Bulletin 15-8

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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. See this excerpt:

"Tissue banks not directly responsible for conducting Corrections or Removals, but that perform activities that could lead to the need for a correction or removal (e.g., tissue recovery, donor screening, donor testing) shall have policies and procedures for the timely notification of all affected parties regarding information related to tissue safety or regulatory requirements."

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.

All changes can be accessed here:

Changes to Standards - Corrections & Removals, Field Notifications 4-6-15

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

H5.000 CORRECTIONS AND REMOVALS -GENERAL, H5.100 Circumstances That May Require Correction or Removal, H5.200 Notification Responsibilities, H5.300 Handling of Tissue, H5.400 Reporting Requirements, H5.500 Correction and Removal Records

J1.200 Contents (of the SOPM)

K1.100 Basic Elements (of a Quality Assurance Program)

L6.000 CORRECTIONS AND REMOVALS (for Tissue Dispensing Services)

M6.000 CORRECTIONS AND REMOVALS -GENERAL, M6.100 Correction and Removal Records (for Tissue Distribution Intermediaries)

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