Posted by Sten Westgard, MS
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Posted by Sten Westgard, MS
Does this look like an error to you?
The latest ISO 15189 version has a new rule. Measurement Uncertainty is no longer optional, it's mandatory.
Do you know how to calculate MU?
Another chance to review instrument performance on the Siemens Vista. Back in 2012, we looked a study that assessed the method performance of cancer markers on the Vista. Now we've found a second study, this time one that compares method performance of the new Vista with the older Immulite methods.
Do two studies tell the same story?
Would your lab like to join a pilot project that monitors patient 50th percentiles? A project that would look across labs and manufacturers to develop a direct, real-time Quality Indicator that would fulfill ISO 15189's requirement for monitoring the quality of analysis of patient samples?
Looking for a few, good labs willing to share data
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Could your lab catch this error?
A recent letter to the Journal of Clinical Pathology showed an example of the consequences of missing a lab error for 10 days. Commendable that this laboratory was willing to share its challenges with the wider world. But it raises the question, how many labs could have caught this error? When we widen our limits with larger SDs and reduce our use of control rules, are we at risk of becoming blind to medically important errors?Does this look like an error to you?
From ISO, What's New? Labs must MU!
The latest ISO 15189 version has a new rule. Measurement Uncertainty is no longer optional, it's mandatory.
Do you know how to calculate MU?
Cancer markers on the Vista, Second look
Another chance to review instrument performance on the Siemens Vista. Back in 2012, we looked a study that assessed the method performance of cancer markers on the Vista. Now we've found a second study, this time one that compares method performance of the new Vista with the older Immulite methods.
Do two studies tell the same story?
Quality Kickstarter: Patient Percentile Monitoring
Would your lab like to join a pilot project that monitors patient 50th percentiles? A project that would look across labs and manufacturers to develop a direct, real-time Quality Indicator that would fulfill ISO 15189's requirement for monitoring the quality of analysis of patient samples?
Looking for a few, good labs willing to share data
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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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