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Why quality matters

Quality is the mantra of medical laboratory professionals, but what is quality? What does it really mean? Why does it matter? Isn’t quality control (QC) good enough? Isn’t it ...
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More than cost: The true impact of errors

April 20, 2022
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...
Ideal layout for a molecular laboratory to reduce contamination events. This layout ensures separation of clean reagents and equipment from exogenous DNA sources (i.e., samples and/or amplicon containing material).

Preventing cross-contamination in a molecular laboratory

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...
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COLA gains pathology deemed status from CMS

March 8, 2022
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 ...
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Document review, competency, proficiency testing, and correlation testing are among the standards cited most often during on-site surveys at clinical labs.

What clinical laboratories should do to become survey ready

Feb. 23, 2022
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 ...
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CLSI publishes new guideline M39 — analysis and presentation of cumulative antimicrobial susceptibility test data

Feb. 17, 2022
The Clinical and Laboratory Standards Institute (CLSI) has published the 5th edition of M39 — Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. This...
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FDA clears Streck’s MDx quality control for BioFire sepsis product

Jan. 31, 2022
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...
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Penn Medicine Princeton Medical Center began an aggressive real-time blood utilization program in July 2016.

Improving red blood cell usage at an academic medical center

Jan. 19, 2022
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...

CLSI publishes a hierarchical approach to selecting surrogate samples for testing

Jan. 13, 2022
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...étiquette-du-médicament-flacon-image196839559
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Establishing expiry date for clinical diagnostic reagents

Dec. 22, 2021
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...
Courtesy of Bio-Rad
Courtesy of Bio-Rad

Bio-Rad launches SARS-CoV-2 S Gene Alpha, Beta, Gamma and Epsilon variant controls for research testing

Nov. 15, 2021
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...