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
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
My esteemed colleague, good friend, and keen-eyed tracker of all things regulatory. Dr. Sharon Ehrmeyer, alerted me to a HUGE change in US regulations.
In April CMS sent out a memo title "Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories"
This memo may contain as big a shift in regulatory policy as IQCP was to EQC. More, after the jump...
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Posted by Sten Westgard, MS
Now that the age of the IQCP is here, laboratories are grappling with the time and effort it takes to build their Individualized Quality Control Plans. How long should it take to build an appropriate IQCP?
- 40+ hours
- 21-40 hours
- 11-20 hours
- 5-10 hours
- Less than 5 hours?
How much time has it taken for you? How much time do you think it should take?
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