Analysis

Consent for blood transfusion

BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c4336 (Published 24 August 2010) Cite this as: BMJ 2010;341:c4336
  1. Anne-Maree Farrell, senior lecturer in law,
  2. Margaret Brazier, professor of law
  1. 1Centre for Social Ethics and Policy, Institute for Science Ethics and Innovation, School of Law, University of Manchester, Manchester M13 9PL
  1. Correspondence to: A M Farrell a.m.farrell{at}manchester.ac.uk
  • Accepted 6 June 2010

Millions of people receive blood transfusions each year, but many will not be fully aware of the risks. Anne-Maree Farrell and Margaret Brazier argue for a formalised consent procedure

Within transfusion medicine, the question of whether separate informed consent should be obtained from patients for blood transfusion has provoked considerable debate. There has long been support for such an approach in the United States.1 A BMJ editorial in 1997 made it clear that reform was on the professional agenda in the United Kingdom, despite the established position that obtaining general consent for medical treatment included consent for blood transfusion.2 At the time, however, professional consensus proved elusive because of concerns over a range of practical problems, including who should be responsible for obtaining such consent and in what circumstances it should be obtained.3 The issue has now been brought to the fore again, highlighted by the recent stakeholder consultation launched by the UK government’s independent Advisory Committee on the Safety of Blood, Tissue and Organs.

In its consultation document, the committee acknowledged that practice on obtaining consent for transfusion of blood components is inconsistent across the UK. In addition, it highlighted several concerns including whether patients are being given information on risks, benefits, and alternatives to transfusion, as well as being informed of their right to refuse transfusion.4 We echo the committee’s concerns. Although current advice states that there is no legal requirement to obtain formal consent from the patient for transfusing blood components,5 we question the basis of such advice and its continuing legal probity.

Informing patients about blood transfusion

In the past, many patients, and their general practitioners, were unaware that they had received blood transfusions during medical treatment.6 Few published data exist on patient concerns about blood transfusion in the UK, but several small studies conducted in the 1990s showed that patients would have welcomed more information about the risks, benefits, and alternatives to blood transfusion.3

Although improvements might have been expected over the past decade, the lack of published audits makes it difficult to ascertain whether the deficit in the provision of information and documentation about blood transfusions has been redressed within the National Health Service (NHS). The UK blood services publish information leaflets about blood transfusion for hospitals and healthcare professionals to give to patients, but the provision of such leaflets to patients is not mandatory and the take-up by hospitals has been variable. A recent audit showed that although such information leaflets were readily available in NHS trusts, many patients who had received blood transfusions had not received them. Perhaps this reflects the fact that NHS trusts do not see issues relating to blood transfusion in general as a high priority.7

Recent legal developments and consent

National health policy and practice has put greater emphasis on patient involvement and choice about medical treatment in recent years. Against this background, there have been important legal developments regarding the information that should be disclosed to patients concerning risks associated with their medical treatment. In a majority judgment handed down in Chester v Afshar by the House of Lords in 2004, it was held that patients should be told of any possible serious risks associated with their proposed medical treatment.8 Lord Steyn observed that in “modern law medical paternalism no longer rules and a patient has a prima facie right to be informed [of] a small, but well-established, risk, of serious injury.”8 He went on to say that the disclosure of information about the risks associated with medical treatment was considered to be of the utmost importance in terms of upholding the patient’s right to autonomy and dignity. Crucially, the Law Lords ruled that to succeed in a claim for negligence the patient did not have to prove that he or she would have rejected the treatment that had been inadequately explained to them, only that they might have sought further advice or time to reflect further before making a decision.

In the wake of this judgment, the General Medical Council issued revised guidance. It emphasises the duty of doctors to act in partnership with their patients with respect to obtaining their consent to medical treatment.9 Doctors are advised to disclose risks arising from treatment that may result in common but minor side effects, as well as rare but serious adverse outcomes that may result in permanent disability or death. The GMC cautions against making assumptions about the patient’s understanding of risk or the importance they might attach to different outcomes. The guidance specifically states that where risks are beyond the minor or routine, the patient’s written consent should be obtained.

These developments underline the need for a different approach to patients receiving blood transfusions in the UK. The procedure has serious infectious, as well as non-infectious, risks, ranging in frequency and severity (table).10 Some risks may be considered small or remote, such as the transmission of infectious diseases, but they are risks that patients are likely to attach importance to because they may result in serious morbidity or death. As the Court of Appeal in Pearce v United Bristol Healthcare NHS Trust made clear, doctors must inform patients of any “significant risk that would affect the judgment of a reasonable patient.”11

Cumulative data on mortality and morbidity from blood transfusion, 1996-200810

View this table:

Time for change

We argue that it is now a legal requirement for patients to be informed of the specific risks posed by blood transfusion, in addition to those risks posed by their medical treatment or surgery. This should be done through a formal consent process initiated by treating healthcare professionals and including a discussion of the risks and benefits of, as well as the alternatives to, blood transfusion. Failure to do so may result in a claim of negligence or even battery. If patients are not made aware that a discrete and additional invasive and potentially risky procedure such as a blood transfusion may be carried out during their treatment, are they sufficiently informed, even in broad terms, of the “nature of the procedure which is intended”?12 If they are not, then there is no consent to that procedure and the administration of the transfusion may be unlawful. It is established law that adult patients with capacity can refuse a blood transfusion, notwithstanding the views of their doctors that it may be in their best interests to have one.13

In the context of surgery, when a transfusion is likely to be needed, patients should be informed and consent obtained before the operation. When it is likely that multiple transfusions may be required at various times during the course of medical treatment, this should be explained and consent obtained at the start of such treatment. In an emergency or an unexpected situation when it is not possible to obtain consent in advance, the transfusion will be lawful in the absence of any evidence that the patient would have refused consent,14 but patients should be subsequently informed that it has taken place and have the reasons for transfusion explained. The fact that patients were informed about the likelihood of receiving a blood transfusion, as well as whether they consented to or refused such transfusion, should be noted in their medical records and the discharge summary. All patients receiving blood transfusions should be provided with an information sheet on discharge detailing possible signs and symptoms relating to adverse outcomes from blood transfusion and what to do if they experience them.

Data should be collected systematically within the NHS to determine the extent to which these requirements are being met, and remedial action should be taken where it is not. National blood policy has emphasised the need for greater patient awareness about the risks and choices associated with the safe and appropriate use of blood.15 Requiring that specific consent be obtained for blood transfusion in the UK is an important step towards not only enhancing such awareness but also recognising the importance of patient autonomy in the context of decision making about medical treatment.

Notes

Cite this as: BMJ 2010;341:c4336

Footnotes

  • doi:10.1136/bmj.c4000
  • We acknowledge the stimulus and support of the Wellcome strategic programme The Human Body, its Scope Limits and Future in preparing this article.

  • Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare no support from any organisation for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

  • Contributors and sources: Both authors have research expertise and teaching interests in the field of medical law. This article was originally based on an idea by AMF, although both AMF and MB contributed to the preparation of the article. The article draws on an analysis of relevant policy and legal documents and case law. AMF is guarantor.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

References