Comment Period Opens for Proposed 13th Edition of Standards for Immunohematology Reference Laboratories

The proposed draft Standards for Immunohematology Reference Laboratories, 13th edition, is now available for public comment. The comment period began Friday, May 19, and will conclude on July 18.

A comprehensive description of the additions and edits in the draft are provided in a summary memo that accompanies the proposed IRL Standards.

Reviewers should note that the proposed 13th edition incorporates the updated quality systems essentials that form the basis for all sets of AABB Standards. The updated quality systems essentials provide a one-page guidance at the beginning of each of the 10 chapters. This guidance includes the following components:

• A description of the chapter and the standards covered therein.
• A list of key terms that mirror the chapter content that should be kept in mind when reviewing the standards.
• A list of key objectives that an assessor could look for during an onsite assessment. (However, this list is not comprehensive.)

These are not requirements to which assessors will refer during assessments. Rather, they are tools to assist users in their understanding of the chapter content.

The 13th edition includes the following significant changes:

• Each chapter now concludes with the record retention table for those standards. A comprehensive record retention table still exists in Chapter 6.
• There is a second example to the RH system in the additional resources row (based on the inclusion of the new entry for another set of RBCs for the RH system). This provides potential laboratories with two more options when attempting to meet the 65% threshold.
• The proposed edition includes new Standards 5.1.10.1.1 – 5.1.10.1.3 to mirror the requirements in the code of federal requirements concerning proficiency testing and what is and is not allowed regarding referrals of tests and testing review.
• A new subnumber 3 in Standard 5.2 concerning the American Rare Donor Program allows accredited laboratories to screen at least 1,000 donors for immunoglobulin A deficiency as a way to meet the participation in ARDP requirement annually.

The Immunohematology Reference Laboratories Standards Committee encourages all interested individuals to provide feedback during the 60-day comment period. The standards in the 13th edition are in the proposed phase and will be finalized after the comment period has concluded. The Committee will review all comments submitted and provide a summary document describing the Committee’s rationale for its final decisions.