DOCUMENT: Leukoreduced Blood Products
CLASSIFICATION: Position Paper
STATUS: Current
Date: August 2001
The American Society for Clinical Laboratory Science is an organization representing clinical laboratory personnel. The society’s mission is to enable its members to provide quality services for all consumers. To achieve this mission, the society strives to improve the public’s health and safety through the promotion of efficient and effective use of laboratory testing, effective standards of practice, and provision of continuing education to improve the competency of practitioners in laboratory science. (1)
The use of leukocyte reduction of blood products for all patients is an issue of great debate. While there is consensus that certain patient populations benefit from the use of leukoreduced blood products, there is concern over the costs associated with universal leukoreduction. The proponents of universal leukocyte reduction of blood components cite a reduction in several transfusion related complications, while the opponents cite the cost and the loss of donors from the donor pool because blood from some donors does not filter well.
The use of a leukoreduction filter with blood products has been shown to reduce transfusion related complications in patient populations that are chronically transfused. (2, 3) These patients, who are exposed to multiple donors, have a greater incidence of refractoriness to platelets, an increase in the incidence of alloimunization to human leukocyte antigens and a greater incidence of febrile non-hemolytic transfusion reactions. Some data suggest that patients who receive multiple transfusions in an acute setting, such as trauma victims and some surgery patients, experience a decrease in post-operative infections and post-operative mortality. (2, 3) Those patients with known immunosuppresion, such a chemotherapy patients and neonates, also benefit from not being exposed to donor leukocytes due to the reduction of the risk of cytomegalovirus disease. In addition, universal leukoreduction will assure that all patients who have an agreed upon need for leukoreduced components will receive them. At present, the patient’s physician must communicate the need for special products.
There are two major concerns with universal leukoreduction. One is the cost of the product. Another concerns the method of preparation and its effectiveness. The unit may be filtered before storage by the collection facility, may be filtered in the laboratory or it is filtered at the bedside by the transfusing facility. The most expensive and most effective method of preparation is filtration before storage by the collection facility. Bedside filtration is less effective because they may be misused or not used at all.
At the January 25-26th, 2001 meeting, the Food and Drug Administration Blood Safety and Availability Committee voted to recommend that universal leukoreduction be implemented as soon as feasible.
The advantages of universal leukoreduction include the decrease in exposure to human leukocyte antigens and cytomeglovirus, the decrease in refractoriness to platelets and the decrease in logistic problems associated with the need to keep two blood supplies. The blood shortages of recent years make it imperative that all products be available for as many patients as possible.
In response to the FDA recommendation, more blood collecting facilities are providing only 100% prestorage leukoreduced products as time passes.
While the increased cost of universal leukoreduction can be daunting, the savings in patient care cost (decreased length of stay, decreased post-operative infection, decreased human leukocyte antigen sensitization, and decreased cytomegalovirus transmission) may compensate.(2,3) While the existing scientific and financial realities are not fully explored at this writing, the preponderance of evidence suggests that we take a patient focused position.
Universal leukoreduction of cellular blood components be implemented as soon as feasible.
The Department of Health and Human Services ensure that adequate funding is provided for this effort.
The Department of Health and Human Services should issue regulations that minimize the impact on the supply of blood products.
ASCLS Mission Statement
American Association of Blood Banks, Leukocyte Reduction, 301-TC, November 6, 2000
Paxton, Anne, Universal Leukoreduction - Fix or Folly?, CAP Today, October 2000.