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
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 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
Some recent articles on the subject of Quality Indicators have reminded me that analytical quality is to laboratory management much like the laboratory is to the hospital: over-worked, under-appreciated, and assumed to be of reliably excellent quality.
- Laboratory Medicine Quality Indicators: A Review of the Literature, Shahram Shahangian, PhD, MS, and Susan R. Snyder, PhD, MBA, Am J Clin Pathol 2009;131:418-431
- A Summary of Deliberations on Strategic Planning for Continuous Quality Improvement in Laboratory Medicine, Dana Marie Grzybicki, MD, PhD, Shahram Shahangian, PhD, Anne M. Pollock and Stephen S. Raab, MD. Am J Clin Pathol 2009;131:315-320.
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Posted by Sten Westgard, MS
This week two Harvard doctors wrote an op-ed for the Wall Street Journal: Why 'Quality' care is dangerous (subscription may be required, depending on time of access). In this essay, they warn of the dangers of what they term the "quality metrics" that provide the basis for "pay-for-performance" systems that may govern physician reimbursement. Under any of the proposed healthcare reforms, P4P schemes may be used as a way to "incentivize" doctors and clinicians to provide the right care to their patients.
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