Regulatory Affairs - Westgard QC - Blog - Page 4 - Results from #60

Tools, Technologies and Training for Healthcare Laboratories

New Book: Basic Quality Management Systems

Posted by Sten Westgard, MS

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Losing ground on HbA1c

Posted by Sten Westgard, MS

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Theranos Bleeds out...

Posted by Sten Westgard, MS

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  396 Hits

Thank you, Haerbin!

Posted by Sten Westgard, MS

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  338 Hits

Westgard in the News: Advance for the Laboratory Manager, February Issue

Posted by Sten Westgard, MS

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Budgets aren't the only things getting squeezed in the lab...

Posted by Sten Westgard, MS

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Sigma-metrics in Korea PT

Posted by Sten Westgard, MS

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ICYMI: Theranos receives last minute transfusion

Posted by Sten Westgard, MS

Theranos300

Remember in 2017 when there were predictions that Theranos wouldn't last out the year?

It appears reports of Theranos' death were greatly exaggerated... or maybe not

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Pop Quiz: How many equations are needed (at minimum) to calculate measurement uncertainty?

Posted by Sten Westgard, MS

In Biochemia Medica, a recent article detailed the Minimum requirements for the estimation of measurement uncertainty:Recommendations of the joint Working group for uncertainty of measurement of the CSMBLM and CCMB.

Can you guess how many?

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Theranos finally bleeds out...

Posted by Sten Westgard, MS

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AACC comments on Proposed New CLIA goals

Posted by Sten Westgard, MS

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Sigma Metrics ... Spotted in Chinese EQA Reports.

Posted by Sten Westgard, MS

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NY Times Editorial Focuses on Failures in Medical Device Regulation

A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:

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Six Sigma Metrics ... Surging in China

Posted by Sten Westgard, MS

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Thanks, NCCL!

Posted by Sten Westgard, MS

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Q and A: Is the 10:x rule still compulsory?

A recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.]  Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...

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