Summary of Significant Changes. Policy. Purpose. Responsibilities

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1 This Management Process Description replaces MPD865/1.1 Copy Number Summary of Significant Changes Effective 01/06/ Welsh legislation changes, 3.4 Completion of FRM4039 when coroner/fiscal involvement with potential donors Completing local and national required databases for audit purposes and data collection with regards to coroner/fiscal s restriction/refusal to organ and tissue donation. Policy Organ procurement should only occur after all requirements relating to consent, authorisation or absence of any objection currently in force within the Member State have been met. In the United Kingdom, in some circumstances, it is necessary for the Coroner or Procurator Fiscal (Fiscal) to determine if an objection to solid organ and/or tissue donation will be raised. The Coroner/Fiscal has a legal requirement to do this, and must be satisfied that neither organ nor tissue donation will impede his/her investigation. Therefore, the Specialist Nurse Organ Donation (SN-OD) must ensure that, to the best of their knowledge, all relevant information is relayed to the Coroner/Fiscal Office so that they may make a decision in relation to raising an objection (consent in Scotland) to organ and/or tissue donation proceeding. Purpose To guide the SN-OD on what key information is needed regarding the circumstances surrounding the patient s admission and how this information is documented and communicated to the Coroner/Fiscal Office. So that the Coroner/Fiscal can assess the case and make a decision regarding permission for donation to proceed. Specialist Nurse Organ Donation Responsible Medical Professional (doctor with delegated responsibility from the clinician in charge of the patient s/potential donor s care) Responsibilities To ensure that the removal of organs and/or tissues for donation only occur following Coroner/Fiscal approval for donation, where appropriate. To ensure that all necessary information pertaining to the potential donor s admission has been obtained and communicated to the Coroner/Fiscal to ensure that an informed decision has been made, either directly or via the responsible healthcare professional in the hospital. To discuss the case with the Coroner/Fiscal, confirm the circumstances surrounding the admission of the patient/potential donor, and the decision surrounding the cause of death to be written on the necessary documentation. Author(s): James Van Der Walt Page 1 of 10

2 SN-OD for the purposes of this document the terminology SN-OD will apply to either Specialist Nurse or Specialist Practitioner with the relevant knowledge, skills and training in organ donation, working within NHSBT Organ Donation Services Teams (ODST) Patient - This term refers to the donor/potential donor. Definitions Fiscal MCCD HCP Procurator Fiscal Medical Certificate of Cause of Death Healthcare Professional FRM4039 Coroner/PF Referral Form Department of Health Guidance for Donor Co-ordinators working with Coroners uidancefordonorcoordinatorsworkingwithcoro nersen.pdf Department of Health Aide Memoire for Coroners 1. INTRODUCTION Applicable Documents Exemplar of Section 9 Witness Statement (Form MG11) m/uploads/attachment_data/file/257982/witnes s-statements.pdf Central Office Procurator Fiscal Service Deceased organ donation can occur in a limited set of circumstances, either following the declaration of death/pronouncement of life extinct (in Scotland) following the irreversible cessation of brain-stem function, or the cessation of circulatory function (AOMRC, 2008). In many cases, the circumstances surrounding the death of the patient would lead the medical teams to contact the Coroner/Fiscal. The Coroner/Fiscal has a legal duty to enquire about deaths in his or her jurisdiction where the cause is either unknown, or where the death is violent of unnatural, and any death which occur in prison. 1.2 In any case where the Coroner/Fiscal is involved, including those cases in which the police are involved, the Coroner/Fiscal has the final decision as to whether either organ and/or tissue donation can proceed (DoH, 2010; COPFS, 2004). In order to assist the Coroner/Fiscal make that decision, the SN-OD has an essential role in undertaking a detailed review of the circumstances surrounding the death of the patient, in addition to having discussions with the medical team involved in the care of the potential donor, to ascertain whether the Coroner/Fiscal s involvement is required. 1.3 Following this review the SN-OD must then ensure that the key information necessary is communicated to the Coroner/Fiscal office for a decision to be made, in conjunction with the clinician in charge of the patient s care. This information is then assessed by the Coroner/Fiscal to determine if organ and/or tissue donation can proceed, without compromising any potential investigation undertaken by either the Coroner/Fiscal or the police. It is vital that the SN-OD documents such communication accurately; so that the meaning is clear (NMC, 2009). Author(s): James Van Der Walt Page 2 of 10

3 2 COLLATION OF INFORMATION 2.1 Obtaining an accurate account of the circumstances surrounding the patient s/potential donor s admission, course of illness, diagnosis and history from the critical care clinician and nursing staff is a crucial first step in determining a detailed history. This is an addition to a detailed review of the medical and nursing notes. Particular note should be taken of any surgical procedures and investigations that have taken place following admission. 2.2 Where the death is suspicious, and the police are involved, contact details for the police, including incident numbers and Senior Investigating Officer details should be documented for referral to the Coroner/Fiscal, so that their officers can have separate discussions to aid in reaching a decision in relation to donation. 2.3 When undertaking a review surrounding the patient s admission, a discussion must be held with the clinician regarding the completion of a medical certificate for cause of death. It is appropriate at this point to then ask the clinician if the Coroner/Fiscal needs to be contacted. An agreement and action plan should be made as to who will contact the Coroner/Fiscal in the first instance, and to ensure that a clinician who has treated the patient is available to speak with the Coroner/Fiscal and/or their officers. 2.4 If either the clinician has already spoken to the Coroner/Fiscal in relation to donation, or if the agreement is for the clinician to speak with the Coroner/Fiscal in the first instance, any conversations held should be clearly documented in the patient s medical records, detailing the agreement of which organs and/or tissues can be donated. The SN-OD must have a conversation with the clinician to confirm details of donation, including full or restricted donation, which organs can be retrieved, and any other requests that the Coroner/Fiscal has made. FRM4039 -Referral Form for Coroner/Procurator Fiscal; should be used as a guide, and completed, wherever the Coroner/Fiscal is involved or spoken to about a potential donor. The SN-OD must ensure that a copy of the clinician s medical entry is held in the donor file. 2.5 If there is any doubt as to whether a Coroner/Fiscal should be contacted, best practice would be to make an inquiry to their offices to confirm if the case requires their attention or not. A list of reasons for contacting the Coroner in England and Wales can be found at Appendix 1, for the Procurator Fiscal in Scotland at Appendix 2, and for the Coroner Service in Northern Ireland at Appendix 3. 3 REFERRAL TO THE CORONER/FISCAL OFFICE 3.1 The decision of when to contact the Coroner/Fiscal should be made on a case by case basis. This is dependent upon a number of factors, which include: Whether the case being referred is a potential DBD or DCD; the referral maybe made following declaration of brain stem death or when there is a plan to withdraw life sustaining treatment. For some Coroner/Fiscal Offices this is of vital importance, as there is no formal jurisdiction for a Coroner/Fiscal to agree to organ donation whilst a patient is still alive. However, the Coroner/Fiscal can provide a provisional indication of their views in these cases. There may be some regions with specific Coronial/Fiscal requirements in relation to DCD (DoH, 2008; COPFS, 2004). Some Coroner/Fiscal Offices require all deaths to be reported to them. Other Coroner/Fiscal Offices only require those deaths that fall within their jurisdiction (such as suspicious/traumatic deaths). In addition, the referral timings may vary (some Author(s): James Van Der Walt Page 3 of 10

4 Coroner/Fiscals only wish to be contacted following the family s acceptance/decision to donate, whilst others may wish to be contacted before the outcome of the donation conversation). It is therefore important that the SN-OD team is aware of the criteria of the appropriate referrals for the different Coroner/Fiscal Offices within their geographical regions. This information will be held locally. 3.2 The SN-OD or Clinician should contact the Coroner/Fiscal Office, where possible, during working hours. This will allow for the Coroner/Fiscal to be contacted more easily and enable a more speedy decision to be made. It will also allow for the Coroner/Fiscal office to have discussions with other Coroner/Fiscals, where the initial injury/incident may have occurred outside their jurisdiction. In addition, the Coroner/Fiscal or their officers will also have easier access to the relevant police officers to discuss the case in further detail, where necessary. If this is not possible, then the on call Coroner/Fiscal and/or their officers should be contacted through the agreed communication channels. 3.3 The initial information to be supplied to the Coroner/Fiscal should include, as a minimum, the following information: Name of donor hospital (the Coroner/Fiscal may have jurisdiction over a number of sites) Name of referring unit (critical care area) Potential donor name, date of birth, hospital number, NHS number (Scotland) Address (including Post Code) Next of kin details, including name, address (including post code) and contact number(s) GP details, including name (where possible), practice name, address and contact number(s) Description of initial incident/injury including location (to determine if other Coroner/Fiscal is potentially involved) Detail of injuries/illnesses including radiological examination results (x-rays/ct scan/mri reports) Detail of any surgical intervention/procedures including dates Availability of pre transfusion blood sample for Coroner/Fiscal use to test for toxicological testing All other past medical history Details of police involvement including investigating team details, Incident Numbers, Senior Investigating Officer contact details (where possible) Date and time of tests to confirm death by neurological criteria (for DBD) Name and position of medical staff performing these tests (for DBD) Date and time of decision to withdraw life sustaining treatment (for DCD) Name of clinician(s) making decision to withdraw life sustaining treatment (for DCD) Name of clinician to speak with Coroner/Fiscal and who will provide relevant criteria to complete medical certificate for cause of death Patient s/potential donor s wish to be an organ and/or tissue donor (if known, to include if deemed consent would apply to the patient) Family s wishes in relation to organ and/or tissue donation (where appropriate) Organs and tissue suitable for donation All other relevant information in relation to donation (where appropriate) Name of SN-OD and contact details 3.4 The SN-OD must use FRM4039-NHSBT Referral Form for Coroner/Fiscal to ensure that all relevant information is given to the Coroner/Fiscal office. The SN-OD must keep a detailed account of all conversations with the Coroner/Fiscal office, and these should be entered into the medical notes and the donor file. Author(s): James Van Der Walt Page 4 of 10

5 3.5 Either the clinician or the SN-OD may instigate the initial conversation with the Coroner/Fiscal, dependent upon regional practice and Coroner/Fiscal direction. If the clinician is undertaking the initial conversation, then best practice would indicate that the SN-OD is available to answer any donation relation queries. If not available, the Clinician should clearly document in the medical records any conversation held with the Coroner/Fiscal office. 3.6 If the SN-OD is undertaking the initial conversation/referral to the Coroner/Fiscal office, then they must ask the Coroner/Fiscal office if they wish to speak with the Clinician at this time. If they do not, the SN-OD must document this, and inform the Clinician of this decision. 3.7 The SN-OD should ask the Coroner/Fiscal or their officer if they are able to give a timeframe for a decision to be reached, if possible. An agreement should be reached as to a timeframe for a response and/or a plan. If there is any significant delay in undertaking a decision there may be an impact upon the SN-OD determining if an approach to the family should be made prior to a Coroner/Fiscal decision. Further advice can be sought from the Organ Donation Services Team (ODST) on-call team manager and/or regional manager. 3.8 If the timeframe for a decision has elapsed, and it is appropriate, then the SN-OD should also contact the Coroner/Fiscal or their officer for further advice. 4 DECISION FROM THE CORONER/FISCAL 4.1 The SN-OD will receive communication via telephone from either the Coroner/Fiscal or their officer in relation to their decision for organ and/or tissue donation. In Scotland written confirmation from the Fiscal involved is required HT (Scotland) Act 2006 as soon as is practicably possible. Usually this is faxed to the donating unit. 4.2 The SN-OD must document clearly the Coroner/Fiscal office decision in relation to donation and take appropriate action as directed by the Coroner/Fiscal office. 4.3 Once a final decision has been given by Coroner/Fiscal office, clarify if the Coroner/Fiscal or their officer wishes to speak with the responsible Clinician at this time. The SN-OD must ensure that clear documentation is entered into the patient s medical records and the donor file, in relation to any conversations held between the Coroner/Fiscal and the clinician. 4.4 On occasion the Coroner/Fiscal may wish to speak to a retrieving surgeon(s) with certain stipulations and requests in relation to the retrieval operation. 4.5 In Scotland the Fiscal office must confirm their decision in relation to organ and/or tissue donation in writing (fax/ ) as soon as practicably possible. Coroner/Fiscal Consent 4.6 If the Coroner/Fiscal agrees to organ and/or tissue donation, the SN-OD should document clearly the decision in the patient s medical records and the donor file. The SN-OD must confirm with the Coroner/Fiscal office any requirements that they may have including: Follow up fax/telephone conversation regarding outcome of donation, including non proceeding outcomes (DCD or DBD) Any relevant documentation to be completed by either SN-OD, Clinicians and Retrieval Surgeons (example, Section 9 Witness Statements - Form MG11) and forwarded to Coroner/Fiscal Office Author(s): James Van Der Walt Page 5 of 10

6 Attendance of pathologist, Coroner/Fiscal officer or police photographer during retrieval operation Follow up communication from SN-OD regarding recipient outcomes. 4.7 The SN-OD must inform the Clinician, donor family (at the appropriate point in the approach/donation conversation) and all other relevant parties (e.g. Police) of the outcome of the Coroner/Fiscal decision, prior to continuing with the donor process. Coroner/Fiscal Refusal 4.8 If the Coroner/Fiscal or their officer refuses organ and/or tissue donation, the SN-OD should ascertain the reasons why donation cannot proceed. Once the reasons have been given by the Coroner/Fiscal the SN-OD should ask if there is any additional information that they can provide to assist the Coroner/Fiscal in their final decision. Examples of solutions to perceived barriers to donation can include: Where directed by regional protocol if a Coroner Officer/Fiscal Officer has objected to donation, the SN-OD should request to speak to the Coroner/Fiscal to further discuss the rationale behind the decision. Whilst full organ donation may not be allowed, restricted permission may be an acceptable compromise for the Coroner/Fiscal. If restricted permission is granted a Clinical Governance form for Coroner/Fiscals should be completed as soon as is practicable. This should be forwarded to the relevant ODST team manager and Clinical Governance Management Group for review. Attendance of forensic and/or Home Office/Crown Office pathologist the attendance of such healthcare professionals can allow for an accepted form of post mortem to take place. If this is something the Coroner/Fiscal agrees to, further advice should be sought from the on call ODST team manager and/or regional manager. Completion of relevant legal paperwork by retrieval surgeons (Section 9 Statements (Form MG11) - voluntary statements provided in compliance with the Criminal Justice Act (1967)) if required by the Coroner/Fiscal (an exemplar of this form can be found at ( Attempts to preserve evidence specialist teams within the police service are able to ensure that evidence is preserved, which will allow donation to proceed. Discussions should be held by the SN-OD with the police teams to consider this possibility. Further discussions with lead clinicians in the care of the patient the injuries to the potential donor may have solely occurred in one area, and the cause of death, whilst unnatural, is clear. Such discussions between clinicians and the Coroner/PF office may assist in permission being granted for donation to proceed. 4.9 Expert advice should be sought by the SN-OD from either the ODST team manager and/or regional manager, where necessary If, following all discussions with the Coroner/Fiscal, an objection is maintained by the Coroner/Fiscal; the SN-OD must document all discussions clearly in the patient s medical records and for the donor file. Author(s): James Van Der Walt Page 6 of 10

7 4.11 The SN-OD must tell the clinician, the patient s family and all other relevant parties (including relevant ODST management) of the Coroner/Fiscal s decision, and confirm that donation cannot proceed in this case As soon as it is practical, the SN-OD must complete the relevant local and national required databases for audit purposes and data collection with regards to coroner/fiscal referral and coroner/fiscal restriction/refusal to organ and tissue donation. 5 COMMUNICATION OF CORONER/FISCAL DECISION TO THE FAMILY 5.1 There will be circumstances in which either the potential donor family has approached the critical care team in relation to organ and/or tissue donation, or the family has been approached and given verbal consent/authorisation or deemed consent can be applied for donation to proceed. In these cases the SN-OD, with the relevant Clinician, should inform the family about the Coroner/Fiscal s decision in relation to donation. 5.2 If the outcome of the decision is to proceed, the SN-OD should inform the family of the decision whilst continuing with the donation process. Coroner/Fiscal details should be given to the family, where instructed to do so by the Coroner/Fiscal office, and they should be informed that a Coroner/Fiscal Officer will be in contact with them to discuss the case. 5.3 If the outcome of the decision is not to proceed, the SN-OD should inform the family of their decision. Best practice is for the SN-OD to explain that all possible avenues for donation to proceed were explored, however, due to the nature of the injuries/illness/circumstances, the Coroner/Fiscal has not been able to allow donation to occur in this instance. Whilst working within the boundaries of their knowledge and experience, all appropriate questions from the family should be answered. When instructed to do so by the Coroner/Fiscal office, their contact details should be given to the family members. The SN-OD will advise the family that a Coroner/Fiscal officer will be in contact to discuss the case, and that they will be able to ask further questions at that time. 5.4 If a family liaison officer from the police is also involved, best practice indicates that the SN-OD have a conversation with them, prior to giving the Coroner/Fiscal decision to the family. It may be that the police officer will take the lead on the conversation, regarding future contact with the Coroner/Fiscal office, as they will be best placed to provide ongoing guidance and support to the family. 6 RECORDING OF INFORMATION 6.1 The SN-OD must record details of all conversations with the Coroner/Fiscal, Police, patient/donor family, clinicians and any other relevant parties undertaken. These details must be located in the patient s/potential donor s medical notes and, where one exists, in the donor file and Electronic Offering System. All documented entries must be signed and dated. Author(s): James Van Der Walt Page 7 of 10

8 APPENDIX 1 Deaths which should be reported to the Coroner in England and Wales (DoH, 2008) The cause of death is unknown It cannot readily be certified as being due to natural causes The deceased was not attended by a doctor during their last illness or was not seen within the last 14 days or viewed after death There are any suspicious circumstances or history of violence The death may be linked to an accident (whenever it occurred) There is any question of self neglect or neglect by others The death has occurred or the illness arisen during or shortly after detention in police or prison custody (including voluntary attendance at a police station) The deceased was detained under the Mental Health Act The death is linked with an abortion The death might have been contributed to by the actions of the deceased (such as a history of drug or solvent abuse, self injury or overdose) The death could be due to industrial disease or related in any way to the deceased s employment The death occurred during an operation or before full recovery from the effects of an anaesthetic or was in any related to the anaesthetic (in any event a death within 24 hours should normally be referred) The death may be related to a medical procedure or treatment whether invasive or not The death may be due to a lack of medical care There are any other unusual or disturbing features to the case The death occurred within 24 hours of admission to hospital, unless the admission was for the purposes of terminal care It may be wise to report any death where there is an allegation of medical mismanagement NOTE: SN-ODs MUST BE AWARE OF THEIR REGIONAL CORONERS REFERRAL PATTERNS AND CRITERIA, HOWEVER, IF IN ANY DOUBT A CORONER S OFFICE SHOULD BE CONTACTED TO DISCUSS THE CASE. Author(s): James Van Der Walt Page 8 of 10

9 APPENDIX 2 Deaths which should be reported to the Procurator Fiscal in Scotland any death caused by an accident arising out of the use of a vehicle including an aircraft, a ship or a train; any death of a person while at work; any death resulting from an accident in the course of work or arising out of industrial disease or poisoning ; any death due to poisoning; any death where the circumstances indicate that suicide may be a possibility; any death under medical care; any death resulting from an accident; any death following an abortion or attempted abortion; any death where the circumstances seem to indicate fault or neglect on the part of another person; any death occurring while the deceased was in legal custody; any death of a new born child whose body is found; any death of a child from suffocation including overlaying; any death which may be categorised as due to sudden death in infancy syndrome or sudden unexplained death in infancy (SUDI). The term sudden unexplained death in infancy (SUDI) is now used by many paediatricians in preference to SIDS (sudden infant death syndrome). This terminology recognises that the mechanism for such deaths is not fully understood and that there may be a number of causes which are not attributable to a single syndrome. any death occurring as a result of food poisoning or an infectious disease; any death by burning or scalding or as a result of a fire or explosion; any death of a foster child; any death of a child in the care of a local authority; any death of a child on a local authority "At Risk" register; any drug related death; any death, if not already reported, where a complaint from the next of kin is received by a Health Board or NHS Trust and the complaint is about the medical treatment given to the deceased with a suggestion that the medical treatment may have contributed to the death of the patient; any death which occurred in a GP's surgery, Health Centre or similar facility; any other death due to violent, suspicious or unexplained cause; (COPFS, 2004) NOTE: SN-ODs MUST BE AWARE OF THEIR REGIONAL PROCURATOR FISCALS REFERRAL PATTERNS AND CRITERIA, HOWEVER, IF IN ANY DOUBT A PROCURATOR FISCAL S OFFICE SHOULD BE CONTACTED TO DISCUSS THE CASE. Author(s): James Van Der Walt Page 9 of 10

10 APPENDIX 3 Deaths which should be reported to the Coroner Service in Northern Ireland There is a general requirement under section 7 of the Coroners Act (Northern Ireland) 1959 that any death must be reported to the Coroner if it resulted directly or indirectly, from any cause other than natural illness or disease for which the deceased had been seen and treated within 28 days of death. Deaths should be referred to the Coroners Service if a medical practitioner has reason to believe that the deceased died directly or indirectly: This list is not exhaustive: As a result of violence or misadventure or by unfair means As a result of negligence, misconduct or malpractice of others From any cause other than natural illness or disease From natural illness or disease for which the patient had not been seen and treated by a registered medical practitioner within 28 days prior to their death In such circumstances as may require investigation In prison or in police custody. A death in hospital should be reported if: You suspect that the deceased may have died as a result of medical negligence or misadventure The death occurred before a provisional diagnosis was made, and the GP is not willing to certify the cause The cause of death is unknown The patient died as the result of the administration of anaesthetic. The General Register Office currently has a statutory duty to report certain types of deaths to the coroner - for example, where it appears that the death occurred during an operation, and deaths due to industrial disease. (Section 7 of the Coroners Act (Northern Ireland) 1959) NOTE: SN-ODs MUST BE AWARE OF THEIR REGIONAL CORONERS REFERRAL PATTERNS AND CRITERIA, HOWEVER, IF IN ANY DOUBT A CORONER S OFFICE SHOULD BE CONTACTED TO DISCUSS THE CASE. Author(s): James Van Der Walt Page 10 of 10