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American Association of Tissue Banks Selfassessment Tool Audit Report (STAR) TISSUE DISTRIBUTION INT

American Association of Tissue Banks Selfassessment Tool Audit Report (STAR) TISSUE DISTRIBUTION INT 2025

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The document is a self-assessment tool and audit report for tissue distribution intermediaries, based on the 13th edition of Standards for Tissue Banking by the American Association of Tissue Banks (AATB). It outlines the requirements for internal and external audits, including necessary documentation, compliance with regulations, quality assurance processes, and training programs. The document serves as a guide to ensure that tissue banks maintain high standards in their operations, including registrations, quality programs, facilities management, equipment maintenance, and record-keeping.

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What does a tissue bank specialist do?

Monitors tissue supply and demand; coordinates import and export opportunities to maximize tissue placement potential. Accurately enters the appropriate acquisition and shipping fees for each tissue

Who accredits tissue banks?

The American Association of Tissue Banks (AATB) sets standards, inspects facilities, and accredits tissue banks in North America.

Are tissue banks regulated by the FDA?

In the United States, all transplant tissue banks must be registered with the FDA and are inspected routinely for compliance to federal regulations. Tissue provided by AATB accredited tissue banks are required to comply with FDA, AATB Standards, and all state and local regulations.

How to become a CTBS certified?

Certified Tissue Bank Specialist, or CTBS, is an individual designation attained by passing the CTBS Exam. This designation signifies that the certified individual has successfully demonstrated an understanding of the basic principles and concepts of tissue banking and the AATB Standards for Tissue Banking.

What is an AATB certification?

Beginning in 1986, AATB initiated a mandatory Accreditation Program for its institutional members to ensure that tissue banking activities are performed in a professional manner in compliance with its Standards.

What is AATB accreditation?

AATB accreditation is based on the Standards and policies developed by the Association. Accredited Institutional Members receive reduced member rates for AATB meetings and workshops, and publications.

What states require a tissue bank license?

18. What other states license tissue banks? The States of New York, Florida, and Maryland have formal state laws that require the regulation of tissue banks.

American Association of Tissue Banks Selfassessment Tool Audit Report (STAR) TISSUE DISTRIBUTION INT 2025

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