The Commission of Inquiry on the Blood System in Canada (Krever Commission, 1997) recommended patient informed consent for the receipt of blood components and blood products derived from human plasma. Since then, the requirement for informed Consent for Blood and Blood Products has been incorporated into consent for treatment policies in hospitals across Canada.
Informed consent is a process undertaken jointly by a patient and a physician to make a therapeutic decision that allows the patient to preserve the primary decision-making role in determining a course of treatment. Information on informed consent can be found on the Canadian Blood Services – Informed Consent for Blood Transfusion page.
Additional Guidance Regarding Informed Consent for Plasma Protein and Related Products
The following is a suggested statement for physician use in obtaining Informed Consent for Plasma Protein and Related Products. The statement primarily addresses infectious disease risk, and may be utilized as a memo or aide for physicians who prescribe PPP's for their patients. If the intent is to utilize the statement for health authority or facility-specific patient pamphlets, we recommend facility review of the language level, and/or translation prior to publication.
"The product that you are about to receive is made from human plasma. The plasma is obtained from carefully selected donors and has been screened by sensitive tests capable of detecting a wide range of blood-borne infectious agents, including HIV, hepatitis B and hepatitis C. The plasma has also undergone additional manufacturing steps that effectively render this product extremely safe from risk of infection. There has not been a single case in Canada of transmission of HIV, hepatitis B, or hepatitis C caused by plasma protein products since modern manufacturing practices were introduced decades ago. The estimated risk of infection from various known blood-borne infectious agents ranges from less than one in a million to less than 1 to 10 million or even lower."
More information can be found in Chapter 7 - Fractionated Blood Products and Associated Pathogen Safety of the Canadian Blood Services - Clinical Guide to Transfusion.
