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 But then this withdrawn memo was also reissued as a draft, with additional draft clarifications.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?
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.
Small point-of-care chemistry analyzers continue to enter the market. Is the latest model an acceptable substitute for core lab quality results?
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?
An analysis of 4 different point-of-care (POC) analyzers and one POC device for HbA1c, based on a study published in 2012. The focus of the study was to find practical POC devices that could support faster decision making for the country's large HIV population. The question is, do any POC devices provide adequate quality for that type of clinical care?
We've talked about Westgard Rules for decades, and we've talked about Six Sigma for years. So what happens when we try to talk about both at the same time? Westgard Sigma Rules
For all its ubiquity in the lab, proper QC isn't easy. Even though every laboratory has to perform Quality Control, that hasn't made the task any simpler. It still relies on the right mean, the right SD, the right control limits, the right rules and numbers of control measurements, and the right interpretation of control data points. If you get one part of this system wrong, it can throw off the correct implementation. Here's an example that was recently published showing the difficulties and challenges of performing proper QC.