Guidelines / Advice

Legal Aspects of Blood Transfusion

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 medical and legal 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 Human Tissue Act (Act No. 65 of 1983) and will soon be regulated under the news National Health Act. Contravention of provisions of the Act, and/or the Regulations, constitutes 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 act as a public protector and take the responsible 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 blood transfusion, for informing the patient of the benefits and risks of treatment prescribed, and for obtaining informed consent.

Responsibilities of doctors who transfuse blood

The responsibility of the practitioner who orders and transfuses blood encompasses the following:

• Transfusing blood only when it is medically indicated.
• Warning patients of the potential risks inherent in blood transfusion.
• Obtaining and documenting informed consent.
• Correctly identifying the patient, and units of blood to be transfused.
• Ensuring the appropriate compatibility tests has 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 of untoward reactions or death.
• Tracing referring 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 patients should understand the treatment and agree that the benefits, risks and alternatives to transfusion have been explained and that they consent to the treatment. It is a process which must be acknowledge and documented.

The attending doctor must, in each case, consider alternatives to conventional transfusion therapy (and consider the risks of alternative therapy), and is responsible for discussing alternatives to allogeneic blood transfusion (such as autologous or directed donation) with the patient. The patient must be informed of the material risks inherent in blood transfusion and of alternatives to it. Failure to do this could amount to a failure to produce informed consent, resulting in legal liability for the doctor should patients suffer adverse effects from the transfused blood component.

Assessing the benefits and the risks

While the residual risk of transmitting HIV, HCV and HBV infection in the area of individual donation nucleic acid testing is remote, doctors must nevertheless assess the benefits and risk in each case and must be able to justify all requests for blood transfusions. Clinicians must be aware of other infectious risks such as malaria, cytomegalovirus (CMV) and bacterial contamination (particularly of platelet concentrates), and of potential non-infectious adverse effects of transfusion such as red cell incompatibility, immune-modulation, transfusion associated graft versus host disease (TA-GVHD) and transfusion related to acute lung injury (TRALI).

Practitioners are advised to keep up to date with international best practices in the field of transfusion medicine and adopt a high standard of care at all times. For example, 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. Swift corrective action must be taken when problems occur. Maintaining a good doctor-patient relationship and initiating private dispute resolution or mediation discussions with aggrieved parties is likely to result in a more favourable outcome.

The hospital or institution who employs doctors and other health care professionals (or permits them to practice 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, either negligently or intentionally, to another, in an unlawful manner. In general, negligence is deemed to be present if the reasonable person who 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, the conduct of the expert or professional is measured against the conduct of the reasonable expert or professional.

The basic elements of a negligence claim 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; and 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 blood transfusion. However, those officials who compiled and/or sanctioned the standards could possibly be held liable if it were shown that the standards themselves were inadequate.

Since blood is a living tissue, inherently variable and incapable of being rendered uniform or completely safe, the standard of ‘strict liability’ generally does not apply and is not part of South African law.

Criminal liability

Apart from the statutory offences created by the Human Tissue Act and the Regulations, blood transfusions may give rise to criminal liability for the common law crime of culpable homicide and perhaps even 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 – which entails the wrongful and negligent causing of the death of another person. A medical practitioner in South Africa (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, for example, play a critical role in enabling treatment to be undertaken in medical disciplines such as haematology and oncology. As outlined above, practitioners who order blood for their patients must be cognizant of their legal responsibilities with regard to the administration of blood.