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...
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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a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies.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...
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Posted by Sten Westgard, MS
I had the pleasure of taking part (albeit remotely) in the Quality at the Crossroads conference in Alexandria, Egypt.
As part of my session, we took questions from the audience, and I thought I would share a few of them with you, as well as a few of the "wrinkles" that labs in Egypt experience that we in the US do not. So here are the questions:
How frequently should I measure Total Error and Measurement Uncertainty?
Can I resort to comparing my EQA result to allowable bias when EQA result is violated and declared incorrect due to tight SD of comparator group?
When using a new manufacturer’s QC, we should establish our own mean and CV, but it would result in tight CV and shift after 20 days. What are the recommendations for this? Is it better to wait more days to establish CV?
Some answers, after the jump...
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Posted by Sten Westgard, MS
The IATA (International Air Transport Association), whose 260 member airlines comprise 83% of global air travel, released their statistics on 2015 airline safety.
Can you guess how safe it is to travel? What was the global jet accident rate?
0.32 per million flights
0.22 per million flights
0.12 per million flights
0 per million flights
The answer, 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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