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Human Tissue AuthorityCode of Practice – The removal, storage and disposal of human organs and tissue

Code 5 July 2006

Paragraphs

Introduction 1–9

Scope of the code 10–14

Removal 15–43

Consent

– Organs/tissue removed from the living 15–17

– Organs/tissue removed after death 18–19– Coroner’s post mortems 20–25– Storing tissue, including blocks and

slides, for scheduled purposes 26–27

Principles of acquisition 28–34

Record keeping 35–39

Cultural/religious considerations 40–41

Preservation for transplantation 42–43

Storage 44–60

Storage of whole bodies 44

Existing holdings 45

Storage of relevant material taken from the living 46–53

Storage of relevant material taken after death 54

Non-consensual analysis of DNA 55

Methods of storage 56

Appropriate storage period 57–60

Disposal 61–83

Policy on disposal 61–62

Organs/tissue removed from the living 63–66

The patients’ wishes 66

Organs/tissue removed after death 67–78

Surplus material from tissue samples 79–81

Existing holdings of unidentifiable and identifiable but unclaimed, human tissue and organs 82

Fetal Tissue 83

Paragraphs

Appendix A: The disposal of existingholdings of unidentifiable and identifiable but unclaimed human tissue and organs

Introduction A1–6

Scope of the appendix A7–14

Criteria to confirm genuinely unidentifiable organs and tissue A15

Making a decision about disposal A16–18

Fetal tissue and the bodies of stillborn babies A19–20

Documentation and record-keeping A21–25

Deciding on the appropriate disposal method A26–32

Disposal options for different types of tissue A33–40

– Incineration A33– Burial A34– Cremation A35–36– Tissue blocks and slides A37–38– Skeletons and bones A39–40

Appendix B: Disposal following pregnancyloss before 24 weeks’ gestation

Scope of the appendix B1–7

Storage of fetal tissue before disposal B8

Disposal options B9–20

– Burial B15–16– Cremation B17–18– Incineration B19–20

Development of NHS Trust policies B21–22

Fetal tissue resulting from abortions carried out by private clinics B23

Reference material available on this subject B24–26

Glossary

Contents

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1 The Human Tissue Act 2004 (The Act)which extends to England, Wales andNorthern Ireland only, sets out a newlegal framework for the storage and use of tissue from the living and for theremoval, storage and use of tissue andorgans from the dead. This includes‘residual’ tissue following clinical anddiagnostic procedures.

2 The Act repeals and replaces the HumanTissue Act 1961, the Anatomy Act 1984and the Human Organ Transplants Act1989 as they relate to England and Wales.It also repeals and replaces the HumanTissue Act (Northern Ireland) 1962, the Human Organ Transplants (NorthernIreland) Order 1989 and the Anatomy(Northern Ireland) Order 1992. There is separate legislation for Scotland – the Human Tissue (Scotland) Act 2006 –and the HTA will perform certain tasks on behalf of the Scottish Executive. Forthe purpose of these codes, the term‘NHS Trusts’ includes Health and SocialServices (HSS) Trusts in Northern Ireland.

3 The Act also establishes the Human TissueAuthority (HTA) as the regulatory bodyfor all matters concerning the removal,storage, use and disposal of human tissue (excluding gametes and embryos)for scheduled purposes. This includesresponsibility for living donortransplantation. This is one of thefunctions which the HTA will carry out on behalf of the Scottish Executive.

4 The HTA is also responsible for givingadvice and guidance on the Act and forlicensing establishments that carry outparticular activities under the Act.

5 One of the HTA’s statutory functions is toissue codes of practice. This is one of thefirst six codes, which should be regardedas complementary:

1 Consent2 Donation of organs, tissue and cells

for transplantation3 Post mortem examination 4 Anatomical examination5 Removal, storage and disposal of

human organs and tissue6 Donation of allogeneic bone marrow

and peripheral blood stem cells fortransplantation.

6 These codes give practical guidance tothose carrying out activities which liewithin the HTA’s remit and lay down the standards expected. These are not a definitive guide to the law and licenceholders should refer to the Act and keepthemselves informed about future legal developments.

7 The guidance given applies to anyoneundertaking relevant activities. Failure to follow this guidance is not in itself a criminal offence under the Act, but the HTA may take any such breach into account when carrying out itsresponsibilities in respect of licensing.

Introduction

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8 The codes have been approved by the Secretary of State and laid beforeParliament in accordance with Section 29of the Act.

9 Any references to the terms ‘tissue’,‘organ’, ‘part organ’, ‘material,‘ ‘bodyparts’ or ‘cells’ in this code refers to‘relevant material’. For definitions of termsused, please refer to the glossary at theback of this code.

Who can give consent?

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10 This code provides a model of goodpractice for all those involved in removing,storing and disposing of human organs ortissue, whether donated by living patientsor removed from the body after death.

11 It does not deal with the legal and ethicalissues relating to the use of human organsand tissue for research, education or otherpurposes.

12 The Act’s consent and licensing provisionsdo not apply if at least one hundred yearshave elapsed since the date of theperson’s death. (This is to preventmuseum collections of historical humanremains being caught by the legislation,and in recognition of the impracticalitiesof tracing relatives for consent purposesfor deaths that occurred long ago.)

13 To determine the Act’s impact on theremoval, storage or disposal of organs or tissue, consider the following:

• is the organ or tissue classified as‘relevant material’ i.e. material, otherthan gametes, which consists of orincludes human cells? 1

• which, if any, of the scheduled purposeslisted in the Act 2 is the material beingremoved or stored for?

• was the material removed from aperson in their lifetime, or after death?

14 Under the Act, fetal tissue and productsof conception are treated no differentlyfrom any other tissue taken from a livingperson. Clearly, however, there areparticular sensitivities relating to the useand disposal of such tissue. See Appendix Bfor guidance on the disposal of fetal tissue.

Scope of the code

1 See Glossary

2 See Glossary

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Consent: organs/tissue removedfrom the living

15 The consent requirements of the Act do not apply to the removal of relevantmaterial from the living but only to theremoval of relevant material taken fromthe dead. Consent for removal of relevantmaterial from a living person continues tobe dealt with by the common law. This isbecause the removal of material fromliving patients is likely to be:

• a part of the patient’s treatment (for example, during surgery or taking a blood sample), or

• part of a deliberate donation of organs,tissue or cells (see the Code of practiceon donation of organs, tissue and cellsfor transplantation), or

• where a healthy person (who may ormay not be a patient) participates aspart of a research project or a trial of a new treatment. The consent of suchindividuals is required before theyparticipate in clinical trials under theMedicines for Human Use (ClinicalTrials) Regulations 2004. The consentgained for participation in such researchmust also cover any planned removal,subsequent storage and uses of relevantmaterial (as defined in the Act).

16 The Department of Health’s Referenceguide to consent for examination andtreatment 3 provides detailed guidance

on obtaining consent for examination and treatment.

17 Relevant material taken from a person in their lifetime continues to be treated as such after their death. It is the point at which the material is removed thatdetermines how it is affected by the Act.

Consent: organs/tissue removedafter death

18 It is an offence under the Act to removerelevant material from a dead body forany scheduled purposes without obtainingconsent other than under the coroner’sauthority or under proper authority forcriminal justice purposes (see paragraphs20–25 below). For further information,see the Code of practice on consent(which deals with the general principles of consent under the Act), and the Codeof practice on post mortem examination(which deals more specifically withobtaining consent for post mortems).

19 In the case of material taken after death solely for use in research, threescenarios exist:

• a specific use in a defined project. This should only occur with consent and where the project has been ethicallyapproved 4 as applicable to the specificproject.

Removal

3 www.dh.gov.uk/policyandguidance/healthandsocialcaretopics/consent/consentgeneralinformation/

The DHSSPS (Northern Ireland) has published its own reference guide to consent for examination and treatment:

http://www.dhsspsni.gov.uk/consent-referenceguide.pdf

4 Defined under Regulations 2006 (The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of

Information about Transplants) to mean approval given by a research ethics authority.

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• undefined research, presuming potentialusefulness in future projects. This typeof removal should only occur withconsent and the procedure for gainingconsent should acknowledge that thepotential uses are unforeseen at thetime, but are broadly related to researchinto human health or the functioning of the human body. Before materialscollected in this way are used in anyfuture project, that project must beapproved by a REC. The REC must betold how the material has been or willbe procured.

• material removed after death forpossible transplantation provesunsuitable for that purpose, but could be suitable for use in research.Such material should only be used forresearch where prior consent for suchuse exists and where REC approval hasbeen obtained.

Consent: coroner’s post mortems

20 Consent is needed for the storage or useof material taken during a coroner’s postmortem for scheduled purposes, once the material is no longer required for thecoroner’s purposes. The Coroner’s Rulesspecify that the coroner must tell thepathologist carrying out the post mortemwhat material to store under theirauthority, and for how long5. The Rules

also require the coroner to tell relatives 6

about any material which may be stored.

21 Consent is not needed for:

• carrying out a post morteminvestigation on the order of a coroner

• keeping material after post mortem on the instructions of a coroner, for the period of time specified by thecoroner, or

• keeping material in connection with a criminal investigation or following acriminal conviction (under the Policeand Criminal Evidence Act 1984 orCriminal Procedure and InvestigationsAct 1996) 7.

22 It is an offence to store and/or usematerial without consent for scheduledpurposes after it is no longer needed forthe coroner’s purposes. Consent forstorage of tissue post mortem shouldalways be obtained.

23 The Code of practice on post mortemexamination describes the need for localprotocols between coroners and healthorganisations to ensure proper communi-cation with the deceased person’s relatives.Discussions about consent to store organsshould ideally take place before the postmortem is carried out, and certainly beforethe coroner’s time limit on storage expires.This not only avoids a second approach to

5 The reference here and in the following paragraphs (21, 23, 24 and 25) relating to a period of time specified by the coroner,

do not apply in Northern Ireland.

6 Throughout this code, the term ‘relatives’ should be taken to include close friends of the deceased person in cases where there

are no relatives.

7 In Northern Ireland the Police and Criminal Evidence (Northern Ireland) Order 1989 takes the place of the Criminal Evidence

Act 1984.


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relatives at a difficult time, but also ensuresthat material is not stored other than underthe coroner’s authority or with consent.

24 If the deceased person’s relatives indicatethat they wish organs or tissue to bedisposed of, this should be done as soonas possible and certainly within two weeksof the deadline on storage specified bythe coroner.

25 Where they have not expressed apreference by the time the coroner’s timelimit expires, the organs or tissue may bestored for up to six weeks. The relativesshould then be advised that unless theyspecify otherwise, the organs or tissuewill be disposed of in a further fourweeks’ time.

Consent: storing tissue, includingblocks and slides, for scheduledpurposes

26 The Act does not distinguish betweenblocks and slides and any other form of human tissue. Whilst it may bedesirable for blocks and slides to be takenand kept for clinical audit, teaching orother purposes, it should not be assumedthat consent to a post mortem impliesconsent to removing and keeping blocksand slides.

27 The implications of a post mortem,including the need to remove organs ortissue for further examination, must beexplained to the deceased person’s

relatives when obtaining consent. Itshould be made clear that consent to theremoval, storage and/or use of organs or tissue for any scheduled purpose is a separate decision from consent toconducting a post mortem examination(whether partial or full).

Principles of acquisition

28 The underlying principle of the Act is that giving or withholding consent to thetaking of organs or tissue from the livingor the dead for any scheduled purpose aredecisions which deserve respect.

29 Procedures for conducting post mortems,and for the removal and storage of organsor tissue for examination, must alwaysmaintain the dignity of the deceasedperson. Every effort should be made toreconstruct the body as far as possible afterthe post mortem. Reconstruction should beof a high standard so that the body can beviewed by relatives.8 Those wishing to seethe body of their relative should be told ifany procedures have caused disfigurement,so that they are prepared. Such informationshould be provided as sensitively aspossible, taking care to try to judge howmuch information individuals would wishto have before going into details.

30 The evidence from those affected by thediscovery that organs and tissue had beentaken from their relatives and storedwithout their knowledge or consentsuggests that a major cause of concern

8 Guidelines on autopsy practice, Royal College of Pathologists, September 2002 (paragraph 7.7).


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was that the material had never beenused for research or any other purposethat might have benefited others. 9

31 It is therefore important that when organsand tissue are taken and stored, their usecan be explained to living donors or to therelatives of deceased donors. Evidencesuggests that most people are willing toconsent to the removal and use of organsand tissue to:

• explain why their relative died• help other family members (for example,

siblings where there may be genetic risk factors)

• contribute to education of clinical staffand quality control, or

• help others in the future throughmedical research.

32 The Code of practice on post mortemexamination provides guidance ondiscussing the implications of donation for research with the deceased person’srelatives, including the need to tell themthat not all material donated willnecessarily be used. However, those givingconsent expect donated material to beused if possible. Similarly, living donorsexpect their material to be put to gooduse. The Code of practice on consentprovides guidance on obtaining consentfrom a living donor and on discussingdonation for research.

33 Material may need to be held for a longtime, possibly decades, before being used– for example because of the need tobuild up materials from a sufficientnumber of donors. It is often impossible to anticipate the future use to whichdonated material may be put.

34 Therefore it is important to explain tothose giving consent that it may not bepossible to say exactly what the materialwill be used for, or when. Many donors or their relatives are willing to provideconsent for future unforeseen uses andthe Code of practice on consent explainsthe benefits of seeking broad or genericconsent where possible. However, ifconsent has only been given for aspecified use when broader consent wassought, the wishes of the donor should be respected and the uses restrictedappropriately.

Record-keeping

35 NHS Trusts and other establishmentsshould ensure they have systems in place to maintain proper records anddocumentation for all tissue and organsthey acquire and/or pass on to others.

36 The Designated Individual 10 named inlicences issued by the HTA should ensurethat such systems are in place. It isimportant to be able to track whathappens to organs and tissue for health

9 Learning from Bristol: the report of the public inquiry into children’s heart surgery at Bristol Royal Infirmary 1984–1995;

Bristol Royal Infirmary, July 2001.

10 See Glossary


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and safety reasons – for example, shouldan infection occur, resulting in the need totrace people who came into contact withthe material. Keeping proper records ofdonated material also demonstratesrespect for the donation.

37 The duty to create and maintain properrecords starts with the establishmentwhere the material is removed from thebody, or where the material is identifiedas surplus to requirements for healthcarepurposes and is set aside for a scheduledpurpose. Such initial records shouldinclude:

• details of who gave consent• exactly what the consent related to, and

any restrictions on use stipulated duringthe consent process

• what processes are applied to the tissue• if tissue is transferred, when and to

whom and• if relevant, when and how disposal is

undertaken.

38 Tissue may be transferred from one placeto another many times. So that an audittrail can be maintained, each establishmentthat handles human organs or tissue musthave systems that can record:

• when the material was acquired, and from where

• what has been consented to• the uses to which the material is put

whilst in the establishment’s care andany processes applied to it and

• when the material is transferredelsewhere, and to whom.

39 European Directive 2004/23/EC requiresthat adequate systems be set up to ensurethe traceability of human tissue and cellsintended for human applications. TheDirective will be transposed into law by Regulations.

Cultural/religious considerations

40 Attitudes to post mortem examination and other uses of organs and tissue differgreatly. Healthcare professionals should beaware of and sensitive to the values andbeliefs of a wide range of cultures andreligions, particularly those of their localcommunity. They should also be awarethat every decision is one for the individualconcerned. Organisations should ensurethat the necessary training and support isgiven, so that employees are equipped toidentify and meet the widest possiblerange of needs and wishes.

41 The Code of practice on post mortemexamination discusses the handling ofcultural and religious views in more detail.

Preservation for transplantation

42 Where any part or parts of a body lying in a hospital, nursing home or otherestablishment is, or may be, suitable foruse for transplantation, it is lawful for the individual in charge to:


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• take steps to preserve the relevant bodypart or parts for use for transplantationand

• store the body for that purpose.

43 However, this authority only extends totaking the minimum steps necessary forpreservation and to the use of the leastinvasive procedure. The Code of practiceon donation of organs, tissue and cells fortransplantation deals with this in detail.


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Storage of whole bodies

44 There are special requirements for thelawful storage of a body for anatomicalexamination, carried over from theAnatomy Act 1984. This is dealt with indetail in the Code of practice onanatomical examination.

Existing holdings

45 It is lawful to store and use for scheduledpurposes, without consent, relevantmaterial and the body of a deceasedperson that is already held in storage for ascheduled purpose on 1 September 2006.However, where the views of thedeceased person or of their relatives orfriends are known, those views must berespected. The existing holdings provisionsdo not apply to the storage and use ofbodies or material, which are the subjectof an authority under the Anatomy Act1984 and where the anatomicalexamination has not been completed by1 September 2006. This is dealt with indetail in the Code of practice onanatomical examination.

Storage of relevant material takenfrom the living

46 The Act makes it lawful to store relevantmaterial taken from a living person forscheduled purposes (Part 1 11) providedconsent from an appropriate person is obtained.

47 Material may be taken from the living in a variety of circumstances, for example:

• in the course of a diagnostic procedure(e.g., blood sample, biopsy)

• in the course of treatment procedures(e.g., the removal of organs or tumoursduring surgery)

• specifically for the purposes of research(e.g., a blood sample taken as part of apopulation screening programme) or

• for transplantation – see the Code ofpractice on donation of organs, tissueand cells for transplantation.

48 The Act allows material taken from theliving for any reason to be stored (andused) without consent for the followingscheduled purposes on the basis thatthese are bound up with the generalprovision of clinical and diagnosticservices:

• clinical audit• education or training relating to

human health• performance assessment• public health monitoring and• quality assurance.

49 Consent is required to store tissue fromthe living for:

• obtaining scientific or medicalinformation about a person which may be relevant to any other person(now or in the future)

• public display

Storage

11 Scheduled Purposes Part 1 refer to purposes requiring consent from both the living and the deceased; Scheduled Purposes Part 2

refer to purposes requiring consent from the deceased only.

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• research into disorders, or thefunctioning, of the human body and

• transplantation.

50 Consent should where possible beobtained for the use of tissue removedfrom the living for research. Where this isnot possible, it is lawful for material takenfrom a living person to be stored withoutconsent for research purposes only if:

• the research is ethically approved• the material is anonymised, and the

researcher takes all necessary steps notto identify the person from whose bodythe material has come.

51 This does not necessarily mean thatsamples must be permanently andirrevocably unlinked – linking can be madethrough a third party where necessary – or that the person holding the samplescannot themselves carry out the research.

52 There may be occasions when a clinicianinvolved in research may also have accessto a secure database which would permitidentification of a sample used in research.Providing the research material is codedand the researcher does not seek to linkthe tissue with the patient, the sample willstill be regarded as non identifiable andresearch in this context is permissiblewithout consent, if approved by aresearch ethics authority.

53 In general, obtaining consent is preferableto developing complex systems forkeeping samples unlinked. It representsbest practice and has the added benefit offacilitating ethical approval by a researchethics authority.

Storage of relevant material takenafter death

54 It is an offence under the Act to storerelevant material taken after deathwithout consent for any scheduledpurposes, apart from material stored forcoroners’ or criminal justice purposes.

Non-consensual analysis of DNA

55 It is an offence to have human tissue,including hair, nail and gametes in thiscontext, with the intention of analysingits DNA without ‘qualifying consent’,subject to exceptions. (This is normallythe consent of the individual from whomthe tissue came or of those close to themif they have died.) This provision appliesUK-wide. Medical diagnosis andtreatment and criminal investigations,etc., are excluded from the offence. (See the Code of practice on consent for details of the consent requirementsrelating to DNA analysis and thepermitted exceptions.)


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Methods of storage

56 Organs and tissue should be stored in linewith current good practice on:

• security • traceability, including information about

risk. Records should detail the locationof the materials

• health and safety, including appropriatecontainment levels for the storage,transportation and handling of materialsthat may pose a risk to staff or others.

Appropriate storage period

57 In the wake of the controversysurrounding organ storage at Alder Heyand Bristol, the Chief Medical Officerrecommended considering a time limit on the storage of organs and tissue. Inpractice, a single time limit could lead to the premature loss of important anduseful collections of material or,alternatively, to material being stored forlonger than necessary, simply because itwould be kept for a fixed period.

58 Long-term storage in tissue banks forfuture research may be acceptable tomany donors or their relatives who havegiven their consent for such storage. But,it should not be forgotten that one of themost consistent complaints of relativesdistressed by organ storage was thattissue and organs had, in fact, simply saton a shelf for years with no prospect ofever being used.

59 NHS Trusts and other organisations should therefore develop local policies for reviewing holdings 12. These should lay down:

• the frequency of review and• the criteria for disposal/further storage.

60 These policies should take account of theduty to the donors to make use of theirdonations wherever possible and thereforethe prospects of the material being put togood use (see paragraphs 30–31 above).

12 See also RCPath guidance on “The retention and storage of pathological records and archives (3rd edition, 2005).


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Policy on disposal

61 NHS Trusts and other establishmentswhich store or use human organs andtissue should develop a clear and sensitivedisposal policy. It is good practice todocument this policy and make it availableto the public.

62 If relatives donate organs, tissue or awhole body to an NHS Trust or otherestablishment for anatomical examination,teaching or research, they may wish toknow how the material will be disposed ofafter use. Clinicians should be prepared todiscuss this issue with them, explainingthe options available and who will beresponsible for any associated costs.

Organs/tissue removed from the living

63 The Act makes it lawful to treat as ‘waste’any relevant material which has comefrom a person who was:

• in the course of receiving medicaltreatment

• undergoing diagnostic testing or• participating in research.

64 It also states that material no longer used,or stored for use, for any scheduledpurpose can be dealt with as waste.

65 Material taken from the living shouldnormally be disposed of by incineration in accordance with current guidelines. 13

See Appendix B of this code for specificadvice on the disposal of fetal tissue.

The patients’ wishes

66 Some patients may wish to retain tissuesamples or make their own arrangementsfor disposal. Such requests should beconsidered on a case-by-case basis,assessing the risk to the patient andothers. Patients should be given sufficientinformation to allow them to make aninformed decision.

Organs/tissue removed after death

67 Tissue and organs should be handled inaccordance with any reasonable wishesexpressed by relatives or the deceasedperson, as long as the method of disposalis legal. The time, place and method ofdisposal should be recorded.

68 Often the bereaved do not know whatneeds to be done following a death. Ahospital’s bereavement adviser/officer orthe coroner’s officer should explain thatthe deceased person’s executor (if there isone) is responsible for the disposal of thebody. They should be in a position to offerrelatives or friends information about theoptions available for cremation, burialand/or funeral arrangements, the legal

Disposal

13 See Safe disposal of clinical waste, second edition, HSE books, 1999.

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requirements and any other relevantdetails. This information will probably beneeded before relatives can make properdecisions about what happens to anytissue or organs stored at post mortem.

69 Healthcare professionals should be familiarwith hospital arrangements (includingthose for babies born dead before 24weeks’ gestation), what is available locally,basic legal requirements and the optionsavailable to those wanting to make theirown arrangements to dispose of organsand tissue. Such information should beavailable in writing (and in an appropriatelanguage) for people to take away withthem. They may wish to discuss it withrelatives or community members beforemaking a decision.

70 Basic disposal options are cremation orburial. There is usually a funeral or otherreligious or non-religious ceremony, eitherarranged by relatives or friends, with thehospital’s help if requested, or arranged by the hospital.14

71 Relatives may want to be reassured about the suitability of any burial or other arrangements the hospital makes.They should be told what the hospital can provide, and that any additionalrequirements will be at their own expense.

72 If someone has given consent to thestorage of tissue or organs, they should beoffered the option of allowing the hospital

to dispose of the residual material after itsfurther examination or use. If material isto be incinerated, care should be taken toensure that the method is appropriate tothe material in question.

73 Alternatively, the hospital may offer tostore the body until the organ can bereturned to it. This may not always bepractical in the case of long delays.

74 Relatives may wish the hospital to arrangefor collection of tissue or an organ, usuallyby a funeral director of their choice, atsome specified time after the post mortemexamination. They can then make theirown arrangements for cremation or burial.

75 Second funerals and burials of this naturecan have significant emotional (andfinancial) implications. These should bediscussed sensitively with those involved.

76 If the deceased person has already beenburied or cremated, and relatives ask for the remaining tissue or organs to bereturned later, these should be released:

• preferably to funeral directors acting forthose who have legitimate responsibilityfor the disposal of the body

• with authoritative confirmation of theidentity of the tissue or organ and

• with confirmation that the cremation orburial authorities have agreed in principleto accept the remains for disposal.

14 Hospitals should consider making arrangements for the respectful burial or cremation of the bodies of babies following stillbirth

or neo-natal death ensuring that women or couples are enabled to express their wishes: see the Department of Health guidance

“When a patient dies – advice on Developing Bereavement services in the NHS” www.dh.gov.uk/publications.


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77 There is no legal bar to releasing storedmaterial directly to relatives, but theproposed method of disposal must belawful and safe and it may be difficult toascertain this. The pathologist shouldnotify the recipient, or the burial orcremation authorities, of any hazardsassociated with the tissue and its fixativeand obtain confirmation that they are ableto handle them appropriately. Forexample, formalin, commonly used as afixative, can cause an allergic disease ofthe lungs and is a low-grade carcinogen.

78 Because of the potential health hazards,releasing organs and tissue directly torelatives for their indefinite storage is not generally advisable.

Surplus material from tissue samples

79 The Act permits disposal as waste ofmaterial that has come from a body in the course of:

• receiving medical treatment• undergoing diagnostic research or• participating in research.

and material that:

• has come from a human body and• ceases to be used, or stored for use,

for scheduled purposes.

80 It is normal practice to dispose of suchmaterial by incineration. This includes:

• tissue fragments trimmed from thetissue sample before it is processed for histology

• the tissue in the sections trimmed froma wax-embedded block before theusable sections are cut and

• the unrecoverable bodily material that is washed out of the tissue during itsprocessing into a wax block.

81 Relatives will expect remains to bedisposed of with respect. As a minimum,stored human body parts, organs andtissue should be disposed of separatelyfrom other clinical waste.

Existing holdings of unidentifiable,and identifiable but unclaimed,organs and tissue

82 There are particular sensitivities arounddisposing of organs and tissue that mayhave been acquired before currentpractices on obtaining consent. SeeAppendix A of this code for guidance.

Fetal tissue

83 Guidance on the disposal of fetal tissue is provided at Appendix B.


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Introduction

A1 The guidance in this appendix takesaccount of advice from the RetainedOrgans Commission (ROC) to theDepartment of Health and the WelshAssembly, 15 based on two rounds ofconsultation carried out by ROC in 2002and 2003.

A2 It advises establishments such as NHSTrusts, medical schools, museums, schoolsand colleges and the police, which mayhave existing holdings of human tissueand organs, on how to dispose of theseholdings, once they have made thedecision that they are no longer needed.

A3 NHS Trusts should offer to help any localschool or college wishing to dispose ofexisting holdings and help to arrangedisposal on their behalf in accordancewith this code.

A4 This guidance only sets out how existingholdings can be disposed of once thedecision has been made that they are nolonger needed. It does not offer advice ondeciding whether or how the material canbe used, or whether or not it should bedisposed of. The HTA’s code of practiceon consent includes guidance on the useof existing holdings. Guidance providedby the Royal College of Pathologists on

storage and storage periods may also behelpful in this regard. 16

A5 Where existing holdings includeidentifiable organs and tissue that havebeen retained at post mortem on acoroner’s behalf to establish cause ofdeath, the coroner’s office must beconsulted before disposal can take place.This is necessary to confirm that thecoroner has satisfactorily completed theirinvestigation into the case and is contentfor the material to be disposed of.

A6 It is acceptable to continue to store somematerial for future use. This guidance isnot intended to imply that it is eithercompulsory or always appropriate todispose of existing holdings.

Scope of the appendix

A7 This appendix covers the disposal of:

• existing holdings of unidentifiableorgans and tissue taken at post mortem examination and

• existing holdings of identifiable, butunclaimed, organs and tissue storedfrom post mortem examination.

Appendix AThe disposal of existing holdings of unidentifiable, and identifiable but unclaimed, human tissue and organs

15 June 2003: Final outcome report on consultation on the use and disposal of unclaimed and unidentifiable human organs and

tissue (Retained Organs Commission). www.nhs.uk/retainedorgans/publications.htm

16 The retention and storage of pathological records and archives. Royal College of Pathologists. Third Edition 2005

www.rcpath.org.uk

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A8 It does not advise on the use ofunidentifiable and unclaimed post mortem organs and tissue for research.

A9 It is intended for use by those involved in formulating local policy and in makingdecisions on the disposal of existingholdings of human organs and tissue(including stored fetal tissue and thebodies of stillborn babies).

A10 It is not intended to be used to provide information to patients orbereaved families.

A11 This document advocates a flexibleapproach and does not attempt toaddress every possible scenario. This isbecause there are many circumstancesthat may lead to the need to dispose ofhuman organs and tissue separately fromthe rest of the body. Decisions should betaken on a case-by-case basis.

A12 It includes guidance on:

• the disposal of material taken at postmortem or as part of an anatomicalexamination and

• stored fetal tissue and the bodies of stillborn babies

If samples are unidentifiable, it can beassumed they are from a post mortemexamination and therefore fall under the remit of this guidance.

A13 It excludes:

• the disposal or organs and tissue takenfrom the living (except in the case ofstored fetal tissue and the bodies ofstillborn babies)

If the existing holdings contain identifiablestored samples known to have been takenfrom the living, even if those individuals are now known to be dead, these can beincinerated in the same way as any othersample of tissue taken from a living person.

• embryos outside the human body (see advice given in the HumanFertilisation and Embryology AuthorityCode of Practice 17) and

• hair and nail from the body of a livingperson.

A14 This guidance does not distinguishbetween different types of tissue, i.e. it covers whole organs, tissue and blocksand slides.

Criteria to confirm genuinelyunidentifiable organs and tissue

A15 Organs and tissue may be considered to be unidentifiable if:

• there is no label or identification markof any description on the organ ortissue sample

• there is a label or identifying mark, but this cannot be linked to any existing register or record, or

17 Human Fertilisation and Embryology Authority, Code of Practice – disposal of embryos, sixth edition, 2003 (www.hfea.gov.uk).


20

• there is a label or identifying markwhich can be linked to a register orrecord, but the identification requireslinks with other registers or records thatno longer exist.

Making a decision about disposal

A16 There is no time limit on the storage ofhuman organs and tissue donated underthe Human Tissue Act 2004. Existinganatomical specimens that have beendonated under the Anatomy Act 1984should be disposed of within three yearsof the date of the donor’s death, unlessconsent has been given for further storagebeyond this time.

A17 Establishments that have existing holdingsof human organs, tissue and blocks andslides need to decide whether particularsamples can and should be disposed of.

A18 Decisions about the disposal of existingholdings should reflect the following three categories:

• existing holdings that are unidentifiableaccording to the criteria in this code If such holdings are no longer to bestored, they should be disposed of inthe same way as other material postmortem is now treated. (Guidance on disposal is provided in paragraphsA33–A40 below.)

• existing holdings that are identifiable,and about which contact has beenmade by relatives. Unless a commitment has been made torelatives to do otherwise, no holdings inthis category should be disposed of.They should be stored until relatives feelable to make their wishes clear. There isno need to make further contact withrelatives. Nor is it necessary for them tocontact the Trust again to ensurestorage is continued unless and untilthey wish to do so.

• existing holdings which are identifiablebut about which no contact has beenmade by relatives.It is reasonable for NHS Trusts andother establishments to considerwhether to dispose of identifiable butunclaimed organs and tissue. Trustsshould allow a period of 12 monthsfrom the date on which the Departmentof Health lifts its moratorium ondisposal of existing holdings beforetaking any action18. During this periodrelatives may make contact with Trustsif they so wish, although Trusts shouldnot initiate contacts. Trusts planning todispose of such holdings will need toconsider what level of local publicity isappropriate in the light of the size ofthe Trust holdings and any action takenso far; as well as any announcementmade by the Department of Health.

18 This twelve month period will not apply in Northern Ireland, where an extensive publicity campaign has already taken place.


21

Fetal tissue and the bodies ofstillborn babies

A19 Where existing holdings include storedfetuses and fetal tissue, establishmentsholding these samples will need to askthe same questions relating to theirdisposal as have been set out elsewhere in this guidance.

A20 Where the holding is a whole body ofwhat is believed to be a stillborn child, anindividual burial or cremation is desirable.Disposal by incineration is not appropriate.This is consistent with existing bestpractice for hospitals to arrange and payfor the burial and cremation of stillbirthsin hospital and the community.19

Documentation and record-keeping

A21 Once a decision has been made to disposeof any identifiable but unclaimed samplesfrom existing holdings, it is essential thatthe reasons for disposal and the methodused are carefully documented. Bereavedrelatives may continue to enquire aboutorgans and tissue that may have beentaken during post mortem examinations oftheir family member. It may be that organsand tissue were stored and have beensubsequently disposed of in accordancewith this guidance – if this is the case, the bereaved relatives should be given full information in a sensitive manner.

A22 Being able to respond effectively to theseenquiries depends on reliable tracking andgood record-keeping. The importance ofappropriate and accurate record-keepingcannot be emphasised enough.

A23 NHS Trusts and other establishments thathave existing holdings of human organsand tissue should develop a clear andsensitive disposal policy which can bediscussed with the bereaved. This policyshould be documented and madeavailable to the public.

A24 If relatives are involved in the donation oforgans and tissue or a whole body for useby an NHS Trust or other establishmentfor anatomical examination, teaching orresearch, they may wish to know how thematerial will be disposed of after use.Clinicians should be prepared to discussthis with them, explaining the optionsavailable and who will be responsible forany associated costs.

A25 The various disposal options for differenttypes of tissue are set out below.

Deciding on the appropriatedisposal method

A26 Organs and tissue should be treated with respect, without placing adisproportionate burden on staff orresources. The disposal method as well as the degree and nature of any

19 Health Service guidelines (91)19 – The welfare of children and young people in hospital, Department of Health, 22 July 1991

http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Tissue/TissueGeneralInformation/fs/en. Northern Ireland

has also produced guidance on this topic: ‘Careplan for Women who experience a miscarriage, stillbirth or neonatal death’.


22

accompanying ceremony will be influencedby the nature of the tissue involved.

A27 Dignified treatment and separate disposalare the minimum requirements fordisposing of stored organs and tissue.This means disposal should be carried outseparately from clinical waste, not thateach tissue sample should necessarily bedisposed of individually. A simple non-religious but respectful ceremony may be appropriate.

A28 However, NHS Trusts and otherestablishments, working with interestedlocal groups, may wish to vary the degreeof ceremony involved in the disposal,depending on the nature of the tissueconcerned.

A29 An example of such collaborative localpolicy-making is the burial of a largenumber of unidentifiable fetuses inLiverpool. This project was led by the NHSTrust, but involved consultation with alarge number of local organisations toagree a disposal method that was locallyand legally acceptable.

A30 Trusts may wish to consider contacting orinvolving local religious leaders regardingtheir planned policies for disposal ofexisting holdings, especially if it is knownthat a large number of samples are frommembers of a particular faith.

A31 If samples are identifiable, but unclaimedand known to be from a person of aparticular faith, it may be appropriate

to approach local faith leaders to see if they would be willing to dispose of the organs and tissue appropriately.Alternatively, they may advise on theproper disposal of these samples.

A32 In keeping with medical confidentiality,the identity of the individual from whomthe organs and tissue were taken mustnever be disclosed.

Disposal options for differenttypes of tissue

Incineration

A33 Unidentifiable, or identifiable butunclaimed, organs and tissue storedfollowing a post mortem examination may be incinerated.

Burial

A34 An establishment wishing to buryunidentifiable, or identifiable butunclaimed, organs and tissue shouldconsult the local burial authorities toestablish what level of service they canprovide. If the establishment wishes tobury this material, and a service is notavailable locally, they may wish to contactother service providers further afield.


23

Cremation

A35 Cremation of body parts, organs andtissue is possible under the Cremation(Amendment) Regulations 2006 20

providing that:

• the death of the person was dulyregistered and

• an application for the cremation of theorgans and tissue has been made by anappropriate person on the proper forms.

A36 If the crematorium’s medical referee is notsatisfied, then the Secretary of State maystill permit the cremation in exceptionalcircumstances.

Tissue blocks and slides

A37 As above, for the incineration and burialof organs and tissue.

A38 Although there is no legal barrier to cremating tissue blocks and slides,crematoria have discretion about whatthey may accept.

Skeletons and bones

A39 As above, for the incineration and burialof organs and tissue.

A40 Skeletons and bones are likely to beunidentifiable, so disposal should followthe guidance for unidentifiable tissue.

20 Different cremation legislation applies in Northern Ireland. Responsibility for this legislation lies with the Department of

the Environment (NI).


24

Scope of the appendix

B1 This appendix is intended to helphealthcare professionals to develop ormodify their hospital’s policy on disposalfollowing pregnancy loss before 24 weeks’gestation. It refers to advice previouslygiven in HSG(91)19 21 and replaces theadvice given in EL(91)144,22 which ishereby revoked. The issues covered in this advice were consulted on by theDepartment of Health in the 2002consultation Human Bodies, Human Choices 23.

B2 The advice is suitable for developingpolicies on the disposal of fetal tissueresulting from a number of differentpregnancy losses, including ectopicpregnancies, miscarriages, earlyintrauterine fetal deaths and terminationfor abnormality or for social reasons. Itshould not be used to give informationto patients.

B3 The term ‘fetal tissue’ is used throughoutfor consistency, although it is recognisedthat ‘pregnancy loss before 24 weeks’covers a large developmental range andmany different kinds of loss.

B4 Although this advice does not mention theneed for consent, hospitals should be awarethat consent from a person with parental

responsibility may be needed for someforms of disposal in their locality. A personwho has parental responsibility will usually,but not always, be the child’s parent.24

B5 Pregnancy loss is a very difficult area ofpolicy development and this appendix isnot comprehensive. It aims to cover themain issues and suggests sources offurther information.

B6 Pregnancy loss should always be handledsensitively. The needs of the woman orcouple should be paramount and disposalpolicies should reflect this.

B7 This appendix does not apply to the following:

• Stillbirths and neonatal deaths Any baby, irrespective of gestationalage, that is born alive and then diesimmediately afterwards is a live birthand neonatal death and should betreated as such in terms of registrationand disposal.

• Unidentifiable stillbirths that have beenstored for teaching or researchSee Appendix A of this code for adviceon the disposal of existing holdings of fetal tissue and the bodies of stillborn babies.

• Embryos created in vitro which have not been transferred into a woman

Appendix BDisposal following pregnancy loss before 24 weeks’ gestation

21 Health Service guidelines (91)19 – The welfare of children and young people in hospital, Department of Health, 22 July 1991

http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Tissue/TissueGeneralInformation/fs/en

22 Executive letter – Sensitive disposal of the dead fetus and fetal tissue, 12 December 1991

23 See guidance produced by Northern Ireland: ‘Careplan for Women who experience a miscarriage, stillbirth or neonatal death’.

24 The category of persons with parental responsibility is as set out in the Children Act 1989 as amended. Further guidance is

available in the Department of Health’s Reference guide to consent for examination and treatment.

25

These are covered by the HumanFertilisation and Embryology Act 1990and disposal should be in accordancewith the Human Fertilisation andEmbryology Authority’s Code of Practice. 25

Storage of fetal tissue before disposal

B8 All fetal tissue should be stored inaccordance with previous Department of Health guidance prior to disposal. 26

Disposal options

B9 A woman or couple should be told that information on disposal options isavailable if they wish to see it. Whenproviding information, account should be taken of the language spoken and any reading difficulties.

B10 It should be clearly documented in thewoman’s medical notes whether or notinformation has been requested andwhether it has been given.

B11 The information provided should explainwho to contact to request a particulardisposal option and the timescale for this.Any personal, religious or cultural needsrelating to the disposal of the fetal tissueshould be met wherever possible andshould be documented in the woman’smedical notes.

B12 All healthcare professionals should beaware of and sensitive to the values andbeliefs of a wide range of cultures andreligions, particularly those of their localcommunity. They should also be awarethat every decision is one for the individualconcerned. Organisations should ensurethat the necessary training and support isgiven, so that employees are equipped toidentify and meet the widest possiblerange of needs and wishes.

B13 Some women or couples may not wish toknow about, or take part in, the disposalof the fetal tissue. Providing they havebeen told that the information is available,their wishes should be respected.

B14 A woman or couple may decide toarrange disposal themselves and they are free to do so.

Burial

B15 Fetal tissue can be buried providing there has been consultation with thewoman or couple, where appropriate.Hospitals/clinics wishing to bury fetaltissue should consult the local burialauthorities to establish what level ofservice is available. If they wish to offerburial, and this service is not availablelocally, they might consider contactingother service providers further afield.Communal burial is permitted for fetal tissue.

25 Human Fertilisation and Embryology Authority, Code of Practice, Sixth Edition, 2003

26 Health Service guidelines (91)19 – Disposal of Fetal Tissue, 12 November 1991. In Northern Ireland, storage should be in line

with the Standards for the management of post mortem examinations.


26

B16 A woman or a couple can bury fetal tissueat home, if they wish, providing certaincriteria have been fulfilled. The tissueshould be supplied in a suitable opaquecontainer. It may be necessary to contactlocal authorities to discuss this option.

Cremation

B17 Although not covered by the CremationRegulations, fetal tissue can be cremated,providing there has been consultation withthe woman or couple where appropriate.Some crematoria are willing to provide aservice to dispose of fetal tissue, but this isat their discretion. Hospitals/clinics wishingto cremate fetal tissue will need tonegotiate with the local crematoria toestablish what level of service can beprovided. If this service is not availablelocally, they might consider negotiatingwith other service providers further afield.Communal cremation for fetal tissue maybe permitted by some crematoria.

B18 Women or couples should be told that thecremation of fetal tissue does not produceany ashes for them to scatter.

Incineration

B19 Fetal tissue from a pregnancy lost before24 weeks may be incinerated, althoughhow appropriate this is depends on theindividual circumstances. A woman orcouple should be told that information on disposal options is available and theyshould be given the opportunity toexpress any personal wishes.

B20 Incineration should be carried out inaccordance with previous Department ofHealth guidance. 27 The maceration andsluicing method of disposal is notpermitted for fetal tissue.

Development of NHS Trust policies

B21 In drafting their policies, NHS Trusts maywish to take into account gestational ageand the nature of the fetal tissue.

B22 Women or couples may seek informationabout the Trust’s policy on the disposal of fetal tissue. All appropriate staff shouldtherefore be aware of policy and practiceand be prepared to discuss these issuessensitively.

Fetal tissue resulting fromabortions carried out by privateclinics on behalf of the NHS

B23 Healthcare professionals may wish todiscuss issues relating to the disposal offetal tissue with the independent sectorclinic carrying out abortions on thehospital’s behalf.

Reference material available onthis subject

B24 NHS Trusts may wish to refer to twodocuments that address this issue in some detail:

27 Health Service guidelines (91)19 – Disposal of Fetal Tissue, 12 November 1991


27

Pregnancy loss and the death of a baby:Guidelines for professionals, NancyKohner – published by the Stillbirth andNeonatal Death Society, 1995; 28

Sensitive disposal of all fetal remainspublished by the Royal College ofNursing, 2001.29

In Northern Ireland, the relevant guidance is the Careplan for Women who experience a miscarriage, stillbirth or neonatal death.

B25 Healthcare professionals are encouragedto build professional networks to helpsupport the development andmodification of their NHS Trust policy.

B26 This advice was developed by theDepartment of Health in association with representatives from:

• Antenatal Results and Choices • British Pregnancy Advisory Service• Child Bereavement Trust• Confidential Enquiry into Maternal

and Child Health• Department of Health, Social Services

and Public Safety (Northern Ireland)• Marie Stopes International• Miscarriage Association • Nursing and Midwifery Council• Royal College of Midwives• Royal College of Nursing• Royal College of Obstetricians

and Gynaecologists

• Royal College of Pathologists• Stillbirth and Neonatal Death Society• Welsh Assembly Government

28 www.uk-sands.org

29 www.rcn.org.uk/members/downloads/disposal_fetal_remains.pdf


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Glossary

30 Wherever the term ‘organ’ is referenced, this also includes ‘part organs’.

These terms have been defined with referenceto the Human Tissue Act and the HTA’s Codesof Practice and should be read in that context.

Allogeneic use: Cells, tissue or organs 30

removed from one person andapplied/transplanted into another.

Altruistic non-directed donation A form ofnon-directed living donation, where an organor part organ is donated by a healthy personwho does not have a relationship with therecipient and who is not informed of whomthe recipient will be.

Anatomical examination: Macroscopicexamination of the body of a deceasedperson, or separate parts of such a body, by dissection for anatomical purposes(teaching or studying, or researching into, the gross structure of the human body).

Anatomical specimen: The body of adeceased person, including separated parts of such a body, to be used or in the course of being used for the purpose of anatomicalexamination. A former anatomical specimen isa deceased body, organ or body part donatedfor anatomical examination which is held oncethe examination of the rest of the body hasbeen completed.

Anatomist: An expert in anatomy.

Anatomy: The science of the structure and organisation of the body and its parts.

Anonymisation: is a procedure to ensure thatif relevant material is removed from a humanbody, all necessary steps are taken to preventidentifying the person from whose body thematerial has come.

Appropriate consent: is defined in the Act by reference to the person who may give consent.

Autologous use: Cells, tissue or organsremoved from and applied/transplanted intothe same person.

Autopsy: A post-mortem examination.

Biopsy: A procedure where tissue is removedfrom a living body for examination under a microscope.

Cells: Individual human cells or a collection of human cells when not bound by any formof connective tissue.

Clinical audit: A quality improvement process that seeks to improve patient careand outcomes through systematic review of care against explicit criteria. Stored tissuepreviously needed for diagnosis, for example,may need to be reviewed as part of this process.

Clinical diagnosis: A process where a disease is identified from medical history-taking, diagnostic tests and physical examination.

29

31 The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants)

Regulations 2006.

32 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL).

Designated Individual: means the individualdesignated in the licence as the person underwhose supervision the licensed activity isauthorised to be carried on. This person isresponsible for securing that other persons to whom the licence applies are suitablepersons, that suitable practices are carried out in the course of carrying-on the licensedactivity and for compliance with the conditionsof the licence. The HTA must be satisfied as to the suitability of this person.

Diagnosis: A process where a disease is identified by signs and symptoms, a history and laboratory tests.

Directed donation: A form of donation where a healthy person donates an organ (usually a kidney) or part of an organ (for exampleliver or lung lobe) to a specific recipient. The recipient could be known to the donor (in the case of genetically or emotionallyrelated donation) or unknown to the donor (in the case of paired / pooled donation).

DNA (deoxyribonucleic acid): the geneticmaterial of humans which is located in the cell nucleus and controls heredity.

Domino donation: When an organ is removedas part of a person’s treatment, it may besuitable for transplant into another person (e.g. a heart originally removed from therecipient of a heart and lung transplant).

Donation: The act of donating human tissue, cells or organs for a scheduled purpose.

Donor: Every human source, whether living or deceased, of human tissue, cells or organs.

Embryo: means a live human embryo wherefertilisation is complete and includes an egg inthe process of fertilisation.

Ethical Approval: Defined under Regulations 31

made under Section 1(9) of the Act to meanapproval given by a research ethics authority.

Existing holdings: Body of a deceased person or relevant material which has come from ahuman body held immediately prior to thecommencement of section 1 of the HumanTissue Act 2004 for use for a scheduled purpose.

‘Gillick’ 32 competent (now also referred to asFraser competent): A test of competence andmethod of determining the ability of a youngperson under the age of 16 to make decisionsregarding their own healthcare.

Haemopoietic: Relating to the production of blood cells.

Heart-beating donors: This refers to thecircumstances where organs and tissue fortransplantation are removed from donorsfulfilling the nationally agreed and legallydefined criteria of brainstem death.


30

Human application: The use of tissue or cells on or in a human recipient.

Independent Assessor: A person who acts as a trained and accredited representative of theHTA, to conduct an interview and prepare areport in circumstances envisaged under theRegulations 33, for some living organ donationsfor transplantation.

JACIE: Joint Accreditation Committee –International Society for Cellular Therapy and European Group for Blood and Marrow Transplantation.

Licensing: A number of activities can only becarried out where the establishment is licensedunder the Act by the HTA for that purpose.The activities are:• the carrying out of an anatomical

examination;• the making of a post-mortem examination;• the removal from the body of a deceased

person (otherwise than in the course of theactivities mentioned above) of relevantmaterial of which the body consists orwhich it contains, for use for a ScheduledPurpose other than transplant;

• the storage of an anatomical specimen;• the storage (other than of an anatomical

specimen) of the body of a deceasedperson or relevant material which hascome from a human body for use for aScheduled Purpose;

• the use, for the purpose of public display, of the body of a deceased person, or relevant material which has come from the body of a deceased person.

Licence Holder: The person who applies forand is granted a licence who can be, but is not necessarily the Designated Individual. TheLicence Holder is responsible for the paymentof any fees charged by the HTA including feescharged in respect of superintendingcompliance with licences and any other fees as specified by the HTA from time to time. The Licence Holder can be a corporate body.Where the applicant is not the proposedDesignated Individual, the HTA must besatisfied that the applicant is a suitable person to be the holder of the licence.

Licensed premises: Where the licensed activity(e.g. storage, or public display) takes place. If the licensed activity will take place at morethan one place, a separate licence will need tobe issued. Premises in different streets or withdifferent postal codes will be considered asbeing in different places. In contrast, differentbuildings on a hospital site could be regardedas the same place.

Living donors: The person donating tissue,cells or organs for transplantation. The mostcommon forms are live kidney donation(where one kidney is removed), or live bone marrow donation.

NHS Organ Donor Register: A confidential,computerised database managed by UKTransplant, which holds details of people whohave signed up to become organ donors inthe event of their death. The register is usedafter a person has died to help establishwhether they wanted to donate and if so,which organs.

33 Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.


31

Non-directed donation: A form of donationwhere a person donates tissue, cells or organsan unknown recipient. Most commonly, this isdeceased donation where the organ is allocatedto the most suitable person on the transplantwaiting list.

Non-heartbeating donation: A form ofdonation in circumstances where the deceaseddonor was not ventilated at the time ofdeath. Donation therefore occurs once deathis certified following cardiorespiratory arrest(i.e. the donor’s heart has stopped beating).

Organ: A differentiated and vital part of thehuman body, formed by different tissues, thatmaintains its structure, vascularisation andcapacity to develop physiological functionswith an important level of autonomy.

Paired donation: Where a close relation, friend or partner is fit and able to donate anorgan but is incompatible with the potentialrecipient, that couple can be matched toanother couple in a similar situation, so thatboth people in need of a transplant receive a compatible organ.

Peripheral blood stem cells: Cells found in thebloodstream which are able to differentiate intoall the cell types found in the blood.

Pooled donation: Where a close relation,friend or partner is fit and able to donate anorgan but is incompatible with the potentialrecipient, that couple can be matched toother couples in a similar situation, so that

all people in need of a transplant receive a compatible organ.

Post mortem: Dissection and examination of a body after death, principally in order todetermine the cause of death or the presenceof disease processes. A hospital post mortemexamination is carried out with appropriateconsent to gain a fuller understanding of thedeceased person’s illness or the cause of death,and to enhance future medical care. Coroners’post mortem examinations are carried outunder the authority of the Coroner andwithout consent to assist Coroners in carryingout their functions. 34

Preservation: The use of chemical agents,alterations in environmental conditions orother means during processing to prevent orretard biological or physical deterioration ofcells or tissues.

Processing: All operations involved in thepreparation, manipulation, preservation andpackaging of tissues or cells intended forhuman applications.

Procurement: A process by which tissues or cells are made available.

Public display: includes organised displaysand exhibitions held in museums, galleries,exhibition venues and educationalestablishments, but not for the purpose ofeducation or training. This definition is subjectto change pending further consideration bythe HTA.

34 Coroners’ post mortems are carried out in accordance with the provisions of the Coroner’s Act 1988 and the Coroner’s Rules 1984

(amended 2005) and the Coroners Act (Northern Ireland) 1959 and the Coroners (Practice and Procedure) Rules (Northern Ireland) 1963.


32

Public health monitoring: Using population-based or epidemiological techniques toascertain the prevalence, spread and patternof an established disease or condition in thecommunity and relating its occurrence topublic health programmes and activities.

Quality assurance: A programme for thesystematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of qualityare being met.

Relevant material: is defined by the Act asmaterial other than gametes, which consists ofor includes human cells. In the Act, referencesto relevant material from a human body donot include:(a) embryos outside the human body, or(b) hair and nail from the body of a living person.

Research: is concerned with creating newknowledge by addressing clearly definedquestions with systematic and rigorousmethods. It is about testing innovations ordiscovering the right thing to do e.g. findingout whether new treatments work and whethercertain treatments or models of service deliverywork better than others. Research forms thebasis of nationally agreed clinical guidelines and standards and is designed to establish best practice.

Research ethics authority: an ethics committeeestablished or person appointed to advise on,or on matters which include, the ethics ofresearch investigations on relevant materialwhich has come from a human body.

Residual tissue: is material left over from a diagnostic or therapeutic intervention.

Scheduled purposes: Scheduled Purposes arethe activities relating to the removal, storageand use of human organs and other tissue,listed in Schedule 1 of the Act that requireconsent. The Purposes are divided into 2 parts:

Part 1: Purposes Requiring Consent: General• Anatomical examination• Determining the cause of death• Establishing after a person’s death the

efficacy of any drug or other treatmentadministered to him

• Obtaining scientific or medical informationabout a living or deceased person whichmay be relevant to any other person(including a future person)

• Public display• Research in connection with disorders,

or the functioning, of the human body• Transplantation

Part 2: Purposes Requiring Consent: Deceased persons• Clinical audit• Education or training relating to human health• Performance assessment• Public health monitoring• Quality assurance

Serious adverse event: Any untowardoccurrence associated with the procurement,testing, processing, storage and distribution of tissue and cells that might lead to thetransmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients,


33

or which might result in, or prolong,hospitalisation or morbidity.

Serious adverse reaction: An unintendedresponse, including a communicable disease, in the donor or in the recipient, associatedwith the procurement or human application of tissue and cells that is fatal, life-threatening,disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

Stem cell: A precursor cell that can developinto more than one kind of cell. For example,early bone marrow cells can develop into redblood cells, white blood cells or platelets.

Storage: Maintaining the tissue underappropriate controlled conditions.

Surplus tissue: Relevant material which hascome from a person’s body in the course of his receiving medical treatment, undergoingdiagnostic testing, or participating in research.

Tissue: Any and all constituent part(s) of thehuman body formed by cells.

Tissue establishment: A tissue bank or a unitof a hospital or another body where activitiesof processing, preservation, storage ordistribution of human tissue and cells areundertaken. It may also be responsible forprocurement or testing of tissue and cells.

Transplant: An implant of an organ, tissue or cells either from and into the same body or from one person to another.

Transplant coordinator: A person who helps a potential transplant recipient to understandthe transplant process and also coordinates the transplant evaluation between the dialysisunit, transplant surgeon, and tissue typinglaboratory. After a transplant, the nurseprovides a communication link between therecipient and the transplant doctors for post-transplant care.

Transplantable material: Defined underRegulations 22 made under Section 34 of theAct to mean the whole or part of any of thefollowing organs if it is their function to beused for the same purpose as the entire organin the human body: kidney, heart, lung or alung lobe, pancreas, liver, bowel, larynx, face,or limb. Defined in the same Regulationsunder Section 33 of the Act to mean organs or part of an organ if it is to be used for thesame purpose as the entire organ in thehuman body, bone marrow and peripheralblood stem cells.


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Learning from Bristol: the report of the publicinquiry into children’s heart surgery at BristolRoyal Infirmary 1984-1995, Bristol RoyalInfirmary, July 2001

Report of the Royal Liverpool Children’sInquiry, January 2001

Department of Health (May 2003) Theinvestigation of events that followed thedeath of Cyril Mark Isaacs; Department ofHealth Isaacs Report Response, July 2003

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