Tools, Technologies and Training for Healthcare Laboratories

Q & A: Is this a 4:1s violation?

Posted by Sten Westgard, MS

We got the following question emailed to the website recently:

Greetings, I was [wondering] if the following case represents [violation] of 4 1s rule?

Control (A) point 1= EXCEEDS 2 SD /-2 SD lines >> warning

Control (A) point 2= WITHIN 2 SD/-2 SD lines >> accepted

Control (A) point 3= EXCEEDS 2 SD /-2 SD lines >> warning

Control (A) point 4= WITHIN 2 SD/-2 SD lines >> rejection

all the point[s] on the same side of the mean.

What do you think? The answer, after the jump

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Thank you, Haerbin!

Posted by Sten Westgard, MS

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A new Sigma-metric software program!

Posted by Sten Westgard, MS

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Q & A: The basis of bias%?

Posted by Sten Westgard, MS

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Thank you, Hanoi

Posted by Sten Westgard, MS

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Exclusive Sigma VP Consultants in China: QuaLab

Posted by Sten Westgard, MS

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Westgard Quality Manager Training: Shanghai

Posted by Sten Westgard, MS

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Come Join Us: Westgard & Westgard at the Heart of Quality

Posted by Sten Westgard, MS

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New Publication: Global Survey of EQA / PT performance

Posted by Sten Westgard, MS

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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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Quality in the Spotlight 2016!

Posted by Sten Westgard, MS

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Coming to Croatia: Zagreb's EFLM course

Posted by Sten Westgard, MS

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New Publication: Useful measures and models for quality

Posted by Sten Westgard, MS

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New publication: PT/EQA on Sigma Scale

Posted by Sten Westgard, MS

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Pop Quiz: what's the EQA failure rate of laboratories?

Posted by Sten Westgard, MS

An interesting abstract was published at the Paris IFCC meeting. It detailed the EQA performance of a set of 12 public laboratories in Catalonia. Can you guess what the failure rate for these labs for biochemistry EQA?

  • 14.5%
  • 14%
  • 3%
  • none of the above

The answer, after the jump...

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Sigma-metrics in Molecular Diagnostics

Posted by Sten Westgard, MS

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Webinar Alert: Simplify your ISO 15189

Posted by Sten Westgard, MS

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Save the Date: Sigma Matters in Atlanta, AACC conference

Posted by Sten Westgard, MS

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A Six Sigma Series from Advance

Posted by Sten Westgard, MS

Last month, Advance for the Laboratory published a three part series on Six Sigma in the Clinical Laboratory, written by David Plaut, Nathalie Lepage, and Kim Przekop:

Part 1

Part 2

Part 3

While it's great that Advance has invested in in-depth coverage of the Six Sigma topic, unfortunately one of their examples in part 2 demonstrates a misunderstanding of the application.

See the mistake, after the jump...

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Q & A: Do I need 4:1s and 10:x rules?

Posted by Sten Westgard, MS

A recent question came in from a technical support consultant for a major diagnostic manufacturer:

"It is for Free T4 analyte. Customer [has] establihed a QC range after 20 QC runs. Mean and SD were derived from 20 runs and %CV achieved from 20 runs is 1.2%. Allowable interassay precision criteria according to CLIA is 6%.

"Now when customer [applies] Mean and SD according to the established range many...times they face QC rules violations of 41s and 10x.

"So can you please suggest, when the SD is too narrow is it necessary to apply these two rules to immunoassays?"

What's your guess? I'll take a stab at an answer, after the jump.

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