Guidelines for red blood cell and plasma transfusion for adults and children
Issues related to informed consent
The following is a general discussion of issues related to informed consent. For a more complete discussion, physicians are referred to Consent: A Guide for Canadian Physicians.8
What is informed consent?
Informed consent is undertaken by a patient and a physician to make a therapeutic decision; it allows the patient to preserve his or her primary role in making the decision to undergo a treatment or procedure.812 As part of this process the physician must conform to a standard of disclosure about the risks and benefits of a particular therapy or procedure:13 to disclose information that the physician knows or ought to know and a reasonable person in the patient's position would wish to know before making the decision.
When possible, discussions about transfusion should take place early enough to allow time to procure feasible alternatives such as autologous transfusion.14 The language should be easily understood by the patient; a preprinted patient information sheet may be helpful but cannot supplant discussion. The discussion must include: description of the blood product or component to be transfused; the expected benefits, including possible consequences if transfusion is not given; the associated risks, including life-threatening risks; and appropriate alternatives. The patient must be given an opportunity to ask questions and the physician must ensure that the patient understands the explanation. Confirmation that the consent discussion has taken place is best noted in the patient's (hospital) chart. Signing a separate consent form for blood transfusion is of no particular advantage and cannot replace the discussion that must occur.15
Transfusion of blood products raises myriad ethical issues including: access to resources; access to alternative treatments; social, psychological, physical and emotional well-being of the patient; differing perceptions of risk; and potential conflicts of opinion and belief between the physician and the patient. The physician should be aware of these issues and the diverse cultural differences and beliefs in our society and act accordingly. A blood transfusion is often only part of a larger medical or surgical intervention, and the risks of the transfusion may be small compared with the total risk associated with the intervention. During the consent discussion, it may be appropriate that the emphasis placed on the various risks (i.e., that of the blood transfusion) reflect their relative magnitude in the whole process.
Special considerations: emergencies, children and incompetent adults
Emergencies
Physicians may treat a patient without consent when the treatment is necessary to preserve a patient's life or health and
- it is not possible to obtain consent because the patient is not mentally or physically capable of giving consent (either inherently or due to his or her medical condition);
- no substitute decision-maker is available;
- there is no evidence of advance directives.10,12
This also applies to emergencies involving children if their parents or guardians cannot be reached. If consent to treatment is refused, no treatment may be given, but the physician should ensure that the patient is competent to refuse treatment.
Children and adolescents
The responsibility for making decisions on behalf of a minor normally rests with the parents or legal guardians. In the case of divorced parents, decision-making power rests with the parent who has legal custody. Decisions should be based on the best interests or welfare of the child rather than those of the parents. Canadian courts have not permitted parents to refuse life-saving transfusions (or any other life-saving treatment) for their children on religious grounds.12 If a physician believes that refusal of a transfusion might endanger the child's life or health, and discussions with the parents or guardians fail to alter the decision, the physician is generally obliged, under provincial child protection laws, to notify and seek assistance from the appropriate authorities.
Generally, minors may consent to or refuse medical treatment if they are competent and capable of appreciating the full nature and consequences of the treatment or refusal of treatment. Although determination of capacity of a minor is the responsibility of the physician, the physician must be aware that provincial legislation may establish presumptive ages of capacity and specific conditions under which parents, guardians or child protection agencies must be notified.16 In most provinces, child protection legislation requires that physicians notify authorities if, for example, they feel a child's life, health or safety is in danger. Some statutes make such reports mandatory for minors who are under a certain age even if the minor would otherwise be sufficiently mature to consent to or refuse treatment.
Incompetent adults
For adults who have never been competent, decisions must be in the patient's best interest. For adults who were once competent but have become temporarily or permanently incompetent, their prior wishes regarding treatment, to the extent that these are known or can be determined, should be respected. Some jurisdictions have passed legislation that provides for substitute consent and prior treatment directions (advance directives) and physicians should be aware of the provisions within their own jurisdiction. The provincial medical colleges and the Canadian Medical Protective Association are useful resources in these matters.
Informing transfusion recipients
Whenever possible, patients (or their guardians) should be informed that they have received a red blood cell or plasma transfusion. Providing this information respects the patient's autonomy and encourages more individual responsibility for health care.
Refusal of transfusion
A competent adult is entitled to refuse or cease any treatment for any reason. Refusal occurs most often among Jehovah's Witnesses, whose religion precludes receipt of blood products. The refusal is valid under any circumstances, even when it will result in the patient's death. Note that this does not apply to children (see Children and adolescents, above). The physician should ensure and, if possible, record that the patient's refusal is fully informed and that the patient is aware of the consequences of his or her decision. Exploration of issues such as depression, which may affect the patient's capacity and choice, should be undertaken. Although the physician who properly advises the patient is not liable for the consequences of a refusal,12 physicians are advised to seek second opinions and legal advice if the refusal is likely to lead to serious morbidity or death.
Recommendations regarding informed consent
- Patients should be informed that transfusion of red blood cells, plasma or both is a possible element of the planned medical or surgical intervention and provided with information about the risks, benefits and available alternatives.
Level of evidence: N/A
- When feasible, the patient's consent to a transfusion of red blood cells, plasma or both should be obtained and recorded in the patient's medical chart.
Level of evidence: N/A
- The physician overseeing the care of the patient should be responsible for obtaining informed consent for red blood cell or plasma administration.
Level of evidence: N/A
- Patients should be informed that they have received a red blood cell or plasma transfusion subsequent to its administration.
Level of evidence: N/A
