Written by: Mediware Consulting and Analytics on Monday, December 13, 2010 Posted in: Blood Management

shg-informed-consentSome time ago my delightful 80+ year-old grandmother was diagnosed with a GI bleed that led to hospitalization and multiple transfusions. As I am the only nurse in the family, she made a point to tell me that she needed blood because her “hemoglobins were low.”

I quickly determined that she had no idea what hemoglobin was but she was confident her transfusion therapy was necessary because her trusted family physician had told her that her “hemoglobins were low.” During her admission, she signed without reading a general treatment consent that included a paragraph about blood transfusion. My grandmother was not told that there are risks associated with allogeneic transfusion nor was any alternative therapy offered. However, she believed that she was receiving appropriate medical care and she had no apparent adverse events with her hospitalization. Was my grandmother given adequate information to make an informed choice about her medical care? Did her physician and hospital meet minimum legal and regulatory requirements regarding transfusion informed consent?

Transfusion informed consent is a necessary element of the physician-patient relationship because transfusion is an invasive procedure (a tissue transplant) with definable significant risks.1 Further, AABB and College of American Pathologists (CAP) state that the patient’s medical record shall include documentation of transfusion consent.2 Meeting this ethical and regulatory obligation need not be complicated but a meaningful discussion between physician and patient comparable to that of any other invasive procedure seldom occurs prior to transfusion.

I believe a major barrier to the physician-patient transfusion consent discussion is the physician’s lack of knowledge about transfusion medicine.3 Most physicians who order blood products have never received formal training in blood component therapy. If the physician does not weigh the risks of transfusion against the benefits when ordering blood products, then that physician will not likely discuss risks and benefits with the patient. It seems highly likely that my grandmother’s physician was treating a lab value given the explanation that her hemoglobin was below normal levels. Until transfusing care providers become knowledgeable about current evidence based transfusion therapy, informed consent discussions will remain inadequate. And a seemingly simple consent process will remain difficult to implement.

The transfusion consent process should begin at the time the physician determines that a patient’s course of treatment may include transfusion. The physician should order transfusion education for the patient and explain in plain words why a transfusion may be needed, the expected benefits, the common risks and the alternatives available to avoid or reduce transfusion. “Providing information ensures patients have sufficient understanding so they have a real chance of making a choice in their best interests.”4 This discussion may take place in the physician’s office when a procedure or course of therapy is planned that includes a known risk for transfusion. Or the discussion might occur at the time the physician orders lab tests to diagnose suspected anemia or thrombocytopenia based upon the patient’s medical history or presenting physical condition.

Patient education that supports transfusion informed consent is essential for an effective consent process. Educational materials are readily available in many formats. Free brochures are available from sources such as NIH5, JAMA6, and SABM7The Patient Education Institute offers a video that explains blood types and transfusion in simple terms.8 Vendors have developed interactive electronic educational materials that patients can review on the internet.9 These commercially prepared materials quickly become outdated and hospitals need to obtain medical staff approval prior to implementing them, however improved education may encourage the patient to reflect on therapy choices and become more engaged in the decision making process. It is essential that patient education materials reinforce and not replace the consent discussion between physician and patient. The physician remains ethically and legally obligated to discuss the risks, benefits and alternatives that are specific to each patient’s medical history and current condition.

The transfusion consent form should also function as an educational tool rather than a legal document relieving care providers of liability.10 One ideal scenario would be that the physician uses the transfusion consent form as evidence of the consent discussion. While referring to a document written at the 5th grade comprehension level,11 the physician explains why the patient may need a transfusion, outlines the steps he will take to prevent or minimize the patient’s exposure to blood products and tells the patient about the common risks of transfusion. The physician also defines the expected impact if the patient chooses not to receive blood. At the conclusion of this discussion, the physician signs the attestation statement on the consent form acknowledging the discussion. At a time prior to receiving a transfusion or prior to undergoing a procedure that may entail transfusion, a nurse confirms that the patient has had an opportunity to review educational materials and has no further questions, then uses the same form signed by the physician to document the patient’s transfusion decision.

My grandmother’s case is typical in hospitals today. Her physician was ethically and legally obligated to discuss the risks associated with transfusion and offer her appropriate alternatives including the choice of no transfusion. The hospital should have provided a consent form that she could understand and supporting educational materials to reinforce the physician’s consent discussion. At the time of this hospitalization, my grandmother was alert and lived independently; she would have enjoyed participating fully in her own healthcare choices.

Selected References  

  1. Fuchs E, The elements of informed consent: is there too much information or not enough? AABB News 2010 May.
  2. AABB 5.19.6. CAP TRM
  3. Obrien KL, Transfusion medicine knowledge in post graduate year 1 residents. Transfusion 2010 Aug; 50(8):1632.
  4. Agard A, Informed consent: theory vs. practice. Nat Clin Pract Cardiovasc Med 2005; 2(6):270.
  5. nhlbi.nih.gov.
  6. Torpy, et al, JAMA Patient Page: Blood Transfusion. JAMA 2004 Oct; 292(13)1646. Citingwww.nhlbi.nih.gov. www.aabb.org. www.redcross.org.
  7. http://www.sabm.org/public/resources.php. Available in English and Spanish.
  8. http://patient-education.com/video.asp?p=search&s=SPV&EXTRA=2&SH=VL&fs=VL&mode=FULL&mvc=gs570102%20&lmsg=yes=FULL&mvc=gs570102 &lmsg=yes. Available in English and Spanish.
  9. Tanner L, Informed consent: hospitals try high-tech ways to advise patients. AP Wire 2010 Nov. 30. 
  10. Brenner L, Beyond informed consent: educating the patient. Clin Ortho and Rel Res2009 Feb; 467(2):348-51.  Agard A, Informed consent: theory versus practice. Nat Clin Pract Cardiovasc Med 2005; 2(6):270.
  11. CMS, 42 C.F.R. §482.24(c)(2)(v).  Interpretive Guidelines for Informed Consent 42 C.F.R. §482.51(b)(2).