Announcement of Changes to Standards
Entering a Six-Month Implementation Period on January 31, 2021
February 1, 2021
The Board of Governors acted on recommendation from the Standards Committee and, on December 18, 2020, 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 implementation period starting on January 31, 2021. A redlined copy of the Standards Manual is attached to this Bulletin and disseminated to all Bulletin recipients to assist in the preparation process. Members are advised to ensure that these changes, which become effective July 31, 2021, are reflected in all relevant standard operating procedures, policies, and staff training files.
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, Bulletin No.19-5, and Bulletin No.20-13). The effective date of said changes has been extended through July 31, 2021.
To assist members in this process, you may request a redlined copy of the Standards, which is watermarked "Effective July 31, 2021", containing all changes announced in this Bulletin, by emailing firstname.lastname@example.org.
There are no changes to AATB's Standards for Non-Transplant Anatomical Donation: 2nd Edition.
The newly approved changes to the AATB Standards for Tissue Banking are as follows:
- 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. (see redline version in the attached Standards Manual)
- 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. D5.820 also covers accurate donor identification requiring a label with a unique identifier, and G1.100 outlines provisions for accurate SOPM specification and consistent application of nomenclature used to describe tissue, cultures, and specimens, as well as units of measurements and processing modality. (see the entire change in the attached redline copy of the Standards Manual)
- 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. (see the entire change in the attached redline copy of the Standards Manual)
- 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. (see the entire change in the attached redline copy of the Standards Manual)
In addition to the material changes outlined above, some nonmaterial corrections have been made to the 14th Edition of the Standards for Tissue Banking, i.e., correction of typographical errors and obsolete references in some standards as follows:
- Standard B1.520 Inspections/Audits of Other Facilities - reference to Appendix V has been removed.
- Standard D4.210 Blood Specimens, Subsection (R) – the reference to D4.360 relating to testing requirements for embryo donors has been removed and replaced with a reference to D4.231 Repeat Testing of Living Donors.
- Standards J1.200 Contents (of SOPM), item 5) – the reference to B1.521 has been removed and replaced with a reference to B1.520 because B1.521 in the 13th Edition has been renumbered in the 14th Edition to B1.520.
- Standard J1.200 Contents (of SOPM), item 7, subitem a) – the reference to D4.350 has been removed and replaced with a reference to D4.210 Blood Specimens.
- Standard J1.200 Contents (of SOPM), item 7, subitem b) – the reference to E4.000 has been removed and replaced with a reference to E3.000 as E4.000 in the 13th Edition was renumbered to E3.000 in the 14th Edition.
- Standard J1.200 Contents (of SOPM), item f) – the reference to E1.300 has been removed and replaced with a reference to E2.000 Processing, which in the 14th Edition encompasses E2.400 Reagents, Supplies, Materials and Equipment, E2.410 Stock Rotation, and E2.420 Containers.
- Standard J5.100 Selection – the reference to E1.300 has been removed and replaced with a reference to E2.400 Reagents, Supplies, Materials, and Equipment.
- Standard K6.000 External Audits – the reference to B1.521 has been removed and replaced with a reference to B1.520 as B1.521 of the 13th Edition was renumbered to B1.520 in the 14th Edition.
If you have any questions, please contact Dr. Roman Hitchev, AATB Vice President and Chief Science Officer, at email@example.com.