Bulletin 15-6

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Changes to Standards

Bulletin 15-6

March 23, 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). Please be aware that over the next three weeks, changes to Standards will be announced each Monday and will require your attention to review and potentially update your Standard Operating Procedures Manual (SOPM) and educate staff.

These changes add expectations for establishing policies and procedures for identification and control of procedures and forms. The Standards Committee identified these expectations had not been adequately represented in the Standards. As an example, the need for a traceable version identifier was previously only found at standard G3.220 Package Insert Content. These updates are necessary because a document control system should be included in every Quality Assurance Program. Ideas for inclusion were adapted from concepts found in international standards.

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 23, 2015). Compliance will be expected on this date.

All changes can be accessed here:

Changes to Standards - Identification and Control of Procedures and Forms 3-23-15

For each standard changed, the links below provide printable updates. Use of "shall" 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).

J1.000 STANDARD OPERATING PROCEDURES MANUAL (SOPM) and J1.100 Identification and Control (J1.100 Purpose and Design)

J1.200 Contents and J1.400 Modifications

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