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AATB's Standards Committee authors and the Board of Governors approves guidance documents which are part of the Standards for Tissue Banking and the Standards for Non-Anatomical Donation.
What are Guidance Documents?
AATB’s guidance documents are guidelines for AATB accredited establishments to use in conjunction with the Standards for Tissue Banking and the Standards for Non-Transplant Anatomical Donation.
AATB's Standards Committee authors and the Board of Governors approves guidance documents which are part of the Standards for Tissue Banking and the Standards for Non-Anatomical Donation.
AATB guidance documents do not establish legally enforceable responsibilities. Instead, these guidelines describe AATB’s current thinking on this topic. They are intended solely for the use of AATB accredited tissue banks in conjunction with the AATB's Standards for Tissue Banking. They should be viewed only as recommendations unless specific AATB Standards or regulatory or statutory requirements are cited. The use of the word "should" in these guidance documents means that something is suggested or recommended, but not required. As with other AATB guidance documents, the recommendations included in this document do not represent the sole approach. Alternative approaches can be used.
Physical Examination Birth Mothers
AATB Guidance Document | Version 1
December 15, 2023
The purpose of this document is to guide the birth tissue donation industry in establishing processes that meet the requirement for a current physical examination as part of donor-eligibility determination, specifically focusing on assessing physical signs of communicable diseases and associated risk factors in birth mothers, providing direction on various examination methods satisfying regulatory standards.
Training and Competency
AATB Guidance Document No. 10 | Version 1
December 19, 2017
The purpose of this guidance document is to help meet the requirement of AATB Standard J2.200 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 tissue packaging systems. Requirements for validating packages at relevant points in the handling of tissue include initial use at recovery or acquisition, through interim stages of tissue processing, then to final packaging.
Environmental Controls & Monitoring of a Dedicated Tissue Recovery Site
AATB Guidance Document No. 8 | Version 1
September 28, 2016
This guidance document provides a variety of approaches for establishing and maintaining environmental controls and monitoring for any DTRS, and 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 Guidance Document provides detailed information to assist tissue banks in development of a comprehensive microbiological surveillance program and describes steps to consider when validating processing of ‘conventional’ allograft tissue (e.g., skin, bone, cartilage, ligaments, tendons, dura mater, amnion, vessels, heart valves, and cellular tissue), similar autograft tissue, and allografts 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 SOP 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 Implementation Guidance 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 and utilization of support documents (see Support Tools) should 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 guidance document was originally issued in March 2007 and underwent extensive editing over a year-long period to create version 2. New sections include "evaluation of services," "gifted tissue for research," and "terms to avoid." Updates were made to expand sections such as "definitions," "family needs," and "components of a support services program."
Evaluation of Body Cooling at Standard D5.400
AATB Guidance Document No. 7 | Version 2
December 9, 2013
The goal 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 guidance document describes components and considerations for developing and implementing an effective quality assurance program (QA Program) process for the DRAI.
FDA Guidance for Industry: Current Good Tissue Practice
AATB Guidance Document No. 3 | Version 2
December 2011
The purpose of this Guidance is to communicate AATB's current interpretations of the Tule for those working in a conventional tissue bank.
AATB/NFDA Best Practices for Cooperation among OPOs, Tissue Banks, and Funeral Service Professionals
July 2013 | Version 1
More than 10 years ago, representatives of the National Funeral Directors Association (NFDA) and the American Association of Tissue Banks (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
Version 2 of this Guidance Document includes updates for Recovery Site suitability, Zone Recovery, and Sequencing.
What are the NADO Guidance Documents?
The American Association of Tissue Banks (AATB)'s NADO guidance documents are guidelines for AATB accredited Non-transplant Anatomical Donation Organizations (NADOs) to use in conjunction with the Standards for Non-Anatomical Donation.
NADO Tissue Donor Physical Assessment Form (RE: NT-D3.210)
June 20, 2018
NADO Tissue Donor Acceptability and Suitability Assessment Form (RE: NT-D3.220)
June 20, 2018
What is the DRAI?
DRAI stands for Donor Risk Assessment Interview. A DRAI questionnaire is used to screen potential donor by recording a potential donor's medical history, behavioral history, travel history, and social history.
There are four DRAI forms. Three are "Uniform" DRAIs designed to collect information regarding deceased donors. 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