HumanTissueAuthority

Codeofpractice4 Anatomicalexamination
September2009

Paragraphs 1-12 13-14

Content
Introduction Scopeofthiscode Statusofthiscode Providinginformationtopotentialdonors Obtainingappropriateconsent Licensing Existinganatomicalspecimens Documentationandrecordkeeping Careofcadavericmaterial Transferorloanofcadavericmaterial Importandexportofbodiesorbodyparts Theuseofimages Charging Glossary HTAstandards References

Paragraphs 1-12 13-14 15 16-17 18-26 27 28-29 30-32 54 55-60 61-63 64-66 67

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Introduction
ThelegislationandtheHumanTissueAuthority
1.TheHumanTissueAct2004(HTAct)www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1coversEngland,WalesandNorthern Ireland.TheHTActestablishedtheHumanTissueAuthority(HTA)toregulateactivitiesconcerningtheremoval,storage,useanddisposalof humantissue.ThereisseparatelegislationinScotlandtheHumanTissue(Scotland)Act2006 www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_1. 2.TheHumanTissue(QualityandSafetyforHumanApplication)Regulations2007(Q&SRegulations) www.opsi.gov.uk/si/si2007/uksi_20071523_en_1implementtheEuropeanUnionTissueandCellsDirectives(EUTCD).TheHTAisa CompetentAuthorityintheUKundertheQ&SRegulations,whichcoverthewholeoftheUK,includingScotland. 3.TheHTAsremitinScotlandisdescribedintheScottishHealthDepartmentletterissuedon20July2006(Ref:NHSHDL(2006)46) http://www.hta.gov.uk/_db/_documents/Information_about_HT_%28Scotland%29_Act.pdfandtherelevantcodesofpractice.Relevant guidancefromWalesandNorthernIrelandisreferencedthroughoutthecodes.

Aboutthecodesofpractice
4.ThecodesofpracticegivepracticalguidancetoprofessionalscarryingoutactivitieswhichliewithintheHTAsremit.Theymayalsobeof interesttomembersofthepublic.Thefirsteditionsofthecodeshavebeenrevisedtoreflectourexperienceofregulation.Wehavemade thecodesmorerelevanttothesectorsweregulatebyincludingcasestudiesandexamples;andhaverestructuredtheminawaythatmakes themmoreuser-friendly. 5.Thecodesaresupplementedbyothermoredetailedguidance,forexampleonlicensingstandards,whichcanbefoundontheHTAs website. 6.TheHTAhasnowpublishedninecodesofpractice,whicharelistedbelow:www.hta.gov.uk/guidance/codes_of_practice.cfm 1. Consent 2. Donationofsolidorgansfortransplantation 3. Post-mortemexamination 4. Anatomicalexamination 5. Disposalofhumantissue 6. Donationofallogeneicbonemarrowandperipheralbloodstemcellsfortransplantation 7. Publicdisplay 8. Importandexportofhumanbodies,bodypartsandtissue 9. Research 7.AllninecodesofpracticehavebeenbroughtintoforcebyHTADirections www.hta.gov.uk/guidance/licensing_guidance/expected_standards.cfm.

Usingthecodes
8.Inthesecodes,thewordmust referstoanoverridingdutyorprinciple,includingallspecificlegalrequirementsderivedfromprimaryand secondarylegislationforexample,therequirementtoholdalicencetostorehumantissueforascheduledpurpose. 9.Weusethewordshouldwhenexplaininghowtomeetthespecificlegalrequirements.Establishmentsareexpectedtofollowtheguidance inthecodes.ObservanceoftheguidanceinthecodesisoneofthewaysinwhichtheHTAassessesthatestablishmentsarecomplyingwith relevantlegislation.FailuretofollowacodeofpracticeisnotinitselfacriminaloffenceundertheHTActbuttheHTAwillcarefullyconsider anybreachofacodeofpracticeandmaytakeappropriateregulatoryaction. 10.Thecodescomplementeachotherandshouldbereadalongsideotherrelevantadviceandguidance,whichiseitherreferencedinthe textorprovidedontheHTAswebsite.Aglossarywithtermsspecifictoeachcodeisavailableattheendofeachdocument,andafulllistof glossarytermsisontheHTAswebsite. 11.YoucandownloadandprintcopiesofthecodesfromtheHTAswebsitewww.hta.gov.uk/guidance/codes_of_practice.cfm.

Otheradviceandguidance
12.AnumberofotherorganisationshavealsoproducedguidanceonissuesintheHTAsremit.Wherethishasbeenproducedincollaboration

withtheHTA,itwillappearonourwebsite.ProfessionalguidelineshavebeendrawnupbytheProfessionalGuidelinesandPractices (Anatomy)Committeeandareavailableonthewebsitesofthreeprofessionalbodieswhichcomprisethecommittee,namely:Anatomical SocietyofGreatBritainandIreland(ASGBI), www.anatsoc.org.uk,BritishAssociationofClinicalAnatomists(BACA) www.liv.ac.uk/HumanAnatomy/phd/baca/andInstituteofAnatomicalSciences(IAS)www.anatomical-sciences.org.uk.TheHTAscodesof practiceandotherguidanceshould,however,beusedasthedefinitivesourceofinformationforissueswithinourremit.Ifyouareinany doubt,pleasecontacttheHTAorseekyourownlegaladvice.Regulatedsectorsshouldalsokeepuptodatewithotherrelevantlegislation.

Scopeofthiscode
13.TheHTActpermits,withconsent,thedonationofwholebodiesforanatomicalexamination.Italsoallowsforthestorageandanatomical examinationofabody,providedthatitiscarriedoutby,orunder,thedirectionofaDesignatedIndividual(DI),withconsent,andproviding thatthedeathhasbeenproperlycertifiedandregistered. 14.Thiscodeprovidesguidanceforpeopleworkingintheanatomysectorandsetsoutthestandardsthatestablishmentsmustmeetinorder toholdalicencetocarryoutanatomicalexaminationsortostoreanatomicalspecimens.

Statusofthiscode
15.AnatomicalexaminationfallswithintheHTAsstatutoryremit.ThiscodeonAnatomicalexaminationreplacesthepreviouscodeofpractice. InaccordancewithSection29oftheHTAct,ithasbeenapprovedbytheSecretaryofStatefollowingconsultationwiththeWelshAssembly GovernmentandtherelevantNorthernIrelanddepartment,andithasreceivedParliamentaryapproval.

Providinginformationtopotentialdonors

16.Itisimportantthatapersonwishingtodonatetheirbodyforanatomicalexaminationisgivenalltheinformationnecessarytomakean informeddecision.Thisinformationshouldbemadeavailableinavarietyofformats(electronic,writtenororal)sothatdonorsmaychoose whichismostappropriateforthem.InformationisalsoprovidedforpotentialdonorsontheHTAswebsite www.hta.gov.uk/about_hta/donating_a_bo www.hta.gov.uk/about_hta/donating_a_body_to_medical_science.cfm . 17.TheHTAhasproducedamodelbequeathalbookletandamodelbodydonationconsentformtoaidanatomyestablishments www.hta.gov.uk/about_hta/donating_a_body_to_medical_science/anatomy_schools.cfm.

Obtainingappropriateconsent
18.UndertheHTAct,appropriateconsentforanatomicalexaminationcanonlybegivenbyindividualswhochoosetodonatetheirbody; consentcannotbegivenbysomeoneelse. 19.ForconsentforbodydonationtobevalidundertheHTAct,itmustbeinwritingand: signedbythedonorinthepresenceofatleastonewitnesswhoatteststheirsignature;or

signedbyarepresentativeatthedirectionofthedonor,intheirpresenceandinthepresenceofatleastonewitnesswhoatteststhe representativessignature.TheHTAacceptsthatitmaynotalwaysbepossibletoobtainwrittenconsentfromtheindividualwhohas chosentodonatetheirbodyorpartoftheirbodyforanatomicalexamination,forexamplewhenapersonwithsufficientmentalcapacity isphysicallyunabletowrite.TheHTAhasthereforeproducedamodelformforarepresentativetosignonbehalfofadonor www.hta.gov.uk/abo www.hta.gov.uk/about_hta/donating_a_body_to_medical_science/anatomy_schools.cfm .Inthesecircumstances,theHTAadvisesthat: thepotentialdonorhassufficientmentalcapacitytomakethedecisiontodonatetheirbodyforanatomicalexaminationand isabletoindicatetheirwishverballyorphysically therepresentativeshouldsigntheirownname,statethattheyhavesignedatthedirectionofthedonorandexplainthe circumstancesofthisdirection theformshouldthenbesignedbyathirdpartybeforebeingsubmittedtothereceivinginstitution

Thisproceduremustoccurpriortothedonorsdeath.Theconsentformcannotbesignedbythethirdpartyafterdeathhasoccurred. Example:Awidowerhadastrokethatlefthimunabletocommunicateinanyform,includinginwriting.Manyyearsago,whenhewas well,heexpressedaninterestindonatinghisbodyformedicalteachingafterhisdeathbutdidnottakethematterfurther.Nowthe manisdyingandhisdaughterwantsherfatherswishestobecompliedwith.Giventhelackofdocumentedconsentandtheinabilityto assessmentalcapacity,thereisnowaytoconfirmthatthemanwishestodonatehisbodyforanatomicalexamination.Therefore,the offerofdonationmustbedeclinedbythelocalmedicalschool. 20.Documentedandvalidconsentforanatomicalexaminationgivenbefore1September2006istreatedasappropriateconsentundertheHT Act. 21.UndertheHTAct,appropriateconsentisnotneededforremoval,storageanduseofmaterialfromadeceasedbodyforanatomical examination,ifmorethan100yearshaveelapsedsincethedateofthepersonsdeath.Appropriateconsentisalsonotneededifthebody hasbeenimported.Theimportandexportofbodiesorbodypartsisdiscussedinparagraphs6163ofthiscode.

22.Anyonewishingtodonatetheirbody,orpartoftheirbody,foranatomicalexaminationshouldpreferablyuseaconsentform,which shouldbekeptaspartofthedonationrecords.TheHTAhasproducedamodelbodydonationconsentform www.hta.gov.uk/about_hta/donating_a_b www.hta.gov.uk/about_hta/donating_a_body_to_medical_science/anatomy_schools.cfm . 23.Individualsmayindicatetheirchoicetodonatetheirbodiesforanatomicalexaminationintheirwill.Inthiscase,anindividualshouldbe encouragedtofillinaconsentformfromtheirnearestmedicalschoolandtoinsertacopyintheirwill.Thebodydonorshouldbemadeaware that,althoughaconsentformdoesnothavetobeusedintheirwill,thewordingoftheirconsentshouldresemblethewordingonthe consentformprovidedbytheestablishmenttowhichtheywishtodonatetheirbody. 24.UndertheHTAct,theprovisionsforlawfulstorageofabodyforthepurposeofanatomicalexaminationaredifferentfromtheprovisions forlawfuluseofabodyforanatomicalexamination.Legislativechangestocertificationorregistrationofdeathmayamendtheseprovisionsin thefuture. 25.Storingabodyforanatomicalexaminationislawfulprovidedthat: thereisappropriateconsent;and thereisasignedMedicalCertificateofCauseofDeathundertheBirthsandDeathsRegistrationAct1953orinthecaseofNorthern IrelandtheBirthsandDeathsRegistration(NI)Order1976. Thisallowsestablishmentstoproceedtostorageandtimelypreservationofabodydonatedforanatomicalexamination,ifregistrationof deathhasbeendelayed. 26.Usingabodyforanatomicalexaminationislawfulprovidedthat: thereisappropriateconsent;and

thepersonsdeathhasbeenregistered.

Licensing
27.DetailedguidanceaboutthelicensingframeworkisoutlinedintheHTAGuidetolicensingforDesignatedIndividualsandLicenceHolders www.hta.gov.uk/licensing/designated_individuals_and_licence_holders/dls_under_the_ht_act.cfm.

Existinganatomicalspecimens
28.UndertheAnatomyAct1984,anatomicalspecimenscouldonlybeusedforanatomicalexaminationduringaperiodofthreeyearsfrom thedateofthepersonsdeath.TheHTActprovidesforsituationswherematerialdonatedundertheAnatomyAct1984wasbeingheldby anatomyestablishmentsatthetimetheconsentprovisionsoftheHTActcameintoforceon1September2006. 29.InrelationtodonationsmadeundertheAnatomyAct1984bypeoplewhodiedbetween1September2003and31August2006,theHT Actstatesthat: ifanatomicalexaminationhadnotbeencompletedby1September2006,theauthoritygivenundertheAnatomyAct1984for anatomicalexaminationcanbetreatedasappropriateconsentforstorageanduseforanatomicalexaminationundertheHTActfor threeyearsfromthedateofapersonsdeathoruntiltheanatomicalexaminationiscompleted,whateveristheshorterperiod;and ifanatomicalexaminationiscompletedafter1September2006butwithinthreeyearsofthepersonsdeath,authoritygivenunderthe AnatomyAct1984toretainbodypartscanbetreatedasappropriateconsentundertheHTActfortheirstorageoruseforresearchor educationortraining.

Documentationandrecordkeeping
30.Allplaceswhereanatomicalexaminationiscarriedoutshouldkeeprecordsinapermanentformforeachbodyorbodypartintheir possession(orinthepossessionofanyotherpersonauthorisedbytheDItoholdtheanatomicalspecimen).Theserecordsshouldbeheldon thepremiseswherethedonatedbodywasfirstreceived,andonanyotherpremisestowhichthebodyorbodypartshavebeenmoved. 31.Recordsrelatingtobodypartsretainedafteranatomicalexaminationshavebeenconcludedshouldbeheldonthepremisesinwhichthe examinationoftheoriginalanatomicalspecimentookplace,andonanyotherpremisestowhichthepartshavebeenmoved. 32.Allrecordsmustbeavailableforinspectionandreview.

Careofcadavericmaterial
54.Duringanatomicalexaminationandstorage,allpartsofthebodyshouldbetreatedwithduerespectandconsideration. Example:Auniversityanatomyestablishmentprovidesteachingtohundredsofhealthcarestudentseachyear,someofwhomattend fromotheruniversities.TheDIisconcernedthatthereisariskthatthedignityofdeceasedpeoplemaynotalwaysbeupheld.She acknowledgesthatphysicalsupervisionofallstudentsatalltimeswouldbeimpossiblebutwantstoputsafeguardsinplacetoavoidthe riskofoccurrenceofsuchanevent.Afterthoroughdiscussionswiththeestablishmentsstaff,theDIputsanumberofnewsafeguards inplace,including: areviewofthesecurityofthepremises aregistrationsystem,utilisingasigning-inbooksothattheDIandotherpersonsworkingunderanHTAlicenceareawareofwhoisin theestablishmentatanygiventime.Thereasonforthevisitshouldberecordedinthesigning-inbook,alongwiththenameofthe personunderwhosesupervisionthevisitorwillbe revisingthelocalcodeofconducttoreflecttherequirementsoftheHTActandtheHTAcodeofpracticeonAnatomicalexamination adeclarationtobesignedbyallrelevantvisitorstoconfirmthattheyhavereadandunderstoodthelocalcodeofconduct prominentsignsrelatingtoimportantaspectsofthelocalcodeofconduct

Transferorloanofcadavericmaterial
55.Bodiesorbodypartsmustbekeptonlicensedpremises,unlesstheDIhasgivenwrittenpermissiontoasuitablenominatedpersonto movethemtoappropriateunlicensedpremises,andtostoreandusethemforauthorisedpurposes. 56.Bodiesorbodypartsmayonlybetransferredorloanedforpurposesforwhichconsentwasoriginallygiven. 57.AnatomicalspecimensorformeranatomicalspecimensmaybeloanedbyaDI,providingthattheyputthepermissionforeachloanin writing.Theloanshouldbeforadefinedtimeperiodandthewrittenagreementshouldbesignedandacopykeptbybothparties. 58.Recordsshouldbekeptofanyloans,includingrelevantdetailsof: thespecimen/scoveredbytheagreement thepersonauthorisedtoholdthespecimen/s theaddresswherethespecimen/swillbeheld thepurposeforwhichthespecimen/sis/arebeingmoved thepurposeforwhichtheauthorisedpersonmayhavepossessionofthespecimen/s theperiodforwhichtheloanissoauthorised 59.TheHTAhasproducedamodelauthorisationformforloanofanatomicalspecimens www.hta.gov.uk/about_hta/donating_a_body_to_medical_science/anatomy_schools.cfm. 60.TheDIremainsresponsibleforthematerialforthedurationoftheloan.TheHTAadvisesthattheborroweragreestocomplywiththe HTActandcodeofpracticeonAnatomicalexaminationandthatstorageisappropriate. Example:Alecturerinauniversityphysiotherapydepartmentwishestoteachhisundergraduatestudentsontheanatomyofthe vertebralcolumn.Ratherthanusingplasticteachingmodels,hewishestoteachasmalltutorialgroupusingaprosectedspecimen.The teachingsessionwillbeonecomponentofaspecialstudydayforhealthcarestudentsbeingheldatadifferentuniversitycampus,which doesnotholdarelevantHTAlicence.ThelecturerarrangesameetingwiththeDIoftheanatomyestablishmenttodiscusswhetheran appropriatespecimencouldbeloanedforthispurpose.TheDIiskeentohelpandisawarethattheHTActallowsforthepossessionof anatomicalspecimensandformeranatomicalspecimensawayfromlicensedpremises.BothpartiesrefertotheHTAscodeofpractice onAnatomicalexaminationandawrittenloanagreementiscreatedfromtheHTAsmodelloanform.Theloanagreementissignedby bothpartiesandeachpartykeepsacopyasarecordoftheloan.

Importandexportofbodiesorbodyparts
61.BodiesandbodypartsareimportedintoEngland,WalesandNorthernIrelandforuseineducationortrainingrelatingtohumanhealthor foranatomicalexamination.TheimportandexportofrelevantmaterialisnotlicensableundertheHTAct.However,thestorageanduseof bodiesorbodypartsforeducationortrainingrelatingtohumanhealthorforanatomicalexaminationislicensable. 62.Importedmaterialshouldbeobtained,used,handled,stored,transportedanddisposedinaccordancewiththeconsentgivenbythe personfromwhomitcame.ImportersshouldsatisfythemselvesandbeabletodemonstratetotheHTAthat,inthecountriesfromwhichthey seektoimporttissue,theseekingofconsentforthepurposetowhichthetissueissubsequentlyputispartoftheprocessbywhichthe materialisobtained. 63.TheimportandexportofrelevantmaterialisdiscussedindetailinthecodeofpracticeonImportandexportofhumanbodies,body partsandtissue .

Theuseofimages
64.Themakinganddisplayingofimages(includingphotographs,filmsandelectronicimages)fallsoutsidethescopeoftheHTAct.However, theHTArequiresDIstoputsystemsinplacetoensuresuitablepracticesarecarriedout. 65.TheHTAendorsestheguidanceonimagesprovidedbytheGeneralMedicalCouncil(GMC)initspublicationMakingandusingvisualand audiorecordingsofpatientshttp://www.gmc-uk.org/guidance/current/library/making_audiovisual.asp. 66.EnsuringsuitablepracticeswherelicensableactivitiesareconcernedincludestheDIensuringthatthedignityofdeceasedpeopleis maintainedatalltimes.Therefore,DIsneedtoputinplacesystemstopreventtheinappropriateuseofimages.

Charging
67.Chargesmaybeappliedtocoverthecostsoftransportingandembalmingbodiesandofpreparingretainedpartsforuseatother establishments.Thesechargesshouldfairlyreflectthecostsinvolved.

Glossary
Anatomicalexamination: Examinationbydissectionforthepurposeofteaching,studyingorconductingresearchintothestructureofthe humanbody. Anatomicalspecimen:Thebodyofadeceasedperson,includingseparatedpartsofsuchabody,tobeusedforthepurposeofanatomical examination. Appropriateconsent: DefinedintheHTActbyreferencetothepersonwhomaygiveconsent.Thisisbroadlyeithertheconsentofthe personconcerned,theirnominatedrepresentativeor(intheabsenceofeitherofthese)thatofapersoninaqualifyingrelationshiptothem immediatelybeforetheydied. Cadaver:Thebodyofadeceasedperson. DesignatedIndividual(DI): Theindividualdesignatedonthelicencetosupervisethelicensableactivitiescarriedout.DIsaretrainedby theHTAtocarryoutthisimportantroleandtheyhavestatutoryresponsibilitiestheymustfulfil. Donation:Theactofdonatinghumantissue,cells,organsorpartorgansforascheduledpurposeeitherduringlifeorafterdeath. Donor:Everyhumansource,whetherlivingordeceased,oftissue,cells,organsorpartorgans. Formeranatomicalspecimen: Anorganorbodypartdonatedforanatomicalexaminationwhichisretainedoncetheexaminationofthe restofthebodyhasbeencompleted. Licensing: AnumberofactivitiescanonlybecarriedoutwheretheestablishmentislicensedundertheHTActbytheHTA.Organisations whoseactivitiesinvolvetheremoval,storageoruseofrelevantmaterialmayneedtoworkunderanHTAlicence.Allestablishmentsworking underanHTAlicencemustworktospecifiedstandardssetbytheHTA. Licensedpremises: Wherethelicensedactivitytakesplace.Ifthelicensedactivitywilltakeplaceatmorethanoneplace,aseparatelicence willneedtobeissuedforeachplace.Premisesindifferentstreetsorwithdifferentpostalcodeswillbeconsideredasbeingindifferentplaces. Incontrast,differentbuildingsonahospitalsitecouldberegardedasthesameplace. Relevantmaterial:DefinedbytheHTActasmaterialotherthangametes,whichconsistsoforincludeshumancells.IntheHTAct, referencestorelevantmaterialfromahumanbodydonotinclude:(a)embryosoutsidethehumanbody,or(b)hairandnailfromthebodyof alivingperson.SeepolicyguidanceonhowtoapplythisdefinitionontheHTAswebsite www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm. Scheduledpurposes:UndertheprovisionoftheHTActconsentmustbeobtainedtoremove,storeorusebodiesorrelevantmaterialfor scheduledpurposes.Thepurposesaredividedinto2parts: Part1:Purposesrequiringconsent:Generalanatomicalexamination;determiningthecauseofdeath;establishingafterapersonsdeaththe efficacyofanydrugorothertreatmentadministeredtohim;obtainingscientificormedicalinformationaboutalivingordeceasedperson whichmayberelevanttoanyotherperson(includingafutureperson);publicdisplay;researchinconnectionwithdisorders;orthe functioning;ofthehumanbody,transplantation. Part2:Purposesrequiringconsent:Deceasedpersonsclinicalaudit,educationortrainingrelatingtohumanhealth,performance assessment,publichealthmonitoring,qualityassurance. Tissue:Anyandallconstituentpart/softhehumanbodyformedbycells. Validconsent:Consentwhichhasbeengivenvoluntarily,byanappropriatelyinformedpersonwhohasthecapacitytoagreetotheactivity inquestion.

HTAstandards
33.TheHTAhasdevelopedanumberofstandards,withwhichestablishmentsmustcomply.Thesestandardsweredevelopedinconsultation withrepresentativesoftheanatomysector.TheyreinforcetheintentionoftheHTActthatconsentisparamountforactivitiesinvolvingthe useofhumantissue;thatdeadbodies,andtissuetakenfromthem,shouldbetreatedwithrespect;andthatthedignityoftheperson maintainedatalltimes. 34.TheHTAstandardsaregroupedundertheheadings:Consent(C);Governanceandqualitysystems(GQS);Premises,facilitiesand equipment(PFE);andDisposal(D). 35.ThefollowingsectionsgiveguidanceonHTAlicensingstandards.Specificguidanceonconsentisgiveninparagraphs1826ofthiscode.

Governanceandqualitysystems
36.TheGQSstandardsfocusoninternalsystemsandprocessesthatareinplacetosupportstaffinthedeliveryofhighqualityservices. 37.Aspartoftheoverallgovernanceprocess,theHTArequiresthatallaspectsofanestablishmentsworkaresupportedbyratified, documentedpoliciesandprocedures.Documentsshouldberatifiedbyaprocessinvolvingmorethanonepersonandbesubjecttoscheduled review. 38.Astandardoperatingprocedure(SOP)shouldbeaclearandaccuraterepresentationofanexistingprocedureorprocess,preferablyset outintheformatofastepwiseguide.SOPsshouldbeunderstandabletoenablenewstafftofollowaprocedurefrombeginningtoend.They shouldbedetailedenoughtoensureuniformitybetweenstaffintheperformanceofaspecificfunctionandshouldbefollowedtotheletterby allstaffwhohavebeenappropriatelytrained. 39.Meetingsrelatingtolicensableactivitiesshouldbesupportedbyanagendaandminutes,andestablishmentsshouldhaveasystemfor dealingwithcomplaintsfromthepublicandotherusers. 40.TheHTArequiresestablishmentstohaveadocumentedqualitymanagementsysteminplace.Thisdoesnotneedtobeelectronic, however,itshouldincludeadocumentcontrolsystem,coveringalldocumentedpoliciesandprocedures. 41.TheHTArequiresDIstoensurethatallstaffworkingundertheauthorityofanHTAlicenceareappropriatelyqualifiedandtrainedin techniquesrelevanttotheirworkandarecontinuouslyupdatingtheirskills.Stafftrainingrecordsshouldshowqualifications,coursesattended, evidenceofattendanceatinductionandorientationtraining,evidenceofrecurrentappraisalandapersonaldevelopmentplan. 42.TheHTArequiresestablishmentstohaveasystematicandplannedapproachtothemanagementofrecords,includingdocumented proceduresforthecreation,amendment,retentionanddestructionofrecords.Recordcontentshouldbeauditedregularlytoensure completeness,accuracyandlegibility.Computerisedrecordsshouldbebackedupandasystemfordatarecoveryshouldbeinplace.Data protectionandconfidentialityshouldbekeycomponentsoftherecordssystem. 43.TheHTArequiresestablishmentstouseacodingandrecordssystemthatfacilitatesthetraceabilityofbodiesandseparatedparts, ensuringarobustaudittrail. 44.TheHTArequiresthatestablishmentshavesystemsinplacetoensurethatalladverseeventsareinvestigatedproperly,andcorrective andpreventativeactionsaretakenwhennecessary,toensurethatimprovementsinpracticearemade. 45.TheHTAencouragesestablishmentstoadviseitofseriousincidentswhichadverselyaffectcompliancewiththeHTActandthiscodeof practice. 46.TheHTArequiresthatdocumentedriskassessmentsofestablishmentspracticesandprocessesarecompletedregularlyandaresubject toscheduledreview.Staffmembersshouldbeabletoaccesstheriskassessmentsrelevanttotheirworkandbemadeawareoflocalhazards.

Premises,facilitiesandequipment
47.TheHTArequiresthatpremisesaresecureandappropriateforthepurposeforwhichtheyareused.Thismeansthatariskassessment shouldhavebeenundertakenandthattherearepoliciesinplacetoreviewandmaintainthesafetyofstaff,authorisedvisitorsandstudents. Policiestoensurethatthepremisesaremaintainedtoastandardthatensuresthedignityofthedeceasedshouldbeinplace,asshould policiestoensurethatconfidentialityismaintained. 48.DIsshouldensurethatsuitableenvironmentalcontrolsareinplacetoavoidpotentialcontamination.Documentedcleaningand decontaminationproceduresshouldbeinplaceandstaffshouldbeprovidedwithappropriatepersonalprotectiveequipment.Airqualityand safeenvironmentalconditionsshouldbesuitablymaintainedandappropriatelymonitored. 49.TheHTArequiresthatestablishmentshaveappropriatefacilitiesforthestorageofcadavericmaterial,consumablesandrecords;including arequirementthatprecautionsaretakentominimisedamageortheft. 50.TheDIisresponsibleforthebodyandbodypartsofthedeceasedfromthetimeofdonationuntiltheburial,cremation,disposalorreturn tothefamily.TheHTArequirestheDItoputinplacedocumentedpoliciesandproceduresforthetransportofcadavericmaterial,includinga riskassessment.Fulltraceabilityshouldbeensuredduringtransportation;recordsoftransportationanddeliveryshouldbekept.Records

shouldalsobekeptofanytransferagreementswithrecipientsofrelevantmaterialandofanywrittenagreementswithcouriersortransport providers. 51.Equipmentshouldbeappropriateforuseanddocumentedcontingencyarrangementsshouldbeinplaceincaseofequipmentfailure. Calibration,validationandmaintenancerecordsshouldbekept,alongwithanywrittenagreementswithmaintenancecompanies.Equipment usersshouldhaveaccesstoreliableinstructionsandreceivetraininginsafeuseandmaintenancewhereappropriate.Additionally,staffshould bemadeawareofhowtoreportequipmentproblems.

Disposal
52.TheDIofanestablishmentwhichacceptsabodymustensurethatrobustandappropriatesystemsareinplaceforitsstorage, examinationandpreservationuntilaftercremationorburialoccursorthebodyisreturnedtothefamily. 53.Itisgoodpracticetoretaintissueremovedfromthecadaverduringdissectionfordisposalalongwiththebody.Bodypartsretainedafter thedisposalofthebodyandanytissueremovedfromthemmaybedisposedofasclinicalwasteseethecodeofpracticeonDisposalof humantissue .Wherepossible,thesepracticesshouldbeexplainedtothedonoratthestartofthedonationprocess.

References
Referencesarelistedintheorderinwhichtheyappearinthecode.Supplementaryreferencesareincludedattheend. HumanTissueAct2004 HumanTissue(Scotland)Act2006 TheHumanTissue(QualityandSafetyforHumanApplication)Regulations2007 HumanTissue(Scotland)Act2006:AguidetoitsimplicationsforNHSScotlandissuedon20July2006(Ref:NHSHDL(2006)46)) HTAcodesofpractice HTADirections TheAnatomicalSocietyofGreatBritainandIreland(ASGBI) BritishAssociationofClinicalAnatomists(BACA) InstituteofAnatomicalSciences(IAS) HTAguidanceondonatingyourbodytomedicalscience HTAguidanceforanatomyestablishments HTAguidetolicensingforDIsandLHs GeneralMedicalCouncil(GMC)guidanceMakingandusingvisualandaudiorecordingsofpatients

Supplementaryreferences
HTAguidetolicensingandapplication E-learningtrainingcourseforDIs WelshLanguageAct HTAsummaryinspectionreports HTAguidetoourkeymessages-whichexplainstheHTAsrolesandresponsibilities HTAe-newsletterwhichprovidesregularnewsandupdatesabouttheHTA'swork