Royal Liverpool Children's Inquiry

Serious Incident Procedures should be developed and put in place.

In the event of a serious incident the Chief Executive and Trust Board shall devise a suitable Serious Incident Procedure similar to those already in place for major disasters and review it from time to time making any necessary alterations.

When the procedure has been devised and prior to implementation the NHS Executive Regional Office shall assess its suitability and thereafter manage its performance, devising and instigating any necessary alterations from time to time.

In devising a Serious Incident Procedure the Chief Executive and Trust Board shall consider the need for a serious incident team independent of the hospital.

In devising a Serious Incident Procedure the Chief Executive and Trust Board shall consider the need for urgent professional counselling: – A proportion of individuals within any group is always likely to require psychological support in the aftermath of disaster. – An individual within the serious incident team shall be nominated to take responsibility for the arrangements and the identification of all those in need. – Suitably trained practitioners shall provide the counselling.

In devising a Serious Incident Procedure the Chief Executive and Trust Board shall take advice from and where necessary include within the serious incident team appropriate experts in bereavement, pathological reactions to bereavement and therapy.

The Chief Executive and Trust Board shall make available suitably trained staff for implementing the Serious Incident Procedure.

The Chief Executive and Trust Board shall inform all staff when a Serious Incident Procedure is in force.

The Chief Executive and Trust Board shall ensure the proper debriefing and support of all staff associated with a serious incident.

Universities and other public bodies shall adopt compatible procedures when acting in conjunction with an NHS serious incident.

Records should be reviewed and updated and an audit trail should be developed and put in place.

The Chief Executive and the Trust Board shall review and update medical and pathology records to include, preferably on computer and cross-referenced, the following information: – name, medical record reference number and date of birth; – date, place of death and death certificate; – name and address of next of kin; – whether Coroner’s or hospital post mortem examination; – date of consent for hospital post mortem examination; – names of pathologist and those in attendance; – post mortem examination reference number; – date of examination; – date of preliminary/final post mortem reports; – date histology completed; – record of specific instructions from the Coroner or clinicians; – record of retained organs, samples, wax blocks, slides, photographs, X-rays, date and method of dispersal or disposal; – case notes; – signed consent form; – copy of any other relevant correspondence or notes; – name and address of general practitioner; – date post mortem report sent to general practitioner; – record of communication of findings to the next of kin.

University records shall provide a confidential audit trail back to the clinical record.

University records shall identify receipt, use, dispersal and ultimate disposal of any organ or sample.

every hospital keep proper records (preferably computerised) as to the source, consent to retain, usage and disposal of organs and tissue;

every authorisation for release of organs for burial or cremation must not be completed until the content of the container is confirmed and the form counter-signed;

a moratorium must be declared if records of organ retention are inadequate during which there should be an immediate cataloguing of organs retained;

parents must never again be drip-fed information but should be kept fully informed.

Whatever the underlying contractual position, the relationship between Universities and Trusts, in respect of individuals and departments with dual clinical and academic functions, shall be one of the utmost good faith in both directions.

The duty of utmost good faith shall require either party to disclose to the other any substantial matter relating to the performance of the individual or department, whether clinical or academic.

Where there is any doubt as to whether a matter is of a substantial nature, if it relates to patient care the doubt shall always be resolved in favour of disclosure.

The appointment of clinical academics shall be approached with fair representation on each side reflecting the proposed split between clinical and academic sessions.

The appointment of external advisors shall be approached on the basis that they are truly external, if not strictly independent in a legal sense. There is no point having external advisers as ‘window dressing’ for a fixed internal view. Where they or representatives of the Royal Colleges give advice, proper weight shall be given to that advice. In giving advice, external advisers shall bear in mind the paramount requirement of patient care where there is a conflict of interest.

A single job description for clinical academics shall be drawn up jointly to represent a fair and realistic expectation of the work envisaged by both parties.

There shall be a joint procedure for disciplinary action against an individual perceived to be failing. It shall contain provision for immediate suspension from patient care as a minimum, irrespective of academic requirements and positions.

There shall be formal annual appraisal of an individual by both parties. They shall share their information in line with the duty of utmost good faith in order to draw up a joint statement of aims in the following 12 months against which the next appraisal is to be judged.

Where there is disagreement each party shall reconsider bearing in mind that patient care is of paramount importance. In the event of continued disagreement an arbitrator may be appointed, but in any case the Trust shall take immediate steps to secure proper patient care.

The relationship between Universities and funding bodies shall be of the utmost good faith and similar considerations shall apply.

Where a new venture, such as the establishment of a Chair or department, is contemplated, both parties where appropriate shall consider in detail the aims and resources available and draw up a realistic business plan before any final commitment is made. As in all these matters, if patient care is to be included in the venture, patient care shall be paramount in its consideration.

There shall be close performance management of any new venture in its early stages and appropriate steps taken to modify the business plan as required.

Any substantial alteration in an existing venture shall be treated as if a new venture.

Where there is good reason to believe that an individual or department may be failing and affecting patient care, it shall be the duty of the Trust with the co-operation of the university, and if appropriate on a joint basis, to investigate. Investigation shall continue until the problems are identified or it is found that in reality no problem exists. Where appropriate, independent outside assistance shall be obtained.

Where problems are identified a plan, jointly where necessary, shall be drawn up to resolve them as soon as possible.

If no solution is found after all diligent attempts, the parties should keep records of their attempts and the reasons why they have failed, such records to be lodged by way of report to the relevant NHS Executive Regional Office.

No clinician shall be appointed to a position of managerial authority in a hospital without having relevant clinical experience for the position.

No clinician should take effective control of a management position until trained in all necessary management techniques and in any relevant legal requirements.

No clinician shall be asked to take on responsibilities that impair the ability to carry out patient care to the appropriate standard.

Hospital managers shall be of a suitable background and calibre for the role expected of them, provided with all necessary training (including continued education) and themselves regularly appraised for the quality of their performance.

Hospital managers without medical qualification shall seek medical advice on matters requiring it. If there is doubt as to the need for advice on any matter relating to patient care, the doubt shall be resolved by seeking advice.

While hospital managers will usually seek medical advice from the medical director or clinical directors in the first instance, if any substantial doubt remains they shall seek advice from independent specialist medical advisers or the Royal Colleges, whether directly or through their regional advisers.

The Department of Health, the Royal Colleges and medical schools shall instruct members of the medical profession in the precise terms and provisions of the Coroner’s Act 1988 and in particular the circumstances in which it is obligatory to report cases to the Coroner.

Clinicians shall give the following basic information to the next of kin when a Coroner’s post mortem examination is to be performed. – The nature of the examination, including the need to open the body and to remove and weigh organs. – The need for samples and possible retention of organs.

Clinicians wishing to retain organs or samples after the end of the Coroner’s process for the purposes currently allowed under the Human Tissue Act 1961 shall follow the Recommendations in Chapter 10.

Clinicians shall not mention to the next of kin the possibility of an examination under the Coroner’s jurisdiction unless the death is reportable to the Coroner.

Clinicians requesting a hospital post mortem examination after the Coroner has declined to authorise an examination shall make it clear to the next of kin that there is no compulsion remaining for such an examination.

Clinicians shall explain the contents and implications of a Coroner’s post mortem report to the next of kin as if the examination had been carried out as a hospital post mortem examination on their own recommendation.

The Coroners’ Society shall instruct Coroners that: – in the proper exercise of their judicial discretion, the decision to order a post mortem examination is not to be delegated to Coroner’s Officers and Deputy Coroners must be available at all times; – organs are not to be retained unless relevant to establishing the cause of death and only when specified by the pathologist in writing.

The Home Office and the Coroners’ Society shall ensure all necessary medical education for Coroners.

The Home Office and the Coroners’ Society shall ensure all necessary training of Coroner’s Officers and ancillary staff.

Coroners shall be introduced, their function and procedures explained and the next of kin invited to express any specific concerns and requests.

If a decision is made to authorise a post mortem examination Coroners shall ensure that the next of kin are advised of: – the reasons for authorising the post mortem examination; – their right to ask the Coroner that the examination be carried out by a pathologist independent of the hospital in which the deceased died; – the place and time of the examination and the identity of the pathologist; – the nature of the examination, including the need to open the body and to remove and weigh organs; – the need for samples and possible retention of organs; – their option to delay the funeral, while the pathologist fixes and examines any organs, to enable the return of the organs to the body for burial or cremation; – their option for a funeral without the return of the organs, in which case they shall be invited to consent to respectful disposal by the Coroner; – their option to make their own arrangements for respectful disposal of the organs.

If a decision is made not to authorise a post mortem examination, Coroners shall notify the next of kin of that decision and give sufficient reasons for the decision.

Coroners shall ensure the expeditious examination and recording of samples and organs.

Coroners shall establish efficient systems for securing final post mortem reports following histological examination.

Coroners shall ensure that all existing retained organs, tissue, blocks, slides, photographs and X-rays are specified within any preliminary and final post mortem reports.

The Royal College of Pathologists shall instruct all practising histopathologists that they shall not retain samples and organs beyond those reasonably incidental to establishing the cause of death unless there is also written consent properly obtained under the Human Tissue Act 1961.

The Department of Health, the Royal Colleges and medical schools shall instruct members of the medical profession in the precise terms and provisions of the Human Tissue Act 1961, on the basis of our analysis, and the need for strict compliance.

The Human Tissue Act 1961 shall be amended to provide a test of fully informed consent for the lawful post mortem examination and retention of parts of the bodies of deceased persons. While we have concluded that there has been little difference between ‘lack of objection’ and ‘informed consent’ in practical terms for the next of kin, it is important that the law and future practice are brought into line and updated.

The class of persons relevant to the obtaining of fully informed consent shall be defined as the ‘next of kin’.

The class of ‘any surviving relative’ shall no longer be relevant to post mortem examination.

There shall be a programme of health education for the public relevant to the medical need for continued post mortem examination and access to organs and samples for therapeutic, educational and research purposes.

The Department of Health, the Royal Colleges and medical schools shall provide training for all those involved in obtaining fully informed consent.

The Human Tissue Act 1961 shall be amended to impose a criminal penalty by way of fine for breach of its provisions in order to encourage future compliance.

Guidelines relating to the requirements of the Human Tissue Act 1961 and the obtaining of fully informed consent shall be drawn up and provision made for breach to result in disciplinary proceedings which could lead to suspension, dismissal or financial penalty.

The Human Rights Act 1998 makes provision for an effective remedy other than in criminal proceedings. If breaches of the Human Tissue Act 1961 amount to breaches of the Human Rights Act 1998 consideration shall be given to incorporating a financial remedy with the Human Tissue Act 1961 itself. If necessary, reference should be made to the Law Commission.

Following examination of the retained organs or tissue, there should be a meeting between the clinician and parents and referral for genetic counselling or other specialist advice if appropriate.

Once fully informed consent is obtained for research purposes, the researchers are entitled to remain in possession of the material retained while research continues. We recommend this extends to accessing archives and DNA analysis. All research remains subject to ethics committee approval.

Local ethics committees be given a supervisory role to police approved research.

Explaining the circumstances of death, identifying when, where and who was present.

Arranging and attending a meeting for relatives with anyone who was present at the death if requested.

Encouraging a meeting between relatives and the treating clinician to explain the clinical circumstances of death and if requested arranging and attending the meeting.

Ensuring that relatives have a full explanation of the reasons for post mortem examination including therapeutic, medical education and research.

Explaining the need for consent to carry out a hospital post mortem examination (HPM) and the retention of organs.

Explaining that consent is necessary for the retention of organs following a Coroner’s post mortem examination (CPM) and that the consent must be obtained before the CPM is undertaken.

Ensuring relatives have sufficient time, privacy and support to reflect upon the request for consent to an HPM or the retention of organs following a CPM or an HPM.

Ascertaining whether the clinician will attend post mortem examination.

Facilitating meetings between parents, clinician and pathologist as appropriate.

Noting discussions between relatives, clinicians and pathologists and providing a copy to each party involved.

Developing and using information packs for relatives on all aspects of death in hospital.

Assisting relatives in the following practical matters: – collecting the deceased’s personal belongings and arranging return to relatives; – ensuring provision of certificate of death and the formal notice; – explaining the procedure to register the death; – providing support in attending the registry office if requested; – arranging contact with funeral director; – arranging contact with hospital chaplain and/or local priest as required; – contacting the Coroner’s office as appropriate; – offering to attend if contact with police necessary; – ensuring that the General Practitioner is informed; – ensuring that schools are informed as appropriate (including the schools of siblings); – assisting the relatives in informing other persons, including other relatives, friends and employers, of the death and its consequences; – assisting the relatives in dealing with the Benefits Agency, insurance company, housing matters; – assisting the relatives to place announcements in newspapers if wished.

Discussing counselling or long-term support needs with relatives, including the needs of wider family members and making contact with appropriate counselling/support agencies if requested.

Ensuring that relatives are aware of the full range of counselling/support resources available including those external to the hospital and bringing these matters to the attention of the relatives.

Accessing translation/interpreting services including services for people with hearing or visual impairment and providing appropriate written/taped information.

Assisting with any other individual problem presented by relatives in consequence of death.

Undertaking general liaison duties.