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Informing The Patient And Obtaining Consent For Transfusion There are two major legal issues pertaining to the clinical aspects of blood transfusion:
Prior to the mid 1980s, a signed informed consent specific for blood transfusion was rarely obtained. Instead, hospitals took the position that informed consent for blood transfusion was implicitly granted when a patient agreed to undergo a medical or surgical procedure or even to be admitted to the hospital. This interpretation of adequate consent for transfusion began to be questioned in the mid 1980s with the recognition of transfusion associated AIDS. After the advent of AIDS, transfusion was perceived as carrying an excessive risk relative to other medical events. Even though this perception was not supported by fact, arguments for obtaining specific patient consent for transfusion gained momentum. Based on these arguments, the American Association of Blood Banks in 1986 recommended that "Patients who receive nonemergent transfusions be informed of the risks and benefits of blood and blood products and consent to their use". Informed consent for transfusion is a standard for accreditation required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Such consent can either be documented by a progress note in the medical chart, a signed consent form, or both. Over the ensuing years, an increasing number of hospitals have instituted the use of specific informed consent forms for blood transfusion. Informed consent should be obtained prior to all blood and blood product transfusions, except in emergency situations. If a patient is incompetent by age or mental status, and if the patient's wishes regarding transfusion are not known, consent should be sought from the parent or legal guardian. In order to be legally valid, the following elements of informed consent must be present:
Immunologic Risks
Approximately 1 in 38,000 red cell units is transfused to the wrong patient. ABO errors cause more transfusion related fatalities than HCV or HIV-1. The only way to prevent these errors from happening is meticulous attention to the patient identification protocol and the introduction of technological advances such as bar coded wristbands. Hepatitis C and HIV-1 viruses have been almost completely eliminated from the blood supply. These improvements have occurred largely through more comprehensive donor history screening, technological advances in infectious disease testing, and development of virus inactivation techniques for coagulation factor concentrates. Since the risks of transfusion transmitted infection are currently very low, it is difficult to accurately quantitate them. Consequently, risk estimates have been obtained with mathematical modeling techniques applied to data sets obtained from infectious disease testing of blood donors or follow-up investigations of selected transfusion recipients. The current risks of transfusion transmitted infection, expressed per unit of blood received, are given in the following table. Transfusion Risk Of Viral Transmission
For the most important transfusion transmissible agents, Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV), the per unit risk is the same for each type of blood component transfused (i.e. red cells, platelets, FFP, cryoprecipitate). In contrast, for Human T cell Lymphotropic Virus Types I and II (HTLV-I/II) there is no risk of transmission from non-cellular blood products such as FFP or cryoprecipitate, since HTLV is highly leukocyte-associated. It is unlikely that transfusion transmitted diseases will ever be completely eliminated for the following reasons:
Recently, there has been renewed concern about the risk of transmitting bacterial infection by blood transfusion. It is known that septic transfusion reactions are more frequent with transfused platelet concentrates than with red cells. Platelets are stored for up to five days at room temperature and provide a better growth media for bacteria than do refrigerated red cells. Data indicate that fatal transfusion reactions due to bacterial sepsis occur at a rate of less than 1 in a million. It is more difficult to assess the rate of significant morbidity from bacterially infected units. Although laboratory data indicate that bacteria can be cultured from 1 in 1000 platelet concentrates, the significance of these findings is unclear. It is not known if small amounts of transfused bacteria cause recipient morbidity. To decrease this risk, the American Association of Blood Banks has determined that blood centers must implement a method to limit or detect bacteria in all platelet products by March 1, 2004. |
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