
<rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom">
<channel>
<title>CMS public comment on Virtual XM: Debate</title>
<link>https://www.ashi-hla.org/forums/posts.aspx?topic=1409647</link>
<description></description>
<lastBuildDate>Sat, 6 Jun 2026 11:54:59 GMT</lastBuildDate>
<pubDate>Wed, 31 Jan 2018 11:33:48 GMT</pubDate>
<copyright>Copyright &#xA9; 2018 American Society for Histocompatibility and Immunogenetics</copyright>
<atom:link href="https://www.ashi-hla.org/forums/topic_rss.asp?id=1409647" rel="self" type="application/rss+xml"></atom:link>
<item>
<title>CMS public comment on Virtual XM: Debate</title>
<link>https://www.ashi-hla.org/forums/posts.aspx?topic=1409647</link>
<guid>https://www.ashi-hla.org/forums/posts.aspx?topic=1409647</guid>
<description><![CDATA[<p><span>The Department of Health and Human Services is seeking public comment for revisions of the 1992 <span>CLIA</span> histocompatibility regulations. They are seeking criteria for when virtual crossmatching provides an acceptable <u>alternative</u> to physical crossmatching in kidney transplantation. Link for this document is:</span></p>
<p><span>I think it is important that Directors view these regulatory changes not from the perspective of practices at their own center but from a patient safety&nbsp;perspective – I would like to start a Discussion/Debate in this secure space with ASHI Directors.</span></p>
<p><span>Given the known limitations of our Luminex assays (serum interference, allele assumptions using low res HLA typing, shared epitopes leading to weaker reactivity on beads (ie Bw4) —I propose maintaining a physical crossmatch for <u>HLA sensitized waitlist candidates</u> to provide the broadest safety net. <br />
</span></p>
<p><span>Relying on Virtual Crossmatch only for candidates showing no HLA sensitization (majority of candidates) on sensitive immunoassays using at least 2 separate sera (safeguard for sample switch) and for whom the date of the most recent serum tested is in compliance with the transplant center's testing agreement (safeguard against re-activation of a candidate who has not had testing done in a long while).</span></p>
<p><span><span>Alternatively, maintain physical crossmatch for <u><span>broadly sensitized candidates and all DSA+ cases </span></u>would provide a more amenable regulation but would NOT provide the greatest patient safety given the limitations in our immunoassays.<br />
</span></span></p>
<a href="http://www.federalregister.gov/documents/2018/01/09/2017-27887/request-for-information-revisions-to-personnel-regulations-proficiency-testing-referral">http://www.federalregister.gov/documents/2018/01/09/2017-27887/request-for-information-revisions-to-personnel-regulations-proficiency-testing-referral</a>]]></description>
<pubDate>Wed, 31 Jan 2018 12:33:48 GMT</pubDate>
</item>
</channel>
</rss>
