Tools, Technologies and Training for Healthcare Laboratories

How uncertainty is used in the real world

Posted by Sten Westgard, MS

During my travels, I came across this at a laboratory which shall remain anonymous, where they are required by ISO 15189 to report measurement uncertainty to their clinicians:

UncertaintyReport

If you can't read that interpretive comment, I'll spell it out after the jump...

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Pop Quiz: Do you suffer from Low QC?

Posted by Sten Westgard, MS [with apologies in advance*]

IsItLowQC

Take the "Low QC" Quiz to see if your laboratory is suffering from this new condition...

  • Do you have a decrease in your desire to QC?
  • Do you have a general lack of energy at work caused by QC?
  • Have you noticed a decrease in your enjoyment of life, possibly due to QC?
  • Are you sad and/or grumpy about QC?
  • Has there been a recent deterioration in your ability to trouble-shoot QC?

Answers, after the jump...

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Pop Quiz: How good (bad) are US hospitals at inflicting adverse harm?

Posted by Sten Westgard, MS

We've all heard the infamous quote now over a decade and a half old: that US hospitals kill between roughly 40,000 and 90,000 patients each year. This was an estimate courtesy of the Institute of Medicine report "To Err Is Human" which made the dire performance of hospitals knowledge that even the general public could understand.

But more recently, studies have been tracking the adverse event rates much more closely. A recent NEJM paper followed four conditions from 2005 to 2011.

Of these four conditions, which do you think has the best Sigma performance when it comes to the occurrence of adverse events?

A. Acute Myocardial Infarction (AMI)

B. Congestive Heart Failure

C. Pneumonia

D. (other) Conditions Requiring Surgery

The answer, after the jump...

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FDA to ISO 15197: Not good enough

Posted by Sten Westgard, MS

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NY: Glucose Meters Going Off-Label?

Posted by Sten Westgard, MS

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New Book: Quality Control for Qualitative Tests, Paulo Pereira, PhD

Posted by Sten Westgard, MS

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A dearth of data in published papers

Posted by Sten Westgard, MS

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EFLM database: 78 steps forward, 272 steps back

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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Sigma Metrics ... Spotted in Chinese EQA Reports.

Posted by Sten Westgard, MS

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Lab Week 2019: Thanks for the Tests

Posted by Sten Westgard, MS

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New Course!! Six Sigma Metrics

Posted by Sten Westgard, MS

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Technopath Clinical Diagnostics and Westgard QC announce Strategic Partnership

Posted by Sten Westgard, MS

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Are performance specifications based on biological variation for hemostatis unfit-for-purpose?

Posted by Sten Westgard, MS

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Univants of Healthcare Excellence Award

Posted by Sten Westgard, MS
An opportunity to demonstrate your patient impact! If we face the reality that the laboratory future must involve a closer interaction with clinical care and outcomes, here's an award that focuses on that very thing. Demonstrate how your lab results improve care and benefit patients, and your healthcare organization will receive and award from a consortium of AACC, IFCC, HIMSS, Modern Healthcare and more: https://lnkd.in/dGBz5Fq hashtagUnivants hashtaglabfuture
[full disclosure: this award is sponsored in part by Abbott Diagnostics, a company with which Westgard QC has business.]
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New Survey: Polling your Concerns about Point of Care QC

Posted by Sten Westgard, MS
 
We've asked the world about their QC, their IQCP, and their Six Sigma. Now we want to know about the quality control practices at the POC, near-patient, and/or rapid diagnostic testing.
 
 
(As is our tradition, several participants will randomly be selected to win a raffle prize: in this case, an early advance copy of the 2019 Poor Lab's Guide to the Regulations, to be published in early 2019.) Please, share your practices - and frustrations - with us about your point of care quality!
 
(Note: this survey is only open to operational laboratories, not for vendors or manufacturers)
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Gracias, XV Congress SMLC, Santiago

Posted by Sten Westgard, MS
 
Thanks to Dr Carolina Prieto and SMLC for inviting me to the XV Congress SMLC in Santiago Chile. I presented on the evolution of the “Westgard Rules” and QC Frequency. This conference serves as an appetizer for a much larger event to come: ALAPAC ML2020 will be here in Santiago. Visit www.smlc.cl for more details. Mark your calendars.
 
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Gracias, Laboratorio de Analisis Clinicos - 1 Day Symposium

Posted by Sten Westgard, MS

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Theranos finally bleeds out...

Posted by Sten Westgard, MS

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Coming to Abuja, December

Posted by Sten Westgard, MS

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