Bulletin 25-1

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Changes to Standards

REVISED AATB STANDARDS COMING INTO EFFECT January 31, 2025

Changes to Standards

Standards for Tissue Banking, 15th edition, having been approved by the Board of Governors as announced in Bulletin 24-6, will become effective on January 31, 2025. 
 
In addition to the revisions resulting from the restructuring of standards, changes to requirements in the following sections are coming into effect: 

  • A4.000 Mergers, Acquisitions, or Dissolution 
  • Appendix II and H19.600 Infection Risk Review regarding donor eligibility criteria, as described in Bulletin 24-5

A clean copy of the Standards is available to AATB Accredited Institutional Members through their AATB Portal Accounts.
 

Corrections to Standards
This version of the 15th edition of Standards also includes, in redline, corrections and clarifications of text as listed below. These changes represent content that was omitted or otherwise altered during the transition from the 14th to 15th editions and must be revised to ensure that requirements are complete and clear. AATB is grateful to the users who provided the feedback that enabled these improvements. While these changes are not meant to constitute revisions of requirements that had been expressed in the 14th edition, because they were not included in the previous release of the 15th edition for implementation, AATB will exercise enforcement discretion with regard to the following changes until March 31, 2025. Any change below that is an expectation of a regulatory agency must be followed, whether or not it is the subject of enforcement discretion by AATB.

 

Primary section corrected Change
D4 Safety The reference to Standard Precautions was omitted and is being reinstated in D4.100:
“3) delineation of Universal Precautions and Standard Precautions as defined by OSHA and the CDC;”
H12 Infectious Disease Testing The following text was omitted and is being reinstated as H12.610:
“(LD) For tissue establishments located within the United States (U.S.), all living donors, excluding autologous donors, shall be tested and found to be negative for WNV NAT when recovery, collection, or acquisition occurs from June 1 through October 31 every year. Ref. H12.750 (R)
(LD) For tissue establishments located outside the U.S. importing tissues to the U.S., all living donors, excluding autologous donors, shall be tested year-round and found to be negative for WNV NAT.”
The following text was omitted and is being appended to H12.750:
“For repeat semen donors who have already had testing performed and for whom retesting at ≥ 6 months is required, testing at each donation is not required. For such repeat semen donors, WNV NAT testing shall be performed at the time of, or within 7 days before or after the first donation that is recovered within the June 1st through October 31st testing period, even if an earlier specimen was already collected and tested.”
H29 Container Labels

Section H29.200 reflected legacy text that has since been revised. The revision is being reinstated:
“The following information shall either appear on the container label or accompany the tissue (i.e., corresponding insert):
1)    disinfection or sterilization procedure utilized (if applicable);
2)    preservative (if utilized) and/or method of preservation (if applicable);
3)    potential residues of processing agents/solutions (e.g., antibiotics, ethanol, ethylene oxide, dimethylsulfoxide); and
4)    the name and address of the tissue bank that made the donor eligibility determination.
5)    The name and address of the tissue bank that determines that the tissue meets release criteria and makes the HCT/P available for distribution.

Responsibility for each individual process listed in items 4 through 5 must be borne by the tissue bank performing that process. If a different tissue bank is responsible for each one of these processes, the labeling or accompanying information should contain the name and address of each tissue bank and specify which tissue bank performed which function.”
H36 Dispensing and Disposal The following references were omitted and are being appended to H36.100:
“See requirements for storage temperatures and equipment, including E7.100 and H3.500.”
H37 Tissue Distribution Intermediaries The title of section H37.000 is being changed from Tissue Distribution Intermediaries to Tissue Distribution to convey the applicability of its requirements.
H37 Tissue Distribution Intermediaries H36.110 was misnumbered and is being deleted from H37.100 as duplicative of E7.100.
H37 Tissue Distribution Intermediaries The following references were incomplete and are being revised in H37.100:
“See requirements for storage temperatures and equipment, including E3.000, E7.100, H3.500, and H26.000.”

 

The crosswalk from the 14th edition to the 15th edition has been revised to reflect these changes and is available to AATB Accredited Institutional Members through their AATB Portal Accounts.
 
No revisions to the 2nd edition of Standards for Non-Transplant Anatomical Donation are coming into effect at this time.


Changes to STANDARDS Entering a Six-Month Preparatory Period on January 31, 2025

There are no changes to Standards for Tissue Banking or Standards for Non-Transplant Anatomical Donation entering a 6-month preparatory period at this time.
 
If you have questions, please contact standards@aatb.org.