Changes to Standards: Revised AATB Standards Coming into Effect 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. These changes were announced with a six-month preparatory period starting on January 31st, 2021, when Bulletin #21-3 was published. A redlined copy of the Standards Manual was disseminated at that time to all Bulletin recipients to assist in the preparation process.
On January 31st, 2021, members were advised to ensure that by July 31st, 2021, these changes are reflected in all relevant standing operating procedures, policies, and staff training files. A clean copy of the Standards containing said changes will be available to AATB members through the AATB Portal within the next few days.
The changes to the AATB Standards for Tissue Banking coming into effect July 31st, 2021, are as follows: (see exact verbiage in the updated Standards manual):
- A change to D5.212 Donor Identity – added clarification about the source of donor identity verification information intended to emphasize the responsibility of hospital and/or tissue bank personnel in accordance with tissue bank’s SOPM.
- A change to D5.330 Acquisition (BT) – verbiage pertaining to postdelivery packaging and labeling has been removed considering that these aspects are exhaustively addressed elsewhere in the Standards, i.e., D5.820 Post-delivery Packaging and Labeling and G1.100 Nomenclature.
- A change to J1.600 Annual Review – the word “annual” has been removed from the title, and the verbiage “of Standing Operating Procedures Manual (SOPM)” has been added to the title of the Standard. The word “annual” has been removed from the text of the Standard pertaining to the requirement to review policies and procedures. Clarification verbiage has been added with the intent to optimize the provisions relating to frequency of reviews and make implementation more relevant to the specific risk assessment of each tissue bank, its applicable regulatory environment, and corresponding third-party standards, e.g., OSHA, ISO.
- A change to J2.400 Training Records – the word “annual” has been removed from items 5) and 6) to align this Standard with the changes in Standard J1.600 (see above).
- A change to J3.100 Work Environment – the word “annual” has been replaced with “in accordance with applicable regulations and guidelines” with the intent to align J3.100 with the changes to J1.600 and J2.400 (see above).
- A change to J3.200 Procedures – the words “standard precautions” have been added to subitem 3) to ensure consistency of J3.200 with the changes to J3.400 (see below).
- A change to J3.400 Universal Precautions and Standard Precautions – the words “standard precautions” have been added to the title and main text of the Standard with the intent to align it with relevant third-party standards, e.g., OSHA, CDC, considering the 1996 change of “universal precautions” to “standard precautions” to broaden the applications, and the Standard Committee resolution to align J3.200 and J3.400 with the provisions pertaining to “universal precautions,” “standard precautions,” and OPIM as defined by the CDC and OSHA.
- In addition, the Board of Governors rescinded previously approved changes to Standards B1.500 Written Agreements/Contracts and B2.210 Qualifications announced in Bulletin #19-1. The rescission has been approved with immediate effect; therefore, the previous amendments announced in Bulletin #19-1 have been removed.
Changes to AATB's Standards for Non-Transplant Anatomical Donation: 2nd Edition:
- NT-G1.200 EVALUATION OF REQUESTS FOR NAM. A technical error in the subsection sequencing has been corrected.