Tag Archives: CLIA

Proficiency testing in the USA

CLIA legislation forces certain obligations on labs in the USA.  Unlike the EU, ISO 17025 / 15189 accreditation is not one of them.  Proficiency testing is: and so it should be. Testing labs with External Quality Assurance (EQA) samples rather than … Continue reading

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“Quality-less Compliance”

ISO standards have not been as successfully pushed into the USA as they have been in Europe.  The US has CLIA instead, and it fails too.  In a disproportinate reaction to public concern over one or more deaths due to misread … Continue reading

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Bureaucracy killing research

While research and the USA largely get by just fine without ISO lab standards and this paper therefore does not mention them, it does illustrate the effects of analogous bureaucracy in the marked decline of clinical research.  Food and Drug … Continue reading

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