Bulletin 15-7

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Changes to Standards 

Bulletin 15-7

March 30, 2015

The Board of Governors acted on recommendations from the Standards Committee and approved changes to the 13th edition (2012) 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 educate staff.

These changes clarify and add expectations for establishing policies and procedures that address labels and labeling involving primarily tissue recovery activities but also services of processing tissue banks. Experience from handling accreditation applications and performing inspections has shown that specific standards apply to recovery activities but clarification for membership was indicated. A few other updates to appropriately represent common activities are included in these revisions.

For accreditation inspection purposes, the changes to standards announced in this bulletin must be implemented no later than six (6) months from today (on or before Wednesday, September 30, 2015). Compliance will be expected on this date.

All changes can be accessed here:

Changes to Standards - Labels and Labeling Involving Tissue Recovery Activities & Services of Processing Tissue Banks 3-30-15

For each standard changed, the links below provide printable updates. Use of "shall", "should" and "must" in the Standards is critical when reviewing these updates. 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).

A2.000 DEFINITIONS OF TERMS

B1.510 Written Agreements/Contracts

D4.351 Specimens

D5.700 Post-Recovery Labeling and Handling

D5.800 Transportation Following Recovery

G1.100 Nomenclature, G1.200 Label List, G1.300 Labeling Integrity, G1.400 Claims

G2.200 Re-Labeling, G2.320 Label Storage

J1.200 Contents (of the SOPM)

If you have any questions, please contact Scott Brubaker at the AATB Office.