Changes to Standards
February 10, 2009
The Board of Governors has approved several changes to the 12th edition of AATB's Standards for Tissue Banking. These changes are related to audits of other facilities, cultures obtained at recovery, certain labeling requirements, archiving Standard Operating Procedures (SOPs), and signature records.
Some highlights of these changes include:
- a change to revert to previous language used in Section B to no longer require inspections/audits of other facilities that are also AATB-accredited. Periodic verification of activities/services remains a requirement;
- a new standard that requires written instructions and use of an appropriate technique for cultures obtained at recovery (if performed);
- a change to labeling requirements to accommodate a shipment collected from a client depositor (this person is not considered a donor);
- a requirement to keep archived SOPs for 16 years after discontinuation. This change in “J1.900 Archives” is congruent with expectations described at “J1.700 Staff Access and Review” and at “J2.100 Training;” and
- a requirement to maintain a record of signatures for those authorized to perform or review tasks. Although not described in the standard, the tissue bank is also expected to construct an SOP that describes action when name changes occur (e.g., due to marriage, divorce, etc.).
For accreditation inspection purposes, Standards changes announced in this Bulletin must be implemented as soon as possible, but no later than 90 days from the publication of this Bulletin, or on or before May 11, 2009.
If you have any questions or comments, please contact Scott Brubaker at the AATB office.