Practical Transfusion Medicine 4th Ed.

22. Medicolegal aspects of transfusion practice

Patricia E. Hewitt

NHS Blood and Transplant, London, UK

Ethical principles

The International Society of Blood Transfusion (ISBT) some years ago instituted a code of ethics setting out the guiding principles for blood donation and transfusion. Following revision, this code of ethics was adopted by the World Health Organization (WHO). It was also used to support ethical standards in the drafting of the European Blood Directive. It is recommended that all blood transfusion provision is in accordance with the principles included in this code. The main provisions are listed below.

· There should be no coercion to donate blood.

· Both donors and recipients must be adequately informed.

· Confidentiality must be maintained.

· Adequate standards should be enforced.

· Clinical need must be the determinant of transfusion therapy.

Regulatory framework in the UK (also see Chapter 17)

The regulatory framework encompassing blood transfusion will necessarily differ according to the legal situation in the country concerned. The framework in the UK is briefly described. Similar arrangements are in place in all developed countries.

Medicines Act 1968

The Medicines Act provides the framework for the regulation and control of all dealings with medicinal products. Prior to the Blood Safety and Quality Regulations (2005), both cellular blood components and fractionated blood components were included within the terms of the Act. Fractionated components (e.g. albumin, coagulation factor concentrates and intravenous immunoglobulin preparations) are individually licensed. The provision of labile blood components (red cells, platelets, fresh frozen plasma and cryoprecipitate) was enabled by means of an organizational licence awarded to individual blood centres by the Medicines and Healthcare Products Regulatory Agency (MHRA) following appropriate inspection and demonstration of compliance with the standards of good manufacturing practice. Such inspections of ‘blood establishments’ are now covered under the Blood Safety and Quality Regulations.

Consumer Protection Act 1987

The Consumer Protection Act creates a strict liability action against manufacturers and suppliers when physical injury or property damage is caused by a defective product.

The Consumer Protection Act 1987 was enacted as a result of a European Community Directive in 1985 and clearly includes within its terms the provision of all blood components and blood products. Its premise is the principle of product liability, i.e. that there is no need to prove that a negligent action has taken place, but merely that the end product is defective and has caused harm. In Section 3 (1) of the Act, a ‘defect’ is defined as follows: ‘There is a defect in the product …if the safety of the product is not such as persons generally are entitled to expect. …’ Blood providers can be held liable under the terms of the Act as producers, suppliers or keepers. The liability therefore extends from the blood centre producing the product to the hospital blood transfusion laboratory, which stores and issues products. There are possible defences within the terms of the Act, such as the ‘state-of-the-art defence’. In essence this means that if a product is found to be defective based on current knowledge, that information cannot be used to prove that the same product was defective sometime previously when the current knowledge was not available (Table 22.1). This defence was not held to apply in the case of the hepatitis C litigation in England, since the defect (the transmission of hepatitis C) was apparent at the time of the claimants' transfusions (1988–1991), although the means of detecting the defect (the availability of a hepatitis C test) was not necessarily available during the whole period.

Table 22.1 Relevant UK statutes.

NHS Act 1999 and Health and Social Care Act 2006

The 1999 Act modernized the NHS in England, Wales and Scotland. Raising standards in the quality of NHS care was at its heart. A statutory duty of quality was placed on all NHS providers, monitored by means of the Healthcare Commission. The spur to set up these statutory provisions had been inequality in care. All aspects of healthcare, including blood transfusion, came under the remit of the Healthcare Commission. Subsequent legislation, in the form of the Health and Social Care Act 2006, brought together existing health and social care regulators into one organization, the Care Quality Commission, with tough new powers to ensure safe and quality care. Additionally, the National Institute for Health and Clinical Excellence (NICE) was set up in 1999 to set standards for high quality healthcare in the UK, to produce clinical guidelines and to produce public health guidelines on how to improve people's health. NICE has produced little guidance in relation to blood transfusion therapy, but other organizations, such as the British Committee for Standards in Haematology (BCSH) regularly produce and review guidelines relating to transfusion practice.

European Blood Safety Directives (2002/98)

The European Blood Safety Directive (2002/98) [1] sets standards relating to blood collection, testing, processing and storage. A ‘daughter’ Directive (2004/33) lays out technical requirements in support of these standards. Together, the two directives were transposed into UK law as the Blood Safety and Quality Regulations 2005 [2], which came into force on 8 February 2005. Two further ‘daughter’ Directives (2005/61 and 2005/62), which cover aspects of traceability, reporting of adverse reactions and events, and specifications for quality systems, came into force by separate amending legislation in 2006.

The regulations impose safety and quality requirements on human blood collection, testing, processing and storage. The requirements apply to all ‘blood establishments’, which include the blood transfusion services in England, Scotland, Wales and Northern Ireland. In addition, the collection and processing of blood components within hospital premises confers the status of ‘blood establishment’ upon the hospital, bringing such activities and premises under the control of the regulations. The regulations replace some of those (in relation to inspection, licensing and accreditation) previously covered under the Medicines Act. They lay down a requirement for inspection not less than every 2 years by the regulatory authority (MHRA). Failure to comply with the licensing regulations can lead to the imposition of a fine or closure of an organization, and, in the worst cases, a fine or imprisonment for the designated ‘responsible person’ of the blood establishment.

Many of the provisions of the regulations, such as traceability, reporting of adverse events and specifications for quality systems, apply to hospital blood transfusion laboratories as well as to blood establishments. The regulations have had wide-reaching implications for both blood services and hospital blood transfusion laboratories.

Quality guidelines

Uniformity and process control within blood services can be achieved by compliance with detailed quality guidelines. The Guidelines for the Blood Transfusion Services [3] in the United Kingdom and the American Association of Blood Banks Technical Manual [4] are two examples of such documents. Although such guidelines do not possess legal status, they set out the requirements to be met for good manufacturing practice. Deliberate noncompliance would be regarded very seriously. Unavoidable noncompliance should be carefully documented and should include a clear explanation of the reasons for noncompliance.

Duty of care

Putting aside the ethical principles, quality guidelines and regulatory frameworks described above, there remains the clear duty of care that must be at the heart of the provision of blood transfusion. This duty must be according to an accepted standard. At present, the standard is determined according to the Bolam principle: ‘The test is the standard of the ordinary skilled man exercising and professing to have that special skill’ [5]. This defines the standard as that of a responsible body of doctors skilled in the same specialty. The standard of care can be supported by the application of professional guidelines, although currently the latter have no legal standing. The duty of care of blood services, according to the defined standard, is both to the blood donor and to the recipient patient.

Duty to the donor

The two general principles that underpin blood donation are that there should be every effort to ensure no harm to the health of the donor and no risk to the health of the recipient patient. The duty to the donor includes compliance with strict medical selection procedures. The donor should be informed about the screening tests performed on the donation and should provide a written consent to testing. Information should be provided on situations that could potentially pose risk to the donor, e.g. the administration of growth factors prior to stem cell donation or the use of general anaesthetic during bone marrow donation. In these instances, a donor would need to consent formally to the procedure. The blood services in the UK make leaflets available at all routine blood donation sessions, to inform prospective blood donors of relevant issues. Additionally, the blood service has a duty to maintain the confidentiality of a donor, particularly in the event of a recipient patient being harmed by blood obtained from a single donor. The duty of care to the donor also extends to the clinician prescribing the blood, to ensure appropriate use, particularly as that donation is provided on a voluntary basis with no expectation of monetary gain.

Duty to the recipient patient

In the UK the standard of care for patients receiving blood transfusion is addressed under the legislation referred to above. It is suggested that, as a minimum, this standard of care should include the provision of adequate information to the recipient patient and ensuring appropriate clinical use of individual blood components.

Consent to transfusion

Any patient being asked to consent to a medical treatment or investigation has the right to be informed of the aims, benefits and risks of the treatment, and to be given details of any alternatives. Without such information, consent is not valid. The standard NHS ‘Patient agreement to investigation or treatment’ form includes a section completed by the health professional who has the discussion with the patient. This section documents that an explanation has been given to the patient about the proposed investigation or treatment, including the possibility of extra procedures that may be found necessary, and blood transfusion is specifically mentioned at this point. The patient signs a general consent to the procedure/investigation described, embracing the possibility of additional procedures, but has the opportunity to list any procedures for which he or she withholds consent without further discussion. The UK Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) held a public consultation on the issue of consent for blood transfusion during 2010, leading to a number of recommendations, including the use of standardized patient information, improved staff training and ensuring best practice is followed, but not recommending that an individual signed patient consent is obtained for transfusion [6].

The patient must have the capacity to consent. No doctor should force a competent adult to accept any treatment even if that adult's decision appears to be irrational. An adult could be incapacitated and therefore unable to give consent because of loss of consciousness or mental retardation. In general, no other person can give consent on behalf of an incapacitated adult. (In some countries, e.g. Scotland, the power of parens patriae applies, where another adult can take responsibility as a parent for an incapacitated individual.) Prior wishes may be taken into consideration where the adult has previously been competent and the treatment is regarded as noncontroversial. Treatment may be given to an adult incapable of consenting if the treatment is urgent and in the patient's best interests. In an elective situation, however, it would be best to seek a ruling from a court of law. The General Medical Council has published a comprehensive guide to consent and this is recommended for more detailed reading [7] (Table 22.2).

Table 22.2 Informed consent must include these elements.

In the case of children, the Family Law Reform Act 1969 makes it lawful for a minor to consent to, or refuse, treatment when he or she reaches the age of 16 years. In the case of a child below 16 years of age, the parents usually give consent, although such children are able to give valid consent in their own right if they are capable of understanding clearly the nature of the proposed treatment [8]. Here, a difficulty could be where parents have specific religious beliefs that prevent them from consenting to blood transfusion for their child. In this instance, a doctor can decide to provide a treatment, including blood transfusion, in the child's best interests. The treatment must be carried out in order to save life or to ensure improvement of or to prevent deterioration in the physical or mental health of the child. This would form the basis of a doctor's individual decision during an emergency situation, but in the case of a planned blood transfusion it would be appropriate to seek a ruling from a court of law. In these circumstances it is recommended that the doctor's medical defence body is consulted for advice on how to proceed.

For consent to be informed and valid, it must be based on adequate information. Attempts have been made to define what constitutes adequate information and it is legally acceptable that the explanation need not include all the potential adverse consequences if the risk of them occurring is small or immaterial. Minor insignificant reactions to transfusion occur relatively commonly, whereas the risk of complications with serious or fatal long-term consequences, e.g. transmission of HIV, is extremely low. However, there is heightened public awareness of such low risk, and it is therefore appropriate for these events to be included in a preliminary explanation. Again, the standard that applies in the UK is that of a responsible body of skilled doctors, the Bolam principle. In the USA, however, a different rule applies, the standard being judged according to that which a prudent patient would think relevant to receive, a situation that is likely to develop within the UK in the next few years.

There must be no coercion in obtaining consent. A competent adult is able to accept or refuse treatment even if that decision could lead to harm or indeed death. If an individual doctor decides to treat an adult without consent, then that doctor should be prepared to explain and justify the decision.

Jehovah's Witnesses

Jehovah's Witnesses, because of their religious beliefs, will never accept normal blood transfusion therapy, although in appropriate circumstances could find cell salvage in continuous circulation acceptable. Many Jehovah's Witnesses carry an Advance Medical Directive, which states the individual's views and requirements to be followed in the event that the individual is unconscious or otherwise unable to express his or her views. Where the situation is one relating to a competent adult, as long as it is clear that there is no coercion, the decision to refuse treatment must be respected, even if it would lead to harm or indeed death of the patient. In an emergency situation, if the patient is unconscious and therefore incapacitated, then prior previously held beliefs must be taken into account and blood transfusion should not be prescribed if those beliefs made it clear that it was unacceptable. In the situation of a child, where the parents' religious beliefs could prevent the child from being given a necessary blood transfusion, it would be advisable to seek a proper legal ruling, which would usually mean the child becoming a ward of court and therefore decisions on the treatment being taken by the court.

Patient recourse

Despite compliance with standards and appropriate care, things do, and will, go wrong. In some countries, e.g. New Zealand and the Scandinavian countries (Sweden, Norway, Finland and Denmark), compensation for medical accidents is provided under a ‘no-fault’ system. However, in most countries there is a need to prove liability. In these circumstances, liability will rest either with the individual doctor or with the health employer if vicarious liability applies (this is the current position in the UK for all NHS work). There have been examples of no-fault compensation awarded in the UK in specific circumstances, e.g. the Vaccine Damage Payment Scheme, which provides payment of a fixed lump sum where serious mental or physical damage has been caused by the administration of specified vaccines. A vCJD compensation scheme, administered by the vCJD Trust, was set up to provide payments for people infected with vCJD through exposure to bovine products or otherwise through exposure to BSE or vCJD within the UK. This scheme therefore covers individuals believed to have been infected through UK blood transfusions. Specifically in relation to blood transfusion, there are schemes (the MacFarlane Trust and the Eileen Trust) for recipients infected with HIV through the use of plasma products and through blood transfusion both before and after the introduction of mandatory screening of the blood supply in the UK. These were ex gratia payments to those affected, with the government emphasizing that they should not be regarded as an admission of liability or as compensation, but as a response to a particular and tragic situation. Requests for similar treatment for individuals infected with other agents, such as hepatitis B and C, were, at first, refused. However, a scheme known as the Skipton Fund was subsequently set up for recipients who had been infected with hepatitis C through treatment with NHS blood components/products, although only those transfused prior to the introduction of testing of blood donations in September 1991 qualify for such payments. Similar treatment does not apply to recipients infected with other agents through blood transfusion, although such cases are small in number. It becomes difficult to explain the different treatments of patients who have suffered apparently similar unfortunate and unexpected adverse effects through treatment with blood transfusion.

A patient who has suffered harm can bring an action either in medical negligence or under product liability. If brought in negligence, there would be a need to prove a breach in the duty of care and that the breach directly caused harm to the patient. If brought under product liability, negligence need not be present; a defective product must have directly caused the harm (Table 22.3).

Table 22.3 Comparison of medical negligence versus product liability.

An example of an action that could be brought under medical negligence would be that of the transfusion of a unit of red cells to the wrong recipient patient because of failure to check patient identification. Here, there would be a clear breach of the duty of care, which is in checking the patient identification against the red cell unit, and it would also be simple to demonstrate that harm, in the form of an acute haemolytic transfusion reaction, had occurred as a direct result of the breach. The recipient patient would be able to seek damages for the injury and compensation for any consequent financial loss. A further example would be where a blood transfusion recipient acquired an infection from the blood transfusion and where the blood transfusion only became necessary because of negligent treatment of the underlying medical condition.

Cases of product liability in relation to blood transfusion in Europe are few. The most notable case was that of a number of recipients (114) in England and Wales who brought a claim under the Consumer Protection Act in 2000–2002 [9]. In his judgement, Burton found that the Blood Service was liable for the damage because the product (i.e. the blood) did not provide the safety that the consumer (patient) was ‘generally entitled to expect’. The claimants were awarded damages on a provisional basis according to the damage (extent of hepatitis C disease) present at the time of the action. Provisional damages allow for the claimants to return with a future claim should their medical condition deteriorate. The judgement in the hepatitis C litigation was not appealed. Similar claims in relation to transfusion-transmitted infection have been settled in the absence of any successful challenge to the ruling. The case attracted much attention within Europe and has been the precedent for claims for other types of ‘defective product’, such as blood bearing white cell antibodies which were the cause of Transfusion Related Acute Lung Injury (TRALI). Other case law within Europe is scarce, although some European countries (e.g. France and the Scandinavian countries) provide for no-fault compensation in relation to infection acquired through medical treatment.

Key points

1. All those involved in the provision of blood and blood components must be aware of the relevant regulatory framework(s).

2. Those prescribing blood transfusion must be aware of consent issues.

3. Valid consent is based on having relevant information.

4. A competent adult can choose to refuse blood transfusion, despite the likely consequences, and that choice must be respected.

5. No-fault compensation/payment schemes apply for some transfusion complications in the UK, but not for all.

6. The Consumer Protection Act has opened the door for claims from blood transfusion recipients without the need to prove negligence.

References

1. Directive 2002/ 98/ EC of the European Parliament and of the Council (2003). Available at: http://ec.europa.eu/health/blood_tissues_organs/key_documents/index_en.htm#anchor0_more (accessed December 2011).

2. UK Blood Safety and Quality Regulations (BSQR). Available at: http://www.legislation.gov.uk/uksi/2005/50/contents/made#top (accessed December 2011).

3. Guidelines for the Blood Transfusion Services in the United Kingdom, 7th edn; 2005 and addendum 2007. Available at: http://www.transfusionguidelines.org.uk/index.aspx?Publication=RB&Section=25 (accessed December 2011).

4. American Association of Blood Banks. Technical Manual, 17th edn. Bethesda, MA: AABB, 2011.

5. Bolam v Friern Barnet Hospital Management Committee. 2 All ER 118; 1957.

6. General Medical Council. Consent Guidance; Patients and Doctors Making Decisions Together. London: GMC; 2008.

7. Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO). Patient Consent for Blood Transfusion; 2011. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_130716?ssSourceSiteId=ab (accessed December 2011).

8. Gillick v West Norfolk and Wisbech Area Health Authority. 3 All ER 402; 1984.

9. A and others v National Blood Authority. 3 All ER 289; 2002.

Further reading

Braithwaite M & Beresford N. Law for Doctors: Principles and Practicalities. London: Royal Society of Medicine Press; 2002.

Goldberg R. Paying for bad blood. Strict product liability after the hepatitis C litigation. Med Law Rev 2002; 10: 165–200.

Grubb A & Pearl DA. Blood Testing, Aids and DNA Profiling. Bristol: Family Law (Jordan and Sons Ltd); 1990.

The Consumer Protection Act 1987. In: Halsbury's Statute of England. London: HMSO.

Warden J. HIV infected haemophiliacs: 90 million more. Br Med J 1989; 299: 1358.