Posted by Sten Westgard, MS
A recent news investigation produced a litany of laboratory errors. Can you guess which of these lab errors actually happened?
- a blood screening test fails to identify a critical blood disorder in a pregnant woman. Her child dies 3 weeks after being born
- an HIV test falsely identifies a husband as HIV positive. The couple separates, the wife unwilling to trust the husband anymore.
- a paternity test sample gets switched: a father is falsely told that his daughter is not his biological child. The family splits up. Nearly 4 years later, the laboratory contacts him and tells him he was the father. The father-daughter bond remains broken.
The answer, after the jump.
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Last month, Advance for the Laboratory published a three part series on Six Sigma in the Clinical Laboratory, written by David Plaut, Nathalie Lepage, and Kim Przekop:
While it's great that Advance has invested in in-depth coverage of the Six Sigma topic, unfortunately one of their examples in part 2 demonstrates a misunderstanding of the application.
See the mistake, after the jump...
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Posted by Sten Westgard, MS
Here's what's new on Westgard Web:
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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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
While traveling in the middle east recently, I was asked by a colleague about the new US IQCP regulations, specifically how to implement them in their foreign laboratory.
Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.
But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?
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Posted by Sten Westgard, MS
A recent question came in from a technical support consultant for a major diagnostic manufacturer:
"It is for Free T4 analyte. Customer [has] establihed a QC range after 20 QC runs. Mean and SD were derived from 20 runs and %CV achieved from 20 runs is 1.2%. Allowable interassay precision criteria according to CLIA is 6%.
"Now when customer [applies] Mean and SD according to the established range many...times they face QC rules violations of 41s and 10x.
"So can you please suggest, when the SD is too narrow is it necessary to apply these two rules to immunoassays?"
What's your guess? I'll take a stab at an answer, after the jump.
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Posted by Sten Westgard, MS
I came across a very valuable paper in Clinica Chimica Acta on the stability of hematology controls for MCV. (Some of you are already guessing what this is going to be about...)
If you take a hematology control, how many SDs should you expect to see it shift at week 5 of use versus the first week of use? In other words, what is the SDI you should expect?
- 1 SDI
- 2 SDI
- 3 SDI
- 4 SDI
- 5 SDI
- higher than 5 SDI
The answer, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Here's what's new on Westgard Web in December...
Posted by Sten Westgard, MS
A recent study reported on the error rates in an inpatient Iranian laboratory. If we pick just the Procedure error rate, which included internal control failure, external control failure, typing error, incorrect released results, and others, what do you think the rate was?
- about 3 Sigma
- about 4 Sigma
- about 5 Sigma
- about 6 Sigma
The answer, after the jump...
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Posted by Sten Westgard, MS
According to a recent CAP Q-Probe, approximately how many glucose tests are being bracketed by QC events?
Is it
- 5,000 tests between QC runs
- 500 tests between QC runs
- 50 tests between QC runs
- 5 tests between QC runs
The answer, after the jump
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