appendix 8 the process for tissue donation

DRAFT FOR CONSULTATION – 14.05.06

SECTION 2

GUIDELINES FOR THE MANAGEMENT OF

POTENTIAL ORGAN AND TISSUE DONORS

CONTENTS

8. Introduction

9. Potential Organ and Tissue Donors

9.1 Heartbeating and Non-heartbeating Donors

10.The Donation Process

10.1 The Role of the Donor/Tissue Transplant Co-ordinator

10.2 The request for donation of organs and/or tissues for

transplantation

10.3 The Process

11.Summary

Appendix 6 The process for organ donation in patients certified dead by

neurological testing of brain stem reflexes (TBSR)

Appendix 7 The process for controlled non-heart beating donation (NHBD) in the

ICU

Appendix 8 The process for tissue donation

Appendix 9 1988 Report of a Working Party on Organ Transplantation in Neonates

8. Introduction

The purpose of this section is to give medical and nursing staff caring for dying or

deceased patients, basic information on the process of organ and tissue donation.

These guidelines are designed to be read in conjunction with the comprehensive

Intensive Care Society Guidelines for Adult Organ and Tissue Donation, where more

detailed information is provided. The Intensive Care Society’s guidelines were

prepared by the Society’s Working Group on Organ Donation and are available via

www.ics.ac.uk

DRAFT FOR CONSULTATION SECTION 2 – 14.05.06 1

Organ and tissue transplantation is one of the major medical success stories of our

time with approximately 90% of transplant recipients alive and well after 1 year. This

success has led to a situation worldwide where demand outstrips supply particularly

with regard to organ donation.

9. Potential Organ and Tissue Donors

Almost anyone dying in hospital is a potential organ or tissue donor. Kidneys and

livers from donors over 80 years old have been successfully transplanted and there

is no upper age limit for the donation of eyes, bone and skin. Due to the fact that

organ transplantation is life saving there are very few absolute contraindications to

organ donation. Patients with certain cancers, a confirmed diagnosis of Human

Immunodeficiency Virus (HIV) or known or suspected classical or variant Creutzfeldt-

Jakob Disease will not be able to donate organs. As tissue transplantation is usually

life enhancing rather than life saving there are additional contraindications to tissue

donation. The Advisory Committee on the Microbiological Safety of Blood, Tissues

and Organs for Transplantation (MSBTO) provides national guidance on donor

evaluation. This guidance can be found at www.doh.gov.uk/msbt

9.1 Heartbeating and Non-heartbeating Donors

Potential heartbeating donors (HBD) are patients in an unresponsive apnoeic coma

resulting from an irreversible cause. This may occur under a variety of circumstances

but is often associated with a traumatic brain injury or intracranial haemorrhage.

Before organ or tissue donation can take place the patient must have been declared

dead following neurological testing of brain stem reflexes.

Potential “controlled” non-heartbeating donors (NHBD) are principally those patients

in intensive care units, who are clinically stable, but for whom continued treatment is

judged not to be in the patient’s best interest and it has been agreed that active

medical treatment should be withdrawn. Organ and/or tissue donation can proceed

once death has been certified following cardiorespiratory arrest.


10. The Donation Process

10.1 The Role of the Donor/Tissue Transplant Co-ordinator

The donor transplant co-ordinator will provide support for health care professionals

and families of potential organ and tissue donors and will facilitate the donation

process. It is essential that the donor transplant co-ordinator is informed of all

potential donors as early as possible so that any retrieval can be conducted in a

timely manner. The co-ordinators are best placed to ascertain suitability of potential

donors, provide advice to staff on donor identification and clinical management and

to discuss the option of organ and/or tissue donation with those closest to the

potential donor.

10.2 The request for donation of organs and/or tissues for transplantation

Before approaching those closest to the patient to discuss the option for donation it is

important to confirm whether, during their lifetime, the patient had expressed their

wish to be a donor by registering on the Organ Donor Register (ODR). If the patient

is not registered this does not mean that they did not want to donate and the option

for donation should still be discussed with those closest to them. The ODR can be

checked by ringing the UK Transplant 24 hour Duty Office on 0117 9757575.

As with the ICS Code, it is important to note that under the Human Tissue Act 2004,

the prior wishes of the deceased take precedence in law over those of the family.

Thus the family cannot agree to donate if the deceased had previously refused, and

the deceased’s prior consent cannot be vetoed by the family (though if there are

strong objections from relatives it might not be appropriate to proceed). More

guidance will be available through the Codes of Practice of the Human Tissue

Authority which are due to come into effect in September 2006

The request for donation may be made by either medical or nursing staff or by the

donor transplant or tissue co-ordinator. However, evidence from the USA and some

areas of the UK has demonstrated that when a collaborative approach is made to the

family by the patient’s clinician and the donor transplant co-ordinator higher consent

rates are achieved.


10.3 The Process

Once agreement for organ and tissue donation has been obtained the donor

transplant co-ordinator will liaise with the health care professionals in the donor

hospital and the transplant units to arrange a suitable time for the retrieval operation.

11. Summary

The non-clinical management of patients prior to organ or tissue donation is shown

below as flow diagrams.

As previously mentioned this section should be read in conjunction with the Human

Tissue Authority’s Codes of Practice (www.hta.gov.uk) and the Intensive Care

Society Guidelines for Adult Organ and Tissue Donation, which provide detailed

information relating to the process for heartbeating and non-heartbeating organ and

tissue donation (www.ics.ac.uk).


http://www.ics.ac.uk/

http://www.hta.gov.uk/

DRAFT FOR CONSULTATION SECTION 2 – 14.05.06

Present

Yes

No

The process for organ donation in patients certified dead by neurological testing of brain

stem reflexes (TBSR)Donor Identification

Up to 85 years of agePlanned for brain stem testing

No

Absent

Absolute contraindications include:

HIV infection, known or suspected CJD

Discuss all potential donors with the donor transplant co-ordinator

Donation is not possible if there are absolute contraindications or no Coroner’s agreement to proceed

Telephone your donor transplant co-ordinators Option of organ donation can be discussed

with the family, usually after first set of TBSR. Once contacted the donor transplant co-

ordinator will attend to discuss the options with the family alongside the critical care staff.

Legal time of death is the first set of tests demonstrating absence of brain

stem reflexes

The donor transplant co-ordinators will document consent to donation from

the deceased or the family

Donor assessment undertaken by donor transplant co-ordinator

Donor registered at UK Transplant

Is the patient to be referred to Coroner?

Contact the Coroner or his Officer to obtain permission for retrieval to proceed

Permission granted?

Yes

The family is supported throughout this process, by the donor transplant co-ordinator and the critical care staff.

An appointment will be made by the hospital for the family to see the hospital bereavement service.

Remember the donor transplant co-ordinator is always available for advice at any time during this process

Organ retrieval takes place in the theatre. The family may see their loved one following donation and are offered follow-up by the donor transplant co-ordinator.

5

Present Absent

No


YesNo

The process for “controlled” non-heart beating donation (NHBD) in the ICU

Donor IdentificationDiscuss possible age restrictions with donor transplant co-ordinator

Planned withdrawal of treatment

Donation is not possible if there are contraindications or no Coroner’s agreement to proceed

The families are informed of the procedure for NHBD, consent documented by the donor transplant co-ordinator Donor assessment undertaken by donor transplant co-ordinator Arrangements made for the withdrawal of treatment with the family and critical care staff Organ retrieval teams on-site and prepared in the operating theatre

Is the patient to be

referred to Coroner?


Permission granted?


Yes

Treatment is withdrawn and the families are supported throughout this process

After five minutes observation of cessation of cardiorespiratory function, death is certified by the critical care medical staff and documented in the medical notes

Organ retrieval takes place in the theatre. The family may see their loved one following donation and are offered follow-up by the donor transplant co-ordinator

Telephone your donor transplant co-ordinators Discuss the option of non-heart beating

organ donation with the family Once contacted the donor transplant co-

ordinator will attend to discuss the options with the family and critical care staff

Absolute Contraindications include:

HIV infection, known or suspected CJD

Discuss all potential donors with the donor transplant co-ordinator


6

Present

No

No


Yes

Absent

The process for tissue donationDonor Identification

Age restrictions do apply(Discuss with tissue or donor transplant co-ordinator)

Absolute contraindications:HIV, Hepatitis C or B, Human T cell lymphocytotrophic virus, Syphilis,

known or suspected CJD or at risk of having any of the above.

Have a central nervous disease of unknown aetiology.Diagnosis of leukaemia, lymphoma or myeloma.

Have Alzheimer’s or an unexplained confusional state.

Donation is not possible under these circumstances

Discuss tissue donation options:Corneas, Heart Valves, Skin, Bone.

Almost anyone can donate one of the above

Contact your local donor or tissue transplant co-ordinator to ascertain what options are available.

It is important to document the deceased’s or relative’s consent to donation.

Specify what the deceased or family have agreed to donate.It is preferable to have a relative’s signature with the consent statement.

Photocopy consent details, which should accompany the body of the deceased to the mortuary

Is the patient to be referred to Coroner


Permission granted?

Contact the donor or tissue transplant co-ordinatorYou will need to have the following information ready.

For the deceased: Their name, date of birth, the time and date of death, the cause of death, details of past medical history and any medications taken and GP details.

For the next of kin: Their name, address and a phone number where they can be contacted. The relative should be informed that the donor or tissue transplant co-

ordinator will call them before the donation can proceed. They will be asked a few simple questions about past medical and social history. The family will have the opportunity to

ask any questions and decide if they would like to know the outcome of the donation.

Yes

Remember the donor or tissue transplant co-ordinator is always available for advice at any time during this process.

7

Appendix 9 1988 Report of a Working Party on Organ Transplantation in Neonates

The 2005 Working party endorse the 1988 working party report. This is reproduced

below without any modification of the original text. The concepts of ‘brain death’ and

‘brain stem death’ are not employed in the 2005 report. The terminology that has

been adopted in the 2005 report rests on the concept of a unitary state of death, as

defined in the introduction of the working party report. This 2005 terminology can be

substituted for the form of words selected within the 1988 report. In particular,

1988 usage 2005 usage

brain stem death(d) death(d) following cessation of brain stem function

brain stem death criteria criteria for certification of death resulting from

cessation of brain stem function

the brain is dead death has occurred as demonstrated by cessation

of brain stem function

The American party report referred to in the 1988 document was published after the

latter was written (but before it was published). The published report can now be

referenced as:

‘Taskforce on brain death in children. Guideline for the determination of brain death

in children. Pediatrics 1987 80: 298-300.’


Conference of Medical Royal Colleges

And their Faculties in the UK

REPORT OF A WORKING PARTY

ON

ORGAN TRANSPLANTATION IN NEONATES

Prepared for the Department of Health and Social Security

Crown copyright 1988


Membership

Sir Raymond Hoffenberg PRCP Chairman

Dr T L Chambers FRCP Honorary Secretary

Sir Douglas Black MD FRCP

Mr E R Howard MS FRCS

Dr D Hull FRCP

Dr K M Laurence FRCPE FRCPath

Dr F J Mccartney FRCP

Mr C H Rodeck FRCOG

Dr N P Halliday (Observer) Senior Principal Medical Officer DHSS

Oral evidence received from:-

Dr J D K Burton

The Rev G R Dunstan

Mr I M C Kennedy

Dr R H Nicholson

Written comments received from:-

Dr M J Dillon (on behalf of the British Association for Paediatric Nephrology)

Dr R G Gosling

Dr B G R Neville

Meetings held on 3rd, 17th March, 30th April and 26th November 1987

+Hereafter referred to as Conference

*A Neonate is an infant aged up to and including 28 days after birth.

Terms of Reference:

To report on the diagnosis of brain death in neonates and all relevant aspects of

organ transplantation from, and into, neonates. (Letter from Dr N P Halliday to the

Chairman of Conference 26.11.86)


REPORT

1. Introduction and background

The working party was established by Conference at the request of the DHSS. Publicity and

controversy had followed a recent heart transplant operation where the donor was

anencephalic infant and the recipient a neonate with congenital heart disease. Questions had

been raised about the validity of the diagnosis of brain death in newborn infants, the use of

newborn infants with major malformations as a source of donor organs and the indications for

organ transplantation at this age.

2. The need for organ transplantation

2.1 The working party was advised that at present, and for the foreseeable future,

organ replacement is not considered appropriate for neonates with terminal liver or

kidney failure and that technical considerations limit the transplantation of small livers

and kidneys into older and larger recipients. There are few ocular conditions which

would be treated by corneal transplantation into a recipient at this age. Corneas are

removed from recently deceased infants (subject to parental permission) just as in

older children and adults: this is ethical and acceptable practice.

2.2 Congenital cardiac malformation unamenable to surgical correction appears to be

the only condition for which organ replacement would be required in neonates: the

procedure is technically feasible but it is currently at an early stage of development.

Figures presented to the working party suggest that in England and Wales

approximately 150 babies per annum might be born with such cardiac malformations

(Appendix I).

3. Supply of donor organs

3.1 Since the only requirement for organs from neonates is for hearts (or, possibly

Heart and lung) then the donor must have a beating heart at the time of retrieval: up to

6 hours may then elapse before the removed heart is place in the recipient. The

practice of organ removal in older children and adults requires that the donor


circulation should be maintained in as near normal a state as possible to limit

ischaemic damage to the donor organ which might prejudice the success of the

transplant. Anatomical and surgical considerations limit the size of the donor organs

to those which can be accommodated within the neonatal thoracic cavity.

3.2 In these circumstances there are two possible sources of donor organs:

a) from newborn infants with non-cardiac congenital malformations which

inevitably and rapidly lead to death. The best known is anencephaly.

b) from otherwise normal donors who sustain major brain injury and to whom

well-established criteria of brain stem death might be applied.

3.3 The number of potential donors appears to be limited and the number who

might be used to supply such organs is probably much lower. For instance, it is not

known how many infants and children survive a major accident to arrival at hospital,

be resuscitated and subsequently be diagnosed brain stem dead, which would allow

their organs to be removed. Such information could probably be acquired through the

reporting system of the British Paediatric Surveillance Unit, but the numbers are likely

to be very small.

3.4 Similarly, it is not known how many of the patients with lethal neurological

disorders would die in circumstances which would allow their organs to be removed

and used.

3.5 The most important points concerning organ removal from infants are:-

a) the legal and ethical considerations in retrieving organs for donation from

infants with lethal malformations but who are not pronounced dead.

b) whether brain stem death criteria can be applied to the neonate and, if so

whether the gestational age at birth should be taken into consideration.

4. Use of infants with lethal malformations


4.1 Still-born infants would not be suitable as organ donors for heart transplantation

which requires a beating heart.

4.2 There are a few congenital malformations that inevitably and rapidly lead to

death: anencephaly and renal agenesis are the most common.

4.3 Such infants (and particularly those with renal agenesis) may have other

abnormalities such a pulmonary hypoplasia which would not make them suitable

organ donors.

4.4 The working party considered in more detail the use of anencephalic infants as

organ donors. Anencephaly is the most severe neural tube defect and, being almost

always self-evident, is easily diagnosable. The cerebral hemispheres are usually

absent and there is a major defect in the cranium with exposed tissue consisting of

meningeal remnant, disorganised central nervous tissue, blood vessels and ependyma:

the brain stem and sometimes the cerebellum are present but abnormal. Those

anencephalic infants born alive usually only live for a few minutes or perhaps hours,

and exceptionally, up to 48 hours. In these circumstances some brain stem function

may be present despite the absence of higher centres.

4.5 Current antenatal surveillance programmes and natural wastage mean that in the

UK few anencephalic fetuses survive to a gestational age when organ retrieval would

be feasible: the working party estimated that in the United Kingdom about 20 such

donors per annum might be available for heart transplantation. (Office of Population

Censuses and Surveys data show that in 1985 there were 59 anencephalic live and

stillbirths in England and Wales).

4.6 Current obstetric and paediatric practice in the UK is not to manage the

pregnancy, labour or neonatal period with the sole aim of prolonging the survival of

an anencephalic fetus or infant. This practice is likely to command public

understanding and support and the working party supports it.


4.7.1 In the case of live-born anencephalics, current legal and ethical considerations

would not allow removal of organs before the subject was pronounced dead. No third

party such as a parent could consent to this.

4.7.2 This means that, subject to parental consent, such an infant would have to be

maintained in an optimal condition until death occurred when the organs could be

removed.

4.7.3. The working party found itself in a dilemma when it considered at what point

organs could be removed from an anencephalic infant. Tests of brain stem function

are applied in adults because the absence of such function establishes that the brain is

dead; they are clearly inapplicable when the forebrain itself is missing. Such infants

clearly have a major neurological deficiency incompatible with life for longer than a

few hours. A view which commended itself to the working party was that organs

could be removed from an anencephalic infant when two doctors (who are not

members of the transplant team) agreed that spontaneous respiration had ceased. In

the adult the diagnosis of brain death plus apnoea is recognised as death. The

working party felt by analogy that the absence of the forebrain in these infants plus

apnoea would similarly be recognised as death*.

4.7.4 In making these recommendations in 4.7.3 the working party is aware of public

support for transplantation and is anticipating that such support would extend to

neonatal heart transplantation for those infants with major cardiac malformations

incompatible with life. It also recognises that some parents will wish to offer organs

from their live-born anencephalic infants and that they will wish this to be carried out

in an ethical and dignified way acceptable to the medical, nursing and other staff

involved in the care of their dying infant. It is hoped that society recognises this

generous impulse and will find the suggested basis for organ removal an acceptable

means or reconciling the interests of both infants – the anencephalic donor and the

recipient with a cardiac malformation.

4.7.5 The working party would condemn pressure from any source being put upon

parents to continue with a pregnancy solely with the intention of organ retrieval.


* We are aware that the Conference of Medical Royal Colleges and their Faculties in

the UK is reconsidering the diagnosis of apnoea with a view to strengthening the

criteria.

5. Brain stem death in the neonate

5.1 It is understood that, providing there was professional confidence that brain stem

death criteria could be applied to the neonate of a certain gestational age, then there

could be no legal or ethical objection to the parents agreeing to, and a surgeon

undertaking, organ retrieval.

5.2 There is little firm evidence that the well established criteria used for diagnosing

brain stem death in older children and adults can be applied to neonates with beating

hearts in the first seven days of life for the purpose of organ removal. The ethics

committee of the Child Neurology Society in the United States has concluded that

there is insufficient information to diagnose brain death at this age and in that country

a joint task force is investigating the matter further and will report soon.*

5.3 Until acceptable criteria for brain stem death in the first seven days of life are

agreed it is the view of the working party that the brain stem death criteria used in

older children and adults cannot be used to justify the removal of organs from such

neonates with beating hearts for transplantation.

6. Other considerations in neonatal organ transplantation

6.1 It would not be acceptable to transplant organs retrieved from outside the UK

under circumstances which do not meet our own strict conditions.

6.2 Since such procedures are at an early stage of development they should be

limited to a few centres so that care is standardised and sufficient experience acquired:

this will help in research and interpretation of the results. Conference wished to

receive the results of these transplantation programmes: such results should include


data about the (unidentified) source of the donor organs and the manner of their

retrieval.

* Since the report was written this task force has now submitted its recommendations

which were published in Paediatrics (1987) Vol 80, no 2 p 298. These do not cover

anencephalics, premature infants or children within the first seven days of life.

6.3 Such centres should be able to offer the full range of medical, surgical and other

care for infants which would normally be available in a children’s department of a

general hospital or a children’s hospital.

6.4 Longer term study is required to provide information about the prospects for

growth of donor organs, e.g. the heart transplanted into a neonate and the effects of

immunosuppression upon the health of the child. A register of such patients would

aid follow-up.

6.5 If a substantial number of neonates are going to become organ donors then a

programme of public and professional education will be required.

6.6 Future developments may enable organs other than the heart to be replaced and

might allow use of other sources of organs or tissues such as stillbirths or fetuses.

Conference should therefore keep the subject of neonatal organ transplantation under

review.


RECOMMENDATIONS

1. Organs for transplantation may be removed from anencephalic infants when two

doctors who are not members of a transplant team agree that spontaneous respiration has

ceased. In the adult the diagnosis of brain death plus apnoea is recognised as death. The

working party felt by analogy that the absence of the forebrain in these infants plus apnoea

would similarly be recognised as death. (para 4.7.4)

2. No pressure should be put upon parents to continue with a pregnancy solely in the

interest of organ retrieval. (para 4.7.5)

3. In view of current uncertainties, organs for transplantation should not be removed

within the first seven days of life from neonates with beating hearts even if they satisfy the

brain stem death criteria which are used in older children and adults. This does not apply to

anencephalic infants. (para 5.3)

4. It is unacceptable to transplant organs retrieved outside the UK unless the

circumstances met our own strict criteria. (para 6.1)

5. Neonatal organ transplantation should only be undertaken in a limited number of

centres offering a full range of paediatric care. The results of these programmes should be

reported to Conference. (Para 6.2 and 6.3)

6. Long term follow-up of recipients will be required and a register of such patients is

suggested. (para 6.4)

7. Further public and professional education concerning transplantation may be required.

(para 6.5)

8. Conference should keep the subject of neonatal organ transplantation under review.

(para 6.6)


APPENDIX I

NEONATAL ORGAN TRANSPLANTS

Demand for hearts

Cardiac malformation Deaths/1000 Expected Live Births per year

Hypoplastic Left Heart 0.163 104

Heterotaxy 0.088 56

Pulmonary atresiawith ventricular 0.002 1septal defect

_____ ___

0.253 161 _____ ___

Based on Office of Population Censuses and Surveys (England & Wales 1984) and the New England Regional Infant Cardiac Program Report.


appendix 8 the process for tissue donation

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