Tools, Technologies and Training for Healthcare Laboratories

The Antwerp Limerick Winner 2016

Posted by Sten Westgard, MS

image from https://s3.amazonaws.com/feather-client-files-aviary-prod-us-east-1/2016-04-12/834fed7ba5db4de0a1f7140bf09c0a27.png
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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Another thing about Theranos...

Posted by Sten Westgard, MS

Theranos300
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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Interview: Westgard in the Pathologist

Posted by Sten Westgard, MS

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Thank you MedLab 2016!

Posted by Sten Westgard, MS

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Q & A from Quality at the Crossroads

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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Pop Quiz: How safe is air travel today?

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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Are we measuring too much?

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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Westgard in the Fab Four (of Pathologists)?

Posted by Sten Westgard, MS

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Westgard Wednesday

Posted by Sten Westgard, MS

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Method Validation Matters: Just Ask Theranos

Posted by Sten Westgard, MS

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Pop Quiz: what's the error rate of diagnosis in US healthcare?

Posted by Sten Westgard, MS

Can you guess just how bad US healthcare is at making the right diagnosis?

Is the error rate in the US related to diagnosis

  • 5%?
  • 10%?
  • 6 to 17%?
  • all of the above?

The answer, after the jump...

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Cleveland Clinic ... Cheating Catastrophe?

Posted by Sten Westgard, MS

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TJC finally enters the IQCP waters

Posted by Sten Westgard, MS

IQCP_logo_15Another shoe has dropped in the regulatory world. Recently, CDC/CMS issued their "how-to" guide for IQCPs, CAP dropped their checklist for IQCPs, and now the other major deemed accreditor has put out their IQCP guidelines: The Joint Commission.

New and Revised Standards for Individualized Quality Control Plans (IQCP) Prepublication Requirements

So what is JCI doing about IQCPs? Join us after the jump

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CAP rolls out the first practical IQCP guidelines

Posted by Sten Westgard, MSCAP-elligibility-IQCP

We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.

IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.

More after the jump.

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Pop Quiz: could this error have happened in your lab?

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.

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MLP Week: Bring Back the Bobble, Labs!

Posted by Sten Westgard, MS

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Free webinar: Simplify your IQCP

Posted by Sten Westgard, MS

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Put your "I" in the IQCP survey

Posted by Sten Westgard, MS

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When did the US become irrelevant to Quality Goal Setting?

Posted by Sten Westgard, MS

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Poll: What are your IQCP Plans?

Posted by Sten Westgard, MS

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