Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.
As the new IQCP regulations kick in, it's been interesting to see the international reaction to them.
I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.
But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.
In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...
-----
Posted by Sten Westgard, MS
The news hasn't been getting any better over at Theranos. Since the Wall Street Journal pierced the facade on Theranos' promise of revolutionizing the lab test industry, there have been additional stories that Walgreens is seeking an exit from their partnership, that some of their premier clinical partners, Intermountain Healthcare and Cleveland Clinic, have not even started work on any validation studies with Theranos technologies, and that Capital BlueCross has put a stop to Theranos blood-drawing at the insurer's retail store in Pennsylvania.
But that's nothing compared the release of the full, but redacted, CMS inspection report of Theranos' Newark, California laboratory.
Earlier, we had seen the top sheet of the report, noting five major violations that meant Theranos was putting its patients in "immediate jeopardy."
The full report, more than 121 pages long, is as bad an inspection report as I have ever seen. More explanation of this, after the jump...
-----
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...
-----
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
-----
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?
-----
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 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 [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...
-----
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...
-----
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...
-----