Williams GNM Review

Professional regulators should review and where necessary improve the support they provide to patients and family members whose care and treatment is an issue in fitness to practise proceedings against a healthcare professional.

A working group should be set up to set out a clear explanatory statement of the law on gross negligence manslaughter. This working group should involve, at a minimum, representatives from the Crown Prosecution Service (CPS), the coroner services, Treasury Counsel and healthcare defence organisations.

All relevant organisations, including, if appropriate, the Director of Public Prosecutions, should produce or update guidance on gross negligence manslaughter in light of the explanatory statement set out by the working group in 1.1. This will promote a consistent understanding of where the threshold for prosecution for gross negligence manslaughter lies.

The Academy of Royal Medical Colleges, working with professional regulators, healthcare professional bodies and other relevant parties, should lead work to promote and deliver high standards and training for healthcare professionals providing an expert opinion or appearing as expert witnesses. These standards should set out what, in the Academy's opinion, constitutes appropriate clinical experience expected of healthcare professionals operating in such roles. Healthcare professionals providing an expert opinion or appearing as an expert witness should have relevant clinical experience and, ideally, be in current clinical practice in the area under consideration. Additionally, they should understand the legal requirements associated with being an expert witness (including the requirement to provide an objective and unbiased opinion).

Healthcare professionals should be supported and encouraged to provide an expert opinion where it is appropriate for them to do so. Healthcare professional bodies, including Royal Colleges and professional regulators, should encourage professionals to undertake training to become expert witnesses, and employing organisations should be prepared to release staff when they are acting as expert witnesses.

Professional representative bodies and regulators should recognise acting as an expert witness as part of a healthcare professional's revalidation or continuous professional development (CPD) process.

Although our terms of reference were limited to gross negligence manslaughter, we heard evidence of more general concerns about experts. This should be reflected in the Academy's work to develop training for healthcare professionals acting in this capacity.

The Chief Coroner should consider revising the guidance on gross negligence manslaughter in Law Sheet no 1 in light of the explanatory statement set out by the working group under 1.1. We expect coroners will routinely consider this guidance in assessing the facts on whether or not a referral for a criminal investigation should be made.

Building on the work of the Homicide Working Group, police forces across England should consolidate their expertise on gross negligence manslaughter by a healthcare professional through the creation of a virtual specialist unit. This unit would support senior investigating officers by making available the experience of previous gross negligence manslaughter cases in the early stages of an investigation.

Advice to senior investigating officers should be updated to reflect the explanatory statement on gross negligence manslaughter set out by the working group (1.1) and the standards for healthcare professionals providing an expert opinion or appearing as expert witnesses (2.1).

A new memorandum of understanding (MoU) should be agreed between relevant bodies, including the College of Policing, the CPS, the Care Quality Commission (CQC), Health and Safety Executive (HSE) the Healthcare Safety Investigation Branch (HSIB) and professional regulators, in relation to the investigation of deaths in a healthcare setting. As a minimum this MoU should establish a common understanding of the respective roles and responsibilities of the organisations involved, support effective liaison and communications between these organisations, and cover what is expected of expert witnesses, in particular that they should consider the role of systemic and human factors in the provision of healthcare.

Signatories to the MoU should disseminate its contents in order to promote a greater understanding of legal issues among healthcare professionals and of healthcare issues (including systemic and human factors) among prosecuting authorities, the police and coroner services. This would help support the development of a "just culture" in healthcare, which recognises both systemic factors and individual accountability.

Where a suspected gross negligence manslaughter case in a healthcare setting has been referred to the CPS, the CQC must be informed so that it can consider whether to carry out a parallel, but separate, investigation of the healthcare provider to determine the role of systemic and human factors in the incident and to identify any changes which might need to be made. The CQC should also consider the findings of its inspection in deciding whether to undertake any follow up action in relation to the provider and/or any wider review of system issues. The relationship between a criminal investigation and any parallel CQC inspection should be set out in the MoU under 3.4.

There must be a thorough local investigation of all unexpected deaths in healthcare settings, both in the NHS and in the independent sectors. The CQC should consider the effectiveness of such investigations as part of its inspection programme of healthcare providers.

In the case of NHS organisations, investigations into unexpected deaths should be carried out in line with NHS Improvement's Serious Incident framework (SIF). In particular family members, carers or advocates must be involved and supported (e.g. through family liaison) from the outset and be kept informed of progress and the outcome. Investigations must be expertly and objectively overseen and, where appropriate, independently-led. A member of the healthcare provider's Board must be appointed to be responsible for ensuring the SIF is followed in relevant investigations. The outcome of such investigations should be reported to the Board and shared with the relevant regulatory, statutory, advisory and professional bodies. A similar methodology for investigations should be adopted by private healthcare providers.

Healthcare providers should ensure that people conducting investigations have received appropriate training, including on equality and diversity. NHS Improvement's SIF should include guidance on how to consider equality and diversity considerations in investigations, including adherence to appropriate equality and diversity standards such as WRES (Workforce Race Equality Standards) standards for the NHS. Wherever possible the investigation team should include Black, Asian and Minority Ethnic (BAME) representation.

Proposals for the establishment of Healthcare Safety Investigation Branch (HSIB) as an Executive Non-Departmental Public Body should be implemented at the earliest opportunity. HSIB will support improved practice across the NHS by undertaking exemplar investigations and supporting the development of skilled NHS investigations.

Royal Colleges, professional representative bodies and healthcare providers should review the availability of independent support for staff involved in legal and regulatory proceedings.

The Royal Colleges, through the Academy, and professional regulators working with appropriate professional bodies should review and, if necessary, amend guidance on how healthcare professionals carry out reflection, stressing the value of reflective practice in supporting continuous professional development. Guidance on carrying out reflection should take a consistent approach across all healthcare professional groups.

Both prosecuting authorities and professional regulators have been clear that they would be unlikely to use a healthcare professional's reflective material either for a criminal investigation or in considering a registrant's fitness to practise. The professional regulators should clarify their approach to reflective material through guidance.

Those professional regulators that have a power to require information from registrants for the purposes of fitness to practise procedures should have this power modified to exclude reflective material. Registrants will still be expected to co-operate with their regulator in line with their code of practice and to be open and honest with patients (or where appropriate the patient's advocate, carer or family) when something goes wrong with their treatment or care (the professional duty of candour).

The Professional Standards Authority (PSA) should retain its right to appeal a decision of a fitness to practise panel to the High Court on the grounds of insufficient public protection. The duplicate power provided to the General Medical Council (GMC) to appeal decisions of the MPTS to the High Court should be removed. This will ensure a consistent approach to appeals across healthcare professions that are statutorily regulated.

Ahead of the legislative change needed to remove its power of appeal, the GMC should review its processes for deciding when to refer a decision of the Medical Practitioners Tribunal Service so that it is transparent and understood by all parties and involves a group or panel decision, as opposed to lying solely with the Registrar.

Among professionals there is little understanding of what actions by a healthcare professional might lead to the public losing confidence in the profession. The PSA, working with professional regulators, should review how the impact on public confidence is assessed in reaching fitness to practise decisions about individual healthcare professionals, and develop guidance to support consistent decision making in this area.

The PSA should review the outcomes of fitness to practise cases relating to similar incidents and circumstances considered by different regulators. This review should seek to determine the extent and reasons for different fitness to practise outcomes in similar cases and, if appropriate, recommend changes to ensure greater consistency.

We recommend that professional regulators ensure that the healthcare professionals they rely upon for an expert opinion in fitness to practise cases have satisfied the requirements set out in recommendation 2.1.

We support the PSA's intention to introduce, as part of its Standards of Good Regulation, equality and diversity standards for professional regulators.

Professional regulators should ensure that fitness to practise panel members have received appropriate equality and diversity training.

The PSA should review whether the outcome of fitness to practise procedures is affected by the availability of legal representation of registrants. This needs to be considered alongside broader proposals for the reform of professional regulation which seek to establish a less adversarial approach to fitness to practise issues through the use of undertakings and consensual disposal.