A transfusion medicine physician in North Carolina reports that his hospital requires consent for transfusion (infusion) of all plasma-derived blood products and derivatives. However, this policy is up for debate by their Executive Committee. Consequently, the inquiring physician would like to know if other institutions require consent for plasma derivatives such as IVIG or clotting factor concentrates?

The following responses have been received.

ADDENDA May 14, 2003

1. A pathology resident in a training program in California reports that the issue of informed consent is much larger than whether or not to obtain consent for plasma derivatives. For example, she was recently performing a consultation in an operating room at an academic medical center hospital, and while she was in the operating room the surgeon was about to administer a blood product. The nurse reminded the surgeon that the patient was a Jehovah’s Witness, and that the patient would not be inclined to accept a blood transfusion. From this situation the resident concluded that if the surgeon had obtained consent from the patient about blood transfusion therapy, it might be possible that the surgeon would have realized the patient had a religious objection to transfusion therapy. However, it was not clear if the patient would reject blood derivatives, such as albumin, clotting factors, IVIG, etc. What came out of this experience is the realization that there is some confusion as to what blood products are acceptable versus unacceptable to individuals who have a personal objection to transfusion of blood products and/or related solutions.

ADDENDA May 15, 2003

2. Editor's NOTE: The following earlier e-network discussions might be germane to the current discussion:

• Informed Consent for Transfusion of Blood Components and/or Plasma Derivatives
• Does The Gann Act in California Require Informed Consent for Transfusion?
• More on Documenting Gann Act Consent
• Is an attending physician's countersignature required for transfusion consent forms?
• Overriding a patient's request to refuse transfusion

... and the Patient's Guide to Blood Transfusions (based on a document developed by the California Dept of Health Services, revised June 2006).

ADDENDA April 9, 2008

3. A colleague located at a healthcare system in Georgia would like to know if other hospitals currently obtain informed consent for IVIG and albumin? If so, how is the consent documented? Is a form used which is similar to that used to document consent for blood products, or is a different form used? The inquiring colleague acknowledges that her hospital does NOT obtain informed consent for IVIG, albumin, and other derivatives of human plasma or recombinant products such as rFVIIa, rFVIII and rFIX.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator