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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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Remember in 2017 when there were predictions that Theranos wouldn't last out the year?
It appears reports of Theranos' death were greatly exaggerated... or maybe not
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Posted by Sten Westgard, MS
In Biochemia Medica, a recent article detailed the Minimum requirements for the estimation of measurement uncertainty:Recommendations of the joint Working group for uncertainty of measurement of the CSMBLM and CCMB.
Can you guess how many?
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:
Posted by Sten Westgard, MS
A recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.] Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...