Bulletin 22-1

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Changes to Standards

Revised AATB Standards Coming into Effect January 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 #21-3, with a six-month preparatory period starting on July 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 January 31, 2022, these changes are reflected in all relevant standing operating procedures, policies, and staff training files. 

A clean copy of the Standards containing said changes is available to all AATB members through the AATB Portal.

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

  • D5.400 Time Limits for Postmortem Tissue Recovery, section (V), subsection 1) has been changed to extend the perfusion time limit for vascular tissue from 12 to 24 hours provided that the tissue is recovered within AATB Standards for warm ischemic time and body cooling parameters. (BoG Consent Agenda, March 18, 2021)
  • B1.500 Written Agreements/Contracts. The changes announced in Bulletin 19-1 have been rescinded with immediate effect; therefore, the rescission is reflected in the Standards coming into effect July 31, 2021 to allow AIMs who may have implemented such changes to return to the pre-Bulletin 19-1 arrangements during the preparatory period, i.e. by January 31, 2022.
  • B2.210 Qualifications. The changes announced in Bulletin 19-1 have been rescinded with immediate effect; therefore, the rescission is reflected in the Standards coming into effect July 31, 2021 to allow AIMs who may have implemented such changes to return to the pre-Bulletin 19-1 arrangements during the preparatory period, i.e. by January 31, 2022.
  • B2.221 Donor Eligibility Criteria. The changes define the responsibilities of the medical director of the tissue bank responsible for determining donor eligibility to make a determination regarding the eligibility of each donor based on predetermined donor criteria established in the SOPM. The provision allowing the tissue bank to adopt donor eligibility criteria used by another organization has been removed.
  • D4.100 Donor Screening. The provision allowing donor screening and donor testing procedures be established under the supervision of a contracted licensed physician has been removed and replaced with a requirement that donor screening and donor testing procedures and donor eligibility criteria be established by the medical director of the tissue bank responsible for donor eligibility determination. The words “or licensed physician designee” have been removed.
  • D4.130 Physical Examination. The words “or licensed physician designee” have been removed.
  • D4.232 Disclosure and Availability of Positive Infectious Disease Test Results. The words “or licensed physician designee” have been removed.
  • F1.000 Tissue Release. The words “or licensed physician designee” have been removed.
  • F1.110 Records for Review. The words “or licensed physician designee” have been removed.
  • F1.112 Autopsy Report. The words “or licensed physician designee” have been removed.
  • F1.120 Infectious Disease Risk Review. The words “or licensed physician designee” have been removed.
  • F1.300 Quality Review. The words “or licensed physician designee” have been removed.
  • F2.100 Tissue Release Based on Tissue Utility. The words “or licensed physician designee” have been removed.
  • H5.500 Field Correction and Removal Records. The words “or licensed physician designee” have been removed.
  • K2.310 Pre-sterilization / Pre-disinfection Records. The words “or licensed physician designee” have been removed.
  • K2.320 Final / Pre-packaging Cultures. The words “or licensed physician designee” have been removed.
  • K4.100 Errors and Accidents. The words “or licensed physician designee” have been removed.
  • K4.200 Complaints. The words “or licensed physician designee” have been removed.
  • K4.300 Adverse Outcomes. The words “or licensed physician designee” have been removed.


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

•    A2.000 Definitions of Terms: DONOR, LIVING DONOR (LD), BIRTH TISSUE (BT)
•    D4.100 Donor Screening
•    D4.120 Physical Assessment
•    D4.210 Blood Specimens, Subsection (BT)
•    D5.720 Delivery and Post-delivery Records, Section Item 2
•    F1.110 Records for Review
•    Appendix III
•    NT-E4.000 Preparation Records

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 July 31, 2022, when the changes will come into effect. 

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