Changes to Standards
July 11, 2013
The Board of Governors recently acted on recommendations from the Standards Committee and approved changes to the 13th edition (2012) of AATB's Standards for Tissue Banking (Standards). These updates include expectations for the Quality Program to establish which supplies, reagents, materials and equipment are considered "critical" and to write relevant policies and/or procedures. By creating new standards, updating a number of them, and introducing a universal definition for "critical," expectations become clear for tracking these items during a variety of tissue banking activities.
These updates will also assist accredited tissue banks to meet the intent of federal regulations and guidance at 1271.210 Supplies and Reagents, some of which qualify as expectations of core Current Good Tissue Practice (core CGTP).
You will notice that some revisions include general improvements to the wording or sequence of certain standards. Although these are not specifically related to the determination of "critical" supplies, reagents, materials or equipment, these additional improvements were accepted.
For accreditation inspection purposes, the changes announced in this bulletin must be implemented no later than 12 months from today (on or before July 11, 2014). Compliance will be expected on this date.
Access this link to view/download all changes approved 'with amendments:'
Access this file to view/download all changes approved 'as amended:'
For each standard updated, the links below provide printable updates for insertion into your Standards book:
- A2.000 Definitions of Terms
- D1.000 GENERAL POLICIES FOR TISSUE RECOVERY OR COLLECTION ORGANIZATIONS
- D5.000 RECOVERY AND COLLECTION POLICIES AND PROCEDURES
- D5.100 Reagents, Supplies, Materials, and Equipment
- D5.110 Stock Rotation
- D5.200 Donor Identification
- D5.210 Verification Procedures, D5.211 Confirmation, D5.212 Donor Identity(these standards were only re-numbered and their sequence changed; their content remains unchanged)
- D5.300 Tissue Recovery and Collection - General
- D5.600 Recovery Records
- D5.700 Post-Recovery Packaging
- E1.300 Reagents, Supplies, Materials, and Equipment
- E1.310 Stock Rotation
- E1.700 Processing and Preservation Records
- J1.200 Contents (of the SOPM)
- J5.100 Selection (of Equipment)
- K1.100 Basic Elements (of a QA Program)
If you have any questions, please contact Scott Brubaker at the AATB Office.