Bulletin 21-2

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Changes to Standards : Revised AATB Standards Effective January 31, 2021

The Board of Governors acted on recommendation from the Standards Committee and on June 22, 2020 approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking. These changes were announced with a six-month implementation period starting on July 31st, 2020 when Bulletin #20-13 was published. A redlined copy of the Standards Manual was disseminated to all Bulletin recipients to assist in the preparation process.

Members were advised to ensure that these changes, which become effective January 31, 2021, are reflected in all relevant standing operating procedures, policies, and staff training files. A clean copy of the Standards coming into effect January 31, 2021 will be available to AATB members through the AATB Portal within the next few days.

There are no changes to AATB's Standards for Non-Transplant Anatomical Donation: 2nd Edition.

Changes To Standards:

The newly effective changes incorporated into the attached copy of the Standards are listed below:

SECTION A GENERAL INFORMATION

A2.000 DEFINITION OF TERMS

  • AVAILABLE FOR DISTRIBUTION (new term definition)
  • COMPETENCY ASSESSMENT (updated definition)
  • COMPLAINT (updated definition)
  • DEVIATION (updated definition)
  • ERROR (updated definition)
  • MANAGEMENT WITH EXECUTIVE RESPONSIBILITY (updated definition)
  • PREVENTIVE ACTION (updated definition)
  • PROCESS VALIDATION (updated definition)
  • PROCESSING (updated definition)
  • QUALITY CONTROL (updated definition)
  • SAFETY (updated definition)
  • STERILE (updated definition)
  • STERILIZATION (updated definition)
  • TERMINAL STERILIZATION (updated definition)
  • TRACEABILITY (updated definition)

SECTION D AUTHORIZATION, INFORMED CONSENT, DONOR SCREENING, AND TISSUE RECOVERY, COLLECTION, AND ACQUISITION

D4.000 DONOR SCREENING AND TESTING - D4.100 Donor Screening - D4.130 Physical Examination (revised Subsection BT)

SECTION D LABELING

G3.000 LABELING INFORMATION - G3.100 Container Labels - G3.120 Content (revised 2nd part, information to be included on the container label unless space limitations require use of a corresponding insert)

If you have any questions, please contact Dr. Roman Hitchev, AATB Vice President and Chief Science Officer at hitchevr@aatb.org.