Changes to AATB Standards
November 30, 2017
The AATB Board of Governors acted on a recommendation from the Standards Committee and approved changes to the 14th Edition (2016) of AATB's Standards for Tissue Banking (Standards). This announcement requires your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and to educate staff.
These changes provide for the possibility of using skin preparation products with stronger antimicrobial characteristics for deceased donors, as long as the use of the specific reagent would not compromise tissue quality and the reagent is appropriately qualified/validated, as outlined in Standards D5.520 Recovery Cleansing and Preparation, E2.400 Reagents, Supplies, Materials and Equipment, and A2.000 Definition of Terms: SKIN PREP. These changes also provide clarification of terms and optimization of requirements pertaining to quality, quarantine, segregation of tissue, and prevention of mix-ups between acceptable and unacceptable materials, as outlined in Standards A2.000 QUALITY and QUARANTINE, D5.100 Reagents, Supplies, Materials, and Equipment, D6.100 and E3.110 Quarantine Controls and E3.200 Segregation of Tissue.
Two new standards, B2.160 Contingency Plan and D1.300 Consideration for the Donor, have also been adopted. The first addresses the need for contingency planning for the preservation of tissue inventories and retention of records in the event of merger, acquisition or dissolution of tissue establishments, and the second addresses protection of the dignity of the donor.
A document containing all of these Standards changes can be accessed here.
The links below provide printable updates for each standard changed, as well as the new standards. For purposes of clarity, text added is underlined, italicized, and appears as blue font (i.e. Example), and text deleted utilizes the strikethrough (i.e.
Example). Articles pertaining to new standards are listed in a designated "New Standards" section as "New Article."
If you have questions, please contact Roman Hitchev, MD.