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Changes to Standards

Bulletin 15-8

April 6, 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, update and add expectations for establishing policies and procedures to properly address a tissue bank's involvement leading to and/or performing what was previously only referred to as the "recall" of tissue. A gap analysis determined the standards covering this topic were incomplete and applicability was unclear. These updates include the adoption of terms found in regulation and they provide direction to be sure federal expectations are met should there be the need for a "correction" or "removal" of distributed tissue (e.g., a recall, market withdrawal, stock recovery). Another new term, "field notification", has also been added.

Although these changes are applicable mostly to tissue banks that process and/or distribute tissue, the update to standard H5.000 CORRECTIONS AND REMOVALS-GENERAL applies to tissue banks that perform other functions.

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 Tuesday, October 6, 2015). Compliance will be expected on this date.

Use of "shall", "should" and "must" in the Standards is critical when reviewing these updates.

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