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
Among first kidney transplant recipients younger than 40 years, older adolescents and young adults (17-24 years) have the highest risk of graft failure, irrespective of age at transplant.
Background-Left ventricular (LV) hypertrophy (LVH) in children is widely defined as a left ventricular mass index (LVMI, g/m 2.7 ) Ͼ95th percentile. However, LVMI increases with decreasing height in young children; thus, the 95th percentile LVMI will depend on the height distribution of the reference population. The objective of this study was to compare the performance of a novel method of expressing LV mass relative to body size (centile curves) with the LVMI method. Methods and Results-LV mass was estimated by M-mode echocardiography in 440 healthy nonobese reference children (birth to 21 years) and 239 children at risk for LVH; the LVMI was calculated for all children. Three samples of 270 children, each with different height distributions, were drawn from the reference population. A sample-specific 95th percentile LVMI was determined for each reference sample. At-risk children were classified as having LVH or not based on each sample-specific 95th percentile. Four LV mass-for-height centile curves were constructed with the Cole lambda-mu-sigma method and data from each reference sample. At-risk children were each assigned an LV mass-for-height percentile with these curves and were reclassified as having LVH if LV mass-for-height was Ͼ95th percentile. The centile method provided a stable estimate of the proportion of at-risk children with LVH regardless of reference group, whereas proportion estimates varied significantly depending on the reference population when the LVMI method was used.
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