Posted by Sten Westgard, MS
Antwerp participants vote on meeting conculsions
As some of you know, the Quality in the Spotlight conference has one dinner that is infamous for its limerick contest. Finlay MacKenzie of the UK presides as the Master of Ceremonies, and all diners are invited to participate in constructing a limerick based on the events of the first day of the conference. Yes, that's right - try to turn statistics into lyrical poetry. A very difficult feat indeed.
And who was 2016's winner, you may ask?
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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
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
A recent op-ed in the New York Times by Dr. Robert Wachter as well as an interview with Don Berwick in HealthLeaders Media broached a taboo topic: is healthcare measuring too much?
'[T]he measurement fad has spun out of control. There are so many different hospital ratings that more than 1,600 medical centers can now lay claim to being included on a “top 100,” “honor roll,” grade “A” or “best” hospitals list. Burnout rates for doctors top 50 percent, far higher than other professions. A 2013 study found that the electronic health record was a dominant culprit. Another 2013 study found that emergency room doctors clicked a mouse 4,000 times during a 10-hour shift. The computer systems have become the dark force behind quality measures.'
How Measurement Fails Doctors and Teachers, New York Times, January 16, 2016
As the global debate over establishing the best error models and performance specifications rages, laboratories are probably asking themselves the same questions that the doctors are asking: how many metrics are too much?
A possible answer, or at least some more questions, after the jump...
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Posted by Sten Westgard, MS
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: