Informed Consent for Transfusion Blood Centers of California Board Meeting 9/29/14

History of Informed Consent Doctrine of informed consent has roots in the ideal of individual freedom A patient is free to say NO or YES without stating reasons The old standard of the medical practitoner using his/her best judgement to determine the care of patient has evolved into duty to inform patient of significant facts so that patient can decide In 1914: Judge Cardozo states “every human being of adult years and sound mind has a right to determine what shall be done to his own body”

History of Informed Consent In 1972, the CA Supreme Court, Cobbs v Grant Provided a seminal opinion defining modern informed consent: “as an integral part of the physician’s overall obligation to the patient there is a duty of reasonable disclosure of the available choices with respect to the proposed therapy and of the dangers inherently and potentially involved in each.

What makes an informed consent Consent is a Process The process that medical practitioners achieve informed consent is NOT just completion of a well crafted form. Informed consent is a process with a set of discussions, questions, response, and considerations Patient must have opportunity to ask questions Consent Requires Comprehension by the Patient Adults judged to be incompetent do not have the legal capacity to give consent. Consent may be procured by spouse or legally authorized rep Minors up to age of 17 are required to have a guardian who can engage in consent process (exceptions – emancipated minors) Consent May Be Revoked at Any Time Prospective Consent is Limited in Time and Scope Duration of consent should be specified to the patient

What makes and Informed Consent Contains Necessary Information The “Reasonable Patient Standard” (CA, NJ, NY, WA): Requires that doctors explain all medically reasonable courses of treatment and non-treatment options in a manner that a reasonable patient in the same or similar circumstances would require to make and informed choice. The “Simple Subjective Standard” (TX, HI, LO): Requires doctor to disclose “enough information” for the patient to make an informed decision. NOTE: No duty to disclose every detail. The duty is to disclose information and risks that a reasonably prudent patient would consider significant. Cobbs v Grant (CA): “the patient’s interest in information does not extend to lengthy discourse of all possible complications….the patient is concerned with risks and death…there is no provider’s duty to discuss the relatively minor risks inherent in common procedures.

What Makes an Informed Consent Contains Necessary Information, continued Explanation/Description of the Intervention Simple for the transfusion process Anticipated benefits Risks/Side Effects Alternatives Opportunity for questions/clarifications Availability of choices

Informed Consent for Blood Transfusion In 1991, AABB issued a memorandum with recommendations for transfusion informed consent. Recommendations were placed in standards in 2000. Standards for Blood Banks and Transfusion Services, 29th edition 5.28.1 Recipient Consent The blood bank or transfusion service medical director shall participate in the development of policies, processes, and procedures regarding recipient consent for transfusion 5.28.1.1 At a minimum, elements of consent shall include all of the following” A description of the risks, benefits, and treatment alternatives (including non-treatment) The opportunity to ask questions The right to accept or refuse transfusion 2006: AABB issued a guidance document Burch J, Uhl J for the Scientific Section Coordinating Committee. Guidelines for informed consent in transfusion medicine. Bethesda, MD: AABB, 2006 TJC and CAP also have requirements for informed consent for transfusion

Informed Consent for Blood Transfusion In 1991 it was still uncommon to obtain informed consent for transfusion in American Hospitals This changed in the next few years A survey in 2003: Separate consent documentation for transfusion was implemented up to 96% of hospitals In CA, there is a requirement to provide patient with standardized informational brochure: “A Patient’s Guide to Blood Transfusion” under the Paul Gann Act

Examples of Risks Associated with Transfusion Categories of Complication High Frequency Fever Urticaria Low Frequency Infection Mistransfusion Patient-specific Volume Overload Acute Lung Injury Hypersensitivity Theoretical/Controversial Immunomodulation CHIKV transmission

Hospital Consent Variability Practice #1: Three critical AABB elements are found within the consent itself and then also refer to the Patient’s Guide to Blood Transfusion

Hospital Consent Variability Practice #2: The consent includes the entire contents of the Patient’s Guide to Blood Transfusions. No additional information other than what is in the “Guide” is provided. NOTE: The Patient’s Guide to Blood Transfusions lacks information about non-infectious risks of transfusion which are much more common than the infectious disease risks that are included in the brochure

Hospital Consent Variability Practice #3: The consent refers to the providing the “Patient’s Guide to Blood Transfusions” to give the patient information regarding risks alternatives. MORE COMMON PRACTICE The Patient’s Guide to Blood Transfusions states that it cannot be considered a replacement for the Informed Consent process prior to blood transfusion. It can be used as a source of information. NOTE: The Patient’s Guide to Blood Transfusions lacks information about non-infectious risks of transfusion which are much more common than the infectious disease risks that are included in the brochure

Considerations Current Patient’s Guide to Blood Transfusion needs to be updated if it is being used as primary source of information in hospital consents In current state, it only includes infectious risks. Needs to also include non- infectious risk which can also cause significant morbidity and mortality. Needs a description of the treatment Benefits of the treatment Can a standardized universal consent be created which includes all information in the Patient’s Guide (plus updates)? If this consent is used, a separate informational brochure would not be required.

Proposed Revisions to Patient Guide to Blood Transfusions