General comments. Turning to the specific questions: 1. The NHS Redress Scheme

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1 Making Amends the CMO s proposals for reforming the approach to clinical negligence in the NHS. Response to the consultation document by The Royal College of Surgeons of England OCTOBER 2003

2 Response of The Royal College of Surgeons of England to a consultation paper from the Chief Medical Officer for England setting out proposals for reforming the approach to clinical negligence in the NHS. The Royal College values the opportunity to comment on this very well researched document. It is noted that views and ideas are invited on any of the issues raised by the report as well as on the specific proposals. General comments The Royal College welcomes this wide reaching review especially as the surgical profession attracts the largest number of clinical complaints. It agrees that the document takes a constructive approach in addressing the important issues of clinical negligence and medical accidents including: lack of explanation and apologies to patients who suffer harm the complexity of the system and time taken from claim to compensation failure to ensure that lessons learned from clinical negligence are shared throughout the NHS the high legal costs of litigation proceedings the relative absence of alternative ways to resolve disputes in medical injury cases the climate of blame, acrimony and confrontation lack of support and advice for those wishing to claim encouragement to doctors to practise defensive medicine damage to morale of clinicians and clinical teams undermining of doctor-patient relationship. Turning to the specific questions: 1. The NHS Redress Scheme What should be the qualifying criteria: the Bolam test currently used on assessing clinical negligence or a broader definition of sub-standard care? The Bolam test (of action in accordance with practice accepted as proper by a responsible peer group) was qualified by the House of Lords in the Bolitho judgment allowing the Court to choose between different bodies of medical opinion. In addition it is evident that harm to a patient often follows a complex set of circumstances cases where a patient is harmed as a result of a complex web of circumstances following the Swiss cheese model of accident causation. Under these circumstances the organization rather than an individual clinician is more likely to be the subject of blame. This is clear from Chapter 1 of the report where examples of sub-optimal service are demonstrated. Clearly there are many criticisms of the traditional system of paying compensation based on tort (breach of duty leading to liability for damages) law and although the Pearson Commission in 1978 rejected the introduction of no-fault compensation it clearly indicated that this decision would need to be reviewed at a later time. It is noted that criteria for payment proposed under the NHS Redress Scheme would be that: there were serious shortcomings in the standards of care harm could have been avoided adverse outcome was not the result of a natural progression of illness and that a series of fast track scheme pilots are proposed to allow the logistics and acceptability of the scheme to be assessed using the Bolam/Bolitho test under current legislation but allowing the opportunity for these cases to be assessed against alternative tests by a medico-legal panel. This would seem to be a very reasonable approach and allow a balance to be drawn in relation to the potential impact on the number of successful claims and the costs of a lower qualifying threshold. Sub-standard care should be clearly defined and not variable.

3 Should there be a minimum qualifying level in terms of the extent of the disability, eg in terms of days off work or in hospital or in terms of the levels of disability? It is suggested that that the minimum qualifying level be set to ensure that the costs of assessment do not outweigh the value of any financial compensation payable. It would however be within the ethos of the proposed scheme to ensure that a package of care is made available for any untoward outcome of treatment. Should there be an upper financial limit to the cases to be dealt with under the scheme? If so, is 30,000 the right starting point? It is evident that the level of 30,000 has been set taking into consideration many factors (paragraphs page 73) and it is noted that in Recommendation 4 there would be scope for upward adjustment in the light of experience of the initial working of the scheme. Should the financial limit for the scheme apply to the whole package of care and cash or the cash element only? It would be appropriate in our view for a care package to aim towards an agreed clinical outcome with the cash element being limited to in the first instance. Should consideration be given to including primary care from the outset? With increasing integration of elements of primary and secondary care it would be appropriate for the scheme to include all patients under NHS care however as general practitioners are not employees of the NHS the arrangements will of necessity differ and a considered and phased introduction would be necessary. Should patients/claimants be entitled to funding for legal advice to assess the fairness of the Redress Package? This should not be necessary provided there is an appropriate appeals mechanism operated by the body which it is anticipated would replace the NHSLA. Consideration should be given to the incorporation of an introductory time limit of four weeks to enable the claimant to seek legal advice Will making it easier to obtain a package of care and support plus modest financial compensation reduce or increase the number of people making applications to the scheme? Why? Could this be mitigated? It is important the information for patients provides in simple terms the aims of the scheme with a realistic approach to their eligibility or otherwise for financial compensation. It is essential that bodies such as PALS are able to competently provide such information in order to diminish the number of frivolous or fraudulent claims that could potentially overwhelm the scheme.it is important to recall that the Action for Victims of Medical Accidents (AVMA) estimate that less than 1% of those harmed by avoidable medical accidents have in the past made a claim. In addition on establishment of the NHS in 1948 the service demand significantly exceeded the expected level. We therefore take the view that there is a risk of a significant increase in the number of applications for the scheme. Strict adherence to the principles of clinical governance, risk management and meaningful audit could help in mitigating the above as could implementation of Good Medical Practice and Good Surgical Practice by all clinicians. In addition the introduction of Error Avoidance techniques advocated within high risk but nevertheless High Reliability Organisations (University of California, Berkeley) could be more widely propagated via for example the NHS Clinical Governance Support Team. The Royal College via the Raven Department of Education has introduced Error Avoidance Symposia and would support an extension of this policy if felt appropriate with the collaboration of such organizations as Patient Safety Training and Global Air Training followed by cascading of skills within individual trusts.

4 2. The NHS Redress Scheme for babies who are severely neurologically impaired What should be the qualifying criteria: is 'birth-related severe neurological impairment' a reasonable test? The definition is felt to be very reasonable as are the eligibility criteria laid down in Recommendation 2. Should a qualifying birth be restricted to one in an NHS Trust? It is suggested that a qualifying birth be one that took place under NHS funded arrangements for care. This would take account of care provided under the terms of the NHS in non-nhs Trust premises including domiciliary births. Should patients/claimants be entitled to funding for legal advice to assess the fairness of the Redress Package? This should not be necessary provided there is an appropriate appeals mechanism operated by the body which it is anticipated would replace the NHSLA. Should patients be able to go straight to court and not use the scheme if they believe they can prove negligence? It is felt that this route should remain available but it is emphasised that every effort should be made to avoid this by a process of Alternative Dispute Resolution (paragraphs page 95) with the availability of Legal Aid guided by the current criteria set out by the Legal Services Commission in paragraph 48 (page 67). Once the claimant has opted to take legal action the Redress Scheme should not be available. Should courts have access to the deliberations of the expert panel if a compensation package is rejected and the case subsequently goes to Court? What might be the impact on numbers claiming compensation? It would be very appropriate for the deliberations of an expert panel to be made available to Court in the hope that this in turn may facilitate a process of Alternative Dispute Resolution. It is hoped that as noted above the control of Legal Aid provision could be controlled by the criteria set out by the Legal Services Commission. Should the right to go to court be removed in favour of a new, speedier, more responsive Tribunal system for all cases of severe neurological impairment? It is noted in paragraph 21 (page 115) that for complex cases a national tribunal system and tariff for all injuries may not reflect the needs of the injured patient nor readily provide for the detailed explanation and apology many patients seek. Such a system may not therefore be appropriate. During the process of the Royal College s consultation we have received examples that support the above. 3. NHS Litigation Authority It is proposed that the new body established to oversee the NHS Redress Scheme should be modeled on or developed from the existing NHS Litigation Authority. This would be very appropriate. What mechanisms would be needed to ensure that a body with this structure would not have a conflict of interest in administering the NHS Redress Scheme and retaining

5 responsibility for assessing claims or recommendations for NHS compensation payments? It is suggested that separation of functions incorporating the existing NHSLA within a single new body would be required together with external quality control. If two entirely separate bodies were to be established there would be a risk of increased complexity and lengthening of time to resolution. Compliance with the Human Rights Act 1998 will inevitably be a requirement for such an organisation. Should this body be a Special Health Authority? A non-departmental Public Body? The NHSLA as a Special Health Authority is functioning effectively and it would seem appropriate for a new body taking over the extended function to be administered in this way. 4. Repeal of Section 2(4) of the Law Reform (Personal Injury) Act 1948 If an NHS cost basis is used to calculate damages for future care costs, should the NHS be required to provide guarantees for this treatment? How might it do this? Would a system of independent case managers be required? It is impossible to provide guarantees of the outcome of clinical care but it would be appropriate for a patient to be provided with an agreed package of care in as expeditious a manner as possible balancing the clinical urgency with that for other patients awaiting care. It is recognized that the NHS will need additional resources in order to develop a capacity to accommodate the requirements of such a scheme to ensure that care is delivered in a timely manner for all patients. 5. Mediation Are there additional ways of encouraging greater use of mediation and other alternative dispute resolution procedures? It is noted in paragraphs that the mediation programme of the NHSLA has recently functioned more effectively. With an increasing number of trained non-legal mediators this should further improve and it is understood that a national programme of training and accreditation is being explored. 6. Claimants costs Are there any further steps that could be taken to control legal costs in clinical cases? Paragraphs (pages 67 70) carefully describe the costs to the public purse of clinical negligence and the capping of legal fees. It is noted that the reforms introduced by the Lord Chancellor s Department and the Legal Services Commission are expected to bring a reduction of costs in the longer term. These include limitation of clinical negligence contracts to specialist panels of lawyers. Comments on recommendations Recommendations 1 6 have been considered in the above text Recommendation 7: We strongly support the appointment of a Board level non-executive who should be responsible for overseeing the scheme. Recommendation 8: We would support continuation of the provision of explanations which patients and families seek; if appropriate expressing regret without the admission of liability. It is to be hoped that this would reduce the number of people pursing a formal litigation process. Recommendation 9: Strongly supported Recommendation 10: Agreed; however with provision of adequate resources is essential

6 Recommendation 11: Supported Recommendation 12: Agreed Recommendation 13: Agreed as it is important to ensure access to all medical records but not to Trust documents and information collected purely for identification of adverse events Recommendation 14 15: See above text Recommendation 16: Agreed in principle but will require close definition and careful control Recommendation 17: Agreed provided that the NHS has developed the requisite resource and capacity Recommendation 18: Strongly endorsed Recommendation 19: Supported The Patient Liaison Group of the Royal College is anxious that consideration be given to the principles of a redress scheme being available for patients treated outside the NHS. In addition members of the group made the following comments. The NHS Redress Scheme Consideration should be given to redress for the families of patients who die or are injured. An option for litigation remains necessary. The complexity of the scheme would present problems for patients. Patients should be individually assessed, rather than just by a tariff. Patients and their carers should be actively involved in decisions about a care package, rather than having one unilaterally imposed. They often know best what services they need, and flexibility is required as needs may change over time. Mediation Patient Advice and Liaison Services, which should now be in place in all trusts, can be a useful and effective resource but patients are often not aware that they exist. It is hoped that the above comments will prove constructive as the responses to the consultation are collated. If further clarification or explanation is required The Royal College of Surgeons of England would be very pleased to provide this. John Lowry Leela Kapila 15th October 2003 The Royal College of Surgeons of England. Registered charity no: The CMO's consultation paper Making Amends can be found at:

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