National service frameworks, clinical guidelines and rulings from the National Institute for Clinical Excellence have become the benchmarks to measure the delivery of care in the NHS.
Inevitably, issuing national guidelines on the type and level of care that shou ld be made available has major implications for clinicians and managers.
A range of national service frameworks covering major clinical areas is planned - the national service framework for coronary heart disease, published by the Department of Health in England, is one of the first examples.
1The report stresses that 'excellence requires that important simple things are done right all the time'. It is described as a 'practical way for people to develop and implement clinical governance and new, modern quality improvement systems'.
This is an important milestone in the move to drive up the quality of services to patients. But will the framework strengthen the rights of patients to quality care? What will happen if a hospital fails to achieve the requisite standards?
And what will happen if the health authority does not provide appropriate funding or the hospital does not deliver? Just what are the legal implications of this guidance?
The framework sets out an 'achievable but challenging timetable for improving services' and includes a commitment to a range of standards, such as a prompt response from the ambulance service to heart attack symptoms and professional assessment for patients with suspected heart problems.
By April 2001 the government wants to reduce the 'call-to-needle' time for thrombolysis for heart attacks by:
improving ambulance responses in 75 per cent of life threatening emergencies to within eight minutes;
increasing to at least 75 per cent the proportion of accident and emergency departments able to provide thrombolysis;
improving the use of effective medicines and the numbers of revascularisation procedures.
These standards are underpinned by clinical governance and the statutory duty imposed by the Health Act 1999.
'It is the duty of each health authority, primary care trust and NHS trust to put and keep in place arrangements for the purpose of monitoring and improving the quality of healthcare which it provides Continued from page 7 to individuals.'
This statutory duty is framed in such a way that it seems unlikely a patient could sue if they receive poor coronary heart disease treatment even if they could demonstrate that the framework had not been met. But this would depend on how the civil courts view the standard of care in actions for negligence.
Making the provision and delivery of CHD treatment a statutory duty means that the organisation will be accountable to the government if it fails to comply. It remains to be seen how the government or the Commission for Health Improvement will enforce the obligation on managers and boards in examples of serious failure. There have been several incidences where the chair or chief executive of a trust has been asked to resign - for example, in Alder Hey children's hospital, Liverpool, when numerous organs of deceased children had been removed without consent, and not all could be accounted for subsequently.
It is possible, therefore, that if a trust or HA failed to meet national framework standards, there could be calls for resignations. The secretary of state could also invite CHI into any organisation suspected of failing to meet recommended standards.
What happens to the patient who misses out, either through care providers failing to meet the specified target, or through not being provided with the appropriate treatment at all?
Patients who sue for compensation have to establish a claim in negligence governed by the standard of the reasonably competent practitioner test. What is reasonable has, in the past, been determined by expert evidence as to what a reasonably competent practitioner should achieve. The framework may become, at the very least, an important tool for the patient to use in support of a claim.
If a hospital failed to achieve the targets set out in the framework, it could have to explain why in court. This could put it on the defensive. An independent expert group chosen by the government devised the framework itself and any independent expert called on behalf of the hospital would only be able to defend non-compliance by attacking the standards themselves and by pointing to alternative research which justified another approach to the setting of standards. National standards and future publications from NICE will help to define what is meant by a reasonable standard of care as required in the Bolam Test.
3In the recent case of Tracey Kent, the Court of Appeal found that if the London Ambulance Service had reached and treated her within the time standard for a seven-mile journey she would not have suffered long-term harm from a severe asthma attack. It ruled that sheer incompetence had led to the delay and, in that situation, in the absence of a reasonable explanation, compensation should be awarded.
This case leads us to speculate that the courts will look to the reasons for failure to achieve the framework in individual cases, and that the framework will set a standard for care which experts will have to refer to in medical negligence litigation.
In terms of clinical governance, professional self-regulation and the work of CHI is expected to move things forward. Setting targets and creating a system of audit and evaluation creates further written evidence as to the efficacy of a local service, if a patient wishes to challenge non-availability or poorly delivered care. Prescription of standards will provide an increased opportunity for patients to seek compensation or redress in relation to failures in delivery or availability of care.
What about the right to treatment in accordance with the milestones and goals which the government has set? In the past the courts, in a series of cases, have been reluctant to investigate the allocation of resources by health organisations and have not been prepared to intervene in challenges over resources, or challenge the discretion of the DoH and healthcare providers over how money is spent. The courts have taken the view that they could only interfere if the secretary of state acted so as to frustrate the policy of the act, or as no reasonable minister could have acted.
However, judicial review is increasingly being relied on as a tool for administrative challenge - there have been successful challenges by transsexuals seeking cosmetic operations.
Similarly, a patient seeking the prescription of the drug beta interferon won a successful case against an HA which had failed to consider guidance in a government circular.
As guidance becomes more prescriptive in pursuit of the laudable aim of achieving consistent standards of quality and delivery of services, then it can only be speculated that the courts may be tempted to intervene and enforce rights to treatment by way of administrative challenge. Certainly health organisations will be well advised to document the way in which policies are developed in response to the 'rolling out' of national service frameworks, in order to justify resourcing decisions in a way previously unnecessary.
A new dimension will come into play when human rights legislation comes into force in October 2000.
Resources are not infinite and the courts will accept that, but they may be prepared to look in more detail at the way care decisions are made. The introduction of optimum standards as goals for health organisations will be a lever in the patient's favour. For example, article 3 of the Convention on Human Rights, which is set out in schedule 1, says: 'No one should be tortured or subjected to inhuman or degrading treatment or punishment.' It could be argued that a gross failure to observe the national standards framework in CHD is inhuman where death is the outcome.
There is every likelihood that, far from removing lawyers from hospitals (which Frank Dobson said was his aim when secretary of state for health), national standard frameworks could actually increase litigation by providing more evidence to patients on how they have been failed by the NHS and how they have been harmed because of failures to follow government guidelines.
1 Department of Health National Service Framework for Coronary Heart Disease. 2000.
2 Health Act. 1999. Section 18. Department of Health.
3 Bolam v Friern Barnet HMC 1957 2 All ER: 118.
4 Regina v Secretary of State for Social Services (ex parte Hinks) . Solicitor's Journal , 29 June 1979.
5 Regina v North Derbyshire HA (ex parte Fisher (1997). Med LR 8: 327.