House of Commons - After Francis: making a difference

After Francis: making a difference - Health Committee Contents

2 An open and transparent NHS

Open culture and professional responsibility

17. Healthcare professionals have an unambiguous professional duty to raise with the relevant authorities any concerns which they may have about the safety and quality of care being delivered to patients. Managers do not operate within the same framework of regulated professional obligations but they should also be expected to raise concerns about matters affecting patient safety and care quality and to be able to do so openly and without suffering personal detriment.

18. The Committee believes that Trusts and other care providers have a fundamental duty to establish an environment where concerns about patient safety and care quality raised by clinicians or managers are addressed openly and directly.

19. Robert Francis told the Committee that an essential element of the recommendations in his report was that "there should be no obstruction to individuals, or groups of individuals, raising honestly-held concerns about patient safety":

He went on to say that

The principal changes necessary to establish a genuinely open culture are discussed below.

20. Robert Francis told the Committee that his recommendations came as a package, which had five principal themes. One of these was the promotion of openness, transparency and candour, not just in relation to individual incidents of harm but in more general terms:

21. The Committee agrees with Robert Francis that the key requirement is for a culture change within the NHS which values openness and transparency in all care delivery—not just when things go wrong. The duty of candour does not simply arise in cases of service failure; the requirement for an open culture which encourages challenge is fundamental to the delivery of high quality care.

THE EXISTING DUTY AND PRACTICE OF CANDOUR IN THE NHS

22. During the course of the Committee's 2011 inquiry into complaints and litigation, the Government announced that it would introduce a new requirement on NHS providers, in their contracts with commissioners, to be open and transparent in admitting mistakes in their care. NHS England (the NHS Commissioning Board) has introduced a contractual duty of candour as one of the service conditions of the NHS standard contract for 2013/14.[18]

23. The new duty in the standard contract applies to patient safety incidents which result in moderate harm, severe harm or death (using the definitions provided by the National Patient Safety Agency) and which are reported to local management systems. While the contractual duty does not apply to incidents which result in low or no harm, guidance to providers requires these incidents to be reported to the patient where appropriate.[19] Under the terms of the contract, the patient (or relative or carer) must be informed of a suspected or actual patient safety incident within at the most 10 working days of the report of the incident to local systems.

24. The terms and definitions for grading patient safety incidents established by the National Learning and Reporting System of the National Patient Safety Agency are set out in Table 1. The Committee comments further on the scope of application of these terms and definitions at paragraph 133 below.

25. The initial notification must be delivered verbally, and face to face where possible, accompanied by the offer of a written notification, and recorded for audit. An apology, both verbally and in writing, must be provided: guidance to providers makes clear that a sincere apology expressing regret for harm caused is not tantamount to an admission of liability, and the risk of litigation should not prevent an apology.
Table 1: National Reporting and Learning System terms and definitions for grading patient safety incidents

Grade of patient
safety incident
Definition

No harm Incident prevented - any patient safety incident that had the potential to cause harm but was prevented, and no harm was caused to patients receiving NHS-funded care.

Incident not prevented - any patient safety incident that occurred but no harm was caused to patients receiving NHS-funded care.

Low harm Any patient safety incident that required extra observation or minor treatment and caused minimal harm to one or more patients receiving NHS-funded care.

Minor treatment is defined as first aid, additional therapy, or additional medication. It does not include any extra stay in hospital or any extra time as an outpatient, or continued treatment over and above the treatment already planned; nor does it include a return to surgery or readmission.

Moderate harm Any patient safety incident that resulted in a moderate increase in treatment and that caused significant but not permanent harm to one or more patients receiving NHS-funded care.

Moderate increase in treatment is defined as a return to surgery, an unplanned readmission, a prolonged episode of care, extra time in hospital or, as an outpatient, cancelling of treatment, or transfer to another area such
as intensive care as a result of the incident.

Severe harm Any patient safety incident that appears to have resulted in permanent harm to one or more patients receiving NHS-funded care.

Permanent harm directly related to the incident and not related to the natural course of the patient's illness or underlying condition is defined as permanent lessening of bodily functions, sensory, motor, physiological or intellectual, including removal of the wrong limb or organ, or brain damage.

Death Any patient safety incident that directly resulted in the death of one or more patients receiving NHS-funded care.

The death must be related to the incident rather than to the natural course of the patient's illness or underlying condition.

Being open: Communicating patient safety incidents with patients, their families and carers, National Patient Safety Agency National Reporting and Learning Service, November 2009, Appendix B

26. Incident investigation reports must be shared with the provider's Board or medical director and the appropriate commissioner promptly following completion of any investigation. Providers are required to inform the patient's commissioner when they are communicating with a patient (or relative or carer) about an incident, though this requirement may be fulfilled by six-monthly reports as part of contract review.[20]

27. If an incident is not reported, but subsequently comes to the attention of a commissioner, the commissioner is required to raise the matter with the provider: if an incident has not been reported to the patient or to local systems, the breach of contract should be treated very seriously: where serious injury or death has ensued, commissioners should consider reporting to the CQC the provider's failure to notify as a breach of the provider's registration requirements.[21]

28. The consequences of the breach of the contractual duty are set out in the contract, and include the commissioner requiring the chief executive to provide a direct written apology and explanation to the individual or individuals affected, the commissioner requiring the provider to publish notification of the breach on its website, or the commissioner notifying the CQC. Commissioners may also recover the cost of the episode of care (or £10,000, where the cost of the episode is unknown) from the provider.[22]

29. The principles now set out in the NHS standard contract with regard to candour with patients are sound, but experience in Mid Staffs and elsewhere makes it clear that such principles have in the past been too often honoured in the breach rather than in the observance. Whatever additional safeguards may be introduced, the Committee regards the enforcement of these principles on all providers of NHS services as a fundamental part of the role of NHS commissioners. Failure to apply to these principles in practice should be seen as a failure of enforcement by commissioners as well as a failure of performance by service providers.

30. Furthermore, the Committee believes that in the requirement for openness and transparency is too narrowly drawn in the NHS Standard Contract. The requirement for candour about mistakes should, in truth, be seen as part of a much wider commitment an open and accountable service. Challenge and debate about outcomes should occur at all levels of quality achievement and in all contexts of care, not just at the bottom. Indeed the Committee believes that if high quality service providers were to set the pace for openness and transparency by making properly anonymised information available on a dramatically improved basis, they would increase the pressure on less good providers to demonstrate that they were matching their standards to the best. Verbal commitments to high quality standards are virtually meaningless if no effective steps are taken to monitor performance.

ACCOUNTABILITY OF COMMISSIONERS

31. In addition to its support for the role of commissioners in enforcing a new culture of openness on providers, the Committee also recommended in its 2011 report on Complaints and Litigation that the NHS Commissioning Board should, when authorising commissioning bodies, place the commissioners themselves under a contractual duty of candour to their populations and to their local HealthWatch organisations.[23] In response, the Government indicated that it would consult on "the expectations which should be placed on commissioners in terms of publicly reporting how often they are made aware of instances of non-disclosure and what action they have taken as a result."[24]

32. In the event NHS England has not placed commissioners under any explicit duty of candour either to local populations or to local HealthWatch organisations. In the Committee's view, such a duty is vital to build public confidence in the commissioning system and to ensure that communities can hold their commissioners of health and care services fully to account for the public money spent and the services commissioned. An effective duty of candour on commissioners would also reinforce the requirement for commissioners to enforce the principles of openness which are set out in the NHS standard contract between commissioners and providers. The Committee continues to believe that commissioners should be under an obligation to collect and publish full information about outcomes achieved for their communities, including a full account of failures to deliver acceptable standards of care. By failing to apply a duty of candour explicitly to commissioners, NHS England is losing an important opportunity to promote a more open and accountable culture throughout the NHS.

THE NHS CONSTITUTION

33. The contractual duty of candour between provider and commissioner, which is accompanied by a revised pledge to patients in the NHS Constitution: the previous pledge

that when mistakes happen, to apologise, explain what went wrong and put things right quickly and effectively

has been superseded by the pledge

to ensure that when mistakes happen or if you are harmed while receiving health care you receive an appropriate explanation and apology, delivered with sensitivity and recognition of the trauma you have experienced, and know that lessons will be learned to help avoid a similar incident occurring again.

34. The Government explains that this new pledge reflects the introduction of the contractual duty of candour, and is more specific in acknowledging where mistakes in care have been made.

35. The Committee believes that the new formulation in the NHS Constitution explaining the duty of candour substantially understates the importance of a more open culture in the NHS. Commissioners and providers should be under a duty of openness about the full range of outcomes achieved, not just about examples of patient harm. More open accountability for outcomes achieved would be an important spur to improvements in the quality of care delivered across the full range of health and care facilities. It must be driven from NHS England, but it must permeate every aspect of care provision. It is the role of commissioners to ensure that the providers of NHS care provide timely, accurate and complete information to both individual patients and commissioners.

THE FRANCIS RECOMMENDATIONS

36. Robert Francis found that current requirements in the NHS "do not cover uniformly and consistently the areas in which [openness, transparency and candour] are needed." He recommended that the following principles should underpin future requirements for openness, transparency and candour in the NHS:

· Every healthcare organisation and everyone working for them, or on their behalf, must be honest, open and truthful in all their dealings with patients and the public.

· Organisational and personal interests must never be allowed to outweigh the duty to be honest, open and truthful.

· Where harm has been, or may have been, caused to a patient by an act or omission of the organisation or its staff, the patient (or, if the patient is deceased, any lawfully entitled personal representative) should be informed of the incident, given full disclosure of the surrounding circumstances and be offered an appropriate level of support.

· Full and truthful answers must given to any question reasonably asked by a patient (or, if deceased, by any lawfully entitled personal representative) about his or her past or intended treatment.

· Any statement made to a regulator or a commissioner in the course of its statutory duties must be completely truthful and not misleading by omission.

· Any public statement made by a healthcare organisation about its performance must be truthful and not misleading by omission.[25]

In applying these principles Mr Francis made three recommendations to amend the legal obligations on providers of healthcare.

37. Mr Francis' first recommendation is that a statutory obligation to observe a duty of candour should be imposed:

i. on healthcare providers "who believe or suspect that treatment or care provided by [the provider] to a patient has caused death or serious injury to a patient to inform that patient or other duly authorised person as soon as is practicable of that fact and thereafter to provide such information and explanation as the patient reasonably may request"; and

ii. on registered medical practitioners and registered nurses and other registered professionals "who believe or suspect that treatment or care provided to a patient by or on behalf of any healthcare provider by which they are employed has caused death or serious injury to the patient to report their belief or suspicion to their employer as soon as is reasonably practicable".

The provision of information in compliance with this requirement "should not of itself be evidence or an admission of any civil or criminal liability, but non-compliance with the statutory duty should entitle the patient to a remedy".[26]

38. Secondly, Mr Francis recommended that there should be a statutory duty "on all directors of healthcare organisations 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."[27]

39. Thirdly, Mr Francis recommended 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;

· To provide information to a patient or nearest relative intending to mislead them about such an incident;

· 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."[28]

Observance of the duty "should be policed by the Care Quality Commission, which should have powers in the last resort to prosecute in cases of serial non-compliance or serious and wilful deception. The Care Quality Commission should be supported by monitoring undertaken by commissioners and others."[29]

The case for a statutory duty

40. In evidence to us, Robert Francis clarified that his requirement for a statutory duty of candour filled a gap in the obligations of NHS organisations to be honest with patients:

A statutory duty was required as a means to, and a precondition of, the substantial change in culture which was required across the NHS. He put it in these terms:

He considered that the contractual duty of candour owed by a provider to a commissioner did not go far enough:

By way of illustration, he referred to a case which had come to light during the inquiry where a consultant's report relevant to the death of a patient consequent on treatment at Stafford General Hospital had been withheld from a coroner's inquest, and from the family, on the basis of legal advice given by the Mid Staffordshire Trust's legal department "because it was believed—honestly believed—by those doing it that it was in the trust's best interests to do that, which is, I am afraid, not a happy story for my profession."[33]

41. This case was discussed at length in Robert Francis' report.[34] Mr Francis criticised the Mid Staffordshire Trust over the failure to disclose to a coroner material which might have been of assistance to him, and concluded that in such circumstances the primary consideration for a Trust's solicitors should be "whether the information in the solicitor's possession would, or could, reasonably be considered to be of assistance to the Coroner, whether or not it showed the trust in a poor light."[35] In the case in question, Mr Francis concluded that "the only possible answer" was that the material should have been disclosed. The trust and confidence of the bereaved family in the Trust had been seriously damaged by the concealment of the report: that concealment "caused more distress than disclosure could ever have done".[36]

42. Mr Francis observed that existing guidance requiring trusts and clinicians to be open with patients and bereaved families about adverse incidents, and to offer them full explanations of what occurred, "should be a very significant factor to be taken into account in deciding where the interests of a trust lie".[37] The inquiry had heard that there was no duty in law—either in statute or in common law—for those in possession of factual information concerning a death to volunteer such information to a coroner, and he therefore concluded that many other solicitors acting for and advising Trusts would have acted no differently. He therefore believed that there was

43. Mr Francis was also critical of the way the Trust had behaved in its response to a civil claim made against the Trust by the bereaved family. The way the Trust had conducted the litigation had revealed "some unfortunate characteristics all too common in clinical negligence claims".[39] A written apology sent to the family by the Trust Chair, in which the hope was expressed that a swift settlement would enable the family "to put this matter behind you and move on",[40] was described as "formulaic, insensitive, patronising and likely to exacerbate wounds rather than heal them".[41] The Trust appeared to have conceded internally that the claim was indefensible and that it would be reasonable for the Trust to settle, and did not seek evidence to the contrary: yet it persisted in denying liability in an attempt to negotiate a lower settlement, a position "entirely inconsistent with the professed policies and guidance calling for openness and transparency about adverse incidents".[42] Despite complaints of the bereaved family about the way the settlement had been handled, the Trust's solicitor maintained that the settlement had been a success.[43]

44. The Committee believes that a defensive and sometimes over-legalistic culture which attaches a higher priority to avoiding liability than improving outcomes represents a pervasive phenomenon which is not confined to the healthcare system. While legal accountability is important, it is even more important that legal advice based on such defensive considerations is not allowed to impede the proper relationship between clinical professional and patient, based on sound principles of professional responsibility.

45. Similarly, defensive and over-legalistic considerations of the best interests of Trusts should not be allowed to override the duty to be open and transparent with patients and relatives about adverse incidents, and to provide to them full explanations of the factors which led to such incidents. It is particularly important that NHS bodies provide full and candid explanations to relatives bereaved as a result of an adverse incident.

46. The Committee discussed with Mr Francis the potential difficulties which a statutory duty of candour might pose for medical professionals and others involved in patient safety incidents, where it appeared that a requirement to be open and honest about any mistakes made might conflict with legal advice from a provider, with an eye to admissions of liability, about what admissions should or should not be made.

47. While Mr Francis recognised that medical professionals required to be open and honest about errors might, in admitting mistakes, open themselves to the possibility of professional misconduct proceedings, he thought that professional regulators would be far more lenient on those who owned up to errors with a serious effect on patient safety than they would on those who denied or sought to cover up their lapses:

REACTIONS TO THE FRANCIS RECOMMENDATIONS

48. In its response to Francis, the Government has indicated that it will consider a statutory duty of candour on providers to inform patients or relatives of cases where the provider believes that treatment or care has caused death or serious injury, and to explain why. The scope of the duty is to be "carefully considered".[45] The Secretary of State told the Committee that "we think that providers should have a duty in law to be transparent with people when they have done harm, and we accept that."[46]

49. The Government has since indicated that the statutory duty of candour will be introduced as a requirement on providers registered with the Care Quality Commission, and that provision for the statutory duty will be made through secondary legislation rather than on the face of the Care Bill [Lords].[47]

50. The report of the Berwick Review of patient safety in England also recommended a statutory duty of candour: "where an incident qualifying as a Serious Incident (as defined by NHS England) occurs, CQC regulations should require that the patient or carers affected by the incident be notified and supported."[48]

51. Berwick also, however, enters some important caveats about the scope of a statutory duty, and indeed about the scope of the contractual duty in the NHS Standard Contract. The Berwick Review eschews "an automatic 'duty of candour' where patients are told about every error or near miss, as this will lead to defensive documentation and large bureaucratic overhead that distracts from patient care". Berwick does recommend that "patients should be given all the information they ask for" and suggests the commissioning of research "to study how proactive disclosure of serious incidents, and the process of engaging with patients in relation to less serious incidents, can best be supported."

52. The Government plans to work with professional regulators to see "what more can be done to encourage professionals to be candid with their patients at all times".[49] This falls short of Robert Francis' recommendation for a specific duty of candour on medical professionals to report to their employer a belief or suspicion that treatment provided to a patient has caused death or serious injury.

53. Berwick explicitly does not support the Francis recommendation of a statutory duty for healthcare workers to report beliefs or suspicions about serious incidents to employers, considering that this duty "is adequately addressed in relevant professional codes of conduct and guidance".[50]

THE ROLE OF CRIMINAL SANCTIONS FOR INDIVIDUALS AND HEALTHCARE ORGANISATIONS

54. The Government has expressed caution about introducing criminal offences to apply to individuals working in healthcare settings, arguing that they may unintentionally introduce a "culture of fear", preventing lessons from being learned. However the Government agrees that "robust action" should be taken in instances where staff are "obstructively dishonest". In addition, criminal sanctions are proposed for staff who deliberately allow fundamental standards of care[51] to be breached. Ministers plan to take advice from the professional regulators and to consider the findings of the Berwick Review on the appropriateness of criminal sanctions to be applied below Board level.[52]

55. The Berwick Review expresses extreme caution about any proposal to apply criminal sanctions to individual staff working in healthcare settings. Such sanctions should only be applied in cases where individuals are demonstrably guilty of wilful or reckless neglect, and only then in accordance with several stringent criteria concerning, for example, the severity of the case and the level of culpability of the individual. The Committee addresses these matters further at paragraph 115 below.

56. Berwick does concur with Francis in recommending that leaders in healthcare organisations "who deliberately withhold information or who provide misleading information" should be subject to penalties.[53]

57. The Government proposes that care providers who "knowingly supply wrong information" or who "deliberately withhold information from families about serious harm or death" are to be subject to additional legal sanctions at a corporate level. Provision for a new offence and for penalties have now been introduced as part of the Care Bill [Lords][54]:

· Clause 81 of the Bill introduces a new criminal offence, to apply to care providers as corporate bodies. Any such provider who supplies information required by statute or another legal obligation which is materially false or misleading commits an offence.[55]

· Clause 82 of the Bill provides that a care provider convicted of an offence is liable to a fine on conviction, with the option for the sentencing court to impose on the provider a remedial order (requiring the provider to put right the misleading information and any materially relevant deficiency in its practices), a publicity order (requiring the provider to publicise the fact of the conviction, details of the offence and the fine imposed and details of any remedial order made), or both.[56]

The Committee's view

58. In its 2011 report on Complaints and Litigation the Committee reached the following conclusion on the introduction of a statutory duty of candour:

59. The Committee is mindful that NHS history is littered with examples of well-intentioned changes which have been superimposed on existing arrangements without sufficient attention being paid to the way in which it is proposed that the new arrangements will interact with existing processes. It is striking, for example, that the clauses in the Care Bill [Lords] which are intended to establish a criminal offence of providing false and misleading information—in effect criminalising a breach of the proposed statutory duty of candour—have specified neither the types of provider, nor the types of information to which the offence will apply, leaving both to be specified later in regulations.

60. The Committee remains to be persuaded of the case for the introduction of a statutory duty in addition to existing contractual duties and professional obligations. It is not clear that the proposed duty, the terms of which remain to be defined in secondary legislation, will constitute an effective means of achieving the fundamental culture change which is required within the NHS.

61. The Committee continues to believe that it is mistake to think of the requirement for a more open culture specifically in the context of failures of care. The culture change which is required within the NHS requires greater openness across the full range of its activities—including examples of care that do not match current best practice, as well as overt failure.

62. The Berwick Review recommends the commissioning of research into how best to support the proactive disclosure of serious incidents and the process of engaging with patients in relation to less serious incidents. While further research into these matters is necessary, and is likely in the medium term to make a positive contribution to candid dialogue between providers and patients, it should not delay the implementation of measures designed to entrench a culture of openness and candour across the full range of NHS activities.

14 Q34 Back

15 Ibid. Back

16 Q85 Back

17 Q36 Back

18 Service Condition (SC) 35. The standard contract is available at http://www.england.nhs.uk/wp-content/uploads/2013/03/contract-service.pdf Back

19 NHS Commissioning Board, 2013/14 NHS Standard Contract: technical contract guidance, 4 February 2013, available at http://www.england.nhs.uk/wp-content/uploads/2013/02/contract-tech-guide.pdf Back

20 Ibid. Back

21 Ibid. Back

22 Ibid. Back

23 Health Committee, Sixth Report of Session 2010-12, Complaints and Litigation, HC 786-I, para 82 Back

24 Government Response to the House of Commons Health Select Committee Sixth Report of Session 2010-11: Complaints and Litigation, Cm 8180, para 73 Back

25 Francis Report, recommendations 173-177, chapter 22 Back