Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
The biggest news coming out of the AACC/ASCLS conference in Houston was made by Judy Yost of CMS.
So the new future is IQCP. Remember what that stands for?
- It's Quickly Coming to Pass
- I've Quit Caring about Performance
- It's Quackery, Chaos, and Pablum
- I'm Quietly Compromising my Processes
Posted by Sten Westgard, MS
On August 16th of this year, CMS issued a new memo about IQCPs. If you recall, 1, 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.
Posted by Sten Westgard, MS
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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Laboratory Quality Control Based on Risk Management
Posted by James O. Westgard, Sten A. Westgard
Posted by Sten Westgard, MS
Westgard QC is proud to announce 2 new public workshops to be held this year:
Both workshops will be held at the DoubleTree Hotel in Madison, Wisconsin.
For more than a decade, the Westgard Workshops have provided in-depth training that can't be found at other conferences. If you want to be more than an anonymous seat in a cavernous hall... If you want to learn whether or not the latest management fad has any real applications in laboratories... If you want honest assessments instead of equivocal statements... If you care more about practical tools than precious theory... You need to attend the Westgard Workshops.
More details on the workshops after the jump...
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Posted by Sten Westgard, MS
Earlier, we posted an article on the website with a darkly humorous take on the passing of the CLSI EP22 guideline, which voted itself out of existence in late 2010. Other websites have also noted its passing.
But it's worthwhile to take a moment to discuss, in all seriousness, where we are with Risk Information, Risk Management, "Equivalent QC", and the CLIA Final Rules. How did we get here? What drove us to this state? Where are we going next?
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Posted by Sten Westgard, MS
The National Oil Spill Commission released a preliminary chapter of its report today. This is the commission charged with finding out what went wrong with the Deepwater Horizon / Macondo oil rig in the Gulf of Mexico that blew up in 2010 and spilled 4 million barrels of oil and killed 11 workers.
Whenever there are big stories in the media, we like to take a look at them to see if we can learn anything, find any connection between the disaster and our own situation in the medical laboratory community. But from a distance, it's hard to see any similarities between oil rigs and labs, right?
Right?
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Alan Greenspan gave some instantly notorious testimony to the US Congress recently:
“I was right 70 percent of the time, but I was wrong 30 percent of the time,”
I'm not sure what was more concerning; the fact that he admitted that almost a third of the time he was wrong, or that he clearly believes that being right only 70% of the time was acceptable. Clearly, for a man once called "The Oracle" and Maestro, he was lowering the bar on the standards for judging him.
Testimony like that raises some instant questions:
- If Alan Greenspan was responsible for setting the direction of the world's greatest economy, is a 30% error rate acceptable?
- If Alan Greenspan was an airline, would you fly him?
- If Alan Greenspan was a core laboratory test, would you buy the instrument?
- If Alan Greenspan was a glucose meter, would you buy the device?
Posted by Sten Westgard, MS
In the January editorial of Clinical Chemistry, Few Point-of-Care Hemoglobin A1c Assay Methods Meet Clinical Needs, by David E. Bruns1 and James C. Boyd, there’s a key paragraph that goes beyond the HbA1c methods covered by the study by Lenters-Westra and Slingerland (Six out of eight hemoglobin A1c point-of care instruments do not meet the generally accepted analytical performance criteria. Clin Chem 2010;56:44 –52.)
“There is increasing recognition of a need to improve the precision of HbA1c assays, in view of the low biological variability of Hb A1c. The NGSP plans to reduce the
acceptability specification for level 1 laboratories to 0.70% and for manufacturers of all Hb A1c methods to <0.75% in 2010 (http://www.ngsp.org/ ngsp/prog/News/manuf09.html; accessed October 28, 2009). The College of American Pathologists (CAP) also has recognized the need to tighten total error criteria for Hb A1c and is in the process of
revising the criteria used in grading proficiency tests (http://www.
ngsp.org/ngsp/prog/News/manuf09.html; accessed October 28, 2009). In 2007,
the limit specified by the CAP for acceptability on HbA1c proficiency testing was +/- 15% of the target value. This limit was lowered to +/-12% in 2008 and to +/-10% in 2009, and it will be lowered to +/-8% in 2010 and to +/-6% in 2011. “
As these quality requirements tighten, how are we going to respond?
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
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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