Informed Consent for Transfusion

Hospitals, regions and provinces have taken different approaches to the definition of a blood product for this purpose. Some hospitals have a process for informed consent for fresh and frozen products while others include fractionated blood products as well.

• Examples of hospital informed consent information/forms
• Other resources

The physician who is ordering the transfusion should explain the risks and benefits of transfusion with the patient. An explanation of the risk of not having the transfusion is an important element. Although controversial, some hospitals have included medications that use albumin as a stabilizer in this policy.

The Royal Commission of Inquiry into the Canadian Blood System (Krever) in its 1997 interim report (recommendations 26-29) describes the processes the treating physician should perform for informing the patient of the risks and benefits of transfusion prior to the transfusion of blood products.

Recommendations from an expert working group formed by the Canadian Medical Association (1997) regarding informed consent have also been published.

An expert working group convened by Health Canada to develop Standards for Blood Safety, and later, the technical committee for CSA Standard Z902-04, Blood and Blood Components, considered the following three themes:

The Informed Consent Process

Obtaining informed consent is the responsibility of the physician who orders the transfusion of blood components. Since this may be unknown in the pre-operative setting, a process should be developed by each hospital or region providing transfusion services. The informed consent process should include, but is not limited to, the following key components:

1. Identification of roles and responsibilities for obtaining informed consent.
2. A discussion with the patient that includes the following minimum components:
   -A description of the blood product
   -The risks and benefits of transfusion
   -Alternatives
3. Mechanisms for handling refusal of transfusion, including communication to the hospital transfusion service, if indicated.
4. Mechanisms for handling patients who are unable or incapable of providing informed consent.

Active participation of nursing education departments is essential for the process to be effective because of the ongoing education and communication required to provide informed consent.

Informing Transfusion Recipients

Many hospitals have implemented systems to notify transfusion recipients. This does not come without inherent challenges. Departments outside of the hospital transfusion service must be included in this process. These include medical records and admitting departments.

Factors impacting this process include:

• Up-to-date information on the patient address and admission data is necessary to ensure mail reaches the correct address/patient. In many hospitals there is a higher incidence of transient patients thus a greater challenge.
• To ensure that deceased individuals are not sent letters regarding transfusion history, ascertain that the patient was discharged living prior to sending letter.
• Chronic transfusion recipients and other outpatients groups are special circumstances because of the frequency of transfusion and hospital status. Should they get a letter annually or bi-annually?

All these must be considered when developing a process for patient notification. Regardless, computerization is key to whether this process is implemented in a timely manner. Hospitals that do not have transfusion service computer systems will find this process most challenging and costly.

Education on the Risks

Although the benefits of transfusion will vary and depend on the clinical situation, the risks of transfusion are quantifiable and should be available to physicians in an easily accessible form. When implementing informed consent programs, the information provided to physicians will need to be reviewed and updated periodically.

Other Resources

Note: Canadian Blood Services offers no endorsement of and assumes no liability for the currency, accuracy, or availability of any information on these sites.

1. Complications and Risks of Tranfusion by Blood Component, a reference table on risks associated with some common blood components.
2. British Columbia's PBCO Physician's Guide 2004 & Quick Reference Card: Blood and Blood Product Utilization 2004.
3. e-network Forum. Informed Consent for Transfusion of Blood Components and/or Plasma Derivatives. California Blood Bank Society.
4. Godolphin W, Towle A, McKendry R. Challenges in family practice related to informed and shared decision-making: a survey of preceptors of medical students. CMAJ 2001; 165 (4).
5. Kluge EW. Informed consent in a different key: physicians' practice profiles and the patient's right to know CMAJ 1999 160: 1321-1322.
6. Moloughney BW. Transmission and postexposure management of bloodborne virus infections in the health care setting: Where are we now? CMAJ 2001 165(4).
7. Pall Corporation. Blood Transfusion: Knowing your options. No date.
8. Robb N. Informed consent and blood transfusions. CMAJ 1996 154: 396-7.
9. The University of Michigan Hospitals & Health Centers. Transfusion Procedures (includes training and competency assessment for informed consent). 2004.
10. WatchTower: Official Website of Jehovah’s Witnesses. Medical Care and Blood. 2005.
11. Wolfish WG. Competency of Adolescents to Make Informed Decisions. CMAJ 2000 163 (11).