Needlestuck

Enacted on the 15th November, 2004, and fully enforced on the 1st September, 2006, the Human Tissue Act 2004 (HTA) [1] is the UK government's woefully impenetrable attempt to clarify the statutory law in England and Wales with regard to the use and storage of human tissue, organs and bodies. The HTA repeals the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989. In response to public concern over the organ retention scandals at Alder Hey Hospital [2] and the Bristol Royal Infirmary [3], and the findings of the Isaacs Inquiry [4], the government hurriedly introduced a consultation document, Human Bodies, Human Voices[5], in July 2002, leading to the introduction of the Human Tissue Bill, in December 2003. In line with much recent legislation, consent was proposed as a fundamental protection for patients, such that virtually all tissue taken from humans could only be used or stored having obtained appropriate consent (from the patient if alive, from the parents of children, or premortem if the patient was now dead), under penalty of fine or imprisonment. Some ramifications of the Bill were immediately apparent, and elicited considerable debate among, and opposition from, the research, legal [6–8] and transplant communities, especially pertaining to anatomy demonstration, research using human tissue [9, 10], tissue databanking [11], genetic research [12] and organ transplantation [13, 14]. Less apparent, unfortunately, were some of the ramifications relating to everyday clinical practice. One scenario in particular has given rise to concern about the protection of healthcare professionals in the event of a needlestick injury. Accidental blood and body fluid exposure is a daily risk for health care workers, with an incidence of approximately 1–5 per 100 person-years [15]. Up to 40% of patients with HIV are unaware of their status when they are admitted to intensive care [16]. Needlestick injuries account for approximately 80% of exposures, are more common with more complex procedures, and can lead to infection with HIV, and hepatitis B, C and/or D [17]. Seroconversion rates are low for HIV (0.3%) and HCV (0.5%), but much higher for HBV (18–30%) [18]. A number of postexposure prophylaxis (PEP) guidelines are available for HIV [19], HBV and HCV [20]. In the case of HIV, PEP should ideally be commenced within an hour of exposure, and continued at least until the HIV status of the source patient is confirmed. Delays in source patient HIV testing can expose health care workers to inappropriate continuation of PEP administration of drugs with significant side-effect profiles. However, there is considerable confusion surrounding the issue of consent when testing a source patient for HIV (or other blood-borne viruses). No specific statute exists, and so the legality of testing lies in the common law. Testing involves physical contact with a patient, and therefore the patient's consent is required. Their consent is legally valid if they are appropriately informed (about the nature and purpose of the test, and the risks and consequences of testing), competent to decide (that is, they understand the information presented to them, remember it, and use it to decide whether or not to have the test), and give consent voluntarily [21]. Competent adult patients can consent to, or refuse, testing for any reason, or for no reason at all. At present, no-one may give consent on behalf of an incompetent patient (for example, an unconscious patient in the intensive care unit). Under the common law in England and Wales, the HIV testing of an unconscious patient is legal if it is necessary and in the patient's best interests (for example, to establish their HIV status for the purposes of treatment). Therefore, in theory at least, a doctor may not test a source patient for HIV for the benefit of an injured healthcare worker either if the patient refuses a test, or if the patient is incompetent/unconscious. However, this is not the advice offered in professional guidelines, namely the General Medical Council's Serious Communicable Diseases guidelines of 1997 [22] (the British Medical Association and Department of Health defer to the GMC in their own advice). The GMC advises that ‘You must obtain consent from patients before testing for a serious communicable disease’ (s.4), and ‘you may test unconscious patients for serious communicable diseases, without their prior consent, where testing would be in their immediate clinical interests’ (s.7), in line with the common law. However, the GMC then advise that ‘you may test an existing blood sample, taken for other purposes’ if the patient has refused testing or is unable to consent, and the doctor has good reason to believe the patient may have a communicable disease for which prophylaxis is available, and an experienced colleague has been consulted, and the patient is unlikely to regain capacity within 48 h (s.8 + s.9), which course of action may not be in line with the common law, even if the patient is informed of the non-consensual test at the earliest opportunity (s.10). The advice states that ‘you must therefore be prepared to justify your decision (to test non-consensually)’ if a complaint is made to the doctor's employer or the GMC, or if challenged in court, but justification could prove difficult. Several arguments might be used. Firstly, the ‘best interests’ argument: the patient was tested because his/her symptoms were unexplained and possibly attributable to HIV/HBV/HCV, requiring diagnosis and 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 court-appointed 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. 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 Radio 4's Inside the Ethics Committee, broadcast 12th September, 2007 [29].