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All Rights Reserved. No part of the contents of this document may be reproduced or transmitted in any form or by any means without the written permission of the publisher. 4 Standard Guidance A. General Provisions A.1 Basis and Scope A.1.1 This document sets forth the conditions that a laboratory must satisfy in order to be accredited by the American Society for Histocompatibility and Immunogenetics (ASHI) to perform testing on human specimens. These Standards have been established by the ASHI Quality Assurance and Standards Committee following review, and response to, public comments. These Standards have been approved by the ASHI Board of Directors. These Standards have been established to help ensure accurate and dependable immunogenetics, histocompatibility, and transplantation testing consistent with the current state of wellestablished laboratory procedures. A.1.2 All laboratories requesting ASHI accreditation must meet the same requirements, regardless of their location in the U.S. or a foreign country and regardless of whether or not they are using ASHI accreditation for compliance with CLIA regulations. Re: A.1.2-Certain rare cases in which Standards are indicated to apply only to UNOS laboratories or only to U.S. Laboratories (e.g., the requirement to include the FDA disclaimer on reports) are exceptions to Standard A.1.2 A.2 Abbreviations ARB Accreditation Review Board ASHI The American Society for Histocompatibility and Immunogenetics. CDC Centers for Disease Control and Prevention CFR US Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments of 1988. CLIA regulations are defined in 42 CFR 493. CMS US Centers for Medicare and Medicaid Services CPRA Calculated Panel Reactive Antibody CREG Cross Reactive Group DNA Deoxyribonucleic acid EFI European Federation for Immunogenetics ELISA Enzyme-linked immunosorbent assay

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