Quality and safety in healthcare revisited: a challenge to anaesthetists

The Francis Report of the Mid Staffs Public Inquiry, published in February 2013, clearly documents appalling care at Mid Staffs NHS Foundation Trust between 2005 and 2009 1. Anaesthetists feature in both the Mid Staffs Inquiry and Bristol Inquiry of the previous decade. Although, in 2001, the Bristol Inquiry panel into excessive deaths following paediatric cardiac surgery were “impressed by the extensive experience of anaesthetists in applying a ‘systems approach’ to safety’ and commended the work of the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland” 2, the Francis Report noted that anaesthetists were mildly criticised in the children's service peer review in 2006 and stated that “anaesthetists on the emergency rota did not have regular involvement in the care of children and might not be maintaining their skills in that area” 3. However, the 2003 children's service peer review had noted that “Arrangements for emergency patients were heavily dependent on the goodwill of some anaesthetists” 4. The Bristol Royal Infirmary Inquiry took three years and concluded that, although the Department of Health (DoH) accepted that it must be responsible and accountable for systems that were in place for monitoring clinical outcomes in the NHS: “We cannot say that the external system for assuring and monitoring the quality of care was inadequate. There was, in truth, no such system” 5. When the first meeting of the Quality Improvement Working Group for the NHS Next Stage Review 6 was convened on 28 November 2007, Lord Darzi quoted Sir David Nicholson as saying that: “The 2000 review [of the NHS] was all about systems reform: how do you reform the NHS, make it more transparent and what are the business lessons. Yet we missed the key thing: quality of care” 7. At that time, the Chief Medical Officer, Sir Liam Donaldson, commissioned three reports 8 on standards and quality of care in the NHS for Lord Darzi's 2008 High Quality Care for All: NHS Next Stage Review from three respected US healthcare organisations: the Institute for Healthcare Improvement (IHI); the Rand Corporation; and the Joint Commission International (JCI). These US reports were submitted to Lord Darzi in early 2008 and were based, partly, on interviews with leaders of key NHS organisations. The IHI report was written by a team led by the then President and CEO, Don Berwick, whom the UK Prime Minister, David Cameron, asked in 2013 to make recommendations following the Francis Report 9. The US reports were very critical of the system for quality improvement in the NHS; describing “a culture of fear and top-down control rather than shared learning and participative improvement” and a “virtual absence of mention of patients and insufficient data for patients to make informed choices” 10. The reports were not published but were eventually released as a result of a Freedom of Information request in 2010 8, 11. Although they were supposed to feed into High Quality Care for All, the claim that they did so was described by a source close to the authorship of those reports as “disingenuous at best” 12. An overview of the three US reports was produced for the Next Stage Review in March 2008 but a Parliamentary Question in December 2013, requesting that it be published, was denied, although the DoH stated that it “recognises the general public interest in making this information available for the sake of greater transparency and openness” 13. The overview, which was eventually released in March 2014 in response to a Freedom of Information request, confirms the US reports' findings of poor quality care in the NHS. If the recommendations of the Bristol Inquiry and the three US reports on the NHS had been acted upon, it could be argued that it might not have been necessary to have the Mid Staffs Public Inquiry. Meanwhile, in an open letter to The Guardian on 31 December 2013, “Leaders of key NHS organisations have demanded an end to what they describe as relentless criticism of the service which exaggerates the extent of poor care and sees GPs and hospital doctors “unfairly bashed” for problems beyond their control” 14. Three of the areas that particularly concerned me regarding the arrangements for quality improvement in the NHS were: the investigation of the quality of clinical care; acting on patients’ complaints; and listening to whistleblowers. The amazing fact is that, since the formation of the Care Quality Commission (CQC) in April 2009, there has, until recently, been no organisation that accepted responsibility for oversight of the quality of clinical care in English hospitals. The Mid Staffs Public Inquiry Counsel's written Closing Submission on 9 December 2011 15 quoted: “the reality is that the CQC's primary responsibility is to regulate against the essential standards and correct care that is not compliant. It is not to investigate possible individual instances of clinical failure or clinical quality…”. The Francis Report, published in February 2013, stated: “it is clear that the principles by which the HSE [Health and Safety Executive] has sought to decide whether or not to involve itself in healthcare cases has led to a particularly unsatisfactory situation when placed alongside the CQC's refusal to investigate individual cases. This has led to a regulatory gap which needs to be closed” 16. The IHI report stated: “We were struck by the virtual absence of mention of patients and families in the overwhelming majority of our conversations” 17. From 1996 to 2004, patients (or their representatives) who were not satisfied with Trusts’ responses to their complaints could put their case to Independent Review Panels that included an independent lay chairman, a coroner, and a representative of the purchaser. These Panels were abolished in 2004 and complaints remaining unresolved at the hospital were sent to the Healthcare Commission; however, in the words of the latter's Head of Operational Development, “certainly in 2004 and 2005, the team was overwhelmed…and couldn't keep their heads above water. So I don't think there was a lot of analysis going on” 18. In 2009, the task was given to the Parliamentary Health Service Ombudsman (PHSO). In 2011–12 the PHSO received a total of 23 846 enquiries from the public, about half relating to hospital services, but she ‘formally investigated’ only 222 of the enquiries relating to acute hospitals, fully upholding 60% 19. Doctors and nurses may have difficulty in drawing attention to potential patient safety issues, and many who are concerned about standards of care are also concerned that speaking out could ‘negatively affect’ their employment 20. In 2010, a survey of doctors’ professional values and reported behaviours found that 17% of 1891 US doctors, and 19% of 1078 UK doctors, had personal knowledge of a doctor who was clinically impaired or incompetent. Of these, 72% and 17%, respectively, had stopped referring patients to that doctor (p < 0.0001), whilst 12% and 34% did not report the doctor because they were afraid of retribution 21. If no action is taken when they express their concerns, the General Medical Council (GMC) advises doctors to take independent advice on how to take the matter further, but doesn't suggest how they can do that without potentially damaging their future medical careers. A doctor who is dismissed may find it difficult to get employment in the monopoly employer NHS. Even if an Employment Tribunal finds that the doctor has been wrongfully dismissed, he/she may have to sign a compromise agreement (‘gagging clause’) to receive compensation for wrongful dismissal. The problem is not limited to clinicians: the CQC has a whistleblowing hotline 22 that receives more than 600 calls a month. Robert Francis stated in his letter to the Secretary of State, when presenting his report in February 2013: “There were and are a plethora of agencies, scrutiny groups, commissioners, regulators and professional bodies, all of whom might have been expected by patients and the public to detect and do something effective to remedy non-compliance with acceptable standards of care…In short, a system which ought to have picked up and dealt with a deficiency of this scale failed in its primary duty to protect patients and maintain confidence in the healthcare system” 23. The Government accepted all but nine of Francis's 290 recommendations, some with modifications. The most important (no. 183), about a legal duty of candour, was that it “should be made a criminal offence for any registered medical practitioner, or nurse, or allied health professional or director of an authorised or registered healthcare organisation; knowingly to obstruct another in the performance of these statutory duties [i.e. (recommendation 182) to be truthful in any information given to a healthcare regulator or commissioner, either personally or on behalf of the organisation, where given in compliance with a statutory obligation on the organisation to provide it]; to provide information to a patient or nearest relative intending to mislead them about such an incident; [or] dishonestly to make an untruthful statement to a commissioner or regulator knowing or believing that they are likely to rely on the statement in the performance of their duties”. The Government's response was that it “does not intend to criminalise untruthful statements to commissioners and regulators made by healthcare professionals” 24. Had this recommendation been retained, it would have meant that whistleblowers would be protected by their legal duty if they spoke out and should not be subject to gagging clauses. There have been, though, some notable changes since the Francis Report. When the Francis Report was published, Prime Minister David Cameron asked Sir Bruce Keogh to investigate the 14 Trusts with the highest death rates. Sir Bruce's report found that none could be given a clean bill of health, and action plans were produced for each 25. He did not find Mid Staffs ‘singular’ as Sir David Nicholson, Chief Executive of the Strategic Health Authority responsible for performance monitoring Mid Staffs, and later of the NHS, had claimed 26, but found that each Trust needed to address an urgent set of actions in order to raise standards of care. After the Keogh reviews, 11 of the 14 Trusts were placed into special measures by Monitor and the NHS Trust Development Authority 27. The CQC's Chairman, Chief Executive and most of the Board have changed, and a new Chief Inspector of Hospitals and four Deputies 28, plus Chief Inspectors of General Practice and Adult Social Care, have been appointed. The aim is to “champion the interests of patients and make critical judgments about the quality of care provided” 29. The CQC has resolved to undertake thorough inspections, and its new Chief Executive has told the House of Commons Health Committee: “The inspections have had between 25 and 30 people on the inspection team, a large preponderance of clinicians and experts by experience as well as inspectors…Public, political and professional confidence has been shaky in the CQC, so one of my measures will be a restoration of public, political and professional confidence.” The CQC's new system of ‘Intelligent Monitoring’ 30, which uses a variety of indicators including adjusted hospital mortality ratios, has already found that 44 Trusts out of 161 had the highest risks, including higher than expected death rates 31. A review of the NHS Hospitals Complaints System in 2013 concluded that: “Trusts should ensure that there is a range of basic information and support available on the ward for patients, such as a description of who is who on the ward and what they do; meal times and visiting times; and who is in charge of care for the patient. Care should be taken to ensure that differences in language, culture and vulnerability are taken account of in this” 32. The PHSO has called for improvements in the way hospital complaints are handled and said that she will formally investigate a higher proportion of patients complaints 33. We have yet to see whether the promised improvements will materialise, and a new ‘PHSO Pressure Group’ aims to “demonstrate… that the Parliamentary and Health Service Ombudsman is not fit for purpose and should be totally reformed” and to “compel the Ombudsman to thoroughly investigate historic cases where there has been no satisfactory resolution” 34. The anaesthetist Steve Bolsin recently received an award from the Royal College of Anesthetists 35 for the role he played in 1990 by drawing attention to the problems with paediatric cardiac surgery at Bristol. David Prior, Chairman of the CQC, said in a recent House of Commons Health Committee hearing: “One of the things I have learned over the last six months is that, to be a whistleblower, you have to be very brave. I have spoken to a couple of surgeons… whose careers have been severely limited because they expressed concerns about what was going on in their hospitals” 36. There is an intention to abolish the widespread so-called gagging clauses that undermine the NHS's culture and transparency. In November 2013 the CQC published its new whistleblowing policy 37. In 2013, the GMC revised its rules regarding raising and acting on concerns: doctors must take prompt action if they think that patient safety, dignity or comfort is – or may be – seriously compromised, e.g. through not receiving basic care to meet their needs, through inadequate premises, equipment or other resources, policies or systems, or because of concerns that a colleague may not be fit to practise and may be putting patients at risk 38. Furthermore, they must make a record of the steps they have taken. In my previous editorial in Anaesthesia 39 I identified anaesthetists as key players in upholding patient safety and noted that the AAGBI's first primary objective is “To advance and improve patient care and safety in the field of anaesthesia and disciplines allied to anaesthesia” 40. However, the Medical Colleges and Royal Colleges have not shone as beacons of transparency at the Mid Staffs Public Inquiry. That may partly represent a failure of medical leadership and the dominance of managers with what the retiring Chief Executive of NHS England, Sir David Nicholson, termed ‘Stalinist’ control 41 from the highly centralised health service. On 26 February, 2014 the Secretary of State, Jeremy Hunt, announced his decision that Mid Staffs is now considered ‘financially and clinically unviable’: it will be dissolved and key services moved to other trusts 42. Sir David commented: “Inevitably, I feel responsible. Really bad things happened to a whole lot of patients” 43. What happened at Mid Staffs should not occur again 44, and anaesthetists are key players in making it thus. I work at the Dr Foster Unit at Imperial College, London and the company Dr Foster Intelligence funds part of our work and publishes some of our data. None of the members of the Imperial College Dr Foster Unit has any shares in, or claims any expenses from, Dr Foster Intelligence. I receive a consultancy fee for my international work.