Informed Consent and Explanation of Blood Options

One of the most important and difficult areas in clinical transfusion medicine is the question of informed choice [consent] for blood transfusion and an adequate explanation to potential blood recipients of blood options (All Blood Options).

In understanding informed choice, it is important to appreciate the following:

(1) There is a need to discuss the risks, benefits, and alternatives to blood transfusion and to ensure and that the potential recipient or his/her representative has an opportunity to ask questions. The rationale for this arises for two reasons: (a) there are real risks associated with blood transfusion. These are the risks of "immediate" death, which can occur with acute hemolytic reactions, acute bacterial infections or rarely anaphylactic reactions. Such real risks are now extremely uncommon, with a frequency of occurrence of less than 1:50,000, and death resulting, in probably less than 1:500,000. There are other risks associated with transfusion, such as minor allergic and febrile reactions, but these result mainly in patient discomfort and short-term morbidity (Chapter 32). These events are more frequent, and, with platelets, may occur in 3-20% of transfusions. The overall frequency is approximately 1%. The likely transmission of any viral disease causing significant morbidity currently is certainly less than 1:3,000 and likely less than 1:34,000. Therefore, in evaluating the real risks associated with allogeneic blood transfusion for red blood cells there are actually no risks of any high frequency (> 1% per unit). On this basis, it has been argued that the need to discuss specific risks of blood transfusion is questionable. (b) The more important reason to discuss risk in blood transfusion is on account of perceived risks. Inherent in this concept is that the patients' perceived risks might be instrumental in making an informed choice. For example, although the per unit risk of transfusion-associated HIV-1 is less than 1:225,000 (and perhaps as low as 1:1,000,000), an individual's fear or concern regarding HIV-1 infection may be such that they may not wish to receive any allogeneic blood. Statistically, this can be discounted, but nevertheless, it is of importance to the person as an individual. Each individual's risk tolerance for undesired low frequency events may vary and cannot be assumed. In summary, no real risks of 'high' frequency are known to exist with transfusion, but discussion of febrile-type reactions or urticaria would seem reasonable. In addition, discussions regarding real risks of very low frequency (< 1:1,000) are important in order to lessen patients concerns. Discussion of benefits should be simple such as improved sense of well being and more energy with red blood cells or prevention of bleeding with platelets or plasma.

Having established a rationale for discussing the risks and benefits of blood transfusion, it is then important to have a consistent process. There are a number of ways by which this can be achieved. Providing patients with printed or audiovisual material in a timely manner in relation to the transfusion may be helpful (these materials can be provided to custodians if the patient is unable to make such an informed choice). It is important, however, that any materials made available should be in a format that is comprehensible to the patient; for example, the language used should be simple in order to facilitate comprehension and a language other than English may be appropriate in certain geographical locations. These materials, however, are only a supplement to, and not a substitute for, a discussion with the patient or with the patients' representative, by a physician or some other informed discussant, such as a nurse, nurse practitioner, or a physicians' assistant. The need for a blood transfusion should first be outlined. Possible risks should then be discussed with alternatives if relevant. An opportunity needs to be offered to the patient to raise any questions or concerns, they may have regarding transfusion.

There are various mechanisms by which the informed choice process can be documented. (a) In the simplest sense, the physician prescription or signature for the blood product could constitute, in itself, the documentation. This is the mechanism by which documentation is occurring by default in these institutions in which there is no specific reference to blood transfusion in any of the formal consent documents. (b) A written notation can be made in the patients progress notes, stating that the patient consented to blood transfusion. The potential problem in this situation is for different types of notes to be written by different physicians raising concern regarding the consistency of the information presented to the patient. Simplifying the progress notes to make a standard statement such as "risks, benefits, alternatives or blood transfusion were discussed with the patient and an opportunity was offered to present questions" might be the best approach, followed by the signature of the physician and/or other health care personnel. (c) Institutional consent forms where specific reference can be made to transfusion. In such cases, a patient's signature could attest to the consent to blood transfusion. There may be further detail regarding risks, benefits, alternatives or, uncommonly, some actual data quantifying these risks. (d) A different kind of consent form is a procedural consent form, (for example, before surgery or a medical procedure such as a liver biopsy). Procedural consent forms, particularly surgical consent forms, will often make specific reference to the possible need for blood transfusion. This is appropriate, as more than 50% of all blood transfusions, occur in association with surgery. The degree of documentation on this consent form may vary from simple single sentences to an extended paragraph. (e) The most contentious manner of documentation is the use of a specific consent form for blood transfusion. This usually outlines the risks, benefits and alternatives in a clear format separating more common from very uncommon risks. This consent form offers the best form of documentation. The difficulty with specific consent forms, is that a considerable amount of time and effort is spent in getting additional

signatures in a situation where the patient or the patients representative is already overburdened emotionally and physically. In addition, failure to obtain this consent (noncompliance) could paradoxically increase legal exposure. Nevertheless, many institutions have elected to establish a transfusion specific consent form. It is also been suggested that the existence of a transfusion-specific consent form is more likely to result in a greater compliance by physicians in discussing risks and benefits with patients, although there is no actual data that this is the case. Both the process of informed choice and the documentation of informed choice should be audited periodically to ensure compliance. These concepts are shown in Table 5.1.

Related to the concept of informed choice is the question of all blood options (ABO). These constitute possible alternatives to allogeneic blood products and are itemized in Table 5.2. Blood options, or alternatives, are an important part of the consent process. Inherent is the option to refuse blood transfusions, most commonly, for example, with Jehovah's witnesses and Christian Scientists. It is important to document such refusal on a consent form, if possible, or in a progress note, in order to prevent inadvertent transfusions and reduce liability. Pharmacological alternatives or augmenters are available, which in some situations are appropriate (Chapter 23). The option for autologous blood (see Chapter 3) requires careful discussion with appropriate patient populations. The potential use of directed donors should neither be encouraged or discouraged. This is because directed

Table 5.1. Considerations regarding informed choice for blood transfusion

1. Rationale for discussing risks, benefits and alternatives a) Real risks b) Perceived risks

2. Process a) Discussion with patient by physician, or informed discussant (nurse, nurse practitioner, physician assistant, etc.)

b) Printed or audio-visual materials made available for recipients

3. Documentation a) Physician signature prescribing the blood product b) Patient progress notes c) Patient signature on:

i) General (or institutional) hospital consent ii) Procedural consent iii) Transfusion specific consent

4. Consistency of Process and Documentation

5. Audit of Both Process and Documentation a) Patient survey (process)

b) Chart survey (documentation)

donations (Chapter 2) are not known to be safer than the standard volunteer donations although the patient may perceive them as such. The physician therefore, should avoid expressing any bias or opposition to the use of directed donors. Lastly, as patient populations become more educated, there may be discussions concerning the use of specialized blood products. Examples of these specialized blood products are the use of leukocytoreduced blood products in colorectal surgery (Chapter 13), which has shown in some studies to reduce postoperative infectious rates and reduce length of stay or virally attenuated plasma, which is prepared from large pools and subjected to chemical treatment (Solvent-Detergent or SD plasma). This product may be inherently safer in that it is less likely to be associated with viral disease transmission. However, the use of a large pool size is worrying, since the SD process does not inactivate nonlipid-enveloped viruses (Chapter 29). A newer form of fresh frozen plasma, called fresh frozen plasma, donor retested (FFP-DR) is also likely to be available. This is plasma which has been quarantined until the donor returns to donate. These products may allay the concerns of some transfusion recipients.

Table 5.2. All blood options

1. Option to Refuse Blood Transfusion a) Jehovah's Witness b) Christian Scientists

2. Option to Seek Pharmacologic Alternatives or Augmenters a) DDAVP (Hemophilia A; von Willebrand's disease)

b) rh-Erythropoietin (renal failure; pre-elective surgery)

c) Estrogens (renal failure)

d) Recombinant FVIII:C or IX:C

3. Option for Autologous Blood a) Predeposit Autologous Blood b) Preoperative Hemodilution or Apheresis c) Intraoperative Salvage d) Postoperative Salvage

4. Option for Directed Donors

5. Option for Specialized Products of Potential Lower Rrisk a) Leukoreduced Blood Products b) Virally Attenuated Plasma c) Fresh Frozen Plasma, Donor Retested

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Responses

  • letteria calabresi
    Can a physician assistant consent blood transfusion?
    6 years ago

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