Changes to Standards
November 12, 2013
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). A new tissue type has been added and is described as follows in A2.000 Definitions of Terms:
"CELLULAR TISSUE (CT) - cells that are autologous or allogeneic, committed or uncommitted, and non-expanded."
Due to technological advances, AATB-accredited tissue banks have developed protocols for producing and distributing certain cellular grafts that meet this definition. This tissue type can require considerations beyond those addressed by general standards, or those specifically established for other tissue types: autologous (A), cardiac (C), Living Donor (LD), musculoskeletal (MS), osteoarticluar (OA), reproductive (R), skin (S), Living Donor surgical bone for allogeneic use (SB), and vascular (V). These updates to Standards not only describe specific expectations for cellular tissue (CT), but also announce revisions to general and tissue-specific standards. Careful review of all updates is advised.
To develop appropriate (CT) standards, input was sought from experts at tissue banks handling these allografts and professionals were enlisted from outside AATB's membership. We congratulate and thank AATB's Cell Task Group for developing these new standards.
Considering AATB-accredited tissue banks cannot be inspected and accredited for only some of the tissue banking activities/services they perform, or for only some of the tissue types in Standards they handle, the (CT) standards fill a gap. Refer to the Accreditation Polices for Transplant Tissue Banks in section "II. Required Elements" at listing C. For accreditation inspection purposes, the changes announced in this bulletin must be implemented no later than 90 days from today (on or before Monday, February 10, 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
- D4.100 General (of D4.000 Donor Suitability)
- D4.354 Required Infectious Disease Tests
- D5.300 Tissue Recovery and Collection - General
- D5.400 Time Limits for Tissue Recovery
- D5.900 Transportation of Tissue Following Recovery
- E1.020 Processing Environment
- E1.035 Additives (of E1.030 Processing Methods)
- E1.040 Sterilization/Disinfection of Tissue
- E1.050 Tissue Evaluation
- E1.061 Techniques, E1.067 Freezing Tissue, E1.068 Cryopreservation
- E1.300 Reagents, Supplies, Materials, and Equipment
- E4.100 Storage Temperatures
- E4.141 Storage Conditions for Commonly Transplanted Human Tissue
- E4.200 Expiration Date/Storage Period
- G3.120 Content (of G3.100 Container Labels)
- G3.220 Package Insert Content
- G3.310 Domestic Shipments (of G3.300 Transport Package Label Content)
- H1.010 Solutions, H1.300 Requests for Donor Status and Tissue Processing Information (of H1.000 Distribution and Dispensing - General)
- H4.100 Temperature Records (of H4.000 Return of Tissue)
- K1.200 Qualification, Verification, and Validation Requirements, K1.210 Validation of Shipping Containers, K1.220 Validation Procedures - Packaging and Freezing Protocols
- K2.210 Pre-Sterilization/Pre-Disinfection Cultures, K2.220 Final/Pre-Packaging (of K2.200 Microbiological Tissue Cultures)
Use of "should" and "shall" in the Standards is critical and must be considered when reviewing these new standards. Some recommendations include revisions that are general improvements to the wording in certain standards or their title. Although these are not specifically related to (CT), the Committee and the Board of Governors made these additional improvements.
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.,
If you have any questions, please contact Scott Brubaker at the AATB Office.