscheduleandarerecordsmaintainedoftheoutcomeofthistesting?Areallmonitoringandalarmsystemsconnectedtoanuninterruptiblepowersupply(UPS)sothatdataaremaintainedshouldtheusualpowersupplyfail?
AretheredocumentedproceduresforsafehandlingofLN2,includingproceduresformonitoringandrecordingLN2levelsandmanualfillingofunits?AreoxygendepletionalarmsinstalledandmaintainedineveryareawhereLN2unitsarehoused?Istheeffectiveoperationofoxygendepletionalarmstestedtoadefinedscheduleandrecordsmaintainedoftheoutcomeofthistesting?IsLN2-specifichealthandsafetytrainingprovidedtoallstaffworkingwithorinproximitytoLN2?Doesthebiobankhaveaccesstosparerefrigerator,freezerandLN2storagecapacitysothatsamplescanbemovedinanemergency?
35
Bestpractice:Doallmechanicalfreezershavedualcompressors?Areback-uprefrigerators,freezersandLN2unitsfullyvalidatedandmaintainedasoperational,andlabelledappropriately?Doback-upsystemsformechanicalrefrigeratorsandfreezersincludetheuseofdryicetomaintaintemperaturetemporarily?Doesthebiobankhaveacontractorservicelevelagreementforoff-sitestoragewithanapprovedsupplierincaseofdisaster,forexamplebylocalcollaborationstoprovidemutualhostingandback-upfacilities?
RoomtemperaturestorageAreallsamplesstoredatroomtemperatureheldatconstanttemperaturewithindefinedandmonitoredparameters?
Bestpractice:Isthereregularmonitoringoftheseparameterswithlongtermrecordsofanyvariationsexceedingdefinedparameters?
TemperaturemonitoringDoesthebiobankoperateasystematictemperaturemonitoringprocedure,including:
• thedefinitionof"alert"and"action"upperand,ifappropriate,lowertemperaturelimits
• adefinedscheduleoftemperaturemonitoring
• recordingoftemperatures(includingtheabilitytodemonstratethetemperaturerecordedonagivendate,atagiventime)
• anindicationofthemaximumtimeequipmentdoorscanbeopen
• arequirementtomonitortemperaturescloselyfollowinganyalarm
• regularalarmchecks
• thecircumstancesunderwhichsamplesshallberelocatedtoalternativestorageunits?
Hasthebiobankimplementedalocalandremotealarmsystemthatnotifiesappropriateindividualswhentemperaturesgooutsiderequiredlimitsandoperatesatalltimesofthedayandnight?
36
Bestpractice:Istherecontinuousautomatedtemperaturemonitoring?Areremotealarmslinkedtothemobilephoneofdesignatedstaff?Canfridgeandfreezerstatusbemonitoredviaweb?
ProcurementPurchasingDoesthebiobankortheorganisationwithinwhichthebiobankishostedimplementadocumentedprocedureforpurchasingequipment,goodsandservices?Hasthebiobankimplementedasystematicprocedureforidentifyingcriticalfacilities,equipment,goodsandservices?Isalistofapprovedsuppliersofcriticalitemsmaintained?Doesthebiobankensurethatallequipment,goodsandservicesaresuitablefortheirintendedpurposebeforetheyareused?Wheneverequipment,goodsorservicescaninfluencethequalityofthefinalproductdoesthebiobankimplementsystemstoensurethattheseitemsareassessedandapprovedorrejectedpriortotheiruse,andarerecordsoftheseassessmentsmaintainedandusedaspartofaregularreviewofsuppliers?Arethesystemsimplementedproportionaltothedegreeofrisktothequalityofthebiobank’sproducts?
Bestpractice:Doesthebiobankhaveaprocedurewhichensuresthattheimpactofanyequipment,productorserviceonthequalityofthetissueordataisassessedanddocumented?Arerecordsmaintainedofthevalidationofthesuitabilityofthecontainersused?
SubcontractingDoesthebiobankassessthesuitabilityofasubcontractortoprovideservicestothebiobankbeforeanyworkissubcontracted,andmaintainrecordsoftheseassessments?Areservicelevelagreementsestablishedbetweenthebiobankoritshostorganisationandanyorganisationthatprovidesservicestothebiobank?Areservicelevelagreementreviewedatintervalsandmodificationsmade,withmutualconsent,ifneeded?Doesthebiobankscontractoutanyofitslaboratoryservices?Ifso,doesitretainrecordsofthenameandaddressofthecontractedfacility,thenameandcontactinformationforkeypersonnelatthelocationwheretheservicesarebeingprovided,documentationoftheinclusivedatesofthecontractperiodandcopiesofthecontractaswellasanyaccompanyingdocumentation?
37
Arethescopeofwork,roles,responsibilitiesandtimelinesforallcontractedservicesclearlyarticulatedandrecorded?Isariskassessmentproducedandarecordheldthatspecificallyaddressesthenatureofthesamplesundertest?Isconsiderationgiventotheamountofsamplethatwillremaininthebiobankandwhetheritwouldbepossible,ifnecessary,torepeatthetestusingthesamecontractor,anothercontractororin-house?
Bestpractice:Isaconsiderationofothercontractorsandinhouseanalysismadeeachtimesubcontractingisundertaken?Isthereanonustoprovethatriskstosamplesarelessifthespecificsubcontractorisusedthanwouldbethecasewithalternativesandthatthegaintothevalueofthesampleswilloutweighanyrisktothesamples?Hasthesubcontractorbeenauditedbyoronbehalfofthebiobankbeforeanycontractwasplaced?
ConsentandwithdrawalDoesthebiobankseekgenericconsentfortheprospectivecollection,storageandresearchuseofdonatedsamplesanddataordocumentclearlythereasonswhygenericconsentisinappropriate?Doesthebiobankimplementprocessestoensurethatconsentisobtainedinlinewithlegalrequirements,withappropriateinformationanddueprocess?Doesthebiobankmaintainrecordsofdonors’consent,includingidentificationoftheperson(s)seekingconsent?Doesthebiobankensurethat,wherelegallyrequired,arecordofinformedconsentisinplacepriortoacceptingasamplecollectedafter01September2006intothebiobank?Wheresamplesheldwithinadiagnosticarchivearemadeavailableforresearch,doesthediagnosticarchiveholdanyappropriatelicencestostoretissueforresearchpurposes?IntheUK(exceptScotland)aresamplesfromtheliving(anddataaboutthem)thatareheldinthediagnosticarchiveandsurplustodiagnosticrequirements,forwhichspecificconsenthasnotbeensought:
• anonymisedbeforetransferoutofthediagnosticarchive,and
• transferredonlyforuseinresearchthathasappropriateethicalapproval?
Isthereaclear,justifiableanddocumentedpolicyforseekingrenewalofconsentshoulditberequired?Ifthispolicypermitsdonorstobere-contacted,isthepolicymadecleartodonorsatthetimeconsentissoughtandspecific
38
consenttore-contactthedonorshallbesought?Doesthebiobankmaintainaprocedurefordealingwithunsolicitedrequeststodonatetissueanddata?Doesthebiobank’sconsentprocessmakeitcleartodonorsthattheyhavetherighttowithdrawtheirsamplesanddatafromthebiobankatanytime?Arethelimitationsonwithdrawal,intermsofsamplesanddatathathavealreadybeenusedinresearch,madecleartodonors?Bestpractice:Isspecificinformedconsentsoughtforeverysample,wherepracticalandappropriate?Doesacopyoftheinformedconsentrecordaccompanythesampletothebiobank?Doesthebiobankendeavourtointegrategenericconsentforresearchbiobankingintoproceduralconsentprocessesinthebiobank’spartnerhospital(s)?Arebiobankstaffmembersinvolvedintrainingallstaff(biobank,NHSorother)whoseekconsentforbiobanking?Iftherearereasonswhythebiobankcannotacceptunsoliciteddonations,isthepotentialdonorprovidedwithdetailsofotherbiobanksthatmaydoso?Doesthebiobankmakeinformationaboutwithdrawalavailableinanumberofformatsandvisibletodonorsatanumberofpointsintime?Aredonor/laypersonsinvolvedindevelopmentofconsentandwithdrawalinformationandprocedures?Iswithdrawalpossiblebyanumberofdifferentroutestomakeiteasyforthedonortowithdraw?Arerequestsforwithdrawalacknowledgedpromptlyandhandledasamatterofurgency?Aredonorsnotifiedwhentheirsamplesanddatahavebeenremovedfromthebiobank?
TypesofsamplesHasthebiobankdocumenteditspolicywithrespecttocollectionofsamples?Ifresearchand/ordiagnosticsamplesareincludedinthebiobank,isthereappropriategovernanceoftissuetransfersbetweentherelevantresearcherand/orNHSTrust(s)andthebiobank?Aresamplestransferredintothebiobankaccompaniedbydetailedinformationonhowthesampleswerecollected,processedandstoredpriortotransfer?
39
Bestpractice:AretherepracticalandstrategicrelationshipsbetweenbiobankandNHSpathologystaffformutuallybeneficialcontinuousimprovementintissueanddatahandlingfordiagnosticandresearchpurposes?IstherestrategicplanningforsustainabilityandmaintainingdonorconfidenceinthefaceofincreasingprivatesectorinvolvementinprovidingNHSdiagnosticservices?Doesthebiobankhaveaccesstoproceduresusedinresearchand/orNHSpathologydepartmentsfromwhichtheyreceivesamples,andisitnotifiedwhenchangesaremadetotheseprocedures?
SelectionofsamplesforbankingDothebiobank'sproceduresensurethatcollectionofsamplesforresearchdoesnotinterferewithdonordiagnosis,treatmentormonitoring,orotherwisecompromisedonorwelfare?Aretissuesamplesassessedbyapathologistorothersuitablyqualifiedmemberofstafftodeterminetheiradequacyforbothclinicalandresearchrequirementsandtoapprovetheselectionofsurplusmaterialtobeusedinresearch?
LegacysamplesDoesthebiobankhavealegacyplanfortheadoptionorrejectionofinvestigator-ledandorphancollectionsoftissueanddata?Doesthebiobankprovideguidancetoexternalholdersofsuchcollections?Whenbringingsamplesinfromotherexternalcollections,doesthebiobankconsiderhowthesampleswereobtained(includingtheconsentfortheiruseinresearch)?Dotherecordsaccompanyingsuchadoptedsamplesallowarecipienttobeconfidentthatallsampleshavebeencollectedlegallyandethicallyfortheuseintended?Arethesedetailsloggedinaccordancewiththestandardon‘SampleTraceability’?Doestherecipientbiobankholdcopiesoftheprotocols/SOPsusedbytheexternalcollectorandanydeviationsfromthem?
Bestpractice:Isariskassessmentmadeonthelikelihoodthattheintendedprotocolwasfollowedasdescribed?Ifthereisanyreasontosuspectthattheprotocolswerenotfollowed,arethesamplesmarkedaccordingly?Wherenoprotocolsareavailable,doesthebiobankmakeanassessmentastotheusefulnessofbankingthesamples?Wherethereisalackofinformation,areworstcaseassumptionsmadeabouttheextentofconsentifevidenceisnotavailabletothecontrary?Isconsentsought,wheneverpractical,forstorageandresearch
40
useofsamplescollectedpriorto2006(existingholdings)?DoesthebiobankundertakeappropriateQConrepresentativesamplesfromacollectionthatisbeingadopted?IsthenatureandtheresultsofthisQCflaggedforallsamplesfromthatcollection(notjusttheonestested)?Whereconsentformsanddonorinformationsheetsarenotavailableforsamples,aresamplesirreversiblyanonymisedbeforebanking?Doesthisincludeacasebycaseanalysisextractingallrelevantdataforeachdonorthatmayhavebeenloggedbytheoriginalrecipient,evaluatingitspotentialrelevanceandensuringonlydatathatcannotbetrackedbacktothedonorisstoredbythebiobank?Whereconsentformsareavailable,arecopiesofeachcompletedconsentformheldbythereceivingbiobankalongwithdonorinformationsheets,anyethicsapplicationandcopiesofanyethicscommitteeapprovalletters?Aresuchcollectionsalwaysconsideredandclearlyidentifiedasasub-collection?TraceabilityIsthereiscompletetraceabilityoftissueanddata,fromdonortoresearcherand/ordestruction,suchthat:
• Eachsampleandaliquothasauniqueidentifier.
• Samplesarelabelledappropriatelysothatidentificationofthesamplesandtraceabilitytodonors/parentsamplesismaintained.
• Eachsampleisassociatedwithaconsentprocedurethatrecordsthedetailofpermissionsorrestrictionsassociatedwiththeuseofthatsample.
• EachsampleisassociatedwithacollectionSOPand,whererelevant,processingandstorageSOPs.
• Eachsampleisassociatedwithanysignificantevent(suchasafreezerthaw)thatmightimpactonthecharacteristicsofthatsample.
• Itispossibletoidentifythelocationofanysampleatalltimes,includingthosethathavebeendistributedtoresearchersordestroyed.Doesthisincludealiquotsandderivativesofsamplessuchassectionsoftissueandextractsofnucleicacids?
• Thebiobankisabletotrackshipmentsfromdispatchtoreceipt,whetherornotacourierisused
Doesthebiobankmaintainachainofcustodyforthesamplesitholds,maintainingrecordsof:
• thenameandroleofanypersonwhoreceivesor
41
handlesthesamples,
• thedatesandtimesthesampleswereineachindividual’scustody
• thedatesandtimesofkeyeventssuchascollectionfromthedonor,placingintotemporarystorage,dispatchtoand/orreceiptfrompathology/biobank/researcher?
Bestpractice:Arerecordsofvalidationofthesuitabilityofalllabelsmaintained,includingevaluationoftheiradherence/readabilityinadverseconditions?Arebarcodesandautomatedmanagementsystemsused?
CollectionofsamplesDoesthebiobankcollectsamplesunderconditionsandusingcontainersappropriateforeachsampletype?Hasthebiobankdocumenteditscollectionprotocolsanddoesitkeeprecordsofanydeviationsfromtheprotocols?Arecollectionprotocolssubjecttoregularreview?Doesthebiobankmaintainrecordsoffactorsrelatedtocollectionwhentheyareofrelevancetothequalityofthesample?
Bestpractice:Wheneverevidenceisavailable,doesthebiobankuseprotocolsbasedonauthoritativebestpracticeorpublishedresearchfindings?
TransportofsamplesHasthebiobankdocumentedproceduresforthetransportofsamples?Dotheseprocedurescovertransportfromtheatreorclinictolaboratoryorbiobankandfrombiobanktoresearcher?Dotheseproceduresrequireprompt,directtransportofsamplessothatthetimesduringwhichsamplesareintransitarekepttoaminimum?Hasthebiobankevaluatedriskstothestabilityofsamplesanddocumentedtheneedforcontroloftemperature,humidityandlightduringtransport?Istemperature,humidityand/orlightcontrolledifthisevaluationhasshownthatsuchcontrolisneeded?Arerecordsoftemperature,humidityand/orlightduringtransportmaintainediftheyhavebeenshowntoaffectthestabilityofthehumanbiologicalmaterial?Arestaffundertakingpicking,checking,packing,transportingand/orreceivingsamplestrainedaccordingtoadocumented
42
procedure?Isspecialisttrainingprovidedforinternationalshipments?Doesthebiobank’schainofcustodyrecordshowwhopicked,checked,packed,transportedandreceivedsamples?Doesthebiobankcomplywithallregulatoryrequirementsrelevanttothetransportofhumanbiologicalmaterial,forexamplethoserelatingtocontainers,packaging,labellingandshipping?Areallshipmentsaccompaniedbyappropriatedocumentationshowingtheorigin,contentsanddestinationoftheshipment?Doesthisdocumentationincludesenderandrecipientcontactdetails?Doesthebiobankconfirmorrequireconfirmationthatthesamplesreceivedmatchthosedetailedonthedispatchnoteorshippingmanifest?Ifthebiobankusesexternalcouriers,doesthebiobankassesstheabilityofanysuchcouriertomeetitstransportrequirements?Doessuchevaluationcover:
• Contingencyplaninplacebycourierincaseofproblems-especiallywithfrozentissue.
• Abilityofcouriertorenewliquidnitrogen,dryiceoricepacksifthereareunexpecteddelaysintransport.
• Compliancewithnationalandinternationalshippingregulations
• CertificationtoISO9001
Bestpractice:Istimeintransitrecorded?Aresamplescheckedagainstadispatchnoteorshippingmanifestbyasecondpersonpriortodispatch?Aretemperaturedataloggersused?Doshipmentsofcoldorfrozenmaterialhavesufficientandappropriaterefrigeranttomaintaintemperaturethroughouttheshippingcyclewithallowanceforatleasta24-hourdelayinarrivaltime?Doesthenotificationofreceipttakeplacebye-mail,faxortelephoneassoonastheshipmenthasbeenchecked?Areanyproblemsnotifiedatthistimeandnotedinthesenders’records?
ProcessingofsamplesArethereclearlinesofcommunicationbetweenthebiobankandanypathologydepartment,mortuaryorothersubcontractorprocessingsamplesonitsbehalf?Isthepathologydepartment,mortuaryorothersubcontractorrequiredtonotifythebiobankofanychangestoitssample
43
processingprocedures?Isthenumberandsizeofallsamplesandaliquotsrecorded?Ifthenumberandsizetobecollectedisstatedinadocumentedprocedure,areexceptionstothedocumentedrequirementrecorded?Bestpractice:Isalltissuedissectedunderthesupervisionof,orbydocumentedagreementwith,aConsultantHistopathologistorequivalent?Arestaffcarryingoutdissecting,freezing,fixing,embeddingorotherwiseprocessingtissueforbankingtrained,asaminimum,toalevelequivalenttoaBiomedicalScientist?
WarmischaemiaIswarmischaemictime(thetimebetweenarterialclampingandtissueremovalfromthedonor)recordedwheneverthisinformationisrequiredforaspecificresearchproject?
Bestpractice:Doesthebiobankmaintainrecordsofwarmischaemictimeforalltissuesamplesthatitholds?
ColdischaemiaDoesthebiobankhaveproceduresinplacetominimisethecoldischaemictimeofsamples?Doesthebiobanksettargetsforandmaintainrecordsofthetime(s)ofeachofthestepsbetweenremovaloftissuefromthedonorandsubsequenteventssuchasreceiptinpathology,placingonice,snapfreezing,placinginfixative,centrifugationorotherprocessingsteps?
Bestpractice:Doesthebiobankreducethesampletemperature,forexamplebyplacingonice,assoonaspossibleafterremovalfromthedonorandpriortofurtherprocessing?
FrozensamplesAreproceduresforfreezingsamplesdocumented?Arerecordskeptoftheprocedureusedandanydeviationsfromthem?
FixedsamplesIstheprocedureusedforsamplefixationdocumented?Isthefixativeusedandthetimethatthesamplespendsinfixativerecorded?
44
StorageofsamplesDoesthebiobankimplementasystematicprocedureforthepreservationofsamples?Dodocumentedprocedure(s)existforallaspectsofthestorageandprotectionprocess?Areduplicatealiquotsofsamplesstoredinaseparatelocation?Doesthebiobankrecordthestoragelocationofallsamplesandaliquotsinadatabaseandwithback-up?Dorecordsofsampleandaliquotpositioninrefrigeratorsorfreezersshowtheexactlocationinthestorageboxtoensuretheirtimelyretrievalandminimisewarming?Arerecordsmaintainedofdateandtimeofremovalfromstorageand,ifappropriate,returntostorageofsamplesandaliquots?
Bestpractice:Arestorageareasandprocessesdesignedtominimisecontactwithchemicalorbiologicalcontamination,andtoensuremaintenanceofsampleintegrityismaximisedtopermitrepeatorequivalentexamination?Aresuchcontrolsextendedtoareasofpackagingandtransport?IsaLIMSsystemused?
SelectionandreleaseofsamplestoaresearcherorotherclientIstheresearcher/clientinvolvedintheidentificationandselectionofsamplesaccordingtoadocumentedprocedure?Arethereclearlydefinedpathwaysandtimelines,mutuallyagreedbythebiobankandresearcher/client?Doesthebiobankassesstheknownneedsoftheresearcheragainsttheknownqualityofthesamplesheldandensurethatsamplesareallocatedtotheresearcheronlywhentheresearcher'sstatedqualityrequirementsaremet?Isalistofsuitablesamplesgeneratedandsignedbytheresearcher/clientandabiobankrepresentative?AretheseagreedsamplesspecifiedintheMaterialTransferAgreement?Arerelevantsamplehandlingdata,includingnotificationifthesamplehasbeenpreviouslyreleasedfromandreturnedtothebiobank,andanyQCtestresultsmadeavailabletotheresearcher?
Doestheresearcher/clientsubmitinterimprogressreportsduringtheiruseofbiobanksuppliedmaterials?Isamutuallyagreedprocessinplacetoreportthesamplestatusatintervals,includingnumbers,locationandusageoftissuesupplied,orallocatedforsupply,bythebiobank?
45
Isthereanotificationprocesstoinformthebiobankpromptlyatstudyclosure,orintheeventofextensionoftissue-basedresearchsuchasthatassociatedwithclinicaltrials?Istherecordoffinalstudyclosuresignedbytheresearcher/clientandabiobankrepresentative?Doesthebiobankhaveadocumentedpolicyandprocedure(s)forreturnofunusedsamplesfromtheresearcher?Ifthispolicypermitsreturnofsamples,arereturnedsamplesheldinquarantineuntiltheirqualityhasbeenassessedaccordingtodocumentedprocedures?Doesthebiobank’sauditprocedureevaluatecompliancewiththeseproceduresandestablishthattissuehasbeenreturnedwhenappropriate?Bestpractice:Requestsreceived,samplesidentified,samplesissuedandprojectinterimandfinalreportsshouldbereportedatmanagementcommitteemeetings.
QualitycontrolofsamplesDoesthebiobankhaveadocumentedprogrammeandproceduresforthequalityassessmentofallsamplesthatitholds?Doesthebiobankundertakeregularauditsofsamplequality?Hasthebiobankimplementedasystematicprocedureforidentifyinganddocumentingthecriticalqualityattributesofreleasedsamples?Arethecriticalqualityattributesofsamplescommunicatedtotheresearcherusingthesamples?Areinternalqualitycontrolrecordsandexternalqualityassurancerecordsreviewedandusedtoidentifychangesthatwillmaximisethepreservationofsamplequality?
Bestpractice:Doesthebiobankworkcloselywithresearcherstoidentifythekeysamplequalitycriteriafortheintendedresearch?Ismorphologicalassessmentperformedoneverysolidtissuesamplepriortodispatch.Doesthebiobankassessandrecordthe%diseased/normal/necrotictissueineachofthesamplesthatitholdsbeforeprovidingittoaresearcher?Doesthebiobankperformqualityassessment(quantityandquality)ofDNAandRNAsamples?
46
ProficiencytestingDoesthebiobankparticipateinrelevantexternalqualityassurance/proficiencytestingsuchasthoseprovidedbyUKNEQASorequivalent?Doesthebiobankdocumentitsparticipationinanyexternalqualityassurance/proficiencytestingschemes,includingtheproceduresforreviewandcommunicationofresultsarisingfromsuchparticipation?Doesthisprocedureincludetherequirementtoinvestigateallanomalousresultsandundertakecorrectiveandpreventiveactionswhennecessary?Ifanotherlaboratoryperformsrelevantproceduresonbehalfofthebiobank,dotheserequirementsapplyfullytothatlaboratory?
TissueanddatadisposalDoesthebiobankhaveadocumenteddisposalpolicywhichsetswhenandhowtissueanddatawillbedisposedof?IstissuedisposalcarriedoutinaccordancewithHTArequirementsandinlightofdonors’wishes?
GovernanceofdonorandsampledataConfidentialityIsthereadocumentedprocedureformaintainingdonorconfidentialitywhichincludesarobustsystemofsampleanonymisationorpseudonymisationanddataprotection?Areappropriatesecuritymeasurestakenwheneverdataistransferredbetweensystemsorindividuals?
Bestpractice:IsanylinkagebetweendonoridentitiesanddonorpseudonymsinlinkedanonymisationsystemsmaintainedinasecuredatabaseheldonaserverbehindtheNHS,hostinstitutionorotherfirewall?Arepaperrecordsheldinasecure,lockedcabinetandisaccesslimitedtonamedindividuals?
DataDoesthebiobankensurethatthedesignandoperationofitsdatabase(s)complywithCaldicottprinciplesandrecommendations?DoesthebiobankhaveHealthResearchAuthority(section251)approval,ifappropriate,tocoveritsdatahandlingactivities?Doesthebiobankhaveaccesstoacopyofanydiagnosticpathologyreportforallofthesolidandcytologytissuesamplesthatitholds?Ifthepathologyreportallowsthedonortobeidentified,doesthedonorconsentprocessensurethatthedonorisawareofthisrequirementandgivespermissionforthebiobanktoholdthisidentifiabledata?DoesthebiobankholdallofthedatarequiredbytheCCB’sData
47
Standard?Arethoseparametersthatareunknownorunavailablemarkedassuch?Bestpractice:Doesthebiobankcollectallofthedataspecifiedinthe“required”and“bestpractice”sectionsoftheCCB’sDataStandard,allowingforgreaterinformationtobemadeavailabletotheresearcher?
DataprotectionDoesthebiobankimplementadocumentedprocedureforassessingdocumentsforcompliancewiththeUKDataProtectionActsbeforetheyareissued?AreallbiobankdocumentsrelatingtodataprotectionreviewedforcompliancewiththeUKDataProtectionActsbyasuitablyqualifiedperson?
Bestpractice:Arealllegallybindingdocumentsreferredtoacorporatelegalcomplianceteamforreviewbeforeissue?
DatasecurityDoesthebiobankimplementadocumentedprocedureforcontrollingaccesstobiobankdatasothatdataisrestrictedtoapprovedpersonnel?Doesthebiobankmanagedatainsuchawaythatitissecurefromlossorcorruptionatalltimes,includingduringtransferintooroutofthebiobank?Doesthedatamanagementsystemspecifyarobustprocessforbacking-upliveelectronicdata?Isdataencryptedbeforeitiswrittentoanyportableelectronicdevicesuchasadiscormemorystick?
Bestpractice:Doesthedatamanagementsystemincorporatedailybackingupofthelivedataarrayinsuchawayastoallowtheentiredataarraytoberecreatedelsewhereintheeventofacatastrophicfailureresultinginlossorcorruptionofthelivedataarray?Arefail-safesystemsimplemented?Areoff-siteorotherwiseremotesecureserversanddatastorageusedforback-up?Areadequateelectronicsecuritymeasuresimplementedtomitigateriskofhackersgainingaccesstoservers(e.g.encryptionofdata)?Arepaperdocumentsstoredinfire-proofcabinetsand/orroomsequippedwithsprinklersystemsoraninertgassystem?
48
DataqualityDoesthebiobankdocumentandregularlyreviewitsprocedure(s)forassuringthequalityofthedataitholds?
Bestpractice:Forelectronicdata:
• Isanindustrystandarddatabasepackageused(i.eSQLServer,OracleorAccess)?
• Aredefaultcodesusedonlywhereappropriate,andnotasasubstituteforrealdata?
• Ifitisnecessarytobypassadataitem,isthemissingdataflaggedforimmediatefollowup?
• Aresystemsprogrammedtoonlyacceptvalidentries?
• Areregularspotchecks,auditsandcomparisonsbetweensystemsusedtoidentifymissingdata?
• Iseveryopportunitytakentocheckdataatsource?
• Arealltablesupdatedregularly?
• Arealldatarecordedandprocessedinaccordancewithsetdeadlines?
• Areerrorsidentifiedandcorrectedasclosetopointofentryaspossible?
ReturnofresearchdatatothebiobankDoesthebiobankhaveajustifiedpolicyforthereturnofresearchdatatothebiobankandisthispolicyclearlycommunicatedtoanyresearcher?Doesthebiobankrequirethatitisgivencitationdetailsforanypublicationsarisingfromuseofsamplesordataithasprovided?Iftheresearchisfundedfrompublicmoney,doesthepolicyindicatetheneedforresearchdatatobereturnedforfuturepublicbenefit?Ifthepolicyincludesarequirementtoreturnresearchresultstothebiobank,doesitincludedetailsofcircumstancesinwhichthismightbewaived?Ifthereturnofresearchresultsisrequired,isthisrequirementincluded,withadefinedtimescaleforreturnofpost-studyresults,inanyMTA?
Bestpractice:Doesthebiobankrequirealldatatobereturnedforfutureuseandenforcecompliance?Doesthebiobankissueremindersannuallytorecipients,requestinganupdateontheiruseofthetissueand/ordata,anypublicationsderivedandacopyofanyderiveddata?
49
END
Doesthebiobankholdthesedatainconfidenceforanagreedperiodpriortomakingthemavailableforuseinfurtherresearch?
