Tools, Technologies and Training for Healthcare Laboratories

Pop Quiz: What's the biggest source of errors in a Nigerian QMS?

Posted by Sten Westgard, MS

A recent article about the experience of QMS tracking in a clinical laboratory in Nigeria raised some interesting questions about sources of errors in "developing world" laboratories.

Where would you expect a Nigerian Human Virology laboratory (HVL) to experience the most problems?

  • pre-analytical processes
  • analytical processes
  • post-analytical processes

The answer, after the jump...

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When did the US become irrelevant to Quality Goal Setting?

Posted by Sten Westgard, MS

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Pop Quiz: What's an acceptable POC defect rate?

Posted by Sten Westgard, MS

MissedTarget

Earlier this month (July) I came across a series of revealing posts on a listserv about the quality of  glucose meters. For me, it raised the question, just what defect rate is acceptable at the point of care?

  • 0.00034%
  • 1%
  • 5%
  • 10%
  • 40%
  • 75%
  • 100%

What level of defect rate do you believe is being seen at the point of care? the answer (after the jump) might astonish you...

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New Book: Basic Quality Management Systems

Posted by Sten Westgard, MS

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Upcoming Workshop: Time to Change Your QC?

Posted by Sten Westgard, MS

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HbA1c: Bias is a big deal, and CV is critical

Posted by Sten Westgard, MS

Two interesting abstracts and papers concerning HbA1c came out recently. As laboratories switch from fasting blood glucose to HbA1c to diagnosis diabetes, the importance of the method performance of HbA1c methods is becoming critical.

But what's more important? Bias or CV?

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Upcoming Workshop: Got Sigma?

Posted by Sten Westgard, MS

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Upcoming Workshop: Right QC, Right Method, Right Controls?

Posted by Sten Westgard, MS

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Journal alert: Sigma-metrics in CCLM

Posted by Sten Westgard, MS

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Q&A: How to Plan for IQCP?

PosteQuestionPathsAheadd by Sten Westgard, MS

As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.

We tried out the question and answer line with CMS, see the results after the jump...

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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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Halloween COLABIOCLI

Posted by Sten Westgard, MS

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5 Questions we still have about IQCPs

Posted by Sten Westgard, MS

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5 Things we Know Now about IQCPs

Posted by Sten Westgard, MS

RiskIsHereOn August 16th of this year, CMS issued a new memo about IQCPs. If you recall, IQCP stands for  Individualized Quality Control Plan, and it's part of the new Risk QC being proposed by CMS as a replacement for EQC. The CLSI guideline EP23, which came out about two years ago, laid out the broad outlines of this new policy, but we have been waiting for the government regulations to spell out the specifics of implementation and interpretation.

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Pop Quiz: If labs want to reach quality, do they need MAPS?

Posted by Sten Westgard, MS

In a recent issue of CCLM, an interesting opinion paper reported on a pilot study of the quality of UK laboratories.

Given 5,812 QC data points on 5 different platforms in 9 different laboratories measured over 6 months, and a quality goal of 7.0%  how many of those laboratories do you think achieved 5-Sigma quality?

  • 100%
  • 75%
  • 50%
  • 25%
  • less than 25%

The answer, after the jump...

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Could your laboratory catch this error? A Coda

Posted by Sten Westgard, MS

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