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The Investigation of Events that followed the death of Cyril Mark Isaacs
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CHAPTER 40

The Royal College of Pathologists: guidance

Introduction

This chapter describes the guidance provided by the Royal College of Pathologists to Fellows and Members of the College in 1991, 1993 and 2000 that set out the College's policies on post mortem procedures and reports.
Sources of information
The chapter is based on:

-  a report issued jointly by the College and the Royal College of Physicians of London and the Royal College of Surgeons of England in 1991;

 

-  guidance documents issued by the College in 1993, 2000 and 2002;

 

-  discussion with Professor Sir John Lilleyman, then President of the College, and Professor Sebastian Lucas at the College on 23 November 2001.

 
1991 recommendations by the Royal Colleges
In August 1991 a report was issued entitled 'The Autopsy and Audit'. This report had been prepared by a joint working party of the Royal College of Pathologists, the Royal College of Physicians of London and the Royal College of Surgeons of England. The report included a number of recommendations that are directly relevant to this investigation.
Recommendations 'concerning the performance of autopsies' included:

'6.1 i)  responsibility for obtaining permission for an autopsy should lie with the consultant in charge of the case. The task may be delegated to junior medical staff in individual cases. Specially trained bereavement officers could approach relatives for consent at the request of the consultant in charge;

 

viii)  the final complete report should normally be issued within 3 weeks of the autopsy, except in cases where the report may be further delayed by special investigations …;

 

ix)  diagnostic or confirmatory paraffin section histopathology should be done in every case. Retention of tissue for purposes other than to establish the cause of death is subject to the requirements of the Human Tissue Act, 1961;

 

x)  Coroner's autopsies should be performed with the same thoroughness demanded by autopsies prompted by clinical requests.'

 
It is notable that the report of the joint working group emphasised that any retention of tissue for purposes other than establishing cause of death should comply with the Human Tissue Act.
In a separate set of recommendations the report included:
'6.2 vi) the value of the autopsy in medical audit should be emphasised in the undergraduate medical curriculum'.
The report of the joint working party is at Appendix 45.
1993 guidelines on post mortem
In April 1993 the College issued guidelines on the content of post mortem reports. This document recommends the information that should be included in all post mortem reports.
At the time these guidelines were issued, they reflected 'best practice' in the way post mortems should be carried out 'whether funded by the National Health Service, Coroner or Procurator's Fiscal' and the content of the reports subsequently provided by pathologists.
This document is relevant to this investigation as no distinction is made between reports on hospital and Coroners' post mortems.
A single standard for all post mortems
The introduction to the guidelines recommends that all post mortems should be carried out to a single standard: 'The Royal College of Pathologists emphasises that a single standard should be applicable to all post mortem examinations, whether funded by the National Health Service, Coroner, or Procurator's Fiscal. The major difference between these types is in the frequency of histological examination. Recent publications indicate the desirability of retention of tissues for histological examination in most cases. The extent to which Coroners will support and finance this is limited, but the principle is clear'.
On histology the guidelines imply that tissue retention should be routine:
'5. Histology report and other investigations

(a) Indicate whether material has been taken for histology.

 

(b) Indicate what other material has been saved, ie toxicology, microbiology, etc.

 

(c) Record tissues sent to any third party for further investigation, such as genetic analysis, tissue culture, etc'.

 
Neuropathology
The guidelines include an appendix on neuropathology that describes the extent of the examination and advises: 'The brain should not be sliced before fixation. Careful macroscopic examination will often provide information for a preliminary cause of death'.

A list of blocks that should normally be taken for histological sampling is included.
Other appendices
There are separate appendices that do not concern this investigation on deaths in babies and infants, maternal deaths and the National Confidential Enquiry into Perioperative Deaths (NCEPOD). However, the guidelines do not mention consent.
The scope of a routine post mortem examination
In discussion Sir John Lilleyman and Professor Lucas emphasised that the 1993 guidelines were 'best practice' when they were issued. The recommended procedures had been developed over time. In the years preceding publication the College would have expected histopathologists to work to similar standards although no formal guidance had been issued by the College.
The College had always advocated a single high standard for post mortems that made no distinction between hospital and Coroners' post mortems.
Influence of the College on post mortem practice in the 1990s
The guidelines issued by the College in 1993 reflected professional opinion and practice. The advice was then that all post mortems should be carried out to a uniform high standard. While laudable in the context of encouraging high class professional standards and practice, this advice obscured the different purposes of hospital and Coroners' post mortems.
The 1993 guidelines did not refer to the fact that a proportion of Coroners' post mortems were ordered against the objections of relatives. Similarly, the Human Tissue Act requirement for consent of the relatives was not mentioned.
The College's review of policy in the light of the retention of organs of children reported from Liverpool and Bristol
Before the first of these reports(1,2) the College had recognised the 1993 guidelines required revision. Many histopathologists had been concerned about the legal and ethical aspects of organ and tissue retention. This prompted the College to start work on revising the guidelines in the mid-1990s and, after full consultation, new guidance was issued in March 2000.
2000 guidance
These guidelines are entitled 'Guidelines for the retention of tissues and organs at post mortem examination'.
These guidelines provide a clear statement of the legal position of organ and tissue retention in Coroners' post mortems. The requirement for consent by the relatives for organ retention is clearly stated.
The guidance includes separate sections on 'post-mortem examinations required by law' and 'post-mortem examinations performed with relatives' agreement'. The different purposes of Coroners' and hospital post mortems are the root cause of the objections of those relatives who would refuse consent for a post mortem if they had a choice. The different purposes are discussed further in Chapter 44.
Principal features of the new guidelines

Respect for the concerns of relatives:

The emphasis in the introduction recognises the concerns that many relatives had expressed: 'The Royal College of Pathologists promotes and maintains high standards of post-mortem examinations, and this includes a requirement to ensure that the bereaved are treated with respect'.

Retention of tissue:

Under the heading 'Legal and ethical principles' the retention of tissues is described:

'The following principles apply to the retention of tissues:

·  Retention of tissue must be lawful, i.e. must not contravene statute or breach a common law tenet (e.g. obscene display).

·  Reasons for the retention of tissue must be defensible, open, and justifiable in law and in clinical practice.

·  Unless the post-mortem examination is directed by law, the procedures must be sufficiently flexible to reflect the wishes of relatives, while maintaining standards of diagnostic accuracy.

·  If the post-mortem examination is directed by law, where possible and practicable the relatives should be fully informed before the examination of what is to be done and its purpose.

Taking into consideration these principles, these guidelines seek to ensure that the retention of tissues and organs at post-mortem examination complies with the relevant legislation and is professionally regulated to high ethical standards'.

 

Organ retention in Coroner's cases:

'Coroner's autopsy reports should state when whole organs have been retained, and the reasons given in the report. However, disclosure arrangements will need to be discussed with local Coroners who may themselves wish to review their approach in the light of these guidelines. Coroners should inform relatives and advise them of the date when the organ(s) may be released. However, if the relatives declare that they wish to have the organ(s) cremated or reunited with the body after burial, Coroners should make it clear that this would be the relatives' responsibility'.


The consent of relatives to retention that goes beyond the Coroner's requirements:

'If retention of tissues or organs not within the remit of the Coroner's post-mortem examination appears desirable, the agreement of relatives should be obtained in accordance with the HTA 1961. The Coroner's authorisation must also be sought; it is only where there are good grounds for refusal that the Coroner's authorisation is likely to be withheld. Coroners may forbid such extra samples to be taken even when the relatives agree, but cannot authorise them without their agreement'.

Advice of the Crown Prosecution Service

The guidelines recorded that the Crown Prosecution Service had given advice about retention of 'relevant material' when criminal procedures might follow.

In these guidelines the College implicitly acknowledged the shortcomings of the earlier document. These guidelines recognise that, while post mortems are a legal safeguard and essential in many cases of sudden death, the extent of procedure can be modified when there are objections from relatives, although not in all cases.
2002 guidelines
In September 2002 the College issued further guidelines entitled 'Guidelines on autopsy practice'. Following from this document, the College will be publishing evidence-based guidance on what should be done in, and retained from, post mortems in different categories of death.
Summary
In August 1991 the report of a joint working party of the Royal College of Pathologists, the Royal College of Physicians of London and the Royal College of Surgeons of England on 'The Autopsy and Audit' emphasised that 'retention of tissue for purposes other than to establish the cause of death is subject to the requirements of the Human Tissue Act'.
'Guidelines for Post Mortem Reports' was published in August 1993 by the Royal College of Pathologists.
This guidance reflected best practice at the time.
The 1991 and 1993 guidance documents advocated a single standard for both hospital and Coroners' post mortems.
The Royal College of Pathologists issued revised guidance in March 2000 after wide consultation. This emphasised the legal and ethical requirements for tissue and organ retention while at the same time maintaining the principle that high standards should apply to all post mortem examinations.
The Royal College's forthcoming guidance on what should be done in and retained from post mortems in different categories of death will be welcome. For relatives who object in principle to post mortems, there will be further benefit if this advice includes recommendations about limiting the extent of Coroners' post mortems once an obvious cause of death has been identified.

References

 

1.  Royal Liverpool Children's Inquiry Report, 2001.

2.  The Bristol Royal Infirmary Inquiry Report, 2000.


 
       
 

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