We are pleased to have a guest essay explaining the latest in Method Verification, specifically the newest version of the CLSI guideline EP15 on Method Verification. For labs seeking a quick check to insure their methods are meeting manufacturer specifications, EP15 may be the right choice
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?
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 But then this withdrawn memo was also reissued as a draft, with additional draft clarifications.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?
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...
On November 24th and 25th of 2014, the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine' was held. The conference organizers released the official restructured hierarchy in 2015.
Results of the survey of laboratories and their IQCP readiness. With less than nine months left, how much work do US laboratories have left to accomplish?
The momentum behind IQCP is accelerating. Companies are launching education initiatives, new software programs, and there are webinars, workshops, and online tutorials. But does anyone really understand what an IQCP is yet? Does anyone know what the P stands for? Problem? Plan? Placebo?