Comment Period Opens for Proposed 7th Edition of Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens

The proposed draft Standards for Molecular Testing for Red Cell, Platelet and Neutrophil Antigens, seventh edition, is now available for public comment. The comment period began today and will conclude July 9.

A summary memo that accompanies the proposed Molecular Testing (MT) Standards provides a comprehensive description of the additions and edits in the draft. Some of the significant changes include:

• Each chapter now concludes with the record retention table for those standards. AABB notes that a comprehensive record retention table still exists in Chapter 6.
• The Molecular Testing Standards Committee edited the reference standards at the end of Chapter 2 for completeness. The representation of the tables has been updated to include an additional column for “rs numbers” while also creating a differentiation of variant description as an overarching header.
• Proposed new Standards 5.1.10.1, 5.1.0.2 and 5.1.10.3 have been added to address requirements set forth by the Centers for Medicare and Medicaid Services concerning proficiency testing referrals and what is and is not currently allowed until the results of proficiency testing are complete and submitted.
• Proposed new Standard 5.3.2, which focuses on laboratories using laboratory-developed tests or research-use-only kits required to meet the standards in the edition most pertinent to them.
• Proposed new Standard 5.6.2 as a first step towards full ISBT nomenclature implementation in accredited laboratories. This style of standard is written in a similar fashion to how standards first appeared in the BBTS and CT Standards when they began the process for implementation of IBST nomenclature and ISBT 128 labeling implementation.

In addition, the proposed 7th edition of MT Standards 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 before the beginning of each of the 10 chapters. This guidance includes:

• A description of the chapter and what the standards therein cover.
• A list of key terms that mirror the content of the chapter and 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.

Users should note that these are not requirements that members will be held against. Rather, they are tools to assist users in their understanding of the content of the chapter.

The Molecular Testing Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 7th 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 that describes the committee’s rationale for its final decisions.