NHS MEL(2000)21

Health Department

Dear Colleague

RETENTION OF TISSUES AND ORGANS AT POST-MORTEM EXAMINATION

Summary

1. The MEL sets out arrangements, based on guidance produced by the Royal College of Pathologists, for the retention of tissues and organs at post-mortem, whether the post-mortem is directed by the Procurator Fiscal or carried out at a Trust’s request with the agreement of relatives.

Action

2. Trusts are expected to adopt the approach set out in the Royal College of Pathologists’ Guidelines for the retention of tissues and organs at post-mortem (March 2000). In particular, Trusts should have available a supply of the College’s leaflet ‘Examination of the body after death’, included as Annex A of the Guidelines, in order that the consent relatives give is fully informed.

3. The Scottish Executive also endorses the use of the model forms drawn up by the College: that at Annex B of the Guidelines, for use when a Trust wishes to carry out a post-mortem with the agreement of relatives; and that at Annex C, for use when the post-mortem examination has been directed by the Procurator Fiscal. A copy of both forms is attached to this MEL.

4. This MEL is available on the Scottish Executive website: http://www.show.scot.nhs.uk

Yours sincerely

27th April 2000
______________________________

Medical Directors, for onward
transmission to all consultants

General Manager, State Hospital

Chief Executive, Scottish Ambulance
Service

Chief Executive, Health Education
Board for Scotland

Director, Scottish Health Advisory
Service

Executive Director, SCPMDE

Tel: 0131-244 2420
Fax: 0131-244 2051
Will.scott@scotland.gov.uk

Background

1. Recent revelations from a number of Trusts throughout the UK concerning the retention of organs following post-mortem examination have highlighted the need to improve understanding between clinicians and relatives about the post-mortem examination. It has not always been clear to relatives that tissues or organs were being retained by a Trust after a post-mortem examination, and some relatives have been caused extreme distress by the discovery that this had happened.

2. The report from the Royal College of Pathologists, Guidelines for the retention of tissues and organs at post-mortem, published in March 2000, is therefore timely. The Scottish Executive endorses the approach set out in that report, an approach which is firmly founded on the principle of informed consent.

The Guidelines

3. The Guidelines make clear (paragraph 2.3) that different conditions apply to hospital post-mortem examinations carried out with the agreement of relatives and post-mortem examinations directed or requested by a Procurator Fiscal.

4. The arrangements in Scotland for Procurator Fiscal examinations are set out in paragraphs 4.1-4.6. Relatives’ consent is not required, but the report recommends (paragraph 8.6) that relatives of those undergoing post-mortem examinations directed by law should be provided with an information leaflet explaining the legal necessity, in certain circumstances, to retain tissues or organs and of their rights to the material when the examination has been completed. A suitable form is provided at Annex C to the report. The Scottish Executive wishes all Trusts in Scotland to use this form, a copy of which is provided as an Annex to this MEL. The College has also produced a leaflet, included as Annex A to their report, which gives information to relatives about ‘Examination of the body after death’. Trusts are advised to obtain a supply of copies, as informed consent depends on relatives having appropriate information.

5. Procurators Fiscal cannot authorise the removal of organs and tissues for research or teaching purposes, and if such material is required, the additional separate agreement of relatives of the deceased must be sought specifically (paragraph 4.6 of Guidelines). The main points to bear in mind in respect of post-mortem examinations performed with relatives’ agreement are:

• A senior and properly trained doctor, preferably a consultant, who knew the relatives best during the patient’s last illness, should obtain agreement to the post-mortem examination (paragraph 5.4);
  
  
• Relatives should be informed that a pathologist can be available to answer any specific questions and concerns (paragraph 5.4);
  
  
• Agreement must be obtained if the primary purpose of retention is specifically for teaching, training or for research. If the primary purpose is research, agreement is required with the approval of the Local or Multicentre Research Ethics Committee (paragraphs 5.4 and 5.8);
  
  
• Written agreement must be obtained for the retention of whole organs in all cases. The prospect of distressing relatives is not a valid reason for not seeking their agreement. Experience shows that agreement is usually given if the reasons for retaining the organ are sound and carefully explained.

6. The Guidelines recommend that hospital authorities must ensure that post-mortem examination forms offer relatives a range of options for which they can separately grant or withhold their agreement (paragraph 8.5). A model form is included in the Guidelines as Annex B, and the Scottish Executive endorses its use by Trusts in Scotland.

7. The Summary of recommendations in the Guidelines is attached as an Annex to this MEL for ease of reference. The report has already been given a wide distribution by the College. Further copies are available from the College at 2 Carlton House Terrace, London SW1Y 5AF, telephone 020 7451 6700. The text can also be found on the College’s website (http://www.rcpath.org)

8. The Scottish Executive Health Department is aware of the census of all hospital pathology departments in England which the Chief Medical Officer at the Department of Health is undertaking. We will examine the recommendations regarding the removal, retention and disposal of organs at post-mortem which the English CMO may make to the Secretary of State for Health in September of this year, and will consider whether there are any implications for the NHS in Scotland.

Annex

Summary of Recommendations in Royal College of Pathologists’ Guidelines for the retention of tissues and organs at post-mortem examination

8.1 Medical schools and hospitals must provide training for medical, and other appropriate personnel (eg, nurses, bereavement counselling officers), in requesting and obtaining agreement for post mortem examinations and in dealing with relatives' concerns about tissue and organ retention. This must form part of the induction programme for house officers, senior house officers and specialist registrars in all disciplines. Similar information must be provided for nurses and other members of the health care team.

8.2 Doctors, or other appropriate suitably trained personnel, seeking agreement for a post-mortem examination must first liaise with the pathologist to determine the necessity of and grounds for retaining tissue so that relatives can make informed decisions.

8.3 Hospital authorities must provide an information leaflet for relatives explaining the purpose of post mortem examinations, the medical benefits of tissue and organ retention, and their rights to grant or withhold their agreement. The Royal College of Pathologists' model information leaflet is available (Annex A).

8.4 Relatives agreeing to post mortem examinations must be given and keep a copy of the form they signed and a copy of the information provided to them. This information must relate to the post mortem examination itself and any retention of tissues and organs.

8.5 Hospital authorities must ensure that post mortem examination forms offer relatives a range of options for which they can separately grant or withhold their agreement. A model form is included in this document as Annex B [copy attached to this MEL].

8.6 Relatives of those undergoing post mortem examinations directed by law (Coroners and Procurators Fiscal) should be provided with an information leaflet explaining the legal necessity, in certain circumstances, to retain tissues or organs and of their rights to the material when the examination has been completed (see Annex C [copy attached to this MEL]). This leaflet should also explain the value of donation of tissues, such as aortic valves, for the treatment of living patients, and outline the mechanisms by which agreement to this can be given.

8.7 Reports of post mortem examinations required by law should state clearly what, if any, tissues or organs have been retained in pursuance of the investigation of the death.

8.8 Hospital and forensic histopathology services must have standard operating procedures for the archiving and disposal of tissues retained from post mortem examinations, ensuring that their disposal procedures meet with public expectations. The storage of retained material must be safe and secure, and the method of disposal must be respectful, safe and lawful.

8.9 In cases where the body of the deceased has already been buried or cremated, any remaining tissue which is not to be respectfully disposed of or, with agreement, to be retained for medical education or research, should wherever possible be released only with authoritative confirmation of the identity of the organs/tissue and of the deceased, to funeral directors chosen by and acting on behalf of those who have legitimate responsibility for the disposal of the body, and where the burial or cremation authorities have agreed in principle to accept the remains for disposal. This does not preclude retained material being released directly to those who have legitimate responsibility for its disposal, but the proposed method of disposal must be lawful and safe. The recipient or the burial or cremation authority must be notified of any hazards associated with the tissue and its fixative (eg, formalin), and confirmation must be obtained that they are able and willing to handle them in accordance with the appropriate COSHH regulations.

8.10 These guidelines should be reviewed periodically and, if necessary, amended in the light of advances in medicine and in pathological techniques, and changing public attitudes and legislation.