Bulletin 22-5

Changes to Standards

Revised AATB Standards Coming into Effect July 31, 2022
The Board of Governors acted on recommendation from the Standards Committee and approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking.

The below changes were announced in Bulletin 22-1, with a six-month preparatory period starting on January 31, 2021. A redlined copy of the Standards Manual was disseminated at that time to all Bulletin recipients to assist in the preparation process. Members were advised to ensure that by July 31, 2022, these changes are reflected in all relevant standing operating procedures, policies, and staff training files. Bulletin 22-3 informed accredited tissue banks that there will be delayed implementation for changes made to section D4.120 Physical Assessment and Appendix III: Tissue Donor Physical Assessment Form Requirements. These changes are not reflected in AATB Standards coming into effect on July 31, 2022.

A clean copy of the Standards containing said changes will be available to AATB members through the AATB Portal within the next few days.

The changes to the AATB Standards for Tissue Banking coming into effect July 31, 2022, are as follows (see exact verbiage in the updated Standards manual):

  • A2.000 Definitions of Terms. The terms “donor”, “living donor (LD)” and “birth tissue (BT)” were revised.
  • D4.100 Donor Screening. Throughout the Standards, including D4.100, “infant” was changed to “newborn”. The recommendation to have policies and procedures for handling information regarding the health status of the newborn reported voluntarily after delivery has been removed. The requirement for written procedures to describe how such information is evaluated has been removed.
  • D4.210 Blood Specimens. Language was added for birth tissue, requiring that a blood specimen is collected from the birth mother at time of delivery, or within 7 days prior to or after delivery.
  • D5.720 Delivery and Post-Delivery Records. The requirement to have record of the “infant donor’s” gestational age has been changed to gestational age of “newborn”.
  • F1.110 Records for Review. “Acquisition” was added as additional language after “recovery”, reflecting accurate terminology for birth tissue.
  • NT-E4.000. “Critical” was added to qualify “equipment”, with regards to required preparation records.

Changes to Standards Entering a Six-Month Preparatory Period on July 31, 2022
Changes to the following Standards have been approved by the Board of Governors with a 6-month preparatory period starting July 31, 2022, and expiring January 31, 2023, when said changes will come into effect.

  • A2.000 Definitions of Terms: Dehydration, Desiccation, Lyophilization, Tissue Distribution Intermediary
  • E2.613 Residual Moisture – Lyophilization/Dehydration/Desiccation
  • E2.710 Lyophilization
  • E2.720 Dehydration/Desiccation
  • M1.000 Tissue Distribution Intermediaries

Redlined versions of the Standards are available by request to the MwER or Management Representative for Accreditation of each AATB Accredited Establishment by emailing standards@aatb.org.

Members are advised to ensure that the changes are reflected in all relevant standard operating procedures, policies, and staff training files by January 31, 2023, when the changes will come into effect.

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