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 [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
Laboratories in the US probably already know this: their healthcare institutions are getting hit with fines from CMS due to excessive 30-day readmission rates for three conditions:
- (AMI) Acute myocardial infarction
- (HF) Heart Failure
- Pneumonia patients
CMS is imposing increasing fines for hospitals that have excessive readmissions. Guess how many hospitals have been fined - and how much money they've had to pay back...
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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
An opportunity to demonstrate your patient impact! If we face the reality that the laboratory future must involve a closer interaction with clinical care and outcomes, here's an award that focuses on that very thing. Demonstrate how your lab results improve care and benefit patients, and your healthcare organization will receive and award from a consortium of AACC, IFCC, HIMSS, Modern Healthcare and more: https://lnkd.in/dGBz5Fq hashtag#Univants hashtag#labfuture
[full disclosure: this award is sponsored in part by Abbott Diagnostics, a company with which Westgard QC has business.]
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
As several people know, the highlight of the Antwerp Quality in the Spotlight conference is not the Westgard Award, but the "Limerick Challenge" of the evening dinner.
In 2016, there was a scandalous episode of nepotism, which resulted in the winning team containing not only myself ("a" Westgard) but also Jochem Goldschmidt ("a" Goldschmidt, son of the conference organizer). Thus, we received lifetime bans from participating in future Limerick contests. And founds ourselves running the Limerick as Quiz Masters this year.
Since the overall theme of the conference this year was "next generation" - that, too, became the theme of the Limerick contest.
Here myself and Jochem on the right are presenting the prize (a bottle of champagne, to be consumed that evening)
After the jump... the winners and the winning limerick
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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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