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Susan Bator, M.D.

From Susan Bator, M.D., Medical Director, LGH Blood Bank
Changes to the blood consent form and process took effect July 6. A licensed provider (physician, PA or CRNP) is required to inform the patient of the risks and benefits of blood transfusion, obtain the consent and sign the consent form.  A provider’s signature is now needed on the consent form. 
Hopefully in the near future the consents will be electronic, but at this time a paper form is needed. The updated consent is one two-sided form: The front includes the approval for blood transfusion, and the back includes special consent for autologous or directed units only and a section for denial of permission (refusal) to transfuse. This form is available at nursing stations and in the ED.  We also will have forms available at physician offices.
The consent is needed for transfusion of red cells, platelets, plasma and cryoprecipitate.  The consent can be signed prior to admission in the Preoperative period and is good for 90 days.  The consent also could be obtained at time of admission or at the time of consenting the patient for surgery.
A signed consent does not mean you have to give blood or wait till you decide a transfusion is absolutely indicated.  It can be obtained for the possibility that blood might be needed for the hospitalization. In the case of a true emergency (i.e. trauma, GI bleed, ruptured aneurysm, OB hemorrhage) where there is no time to get consent, the consent is not required.  For outpatients receiving frequent transfusions (i.e. oncology setting or renal failure patients, among others) the consent is good for 6 months.  If the patient is admitted, however, we require the consent to be signed per admission.
Nursing can access information on blood transfusions from Health Wise, and a short informational sheet is available to patients in the hospital regarding blood transfusion benefits and risks. This can be given to the patient by nursing staff as an aid in the informed consent process. 
Physician/licensed provider must obtain the informed consent per JCAHO and Medicare.
Medicare law and blood consent requirements
“Section 504. Informed consent.
Duty of physicians except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures:
Administering a blood transfusion.
Consent is informed if the patient has been given a description of a procedure … and the risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure.”
Risks of transfusion (most included on consent form)
HIV: 1 in 1,900,000
HCV: 1 in 1,700,000
HBV: 1 in 330,000
HTLV1 (Human T cell lymphotrophic virus): 1 in approximately 3 million (not on form)
Allergic/urticarial: 1-3%
Febrile non hemolytic reactions: 0.1 to 1%
Acute hemolytic reactions: 1 in 76,000 and fatal in 1 in 1.8 million
Severe allergic/anaphylactic reactions: 1 in 20,000 to 50,000
TRALI (transfusion related acute lung injury): 1 in 1200 to 190,000
Circulatory overload: 1% (not on form)

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