Legislation to protect ‘reflective practice’ records from disclosure
Healthcare Regulatory Partner Simon Turner provides an overview of the Hamilton review report and its recommendations.
A requirement on the GMC to obtain two concordant expert reports before bringing a clinical conduct/competence case; and a requirement upon coroners to consult with the Chief Coroner when considering police referral, are among 29 wide-ranging recommendations made by the GMC commissioned ‘Hamilton’ review of gross negligence manslaughter (GNM) and culpable homicide (Scotland) published this month. Healthcare Regulatory Partner Simon Turner provides an overview of the Hamilton review report and its recommendations.
The review (led by assistant coroner and former cardiac surgeon Leslie Hamilton with a 10-member panel) was commissioned by the GMC in 2018 following widespread concern about the case of Dr Hadiza Bawa-Garba, a senior trainee paediatrician newly returned from maternity leave at the time of her involvement in the death of 6-year old Jack Adcock, which led to her conviction for GNM. Her registration was subsequently suspended by an MPTS panel, a decision challenged by the GMC in a High Court appeal, leading to her erasure. This was later overturned in the Court of Appeal.
Although outcry around that case was one of the catalysts for the review, the report makes clear that the review panel have not considered the details of that or other cases where doctors have been convicted of GNM. Instead it has sought ‘to examine the broader issues raised by those cases in which serious incidents leading to patient deaths are brought into the criminal and the regulatory arena and the wider system in which they occur’. Changing the law was also ‘not within the remit or competence of the review’. Instead the purpose was, the report states, to address a ‘toxic fear’ in the profession following the Bawa-Garba case by shining a light on ‘how the system currently operates and how it is seen by those working within it’ and to make recommendations ‘aimed at the better application of a just and fair culture when things go wrong’.
The resultant 29 recommendations are wide-ranging in their scope. They encompass organisations from the GMC itself to healthcare providers, coroners, the police/CPS and those who represent doctors. Many of the recommendations echo those of the Williams review of June 2018 and many will prompt considerable debate in the profession. Some of the key findings and recommendations from the 80-page report ‘Independent Review of Gross Negligence Manslaughter and Culpable Homicide’ (June 2019), are explored below.
The environment of medical practice; systemic failures, corporate accountability and embedding a just culture
The review panel heard evidence about the impact of systems pressures on doctors to maintain standards and their fears of being blamed and prosecuted for making a mistake. Acknowledging that catastrophic harm to patients is very rarely the result of an error made by a single individual; the panel recognised that typically, it involves the alignment of a series of weaknesses and failures across a system. Blaming an individual for those wider failings is, the panel asserts, unlikely to encourage candour when things go wrong, nor support learning and prevention of future harm.
Consequently, the panel recommended, echoing the Williams review, that where a doctor is being investigated for gross negligence manslaughter, ‘the appropriate external authority should scrutinise the systems within the department where the doctor worked’. In cases where the doctor is a trainee, ‘this should include scrutiny of the training and education environment by the bodies responsible for education and training’. (Recommendation 10)
Noting that understanding human factors (ergonomics) is increasingly prominent in organisations’ thinking about how to manage risk and respond to harm, the review panel considered it equally relevant to investigations in the criminal and regulatory arena. The panel also explored the lack of corporate manslaughter prosecutions against healthcare service providers, opining on evidence heard as to the difficulty of proving ‘a direct causal link between high level policy decisions and the death of an individual patient’.
Whilst acknowledging ‘there must, however, be an impetus for corporate accountability and learning’, the review panel stated that calling for more prosecutions for corporate manslaughter is not the answer. “If blaming individual clinicians is seen as unfair and a barrier to candour and learning, shifting the blame in order to criminalise managers is no better. If we truly wish to learn, not blame, we cannot simply point the finger at a different individual and imagine the problem is solved’.
The panel endorsed the National Confidential Enquiry into Patient Outcome and Death and noted the recommendation of the recently published review of the ‘Fit and Proper Person Test’ for directors of NHS bodies in England. The review panel opined that, in England, consideration should be given to whether the newly established Healthcare Service Safety Investigation Branch should be part of any scrutiny to help ensure that lessons are learned and disseminated.
Medical expert evidence
The panel recognised the opinions of medical experts regarding the standard of care provided ‘can be pivotal to the outcome of the case’, whilst acknowledging ‘widespread lack of confidence among doctors in a system that is reliant on the confidence placed in experts’.
This lack of confidence flowed from, the review panel noted, concerns surrounding the difficulty of finding suitable experts; the expertise of those who put themselves forward; complaints about their objectivity and lack of familiarity with the reality of practice in the relevant field at the relevant time. Echoing the Williams review, the panel noted concerns as to the readiness of experts to tailor their opinions according to clients’ needs, failure to understand their role in the legal process, and the lack of quality assurance of their work. ‘The scale of the concerns voiced to us cannot be ignored’, the panel asserted.
Noting these issues persist despite existing process rules and guidance available to experts, the panel endorsed the Williams review recommendation, in the absence of a system of accreditation, that the Academy of Medical Royal Colleges ‘should lead work to promote and deliver high standards and training for healthcare professionals providing expert opinion or appearing as expert witnesses’. The panel also endorsed the Williams review recommendation that colleges and specialty associations should encourage their members to provide expert opinion. Allied recommendations included the need to require those providing expert witness reports/evidence:
- to state in specific sections of their report the basis upon which they say they are competent to provide an expert opinion on the
- matters in question and
- to state where their views fit on the spectrum of possible expert opinion within their specialty.
- to calibrate their reports to indicate, with reasons, whether an individual’s conduct was, in all the circumstances, within the
- standards that could reasonably have been expected, below the standard expected; far below the standard expected; or whether the individual’s conduct was [using the language applied in GNM case-law] ‘truly exceptionally bad’.
In response to the concern about experts distant from the realities of practice, the review panel recommended that doctors should only provide expert opinion to the coroner, procurators fiscal, police, CPS, GMC or to the criminal court on matters which occurred while they were in active and relevant clinical practice (Recommendation 12).
Recognising there will be some skepticism from the profession, the panel nevertheless commended the GMC as the only organisation they had seen which operates a systematic means of assuring the quality of its experts. This was linked to the recommendation that the GMC should make transparent its processes for recruitment and quality assurance of those doctors providing expert reports. It should also explore how it can support just decision making in other parts of the system by giving access to its pool of medical experts to the police, procurator fiscals, coroners, defence and prosecutors.
Finally in considering a requirement in criminal and/or regulatory proceedings for two concordant expert opinions before proceeding, the panel noted that the arguments for and against are finely balanced. They nevertheless considered there would be value in exploring the efficacy and cost-effectiveness of having this requirement in criminal and/or regulatory prosecutions. At recommendation 14, they concluded that ‘any decision to bring a misconduct case about clinical competence to the MPTS reliant on expert evidence should require the support of two expert opinions. The GMC should assess the efficacy and cost-effectiveness of using concurring expert opinion from two relevant medical experts to inform its fitness to practise investigations in cases raising questions about clinical competence’.
Processes leading up to criminal investigation
The panel noted with concern that despite various frameworks and guidance in all four countries of the UK, they had heard repeatedly that the quality of local level investigations carried out is ‘inconsistent and often poor with damaging consequences for the staff involved’.
They observed that ‘lack of confidence in local processes contributes to a more general sense of embattlement in an already hard pressed medical profession’, raising the issue of proper recognition of the distress of the healthcare team involved and concerns around individuals’ exclusion from, or lack of information about the process, or insufficient access to advice about their rights.
Two key issues were identified - the composition of the local investigation team and the (lack/quality of) training of investigators. A linked concern was the lack of time (with many investigators combining the role with their clinical ‘day job’). The (lack of) independence of the investigating team was also highlighted as a key issue, the panel asserting that it is not practical or affordable to institute a full external inquiry after every significant incident, but that in the case of an unexpected death ‘there is a need for greater externality’. Again, the panel saw the HSIB as potentially playing an important role.
The panel highlighted the need for ‘a just culture focused on learning not blaming’, albeit recognising the potential dissonance of this with processes leading to disciplinary or criminal proceedings. Nevertheless, at recommendation 15, the panel clearly asserts its view that ‘Improvements in patient safety are most likely to come through local investigations into patient safety incidents focused on learning not blame’. Recent developments in the frameworks for such investigations were endorsed, in particular the fact that they ‘emphasise the need for the investigation team to have the time and the appropriate experience, skills and competence (including understanding of human factors) to undertake investigations, and the necessary degree of externality to command confidence in the process’.
Noting that local implementation of national policies is patchy, recommendation 16 urges appropriate authorities in the four UK countries to ‘quality assure the effective application of local investigation frameworks for patient safety incidents. This external scrutiny should include a specific focus on how healthcare service providers address human factors issues within their investigation processes’.
Although praising the work of the Chief Coroner to bring consistency to the system, the panel noted there is still evidence of considerable variability of approach by coroner, compounded by the rarity of GNM cases in a healthcare setting.
The panel endorsed the Williams review’s concern that the relevant Chief Coroner’s guidance on ‘unlawful killing’ is inadequate in relation to GNM and needs an overhaul. Further, in view of the gravity and rarity of GNM cases and the need for consistency, the panel recommended that ‘if a coroner feels that a doctor’s conduct might reach the threshold for GNM; they should discuss this with the Chief Coroner’s Office before the police are notified’ (Recommendation 17). They rejected (as facing insurmountable legal and practical problems) suggestions that where the coroner, police or prosecuting authorities are notified of a case they should, in the first instance, refer the matter to the GMC before any criminal investigation or prosecution is considered
Noting that doctors’ unease about the coronial process may reflect a lack of preparedness and a lack support before and during an inquest, recommendation 18 urges healthcare service providers to ‘provide support and guidance for doctors who are involved in an inquest or fatal accident inquiry so that they have an appropriate understanding of the process and their role in proceedings’.
Police investigations and decisions to prosecute
The panel reiterated that it was not their task to examine the state of the law on GNM / CH or call for changes to the law. Instead they examined ‘how the context of medical practice can be better understood when it comes into contact with the criminal law’. They strongly endorsed the Williams review recommendations for the CPS in England to develop an agreed statement of the existing law on GNM and to consolidate police expertise in the investigation of GNM by healthcare professionals, through the creation of a virtual specialist unit.
Noting concerns about the process by which the CPS makes prosecution decisions in such cases, the panel’s recommendation 20 urges the CPS to ‘consider what measures it could take to enhance the transparency and understanding of its decision-making process (including how experts are recruited and the use/disclosure of expert evidence) to provide reassurance about how decisions are made’.
Returning to the subject of medical advice available to investigating officers, the panel noted police evidence as to the close scrutiny and pressure they face to investigate fully whenever there are allegations of serious criminal conduct in a healthcare setting; that the threshold for investigation is low and the value they place upon receiving early, independent medical advice to inform their understanding.
Recommending that when the police receive notification of an unexpected death ‘they should have early access to appropriate, independent medical advice to help determine whether an investigation is warranted’ (recommendation 19), the panel identified that Responsible Officers (RO) ‘would be well placed to co-ordinate the provision of suitable independent advice…in the initial stages of an investigation into GNM or CH’. The panel proposed that ‘NHS Improvement should develop a pilot study to explore the practicalities and efficacy of involving High-Level ROs…in securing suitable advice for the police before such an approach is considered for rest of the UK’.
The General Medical Council
The first two panel recommendations focus upon the need for the GMC to regain the confidence of the profession, ‘severely damaged’ by the debacle over the Bawa-Garba case. The GMC is to acknowledge that damage and learn from that experience in the way it regulates and is to take immediate steps to rebuild trust. These steps are to include ‘examining the processes and policies that contributed to that loss of confidence’ and consideration of how it can ‘better support a profession under pressure as well as promoting a fair and just culture’. (Recommendations 1-2)
Allied to this exercise are a number of recommendations concerning encouragement of equality, diversity and inclusion (in particular for overseas and BAME doctors); the provision of practical advice (on NHS structures and contracts; cultural and social issues; PDPs, appraisal and revalidation etc) to overseas doctors new to UK practice (recommendations 5-9). Similarly, recommendation 27 urges the GMC to work with medical defence bodies, healthcare providers and others to explore how doctors under investigation might be better supported. With the Bawa-Garba case clearly in mind, the panel also recommends healthcare service providers should do more to provide induction and support for all doctors returning to clinical practice after a period of significant absence. This should include a return to work meeting, appropriate supervision and bespoke support during the induction period.
Perhaps the least surprising recommendation is the endorsement of the Williams review’s call and UK Government plans to amend the Medical Act to remove the GMC’s power, under section 40A, to appeal MPTS decisions (recommendation 21). The panel rejects calls for the GMC to refrain from using the power pending the law change, but urges Government to introduce the reform ‘without delay’. The panel also supported the Williams’ recommendation that the GMC should, in the meantime, review its processes for deciding when to appeal a MPTS decision so that they are transparent and understood. It endorsed changes already made including creation of a high level decision-making panel; a commitment to consultation with the Professional Standards Authority (PSA) before taking a decision to appeal; and publication of its decisions to aid transparency.
Noting their terms of reference required them to explore the ‘meaning, appropriateness and measurement of public confidence as an objective of the regulatory process’, the review panel stated that this includes ‘understanding patient and public expectations of regulatory processes after a doctor has been convicted of a criminal offence’. To do so, the review panel commissioned independent research to explore with members of the public how they would expect the GMC to respond to specific behaviours, acts and omissions by doctors. ‘We were particularly interested in how such actions were perceived when criminal sanctions against a doctor are involved’. Amongst the key findings of that research, which can be read in full on the GMC’s website, the panel noted that:
- Individual cases of wrong doing were generally regarded as ‘one-offs’ and had little impact on confidence overall
- A mistake is insufficient, the doctor’s actions must have been intentional or reckless and the outcome resulted in lasting harm or death
- Any attempt by a doctor to cover up, falsify or blame others for clinical errors also implied criminality.
- The existence of a criminal conviction hardened public views. Where a doctor had been convicted of GNM or CH
- Well over half of respondents thought the doctor should be erased from the register (albeit a suspended sentence added nuance to the views expressed)
- The public generally responded less severely to a series of clinical errors set in a wider context (including mention of the doctor being very busy) than they did to a one-off clinical error made by a doctor in a position of authority
- The consequences of the error for the patient were the single most important factor in shaping the public view
- Reasons for preferring a lesser sanction included lack of malicious intent; where systems pressure have played a role; recognition that mistakes are a natural part of learning and that medicine is a high-stakes profession
- The consequences of the error for the patient were the single most important factor in shaping the public view.
The panel was quick to recognise this last point poses real difficulties in a system where it was necessary to ‘disentangle action from outcome’ and where the primary purpose is supposed to be forward looking, not punishing a doctor for past actions. Nor, the panel felt, does it sit comfortably with an emphasis on learning not blaming. Consequently, at recommendation 22 the panel urged the GMC to ‘work with the public and patient organisations to support better understanding of its role in regulating the medical profession within a system under pressure. The GMC must demonstrate how that understanding has shaped, and continues to shape, its policies’.
Conversely, the review panel also recommended the GMC/MPTS to review its guidance for Tribunal panels decision-makers to ensure that the guidance takes proper account of the research findings.
The time taken for fitness to practise cases to run their course, with all the attendant mental, emotional and professional toll on the doctors involved (and their families), was again a concern. Recommendation 24 directs the GMC ‘to strive to reduce’ the timescales and where a case does not progress, it should be subject to senior level review. Accepting evidence that the GMC’s capacity to improve its processes is currently constrained by its governing legislation, recommendation 25 urges the UK Government to bring forward reform at the earliest opportunity ‘to give GMC greater discretion to determine which cases are appropriate for investigation and greater scope for disposing of fitness to practise cases efficiently and consensually’.
The panel also examined reflective practice (a matter upon which there was much debate at the time of the Bawa-Garba case) which it endorses as ‘central to learning and to safe practice and fundamental to medical professionalism’. Despite GMC assurances that it had not asked for, or made use of, Dr Bawa-Garbas’s reflective practice records, there were reports of doctors’ disengagement with reflective practice for fear that their written reflections may be used against them in court or in regulatory proceedings.
The panel acknowledged the GMC reassurance that it will never ask for doctors’ reflective records as part of its fitness to practise processes and the advice on safe recording in reflective practice (with accompanying toolkit) published in September 2018 by the GMC, MSC, CoPMeD and the AMRC. “It is our view”, the panel asserts “that by following this guidance doctors will be less vulnerable to having their reflective notes used in court or other proceedings”. Nevertheless, the panel accepts that greater protection is warranted given doctors’ recorded reflections are not subject to legal privilege and the GMC does not control the conduct of the courts. Noting the Williams review’s recommendation that the Medical Act be amended to prevent the GMC seeking reflective material, the panel also recommends that Parliament consider how such reflective records can be given legal protection (recommendation 26).
The report provides much food for thought which will prompt considerable debate in the months ahead as follow-up work is undertaken to try to bring practical effect to the recommendations made. Many of these recommendations are concerned with ensuring existing systems and processes are more effectively implemented, whilst others look for more radical reform which history tells us is often slow in coming. Nevertheless the report builds upon, and is largely consistent with, the work of the Williams review 12 months ago and it is hoped will provide further momentum toward its stated aim of encouraging ‘a just and fair culture when things go wrong’.
A full copy of the Hamilton review and accompanying documentation, including the research referred to above can be found on the GMC’s website.