Education and debate

Personal paper: Disclosure of clinical audit records in law: risks and possible defences

^a Departments of Clinical Audit and Risk and Litigation, Peterborough Hospitals NHS Trust, Peterborough PE3 6DA

Correspondence to: Dr Womack

	Introduction

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

Clinical audit records have some degree of protection. The BMA recommends that access to audit information should be limited "to only those individuals, within the organisation, with a legitimate interest," the organisation having further privilege "to control and restrict anonymised audit information for external organisations or individuals."¹ The code of practice on openness in the NHS aims to ensure, among other things, that people "have access to available information about the services provided by the NHS," including "quality standards."² It does not, however, propose publishing information about the performance of an individual clinician or the quality and outcome of the care of individual patients.² The code also details information that may be withheld, and clinical audit records may fall into one or more of the four following exempt categories:

• Personal information—people do not usually have right of access to details of other patients' diagnoses, treatments, or outcomes

• Internal discussion and advice—this is to ensure that frank internal debate is not inhibited

• Management information—this applies if clinical audit records are considered to be administrative (see below)

• Information given in confidence—this applies to all clinical records unless outweighed by the public interest

Strict guidelines in this clinical audit department cover security, dissemination, and disposal of audit information, over and above the trust employees' obligation and the Data Protection Act.

	The law on disclosure of clinical audit records

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

There is no case law relating to disclosure of clinical audit records in the United Kingdom. However, the law relating to disclosure in legal action involving personal injury or death is covered by the Supreme Court Act 1981. A clear, concise account of the legal aspects of disclosure of medical records is provided in a booklet published by the Medical Protection Society.³ Clinical audit records are not subject to legal professional privilege because this privilege applies only if the main reason for producing a document is litigation, which may be actual or contemplated.¹ All other documents, including clinical audit records, are potentially subject to disclosure to a plaintiff's lawyers.

Similar fact evidence usually applies to criminal proceedings but also extends into civil actions and refers to disclosure of documents relating to circumstances similar to the subject of the legal action. An appeal court ruling held that similar fact evidence is only relevant to counter defences such as accident or coincidence.⁴ So if, for example, an NHS trust claims a defence of accident or coincidence in explaining an adverse clinical event, then audit records relating to the particular clinical procedure would be become disclosable.

	Risks of disclosure

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

A clinical audit cycle incorporates measurement of an agreed standard of patient care with problem solving and developing a strategy for improvement. It is the identification of clinical variance from an agreed standard—that is, perceived poor clinical performance—that may be useful to a plaintiff's solicitor in litigation.

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Clinical audit records are an aggregate of data that are collected and presented in a way that ensures, so far as is possible, that individual patients and clinicians are not identifiable. If audit records were totally anonymous there would be little value in lawyers requesting disclosure. In our experience, plaintiff solicitors understand that their client (our patient) is likely to be identifiable at times during the audit pathway. Anonymity is not always possible—for example, when an audit record shows only one patient having a particular postoperative complication or only one clinician performing a particular procedure. Furthermore, if a request for disclosure occurs at the time of an ongoing audit, as may happen after an adverse incident, patient and clinician details may have to be released before the original data have been shredded and the results rendered anonymous at the final report stage. We believe that absolute anonymity, to protect against harmful disclosure in litigation, would seriously inhibit the process of clinical audit.

	Possible defences against disclosure

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

If a plaintiff's solicitor requests audit records you should seek legal advice. We have identified four possible defences to the disclosure of clinical audit records in cases of litigation.

Confidentiality—The audit record will contain information from the plaintiff's contemporaneous clinical case notes that can already be admitted as evidence. If a plaintiff or clinician is identifiable in the audit record then other patients and clinicians may also be. We would argue that the plaintiff has no right of access to the records of other patients.

Administrative record—In the United States clinical audit records have been considered to be part of the administrative, business, or peer review record of a healthcare organisation since 1970 in an attempt to protect them from being disclosed.⁵ Our NHS trust board endorsed a statement prepared by the clinical audit committee and the risk and litigation manager which states that audit records are not made contemporaneously with patient treatment and should not be acceptable in law as a basis for determining the care provided. However, in the United Kingdom generally, clinical audit records are unlikely to be relegated to mere administrative documents even as a protective measure as this would undermine the fundamental principles of clinical audit—that it should be professionally led, be seen as an education process, and form part of routine clinical practice.⁶

Similar fact evidence—The simple defence to potentially damaging disclosure of audit records when a plaintiff's case is directed against a system of conduct or process is not to claim that the incident was accident or coincidence.

Immunity in the public interest—Certificates granting immunity in the public interest are issued by the Department of Health to help ensure the proper functioning of public services. Immunity certificates usually apply to the police, and whether courts would apply them to clinical audit records in the NHS is uncertain. However, a precedent has been established in that immunity in the public interest has been extended to the national confidential inquiry into perioperative deaths, provided that no copies of the inquiry's forms are kept by the clinicians.⁷ This further emphasises the importance of shredding all the information collected on patients on completion of an audit and of ensuring that patient and clinician details in the final documentation are anonymous.

	Conclusion

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

Clinical audit is an integral part of clinical practice and clinical effectiveness.⁸ In cases of legal action we believe that clinical audit records should be subject to the same degree of protection as offered in everyday practice by the guidance of the BMA's clinical audit committee¹ and the code of practice on openness in the NHS.² To maintain and protect the process of clinical audit we also believe that legal requests for disclosure of audit documents be met with the strongest possible resistance. It will require a test case in the courts to settle the legal issues, but fear of exposure in litigation must not be allowed to prejudice the advances being made in clinical audit or reduce the willingness of any clinical professional to participate in an honest and open manner.

	Acknowledgements

We acknowledge the following organisations for their comments on our views: Berrymans Solicitors, BMA, College of Nurses of Ontario, Department of Health, Healthcare Quality Quest, Medical Protection Society, National Confidential Enquiry into Perioperative Deaths, Office of the Official Solicitor, and the Royal College of Surgeons of England (Audit Unit).

	References

Top Introduction The law on disclosure... Risks of disclosure Possible defences against... Conclusion References

1. British Medical Association Clinical Audit Committee. Ethical issues in audit. London: BMA, 1995.
2. NHS Executive. Code of practice on openness in the NHS. Leeds: NHS Executive, 1995. (EL(95)42.)
3. Panting GP, Palmer RN. Disclosure of medical records. London: Medical Protection Society, 1992.
4. Allison G. Disclosure of risk management documentation. Health Care Risk Report September 1995:13-5.
5. United States District Court for the District of Columbia, Bredice v Doctors Hospital Inc;50 FRD 249 1970;50 FRD 187 1970.
6. NHS Executive. Clinical audit: meeting and improving standards of healthcare. Leeds: NHS Executive, 1993. (EL(93)59.)
7. NCEPOD. Report on the national confidential enquiry into perioperative deaths. London: NCEPOD, 1989:11.
8. NHS Executive. Promoting clinical effectiveness. Leeds: NHS Executive, 1996. (EL(95)105.)

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