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Committee Update:
Quality Assurance & Standards Committee (QAS)

Linda Dunn

Linda Dunn and Chris Bishop (Former QAS Chair)

Marcelo Pando

Chair: Linda Dunn
Co-Chair: Marcelo Pando

Each year the ASHI Quality Assurance & Standards Committee (QAS), with help from the Accreditation Review Board (ARB), reviews the ASHI Standards for content requiring updates or revisions.

This annual review ensures that the standards keep pace with changes in the field and meet necessary federal requirements by comparing ASHI QAS, CMS (CLIA), FDA, NMDP and OPTN policies and regulations. Committee liaisons from the ARB, NMDP and EFI contribute content and interpretation guidance throughout the review process.

From January to July the QAS meets through a number of conference calls and, with input from the ASHI Board of Directors and the ARB, creates a draft that contains new and revised standards.

This draft is distributed for public comment during the month of August. The committee reviews all comments received and distributes a revised draft (including public comments and responses) to the Board and ARB for consideration. Once all questions have been addressed, the draft is submitted to ASHI Publications for clean-up and to create the final version for submission to CMS by mid-November.

The QAS and ARB respond to any questions received from CMS and, once approved, the new ASHI Standards become effective on Jan. 1.

The 2015 QAS Committee consists of two co-chairs, 11 members, three liaisons (ARB, EFI, NMDP), and two ASHI representatives.

The 2014 standards version is posted in the Lab Center of the ASHI website.
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The Federation of Clinical Immunology Societies (FOCIS)
It is necessary to understand new developments in a multitude of autoimmune diseases and in the basic immunology of autoimmunity to stay the cutting edge of your field. The Federation of Clinical Immunology Societies (FOCIS) is composed of more than 900 individual worldwide clinicians and researchers improving human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases.
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Kidney Allocation System (KAS) 'Out-of-the-Gate' Monitoring: OPTN Report — Jan. 13
Read the OPTN report of early data regarding the performance of the new kidney allocation system. The OPTN will be publishing these reports every two weeks in order to determine how the new system is working. As you can see in the current report, the new system is allocating more organs for highly sensitized candidates. Just over one in six transplants in the first three weeks of the new system went to candidates with cPRA of 99 or 100. Along with that, the number of kidneys that were transplanted outside the local Donor Specific Area went from 1/5 to 1/3.
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Nominees Chosen for 2015 OPTN/UNOS Board of Directors Election

At its November meeting, the OPTN/UNOS Board of Directors approved the following slate of nominees for Board appointments beginning in June 2015. The OPTN Board of Directors also functions as the UNOS Board of Directors. OPTN/UNOS member voting representatives will receive a ballot and biographical information for the nominees in January or February (specific date to be determined).

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OPTN/UNOS Policy and Bylaw Proposals

Distributed for Public Comment
Jan. 27

This document contains ten proposals being offered for public comment. These proposals were developed by OPTN/UNOS committees. When the public comment period ends on March 27, 2015, each sponsoring committee will review the feedback it receives and consider modifications to the original proposals. The OPTN/UNOS Board of Directors will review and vote on these proposals at its meeting on June 1-2.

Please click on the link to provide your comments on these proposals.

You may also send general feedback to

Please submit all comments no later than March 27. For general questions about the proposals, please contact your Regional Administrator at (804) 782-4800.

We welcome your feedback on these proposals and other aspects of the public comment process as we continue to improve the way that we communicate with the community.

Thank you in advance for your careful review and feedback on these proposals.

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Regional Workshops

2015 ASHI Regional Education Workshops
Workshop 1: San Antonio, Texas - Thursday, April 30 - Saturday, May 2
Workshop 2: Philadelphia, Pennsylvania - Thursday, June 18 - Saturday, June 20

For more information on the ASHI Regional Education Workshops, please visit the Regional Meetings page.

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High-resolution HLA-A, HLA-B and HLA-DRB1 haplotype frequencies from the French Bone Marrow Donor Registry
Human Immunology
Scientists have estimated human leukocyte antigen (HLA) haplotype frequencies using the maximum likelihood mode, which accommodates typing ambiguities. The results of the frequency distribution of the 7015 haplotypes obtained are presented in this study. These include a total of 114 HLA-A, 185 HLA-B and 76 HLA-DRB1 unique alleles at each locus.
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Long-lived immunotherapy stem cells
The Scientist
Researchers have tracked a type of immune cell called T memory stem cells in patients who received infusions of genetically modified lymphocytes more than a decade ago. According to a paper published Feb. 4, in Science Translational Medicine, the team found not only that a population of the stem cells are still present, but also that they give rise to other types of T lymphocyte.
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FDA rethinks regulatory approach for next-generation sequencing
Amid President Barack Obama's planned Precision Medicine Initiative, the U.S. Food and Drug Administration is evaluating its regulatory approach to next-generation sequencing (NGS). While most diagnostic tests fit the FDA's "one-test, one-disease paradigm" for evaluating a test's analytical and clinical performance, NGS produces a massive amount of data that might require a new approach, FDA Commissioner Margaret Hamburg wrote in a blog post.
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ASHI Insights
Colby Horton, Vice President of Publishing, 469.420.2601
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