4 Consultant Physician in Gastroenterology, Aberdeen Royal Infirmary. 5 British Society of Gastroenterology, 3 St Andrews Place, London

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1 Submitted electronically to the Review on 23 July 2018 Clare Marx review for the GMC 1 Dr Alastair W McKinlay GMC , President-Elect of the British Society of Gastroenterology providing evidence on behalf of the British Society of Gastroenterology (with review and sign off from the BSG President and BSG Executive and Elected Councilors) 2 Dr Alastair W McKinlay 3 UK 4 Consultant Physician in Gastroenterology, Aberdeen Royal Infirmary 5 British Society of Gastroenterology, 3 St Andrews Place, London 6 a.mckinlay@nhs.net 7 Responding on behalf of a professional representative organisation, British Society of Gastroenterology 8 Consultant 9 What Factors turn a mistake resulting in a death in to a criminal act? All doctors make mistakes and in some cases, these could unintentionally hasten the death of a patient. These might include errors of omission where a result or clinical sign may be misinterpreted or not seen, or situations where treatment is delayed or unintentionally omitted. Any doctor in active clinical practice may, at some stage, make a mistake which significantly contributes to a person s death. At times this may have caused death to occur significantly sooner. These terms are important because they were used by Judge Nichols in his summing up of the Bawa-Garba Case. In a very real sense therefore, all doctors occasionally make the kind of errors that the Judge used to define manslaughter by gross negligence.

2 If a Judge s definition of a serious crime is effectively universal, then it suggests that the criteria being used as legal tests are of little or no value. This is important, because in a medical legal case the court has two areas of concern which must be weighed up accurately. In the Bawa-Garba Case, Judge Nichols was praised for his summing up in terms of the law, but it could be argued that his assessment of the medical evidence, particularly in terms of the chance of the child s survival was inadequate and based on a very small number of expert witnesses. If a legal judgement is to be secure and used for the purposes of case law, then terms like significant or significantly shortened, must be defined more closely and be based around fact rather than the whim of a jury. If all doctors occasionally make mistakes which hasten the death of a patient then this criterion on its own cannot be used as a justification for bringing formal proceedings. In considering whether a criminal act has been committed the prosecution must establish gross clinical negligence has occurred. The term is, again, poorly defined. Gross clinical negligence suggests that the actions fall significantly short of that which might be expected of a doctor of similar standing, under similar circumstances. Again the context of the error is crucial, Significantly is an extremely subjective term. Is it fair to leave a decision about extremely complex medical conditions to a jury with no technical knowledge, other than that presented, under adversarial conditions, in court? For that matter, is it appropriate to leave such decisions to a judge with no scientific training, or knowledge of statistics? Whilst Judge Nichols may have understood the legal arguments, his acceptance of a mortality rate ranging from 4 to 28%, without questioning the statistical significance of such a wide range, suggests that he did not understand the statistical uncertainty that this implied. Whilst he may have been legally unbiased, his summing up suggests that he was unconscious of his own scientific and statistical shortcomings and, therefore, was possibly open to unconscious bias. If an action is truly reckless for example, then it suggests that the professional has actively ignored, or failed to seek advice, or actively overridden the advice of other members of the team. For a mistake to become a criminal act not only must the actions or omissions of the individual and the subsequent consequences for the patient, be taken in to account, but consideration must also be given to the context within which the mistake occurred. For example, in endoscopic retrograde cholangio pancreatography (ERCP) the successful removal of gallstones from the common bile duct is critically dependent on cutting the sphincter at the lower end of the bile duct. The sphincter lies very close to a large artery and the position of the artery varies from individual to individual. In carrying out the procedure of sphincterotomy, the endoscopist has to judge the size of the cut against both the patient s anatomy, but also in relation to the size of stone that needs to be removed. If the endoscopist misjudges the situation and extends the cut by as little as 1mm, which might take less than 0.1 seconds, it is possible to hit the artery and cause life threatening hemorrhage. Although this can usually be treated, there is still a

3 recognised death rate from this complication. The mistake undoubtedly can significantly shorten the patient s life, but failure to remove the stone and clear the bile duct can also result in life threatening sepsis, which may also significantly shorten the patient s life. The judge s use to the term significant which was his main basis in addressing the jury, is therefore, largely meaningless. Other more clearly defined and precise terms are needed if a mistake is to be changed into a criminal act. Similar arguments apply to the work environment. If a doctor is asked to work under conditions which are intrinsically unsafe or where operational policy, equipment, or support services are inadequate, then it is invidious to ascribe all the blame for a death to a single individual. This includes the issue of under-manning where a doctor is forced by circumstances, or sometimes by the actions of other people such as administrators or managers, to practice under circumstances which are grossly sub optimal. Such circumstances arise frequently and cannot always be predicted. For example, the number of admissions to a unit can sometimes reach levels that could not be reasonably predicted in advance and a doctor or team may find themselves facing a disproportionate number of patients, all of whom require a high intensity of care. The advice given by the GMC in the aftermath of the Bawa-Garba case, that doctors should notify their Line managers of any adverse factors, is hopelessly inadequate. Most doctors would need to be on the phone to their Medical Directors every day. Under circumstances where the demand outstrips the available resources doctors are actually taught to triage and care is directed to the most critically ill. This means that inevitably, some patients who are perhaps marginally less ill will get less care than they might otherwise have received and could, therefore, die earlier than might have been expected. When a Medical Team facing overwhelming odds are attempting to deliver care to the best of their ability, tests which revolve around significantly altering the outcome for a patient become largely meaningless, but this was effectively the test used by the Judge in the Bawa-Garba Case. The same argument might apply to a doctor who goes to work, to maintain a service for patients, when colleagues are ill. The doctor working to the best of their ability might save a significant number of lives, but still be unable to meet all the needs of other patients. This principal is recognised in most frameworks of medical ethics, where the principal of justice means that no one person has the right to all available treatment. In circumstances where a mistake occurs therefore, it is essential that the investigating authorities consider not only the care given to an individual patient, but the other demands being made on the doctor at the same time by other patients, who have an equal right to good care under human rights legislation.

4 When a mistake occurs that shortens a patient s life, it is not, therefore, acceptable to simply consider the patient s care as if they were the only person that the doctor was obliged to look after. A mistake must be considered in the full context of the doctor s work that day, the environment in which they were working and the resources available to them. In the case of Dr Bawa-Garba, not only was there an IT failure resulting in a delay in results, but she was working with Agency Nurses and looking after 4 different Units. To judge her care in the case of one individual patient without making allowance for the other patients that she was looking after is therefore unreasonable. By turning it in to a criminal act, it could be argued that the authorities and the presiding Judge, were only considering one person s rights and ignoring all the other patients who were under the care of the doctor. In summary therefore, the factors that turn a mistake in to a criminal act cannot be viewed in isolation but have to be reviewed within the full context in which the error occurred. This must include an examination of whether the working environment was acceptable, whether the medical and nursing teams were adequately supported and the demands that were being made on them by other patients, who have an equal right to safe and effective treatment. Expecting a doctor to devote all their time to an individual patient and ignore others is unethical. A mistake should therefore only be considered a criminal act when it is clear that there are no contributing factors from the operational environment in which that individual was working at the time. If it is clear that a mistake occurred that shortened a patient s life, but the context indicates that it was due to the work environment in which care was being given, then the prosecution should be made against the NHS rather than the individual. These issues are important in the Bawa-Garba case. The Judge concentrated his summing up on the actions of the individual doctor, although evidence had been presented that she was working under extremely difficult circumstances. The Judge chose to ignore these and effectively instructed the jury to concentrate on her individual care of an individual patient. Whilst there might be some legal logic in this, the Judge s approach disregarded the circumstances in which most doctors operate at present. It also led to the impression that the intention of the court was to scapegoat individuals rather than apportion blame to a hospital system that was clearly not optimal. Once Dr Bawa-Garba had been convicted of manslaughter by gross negligence, the General Medical Council had very little choice but to remove her from the Register. The fact that they were forced into that action by the current law suggests that the law is wrong and needs to be reformed. The focus of the Crown Prosecution Service, or Procurator, should be directed primarily at a system analysis, identifying the corporate components that led to the outcome.

5 10 What factors turn a criminal act into Manslaughter or Culpable Homicide? The wording of this question is somewhat strange. It assumes that a mistake has already been judged to be a criminal act and that the decision is now whether it constitutes Manslaughter or Culpable Homicide. Defining Manslaughter is difficult. Most definitions accept that Manslaughter is where a death occurs as the result of the actions of an individual or organisation and where there is no malice aforethought, or circumstances that would amount to murder. If a mistake has been judged to be a criminal act then the issue is whether there is supporting evidence that the action was premeditated, as for example in the case of Harold Shipman, or whether it was unpremeditated and therefore Manslaughter. In rare circumstances the issue of murder will arise and where it can be clearly shown that there has been planning, personal gain, or malice, then the profession would undoubtedly support prosecution for murder, because such actions clearly undermine trust in the profession as a whole. In some cases the issue of motive will also be involved, although in medical cases this is rarely related to money but more often to more abstract gains such as control, and the vicarious wielding of power. However, in most cases there is no malice aforethought and if the tests applied to the case involve nebulus words such as significant or significantly shortening or gross negligence without any attempt at a standardised definition, then the charge of manslaughter seems poorly defined and arbitrary. In addition, applying a charge of manslaughter to an individual, greatly diminishes the opportunities for learning from the mistake and preventing similar cases occurring. In the case of Dr Bawa-Garba the decision of the CPS to concentrate on the individual rather than the organisation probably resulted in a lot of useful learning being lost. Another problem with the charge of manslaughter by gross negligence and the test of significantly shortening life is that it rests entirely on the opinion of expert witnesses. In the Bawa-Garba Case for example, the chance of death from Group A streptococcal pneumonia was described in court as being between 4 and 20.8%. In a child with Group A Streptococcal pneumonia, a repaired heart, underlying Down syndrome and who was already in septic shock at the time of admission, 20.8% seems conservative whilst 4% seems ludicrously low. It is not clear from the trial summary whether these assessments were properly challenged in court. This is absolutely fundamental, because the Judges direction to the jury was based around the patient s chance of dying. A major problem at present is that very few doctors are prepared to act as expert witnesses. The adversarial system, the failure of the judiciary to protect expert witnesses and the fact that expert witnesses themselves have on occasions been

6 struck off, means that most doctors are not prepared to go to court. The pool of expert witnesses is, therefore, extremely small and this may in fact unintentionally allow unrepresentative opinions. It is interesting in the Bawa- Garba case, the expert witness cited was a Paediatric Intensivist: someone who spends their working practice within an Intensive Care Unit. Whereas the care that was subject of the trial was about care being given by a doctor in training, on a General Paediatric Ward. The importance of context is again apparent. This suggests that the enquiry into a medical mishap should be approached in a different way. The enquiry should be conducted in a rigorously structured format using a root cause analysis approach or similar. The context of the error should be thoroughly explored. System failings and the role of management and health authorities should be investigated. If other factors are involved, the charge of Corporate Manslaughter should be brought, where the error of the individual is seen to occur within the wider context of the organisation. Only if an error has occurred in a system that is well resourced, under circumstances that were not exceptional and where it is clear that the doctor has been reckless or ignored advice, should criminal proceedings be made against that person. If these criteria are not met, then a new legal process specifically tailored to medical circumstances should be introduced and used. 11 Do the processes for local investigation give patients the explanations they need where there has been a serious clinical incident resulting in a patient s death? If not, how might things be improved? When properly carried out, local investigations should give patients the explanations they need when there has been a serious clinical incident resulting in a death. The duty of candour, now enshrined in law, is taken very seriously by the profession. Local investigations offer far greater opportunity for a discussion with relatives and for the expression of appropriate regret. 12 How is the patient s family involved in the local trust/board/hospital investigation process and in feedback on the outcome of the investigation? The patient s family must be given the opportunity to express their concerns either verbally, or in writing, or by whatever method offers them least distress and recognises the extremely difficult situation in which they find themselves. The process of gathering evidence and trying to establish what had occurred should be a factual exercise and should be carried out by the Health Board or Trust. The family should be kept informed of progress and given appropriate timelines. Relatives should be invited to comment on the evidence and highlight

7 areas where it does not meet their expectation and in most cases, should have the opportunity to meet the Medical Team involved in the patient s care. Sessions should be structured and adequate time allowed for discussion. Hospital Trusts and Boards should recognise this and doctors must have enough time freed up to allow a meaningful interaction. 13 What is the system for giving patients families space for conversation and understanding following a fatal clinical incident? Should there be a role for mediation following a serious clinical incident? There should be a role for mediation following a serious incident. Such a service must have the confidence of the family or relatives and therefore probably needs to be truly independent. 14 How are families supported during the investigation process following a fatal incident? It is not possible to give a generic answer as to how families should be supported during the process of an investigation. This will be a very individual consideration and will be affected by what stage they are in the grieving process. It is essential however that they are asked if they have needs and that appropriate counselling is offered. 15 How can we make sure that lessons are learned from investigations following serious clinical incidents? When a serious event has occurred and it is clear that lessons need to be learned families have to be given assurance that the issues are being addressed. This means that a person in a senior position within the Health Board or Trust takes responsibility and that families are given an opportunity to come back, after a period of time, to learn what has been achieved. It is essential however that the investigations are fair. Families must be involved in investigations into serious clinical events, but they do not have the right to dominate or lead that enquiry, nor should an enquiry be seen as a route to take revenge on individuals or clinical teams. Ultimately an investigation that has been conducted competently, should represent an asset to the organization. It should include an open review of the events, an action plan, a financial impact report and a risk assessment of any options. A proper dissemination through the organization should be in all parties interests.

8 16 Do you think the current arrangements for reporting and investigating serious clinical incidents within healthcare settings are effective and fair? If not what is wrong and how might they be improved? We think that when a review is carried out correctly and openly then they should be fair and can be used effectively to bring about change. Unfortunately, not all enquiries are conducted in an optimal way. When a serious event occurs a patient not only has a right to give their version of events but it is also essential if a complete view is to be reached. There are now some instances where health boards and trusts have not invited patients to give their view and where results of a serious event analysis have not been made available to the patient. The duty of candour may encourage a more equitable approach but there probably should be accepted templates and guidance. If these are departed from it should be a duty of the investigating authority to indicate why the process was not followed. 17 Would there be benefits in ensuring a human factors assessment approach in local investigations as opposed to a root cause analysis? We believe that there is a place for both approaches. Human factors as described in item 17 are clearly very important in many serious events. Often, they generate useful learning and clear pointers for improvement. Root cause analysis does have a place in certain context and may for example be useful if the human factors analysis indicates more structural organisational causes. Not all health boards and trusts have people trained in these techniques and very few doctors have had formal training. There therefore may be a case for NHS organisations to have a pool of experienced and trained investigators who take on the more serious allegations. 18 Typically, who is involved in conducting investigations following a serious clinical incident? In most health boards and trusts incidents are logged on a reporting system such as Datix and are regularly reviewed by senior managers. It is therefore often the decision by management to institute and investigation particularly if a serious complaint has been received. It should be noted however that many doctors will also highlight the need for an investigation particularly if it is clear that a combination of errors or events have led to an incident or more rarely if there is a suspicion that there have been significant failings in another health professional. Senior managers do often have some training in investigating serious clinical incidents and it is interesting that in at least one health board we are aware of, a

9 Senior Retired Manager was brought back on a part time basis to enable the board to bring itself up to speed on investigations. The amount of training that managers receive is variable and the amount of training received by doctors in formally investigating serious events is minimal and probably does need to be addressed. 19 How competence and skill of those conducting investigations is assessed? In our experience, formal assessments are actually very rare and should perhaps be made more formal. 20 In your Hospital Trust Board is there a standard process or protocol for conducting investigations following a serious clinical incident leading to fatality? Most health boards and trusts do have standard protocols which are usually initiated by Senior Management or the Medical Director. These are usually enshrined in standards and policy or standard operating procedures. A review of different protocols would be interesting to see how much variation there is. 21 What measures are taken to ensure the independence and objectivity of local investigations? We suspect that this is variable. In most health boards an SEA is usually carried out by management and would include a senior doctor or nurse and often a member of Human Resources. If the issues are particularly important then a non-executive member of the board may be assigned. Lay representation other than non-executive board members is often quite rare partly because interested representatives are often in short supply and are required on many different committees and in many different roles, for which they often receive no remuneration. 22 What is the role of independent medical expert advice in local investigations? The request for independent medical advice usually comes from a Medical Director or Senior member of the Board. In our experience colleagues do take this role very seriously particularly as it can involve a significant amount of work. Reading and summarising a complex case note can take many hours as paper records are often in a poor condition and may not even be in a time ordered sequence. Increasing use of electronic records carries its own difficulties. Letters and other documents are often in time order and results are often easier to assess and less likely to be missing. Most ward records are still paper based and these have to

10 be scanned, the quality of scans is often poor and the software available for reading large numbers of scanned paper notes is not particularly user friendly and often takes much longer. If a doctor is asked to carry out an independent case review the work is often carried out in their own time and they should be entitled to charge an appropriate fee. Independent experts are usually selected on a fairly arbitrary basis. The people who are most aware of doctors with a particular interest are usually members of the Department being investigated. Potentially leaving boards open to a charge of the old boy or girl network. In reality most doctors who provide an independent report take the process very seriously and try hard to provide an independent summary of the events and honest conclusions. It is worth noting however that the pool of expertise available to local enquiries is much greater than that available when the process becomes a legal issue. Expert witnesses are now required to have training and most doctors do not like appearing in court even as an expert witness. The number of available opinions for courts is therefore much more restricted. Some expert witnesses may even have retired from clinical practice. The quality of opinions is therefore not always guaranteed. Enquiries conducted at a local level usually have access to a far greater range of opinions, most usually in active practice, often with a much greater knowledge of a particular clinical problem involved. Access to appropriate expertise is therefore sometimes limited and not always available. Very few doctors have training and unconscious bias. 23 How are independent experts selected, instructed and their opinions used? Is access to appropriate expertise always available? Do they have training in unconscious bias? Do not know of any evidence. Suspect not. 24 Are there quality assurance processes for expert evidence at this stage? There are no quality assurance processes for expert evidence. 25 How can we make sure that lessons are learned from investigations following serious clinical incident? See above.

11 26 What support is provided for Doctors following a serious clinical incident that has resulted in the death of a patient? Psychiatrists often have more formal networks of mentoring and support but for most doctors involved in Acute medical specialities including Surgery, Medicine and in our case Gastroenterology, there are no formal groups for support, other than through the doctor s own General Practitioner. Indeed, support often only becomes available if the doctor becomes ill and has to report themselves to the Occupational Health Service. Junior doctors are provided with Educational Supervisors and opportunities for counselling but Senior doctors and Consultants have virtually no access to any form of support either formal or informal. It should be noted that the British Society of Gastroenterology has recently started a programme of mentoring. We are training some of our members to be mentors but also encouraging doctors to apply for mentoring particularly if they are at transition stages of their career, or facing lifestyle changes or critical events. 27 How and when are decisions made to refer a fatality to the Coroner or in Scotland to the Police. Who does it and who do you think should do it? In Scotland there are clear guidelines defined in Death and the Procurator Fiscal which indicates which deaths need to be referred to the Procurator. There are similar requirements for referral to a Coroner s court in England. In Scotland a senior doctor, usually but not exclusively a Consultant, will ring the Procurator Fiscal service and discuss the case. Generally, speaking if an issue is felt to be serious enough to warrant referral to the Coroner or Procurator the process of referral should be carried out by a senior doctor usually a Consultant. 28 What evidence is there that some groups of Doctors are more or less likely to be subject to investigation leading to charges of GNM CH? We are not aware of any evidence that suggests that particular groups of doctors are more likely to be subject to investigation. However, a death following a clinical procedure or operation is usually more obvious than a death due to a complex series of causes on a ward and we would suspect that doctors involved in the craft specialities, such as Obstetrics and Gynaecology, Surgery, Cardiology and Gastroenterology may be more likely to be investigated for GNM-CH

12 29 Do you think there are barriers or impediments for some groups of doctors to report serious incidents and raise concerns? More specifically are there additional barriers for BME (black, minority and ethnic) doctors? If so, which groups are affected by this and how can those barriers be removed? We know of no evidence that there are barriers or impediments for some groups of doctors to report serious incidents. Guidance from the General Medical Council makes it very clear that it is a doctor s duty to report serious issues irrespective of the circumstances. Obviously, there is a concern that staff may find it more difficult to report a Senior member of a team than perhaps those in a more Junior position. Doctors maybe less likely to report serious incidents if they perceive a risk to their reputation, employment prospects, or if they fear that it may result in a criminal conviction. This applies to reporting of serious incidents they have been personally involved in, but also to incidents that colleagues may have been responsible for. There is still concern that whistle-blowing has a potential for harm to the reporter. In this respect, the Bawa-Garba case has greatly increased the fear of prosecution, and has potentially had a very detrimental impact on encouraging doctors to report concerns. 30 What is your knowledge and experience of cases involving clinical fatalities that have been referred to the Police or Procurator Fiscal? In England referral to the Coroner s court is a fairly frequent occurrence which most doctors will have experience of at some point during their career. In Scotland discussions with the Procurator Fiscal s Death Reporting Team are common, but relatively few cases progress to a Fatal Accident Enquiry. The decision to call a Fatal Accident Enquiry rests with the Procurator who is also the Senior Prosecutor in Scotland. Fatal Accident Enquiries are usually held in front of a Sherriff. Criminal charges can follow the outcome of a Fatal Accident Enquiry although it is unusual. The general impression is that fewer cases go to a fatal accident enquiry in Scotland than to a Coroner s Court in England, but when an FAI occurs the investigation is rigorous and conducted in open court. The outcomes are, therefore usually taken very seriously. 31 To what extent does an inquest or Fatal Accident Enquiry process draw on the evidence gathered in the past, post incident investigation? An Inquest or FAI can use post incident enquiry evidence. Any investigatory process, whether carried out by a Trust or Health Board can make the participants wary, and cause significant stress, but this is much less than is

13 precipitated by any form of legal process, where all parties tend to become much more defensive. 32 The role of independent of medical expert evidence is important in an inquest or fatal accident enquiry? As indicated previously, the number of independent medical experts is often very limited and we are aware that solicitors can find it extremely difficult to identify a doctor who is prepared to compile an independent report. It is our opinion that the judicial process puts a lot of doctors off acting as expert witnesses, as the process can be very upsetting and the expert witness often emerges feeling that they are the person on the dock, rather than an important advisor on highly technical issues. In our opinion, the whole process of finding expert witnesses needs review. 33 How are independent experts selected and instructed and opinions used? Expert witnesses are now expected to have had formal training and many courses are available. Very few doctors in full time active clinical practice have either the time or inclination to attend such courses and therefore there is a danger that the whole process selects people who are not truly representative of current opinion. 34 Do the same standards and processes for experts apply when they are providing their opinion for local investigation, an inquest or a fatal accident enquiry process? We have already answered this question. Expert witnesses drawn for a Fatal Accident Enquiry or Criminal Investigation usually have had some training regarding their role in court. This requires a significant investment in time and may end up selecting people who are not truly representative of current professional opinion. Expert opinion for local enquiries can be drawn from a much wider pool and paradoxically may represent a higher level of expertise and skill than is available to the courts. 35 Are there quality assurance processes for expert evidence at this stage? There are no formal quality assurance processes.

14 36 To what extent does the criminal investigation and/or prosecution process draw on or rely on the evidence gathered in the post incident investigation by the hospital/trust/board or other healthcare setting? The post incident investigation represents evidence and therefore can be drawn on for any criminal prosecution. It raises the interesting issue that evidence for local Trust or Board investigations is not subject to the formal processes that would be required for submission to a court. For example a doctor participating in a local investigation will not expect to need, or require legal advice before making a statement that might subsequently turn out to be incriminating. 37 What is the charging standard applied by prosecuting authorities in cases of GNM/CH against medical practitioners? How does the charging standard weigh the competing public interest in improving patient safety? We are not sure what this question means and therefore cannot provide evidence. 38 Are there factors which potentially hamper key decision makers in making fully informed decisions in each stage of the process? A criminal investigation is usually opened weeks, months or even years after an event occurred. It can be extremely difficult to determine retrospectively the wider context in which an alleged action occurred. The situation in which the event happened may have been very complex with many separate factors operating. We have already emphasized the importance of context in the decision to pursue a criminal action. (see section 9 and 10). When a significant delay in a criminal charge occurs the context of the case may have become unclear. It may be simpler to consider an action against an individual rather than undertake a prosecution of a corporate body such as a Trust or Health Board. There may, therefore, an unintentional bias towards pursuing a charge of manslaughter against an individual, rather than attempting a more complex charge of corporate manslaughter. 39 Do key decision makers have necessary support to make fully informed decisions? In our experience, legal decision makers very rarely have the necessary support to enable them to make an informed decision. Evidence for the Coroner and Procurator is usually gathered by Police Officers. Giving a statement is often a very laborious process and has to be spelt out (literally) and explained. Often one is left with a statement that approximates to what has been said but may not capture the nuances and is almost certainly written without any clear

15 understanding. Yet these statements often form the basis on which a decision to hold an FAI or prosecute are made. The assessment of complex medical cases needs reliable unbiased professional advice. At present the pool of advisors is limited, unregulated, and not subject to any form of appraisal or assessment. We believe that there is a need for detailed prosecutorial guidance. 40 Why do some tragic fatalities end in criminal prosecutions while others do not? This is a good question without any clear answer. This strongly suggests that the process needs to be reviewed. 41 Under what circumstances would it be more appropriate to consider cases involving fatal clinical incidents within the regulatory system rather than the criminal system? The criteria for a criminal investigation should be extremely high. The number of professionals who deliberately want to cause harm or injury is very small. The number of grossly incompetent practitioners is also small and the legal system has a very poor record in detecting such people. It is worth remembering that Dr Harold Shipman murdered over 300 patients in full view of the legal processes that had been set in place to review death certificates and other mandatory documentation. Dr Shipman was discovered by another doctor. Criminal processes therefore have a very poor record in terms of maintaining clinical standards or even preventing injury to patients. Regulatory processes, which have a much greater input from the professions, are much better suited to maintaining professional standards and also removing practitioners who are failing to meet those standards. They are also conducted more rapidly and therefore potentially remove dangerous practitioners faster from the system. In the Bawa-Garba case, criminal proceedings were brought over 5 years after the event itself. Leaving aside the issue of whether the conviction was correct, the legal system had failed to provide protection for the public most of that 5 year period. The charge of manslaughter is, therefore, not only poorly defined and inconsistently used, but also relatively inefficient in protecting the public. We would suggest that it should be completely reviewed. The law already acknowledges that certain situations require special processes. For example, it is accepted that motoring offences require different measures. Many people are prosecuted for specific offences such as death from dangerous driving and some are even jailed. Very few motorists are charged using the blunt instrument of manslaughter by gross negligence.

16 System failures are very difficult to prosecute under the heading of manslaughter. It may be much more effective to investigate and apportion blame under a tribunal or regulatory framework. Finally there is the issue of public interest. Some errors may highlight very significant system failures that may be widespread, or endemic, in which case it might be argued that a criminal action would be justified to protect the public. A fatal accident enquiry, or in extreme cases a public enquiry such as occurred in the case of the Mid Staffordshire Trust, might be appropriate, but investigating such issues through the prosecution of an individual doctor, is unlikely to be useful, as the Bawa-Garba case has demonstrated. 42 what is the role of independent medical expert evidence in criminal investigations and prosecutions? This has already been discussed. 43 How are independent experts selected, instructed and their opinions used? Independent medical experts are self selecting. They have to have enough space in their practice to allow legal work and to attend court if required. It takes a certain personality to appear in court. The process carries risks of selecting doctors whose opinions are not representative or whose practice is out of date. Solicitors undertaking Medico-Legal work often have to approach large numbers of doctors before they will find one who is willing to provide a report. While expert witnesses remain a self-selecting group, the danger of unconscious bias remains extremely high. 44 Do the same standards and processes for experts apply with regard to evidence in local and legal enquiries? Generally local enquiries do not usually employ a formal legal framework for taking evidence. Those participating in an enquiry are not usually informed that their evidence may be used against them or in court. In reality this would be contrary to the entire philosophy of the NHS, which is seeking to create a no blame culture to encourage people to be honest and to reflect on their actions. 45 Are there quality assurance processes for expert evidence at this stage? Not that we are aware of.

17 46 What lessons can be learned from the system in Scotland? The system in Scotland appears to function more effectively. First, any cases where there may be a legal issue or statutory requirement, are referred directly to the Procurator Fiscal s office. The Procurator Fiscal s in Scotland have issued clear guidance as to what should be notified, in the document Death and the Procurator Fiscal. The initial stages of the investigation are relatively low key and informal. The doctor reporting the death, usually the Consultant, will talk to a specially trained death reporting officer who will take the details and consult with the Procurator Fiscal. Unlike the Coroner s court, the Procurator Fiscal not only has the power to instruct a post mortem but can also send police officers to directly question those involved, usually within a day or so of the incident occurring. A decision to take matters further is made by a Senior Law Officer in the Procurator Fiscals office and in a majority of cases, where there is thought to be no criminal offence or matter involving public safety, the case can be closed and the body and paperwork released to the family promptly. When the Procurator Fiscal feels that issues should be explored further or determines that there are concerns amongst the family, they can order a Fatal Accident Enquiry in front of a Sherriff. Unlike a Coroner s court where the main concern is the cause of death, a fatal accident enquiry can examine the whole process and can directly recommend that a criminal prosecution is brought. It should be remembered that a Sherriff, in Scottish Law has the same status as a Crown Court Judge in English Law. The Procurator Fiscal is the Chief Prosecuting Officer under Scottish Law. If the evidence presented to the Procurator during the initial enquiries or after a fatal accident enquiry, suggests that death has been caused by gross negligence, corporate negligence or serious system failures, then the Procurator can instruct that criminal proceedings are initiated immediately. As far as we are aware, the charge of culpable homicide has not been used in a medical context in Scotland, but many of our Scottish members have participated in, or been subject to, a Fatal Accident Enquiry. The process is rigorous and generally more constructive than criminal proceedings in England. In particular, a Sherriff conducting a fatal accident enquiry would, in our experience, be more likely to have viewed a doctor s error in its wider context. 47 What is your experience of the GMC s fitness to practice process in cases where a Doctor has been convicted of a serious criminal offence? It is relatively rare for doctors to be convicted of serious criminal offences and therefore our experience as a professional body is limited.

18 In our experience, the General Medical Council s Fitness to Practice processes view a criminal conviction very seriously. In the majority of cases it will involve a practitioner being struck off the register. The GMC can, however, recognise that a doctor is professionally competent, has been of good character and therefore may be rehabilitatable in terms of their professional practice. In the case of Dr Bawa-Garba, the judge recognised her previous good character and reputation, but chose to but ignore it. The conviction has effectively made her professional career unrecoverable. This does seem to be against the spirit of natural justice. 48 The GMC has a statutory duty to promote or maintain public confidence in the medical profession that said what factors do you think the GMC should balance when trying to fulfill these duties? The terms truly exceptionally bad or behavior/rule violations resulting in serious harm or death, sound impressive but in reality, are difficult to define. The GMC should always protect the public. As we have previously suggested all doctors make mistakes and all of us make mistakes that sometimes hasten death. In cases where there is a clear, repeated record of serious error, or where review of a practitioner s record suggests that behaviours are deeply entrenched and unlikely to change, the GMC should remove that person from practice. In many cases, however, a doctor s career may have been satisfactory, without previous blemishes and potentially rehabilitatable. Under these circumstances the GMC should provide immediate protection to the public by limiting the doctor s ability to practice, but should also indicate the measures that must be taken to ensure that they return to practice safely. Unlike a criminal court, the GMC has the ability to review cases over time and if there are clear signs of improvement can act upon them. The GMC s huge advantage over a criminal court is its ability to provide a nuanced response and to monitor whether criteria have been met. 49 What information would you like to see from the GMC and others about the role of reflection in medical practice? The GMC has already indicated that reflection is very important. We would not like to see this undermined. Doctors reflections should be taken in context. They are often an extremely personal and frequently agonised response in very distressing circumstance. It is quite rightly accepted that medical errors cause families and carers immense harm and distress. Medicine is however a vocation, and being aware that an error has caused serious harm can have a devastating effect on a conscientious practitioner. A reflection made after an event is often made when the doctor him/herself, is not in full possession of the facts.

19 Whilst it is difficult to see how reflections can be excluded from the evidence process, they must be taken in context and also viewed as being potentially unreliable. Unreliable evidence should have no place in a criminal investigation. Reflection practice usually shows a desire to improve the quality of care and safety of patients. Anything that inhibits reflection, even unintentionally, will ultimately prove detrimental. Self- reflection can also show that a doctor has been truly contrite, has examined their practice and is willing to make changes. It is interesting that the judge in the Bawa-Garba case suggested that she had not shown remorse and perhaps access to a written self reflection might have a different picture. 50 What emotional, pastoral and other support is available for Doctors who have an allegation or a charge of gross negligence, manslaughter etc being investigated by the GMC? There are no formal emotional or pastoral methods of support. Regrettably many doctors have to go off sick to get any form of support. The GMC s record in this area is very poor. 51 How can learning from a fatal incident best be shared? Should the regulator have a role in this? The regulator should definitely have a role in sharing good practice. Virtually all doctors are members of a professional society or grouping. The British Society of Gastroenterology has a long record of providing standards, guidance and quality improvement programmes. Maintaining high professional standards amongst Gastroenterologists is at the heart of our organisation. Similarly Defence organisations such as MPS, MDU and MDDUS have been very proactive and constructive in this area. The regulator however frequently fails to use professional groups to disseminate knowledge and the GMC should adopt a more inclusive approach. 52 Do you have any other points which you wish the review to take in to account? We welcome the opportunity to provide evidence to the review on behalf of Gastroenterologists in the UK. The framework of questions is detailed but in many places has been repetitive and very time consuming. We hope that the review will look at all the evidence that has been provided. The British Society of Gastroenterology remains committed to promoting the highest standards of clinical practice in

20 Gastroenterology and also to work for improved standards of safety and governance for patients.