The cost of errors and its antithesis, the cost of quality, is often written about in terms of financial impact to medical laboratories and the healthcare system. This article...

Polymerase Chain Reaction (PCR) is a standard laboratory technique used to amplify a specific sequence of DNA many times over. This technique has become an important tool in clinical...

COLA announced that the Centers for Medicare & Medicaid Services (CMS) has awarded COLA deemed status for the pathology specialty.“Now that COLA has deeming authority for the ...

Laboratories conducting diagnostic testing, classified by the U.S. Food and Drug Administration (FDA) as non-waived, are required to be compliant with the 1988 regulations of ...

The Clinical and Laboratory Standards Institute (CLSI) has published the 5th edition of M39 — Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. This...

Streck said its quality control kit for the BioFire BCID2 Panel for sepsis has been granted clearance by the U.S. Food and Drug Administration (FDA). MDx-Chex for BCID2 is a patient...

Blood utilization has become a more focused effort over the last decade. Accrediting bodies like the Joint Commission have asked hospitals and health systems to actively monitor...

The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of guideline EP39 —A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation...

Product shelf life is an essential product performance requirement that, along with other design requirements, is used to determine the safety and efficacy of a clinical diagnostic...

Bio-Rad Laboratories has launched the SARS-CoV-2 S Gene Alpha, Beta, Gamma and Epsilon Variant Controls as part of the company’s Exact Diagnostics line of molecular quality control...