Informed Consent for Transfusion

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Informed Consent for Transfusion

• Blood Centers of California
• Board Meeting
• 9/29/14

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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

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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
  physicians 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.

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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

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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 patients interest in
  information does not extend to lengthy discourse
  of all possible complications.the patient is
  concerned with risks and deaththere is no
  providers duty to discuss the relatively minor
  risks inherent in common procedures.

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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

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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

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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
  Patients Guide to Blood Transfusion under the
  Paul Gann Act

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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
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Hospital Consent Variability
Practice 1 Three critical AABB elements are
found within the consent itself and then also
refer to the Patients Guide to Blood Transfusion
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Hospital Consent Variability
Practice 2 The consent includes the entire
contents of the Patients Guide to Blood
Transfusions. No additional information other
than what is in the Guide is provided. NOTE
The Patients 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
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Hospital Consent Variability
Practice 3 The consent refers to the providing
the Patients Guide to Blood Transfusions to
give the patient information regarding risks
alternatives. MORE COMMON PRACTICE The
Patients 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 Patients 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
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Considerations

• Current Patients 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 Patients
  Guide (plus updates)? If this consent is used, a
  separate informational brochure would not be
  required.

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Proposed Revisions to Patient Guide to Blood
Transfusions