Bulletin 21-8

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Announcement of Changes to Standards Entering a Six-Month Preparatory Period on July 31, 2021

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 (see below). These changes are announced in this Bulletin with a six-month preparatory period starting July 31, 2021. Members are advised to ensure that the changes are reflected in all relevant standard operating procedures, policies, and staff training files by January 31, 2022, when the changes will come into effect. A redlined copy of the Standards Manual will be emailed to accredited tissue bank MwERs to assist in the preparation process. You may request a redlined copy of the Standards containing all changes announced in this Bulletin by emailing accreditation@aatb.org. The copy will be watermarked "Effective January 31, 2022".

 

The newly approved changes to the AATB Standards for Tissue Banking are as follows:

  • 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 The changes announced in Bulletin 19-1 have been rescinded with immediate effect; therefore, the rescission is reflected in the Standards coming into effect July 31st, 2021, i.e., amendments announced in Bulletin 19-1 have been removed.
  • 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 The changes announced in Bulletin 19-1 have been rescinded with immediate effect; therefore, the rescission is reflected in the Standards coming into effect July 31st, 2021, i.e., amendments announced in Bulletin 19-1 have been removed.
  • 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.

 

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