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Appendices: 1. Needlestuck 2. Analysis of benefits and harms of blanket testing 3. Analysis of Presumed Consent 4. Analysis of non-consensual testing 5. Analysis of Status Quo 6. Analysis of Next of Kin Assent/Consent 7. Patient perspectives
Anaesthesia, 2007, 62, pages 1199–1201 ..................................................................................................................................................................................................................... Editorial 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 Ó 2007 The Author Journal compilation Ó 2007 The Association of Anaesthetists of Great Britain and Ireland 1199
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Recommendations for the Safe Transf
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CONTENTS Section I Summary and Reco
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SECTION II - BACKGROUND In 1996 the
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SECTION IV - ORGANISATION AND COMMU
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SECTION V - STAFFING REQUIREMENTS A
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A p p ropriate re s p i ra t o ry s
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SECTION VII - THE TRANSFER The tran
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SECTION VIII - EQUIPMENT AND DRUGS
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SECTION IX - EDUCATION AND TRAINING
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SECTION X - RESOURCE IMPLICATIONS F
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APPENDIX I INDICATIONS FOR INTUBATI
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APPENDIX III ADDITIONAL INFORMATION
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AAGBI SAFETY GUIDELINE Suspected An
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GUIDELINES Suspected Anaphylactic R
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available from www.hse.gov.uk 14.4
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DB DoH EBME EC EU FRCA HN HSE IEC I
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Eire Tel: 00353 1 676 4971 Website:
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Peri-operative management of the ob
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Guidelines Peri-operative managemen
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