Tools, Technologies and Training for Healthcare Laboratories

CLIA Final Rule

CMS goes off-off-label

CMS took an unusual step on March 13th, 2015. They temporarily withdrew a memorandum they had issued in November 21, 2014 on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS). But then this withdrawn memo was also reissued as a draft, with additional draft clarifications. What's going on?

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Is this the end of EQC 1, 2, 3?

The Current State of Equivocal QC Practices

This article is an attempt to capture the state of opinion about EQC. As such, it is very dependent on the context of this particular moment (June 2005). Opinions and positions have been fluid. It is likely that in the coming months there will be further changes in attitude and adoption of EQC. We therefore do not claim that we have determined the definitive mood on this issue. All we can assert is that we have grabbed a snapshot.

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"Equivalent" QC Option 4: Back to the future

Back to the Future: CLIA EQC Option 4

A recent meeting held by the Institute formerly known as NCCLS (now CLSI) proclaimed EQC as the "QC for the Future", then promptly proposed a new option that would replace thecurrent options. Even more interesting, the new option comes out of CLIA's past...

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A Scientific Rationale for Equivalent QC?

CLIA Final Rule:
An Open Letter Regarding
the Scientific Rationale for Equivalent QC

For those wondering about the new "Equivalent QC" procedures, the AACC POC listserve has been a must-read. Arguments about the validity, acceptability, and practicality of "eQC" have been raging back and forth. Recently, someone posted an open letter to CMS, asking for the scientific rationale behind eQC. CMS replied with a statement. For those who don't subscribe to the AACC POC listserve, we're happy to post the entire conversation here.

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