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
During my travels, I came across this at a laboratory which shall remain anonymous, where they are required by ISO 15189 to report measurement uncertainty to their clinicians:
If you can't read that interpretive comment, I'll spell it out 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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