Bulletin 19-1

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Changes to Standards​

Bulletin 19-1​

January 31, 2019​

Following guidance provided by the Board of Governors, AATB is introducing a new schedule for the approval and announcement of changes to standards pertaining to the 14th Edition and the 2nd Edition of the NT Standards (collectively referred to as "Standards"). The highlights of the new Revision Approval and Announcement System effective January 1, 2019 can be found here:

Changes to Standards: Revision Approval and Announcement System

Considering the Revision Approval and Announcement System outlined above, on October 9 and December 11, 2018, the Board of Governors acted on recommendations from the Standards Committee and approved the following 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) to be announced on January 31, 2019.

For each Section changed, the links below provide printable updates. For purposes of clarity, added verbiage appears as blue font (Example); text deleted appears as red font and utilizes the strikethrough (Example).

1. Section B General Organizational Requirements of a Tissue Bank

B1.500 Written Agreements/Contracts

B2.210 Qualifications

These amendments provide AATB-accredited processing tissue banks and their recovery partners with the option to use the expertise of the processor’s medical director to oversee donor screening and donor testing by defining such responsibilities in a written agreement between the two organizations, thus allowing the recovery partner to meet the standard’s requirement to have a medical director by utilizing the services of the processor’s medical director.

2. Section D Authorization, Informed Consent, Donor Screening, and Tissue Recovery, Collection and Acquisition

D4.100 Donor Screening

D4.230 Required Infectious Disease Tests

D4.231 Repeat Testing of Living Donors

D5.830 Tissue Transport

These amendments clarify the requirement for medical director’s oversight with regards to establishing donor screening and donor testing procedures, the responsibility of the processor’s medical director for establishing donor eligibility criteria, as well as the requirement for collaboration with the medical director of the establishment responsible for donor eligibility determination. In addition, these amendments align Section D with applicable FDA guidance documents on WNV NAT testing applicable to living donors and donors of reproductive tissue, and they also align the requirements pertaining to tissue transport of Section D with the amendments of Section K pertaining to packaging qualification and transport/shipping validation.

3. Section K Quality Assurance

K1.220 Packaging Qualification and Transport / Shipping Validation

The amendment aligns the requirements pertaining to packaging qualification and transport/shipping validation laid down in Section K with the FDA’s current good tissue practices, i.e. § 1271.265(d). Specifically, the amendment provides an exemption from the requirement for qualification of transport packages if they are industrially designed for their intended use, as well as an exemption from the requirement for transport/shipping container validation, unless the container is used for finished tissue, if each event is adequately verified and documented (the requirement for finished tissue container validation remains).

4. NT Section H Labeling, Packaging, Transport and Distribution

NT-H1.300 Labeling Integrity

NT-H3.400 Container Label - removed

NT-H5.100 Validation and Expiration of Transport Container

NT-H5.200 Quality Control of Reusable Shipping Containers

These amendments adjust the use of the terms “package” and “container” in their correct context, i.e. “package” for labeling, and “container” for transport/shipping.

5. NT Section L Quality Assurance

NT-L1.100 Basic Elements

NT-L1.200 Qualification, Verification and Validation Requirements

NT-L1.220 Container Qualification and Transport/Shipping Validation

NT-L1.300 Purchasing Controls

These amendments adjust verbiage pertaining to the basic elements of a QA program of a NADO, including the requirement for sharing information with transplant tissue banks, purchasing controls, as well as updating the scope of critical components subject to qualification or verification, and the correct use of “container” vs. “packaging” in the context of transport/shipping validation.

This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and educate staff.

All changes to standards announced in this bulletin have a 6-month implementation period starting on January 31, 2019.

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