Clinical guidelines are systematically developed, evidence-based and clinically viable, aimed at providing patients with consistent, high-quality care. To date, their use to set the standard of care in medical disputes has been limited. Indeed, the traditional criterion of the Standards of Care Act is the Bolam test, which measures the standard of care based on what is done in medical practice, not what should be done. This is derived from expert testimony in court, and clinical guidelines have so far played a secondary role. In the future, clinical guidelines will likely become more relevant to clinical negligence law. The fundamental issue of clinical negligence is whether or not an accused physician has breached the standard of care. The Bolam test was seen as a license for the medical profession to set its own standard.48 Recent clinical governance initiatives are critical to establishing the standard of practice for physicians in primary and secondary care. Clinical guidelines are an essential part of clinical governance. Continuing professional development and assessment are part of the clinical governance strategy and are recognized by the medical profession`s regulatory authority, the GMC, as key elements of the revalidation process. A new impetus for compliance with externally recognized standards could come from the patient empowerment process. The public and patients will inevitably be more involved in clinical decision-making through organizations such as NPSA and PALS. The requirements of these groups would be the use of nationally recognized clinical standards. Failure to comply with established guidelines does not necessarily imply an unfavourable outcome for the defendant.
In Lowry,16 the plaintiffs argued that the attending physician arbitrarily departed from the American Heart Association`s guidelines for advanced cardiac life maintenance by administering atropine instead of adrenaline. The respondent physician argued that the guidelines were not binding and could therefore be set aside in individual cases by a clinical judgment. The Court of Appeal upheld the judgment in favour of the defendant and did not consider the guidelines to be more persuasive than the facts of the case itself. In recent years, there have been a variety of guidelines and protocols published locally, nationally and internationally by NICE, the Royal Colleges, the Department of Health, NHS Trusts and other organisations. Their aim is to facilitate best practice in a standardised way, ensure consistency of care, ultimately leading to improvements in patient safety and, in turn, reducing the cost of negligence claims against the NHS. Catherine Penny, Managing Partner at the law firm Stevens & Bolton, offers advice on how healthcare organisations can challenge NICE policies The process by which these policies are formulated is based on the principle of “sufficiency and accountability” expected of a public body. This means that decisions must be publicly available, that reasoning must be based on evidence that there is a mechanism for appealing decisions, and that there is regulation of the process.37 These conditions are met by NICE in its decision-making process38. This does not mean that NICE decisions are immune to challenge, and there have indeed been challenges through judicial review.38 However, NICE`s procedural orientation in decision-making, as well as the continuous formulation of standards of good administrative behaviour, contribute to promoting transparency and building confidence in the legitimacy of its process38. The general rule regarding compliance with national policies and state guidelines was established in R-v- North Derbyshire Health Authority, ex parte Fisher (1997), a case prior to the introduction of the NICE Guidelines. In the present case, the defendant was allowed to depart from national policy only if there was a “special factor” resulting in an “exceptionally justified type of withdrawal”. In the case of R (Elizabeth Rose), CCG`s rejection of ulcerative colitis treatment was not considered a particular factor that would allow her to deviate from the NICE guidelines.
In addition, Justice Jay noted that the CCG had not presented a significant case that exceptionally warranted a deviation from the R-v-North Derbyshire Health Authority`s criteria guidelines. The rejection of the CO guidelines was not sufficient to justify non-compliance with the guidelines. It also argues that the NICE Guidelines not only provide guidance, but are increasingly becoming binding rules that must be followed. Regardless of how the guidelines are developed, in general, if you are a patient in England and a treatment you want is recommended by a NICE policy, you should be able to receive it. NHS clinicians see the NICE guidelines as the benchmark for the best treatment available to patients, and while it`s not legally binding, the reality is that if clinicians don`t follow the guidelines, they need to explain why, especially if something goes wrong. The first step in judicial review is to write to NICE, inform nice of the proposed application and set out the detailed basis for the challenge. This gives NICE the opportunity to respond and, in some cases, accept that they have made a mistake and agree to adapt the guidelines or guidelines. The current UK government is committed to an approach that ensures consistency and consistency in healthcare across the country.
This is confirmed by the expectation that NICE will play a leading role in “developing new guidelines and ensuring that they reach all parts of the healthcare system”1 and “we will expect the guidelines produced by NICE to be implemented consistently across the NHS”39 Section 19 of the Health Act 1999 established the Commission for Improvement. Health (CHI), which has overall responsibility for the entire quality system in the NHS. CHI ensures that systems to improve the quality of healthcare function satisfactorily and is responsible for inspecting and monitoring local clinical governance agreements. Guidelines inform clinical practice, but do not dictate it. They do not replace the knowledge and skills of clinicians. However, physicians are expected to be aware of all nationally recognized guidelines that apply to their specialty. For an anaesthetist, this could include guidance from NICE, the Royal College of Anaesthetists, the Association of Anaesthetists of Great Britain and Ireland and advice from the GMC. Physicians should also be aware of local guidelines that are relevant to their hospital/department.
Some have argued that the current system of adversarial liability based on tort for clinical negligence encourages the concealment of errors and wastes resources.45 Options for reform include the use of alternative dispute resolution and mediation. The use of alternative methods to resolve disputes is a key element of the overarching objective of the 199847 of the Code of Civil Procedure (CPR). An unreasonable refusal to use alternative dispute resolution could be a relevant factor in deciding issues of cost allocation for the parties to a claim. To promote CPR, trusts can use individual strategies to reach an out-of-court settlement in the event of medical incidents. As part of ADR strategies, trusts can become more active in enforcing the use of clinical guidelines through their clinical governance structures. The NICE website does not refer to the guidelines as mandatory, but recommends that organizations and practitioners providing services consider the NICE guidelines when treating patients. However, in the case of R (Elizabeth Rose), CCG Thanet reviewed the guidelines but decided not to apply them because it did not agree with them. While practitioners can demonstrate that they have considered the guidelines, they are unlikely to avoid liability in the civil courts if they do not apply them.
A shift towards the use of guidelines to determine the standard of care was noted in Early23, a trial decision. The accused were prosecuted for two reasons. The first was that the treating anaesthetist was negligent, and the second was that the applicant`s intubation procedure was defective. The procedure used for intubation was based on an oral guideline. Both prosecutions failed, and the judge said: “As far as this procedure is concerned, she was submitted to the hospital`s anesthesia department. All of Newham`s consultants came together. which then decided that this was an appropriate procedure, and the minutes of the discussion were kept. The judge clearly demonstrated that he was influenced by the fact that a meeting of the consultants had taken place at which relevant guidelines had been discussed, and he accepted these guidelines as the standard of reasonable medical practice. Little has been published on the effective application of the Directives in litigation.
In the Hyams study,15 the authors examined 259 claims from two professional liability insurance companies. Only 17 (7%) of the claims related to the use of clinical guidelines. Of these 17, 12 were used by the plaintiff (as a sword), 4 by the defendant (as a shield) and in 1 the use was indefinite.