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Needlestick injuries - a testing time.

Critical care staff need to be aware of recent changes in the law. Using the example of human immunodeficiency virus (HIV) and hepatitis screening after needlestick injuries involving unconscious patients, this editorial will examine the implications of the Human Tissue Act 2004 (HTA) and the Mental Capacity Act 2005 (MCA) for critical care practice and explore potential solutions to the problem. In response to high-profile public concerns over unethical organ retention at Alder Hey Hospital and the Bristol Royal Infirmary, the government introduced the Human Tissue Bill that was enacted as the HTA in 2004 and enforced from 1 September 2006. Among other things, the Act requires that virtually all tissues (including blood samples) taken from humans can only be tested or stored with the explicit consent of the person from whom it was taken. Failure to obtain consent could render an offender liable to a fine or imprisonment. Although concerns were raised during the passage of the Bill, one important implication of the HTA has arisen – it concerns the testing of an unconscious patient’s blood for bloodborne viruses (BBVs) in order to guide the treatment of health care workers who sustain needlestick injuries from that patient (White, 2007). Needlestick injuries are a daily risk for health care workers, particularly those involved in the care of critically ill patients, although the actual incidence of injury is low: in a 25-year career, a health care worker might expect to sustain a single needlestick injury. Nevertheless, needlestick injuries can lead to infection with HIV and hepatitis B, C and/or D, although seroconversion rates vary: 0 3% for HIV and 18–30% for hepatitis B. Post-exposure prophylaxis (PEP) is available for both viruses. In the case of HIV, PEP should be started within 1 h of exposure and continued until the HIV status of the source patient is confirmed (UK Chief Medical Officer’s Expert Advisory Group on AIDS, 2004). Delayed confirmation exposes the injured health care worker to the significant side effects of drugs used in PEP. Prior to the HTA, the common law in England and Wales allowed the BBV testing of an unconscious patient only if (doctors) considered necessary and in the patient’s best interests (e.g. to establish their HIV status for the purposes of treatment). This is the advice followed by the Nursing and Midwifery Council (2006), in deference to the Department of Health. Therefore, in theory at least, a doctor may not test a source patient for HIV for the benefit of an injured health care worker either if the patient refuses a test or if the patient is incompetent/unconscious. However, in its 1997 Serious Communicable Diseases guidelines, the General Medical Council (1997) (to whom the British Medical Association and Department of Health defer) advises that ‘you may test an existing blood sample, taken for other purposes’ if the patient has refused testing or is unable to consent, and certain other circumstances apply, although ‘you must. be prepared to justify your decision (to test non-consensually)’ if a complaint is made to the doctor’s employer or the General Medical Council (GMC), or is challenged in court. In light of the HTA, the GMC has now withdrawn its advice, pending legal clarification. The HTA requires that appropriate consent is obtained from living patients in order to store or test human tissue. This includes the use of blood for BBV testing when the purpose of testing is relevant to a third person. Nonconsensual testing is only permitted by the intervention of the Secretary of State, who can authorize a doctor to use tissue to ‘obtain scientific or medical information about a living . person which may be relevant to another’ (i.e. an HIV test after needlestick injury), provided this is preformed in the patient’s ‘best interests’ rather than for the benefit of the injured health care worker. Moreover, the MCA (White and Baldwin, 2006), enforced on 1 October to specifically empower and protect people who lack the capacity to consent, offers no further assistance. Under the MCA, all treatment decisions relating to a patient over the age of 16 years who lacks the capacity to give consent must be necessary and made, once again, in that patient’s best interests. As a result of the HTA and MCA, therefore, the following applies: in the event of a needlestick injury to a health worker, blood may only be taken from an unconscious patient for BBV testing provided that testing would be in the best interests of the patient, or once the patient has regained capacity to consent, anyone who tests the patient nonconsensually for BBVs may be liable to imprisonment. This has been confirmed (to me) by the Public Guardianship Office (who deal with enquiries relating to the MCA) and the Human Tissue Authority, the latter of whom recognize the problem and are negotiating a solution. What solutions might there be to this problem? Several are possible, but none are satisfactory. First, one might test the patient non-consensually, but covertly. This is obviously not advocated but is an indicator of the problem for health care workers that this avoidable dilemma has created. Secondly, one could test the patient non-consensually and invite a legal test case, defending any action on the grounds either that the patient’s ‘best interests’ might be best served by GUEST EDITORIAL