February 12, 2009
Janet Corrigan, PhD, MBA
President and CEO
National Quality Forum
601 13th Street NW
Ste. 500 North
Washington, DC 20005
Dear Dr. Corrigan,
I am writing on behalf of AABB to express a concern regarding the definition of a transfusion-related event included in the National Quality Forum’s (NQF) list of reportable events. AABB (formerly known as the American Association of Blood Banks) is the professional association that establishes standards and accredits community and hospital-based blood banks, transfusion services, reference laboratories, and bone marrow and peripheral blood stem cell collection and processing laboratories. The Center for Medicare and Medicaid Services has granted AABB deemed status under the Clinical Laboratory Improvement Amendments (CLIA) for accrediting hospital transfusion services, blood banks and reference laboratories. AABB is dedicated to advancing transfusion patient safety.
It recently has come to our attention that there may be a mistake in the description of NQF’s reportable event 4B, which refers to "Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products." AABB believes the term "HLA incompatible" should not be included in this sentence, since HLA-incompatibility does not usually cause hemolytic transfusion reactions, and only occurs in rare cases. HLA compatibility is not part of routine compatibility testing performed for blood transfusions.
Although HLA incompatibility due to HLA antibodies present in blood products is believed to be a leading cause of transfusion associated mortality through acute lung injury, this is not a hemolytic transfusion reaction. More importantly, this is a complication of blood transfusions that is not due to error on anyone's part. Rather, it is due to use of blood products that might contain HLA antibodies for which there is no FDA approved donor screening test currently available. AABB has focused attention on blood collection interventions which can reduce the number of plasma-containing blood products from donors who might have HLA antibodies. In addition, AABB is encouraging more stringent and appropriate use of plasma transfusions that are most commonly associated with this type of transfusion reaction. It may be that the increased awareness of acute lung injury due to the cross-reaction of a donor’s HLA antibodies with a patient's leukocytes was the basis for the inclusion of the "HLA-incompatible" phrase with ABO incompatible hemolytic reactions. Although transfusion fatalities due to HLA antibody cross-reaction are reportable to the FDA, unlike ABO-incompatible blood transfusions which are almost always due to error, HLA-incompatible blood transfusions are not due to error and should not be included in the list of reportable events.
Therefore, AABB respectfully requests that the NQF change the description of item 4B to read: “Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products.” We appreciate the role the NQF has played in promoting patient safety through the creation of the list of reportable events, and further appreciate the inclusion of ABO-incompatible blood transfusions as one of the events deserving of attention.
Please feel free to contact Theresa Wiegmann, AABB Director of Public Policy (301-215-6554 or Theresa_L@aabb.org), if you have any questions or require further information.
Karen Shoos Lipton, JD
Chief Executive Officer