[Posted by Sten Westgard, MS, from the AACC Press Release]
Posted by Sten Westgard, MS
As we write, the National Basketball Playoffs are underway. The home team for Westgard QC, the Milwaukee Bucks, just went down to defeat in the final game of a 7-game series.
Those who follow basketball know that in a series like this, the teams basically alternate home court advantage. The Bucks went to Atlanta to play the Hawks for two game,s then the Hawks came to Milwaukee to play the Bucks for two games, etc. But while there is a home court advantage in the audience (which didn't work: both teams won away games), the courts in every stadium are the same. The basketball hoop in Atlanta is the same as the basketball hoop in Milwaukee. Why is that?
Because the rules specify a consistent goal. The NBA has a rule book which states the precise size of the court, equipment and basket size. A basket, for example, "shall consist of a pressure-release NBA approved metal safety ring 18" in inside diameter with a white cord net 15" to 18" in length." Every stadium must comply with this rule.
Likewise, there is a single standard for the basketball: "The National Basketball Association (NBA) allows only one official ball: The ball must be the official NBA game ball manufactured by Spalding. The ball is orange in color, 29.5 inches in circumference and weighs 22 ounces (size 7). It must also be inflated to between 7.5 and 8.5 pounds per square inch."
Sorry for the long prologue. But wouldn't it be nice if labs were the same?
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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
In June of this year, Zoe Brooks presented an AACC-sponsored webinar with the title, Laboratory QC: Bridging the Gap Between Theory and Practice. During this webinar, Zoe presented a poll and more than 100 participants responded. The results are very interesting...
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Posted by Sten Westgard, MS and James O. Westgard, PhD
As reported elsewhere on the website, several of the symposiums this year were on standardization and harmonization for various analytes. This year, however, there was an added note of urgency. For many laboratorians, standardization seems like a somewhat esoteric subject, important but not necessarily pressing. But with the expectation of widespread implementation of electronic medical records, the problems with “comparability” of test results (and analytical methods) are about to become stark.
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Posted by Sten Westgard, MS
A recent abstract from the 2009 IFCC/EFCC (Euromedlab) caught my eye:
Quality Indicators for Laboratory Process; assessment in the Trento Department of Laboratory Medicine.
I Caola, C Pellegrini, N Bergamo, E Saurini, P Caciagli.
CCLM 2009
Examining the quality records of five laboratories, they applied a set of Quality Indicators from the IFCC. Errors were tracked and tabulated. The results are quite interesting.
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
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In a recent article in Annals of Clinical Biochemistry, a group over in the UK did an unusual thing - they audited their IQC (internal quality control) practices. The North Thames Audit and Quality Assurance Group use a questionnaire to assess the IQC practices in 54 laboratories in part of the United Kingdom. Here's the specific citation:
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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