Changes to Standards and New Guidance
January 4, 2011
The Board of Governors has approved several changes to the 12th edition of AATB's Standards for Tissue Banking. The Standards changes announced in this Bulletin are "immediate" because the changes made only clarify intent, are already being followed, or do not otherwise make the requirement stricter. For accreditation inspection purposes, all changes should be implemented as soon as possible where applicable to your Tissue Bank.
These changes are related to: monetary compensation for donors of reproductive tissue; retention of archived donor samples; and tissue cultures, including sampling plans and test methods. Background information supporting these changes is provided below along with links to printable updates including the new guidance document.
D3.000 MONTERAY COMPENSATION TO DONORS
- Wording in this general standard did not adequately address donors of reproductive (R) tissues. Since the standard was written broadly, it could be misinterpreted. For clarification, a specific standard for these donors has been added.
- The American Society for Reproductive Medicine (ASRM) Guidelines are widely used and accepted by Assisted Reproductive Technology professionals, donor advocacy groups, and donors. These guidelines are now referenced here.
D4.357 Archived Samples
- The retention time period for archiving donor samples is now closer to harmonization with Standard B1.600, Contracted and Non-contracted Laboratory Services, where record-retention requirements for laboratory-generated records are 10 years from the "test run" date.
- Laboratories archiving donor specimens will not always have access to the "expiration date" of tissue allografts or their "date of distribution," so retaining archive samples for 10 years after Recovery or Collection is more appropriate.
- Ten years is a long time to archive frozen specimens because: - it is several years past expiration dates for most tissue types (i.e., 5 years or less) or any distribution date, which are two parameters on which the standard focused;
- information in package inserts for infectious disease test kits does not indicate that archived (frozen) serum or plasma has been evaluated for suitability when used for retesting after many years (such as 10 years) in frozen storage; and
- the possibility that a new or emerging pathogen will affect processed, preserved tissue in current inventories, and that the risk assessment of the new pathogen would be relevant to a donation made many years ago is extremely remote.
- The 10-year time period remains in place, so there is no loss of original intent. It is now manageable by starting the time period based on one, accessible date. Compliance is less burdensome.
A2.000 DEFINITIONS OF TERMS, K2.210 Pre-Sterilization/Pre-Disinfection Cultures, and Interim Guidance Document No. 5, Standard K2.210 Pre-Sterilization/Pre-Disinfection Cultures
Due to new data regarding microbiological test methods for recovered human tissue, as well as a need to establish microbiological sampling plans and test methods for Tissue, updates are made to Standards and an Interim Guidance Document has been issued. The Interim Guidance is referenced within the standard and is required.
During 2011, the AATB will publish more detailed guidance related to validation of microbiological test methods and processing steps, and the establishment and maintenance of a microbiological surveillance program will be described.
A2.000 DEFINITIONS OF TERMS and K2.220 Final/Pre-Packaging
- To avoid any perceived misunderstanding, additions are made which clarify intent that microbiological testing of tissue does, in fact, include detection of bacteria as well as fungi.
As a reminder, changes to Standards are supplied to you as printable documents so they can be easily inserted into the 12th edition of AATB's Standards for Tissue Banking if kept in a three-ring binder. For purposes of clarity, text that has been added is underlined and italicized (e.g., Example), and text that has been deleted utilizes the strikethrough (e.g.,
Go to the Association's website, www.aatb.org, access "Standards and Regulatory," "AATB Standards for Tissue Banking," "Standards Updates," then "Standards Updates to the 12th Edition" to view all the published updates to the current edition. These are individual, printable versions that can be inserted into the applicable Standards' section. The new interim guidance document will be listed at the link "Guidance Documents" within "Standards and Regulatory."
All updates will be incorporated in the publication of the next edition of Standards.
If you have any questions or comments, please contact Scott Brubaker at the AATB office.