During my last trip to India, I had the fortune to Dr Satish Ramanathan and Dr CN Srinivas of MIOT Hospitals, Chennai. They shared with me some unique challenges that laboratories face in India, namely the disconnect between the NABL 112, which is the local implementation of ISO 15189, and the other global standards and guidelines. Here are just a few of the discrepancies between NABL, CLSI EP23, and ISO 15189 that they have found.
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
On December 10th 2014 the first Empower IVD ● Globe user meeting was held in Ghent. The aim of this meeting was to report on the status of the Empower project, which promotes the quality, stability, and comparability of global In Vitro Diagnostic (IVD) testing. More than a year ago, we were excited to help spread the word about this project. It's even more gratifying to see the results of the pilot stage.
Hassan Bayat of Sina Lab in Iran contributes additional discussion points to the Clinical Chemistry Journal Club coverage of the Woodworth et al study of HbA1c methods.
While we celebrate 15 years of evidence-based quality goals, we also have a few persistent questions. Why are some goals listed as desirable, optimal, or minimal? Find out why...