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Changes to Standards

Bulletin 20-2

January 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 and the 2nd Edition of the AATB Standards for Non-Transplant Anatomical Donation (NTAD).

Unless specifically announced as URGENT, all changes have a fixed 6-month implementation period. This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and educate staff.

Please be advised that the changes to Standards published in Bulletin #19-6 (issued on July 31, 2019) go into effect today, January 31, 2020, with the exception of the changes to Section B, i.e. B1.500 and B2.210. The effective date of the changes to Section B1.500 and B2.210 was extended via Bulletin #19-5 (published July 9, 2019) and Bulletin #19-7 (published December 16, 2019) and is now July 31, 2020.

A separate email will be sent to all AATB members with the full PDF copies of the Standards and NT Standards incorporating the following changes.

Changes to the 14th Edition, AATB Standards for Tissue Banking

INTRODUCTION

The Introduction to the 14th Edition has been amended to align it with a change to Section A2.000 DEFINITION OF TERMS. Specifically, the amendment provides a clarification that, if a term defined in Section A2.000, is used without italics, then the intent is to apply the common meaning of the word in its colloquial use, and not the strict definition laid down in A2.000.

SECTION A GENERAL INFORMATION

               A2.000 DEFINITION OF TERMS

The Preamble of A2.000 has been amended to clarify that if a term defined in A2.000 is used in its non-italicized format, the intent is to apply its common colloquial meaning and not necessarily the strict definition of A2.000.

Five new terms have been added to Section A2.000. Specifically, (i) “packaging systems”, (ii) “primary package”, (iii) “secondary package”, and (iv) “transport systems” have been added to achieve alignment between Section A2.000, Standard K1.220 Packaging Qualification and Transport/Shipping Validation, and Guidance Document No.9 Qualification of Packaging and Validation of Shipping/Transport Procedures. In addition, a 5th term, i.e. “image” has been added to achieve alignment between Section A2.000 and the newly added item 17) to Standard J1.200 Content in regard to captured images in the donation process.

SECTION F TISSUE RELEASE

F1.140 (A) Interpretation of Infectious Disease Test Results 

The amendment of Section F, Standard F1.140 updates the reference chain outlined in the Autologous Section (A) of the Standard. Instead of a reference to Standard E3.200 Segregation of Tissues, which applies only to reproductive tissue but not to autologous tissue, the amendment provides a reference to Standards D6.100 Quarantine Controls, and D6.200 Segregation, which is applicable to all types of tissue, including Autologous.  

SECTION J GENERAL OPERATIONS

           J1.200 Contents

A new requirement has been added as item 17) under J1.200 pertaining to the Contents of the SOP Manual (SOPM) of tissue banks. Specifically, the SOPM must now contain policies and procedures for defining appropriate use, confidentiality, security and retention of images of the donor and/or tissue, captured in the donation process.

SECTION K QUALITY ASSURANCE

K1.220 Packaging Qualification and Transport/Shipping Validation

The amendment of K1.220 takes into account the definitions of “container” and “package” provided in A2.000, as well as the definitions of “packaging systems”, “secondary package”, “primary package”, and “transport systems” provided in Guidance Document No.9 Qualification of Packaging and Validation of Shipping/Transport Procedures, and replaces the terms “package” and “shipping container” in K1.220 with the terms “packaging system” and “transport system”, respectively.

K5.000 INTERNAL AUDITS

The amendment of K5.000 adds Acquisition as a required annual internal audit area along with the other required audit areas, i.e. donor evaluation and acceptance; tissue recovery, collection; processing, preservation and packaging; donor and tissue testing; quarantining; labeling; storage; distribution; electronic systems; and records management.

APPENDIX II CRITERIA FOR PREVENTING TRANSMISSION of RCDADs THROUGH TRANSPLANTATION OF HUMAN TISSUE

Behavior/History Exclusionary Criteria, Item # 18) persons determined to be at risk for variant CJD (vCJD) …

The amendment updates the names of some countries listed in Item 18), paragraph c) as they have changed since the announcement of Appendix II. In addition, considering that the intent of item 18), paragraph c) is to present an exhaustive list of countries, the amendment adds the abbreviation “i.e.” to indicate a finite list.

 

Changes to the 2nd Edition, AATB Standards for Non-Transplant Anatomical Donation

NT SECTION A GENERAL INFORMATION

The amendments to NT Section A align some titles in the Table of Contents as well as the terms “annual” and “transport” with previously published Bulletin announcements. The changes are non-substantive in nature.

NT SECTION C RECORDS

               NT-C1.410 NON-ACCREDITED ORGANIZATIONS

The amendment to NT-C1.410 is intended to clarify the difference between NAM distribution for research use vs distribution to third NADO, recovery organization, or processor.

 

All changes announced herein have a six-month implementation period starting on January 31, 2020 and shall be effective on July 31, 2020.

If you have any questions, please contact Dr. Roman Hitchev at hitchevr@aatb.org.