Informed Consent for Blood Transfusion

Informed Consent for Blood Transfusion – February 23, 2023

The material presented here was initially developed by Christopher P. Stowell, MD, PhD, and

was reviewed and updated by the Association for the Advancement of Blood & Biotherapies

(AABB) Patient Blood Management Education Committee:

Alesia Kaplan, MD

Suzanne A. Arinsburg, DO

Kathleen E. Puca, MD, MT(ASCP)SBB

Emily Coberly, MD

Introduction and History

Although informed consent for medical procedures began evolving in the early decades of the

century, the idea of applying it to blood transfusion did not really begin developing until the

1980s when the transmission of infectious agents such as the human immunodeficiency virus and

hepatitis C virus alarmed patients and health-care providers alike. In 1986 and 1994, AABB

made recommendations to its members for obtaining informed consent from patients for blood

transfusion, which eventually became a standard in 2000.

Other accrediting agencies such as The Joint Commission, DNV (Det Norske Veritas), and the

College of American Pathologists have also established requirements related to informed

consent, and it is required by law in some jurisdictions in the United States (eg, California, New

Jersey, and Pennsylvania). During this period of time, obtaining informed consent for transfusion

went from being an uncommon practice to one that was followed by a majority of hospitals in

the United States. Although informed consent for transfusion is required or recommended in

other developed countries, its implementation is heterogeneous in practice.

The Basis of Informed Consent: Ethics

The concept and practice of informed consent lies in five fundamental principles of medical

ethics: autonomy, veracity, beneficence, non-maleficence, and justice.

• Autonomy is the principle that individuals have the right to determine the actions they

take and the choices they make. In the context of informed consent, it is their right to

determine what will be done to their bodies and is rooted in the concept of individual

freedom as well as the right to privacy.

• Veracity is the principle that interactions between care providers and patients must be

founded on truth telling. The care provider is obligated to convey information as

accurately as possible, and also must fulfill any “promises” to the patient in terms of care,

follow-through, and not withdrawing care without making alternate provisions.

• Beneficence is the principle that the health-care provider will strive to improve the well-

being of the patient, and will act in the best interest of the patient.

• Non-maleficence is the principle that the caregiver strives to avoid doing harm to patients

and seeks to protect them from pain and suffering.

• Justice is the principle that is based on the recognition of the equality of all persons who

should receive care in proportion to their need. In a financially constrained environment,

it means that limited resources should be allocated fairly.

Informed Consent for Blood Transfusion – February 23, 2023

Informed consent is driven largely by the first ethical principle of autonomy, the right of a person

to determine what course of medical action to pursue. However, veracity is also at the heart of

the information exchange, which makes it possible for a patient to make a truly “informed”

decision.

The Basis of Informed Consent: Informed Consent and the Law

The legal definition of informed consent is usually considered to have originated from a decision

by Judge Benjamin Cardozo in 1914 who wrote that “every human being of adult years and

sound mind has a right to determine what shall be done to his own body.”

The modern concept of informed consent was defined in a ruling in Cobbs vs. Grant by the

California Supreme Court in 1972. In this case the patient, who developed a number of

complications of gastric surgery, alleged that the physician had not disclosed to him in advance

the possibility of any of those adverse outcomes.

The ruling stated that “as an integral part of a physician’s overall obligation to the patient there is

a duty of reasonable disclosure of the available choices with respect to proposed therapy and of

the dangers inherently and potentially involved in each.”

The legal understanding of informed consent includes the following key points:

• Consent is a process of communication between a patient and a caregiver, which is

proportional to the magnitude of the health-care intervention and its inherent risks.

• The patient must be competent to make an informed decision. This implies that the

patient must be able to understand the information being provided and the consequences

of action (or inaction).

• Consent must be obtained prior to the intervention, except in certain extenuating

circumstances.

• Consent must be made voluntarily, free from pressure or coercion on the part of the

health-care provider or any third party.

• Consent is revocable. A patient may withdraw consent at any point.

Generally, informed consent is a matter of state law, so it is important to determine whether the

state in which you are practicing has informed statutes or whether specific state law has evolved.

Over time, medical practice and the body of case law has further refined the basic elements of

informed consent. These elements include:

• Information provided to the patient.

o Explanation of intervention.

o Benefits.

o Risks.

o Alternatives.

o Opportunity for questions/clarification.

• Availability of choices including refusal.

• Autonomous patient decision.

• Documentation of process.

Informed Consent for Blood Transfusion – February 23, 2023

The first of these elements consists of the information, which is provided to the patient by the

healthcare provider. This information should include an explanation of the intervention, the

anticipated benefits, the material risks, and the alternatives. Part of providing information is

ensuring that the patient understands it. To this end, the patient must be given the opportunity to

ask questions and seek clarification from a health-care professional capable of providing

answers.

The second element of the informed consent process is that the patient must have choices,

including that of declining the suggested therapy or choosing an alternative therapy, if available.

The third element is that the patient must be able to make an autonomous decision, which is

neither coerced nor unduly influenced by the health-care provider or a third party, to accept or

refuse the intervention, and is predicated on the competence of the patient.

Finally, the process must be documented.

The Process of Informed Consent: Informing the Patient – The Process of Disclosure

At the core of the consent process is the duty of the health-care provider making the decision to

transfuse to inform the patient. The process of providing the patient with information about the

intended intervention is called disclosure. Although the health-care provider making the decision

to transfuse is usually responsible for carrying out the process of informing the patient and

obtaining consent, this task may be delegated to a member of the health-care team who is

working on behalf of that health-care provider, such as a nurse practitioner or a medical resident.

The principle underlying disclosure is that patients must be provided with adequate information

about the transfusion so that they are able to make informed, independent decisions about what

they will permit to be done to their own bodies. The principles of veracity and autonomy

underlie the words “informed” and “independent decision.”

In the decades since the Cobbs vs. Grant decision, courts have moved in the direction of

applying a patient-oriented standard for what information should be disclosed which is based on

supplying information that could reasonably be expected to affect the decision made by a

competent patient to accept or reject a proposed medical intervention.

The Process of Informed Consent: Explanation of the Intervention

The first step in the process of disclosure is for the health-care provider to describe the

therapeutic or diagnostic intervention. In the case of transfusion, this description is relatively

straightforward, but may require some explanation of what the blood components are.

The health-care provider must explain to the patient the rationale behind the transfusion of blood

components, and what it may reasonably be expected to achieve. The nature of the anticipated

benefit, its magnitude, and the probability that it will be achieved may all affect the willingness

of the patient to assume risk.

This discussion is complicated by the fact that the indications for transfusion and its clinical

impact are not as well founded in evidence-based medicine as some other medical interventions.

Poor clinical outcomes have been shown to correlate with low hemoglobin levels, although

Informed Consent for Blood Transfusion – February 23, 2023

several randomized clinical trials of RBC transfusion have not shown any benefit of transfusing

patients to the higher of two target hemoglobin levels.

The data from randomized clinical trials demonstrating the benefits of transfusing other blood

components are also limited. With this caveat in mind, the health-care provider must convey to

the patient what the benefits may be for that particular patient. Transfusions are often

administered to alleviate symptoms, such as transfusing RBCs to an anemic patient with

dyspnea, or platelets to a thrombocytopenic patient with gastrointestinal tract bleeding.

Transfusions are also frequently used to prevent complications, such as RBCs to a patient with

coronary artery disease to prevent cardiac ischemia or platelets to a patient recovering from

chemotherapy to prevent spontaneous bleeding. The health-care provider must also communicate

to the patient how likely it is that the transfusion will accomplish the therapeutic goal.

The Process of Informed Consent: Material Risks

An important aspect of the informed consent process, and the one that has attracted the most

attention, is the disclosure of the risks of transfusion. The legal standard does not require the

description of every possible risk; however, the patient should be informed about those risks that

would be likely to affect the decision of a prudent person to accept the transfusion. These

“material” risks are ones that are likely to influence the decision of the patient to accept or reject

the intervention.

The risks of any medical intervention, including transfusion, may be organized in four

categories. These categories include:

• High-frequency complications (fever, urticaria).

• Low-frequency complications (HIV infection, mistransfusion).

• Patient-specific complications (volume overload, hypersensitivity).

• Hypothetical/controversial complications (immunomodulation, Creutzfeldt-Jakob

prion transmission).

The disclosure of common and patient-specific complications is relatively clear, but the

discussion of rare or hypothetical risks is considerably more difficult.

Despite the fact that the frequent complications of transfusion, such as febrile, non-hemolytic

transfusion reactions, do not cause significant morbidity, they should be disclosed simply

because of the high likelihood that they will occur. Although the possibility of experiencing

minor complications such as these are unlikely to dissuade a patient from transfusion, this

foreknowledge does help prepare a patient to deal with such a reaction with the understanding

that it is not dangerous, albeit uncomfortable.

The health-care provider should also discuss complications of transfusion to which the individual

patient may be particularly susceptible, for example, volume overload with associated dyspnea in

a patient with impaired cardiac or renal function.

The question of which of the uncommon or rare complications of transfusion should be disclosed

to patients is more difficult. In general, risks of a medical intervention that carry the possibility

of death, loss of a sensory function, paralysis, or mental impairment would be seen as significant

adverse outcomes that most patients would want to know about. The complications of

Informed Consent for Blood Transfusion – February 23, 2023

transfusion most frequently responsible for deaths are transfusion-associated circulatory overload

(TACO), transfusion-related acute lung injury (TRALI), acute hemolytic transfusion reactions,

and bacterial contamination, so these should be discussed as part of the disclosure process.

It is probably not necessary to list every rare, serious complication of transfusion, if only because

an overwhelming amount of frightening information can subvert the disclosure process by

impairing the ability of a person to register and understand any of the information being provided

to him or her, frightening or otherwise. The disclosure of these very uncommon adverse

outcomes is also complicated by the general difficulty of conveying information about the

frequency of rare events. Patients may find it difficult to interpret degree of risk when it is

expressed numerically, and especially when those numbers are very small.

One approach is to compare the frequency of the transfusion complication to the frequency of a

more familiar event such as coin tossing or a motor vehicle accident, or to another medical

intervention such as death due to reaction to anesthesia.

Another troublesome area concerns those risks that are hypothetical, or where the association

with transfusion is controversial. Recent examples in the transfusion medicine arena include

possible transmission of the Creutzfeldt-Jakob prion or infectious agents that are not endemic to

the US but may be carried by travelers, and a transient immunosuppression observed in

recipients after transfusion of allogeneic blood.

Although it could be argued from an ethical standpoint that such risks should be disclosed, the

intent of the informed consent process is to make it possible for the patient to make a rational

decision about a medical intervention, and this decision does not require perfect or exhaustive

knowledge. In addition, the legal requirement is to provide the patient with information about the

“material” risks of the procedure, not “all” or “all possible” risks.

The Process of Informed Consent: Risks -The Patient’s Perspective

The patient’s understanding of the risks of transfusion may not be entirely congruent with the

health-care provider’s perception and may also be grounded in a different perspective. Two

different cognitive systems may be used in assessing risk: assimilative perspective and

precautionary perspective.

The first cognitive system, the assimilative perspective, is based on the principle that a risk does

not exist if there is no proof of harm. This perspective bases decision-making on the assessment

of scientific and clinical data and relies on the rigor of the scientific method. However, even the

scientific approach may have blind spots if the relevant data are not collected or if the research

questions are not framed correctly. It also requires conscious, cognitive effort, and is a slow

process. The assimilative perspective generally informs the decision-making of health-care

providers.

However, risk assessment by patients as well as policy makers has generally relied heavily on the

precautionary perspective. This perspective is based on the principle that a risk exists unless

there is proof otherwise. It has the benefit of also avoiding risks that are unexpected because

scientific and clinical knowledge are inevitably incomplete. However, it often fails to weigh the

Informed Consent for Blood Transfusion – February 23, 2023

risks of not acting, discourages innovation, and has led to increased expenditure of resources for

minimal gains in pursuit of a “zero risk” blood supply. The precautionary approach is generally

based on an experiential cognitive model where the response to perceived risks is instinctive and

rapid.

In addition to the cognitive perspective, a number of other factors may affect a patient’s

perception of risk. There are four characteristics of a risk that may affect the way a patient

perceives and reacts to it: (1) frequency of the adverse outcome, (2) consequences of that

outcome, (3) the “dread” quality of those consequences, and (4) their imminence.

A patient’s perception of the frequency of an adverse outcome may also be influenced by his or

her awareness of its existence. A patient who has a relative or friend with HCV infection is likely

to overestimate the likelihood of obtaining such an infection via transfusion. High visibility of a

risk in the media can lead to the phenomenon of “social amplification” whereby the perceived

frequency of the risk is magnified in the mind of the patient. For example, the public is much

more concerned about being attacked by a shark, a very low probability event that is almost

always reported in the media, than a dog attack, which is far more common but rarely reported.

The consequences of the complication also affect a patient’s reaction to it, with serious outcomes

such as death, loss of a sensory function, paralysis, or mental impairment quite naturally

influencing the patient’s response. In addition, some adverse events are more feared or “dreaded”

than others. People may dread being attacked by killer bees or being infected with HIV through

transfusion but are not as fearful of motor vehicle accidents or transfusion-associated circulatory

overload.

Patients also tend to be more fearful of complications that occur shortly after the medical

intervention (ie, are more “imminent”) than they are of those that are significantly delayed. The

lack of “imminence” may account for the relatively measured reaction to transfusion-transmitted

HCV, for example.

The willingness of a patient to take on the risk of a medical intervention may also be affected by

other factors, among them the nature and magnitude of the anticipated benefit. Not surprisingly,

patients are willing to take on a greater degree of risk for what they consider to be a significant

benefit. Risks that are taken on voluntarily are also perceived to be lower, perhaps because the

patient feels a sense of control.

Patients are more likely to accept an adverse transfusion outcome that is familiar to them (eg,

fever, HCV infection) than one that is not (eg, hypersensitivity rash, Babesiosis). Finally, the

assessment of risk may be associated with certain demographic factors. For example, it has been

suggested that transfusions may be perceived as riskier by females, minorities, and persons with

lower income and education level. Factors affecting the understanding of risk are summarized in

Table 1.

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Table 1. Factors Affecting the Understanding of Risk

Category

Factor

Demographics

• Gender

• Socioeconomic status

• Minority status

• Educational level

Benefits

• Value of benefit to patient

• Magnitude of benefit

Likelihood

• Frequency

• Perceived frequency

• Familiarity

Nature

• Severity

• “Dread” quality

Control

• Voluntariness

• Shared

The Process of Informed Consent: Alternatives

Following a review of the proposed hemotherapy and its risks, the health-care provider should

discuss possible alternatives. One of the alternatives, of course, is for the patient to decline the

transfusion. This situation will be discussed in more detail in the last section.

There are numerous alternatives to transfusion that have been designed to stimulate endogenous

production of RBCs, neutrophils, and platelets (eg, cytokines) and to minimize the loss of blood

intraoperatively (eg, acute normovolemic hemodilution, blood recovery, and reinfusion) and

outside of the operating room (eg, minimizing blood draws for diagnostic and monitoring

purposes).

In discussing the various alternatives to component transfusion with the patient, the health-care

provider must bear in mind their suitability and availability. Preoperative strategies to avoid

transfusions include, but are not limited to, iron supplementation to correct iron deficiency

anemia; administration of erythropoietin; and review and modification of anti-platelet,

anticoagulation, and non-steroidal anti-inflammatory drug (NSAID) therapy. Perioperative

strategies to reduced blood loss include use of cell savers (capture of autologous blood during

surgery and reinfusion), laboratory-guided transfusion therapy, use of tranexamic acid, and

application of fibrin sealants (plasma-derived surgical hemostatic agents). Pre- and perioperative

management of a patient to avoid allogeneic transfusions should occur on an individual basis. It

is based on suitability and resource availability at an individual health-care facility.

The Process of Informed Consent: Communication and the Process of Informed Consent

At its core, informed consent is a process of communication between the health-care provider

and the patient. Although the preceding sections have dwelt on the obligation of the health-care

provider to disclose information, the process must also provide the opportunity for the patient to

ask questions and communicate to the health-care provider his or her desires, goals, fears, and

Informed Consent for Blood Transfusion – February 23, 2023

preferences. Communication between patient and health-care provider is vital to this process;

however, it is sobering to realize how little patients recall of these interchanges or of the

information that was conveyed during the process of obtaining informed consent for transfusion.

Results from two surveys found that while 71-80% of consented transfusion recipients

remembered the conversation with a health-care provider for a blood transfusion, only 23-56%

indicated recollection of specific transfusion risks, and far less, only 12% of patients, had recall

of alternatives to blood.

5,6

A lot of factors can affect a patient’s cognitive ability to understand

informed consent. For example, pain can impact a patient’s cognition and it precludes a provider

from obtaining a valid informed consent. The elderly patient population is also vulnerable due to

age-related decreased physical abilities (hearing and vision loss) and a higher prevalence of

impaired cognitive abilities that occur with age. More research should be done in this area to

enhance comprehension of informed consent by these vulnerable patient populations.

7-12

A number of factors may affect our ability to communicate successfully with patients in this

setting (Table 2).

Table 2. Communication Obstacles between Patient and a Health-Care Provider during

Informed Consent

Communication Obstacles

Linguistic Factors

• Medical/technical language

• Education/social group

• Language

Vulnerable patient population (uncontrolled pain, elderly)

Cultural barriers

Atmosphere

Confidentiality

Translation of Medical and Technical Information: The first communication barrier to overcome

is the translation of medical and technical information into language that can be understood by

people who do not have much background in medicine or biology. This is further complicated by

the low level of health-care provider knowledge of basic aspects of transfusion medicine, or even

a clear understanding of the elements of informed consent.

Education and Socioeconomic Status: Differences in education and socioeconomic status

between the health-care provider and patient may also be an obstacle to communication. A

survey of transfusion informed consent forms found that on average they were written at the

junior college level, which is attained by only 26% of people in the US.

3,7-10

Speaking Different Languages: The third communication barrier is imposed when the health-care

provider and patient speak different languages. Even though family members and friends can

accompany the patient during a healthcare visit and act as interpreters, most health-care facilities

provide language services that include qualified sign and spoken language interpreters, over-the-

phone interpretation services, and written information in the patient’s preferred language. This

Informed Consent for Blood Transfusion – February 23, 2023

allows for better understanding of disease information, prognosis, risk, and treatment, and leads

to improved decision-making ability of patients regarding their health. Overall, a qualified

interpreter allows for more accurate and unbiased communication between the healthcare

provider and the patient without sacrificing patient confidentiality. Bilingual health-care workers

who are proficient in non-English languages also can communicate with the patient without an

interpreter.

Cultural factors may also compromise communication between health-care provider and patient,

especially if certain topics, such as pregnancy, a diagnosis of cancer, or death, are regarded as

awkward, if not taboo.

The Process of Informed Consent: Consent Must Be Voluntary

The principle of autonomy demands that the patient must not be coerced into accepting (or

rejecting) therapy by the clinical situation, the health-care provider, or a third party, such as a

family member. An effort should be made to give patients the time and unpressured environment

to make measured assessments of the benefits, risks, and alternatives of the proposed transfusion,

and to make independent decisions.

Although health-care providers should be clear about why they are recommending transfusions,

they should avoid over-optimistic assessment of its benefits, or overly dramatic portrayal of the

risks of the alternatives, including no transfusion. In fact, overly enthusiastic advocacy has been

shown, at least in the research setting, to increase the likelihood of refusal of consent. A patient

may also be influenced by the way in which the information presented to him or her is framed.

Information framed as a gain (out of every 100 patients, 99 will do well) as opposed to a loss

(out of every 100 patients, 1 will do poorly) is more likely to be perceived positively, even

though the described risks are identical.

Finally, the health-care provider should be aware of the possibility that the patient’s decision

may be influenced by the presence of third parties, such as family members, friends, or spiritual

advisors. If third parties have been involved in the discussion, then the health-care provider

should attempt to have a private conversation with the patient to confirm that the decision truly

represents the wishes of the patient.

Administrative Aspects of Informed Consent: Who May Give Consent

Informed consent is predicated on the competence of the patient. Competence in this context

means that the patient can understand what a transfusion is; the information disclosed about

benefits, risks, and alternatives; and is capable of making a decision about how to proceed. If an

adult patient is incompetent, even temporarily (eg, unconscious, heavily sedated), then consent

may be obtained from a guardian, health-care proxy, or next of kin. The surrogate decision

maker must conform to the ethical standard of substituted judgment, which requires that

decisions must be made with the best interests of the patient in mind, and that would best reflect

the patient’s own wishes.

It is important to understand that if the healthcare professional identifies that the patient has an

impaired capacity in decision making, the patient’s decision making could be impaired regarding

Informed Consent for Blood Transfusion – February 23, 2023

a specific type of decision and not to all types of decisions (eg, understanding the disease and the

need for surgery but not understanding the need for blood products). It is crucial for a health-care

provider to know when to involve a surrogate decision maker in those cases. This process has

been described as a sliding-scale share decision making for patient with reduced capacity.

12,14

Although consent must be obtained from a parent or legal guardian to perform any medical

procedure on a minor child, there is increasing recognition of the ability of children to participate

in a meaningful way in medical decision making, which has led to increasing recognition of the

role of obtaining a child’s assent to treatment. The assent of a minor who is old enough to

understand the procedure is often obtained. The situation for adolescents has become somewhat

more complex. Although adolescents are generally considered to be minors for legal purposes,

some jurisdictions recognize the concept of the mature minor (Table 3).

The courts have also recognized the status of the “emancipated” minor who may consent to

medical procedures on the same basis as competent adults (Table 3).

Table 3. Obtaining a Child’s Assent and Consent to Treatment

Term

Explanation of term

The assent of the minor who is old enough to

understand the procedure is often obtained.

The minor can participate in assent to

treatment, although consent must be obtained

from a parent or legal guardian.

Adolescents are generally considered to be

minors for legal purposes; however, some

jurisdictions recognize the concept of the

mature minor.

A mature minor is an adolescent (usually)

who is capable of understanding the medical

information disclosed, able to make

reasonable judgments, and independent

enough to make decisions that represent his or

her own wishes.

The courts have also recognized the status of

the “emancipated” minor who may consent

to medical procedures on the same basis as

competent adults.

Minors are considered to be “emancipated” if

they are married, in the armed forces, or live

independently, managing their own finances.

Administrative Aspects of Informed Consent: Timing

Consent must be obtained prospectively, except in the setting of a true medical emergency.

Ideally, the process of disclosure and obtaining consent should be done sufficiently in advance of

the transfusion to allow patients the time to reflect on their decisions and request additional

information, if needed. Note that some of the alternatives to transfusion may require substantial

lead-time to be effective (eg, iron replacement therapy, erythropoietin).

In the setting of a medical emergency, it may be impossible to obtain consent prospectively, or

doing so would interfere with good patient care. As is the case with any other emergency

medical treatment, transfusion may be carried out without first obtaining consent for patients

who may be put at risk of death or serious morbidity by the failure to act. Once the clinical

situation has stabilized, it is good practice to explain what emergency steps, including

Informed Consent for Blood Transfusion – February 23, 2023

transfusion, were taken and why, and obtain the patient’s agreement that the interventions were

warranted.

Administrative Aspects of Informed Consent: Frequency

As a general rule, the informed consent process must be carried out for each medical

intervention. In the context of transfusion, the definition of medical intervention is not so clear.

For example, medical intervention could be considered to be a plan to which a patient with a

myelodysplastic syndrome has consented for a series of RBC transfusions aimed at maintaining

the hemoglobin level at a specific target.

A medical intervention may be considered to be all of the transfusions given to a patient during

an admission for a surgical procedure. It could also be argued that each transfusion represents an

independent medical decision in which the patient should be a partner, and therefore the

informed consent process should be repeated.

Since there are no universally accepted standards, each institution must develop a policy for

handling consent for repeated procedures in conjunction with counsel and considering local

precedent. If consents covering multiple transfusions are permitted, then some limits should be

imposed as to the number of events, or the period of time over which the consent is operative.

Note that the consent process must be repeated if there are any material changes to the

information that was initially disclosed to the patient, including changes to any patient-specific

risks, even if institutional policy allows for a documented informed consent process on one

occasion to cover multiple events.

It is also good medical practice to obtain the patient’s approval prior to administering each

transfusion, even if the patient has consented to undergoing multiple procedures. Patients have

the right to revoke their consent at any time, in which case any transfusions in progress must be

terminated immediately.

Administrative Aspects of Informed Consent: Products and Requiring Consent

When patients are admitted to a hospital, they usually sign a general “consent to treat,” which

covers many diagnostic and therapeutic interventions. Interventions with the potential for

significant morbidity or mortality require the specific informed consent of the patient, however.

Most hospitals develop policies, specifying which interventions require documented informed

consent (eg, central line placement, most surgical procedures, most endoscopy procedures). This

list includes transfusion of blood components and transplantation of tissues and organs. Blood

components, tissue and organs are biologically complex and vulnerable to contamination with

infectious agents, and thus may carry significant risk.

The risk of infectious disease transmission is much lower for recombinant clotting factors

concentrates as well as highly processed plasma derivatives and tissues, so practices regarding

consent for their use are not uniform (Table 4).

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Table 4. Hemotherapies and Tissues Requiring Informed Consent

Hemotherapy

Consent Required

Consent Variable

Products

Blood components

• Whole blood derived: RBC, plasma,

platelets, cryoprecipitate

• Apheresis derived: RBC, platelets,

plasma

Plasma-derived proteins: albumin, IVIG,

RhIG, hyperimmune globulins, PCC, FVII,

FIX, ATIII

Recombinant proteins: FVIII, FIX, FVII,

erythropoietin, GCSF, GMCSF

Highly processed tissue-bone plugs

Procedures

Patient-donor: cellular therapy product

collection PABD

Therapeutic phlebotomy

Therapeutic apheresis

Acute normovolemic hemodilution

Intraoperative blood recovery and

reinfusion

Postoperative blood recovery and reinfusion

RBC, red blood cells; PABD, preoperative autologous blood donation; IVIG, intravenous

immunoglobulin; RhIG, Rh immunoglobulin; PCC, prothrombin complex concentrate; FVII,

factor VII; FVIII, factor VIII; FVIX, factor IX; ATIII, antithrombin III; GCSF, granulocyte cell

stimulation factor; GMCSF, granulocyte/macrophage cell stimulating factor.

Administrative Aspects of Informed Consent: Documentation

The process of obtaining informed consent for transfusion must be documented in the patient’s

medical record. Informed consent is not this document, however; rather, it is the entire process of

engaging in a meaningful dialogue with the patient. The document merely attests to the fact that

the process was carried out.

At a minimum, this document should note that:

• The procedure was explained.

• The benefits, risks, and alternatives, including refusing therapy, were discussed.

• An opportunity for questions was provided, and the patient’s questions, if any, were

answered.

• The patient consented (or not) to the procedure.

• The patient and the healthcare provider making the disclosure signed the document.

Some institutions also require notation of the specific risks, benefits, and/or alternatives

discussed, in addition to the minimum information listed above.

There are different ways in which this documentation can be accomplished. A hand-written note

in the patient’s chart is adequate, assuming it covers the elements listed above, although many

institutions use some sort of form, which can be designed to prompt the health-care provider who

is obtaining consent for the essential elements. Forms specifically designed for transfusion may

be used. Alternatively, the consent for transfusion may be incorporated into the consent form

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used for surgery or other invasive procedures. Some institutions use forms with detailed

information about the risks, benefits, alternatives, etc., but others use forms that are quite

generic.

The decision as to what type of form to use generally reflects the preference of counsel at each

institution. Risks of transfusion that are specific to the patient (eg, risk of transfusion-associated

circulatory overload in a patient with existing congestive heart failure) should be captured in the

notes in the chart or on the form.

Increasingly, documentation of informed consent for transfusion will exist in the patient’s

electronic medical record, which has the advantage of making it readily available to anyone

involved in the care of the patient.

Informed Consent for Patients: The Duty of the Institution

Each institution has a duty to its patients to have systems in place for obtaining and documenting

informed consent for transfusion. The medical director of the hospital transfusion service is

required by both AABB and the College of American Pathologists to play a role in developing

and implementing these procedures.

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

The policies and procedures developed to ensure that a process of informed consent is carried out

prior to transfusion should specify at a minimum:

• Which products or procedures require informed consent.

• Who may carry out and document the informed consent process (eg, physicians,

nurse practitioners).

• Who may give informed consent (eg, the issue of minors, incompetent adults).

• When informed consent must be obtained (ie, frequency, duration, procedure-

related).

• What information should be conveyed to the patient.

• How informed consent will be documented.

• How staff will be trained and continued competence assured.

• How compliance with the policy will be assessed.

• How emergency situations will be handled (waiver of consent).

• How refusal of care will be handled and documented.

Refusal of Consent: Jehovah’s Witnesses and Other Patients

Informed Consent for Blood Transfusion – February 23, 2023

As described earlier, informed consent is based on the ethical and legal principles of autonomy

and the right of a competent patient to determine what medical interventions he or she will

accept.

These rights include that of refusing a recommended medical intervention, even one that is

potentially life-saving. The right to refuse treatment has been consistently upheld by a body of

case law and judicial decisions in the United States as well as abroad.

It is the obligation of the health-care provider to respect the patient’s autonomy and honor the

decision however difficult it may be for a health-care provider who does not share the patient’s

belief system, and particularly when the consequences of refusal could be death or permanent

injury.

The Approach to the Patient Who Refuses Therapy: Disclosure and Choice

As a very first step, it should be determined whether or not the individual health-care provider or

the institution is equipped to care for patients who refuse transfusion and other hemotherapies.

If not, and if the situation does not call for emergent care, then arrangements should be made to

transfer care to health-care providers who are prepared to handle these patients. Meanwhile, the

health-care provider is obligated to care for the patient according to his or her wishes and may

not “abandon” the patient, which would be unethical and illegal.

In an elective situation, the approach to the patient who may refuse transfusion is similar to the

approach for any patient and includes a description of the planned transfusion and its rationale,

and the disclosure of the risks, benefits, and alternatives.

The blood components proscribed for Jehovah’s Witnesses include: red cells, leukocytes,

platelets, and plasma. Note that a few other religious groups proscribe blood transfusion, and

patients refuse transfusions for other reasons as well. Assumptions should not be made about

which hemotherapies a patient will or will not accept, but rather the options should be reviewed

for each patient. The consequences of refusing transfusion should also be explained carefully,

especially if there is a chance of a very serious adverse outcome, such as death, loss of a limb or

sensory function, or mental impairment. The patient should also understand the possible benefits

of the hemotherapy that would be given up. It is important that the patient states explicitly a

willingness to incur these serious consequences, including death, loss of limb, etc., rather than to

receive a transfusion. For patients refusing transfusion, the discussion of possible alternatives

assumes special importance. It should be explicitly explained to the patient which of the

alternatives are both available and suitable for the circumstances that the patient would accept.

Documentation of Refusal

Once a plan specifying which therapies the patient will accept and which will be refused has

been agreed to by the patient and care providers, it should be made a part of the medical record

and available to those health-care providers who will be participating in the care of the patient.

Paradoxically, it is useful to inform the blood bank about patients who are refusing transfusion

since it is well positioned to prevent inadvertent transfusion.

Informed Consent for Blood Transfusion – February 23, 2023

At a minimum, a “refusal of care” document must state that the consequences of declining care

were explained to the patient, alternatives were discussed, and that the patient is willing to accept

these consequences, including death, rather than accept transfusion. Both the responsible health-

care provider and the patient should sign the document. The refusal of care may be documented

by a note written into the medical record or a form.

Many Jehovah’s Witnesses have either executed advance medical directives specifying their

wish to refuse transfusions or carry with them a form provided by the Jehovah’s Witness church.

It is also a good practice to make a copy of this document as a part of the patient’s medical

record.

Table 5 lists some accepted and not accepted hemotherapies for Jehovah’s Witnesses.

Table 5. Hemotherapies Acceptable and Not Acceptable to Jehovah’s Witnesses.

Unacceptable

Treatments

Personal Decision

Acceptable Treatments

• Whole blood

• Red blood cells

• White blood cells

• Platelets

• Plasma

• Preoperative

autologous blood

donation

• Intraoperative or postoperative

blood recovery and reinfusion

• Acute normovolemic hemodilution

• Intraoperative autologous blood

component preparation

✓ Plateletpheresis

✓ Fibrin gel

✓ Platelet gel

• Cardiopulmonary bypass

• Apheresis

• Dialysis

• Plasma derivatives

✓ Cryoprecipitate

✓ Albumin

✓ Clotting factor

concentrates

✓ Immune globulins

✓ Vaccines

✓ Fibrin glue

• Epidural blood patch

• Cellular therapy products

• Solid organ transplantation

• Intraoperative conservation

techniques

✓ Controlled hypotension

✓ Anatomic dissection

✓ Hemostatic surgical tools

✓ Meticulous surgical

hemostasis

✓ Regional anesthesia

✓ Minimally invasive surgery

✓ Topical hemostatic agents

• Phlebotomy

• Angiography

• Pharmacologic hemostatic agents

✓ Desmopressin

✓ Tranexamic acid

✓ c-Aminocaproic acid

✓ Aprotinin

✓ Recombinant clotting

factor concentrates (VII,

VIII, IX)

• Recombinant hematopoietic

growth factors (albumin free)

✓ Erythropoietin

✓ GCSF

✓ GMCSF

• Perfluorocarbon based oxygen

carriers

• Non-blood volume expanders

Informed Consent for Blood Transfusion – February 23, 2023

✓ Crystalloid solutions

✓ Hydroxyethyl starch

GCSF, granulocyte cell stimulation factor; GMCSF, granulocyte/macrophage cell-stimulating

factor.

Refusal of Care in Emergencies

Emergency situations, especially those involving significant blood loss, raise special concerns in

Refusal of Care situations where the opportunity to explore the patient’s wishes is minimal.

There are several situations in which the patient’s wish to refuse transfusion must be honored,

namely:

• The patient is competent, conscious, and refuses transfusion (with or without a signed

refusal document).

• The patient is incompetent temporarily (eg, unconscious, sedated, in extreme pain) or

is incompetent chronically but:

o There is some sort of documentation of refusal in the medical record (eg,

refusal of care document, advance directive).

o The patient is carrying an advance directive or a form provided by the

Jehovah’s Witnesses (with valid signatures), or such a form is provided by a

third party (eg, family member, church member).

o There is documentation (eg, notation in the medical record) that the patient is

a Jehovah’s Witness, or member of another religions group that forbids

transfusion.

o The patient previously expressed orally the wish to refuse transfusion to

someone involved in the emergency care of the patient.

o The patient’s refusal is communicated by next-of-kin, health-care proxy, or

guardian (if chronically incompetent).

If the medical team providing emergency care is unaware that the patient is a Jehovah’s Witness

or if none of the above conditions are met, then transfusions given for standard indications do not

constitute battery.

Who May Refuse Care

Patients who are considered to be competent to consent for medical care including transfusion

may also refuse therapy, even if death or injury are likely to ensue. However, in situations where

the patient is not competent to consent to or refuse care, and third parties make these

determinations, conflicts may arise.

The Incompetent Adult

A guardian or health-care proxy for a permanently or temporarily incompetent adult may refuse

transfusions, including those that might be life-saving, if there is reasonable evidence that, when

competent, the patient expressed a desire to refuse transfusions, even at the cost of life. These

circumstances are clear if the patient executed an advance medical directive or was an active

member of the Jehovah’s Witness church, as described above. The situation is more difficult if

Informed Consent for Blood Transfusion – February 23, 2023

the beliefs of the patient while competent are not clear or were not expressed directly to the

substitute decision maker. Under these circumstances, the courts have usually ruled that the

interest of the State in sustaining life and protecting the well-being of the patient outweighs the

authority of the substitute decision maker to refuse care, which might result in permanent harm

to the incompetent patient.

Competent Adults with Dependents

Conflicts have also arisen in situations where the death of a competent adult due to refusal of

transfusion would leave minor children without parents and means of support. In some cases,

competent adults with minor dependents have been required by the courts to undergo life-

sustaining treatments including transfusion. These cases pit the adult’s rights of free speech and

practice of religion against the interests of the State in providing for the well-being of the

children by preventing the loss of a parent as well as preventing them from becoming wards of

the state. In other cases, parents have been permitted to refuse therapy if they could demonstrate

that their dependent children would be adequately provided for in the event of their demise.

More recently, however, courts have been ruling that the right of the parent to make an

autonomous determination about refusing therapy overrides the interest of the State in preserving

the well-being of the dependents.

Pregnant Women

Conflicts may also arise where refusal of care by a pregnant woman may endanger the life of her

fetus, especially if the pregnancy has progressed to the point when the fetus would likely be

viable if born at that point, usually by the third trimester. Courts have frequently ordered

transfusion and other therapies to preserve the life of the mother and thus that of the fetus, based

on the interest of the State in protecting the lives of the unborn until such time as they can make

medical decisions for themselves.

Minors

The situation in which parents have wished to refuse life-saving therapy for children on religious

grounds has also created difficulties for health-care providers. In general, however, case law has

established that parents do not have life or death authority over their children and do not have

absolute rights to refuse treatment for religious (or other) reasons for their minor children. The

parental right to accept or refuse medical care on behalf of the child is outweighed by the

interests of the State in preserving life, and in particular ensuring the survival of the child to the

point when he or she is competent to make health-care decisions independently.

Minors in general may neither consent to, nor refuse, medical therapy, especially if it is intended

to prevent serious injury or death. The situation with respect to mature minors is particularly

fraught with difficulty, and legal decisions involving adolescents refusing transfusion for

religious reasons have been inconsistent. Hence, it is important to consult hospital counsel.

Emancipated minors are considered to be equivalent to competent adults for the purposes of

consenting to or refusing therapy.

Hospitals that do not have the expertise or infrastructure to care for patients who refuse

transfusion should at least develop a process for referring the patients to appropriately equipped

facilities. Institutions that do plan to manage patients who refuse transfusion should develop and

Informed Consent for Blood Transfusion – February 23, 2023

implement suitable policies and procedures that assure high quality care that is consistent with

the beliefs and wishes of these patients.

Conclusion

The processes of medical decision-making and informed consent have become irrevocably

intertwined as patients increasingly expect that they will be well informed and participate

actively in the decision to undergo any medical intervention. These expectations also exist for

blood transfusions and other hemotherapies that carry risks of adverse outcomes and are still

shadowed by memories of the discovery of HIV and HCV transmission by transfusion. The

existence of both these tangible risks and a patient’s perception of risk make it even more

appropriate to carry out the process of informing the patient and obtaining consent. This process

may be therapeutic as well by contributing to the patient’s understanding of these risks as well as

through the sense of control that making an informed and deliberate choice can foster.

Bibliography

1. Stowell, Christopher P. Sazama K. Informed consent in blood transfusion and cellular

therapies: Patients, donors, and research subjects. Bethesda, MD: AABB Press, 2007.

2. Holland PV. Consent for transfusion: Is it informed? Transfus Med Rev 1997;11(4):274-

85.

3. Friedman M, Arja W, Batra R, et al. Informed consent for blood transfusion: What do

medicine residents tell? What do patients understand? Am J Clin Pathol 2012;138(4):559-

65.

4. Nuttall GA, Brost BC, Connis RT, et al. Practice guidelines for perioperative blood

transfusion and adjuvant therapies. Anesthesiology 2006;105(1):198-208. [Available from

https://pubs.asahq.org/anesthesiology/article/105/1/198/9387/Practice-Guidelines-for-

Perioperative-Blood (accessed December 22, 2022).]

5. Cheung D, Lieberman L, Lin Y, Callum J. Consent for blood transfusion: Do patients

understand the risks and benefits? Transfus Med 2014;24(5):269-73.

6. Court EL, Robinson JA, Hocken DB. Informed consent and patient understanding of

blood transfusion. Transfus Med 2011;21(3):183-9.

7. Hopper KD, TenHave TR, Tully DA, Hall TE. The readability of currently used

surgical/procedure consent forms in the United States. Surgery 1998;123(5):496-503.

8. Hopper KD, TenHave TR, Hartzel J. Informed consent forms for clinical and research

imaging procedures: How much do patients understand? Am J Roentgenol

1995;164(2):493-6.

9. Eltorai AEM, Naqvi SS, Ghanian S, et al. Readability of invasive procedure consent

forms. Clin Transl Sci. 2015;8(6):830-3.

10. Glaser J, Nouri S, Fernandez A, et al. Interventions to improve patient comprehension in

informed consent for medical and surgical procedures: An updated systematic review.

Med Decis Mak 2020;40(2):119-43. [Available from

http://journals.sagepub.com/doi/10.1177/0272989X19896348 (accessed December 22,

2022).]

11. Aja B. The effects of pain on informed consent. Nurse Anesthesia Capstones 2017.

[Available from http://dune.une.edu/na_capstones/10 (accessed December 22, 2022).]

Informed Consent for Blood Transfusion – February 23, 2023

12. Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older

adults: A structured literature review of empirical research. J Am Geriatr Soc

1998;46(4):517-24. [Available from https://onlinelibrary.wiley.com/doi/10.1111/j.1532-

5415.1998.tb02477.x (accessed December 22, 2022).]

13. Breen LM. What should I do if my patient does not speak English? JAMA

1999;282(9):819.

14. Lahey T, Elwyn G. Sliding-scale shared decision making for patients with reduced

capacity. AMA J Ethics 2020;22(5):E358-364. [Available from:

https://journalofethics.ama-assn.org/article/sliding-scale-shared-decision-making-patients-

reduced-capacity/2020-05 (accessed December 22, 2022).]