by Laurie J Sutor, MD, MBA
The 31st edition of AABB Standards for Blood Banks and Transfusion Services went into effect on April 1, 2018. There were several changes and additions of note, a few of which are of interest to hospital blood banks. Selected changes are highlighted below. Note that this article does not comprehensively cover the changes to Standards.
5.14.5 There shall be two determinations of the recipient’s ABO group as specified in Standard 5.14.1. The first determination shall be performed on a current sample, and the second determination by one of the following methods: 1) Testing a second current sample, 2) Comparison with previous records, or 3) Retesting the same sample if patient identification was verified using an electronic identification system or another process validated to reduce the risk of misidentification. In the previous edition of Standards, this requirement only applied to samples used for electronic crossmatch. Now it will apply to all samples used for ABO testing. This change brings AABB in line with other agencies such as College of American Pathologists which already have had similar requirements in place. The gray area will be section 3) – what will qualify as a “process validated to reduce the risk of misidentification?” AABB has indicated that a dedicated blood bank ID bracelet system may qualify if the facility has done the appropriate validation and training and is tracking errors in specimen collection and patient identification.
5.15.1 Recipients shall receive ABO group-compatible red blood cell components, ABO group-specific whole blood, or low titer group O whole blood (for non group O or for recipients whose ABO group is unknown). This has been changed to allow for the growing practice of giving group O whole blood to trauma patients. A related standard is: 184.108.40.206 If low titer group O whole blood is used, the BB/TS shall define low titer group O whole blood and shall have policies, processes and procedures for: 1) The use of low titer group O whole blood, 2) The maximum volume/units allowed per event, and 3) Patient monitoring for adverse effects. This is a new standard.
220.127.116.11 Methods known to prevent transfusion associated graft-vs-host disease (GVHD) shall be used and include either irradiation or the use of a pathogen reduction technology that is known to inactivate residual leukocytes and is cleared or approved by the FDA or Competent Authority. This is a new standard that recognizes the increasing use of pathogen reduced platelets and their effectiveness in preventing GVHD.
7.3 The BB/TS shall use nationally recognized classifications for donor and patient adverse events. This is a change – the previous versions of standards did not require the use of nationally recognized classifications. These can be found in various places such as the CDC website: https://www.cdc.gov/bloodsafety/basics.html
Two new standards relating to proficiency testing: 18.104.22.168.1 When an external proficiency testing program is not available, there shall be a system for determining the accuracy and reliability of test results. And 22.214.171.124.2 Proficiency testing shall include comparison of test results from an outside laboratory.