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Your Privacy Choices
AATB offers a collection of resources developed by industry experts from AATB councils and committees. These materials are designed to support accredited establishments and other stakeholders in promoting high standards of quality, regulatory compliance, and operational effectiveness across the tissue banking community.
Many of these resources are intended to supplement AATB’s Standards for Tissue Banking, offering additional context and guidance to aid in their interpretation and implementation. While these materials provide valuable insights, they do NOT create new requirements for accredited establishments.
The resources available include:
Standards Supplements (formerly known as Guidance DocS)
What are Standards Supplements?
AATB’s Standards Supplements are resources for AATB-accredited establishments to use in conjunction with the Standards for Tissue Banking. In general, these guidelines describe AATB’s current thinking on a topic. Standards Supplements may offer context, detail, or other guidance not included in Standards. They are purely advisory and are not intended to create requirements for accredited establishments. They should be viewed only as recommendations unless specific AATB Standards or regulatory or statutory requirements are cited. Any recommendations included in these documents do not represent the only allowable approach; alternative approaches can be used as long as they satisfy the intent of the standard. Because Standards Supplements were previously known as Guidance Documents, they will retain that terminology until they are revised.
For FDA guidance documents for human tissue for transplant, please visit their website HERE.
Physical Examination Birth Mothers
AATB Guidance Document | Version 1
December 15, 2023
The purpose of this document is to guide the birth tissue donation community in establishing processes that meet the requirement for a current physical examination as part of donor eligibility determinations. It specifically focuses on assessing physical signs of communicable diseases and associated risk factors in birth mothers by providing direction on various examination methods that satisfy regulatory requirements.
Training and Competency
AATB Guidance Document No. 10 | Version 1
December 19, 2017
The purpose of this document is to help establishments meet the requirement of AATB Standard C2.200 (15th edition)/J2.200 (14th edition) and provide tissue banks with a framework for a robust training and competency program.
Qualification of Packaging and Validation of Shipping/Transport Procedures
AATB Guidance Document No. 9 | Version 1
October 23, 2017
This document provides instructions for qualifying/validating tissue packaging systems from initial use at recovery or acquisition through stages of tissue processing, and then to final packaging.
Environmental Controls & Monitoring of a Dedicated Tissue Recovery Site
AATB Guidance Document No. 8 | Version 1
September 28, 2016
This document provides a variety of approaches for establishing and maintaining environmental controls and monitoring for any dedicated tissue recovery site (DTRS). A tissue recovery agency should consider applying these guidelines to each DTRS it maintains.
Microbiological Process Validation & Surveillance Program
AATB Guidance Document No. 5 | Version 2
July 18, 2016
This document provides detailed information to assist tissue establishments in development of a comprehensive microbiological surveillance program and describes steps to consider when validating processing of allografts and autografts, including tissue regulated as biologics, medical devices, or combination products.
Tissue Donor Physical Assessment Form
AATB Guidance Document No. 1 | Version 2
June 27, 2015
The purpose of this document is to describe how to properly complete the two-page AATB Sample Tissue Donor Physical Assessment Form.
Uniform DRAI Forms Implementation
AATB/EBAA/AOPO Implementation Guidance Document | Version 2
May 20, 2015
This document outlines expectations and contains useful descriptions and references for the person administering any of the Uniform Donor Risk Assessment Interview (DRAI) forms (i.e., Donor >12 years old, Child Donor ≤12 years old, and Birth Mother). Following these instructions will promote uniformity in donor screening activities and optimize donation outcomes.
Providing Service to Tissue Donor Families
AATB Guidance Document No. 4 | Version 2
March 9, 2015
This document provides recommendations for best practices related to standard of care for all families who authorize tissue donation.
Evaluation of Body Cooling at Standard D5.400
AATB Guidance Document No. 7 | Version 2
December 9, 2013
The purpose of this document is to provide definitions, examples of source documentation, strategies to document cooling intervals, and to provide guidance for various cautionary situations.
Effective Quality Assurance of the Donor Risk Assessment Interview
AATB/EBAA/AOPO Implementation Guidance Document | Version 2
September 16, 2013
This document describes components and considerations for developing and implementing an effective quality assurance process for the DRAI.
AATB/NFDA Best Practices for Cooperation among OPOs, Tissue Banks, and Funeral Service Professionals
Version 1
July 2013
Representatives of the National Funeral Directors Association (NFDA) and the AATB reached an historic agreement on a set of best practices involving organ and tissue donation. The purpose of this effort was to eliminate as many of the impediments to the facilitation of the donation process as possible.
Prevention of Contamination and Cross-Contamination at Recovery: Practices & Culture Results
AATB Guidance Document No. 2 | Version 2
May 29, 2007
The purpose of this document is to provide recommendations for preventing contamination and cross-contamination through proper recovery practices, management of culture results, and recovery site suitability.
Quality Agreements
Version 2
June 1, 2025
The purpose of this document is to help tissue establishments develop quality agreements with the individuals or organizations they do business with.
What is the DRAI?
DRAI stands for Donor Risk Assessment Interview, which is intended to meet the regulatory requirement for a donor medical history interview. A DRAI form is used to screen potential donors by documenting their medical, behavioral, travel, and social history.
There are four DRAI forms. Three are "Uniform" DRAI or UDRAI forms designed to collect information regarding deceased donors, and the fourth is for use when evaluating donors of birth tissue.
Uniform DRAI - Birth Mother (for use in certain child donor scenarios)
December 17, 2024
What are AATB Tools?
AATB Tools are resources that provide tissue establishments with best practices or other helpful guidance in areas that might not be directly related to the technical aspects of tissue banking.
AATB Educational Resource Tool: Change Control
Version 1
July 15, 2025
The purpose of this document is to provide some best practices and a general process for change control that may be employed case-by-case or as part of a program.