Thematic report on organ retention

Authorisation

4.1 In all cases, the pathologist requires authorisation from COPFS prior to performing a post-mortem. The instructing Procurator Fiscal will advise on any particular requirements such as toxicology. On completion of the post-mortem, the pathologist will provide the cause of death, or where it is not established, discuss further lines of investigation with SFIU.

Medical Certificate

4.2 The pathologist in every case will issue a medical certificate of the cause of death (commonly known as the death certificate)^[38]. The death certificate is a prescribed form providing the cause of death and it enables the Registrar to issue a certificate of registration of the death which then allows burial or cremation. The death certificate will normally be issued following the completion of the post-mortem. In some cases, the cause of death may initially be recorded as unascertained until further investigation such as toxicology is carried out. The certificate can be amended following the results of the further investigation.

Release of the Deceased's Body

4.3 On receipt of the medical certificate of the cause of death, the Procurator Fiscal will in most cases authorise the release of the body for burial or cremation. The authorisation by the Procurator Fiscal to release the body denotes that their investigation is complete and can be taken as notification that tissue samples are no longer required and fall to be retained as part of the medical record of the deceased.

4.4 At present the pathology service providers' contracts provide that the pathologist should issue the death certificate on the same day as the post‑mortem. However, if the pathologist requires to undertake any further examination, the body will not be released when the certificate is issued.

4.5 In some jurisdictions, however, the pathologist's practice is to issue the death certificate only when the deceased's body is released. This practice has the attraction of both elements of the process being dealt with as a single step and ensures that the examination of the deceased is complete when the death certificate is issued. This should not incur any additional delay in organising a funeral as the critical information to enable arrangements to be finalised is when the body is likely to be released by the Procurator Fiscal.

Recommendation 5

There should be a presumption that the death certificate should be issued when the deceased's body is released by the Procurator Fiscal.

Organ Retention Database

4.6 One obvious defect in the previous arrangements was a lack of any reconciliation process between COPFS and the pathology service providers. If there had been such a process, it would have highlighted that there were organs being held at mortuaries and other establishments where the examination had been completed but the pathologist had not received any notification of the wishes of the nearest relatives for disposal. In addition, there was no internal COPFS reconciliation process. If a centralised record of cases where organs were retained had been held by another part of the organisation, for example at an Area level, then the oversight in the cases referred to previously would have been identified.

4.7 To remedy this deficiency, one of the most significant measures introduced by COPFS following their audit was the establishment of a National Organ Retention Database. The database is held on an Excel spreadsheet and is retained and updated by SFIU National.

4.8 In any case where an organ is retained subsequent to the deceased's body being released, it is incumbent on the SFIU team in each Federation to notify SFIU National to add it to the database. Once it is recorded on the database SFIU National monitors the retention of the organ.

4.9 The new database records the date of post-mortem, who performed it, the type of organ retained, the reason for retention, details of the nearest relative and associated communication, the date that the examination of the organ is complete and can be released to the nearest relatives for burial or cremation or disposal by the pathologist. It also provides a field for any additional information such as the wishes of nearest relatives regarding the disposal of organs^[39].

4.10 As at June 2014, there were 6 cases recorded on the organ retention database. In three cases, the investigation into the cause of death is concluded and COPFS is in contact with the nearest relatives to obtain their wishes on the burial or cremation of the organs. In the other three cases, there is an ongoing investigation or court proceedings.

Organ Retention Notification

4.11 Central to the operation of the national organ database is the notification procedure. In any case where an organ is retained, there must be written notification from the pathologist to the Procurator Fiscal and written acknowledgement by the Procurator Fiscal. When notification that an organ has been retained is received from a pathologist, it should be sent to a nominated person at SFIU National responsible for updating the Organ Retention Database.

Recording Procedures

4.12 With the exception of the death certificate form, we found that recording mechanisms for authorising post-mortems, releasing the body and notification of any organs retained varied not just between the three Federations but even within Federations. The differences are primarily due to the diverse documentation and processes used by different pathology service providers. In addition, a range of different forms and means of communication has evolved between pathology departments and those dealing with death investigation in COPFS, with most deriving from the pre-Federation structure.

4.13 In most jurisdictions notification of organs, retained after the deceased's body has been released, will be recorded on a specific organ retention form - although the forms differ as to the type of information recorded - and they are communicated in a number of different ways - faxed, emailed or sent through the postal system to SFIU.

4.14 COPFS, recognising the inconsistency of practices and formats being used to record the retention of organs, entered into discussion with the pathology service providers to introduce two standardised 'Body Release' forms for use throughout Scotland - one form for cases where organs have been retained and another where no organs have been retained.

4.15 The proposed form to be completed when an organ or organs have been retained contains details of the type of organ retained, where it is stored, when it is likely to be released and a section for the Procurator Fiscal to authorise the release of the body. It does not provide for details of when the examination of the organ is concluded or authorisation regarding disposal of the organ. Some of the current forms in use do provide this information and also record all communication between the Procurator Fiscal, pathologist and the mortuary.

4.16 One disadvantage with the proposal to introduce two forms is that it will result in forms being submitted for every post-mortem (approximately 5,000 a year). There was concern expressed by some pathology service providers that such a proposal may result in the critical form, that is the form advising that an organ has been retained after the deceased's body has been released, being overlooked and not readily identifiable.

4.17 The overriding purpose of any system monitoring the retention of organs is that it must be able to easily identify the exceptional cases where an organ has been retained. In considering how to achieve that aim, there has to be an agreed understanding of the professional responsibilities of the pathology service providers and COPFS.

Responsibilities of Pathology Service Providers and COPFS

4.18 If the pathologist is of the opinion that it is necessary to retain an organ after the deceased's body has been released, the pathologist must inform the Procurator Fiscal and obtain authorisation.

4.19 Thereafter, it is the responsibility of the Procurator Fiscal to inform the nearest relatives, to obtain their wishes regarding the disposal of the organ at the completion of the examination and to communicate their wishes to the pathologist.

4.20 It then falls to the pathologist to dispose of the organ in accordance with the written instruction from the Procurator Fiscal.

4.21 The pathology service providers and those dealing with deaths in COPFS acknowledged and agreed with the above description of their respective responsibilities.

4.22 Proceeding on that agreed understanding and given the extremely low number of organs that will be retained after the deceased's body has been released, in comparison to the number of cases where a post-mortem is instructed, we advocate the implementation of a single organ retention form to be completed in those exceptional cases where an organ is retained.

4.23 Unless notification of retention is given and the organ retention form submitted to the Procurator Fiscal, in all other cases the Procurator Fiscal will be entitled to proceed on the basis that on completion of the post-mortem and a medical certificate with the cause of death being issued by the pathologist, the body is complete and there are no organs retained.

Recommendation 6

COPFS should introduce one national organ retention form to be completed by the pathology service provider and COPFS in any case where an organ is retained after the body is released. The form should contain the following mandatory information:

• details of the deceased
• the type of organ retained
• where it is located
• how long it is likely to be retained
• when examination is complete
• date the body is released
• the instruction on disposal

Good Practice

The hard copy of the sudden death file should be clearly marked to highlight that an organ has been retained. The 'Death Report Task Instructions' which provide step-by-step actions to be taken by staff dealing with deaths investigation should be updated to include a step to advise SFIU National that an organ has been retained.

Good Practice

In any case where an organ is retained and an organ retention form is generated, all correspondence including emails and the organ retention form should be uploaded into the Standard Office System (SOS-R) file containing the death report and associated documentation.

Reconciliation Process

4.24 The organ retention database is the national repository of all data on organs retained and is the source of the information used in the reconciliation process.

4.25 Currently, at the beginning of each month, SFIU National creates a list of outstanding cases from the organ retention database. The list is emailed to all the mortuaries used by the pathology service providers. It is expected that mortuary managers/pathologists will undertake a physical check and send an email confirming that the information is accurate or provide an explanation if it does not accord with their records.

4.26 The information provided includes:

• name of deceased
• type of organ retained
• date of retention
• purpose of retention
• where it is currently held
• likely date of return
• date Procurator Fiscal is notified

4.27 There are some aspects that would benefit from further clarification and more robust procedures. Firstly, not all the pathology service providers appear to be aware that a monthly return is required and, in some areas, the pathology service providers have interpreted the request as only requiring a return if their information does not accord with that contained in the email. There is a lack of clarity in some departments on who is responsible for providing the information to SFIU National and returns are not being received in a timely manner. In at least one entry the information regarding the case was erroneous and there were cases where an instruction on disposal of the organ had been provided by the nearest relatives but the entry had not been removed from the database.

4.28 Given the importance of a robust reconciliation procedure and the small number of cases where organs are retained, there are a number of measures recommended to strengthen the process.

Recommendation 7

For reconciliation purposes, a copy of the national organ retention database should be sent each month to a nominated post holder such as the mortuary manager or the administrative manager for each pathology department.

• The requirement to provide a monthly return, including timescales for returns, should be incorporated into all pathology service providers' contracts.
• There should be an agreed stage when entries are removed from the national organ retention database. For example, when the wishes of the nearest relative have been provided to the pathologist.
• SFIU National should create and maintain operational instructions for duties relating to the operation of the Organ Retention Database.

4.29 The benefit of sending a copy of the database rather than a list of cases is that it will allow any information wrongly entered to be identified quickly by the relevant pathology department and the database will have up-to-date information on the status of the case and helpful commentary such as likely review periods. It also introduces certainty that the data being reconciled by SFIU National and the pathology service providers is the same. Annex C provides a flowchart of the proposed recording process for a retained organ.