House of Commons - Patient Safety

Patient Safety - Health Committee Contents

4 Harmed patients and their families or carers

57. When a patient is harmed, the NHS organisation responsible has, according to the NPSA, a duty to:

be totally honest with the patient (or their family or carers) about what has happened;
give a full explanation;
apologise unequivocally;
give an undertaking that all the necessary steps will be taken to avoid the same harm coming to another patient.

58. To fail in any of these duties is to compound the harm done. As Josephine Ocloo, whose daughter's treatment was a matter of serious concern, told us, harmed patients can be "doubly harmed through being unable to get explanations, justice and accountability".[48]

59. In this chapter we consider whether the NHS is meeting its obligations to harmed patients and their families or carers in respect of being open in this way. We also look at how the NHS handles complaints about services—which are supposed to allow harmed patients and their families or carers to bring unsafe care to light and have it appropriately addressed. We look too at progress towards ensuring redress for harmed patients without the need for litigation—which would both remove medico-legal obstacles to openness about incidents (and to learning from them), and spare harmed patients distressing and lengthy legal proceedings.

Being open

60. During the inquiry we heard harrowing cases of failures in communication from the relatives of harmed patients, who recounted a distressing lack of openness on the part of NHS organisations and staff. Mrs Clare Bowen, for instance, said the following about the circumstances surrounding the death in 2006 of her daughter Bethany during surgery:

Beth was admitted to hospital. Everything was going, so far as we knew, well. She went down to surgery and the next thing we knew the doctors came back up and told us that they had cut a major blood vessel and Bethany had bled to death on the operating table. Subsequently, a lot of information came to light because we fought for it. The hospital were very reluctant to give us any information; we had to ask for everything we were given. Their story changed considerably over time. We found out that the blood vessel they were talking about was her aorta. That they could not have cut through her aorta, that it must have been a problem with her heart—even though she had two cuts in her aorta and cuts to her stomach and her bowel. We found out that a trainee was using a brand new piece of equipment called a morcellator on Beth. This bit of equipment had never been used in paediatrics in the UK before. It is used widely in gynaecology. They had not received any new training on this. Actually, they decided to use this equipment after the consent form was signed. The additional risks just were not told to us […]

61. A series of reports have shown that too many people have had experiences of this kind and have called for more openness. The NAO investigation in 2005 and the following PAC report in 2006 found that there was still too little openness with patients over safety incidents. The NAO found that Trusts "named concerns about the risk of a claim under the NHS clinical negligence scheme[50] as reasons cited by staff as having discouraged them from apologising or from being open following an incident".[51] The PAC recommended that all NHS organisations should abide by the NPSA guidance Being open: communicating patient safety incidents with patients and their carers (2005) and, as a matter of course, inform patients and their carers if an incident had occurred. The DH agreed and thought that the planned NHS Redress Scheme (to provide an alternative to clinical negligence litigation) would help bring about greater openness[52]—although, as we discuss below, the Redress Scheme still has yet to be implemented. In December 2006, the CMO's review group recommended that "All NHS organisations should develop and implement local initiatives to promote greater openness with patients and their families when things go wrong and to provide required support".[53]

62. We heard evidence from Dr Susannah Long, a junior doctor, and Sarah Dheansa, a Matron, that some, if limited, progress had been made in recent years:

Q 435 Sandra Gidley:

Dr Long: I personally have no problem with doing that. It tends to start putting things right when something has gone wrong if you can be very clear and explain, "We didn't mean this to happen, but it has, and this is what we are going to do about it for you" […]

Ms Dheansa: I would echo that it is a lot more open. There is much fear of litigation and the reputation [damage] to the hospital, et cetera, but from a clinical point of view I would say that we are now able to be very, very open.

63. The lack of training in communicating with patients is a serious matter of concern. Some clinicians had had a good experience. A junior doctor interviewed by Imperial College for this inquiry "recalled having training in medical school about dealing with patient families and breaking bad news".[54] Another junior doctor, Dr Simon Kreckler, told us that:

64. However, others thought there was a lack of formal training:

Q 436 Sandra Gidley:

Dr Long: I think I learned by observation, not explicit training.

65. Imperial College asked a nurse whether she had been specifically trained to speak to patients' families in the event of something going wrong. She replied: "No, I guess not. We are taught that we should talk to patients and families if something does go wrong, but there's no easy five-step guide on how to do this."[56]

66. Graham Tanner, one of the Patient Safety Champions for England and Wales, stated that:

67. According to Action against Medical Accidents (AvMA):

They recommend that:

- The Healthcare Commission/new Care Quality Commission actively monitor NHS bodies' implementation of the Being Open guidance/safety alert and uptake of the training.

- Resources are made available for NHS bodies to take up training on 'Being Open'.

68. AvMA was critical of guidance issued to Trusts by the NHSLA in 2007 on giving apologies and explanations when a patient is harmed:

69. However, AvMA welcomed new guidance issued in May 2009 by the NHSLA which states that it is desirable in cases of harm for clinicians "to sympathise with the patient or the patient's relatives; to express sorrow or regret at the outcome; and to apologise for shortcomings in treatment". The NHSLA is "keen to encourage both clinicians and NHS bodies to supply appropriate information whether informally, formally or through mediation". It stressed that these "earlier, more informal, apologies and explanations" were distinct from formal admissions of liability and would be treated as such by the NHSLA. The guidance also explicitly refers Trusts to Being open.[62]

70. Further steps to improve openness are planned following a review of Being open by Professor Albert Wu of Johns Hopkins University, in the USA, which was commissioned by the DH and resulted in six options for action being recommended.[63]

71. Mr Fletcher of the NPSA welcomed the review and, in particular, its recommendations for strengthening implementation through more targeted training of senior clinicians.[64] Plans to implement the review's recommendations are being finalised.[65]

The role of the coroner

72. Even if the NHS is not open with patients, in the case of fatal incidents, the families of harmed patients rightly expect to obtain frank and comprehensive information through the work of the coroner. However, most unfortunately, this was not the experience of the relatives of harmed patients from whom we took evidence.

73. Following the death of her daughter Krista in circumstances giving significant cause for concern, Ms Ocloo requested a coroner's inquest but was rebuffed:

74. Mrs Bowen was granted an inquest into her daughter's death, but found it unhelpful:

Dealing with complaints

75. The NHS complaints system has undergone a long process of evolution over nearly 40 years; this is summarised in Box 5.Box 5: Development of the NHS complaints system, 1973-2009

1973 Health Service Ombudsman (Health Service Commissioner) created, with the ability to examine unresolved complaints about NHS services and make recommendations, but no power to enforce compliance.

1974 Community Health Councils (CHCs) created, with a remit that includes assisting complainants.

1996 Creation of three-stage NHS complaints resolution system:

Stage One: Local resolution
Stage Two: Independent Review (by Independent Review Panel)
Stage Three: Investigation by the Ombudsman

2001 Patient Advice and Liaison Services (PALS) begin to be introduced into Trusts, with a remit that includes assisting with the speedy resolution of problems and acting as a gateway to the formal complaints process.

2003 CHCs abolished and Independent Complaints Advocacy Services (ICAS) begins operating (commissioned by the DH from the voluntary sector), giving independent advice and support to NHS complainants. Independent Review stage of complaints process handed to Commission for Health Improvement (CHI).

2004 Independent Review stage handed to the HCC, which also regulates the standard of complaints handling and the implementation of learning from complaints by NHS bodies.

2009 NHS and social-care complaints systems are put on the same footing, and new regulations come into force. Independent Review stage is abolished; and Care Quality Commission (CQC) takes on responsibility for regulating NHS bodies' handling of complaints.

76. In her evidence to us, Ann Keen MP, Parliamentary Under Secretary of State at the DH, was in no doubt about the effectiveness of both PALS, which act as the gateway to the complaints system, and ICAS, which assist in seeking local resolution of complaints:

Q 947 Dr Taylor:

Ann Keen: From our experience and from the feedback we get, PALS supply an excellent service to patients. The reporting on the PALS services is excellent […]

Q 949 Dr Taylor:

Ann Keen: Very much so […]

77. Other witnesses were also positive about PALS.[68] However, Mrs Bowen took a very different view based on her experience following her daughter's death in 2006:

78. She was in no doubt that the problem was that PALS were paid by the Trust that they were dealing with and were not independent:

79. Mrs Bowen's experience reinforces the conclusions of several publications, by the Health Service Ombudsman, HCC and NAO, which have noted the persistence of very serious deficiencies in the NHS complaints system, despite the changes of 2004 (see Box 6).[71]Box 6: Shortcomings identified in the NHS complaints system

The system is not centred on the patient's needs.
There is a lack of public understanding about the complaints process.
There is confusion about how to complain.
Complainants have difficulty in navigating the system.
People feel intimidated and that their complaint will not be taken seriously.
The complaints system is fragmented.
The quality of local complaints handling in the NHS is often poor.
Staff lack the capacity and competence to deliver a quality service.
The right leadership, culture and governance are not in place.
Just remedies are not being secured for justified complaints.
Better use could be made of complaints data to improve services.

80. The DH is confident that the latest changes to the complaints system will resolve these issues once and for all. Lord Darzi told us:

Q 940 Dr Taylor:

Professor Lord Darzi of Denham: Yes.

81. The CMO, Professor Sir Liam Donaldson, added that:

82. However, this confidence in the new arrangements was not shared by the relatives of harmed patients from whom we took evidence, such as Ms Ocloo:

83. In New Zealand we found an apparently successful model for a complaints system, in which the independent Health and Disability Commissioner acts as a strong statutory guarantor of patients' rights (see Box 7).Box 7: The role of the New Zealand Health and Disability Commissioner in resolving complaints

The Office of the Health and Disability Commissioner (HDC) is a New Zealand crown entity responsible for promoting and protecting the rights of health and disability service consumers; and facilitating the fair, simple, speedy, and efficient resolution of complaints.
Providers are required to respond in a timely and appropriate way to any complaints made to them. Complaints can also be made directly to one of HDC's Health and Disability Consumer Advocates, who can assist in trying to resolve the complaint locally.
Anyone can make a complaint to HDC, orally or in writing. This includes not only consumers, but also their families and carers, and other third parties—including staff members in a health or disability service. HDC does not have to receive a complaint in order to take action. The Commissioner can also undertake an inquiry on his own initiative, and may do this where serious public concerns have been raised about the safety of a service.
The Commissioner may take an educational approach, ask for an apology or recommend action, which is followed up in the same way as recommendations arising from investigations. He may formally refer the complaint to the provider, or to advocacy or formal mediation for resolution between the parties.
At any time, the Commissioner has the discretion to refer matters to another person or authority where he considers it in the public interest to do so. He must refer matters to the appropriate person or authority when an investigation has revealed a significant breach of duty or misconduct; and at any point during the complaint handling process when he has reason to believe that the practice of a health practitioner may pose a risk of harm to the public.
All complaints made directly to professional registration bodies must be referred by them to HDC. Once referred to HDC, no disciplinary action can be taken by the professional body until HDC has dealt with the matter and decided to take no further action. Only at this point can the professional body take up the matter itself.

84. The Commissioner effectively combines the Independent Review and Ombudsman stages of the NHS complaints system in England as it existed until recently—and with greater authority and resources.

Compensation and redress

85. Many harmed patients and their families or carers are obliged to bring clinical negligence cases to obtain financial compensation and redress from the NHS and, in some cases, to obtain full information, an explanation and an apology. There is widespread agreement that litigation is an extremely unsatisfactory means of achieving these ends. It can be distressing, unfair, slow and costly, with the NHS paying substantial legal costs in each case. It also tends to encourage NHS organisations to be defensive towards harmed patients and their families or carers, and inhibits the development of a safety culture.

86. In 2003, the CMO proposed a new system for patients harmed by NHS care, as an alternative to litigation in a large proportion of cases—the NHS Redress Scheme.[75] This was accepted by the Government and plans for the Scheme were worked out (see Box 8).Box 8: Key principles of the planned NHS Redress Scheme

obtaining redress to be a consensual process, as opposed to the adversarial process involved in litigation;
proceeding under the Scheme to be voluntary;
patients to be eligible for redress for serious harm during NHS care, provided it was avoidable and not the result of the natural course of the patient's initial illness or condition;
the right to litigate to remain, but with a presumption that litigants have first applied to the Scheme;
those accepting redress under the Scheme to be required to waive their right to go to court on the same case;
the same tests for negligence to be applied as under current tort law in clinical negligence cases;[76]
the upper limit for compensation to be set at £20,000 initially;
the Scheme to be a risk-pooling membership scheme for NHS service-providers in England, with NHS commissioners providing cover in the case of independent-sector providers of NHS care.

87. Enabling legislation (the NHS Redress Act) was passed in 2006, providing the legislative framework to allow the Secretary of State to establish the NHS Redress Scheme. It was expected that the Scheme would begin operating in 2008, but this has not happened. There is widespread support for the principle of a Redress Scheme and the lengthy delay in its introduction has caused consternation. Mr Tanner, one of the Patient Safety Champions, told us:

88. We discovered that the Government still has no definite plans to establish the Scheme. Ann Keen MP, told us:

89. In New Zealand, we examined a form of redress scheme, which is much bolder in scope than the planned NHS Redress Scheme (see Box 9). The New Zealand scheme has existed since the 1970s and is considered successful and popular in that country. We were told that the elimination of litigation over clinical negligence in this way worked well for patients and healthcare providers; and that it had significantly reduced medico-legal barriers to developing a safety culture. We have received evidence commending this system as a model.[79] On the other hand, we also heard some concerns. Steve Walker, Chief Executive of the NHSLA, informed us that the New Zealand scheme "has been constrained at least twice since inception, because initially it was seen to be too wide".[80]Box 9: The role of the New Zealand Accident Compensation Corporation in compensating for medical harm

The New Zealand Accident Compensation Corporation (ACC) is a statutory body operating a universal compensation scheme in lieu of all forms of litigation over personal injury, including in cases of medical harm ("treatment injury").
The system is funded from levies and taxation, and funds medical treatment arising from treatment injury, as well as compensating victims of harm.
There is no need to prove negligence, as would be required under tort law. This has led some to term this a "no fault" system, but the ACC does have a set of "exclusionary criteria", whereby harm is not compensable if it is the necessary or ordinary consequence of treatment.

Conclusion

90. Harmed patients and their families or carers must receive honest information, a full explanation, an unequivocal apology and an undertaking that the harm done will not be repeated. While, the NHS has made progress in this regard, there is still too often a lack of frankness on all these counts.

91. The new NHS Litigation Authority guidance on giving apologies and explanations is welcome and we urge its implementation. We also recommend further consideration be given to the CMO's proposal for a statutory duty of candour in respect of harm to patients.

92. Relatives have a right to expect that coroner's inquiries will provide information about the reasons for deaths. We are disappointed that some harmed patients' families do not believe that coroners provide the objective inquiry and independent review that is needed. We believe coroners are too narrowly focused on the immediate cause of injury rather than underlying causes, as evidenced by the case of Bethany Bowen.

93. The NHS continues too often to deal poorly with complainants and fails to use complaints as a means of improving services. We are sceptical that there will be a major improvement following the latest in a protracted series of changes to the complaints system.

94. We are concerned that Patient Advice and Liaison Services, which are effectively the gateway to the NHS complaints system, are provided by NHS organisations themselves. While many PALS services undoubtedly do a good job for patients, their lack of independence makes it more likely that some at least will be "defensive and unhelpful", as a witness found them to be, when a patient has been harmed. PALS should not be hosted by individual NHS organisations and must be independent. We recommend that the Department report on the adequacy of PALS staffing by publishing the number of staff dedicated to PALS affairs by whole-time equivalents for each Primary Care Trust, acute Trust and Foundation Trust.

95. We are very concerned about the loss of the Independent Review stage of the complaints process, which we regard as a retrograde step. There is no guarantee that the new regulations will improve the handling of complaints at local level. Moreover, we doubt the Ombudsman has sufficient resources to be able to act as an adequate "backstop" for the many people whose complaints are not adequately addressed locally. We recommend a reversion to the three-stage model for the NHS complaints system as soon as possible, with the Care Quality Commission, or another appropriate body, taking on the Independent Review stage.

96. In addition, we recommend that the DH consider the possible application in England of the model provided by the independent Health and Disability Commissioner in New Zealand, to encompass both the Independent Review and Ombudsman roles.

97. The failure to be open and to satisfactorily address complaints is in large part due to the fear of litigation. We are appalled at the failure of the DH to implement the NHS Redress Scheme three years after Parliament passed the necessary legislation. The DH has explained that it wishes to focus on complaints reform and will consider the matter of redress "When the reformed complaints arrangements are embedded". We find this wholly unsatisfactory. By dragging its heels over implementing the NHS Redress Scheme, the DH is forcing harmed patients and their families or carers to endure often lengthy and distressing litigation to obtain justice and compensation. It is also obliging the NHS to spend considerable sums on legal costs, and encouraging defensiveness by NHS organisations. In addition, it is hindering the development of a safety culture in the NHS, which cannot flourish in the midst of powerful tensions between the desire to be open and medico-legal concerns. We recommend that the Redress Scheme be implemented immediately.

98. If anything, the Government should be considering more radical measures in this direction, rather than shying away from the limited changes for which it has already legislated. We urge consideration of a scheme like that in New Zealand, where litigation over clinical negligence has been entirely replaced by a statutory right to compensation for "treatment injury" from an independent fund, without the need to prove negligence as required under tort law.

48 PS 82 Back

49 Qq 165, 176. The Committee has received a memorandum from Oxford Radcliffe Hospitals NHS Trust stating that "shortly after Bethany's death, the surgeon in charge met with her parents and explained (what the surgeon at the time thought to be the case) that the morcellator had caused the damage and that the bleeding from the damage to the aorta had caused the death. However, over the forthcoming days and weeks, and then extending to the inquest, surgeons and investigators and our external expert reviewer questioned whether this explanation made sense. We recognize that giving an initial explanation which is later questioned as different facts emerge can be perceived as becoming defensive." The memorandum also states that the Trust "values greatly Mrs Bowen's personal account of her experience, and commends her evidence to the Committee" and has learned important lessons from this case (PS 102). Back

50 The voluntary Clinical Negligence Scheme for Trusts (CNST) is a form of "risk-pooling", with NHS organisations paying an annual contribution to belong to the scheme and able to claim from it in the event of litigation. Members of the CNST must undergo a rigorous risk management programme. The core of this is provided by a range of NHSLA standards and assessments. Healthcare organisations are regularly assessed against these risk management standards, which have been specifically developed to reflect issues that arise in the negligence claims reported to the NHSLA. Back

51 Committee of Public Accounts, A safer place for patients, para 6 Back

52 Treasury Minutes on the Forty-seventh to the Fifty-first Reports from the Committee of Public Accounts 2005-2006, Cm 6908, October 2006, paras 20-21 Back

53 Department of Health, Safety First, 2006, p 29 Back

54 Centre for Patient Safety and Service Quality, Imperial College, commissioned research Back

55 Q 439 Back

56 Centre for Patient Safety and Service Quality, Imperial College, commissioned research Back

57 Ev 119 Back

58 Ev 221 Back

59 The CMO recommended that there should be a legal obligation (rather than merely a professional or ethical one) on clinicians and managers to inform patients if harm occurred during treatment (Department of Health, Making Amends: A consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS, June 2003). The recommendation was not accepted by the Government. Back