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Legal Aspects of Blood Transfusion

SANBS Clinical Guideline, 6th Edition, 2023

Responsibilities of doctors who transfuse blood components

Informed consent

Assessing benefits and risks

Delictual liability

Criminal liability

Further reading


Blood transfusion is a cornerstone of modern medical practice. It is an essential component in the medical management of patients in almost every field of clinical practice.

Medical practitioners who order blood for their patients are faced with the challenge of managing the blood transfusion needs of the patient in an evidence-based approach and balancing the expected clinical benefit with the risks inherent in the transfusion of blood.

Blood should only be ordered when there is an appropriate medical indication for a transfusion and practitioners must be able to justify all requests for blood products. Blood transfusions are currently regulated by the National Health Act (2003) and its associated Regulations. Contravention of provisions of the Act and/or the Regulations may constitute an offence.

In the broad doctor-patient relationship, it is generally accepted that the doctor (and the blood transfusion service) owe a duty of care to the patient. The doctor and the blood service are in a unique position to prevent harm:

  • The blood service is required to take reasonable steps to make the blood supply as safe as possible
  • The attending doctor, who has a closer relationship with the patient, is responsible for:
    • assessing the clinical need for a transfusion
    • informing the patient of the benefits and risks of the treatment prescribed
    • obtaining informed consent.

Responsibilities of doctors who transfuse blood components

There are several well-documented reasons why the implementation of PBM should receive attention – and even be fasttracked – in South Africa.

The responsibilities of the practitioner who orders and transfuses blood encompass the following:

  • Transfusing blood only when it is medically indicated
  • Warning patients of the potential risks inherent in blood transfusion and informing them of the available alternatives
  • Obtaining and documenting informed consent
  • Correctly identifying the patient and the number of units of blood to be transfused
  • Ensuring that appropriate compatibility tests have been performed
  • Ensuring that the blood has been correctly handled prior to and during transfusion
  • Ensuring that the blood has not passed its expiry date
  • Permitting responsible persons to administer blood to the patient
  • Transfusing blood at the proper rate
  • Observing and monitoring the patient at the commencement of, and during, the transfusion
  • Effectively managing any untoward transfusion reaction
  • Retaining blood samples as required
  • Reporting untoward reactions or death
  • Tracing, counselling and testing recipients of blood transfusions identified through the transfusion-transmissible infection Lookback Programme.

Informed consent

As with any medical treatment, patients have a right to decide whether or not they want the treatment. As far as possible, the patient should understand the treatment, agree that the benefits, risks and alternatives to transfusion have been explained, and then consent to the treatment. This is a process which must be acknowledged and documented.

The attending doctor must, in each case, consider alternatives to conventional transfusion therapy (and consider the risks and benefits of those alternative therapies). They are also responsible for discussing alternatives to allogeneic blood transfusion (e.g. autologous or directed donation) with the patient.

Failure to inform the patient of the material risks inherent in blood transfusion and its alternatives could amount to a failure to procure informed consent, resulting in legal liability for the doctor should the patient suffer adverse effects from the transfused blood component.

Assessing benefits and risks

While the residual risk of transmitting human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) infection is remote in the era of individual-donation nucleic-acid testing, doctors must nevertheless assess the benefits and risks in each case and must be able to justify all requests for blood transfusions.

Clinicians must be aware of:

  • Other infectious risks, e.g. malaria, cytomegalovirus (CMV) and bacterial contamination (particularly of platelet concentrates)
  • Potential non-infectious adverse effects of transfusion, e.g. red cell incompatibility, immune-modulation, transfusion-associated graft versus host disease (TA-GvHD) and transfusion-related acute lung injury (TRALI).

Practitioners are advised to keep up to date with international best practices in the field of transfusion medicine and to adopt a high standard of care at all times, e.g. clinicians need to:

  • Be aware of the indications for, and the availability of, leukocyte-depleted blood components and/or gamma-irradiated blood components
  • Know the appropriate clinical indications for blood components
  • Be aware of the potential risks of transfusion and give consideration to alternative treatment
  • Take swift corrective action when problems occur
  • Maintain a good doctor-patient relationship
  • Initiate private dispute resolution or mediation discussions with aggrieved parties, as doing so is likely to result in a more favourable outcome

The hospital or institution that employs doctors and other healthcare professionals (or permits them to practise in their facilities) also has a responsibility in the selection, education, retention and supervision of its medical staff, including the responsibility of the medical staff to obtain informed consent.

Delictual liability

Generally, delictual liability arises when some harm or damage is caused to another, either negligently or intentionally, in an unlawful manner.

In general, negligence is deemed to be present if the reasonable person would have foreseen harm to the plaintiff and would have taken steps to avoid such harm, and if the defendant failed to take such steps. In the case of experts and professionals, conduct is measured against the conduct of the reasonable expert or professional.

The basic elements of a claim based on negligence are:

  • The defendant owed a duty of care to the plaintiff
  • The defendant breached the duty
  • The plaintiff’s injury was directly or proximately caused by the breach
  • The plaintiff suffered damages as a result

It is generally considered that it may be difficult to prove that a blood transfusion service or medical doctor acted negligently in the administering of blood if they adhered to the legislation, regulations and standards for practice applicable at the time of the transfusion.

Criminal liability

Apart from the statutory offences created by the National Health Act and Regulations, blood transfusions may give rise to criminal liability for the common law crime of culpable homicide and perhaps assault.

If a patient dies as a result of negligence on the part of the practitioner, or of the blood transfusion service, the individuals involved may be charged and convicted of the crime of culpable homicide – the wrongful and negligent causing of the death of another person. In South Africa, a medical practitioner and (on a separate occasion) a blood-transfusion medical-laboratory technician have previously been convicted of culpable homicide after incompatible blood was administered to a patient.

Assault may be deemed to have been committed if a blood transfusion is administered to a patient without the necessary consent. Blood transfusions are an essential component of medical practice. They are frequently life-saving and dramatically improve survival rates and morbidity – particularly in the fields of trauma and surgery – and play a critical role in enabling treatment to be undertaken in medical disciplines, e.g. haematology and oncology. As outlined above, however, practitioners who order blood for their patients must be cognisant of their legal responsibilities with regard to the administration of those blood components.

Further reading

  1. South African Government. National Health Act 61 of 2003. Accessed March 7, 2023. https://www.gov.za/documents/national-health-act
  2. South African Government. Regulations relating to blood and blood products. 2012. Accessed March 7, 2023. https://www.gov.za/sites/default/files/gcis_document/201409/35099rg9699gon179.pdf
  3. South African National Blood Service & Western Cape Blood Service. Standards of practice for blood transfusion in South Africa. 2016. Accessed March 7, 2023. https://satiba.org.za/wp-content/uploads/2021/10/standards-for-blood-transfusion-v7.pdf
  4. International Society of Blood Transfusion. A code of ethics for blood donation and transfusion. 2017. Accessed March 7, 2023. https://www.isbtweb.org/resource/english.html
  5. Grainger B, Margolese E, Partington E. Legal and ethical considerations in blood transfusion. CMAJ. 1997;156(11):S50-S54.
  6. Management of patients who do not accept transfusion. Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee. 2014. Accessed March 7, 2023. https://www.transfusionguidelines.org/transfusion-handbook/12-management-of-patients-who-do-not-accept-transfusion

Clinical Guidelines for the Use of Blood and Blood Products in South Africa, 6th Edition, 2023

NeoHealth® ID 19039 · updated 9/8/2023