Legal safeguards for the audit process

Are essential for effective clinical governance

Clinicians are under siege from patients and politicians alleging limitations in professional self regulation. In Britain the General Medical Council's attempts to retrieve the situation are criticised by some as belated, or even unjust,1 and the emergence of clinical governance in the NHS is regarded by some as an arbitrary system for imposing uniform standards and monitoring compliance. Are such misgivings reasonable? Clinical governance should promote high quality care by making individuals accountable for setting, maintaining, and monitoring standards, to produce a hitherto elusive culture of clinical excellence.2 Systems of clinical risk management and audit should contribute to this process by facilitating greater self evaluation, open debate about clinical practice, and the routine investigation of adverse events. For clinicians to learn and improve, conclusions reached during these processes need to be documented Clinicians also need to feel safe with the process and that it will not be used against them.

In practice these worthy objectives are undermined by two legal concerns relating to confidentiality and to disclosure of documents before litigation. Firstly, problems relating to confidentiality arise when clinical audit becomes multidisciplinary, as prescribed for effective risk management.3 Although worthwhile audit may theoretically exist without identifying individuals, practical experience suggests that open meetings function best when the clinicians taking part can identify patients and recollect circumstances that influenced their decisions. Open and informed discussion must be documented to enhance educational value, allow reference to clinical records, and provide evidence of the clinical governance process.

Threats to this process posed by patients' rights of confidentiality may be more apparent than real, in that nowhere are clinicians experiencing many claims alleging breach of confidentiality However, in Britain audit activities are protected neither by statute nor by case law. In a changing medicolegal climate the argument that public interests are better served by attempting to raise clinical standards than by maintaining anonymity remains untested in court. Indeed, the General Medical Council may have conceded this issue in advance by advising that confidentiality should be maintained during teaching and audit in the absence of specific consent.4 As for common law, it does not protect audit. A determination of how the reasonable person holding confidential information should behave in such circumstances could be finely balanced, as would any argument weighing individual rights against the general benefits of the audit process 5 6

The second problem of disclosure poses immediate and practical problems. In law, requests for information relating to patients contemplating litigation include all documentation traceable to individuals Identifiable material must be disclosed, a requirement enforceable by court order.7 Where documentation has as its “dominant purpose” submission to legal advisers in anticipation of litigation, it becomes privileged and protected from disclosure. Privilege does not extend, however, to dual purpose audit or clinical risk management documentation with coexisting objectives of feeding concerns back to clinicians. Logically, this must inhibit quality assurance initiatives.

Can clinical governance be facilitated and clinical audit protected? One solution, adopted in other countries, is to provide legal protection for audit, though this would require legislation. Specifically, activities fulfilling agreed criteria could be registered in advance and legal privilege afforded to documentation arising from them It would then be reasonable to provide a carefully regulated degree of medicolegal safety for the documentation and dissemination of activities aimed at improving quality, including approved clinical audit and risk management activities. General protection for all quality assurance activities would be inappropriate. Registration with a body representing a range of medical, legal, and lay opinion would be required. This body would assess any public interest element and could have powers to allow discovery where necessary to serve strong competing public interests.

This solution appears to work where it has been adopted. In Australia quality assurance initiatives can be undertaken in the long term best interests of patients. The Health Insurance (Quality Assurance Confidentiality) Amendment Act 1992 offers legal privilege to qualifying clinical audit and risk management documentation. Notably, medicolegal safety is cited as an important ingredient in the success of the Australian incident monitoring study, in which clinicians across the Australian anaesthetic community combined to produce contemporaneous reports of “near-miss” and actual adverse events.8 In the United States most states have similar legislation offering protection to qualifying quality assurance programmes.

Clinical governance initiatives assume a role for audit and risk management programmes in improving standards. Should the legislature protect these activities? Such measures are not as urgently needed as the current reforms in medical negligence litigation, where there is at last a real prospect of injured patients being properly served by the legal process.9 Also, it may be inappropriate to seek medicolegal protection until the medical profession can deliver greater openness when things go wrong; in this respect it must become routine to disclose adverse outcomes involving negligent treatment, unless this would inflict further harm. Nevertheless, if the law is an impediment to raising clinical standards we should seek to amend it.