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

The currently available indication criteria of living donor liver transplantation (LDLT) for patients with hepatocellular carcinoma (HCC) have high prognostic power but insufficient discriminatory power. On the basis of single-center results from 221 HCC patients undergoing LDLT, we modified the indication criteria for LDLT to expand recipient selection without increasing the posttransplant recurrence of HCC. Our expanded criteria, based on explant pathology, were largest tumor diameter Յ 5 cm, HCC number Յ 6, and no gross vascular invasion. One hundred eighty-six of the 221 HCC patients (84.2%) met our criteria, 10% and 5.5% more than those that met the Milan and University of California at San Francisco (UCSF) criteria, respectively. The overall 5-year patient survival rates were 76.0% and 44.5% within and beyond the Milan criteria, respectively; 75.9% and 36.4% within and beyond the UCSF criteria, respectively; and 76.3% and 18.9% within and beyond our expanded criteria, respectively. Although these 3 sets of criteria had similar prognostic power, our expanded criteria had the highest discriminatory power. Thus, these expanded criteria for LDLT eligibility of HCC patients broaden the indications for patient selection and can more accurately identify patients who will benefit from LDLT. Liver Transpl 14: [935][936][937][938][939][940][941][942][943][944][945] 2008. See Editorial on Page 911Liver transplantation is an effective treatment for unresectable hepatocellular carcinoma (HCC), but posttransplant HCC recurrence is associated with a dismal prognosis. 1-6 Eligibility guidelines for transplantation, such as the Milan and University of California at San Francisco (UCSF) criteria, have been adopted to reduce the posttransplant recurrence of HCC and the wasting of donor organs. 1,3 The Milan criteria were originally established on the basis of pretransplant imaging findings but were reevaluated on the basis of explant liver pathology, whereas the UCSF criteria were based on explant pathology but validated by pretransplant imaging findings. 1,3 Each of these 2 sets of criteria is derived from the experience with deceased donor liver transplantation (DDLT) at a single center. Application of these criteria to living donor liver transplantation (LDLT) has resulted in patient survival outcome very similar to that following DDLT, as shown in large-volume multicenter cohorts from Japan and Korea. 5,6 Moreover, the prognostic powers of the Milan and UCSF criteria are the same in both DDLT and LDLT.Discrepancies between the pretransplant radiological and explant pathologic stagings can occur, and candidates for DDLT should be selected after consideration of the extent of HCC at the time of listing and any further progression of HCC during the waiting period. LDLT, because of its shorter waiting time, is less affected by tumor

With the development of modern solid-phase assays to detect anti-HLA antibodies and a more precise histological classification, the diagnosis of antibody-mediated rejection (AMR) has become more common and is a major cause of kidney graft loss. Currently, there are no approved therapies and treatment guidelines are based on low-level evidence. The number of prospective randomized trials for the treatment of AMR is small, and the lack of an accepted common standard for care has been an impediment to the development of new therapies. To help alleviate this, The Transplantation Society convened a meeting of international experts to develop a consensus as to what is appropriate treatment for active and chronic active AMR. The aim was to reach a consensus for standard of care treatment against which new therapies could be evaluated. At the meeting, the underlying biology of AMR, the criteria for diagnosis, the clinical phenotypes, and outcomes were discussed. The evidence for different treatments was reviewed, and a consensus for what is acceptable standard of care for the treatment of active and chronic active AMR was presented. While it was agreed that the aims of treatment are to preserve renal function, reduce histological injury, and reduce the titer of donor-specific antibody, there was no conclusive evidence to support any specific therapy. As a result, the treatment recommendations are largely based on expert opinion. It is acknowledged that properly conducted and powered clinical trials of biologically plausible agents are urgently needed to improve patient outcomes.