Standarization or Standarisation? Harmonization or Harmonisation? In 2019, we seem to be headed toward a schism in performance specifications, rather than a consensus. Here's a current comparison of Global Performance Specifications for Chemistry Assays.
In February 2019, the Centers for Medicaid and Medicare issued proposed changes to the CLIA regulations. This is potentially the largest shake-up in US regulations in decades.
James O. Westgard reflects on the unique circumstances of our time, and how Quality is more important than ever.
CLIA has posted a proposed set of new quality requirements for proficiency testing. Here's what was listed in the Federal Register for public comment.
Innovative Diagnostics has become the first (and fastest) private laboratory in Singapore to achieve the Verification of Performance in May 2016. Further, it verified an additional branch (Camden) of the laboratory in September 2016. A total of more than 80 analytes, including chemistry, immunoassay, hormones and tumor markers on multiple instruments.
Stamford Hospital Laboratory is the first laboratory in Connecticut to reach Sigma Verification.
A recent study assessed the performance of a new hematology analyzer, the Landwind LW D3600.