Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard
This month, Dr. Westgard was teaching his spring semester class for the University of Wisconsin Medical Technology school. He likes to use recently published papers in the scientific literature as a way to relate his lessons to things happening in the "real world" of the laboratory.
This semester, he has written up a number of lessons covering HbA1c methods, performance, and quality requirements based on the article in Clinical Chemistry, Few Point-of-Care Hemoglobin A1c Assay Methods Meet Clinical Needs, by David E. Bruns1 and James C. Boyd and a 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.)
For your convenience, here are the lessons in order...
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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
Posted by Sten Westgard, MS
Back in April we posted about What Doctors know, a revealing study of "junior doctors" - what we call residents in the US. If you follow the link, and/or read the study, you'll find out that doctors don't know much about laboratory test results.
However, it could be argued that doctor ignorance isn't that critical, since the doctors can always ask their friendly neighborhood laboratorian for help and advice in test interpretation.
Alas.
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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 James O. Westgard, Ph.D.
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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