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Changes to Standards

Bulletin 20-13

July 31, 2020

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) on June 22, 2020. In addition, the Board of Governors approved a six-month extension of the effective date of previously approved changes to Section B1.500 Written Agreements/Contracts and Section B2.210 Qualifications, referred to collectively as “the medical director amendments” (see Bulletin No.19-1 and Bulletin No.19-5). The effective date of said changes has been extended through January 31, 2021.
 
 
Changes to the Standards Effective July 31, 2020
 
Members are advised that the changes to Standards announced earlier this year on January 31, 2020 (Bulletin No.20-2) are now in effect and binding as of 12:00 a.m. (24:00 h) Eastern time today, July 31, 2020. A clean copy of the Standards coming into effect today (July 31, 2020) has been emailed to all AATB members will be available through the AATB Portal within the next few days.
 
 
Revised AATB Standards With Effective Dates of January 31, 2021
 
All changes announced below have a fixed 6-month implementation period that begins on July 31, 2020 and ends on January 31, 2021, i.e. the changes announced herein will come into effect on January 31, 2021. This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and educate staff. To assist members in this process, a redline copy of the Standards which is watermarked “Not in Effect until January 31, 2021” containing all changes announced below has been disseminated via email to all AATB members.
 
 
Changes to the AATB Standards for Tissue Banking, 14th Edition, recommended by the Standards Committee and approved by the Board of Governors during the first two quarters of 2020 with a 6-month implementation period starting on July 31, 2020 and coming into effect on January 31, 2021
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, ANDTISSUE 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.