July 16, 2009
Dear Accredited Facility:
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.
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.
After careful consideration and input from the standards and accreditation program committees, the board has determined that facilities that do not meet the ISBT requirement by November 1, 2009 will be placed on Conditional Accreditation, rather than full 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)
Because your facility has not been assessed since implementation of the standard you must submit evidence (see attachment 1) that your facility is now or will be compliant with Standard 220.127.116.11.1(1) by November 1, 2009, in order to maintain your full accreditation status. If your facility will not meet the November implementation deadline, your facility accreditation status will be changed to Conditional. 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. All facilities that have an accreditation cycle occurring in the 4-O, 1-E, or 2-E time frames will be assessed according to those schedules and will be evaluated for compliance to the requirement for implementation of ISBT 128.
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