July 16, 2009
We are writing to inform you of a decision made on July 10th by the AABB Board of Directors that will affect how we classify facilities that do not meet AABB Standard 188.8.131.52.1(1) for labeling of blood and blood components using ISBT 128. Because your facility had requested a variance to this requirement, it will likely be affected by this decision, so we wanted you to be immediately aware of the issue.
After careful consideration and input from the standards and accreditation program committees, the board has determined that all accredited facilities that do not meet the ISBT 128 requirement by November 1, 2009, but which are in the process of implementation, will be placed on Conditional Accreditation status. The Accreditation Program Policy Manual defines Conditional Accreditation as follows:
Facility has partial or limited conformance with requirements. Conditional status is removed when facility satisfactorily responds to nonconformities or a focused reassessment results in adequate resolution. (Appendix 4.4.2.A, APPM, Version 7)
In the event that your facility is placed on Conditional Accreditation status the appropriate regulatory agency and accrediting bodies will be advised of your change in status. Once the requirement for implementation of ISBT 128 is met, AABB will, at your expense, need to reassess your facility to verify compliance before full AABB accreditation will be reinstated.
The 25th edition of AABB’s Standards for Blood Banks and Transfusion became effective on May 1, 2008, and remains effective until November 1, 2009. Included in the 25th edition is standard 184.108.40.206.1, which requires that all blood labeled on or after May 1, 2008, be labeled using ISBT 128. This international labeling standard replaces the Codabar symbology which is no longer supported and has significant problems, such as substitution errors, no check digit, and donation identification numbers that are not unique. In contrast, ISBT 128 is an alphanumeric, high density, widely supported symbology that provides for improved patient safety and inventory control and reduces regulatory errors.
The AABB Board of Directors believes that noncompliance with the requirement to implement ISBT 128 is an important patient safety issue. Additionally, the continued use of Codabar creates a national blood supply that is divided by two labeling systems which poses serious concerns in the event of a disaster. Those facilities that have not converted to ISBT 128 may not have the ability to receive blood with ISBT 128 labels or will have to resort to manual methods that are more error-prone.
As the professional association responsible for maintaining and enhancing the safety of the nation’s blood supply, AABB is committed to immediate implementation of ISBT 128. By adopting a uniform labeling system, we will be able to improve patient safety as well as inventory control, helping to ensure that blood is always available when and where it is needed.
We value your membership in AABB and hope to count you as a partner in our goal of achieving full implementation of this important safety measure. If we can provide any assistance in helping you meet this requirement, or you have specific questions, please contact the accreditation department at firstname.lastname@example.org.
Jay Menitove, MD
Karen Shoos Lipton, JD
Chief Executive Officer