Bulletin 24-5

Print/PDF Version

Early Notification of Changes to Donor Eligibility Requirements (Appendix II) and DRAIs

AATB is issuing this Bulletin to communicate changes to donor eligibility requirements before publication in the 15th Edition of Standards for Tissue Banking (Standards). This Bulletin also includes the following resources, which reflect the new requirements:

Since their most recent publication, the Uniform Donor Risk Assessment Interview forms (UDRAIs) and Appendix II were revised to address changes in tissue banking Standards. These include the recently published criteria for reducing the risk of transmission of Mycobacterium tuberculosis (MTB) through tissue transplantation and removal of Ebola and Zika virus donor exclusions.

The DRAI for birth tissue is the product of the AATB Birth Tissue Council (previous Living Donor Council) and is a new tool to aid in screening and donor-eligibility determination for potential birth tissue donors. This birth tissue DRAI also incorporates all current federal and Standards requirements. 

The requirements for reducing the risk of MTB transmission reflect AATB's commitment to ensuring scientific evidence-based decision making. The donor screening criteria were developed by the Physicians Council following an extensive review and analysis of available literature. This research has been peer-reviewed and published in the Transplant Infectious Disease journal. AATB also updated its Frequently Asked Questions regarding screening for MTB.

The Appendix II revision, including the MTB screening requirements, will be included in the 15th edition of Standards, which will be released on July 28, 2024 and become effective on January 31, 2025. When effective, these requirements will supersede those specified in Bulletin 23-6. The intent of these revisions is to provide accredited establishments with expedited standards. AATB did not seek Council comment before their release for implementation. Accredited establishments may implement operational changes to conform to these new requirements upon publication of this Bulletin. AATB accredited establishments must continue to comply with all applicable laws and regulations, including any state-specific requirements for donor screening. 

The 15th edition of Standards will also include the following revision to H19.600 Infection Risk Review (F1.120 in the 14th edition), as follows:

"The Medical Director shall not determine an allogeneic donor eligible with any of the following findings:

  1. evidence of significant active infection at the time of donation for relevant communicable disease agents or diseases (RCDADs). These include, but are not limited to: septicemia, viral disease (e.g., HIV, viral hepatitis, West Nile virus, rabies, Ebola virus disease, Zika virus infection, etc.), human transmissible spongiform encephalopathies, untreated syphilis, clinically active tuberculosis, leprosy (Hansen's disease) or systemic mycosis; and/or
  2. clinical evidence of or risk factors for relevant communicable disease agents or diseases (RCDADs) as specified in Appendix II."

This revision is intended to support the appropriate application of Appendix II and donor-eligibility determination by clarifying the distinction between reviews for active infection and RCDADs. 

The implementation guidance document, “Uniform Donor Risk Assessment Interview Forms” will be reviewed in the near future for potential revision.

If you have questions, please contact standards@aatb.org.