Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
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
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
Dr. Westgard talks about the new era of QC at the Thermo Fisher workshop.
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
As many of you know, the FDA has issued new draft guidelines about Blood Glucose Monitoring Test Systems for Industry and Manufacturers.
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
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Posted by Sten Westgard, MS
As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.
We tried out the question and answer line with CMS, see the results after the jump...
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Posted by Sten Westgard, MS [with apologies in advance*]
Take the "Low QC" Quiz to see if your laboratory is suffering from this new condition...
- Do you have a decrease in your desire to QC?
- Do you have a general lack of energy at work caused by QC?
- Have you noticed a decrease in your enjoyment of life, possibly due to QC?
- Are you sad and/or grumpy about QC?
- Has there been a recent deterioration in your ability to trouble-shoot QC?
Answers, after the jump...
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