Guidance Documents

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What are the AATB Guidance documents?

The American Association of Tissue Banks (AATB)'s guidance documents are guidelines for AATB accredited tissue banks to use in conjunction with the Standards for Tissue Banking.

AATB's Standards Committee authors and the Board of Governors approves guidance documents which are part of the Standards for Tissue Banking.

AATB Guidance Document No. 1

Tissue Donor Physical Assessment Form

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. The information contained on these pages and in relevant medical records will be used as an aid to determine donor suitability in order to proceed with tissue recovery. (See standards D4.210, D4.220, D4.230, and D4.310)

AATB Guidance Document No. 2

Prevention of Contamination and Cross-Contamination at Recovery: Practices & Culture Results

Version 2

May 29, 2007

In early 2006, a technical work group was formed to expand the content of this Guidance to include another factor that could prevent contamination and cross-contamination at recovery. Suitability of the site where tissue recovery takes place must be evaluated and determined to be acceptable prior to recovery (see revised Standard D5.500 Recovery Environment). The goal is to set specific guidelines/suitability parameters that define required controls. There is not an expectation that actual detailed monitoring be performed at each Recovery Site. Parameters have been developed that, when applied, can ensure that the environment in which recovery occurs meets minimum specifications and should not introduce, transmit, or spread contamination. These additional controls are appropriate and reasonable and have been formulated by this work group from practices tested and used by AATB-accredited tissue banks.

In January of 2007, another work group of subject matter experts was organized to collect information regarding how tissue banks were applying the Zone Recovery concept and Sequencing to their recovery operations. These practices were reviewed for consistency and common practices were added to this guidance. There is consensus that documentation methods that describe zones and Sequencing facilitate tissue suitability determinations. Version 2 of this Guidance Document includes updates for Recovery Site suitability, Zone Recovery, and Sequencing.

AATB Guidance Document No. 3

Current Good Tissue Practice

Version 1

June 27, 2006

The FDA's CGTP Final Rule was published on November 24, 2004 and became effective on May 25, 2005. Questions remain regarding acceptable interpretations of how to adequately meet the intent of the Rule. The purpose of the initial version of this Guidance is to communicate AATB’s current interpretations of the Rule for those working in a conventional tissue bank. There are no references in this version to operations specific to reproductive tissue banking since that specialty is currently exempt from this Rule.

AATB Guidance Document No. 4

Providing Service to Tissue Donor Families

Version 2

March 9, 2015

The AATB's Standards for Tissue Banking at Standard D2.600 Services To Donor Families, and AATB’s Standards for Non-Transplant Anatomical Donation at Standard NT-D2.600 describe Services to Donor Families or a referral to a support system must be offered to the Authorizing Person. The requirements additionally expect subsequent communications and periodic evaluation of services to be documented, maintained, and readily available, and a reference to AATB Guidance Document No. 4 is made. To meet the intent of these standards Tissue Banks and Non-transplant Anatomical Donation Organizations must consider this guidance document when providing Services to Donor Families.

AATB Guidance Document No. 5

Microbiological Process Validation & Surveillance Program

Version 2

July 18, 2016

AATB's Standards for Tissue Banking(Standards) and various global regulatory authorities with oversight of cell and tissue establishments require validation of procedures related to tissue processing. Lack of stepwise instructions for validating such procedures is a recognized gap that exists worldwide. 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. Scenarios (see examples and annexes) are included to further illustrate expectations.

AATB Guidance Document No. 6

Recovery Partner Audit Tool

Version 1

September 1, 2011

To assist AATB-accredited tissue banks to completely and properly audit non-accredited recovery partners, an AATB task force, composed of AATB members, developed a “Recovery Partner Audit Tool” and this corresponding Guidance Document as a useful resource. Tissue banks auditing non-AATB-accredited recovery partners must use the Recovery Partner Audit Tool or submit their own tool to the Director of Accreditation at the AATB Executive Office for evaluation. If the tool is deemed to be comparable to the Recovery Partner Audit Tool, you will be able to use that tool.

AATB Guidance Document No. 7

Evaluation of Body Cooling at Standard D5.400

Version 2

December 9, 2013

On March 18, 2010, an AATB Bulletin (No. 10-05) was issued that described changes to Standard D5.400 Time Limits for Tissue Recovery [7]. Where time limitations originally referred to when the donor body was not cooled for 15 "consecutive" hours, changes were made to limit when the donor body was not cooled for 15 "cumulative" hours. This change has resulted in interpretation that additional documentation is required. A perceived flaw of allowing up to 15 consecutive hours of non-cooling in some circumstances could theoretically allow for recovery of a donor's tissues to begin with literally only minutes of body cooling having occurred, yet the body was subjected to a non-cooled environment many hours but under 24 hours. 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.

AATB Guidance Document No. 8

Environmental Controls & Monitoring of a Dedicated Tissue Recovery Site

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. This document does not imply that all potential sites where tissue recovery can take place must meet these guidelines. To date, contamination from the site of recovery has not been determined to be the root cause of an adverse reaction in a tissue recipient.

AATB Guidance Document No. 9

Qualification of Packaging and Validation of Shipping/Transport Procedures

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. The validation of procedures used to transport tissue is a key element for protection of tissue and is included in the scope of this guidance. This document uses the terms shipping and transport interchangeably.

This document does not cover requirements for labeling or address the use of donor, tissue identification numbers. For detailed expectations for labeling, refer to relevant sections in AATB Standards.

AATB Guidance Document No. 10

Training and Competency

Version 1

December 19, 2017

Training and competency can be conducted and documented in a multitude of ways. This guidance document will outline some different approaches that may be undertaken to accomplish training/competency but will by no means be an all-inclusive list.

Training and competency has to be an organizational wide effort. The training process begins when an employee is first hired and receives their initial training/competency and follows through periodic reviews of that competency. This includes retraining/competency checks as required by deviations, complaints or audits and when processes are changed or added. The Quality Department plays a prominent role in ensuring that training and competency are completed effectively through audits, monitoring of the training program and CAPAs.

AATB Guidance Document No. 11

Creation, Retention, and Security of Images Used in Tissue Banking

Draft

February 27, 2018

The creation, retention and security of images present challenges that all organizations should consider. These considerations include thoughtful evaluation of the type of device used to create the image, how these images will be used and evaluated, methods for securely transferring images from the initial device to subsequent devices, short and long-term storage methods, and the security and reliability of the entire process. Every tissue bank should have employee confidentiality policies that ensure records are handled appropriately by staff. Establishing written policies and procedures with medical examiners/coroners regarding obtaining and handling images should be considered a best practice. Images used for donor eligibility evaluation must be retained as part of the permanent donor record in accordance with required record retention policies and procedures.

The following Guidance Document is provided to assist AATB accredited organizations when establishing policies and procedures related to the capture and control of images. Due to rapidly evolving technology, organizations should periodically evaluate their policies and procedures.

AATB Guidance Document No. 11

Comment Submission Form

February 2018

Comment submission form for Guidance Document No. 11 Creation, Retention, and Security of Images Used in Tissue Banking.

AATB/EBAA/AOPO Implementation Guidance Document

Uniform DRAI Forms (Donor > 12 yrs old)

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.

To access components and considerations for developing and implementing an effective quality assurance program for personnel performing the DRAI process, refer to the current version of the AATB-EBAA-AOPO Guidance Document titled "Effective Quality Assurance of the Donor Risk Assessment Interview."

AATB/EBAA/AOPO Implementation Guidance Document

Effective Quality Assurance of the Donor Risk Assessment Interview

Version 2

September 16, 2013

This guidance document provides expectations and describes best practice for managing an effective QA Program that provides a high level of assurance the DRAI process is being performed consistently as intended.

AATB/NFDA Best Practices for Cooperation among OPOs, Tissue Banks, and Funeral Service Professionals

July 2013

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. Many of these problems resulted from a lack of communication and understanding of different roles and responsibilities between and among funeral service professionals, tissue banks and organ procurement organizations in order to allow each to better serve the needs of the families in their shared communities.

AATB/ICCBBA Interim Guidance Document (IG-028)

For Use of ISBT 128 by North American Tissue Banks

Version 1.2.0

September 2012

The purpose of this document is to provide guidance on the implementation of the ISBT 128 Standard for tissues to those banks that are moving forward with the introduction of ISBT 128.

Policy for the Use of Trademarks, Servicemarks, and Certification Marks

July 30, 2016

This policy is intended to ensure consistency, appropriate use, and the integrity of the AATB's logos and service marks. These guidelines apply to all use of American Association of Tissue Banks logos and marks by any person.

Appendix III Tissue Donor Physical Assessment Form

July 18, 2016

This form is to be used in conjunction with the Appendix III Tissue Donor Physical Assessment Form Requirements.

Appendix III Tissue Donor Physical Assessment Form Requirements

July 18, 2016

This new appendix was derived from a document formerly titled "AATB Guidance Document No 1, v2 Tissue Donor Physical Assessment Form, 6-27-05." As an appendix, compliance is mandatory. The form and instructions that follow must be used to document the tissue donor physical assessment.