CLIA Final Rule
The official guide to developing IQCPs is finally out! What does it tell us about laboratory implementation of Risk Management for Quality Control? Do we even need the EP[tm] 23A guideline anymore?
While the 2015 IQCP survey was mainly targeted at US laboratories, since that's where the regulation has been developed and will have the power of law, a significant number of respondents were from outside the US. Their responses and views are an interesting contrast to those of laboratories inside the US. What would you guess, that labs within the US or outside the US are more prepared to implement IQCP? The answer may surprise you...
In addition to the IQCP survey questions, there was an opportunity for participants to speak directly and openly about their experience with IQCPs. It makes for some interesting reading, to hear the unfiltered responses of laboratorians...
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 But then this withdrawn memo was also reissued as a draft, with additional draft clarifications.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?
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.