Patient Safety - Health Committee Contents


Conclusions and recommendations


Patient safety policy since 2000

1.  Since 2000, the Department of Health has sought to move the NHS away from a "blame culture", in which harm to patients is unfairly attributed to individual healthcare workers, to an open, reporting and learning culture, which can identify and address the systemic failings that are responsible for the vast majority of avoidable harm. At the same time, a mechanism (the National Reporting and Learning System) and an organisation (the National Patient Safety Agency) have been created to facilitate systematic reporting of, and learning from, patient safety incidents, and improvement of services. These measures mean the NHS has led the way for healthcare systems throughout the world in the development of patient safety policy and for this credit is due. In his reports in 2007 and 2008 Lord Darzi stressed the importance of safe care in the NHS as part of his Next Stage Review. (Paragraph 30)

2.  In addition, the Health Foundation has established the Safer Patients Initiative which seeks to encourage clinicians and other staff to look for the best ways of reducing the harm done to patients. (Paragraph 31)

3.  We are, however, concerned that Lord Darzi's emphasis on quality and safety is an indication that, for all the policy innovations of the past decade, insufficient progress has been made in making NHS services safer. We note that the report commissioned by the Chief Medical Officer in 2006, Safety First, concluded that patient safety was attaining a significant national profile, but was "not always given the same priority or status as other major issues such as reducing waiting times, implementing national service frameworks and achieving financial balance". This concern is heightened by the recent cases of disastrously unsafe care that have come to light in a small number of Trusts. (Paragraph 32)

Measurement and evaluation

4.  The evidence, particularly that from case note reviews, both in England and internationally, indicates that the extent of medical harm is substantial, even on a conservative estimate, and that much is avoidable. International studies suggest that about 10% of all patients who are admitted to hospital suffer some form of harm. Judging how far patient safety policy has been successful requires more reliable data regarding how much harm is done to patients. Unfortunately, neither the NPSA nor the DH was able to provide us with that. Government estimates of avoidable harm and the attendant financial costs are extrapolations from old, very limited, data; and no attempt has been made to produce reliable up-to-date figures. (Paragraph 55)

5.  We remind the Department of the value of the random case note review that was a part of Royal College inspections for accreditation for training of junior doctors. We commend to all hospitals the practice of conducting regular sample case note reviews, as is done at Luton and Dunstable Hospital, to provide a clear indicator of local performance in making services safer. We recommend that the NPSA monitor progress by the NHS in improving patient safety, using local sample case note peer review data and other sources of information on harm to patients. (Paragraph 56)

Harmed patients and their families or carers

6.  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. (Paragraph 90)

7.  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. (Paragraph 91)

8.  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. (Paragraph 92)

9.  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. (Paragraph 93)

10.  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. (Paragraph 94)

11.  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. (Paragraph 95)

12.  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. (Paragraph 96)

13.  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. (Paragraph 97)

14.  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. (Paragraph 98)

An open, reporting and learning NHS

15.  After the expenditure of much effort and funding on the National Reporting and Learning System, clear progress has been made in incident reporting; but we are concerned that the NRLS is nevertheless still limited in its effectiveness. (Paragraph 113)

16.  We welcome the fact that the NRLS is now collecting significant amounts of data, which are being used to generate statistical and other output to help make services safer. However, we are concerned that there remains significant under-reporting, particularly in respect of incidents in primary care; medication incidents; serious incidents; and reporting by doctors. (Paragraph 114)

17.  A major reason for under-reporting is the persistent failure to eliminate the "blame culture" in much of the NHS. Another important factor is fear of litigation or prosecution, underlining the need for the Government to address the medico-legal aspects of patient safety; we particularly recommend the decriminalisation of dispensing errors on the part of pharmacists. The "one size fits all" nature of reporting systems is also a significant problem. We welcome the NPSA's recognition of the need to address this by developing reporting systems that are appropriate to different specialties (such as general practice and anaesthesia). We recommend that work on this be treated as a major priority by the Agency. (Paragraph 115)

18.  We believe that as much as possible of the data collected by the NRLS on reported incidents should be published, in the interests of openness and learning about patient safety. We, therefore, welcome the decision to start publishing this data broken down by individual NHS organisation. (Paragraph 116)

19.  While acknowledging the importance of incident reporting for patient safety, we question whether the NRLS, as presently constituted, is as useful and as cost-effective as it should be. The System currently amasses a good deal of summary data of doubtful usefulness, particularly on: common types of incident that are already well understood, such as slips, trips and falls; and less serious ("Low harm" and "No harm") events, of various types. However, unlike reporting systems in other safety-critical industries, and in other healthcare systems, it does not systematically gather in-depth (root-cause analysis) data on serious and sentinel events. We recommend that consideration be given to rebalancing the NRLS accordingly. We also recommend that root-cause analysis be undertaken much more widely, and better, in the NHS in respect of serious and sentinel events in general and less common types of these in particular. We believe this might be facilitated by the establishment of a body along the lines of the Department for Transport's Accident Investigation Branches, which could undertake independent root-cause analysis of serious and sentinel events in cases where there are likely to be significant new lessons to learn. In cases involving a patient's death, this could have the additional benefit of providing their family with the full explanation that coroners do not seem always to provide. We recommend that the DH look into the feasibility of this. (Paragraph 117)

20.  No reporting system, however well it functions, can capture all the information about patient safety issues and solutions that is needed to help make services safer. Data must be collated from as wide a range of sources as possible. We acknowledge the work that the NPSA has already done in this regard, particularly through the Patient Safety Observatory, and we recommend that this should be made a major priority for the Agency. (Paragraph 118)

Patient safety at the front line

21.  Too often known patient-safety solutions fail to be adopted in the NHS even when they are disseminated by means such as Patient Safety Alerts. They are handed down from on high as diktats (if they are passed on at all) without frontline clinicians being convinced of their effectiveness. Moreover, a culture persists in which various types of harm to patients are seen as inevitable when in fact they are avoidable if the right steps are taken. (Paragraph 148)

22.  Some organisations, however, have shown that it is possible for improvements to be fully integrated in frontline services by engaging and involving clinicians, and other healthcare workers. The focus needs to be on tangible improvements to health, drawing on staff's own initiative. (Paragraph 149)

23.  "Lean" thinking, using the initiative of frontline staff to increase efficiency and use time more effectively, is beginning to be introduced into the NHS through schemes such as the Productive Ward programme and the Safer Patients Initiative. This approach has much to commend it. If less efficient ways of working can be eliminated then more can be achieved and standards of care raised. (Paragraph 150)

24.  Lack of non-technical skills can have lethal consequences for patients. However, the NHS lags unacceptably behind other safety-critical industries, such as aviation, in this respect. Human Factors training must be fully integrated into undergraduate and postgraduate education, as we discuss more fully below. (Paragraph 151)

25.  Routines and, in particular, checklists are an important aspect of safety in healthcare as in other activities. We welcome the implementation of the World Health Organization Safe Surgery checklist. While similar measures are already used in NHS hospitals, we are concerned that such checklists are not always followed because clinicians regard them as diktats and do not always see the point of them. We recommend that clinicians who persistently disregard these checklists should undergo retraining. (Paragraph 152)

26.  Despite the massive increase in the numbers of NHS staff in recent years, inadequate staffing levels have been major factors in undermining patient safety in a number of notorious cases. It is clearly unacceptable for care to be compromised in this way. NHS organisations must ensure services have sufficient staff with the right clinical and other skills. (Paragraph 153)

27.  Regarding the new European Working Time Directive rules, we are not convinced by the more alarmist claims being made that these will seriously jeopardise patient safety when they are introduced on 1 August 2009. But we do seek assurance from the DH that everything possible is being done to ensure that safety is not compromised. Professor Sir Bruce Keogh, the NHS Medical Director, did agree that 1 August "is going to be very challenging" and he told the Committee that derogation for some services and the impact on training were being looked into further. (Paragraph 154)

Technology and patient safety

28.  While the potency and complexity of modern technology mean that it carries great potential for harm, it can also make a major contribution to patient safety. During the inquiry we took evidence about a number of technologies which could make significant improvements to care but which were being implemented far too slowly. (Paragraph 176)

29.  Automated decision-support systems can help improve patient safety, notably in primary care. We note the slow progress made in integrating National Institute for Health and Clinical Excellence guidance into such systems and recommend that a timetable be set for achieving this. (Paragraph 177)

30.  Electronic prescribing-support systems should be introduced throughout the NHS and set up with the alerts feature appropriately configured. (Paragraph 178)

31.  Automatic Identification and Data Capture technology, such as barcoding, has the potential to reduce significantly certain types of error. Impressive pioneering advances, such as those in relation to blood transfusion at Oxford Radcliffe Hospitals NHS Trust and to medication at the Charing Cross Hospital, have been made in this respect, but we have grave concerns about their slow uptake across the NHS. We are concerned at the DH's decision not to review progress on Coding for Success. Its reasons for not doing so are unacceptable in view of the slow progress to date. (Paragraph 179)

32.  The continued delay in the Electronic Patient Record also represents a huge missed opportunity to improve patient safety by improving the communication of clinical data (particularly between care settings), which would reduce administrative errors and facilitate better continuity of care. (Paragraph 180)

33.  We are alarmed at the lengthy delay in implementing Professor Toft's 2001 recommendation regarding the development of spinal needles that cannot be connected to a Luer syringe. It is totally unacceptable that an identified and simple technical solution to a catastrophic problem should take so long to be put into practical use. The Chief Executive of the NHS must explain why this delay has taken place and ensure that such delays never occur again. It is unacceptable that the NHS does not have a mechanism to ensure that changes such as this, which impact seriously on patient safety, occur in a timely fashion. (Paragraph 181)

Education and training curricula

34.  There are serious deficiencies in the undergraduate medical curriculum, which are detrimental to patient safety, in respect of training in: clinical pharmacology and therapeutics; diagnostic skills; non-technical skills; and root-cause analysis. These must be addressed in the next edition of Tomorrow's Doctors. The DH and GMC must monitor the quality of new medical graduates' use of the skills listed above. Elements of patient safety are taught, but this tends to be done implicitly rather than explicitly; this should also be addressed in the curriculum, which must make clear that patient safety is the first priority of medical practice. Patient safety must also be fully integrated into postgraduate medical education and training as a core element, not an optional extra. (Paragraph 195)

35.  Patient safety, including Human Factors, has yet to be fully and explicitly integrated into the education and training curricula of healthcare workers in general. This training should include the recognition that errors will inevitably occur in certain circumstances. There are convincing arguments for interdisciplinary training to foster good teamwork skills across professional boundaries: those who work together should train together. (Paragraph 196)

Commissioning, performance management and regulation

36.  As we have argued elsewhere, we have grave doubts about Primary Care Trusts' performance in their commissioning role. The DH's hope is that World Class Commissioning will transform PCTs, but there is a danger that it will be another tick box exercise. As we stated in our report on the Next Stage Review we welcome the principle of linking payment to the quality of care, but recommend that it be tested first in a pilot project. We support the use of Never Events by PCTs, but have doubts about whether they should involve a financial penalty; we recommend this be the subject of a pilot project. (Paragraph 256)

37.  The performance-management role of Strategic Health Authorities appears to be ill-defined and to vary between SHAs. We are not convinced that this function is being effectively discharged throughout the NHS. There seems to be no definition of it laid down by the DH; and the Department was unable to supply this when we asked. We recommend that the DH produce a formal definition of the performance-management role of SHAs. (Paragraph 257)

38.  Regulation has been burdensome and costly and its main mechanism, the Annual Health Check, has failed to pick up major failings in healthcare, although the HCC did through other means identify the problems in cases such as Mid-Staffordshire Trust and things would have been even worse without regulation. We do not, of course, know how much poor care the Annual Health Check failed to identify. (Paragraph 258)

39.  Regulation in the past decade has been characterized by an expansion in rule-based mechanisms, looking at processes and procedures rather than actual outcomes and consequences and professional competence. Too often the rule-based approach has been unable to capture the complexities of frontline care. Worse, it may fail to engage professionals, who are quick to recognize opportunities to work around rules. Inappropriate rules will foster ingenuity in compliance but detachment from the more demanding role of asserting and fulfilling the needs of patients. Sustained improvement depends on releasing the potential of staff to see, develop and own solutions. (Paragraph 259)

40.  The new Care Quality Commission's registration system must focus on the outcomes being achieved by NHS organisations rather than formal governance processes; it must ensure that organisations only collect information which they should be collecting for their own purposes. (Paragraph 260)

41.  We recommend the DH consider how to reinstate the best aspects of the Royal Colleges' inspections in the new system. (Paragraph 261)

42.  The relationship between commissioning, performance-managing and regulating bodies is not defined clearly enough. There are, as Baroness Young put it, "a lot of players on the pitch" and we are concerned that too often they are not an effective team. There is evidence of overlapping functions and multiple submission of information to different regulators. Most disturbing of all is that Foundation Trusts appear to be operating in an entirely different regulatory framework from non-Foundation Trusts. (Paragraph 262)

43.  What all the complex panoply of organisations has actually achieved is called into question by the fact that these systems have been shown recently to have failed in several instances promptly to expose and address major instances of unsafe care. (Paragraph 263)

44.  The case of Mid-Staffordshire Trust has also exposed serious shortcomings in Monitor's assessment process when granting authorisation. Not only did Monitor fail to detect unsafe care—it effectively allowed the Trust to compromise patient safety in premature pursuit of Foundation status. We note the Healthcare Commission found that achieving Foundation status was one of the factors that distracted the Trust from patient safety issues. Monitor's acceptance at face value of the Trust's excuse that its poor mortality figures were a statistical anomaly is wholly unacceptable. (Paragraph 264)

45.  We are also concerned about Monitor's role in regulating Foundation Trusts following authorisation. We are told that Monitor does not replicate the performance management role played by SHAs in respect of Trusts, but it is unclear by exactly which means Foundation Trusts are intended to be performance managed—or whether they are supposed to be performance managed at all. In Monitor's defence it could be said that too many SHAs have also done no effective performance management. (Paragraph 265)

46.  There appears to be considerable potential for confusion, and possibly conflict, regarding the respective roles of Monitor and the CQC, as Monitor itself has indicated. The DH must clarify exactly what these two organisations' regulatory roles are in respect of Foundation Trusts and how those roles fit together. (Paragraph 266)

47.  While the NHS Litigation Authority has performed an important role in setting standards, its involvement in scrutiny of NHS bodies leads to burdensome and wasteful duplication of time and effort for both Trusts and regulators. Moreover, the role of indemnifying Trusts against litigation over clinical negligence is quite distinct from the role of setting standards on safe care and safety culture—and there is potential for tension between the two, notably regarding openness about unsafe care. We recommend that the inspection process currently undertaken by the NHS Litigation Authority should be subsumed within the work of the Care Quality Commission. (Paragraph 267)

48.  The DH should produce a succinct statement regarding how commissioning, performance management and regulation are defined, and how they (and the organisations responsible for them) relate to each other. (Paragraph 268)

The role of managers and Boards

49.  There is disturbing evidence of catastrophic failure on the part of some Boards in cases such as Maidstone and Tunbridge Wells Trust and Mid-Staffordshire Trust. While other Boards are not failing as comprehensively, there is substantial room for improvement. (Paragraph 288)

50.  Boards too often address governance and regulatory issues, believing that they are thereby discharging their responsibilities in respect of patient safety—when what they should actually be doing is promoting tangible improvements in services. The concept of clinical governance may be to blame for spawning a structural approach, focused on processes rather than on the actual state of frontline services. (Paragraph 289)

51.  Many managers and non-executive members of Boards with responsibility for patient safety seem to have little or no grounding in the subject. There is a case for providing specialist training in patient safety issues, particularly to non-executives, to help them scrutinise and hold to account their executive colleagues. We agree with Lord Patel's suggestion about giving one non-executive member of each Board specialist training, to allow them to take particular responsibility for it. The example of Luton and Dunstable Hospital in having committees of the Board of Directors to look specifically at patient safety and patient experience should be recommended to all Trust boards. (Paragraph 290)

52.  Patient safety must be the top priority of Boards. In order to fulfil their duty to ensure "that the quality and safety of patient care is not pushed from the agenda by immediate operational issues", patient safety should without exception be the first item on every agenda of every Board. (Paragraph 291)

53.  We commend to NHS organisations the measures piloted as part of the Safer Patients Initiative to ensure that Boards maintain safety as their foremost priority, namely

  • implementing tried and tested changes in clinical practice to ensure safe care;
  • banishing the blame culture;
  • Providing the leadership to harness the enthusiasm of staff to improve safety;
  • changing the way they identify risks and measure performance, by using information about actual harm done to patients, such as data from sample case note reviews.

We strongly urge the adoption of these throughout the NHS. (Paragraph 292)

54.  In addressing the blame culture, we recommend that Trusts use means such as the Texas Safety Climate Survey to measure and monitor how far staff feel confident about being open and reporting incidents. (Paragraph 293)

55.  We strongly endorse the DH's view that no Board in the NHS should always be meeting behind closed doors. We urge the Government to legislate as necessary to ensure Foundation Trust Boards meet regularly in public; the public should only exceptionally be excluded. (Paragraph 294)

56.  Many healthcare workers remain fearful that if they are open about harm to patients they will be unfairly blamed for causing it; and that if they whistleblow they will be victimised. Where information is available about incidents, it is too often not used to make lasting improvements to services. We have insufficient evidence to comment on the adequacy of statutory protection for whistleblowers. However, the information we have received indicates that the NHS remains largely unsupportive of whistleblowing. We recommend that the DH bring forward proposals on how to improve this situation and that it give consideration to the model operated in New Zealand, where whistleblowers can complain to an independent statutory body. We recommend that Annex 1 of the Health Service Circular, HSC 1999/198, "The Public Interest Disclosure Act 1998—Whistleblowing in the NHS" be re-circulated to all Trusts for dissemination to all their staff as a matter of urgency. (Paragraph 295)

57.  Regarding Mid-Staffordshire Trust, we are unconvinced of the case for a full public inquiry into the Trust, given the work that has already been done by the HCC, Professor Sir George Alberti and Dr David Colin-Thomé, and the likely further disruption to the Trust. However, we do see merit in the idea, recommended to us by the Royal College of Nursing, of holding hearings in private to allow members of staff to give evidence confidentially to discover how the state of affairs progressed so far without detection by the Trust Board. As this would look at the past and involve those in post in previous years, it would not impede the process of improvement and the rebuilding of confidence in the hospital. Although held in private its findings should be made public with protection of individual witnesses as appropriate. (Paragraph 296)

The role of the DH and Government

58.  The Government is to be praised for being the first in the world to adopt a policy which makes patient safety a priority. However, Government policy has too often given the impression that there are other priorities, notably hitting targets (particularly for waiting lists, and Accident and Emergency waiting times), achieving financial balance and attaining Foundation Trust status, which are more important than patient safety. This has undoubtedly, in a number of well documented cases, been a contributory factor in making services unsafe. We welcome Lord Darzi's statement in the Next Stage Review of the importance of quality and safety. From now on, all Government policy in respect of the NHS must be predicated on the principle that the Service's first priority, always and without exception, is to ensure that patients in its care do not suffer avoidable harm. The Government should state clearly that safety is the overriding priority of the NHS and that, if necessary, other targets should be missed where patient safety is being jeopardised; for example, A&E patients should not be moved to unsuitable wards just to meet the four-hour maximum waiting target. (Paragraph 301)

59.  The key tasks of the Government are to ensure that the NHS:

  • develops a culture of openness and "fair blame";
  • strengthens, clarifies and promulgates its whistleblowing policy; and
  • provides leadership which listens to and acts upon staff suggestions for service changes to improve efficiency and quality and, by the provision of examples and incentives, encourages and enables staff to implement practical and proven improvements in patient safety.

In addition, the Government should examine the contribution of deficiencies in regulation to failures in patient safety. (Paragraph 302)


 
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