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Editorial Anaesthesia, 2007, 62, pages 1199–1201 ..................................................................................................................................................................................................................... treatment. This would require a high standard of circumstantial medical evidence suggesting this to be the case. Second, the ‘good egg’ argument: the unconscious patient is assumed to be a kind person, who would consent to testing if s ⁄ he were competent, and therefore, have his best interests served through not subjecting the injured healthcare worker to either the anxiety of not knowing the patient’s HIV status, or the side-effects of PEP. Finally, the ‘rights’ argument: that the healthcare worker’s right to discover the patient’s HIV status (possibly with reference to Articles 2 and 3 of the Human Rights Act 1998 (HRA) [23]) is more pressing than the patient’s right to not be tested (possibly protected by Articles 2, 3 and 8 of the HRA). In practice, such justification is yet to be tested in a UK court [24], and is now unlikely to be, as the GMC has recently rescinded paragraphs 8–11 of Serious communicable diseases, in light of the Human Tissue Act 2004 and the Mental Capacity Act 2005. According to the HTA, appropriate consent from living patients is legally required [1(1)(d) + (f)] for storage and use of human tissue (which includes blood for HIV testing) for the purpose inter alia of obtaining scientific or medical information about a living or deceased person which may be relevant to any other person [Schedule 1, s.1(4)]. Storage and use of tissue from patients who lack capacity (i.e. many intensive care patients) is unlawful (s.6), unless allowed by the Secretary of State, in this instance according to the Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) Regulations 2006 [25]. The Regulations allow for non-consensual storage and use of 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 inter alia that the nominated doctor taking the blood does so in ‘what s ⁄ he reasonably believes to be in the best interests of the person lacking capacity from whose body the material came’. So again, blood may only be taken if the intent is to benefit the patient, and not the healthcare worker. The Mental Capacity Act 2005 [26] (MCA) is no more helpful in terms of the non-consensual testing of patients who lack legal capacity. From October 2007, patients over 16 years of age must be assumed to have capacity unless they are found to lack capacity. Any decision to test a patient without capacity for HIV must continue to be made in the patient’s best interests, if there is no other way to establish his ⁄ her HIV status. Although it will remain the case that the doctor will usually decide (s ⁄ he must be able to justify that decision in court), any decision must be made in the patient’s best interests (i.e. not the interests of the healthcare worker sustaining a needlestick injury). Interestingly, a properly appointed donee of an Lasting Power of Attorney, or a courtappointed deputy, may give proxy consent for blood testing, but again they must do so in the patient’s best interests. In addition, a patient may, in theory, consent to or refuse HIV testing by means of an advanced directive. Effectively, therefore, the combined effects of the HTA and MCA have firmly closed the backdoor to testing afforded by the GMC’s previous guidelines, and threatened doctors with imprisonment if they test patients for HIV non-consensually. This problem was foreseen during the passage of the Mental Capacity Bill, but an attempt by the British Medical Association to amend the Bill to allow non-consensual HIV testing to ‘avert the death of, or serious illness in, another person’ was withdrawn, after assurances from the government that this circumstance would be clarified in the Code of Practice accompanying the Act [27]. Predictably it wasn’t – there is no reference to HIV testing in all 302 pages of the Code of Practice [28]. Section 6 of the Code deals with the protections that the Act offers for healthcare workers (amongst others), but repeats the maxim that any intervention must be in the patient’s best interests. In an attempt to clarify the law in relation to HIV testing, I contacted both the HTA and the Court of Protection (the latter via the Public Guardianship Office). Both agencies were very helpful. After consultation, the HTA sent me the following statement for publication: ‘The HTA are aware of the complex issues this situation generates. The HTA are currently part of discussions on this issue being led by the Department of Health, BMA and other organisations in relevant sectors. The general status of the situation is that this issue is still under discussion and the regulations are still being drafted. Therefore, at present it is difficult for the HTA to comment further on this area. We are waiting further clarification from the Department of Health at which point we will be in a position to move forward on this area of work. Please keep checking the HTA and relevant websites in the sector for any news on this issue’. The Public Guardianship Office referred me to the Human Tissue Branch of the Department of Health, who concurred with the above analysis of the problem, and stated by letter: ‘We are actively considering this complex issue and have – as the HTA advised you – been in discussion with a number of interested bodies. We hope to be in a position during the summer to consult on new proposals for addressing some of the concerns expressed’. To summarise, anaesthetists must beware: in the event of a needlestick injury to a healthworker, blood may only be drawn from an unconscious patient for the purposes of communicable virus detection, provided that to do so would be in the best interests of the patient. The medical and nursing professions, in partnership with the Department of Health and the Courts, would be well advised to strenuously seek an expeditious solution to this impasse to optimise the postexposure treatment of healthcare workers after needlestick injuries. Acknowledgements I would like to thank the Human Tissue Authority, Public Guardianship Office and Department of Health for their prompt assistance, as well as Dr Steve Yentis for initially raising the issue. An interesting discussion of the ethics surrounding these issues can be found on Ó 2007 The Author 1200 Journal compilation Ó 2007 The Association of Anaesthetists of Great Britain and Ireland
Anaesthesia, 2007, 62, pages 1199–1201 Editorial ..................................................................................................................................................................................................................... Radio 4’s Inside the Ethics Committee, broadcast 12th September, 2007 [29]. Stuart M. White Consultant in Anaesthesia Brighton Anaesthesia Research Forum, Brighton and Sussex University Healthcare NHS Trust Eastern Road Brighton, East Sussex, BN2 5BE, UK E-mail: igasbest@hotmail.com References 1 HMSO. The Human Tissue Act, 2004. http://www.opsi.gov.uk/acts/ acts2004/20040030.htm [accessed 10 October 2007]. 2 Redfern M. The Royal Liverpool Children’s Enquiry. January 2001. http://www.rlcinquiry.org.uk/ download/index.htm [accessed 10 October 2007]. 3 Kennedy I. The Bristol Royal Infirmary Inquiry. Final Report. July 2001. http://www.bristol-inquiry.org.uk/ final_report/index.htm [accessed 10 October 2007]. 4 HM Inspector of Anatomy. The Investigation of events that followed the death of Cyril Mark Isaacs. May 2003. http://www.doh.gov.uk/cmo/ isaacsreport/ [accessed 10 October 2007]. 5 Department of Health. Human Bodies, Human Choices. The Law on Human Organs and Tissue in England and Wales. A Consultation Report. July, 2002. http://www.doh.gov.uk/ tissue/humanbodieschoices.pdf [accessed 10 October 2007]. 6 Liddell K, Hall A. Beyond Bristol and Alder Hey: the future regulation of human tissue. Medical Law Review 2005; 13: 170–223. 7 McHale J. The Human Tissue Act 2004: innovative legislation – fundamentally flawed or missed opportunity? Liverpool Law Review 2005; 26: 169–88. 8 Mavroforou A, Giannoukas A, Michalodimitrakis E. Consent for organ and tissue retention in British law in the light of the Human Tissue Act 2004. Medicine and Law 2006; 25: 427– 34. 9 Furness PN. The Human Tissue Act. British Medical Journal 2006; 333: 512. 10 Editorial. Effective implementation of the Human Tissue Act. Lancet 2006; 368: 891. 11 Underwood JC. The impact on histopathology practice of new human tissue regulation in the UK. Histopathology 2006; 49: 221–8. 12 Lucassen A, Kaye J. Genetic testing without consent: the implications of the new Human Tissue Act 2004. Journal of Medical Ethics 2006; 32: 690– 2. 13 Bell MD. The UK Human Tissue Act and consent: surrendering a fundamental principle to transplantation needs? Journal of Medical Ethics 2006; 32: 283–6. 14 Bell MD. Emergency medicine, organ donation and the Human Tissue Act. Emergency Medicine Journal 2006; 23: 824–7. 15 Elder A, Paterson C. Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices. Occupational Medicine 2006; 56: 566–74. 16 Huang L, Quartin A, Jones D, Havlir DV. Current concepts: intensive care of patients with HIV Infection. New England Journal of Medicine 2006; 355: 173–81. 17 Health Protection Agency. Eye of the Needle. Surveillance of significant occupational exposure to bloodborne viruses in healthcare workers. January 2005. http://www.hpa.org.uk/ infections/topics_az/bbv/pdf/eye_ of_the_needle.pdf [accessed 10 October 2007]. 18 Rapiti E, Prüss-Üstün A, Hutin Y. Assessing the Burden of Disease from Sharps Injuries to Health-Care Workers at National and Local Levels. Geneva: World Health Organization, 2005. http://www.who.int/quantifying_ ehimpacts/global/7sharps.pdf [accessed 10 October 2007]. 19 UK Chief Medical Officer’s Expert Advisory Group on AIDS. HIV postexposure prophylaxis. http:// www.dh.gov.uk/assetRoot/04/08/ 36/40/04083640.pdf [accessed 10 October 2007]. 20 Puro V, Cicalini S, De Carli G, et al. European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus. Euro Surveillance 2005; 10: 260–4. 21 Consent. In: White SM, Baldwin TJ. Legal and Ethical Issues in Critical Care and Perioperative Medicine. Cambridge: Cambridge University Press, 2004: 49–71. 22 General Medical Council. Serious communicable diseases. October 1997. http://www.gmc-uk.org/ guidance/current/library/serious_ communicable_diseases.asp [accessed 10 October 2007]. 23 White SM, Baldwin TJ. The Human Rights Act, 1998: implications for anaesthesia and intensive care. Anaesthesia 2002; 57: 882–8. 24 Halpern SD. HIV testing without consent in critically ill patients. Journal of the American Medical Association 2005; 294: 734–7. 25 Human Tissue Act 2004 (Persons Who Lack Capacity to Consent and Transplants) Regulations : SI no. 1659. 1. http://www.opsi.gov.uk/ SI/si2006/20061659.htm [accessed 10 October 2007]. 26 White SM, Baldwin TJ. The Mental Capacity Act, 2005. Implications for anaesthesia and intensive care. Anaesthesia 2006; 61: 381–9. 27 Mental Capacity Bill. Hansard, 1st February 2005, 194. http://www. publications.parliament.uk/pa/ ld200405/ldhansrd/vo050201/text/ 50201-27.htm#50201–27_spnew1 [accessed 10 October 2007]. 28 Department for Constitutional Affairs. Mental Capacity Act 2005. Code of Practice. http://www.dca.gov.uk/ legal-policy/mental-capacity/mca-cp. pdf [accessed 10 October 2007]. 29 British Broadcasting Corporation. Inside the Ethics Committee. Can an unconscious patient be tested for HIV without his consent? Broadcast 12th September 2007. http:// www.bbc.co.uk/radio4/science/ ethicscommittee_s3_tr3.shtml [accessed 10 October 2007]. Ó 2007 The Author Journal compilation Ó 2007 The Association of Anaesthetists of Great Britain and Ireland 1201
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