The Westgard Rules

What's New: February 2018

Posted by Sten Westgard, MS

Here's what's new on Westgard Web this month, a special set of articles on hematology and QC.

Does Hematology hearken back to substandard QC?

Within the laboratory, biochemistry and hematology are often housed far apart from each other. But should their QC practices be distanced, too? Analyzing the hematology-specific results of our Global QC Survey, we find that while instrumentation has gotten more advanced, QC habits have not. There is a lot of room for improvement in the way hematology sections run controls.

Hematology: How often are they "out"?
 

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Sysmex XN compared to Sysmex XE


A recent study compared two different generations of the same hematology analyzer, Sysmex XN and Sysmex XE.  We would expect there to be a good comparability of results between the analyzers. That's what we would expect...

When two generations of the same analyzer disagree, who do you say is wrong?
 

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A correction: updated metrics on a 2016 analysis of Sysmex XN-2000

In 2016, we performed a Sigma-metric analysis of a 2016 paper on the performance of a Sysmex XN-2000. The authors contacted us this year to state they made mistakes in the original paper, and they have updated the analysis based on those corrections.

Corrected analysis of an updated paper on Sysmex XN-2000
 

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Consolidated Comparison of Analytical Hematology Performance Specifications

CLIA, Rilibak, IQMH, RCPA 2010, "Ricos Goals" and Rilibak, and ESFEQA. They all specify targets for allowable analytical performance in hematology. How do these goals compare?

Is there a consensus on the allowable total error for hematology parameters?

What's New on Westgard Web: January 2018

Posted by Sten Westgard, MS

Just added! A 1-day workshop on QC, February 1st, Alexandria, Egypt

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 An Olympus AU 680 and AU 2700:
assessment results from a veterinary lab


At the 2017 ESVCP conference in London, I was exposed to the pioneering work being done in veterinary laboratory medicine to apply Six Sigma. In one of the studies cited there, Olympus 680 and AU 2700 were evaluated with the same controls as "normal labs" use. This assessment therefore applies to the instrument, regardless of the species you are serving.

Have Olympus chemistry assays gone to the dogs (and cats and horses...)?
 

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QC Survey Results for Latin and South America



In advance of our workshop training tour through Mexico, Panama, and Colombia, we targeted a Spanish-language QC Survey for Latin and South America. The results are surprising.

Is QC better, worse, or just different in Latin and South America?
 

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Sigma-metric Analysis of LabKey


A small specialized biochemistry analyzer for the veterinary laboratory was assessed with traditional controls, as well as feline and canine pools.

Is this instrument unsafe for any species?

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QC Practices in the Veterinary Lab World


In collaboration with the ESCVP, a survey of QC practices of veterinary laboratories was conducted. It captured the major differences between labs that work with the human species and labs that don't.

Do Vet Labs perform better QC than human labs?

 

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Where will the Westgards be? Part 2018

It's never too soon to starting saving the date.
March 19-20, Antwerp Belgium. It's the next Quality in the Spotlight Conference, focusing on the next generation of Quality. See who wins the Westgard Award.

See "the" Westgard, "a" Westgard, and a lot of other, much more interesting people.
 

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Congratulations to the latest Sigma VP Labs

In November, Westgard QC welcomed a trio of new laboratories into our Sigma VP program.

Clinic Laboratory of Women's Hospital, School of Medicine, Zhejiang University, Hangzhou


Shengjing Hospital, Shenyang


People's Hospital of Xinjiang Uygur Autonomous Region

Interview: Quality First

Posted by Sten Westgard, MS

For those of you who want a preview of our "Trust but Verify" training at AACC University this Sunday in San Diego, here's an interview with me and David Koch, past president of AACC, who holds the record for the longest tenure in this workshop series. Method Validation/Verification is the longest running training workshop at the AACC/ASCLS conference. I am proud to be a small part of it.

https://www.aacc.org/publications/cln/cln-stat/2017/july/25/quality-first

What's New: April 2017

Posted by Sten Westgard, MS

Here's what's new in April on Westgard Web:

Sigma-metric analysis of albumin assay harmonization


A recent 2017 study in Clinical Chemistry evaluated the trueness of 24 albumin assays. It provides even more evidence that the difference between BCG and BCP is significant. But it also shows significant differences between diagnostic manufacturers. And it also shows significant differences between some instruments, even when they're from the "same" manufacturer. It's proof that even with the strong emphasis on harmonization, there are miles to go before patients can get reliably similar results.

What's the allowable bias between albumin assays?

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Last chance to take part in the Great Global QC Survey


Over 700 participants from over 95 countries have already shared their QC stories with us.
But we still want to hear YOUR QC story.

We're trying to learn how QC is really done around the world.
Please, tell us (anonymously) how you run QC in this global survey.

Remember, there's still a host of prizes to be won if you participant, from books, bobble-heads, and even a free Westgard workshop.

We are grateful to have the Westgard Workshop sponsored by Technopath Clinical Diagnostics

 

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Hot off the press: Risk, Error, and Uncertainty

Westgard, Armbruster and Westgard are the guest editors of the March 2017 issue of Clinics in Laboratory Medicine. We are pleased to present 15 chapters written by 37 authors. This concise single-volume not only tackles all the hot topics of laboratory quality, including the vigorous debates on models and theory, but also shows the real-world case studies of quality management tools in practice.

How to manage quality in the age of metrology?
Reconcile risk, total your errors and measure your uncertainty
 

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Sigma-metric analysis of chemistry analyzers in China


The Chinese laboratory market has been growing faster than any other part of the world. Less noticed is the growth and quality of their scientific literature. During a recent trip to the country, I enlisted the help of several laboratory professionals to translate some Sigma-metric and performance studies. It turns out, China may be publishing more on Sigma-metrics than any other country in the world.

What do Sigma-metrics tell us about chemistry analyzers in China? Is an AU 680 in China performing the same way it would perform in the West?
 

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ISO 10012:2003 Measurement Management Systems
Dr. Paulo Pereira continues his series on ISO standards, focusing on the supporting standard that specifies "Requirements for measurement processes and measuring equipment.”  Dr. Pereira explains how these requirements support, overlap, or fill in gaps left by ISO 15189 and ISO 9001.


Are you interested in verifying and validating your measurement equipment, rather than simply assuming they work? There's an ISO for that

 

 

Ruian People's Hospital achieves Sigma VP


In March, Westgard QC was pleased to award the Sigma Verification of Performance to Ruian People's Hospital in China
 

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Sir Run Run Shaw Hospital achieves Sigma VP

In March, Westgard QC was pleased to award the Sigma Verification of Performance to Sir Run Run Shaw Hospital in China.
 

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Wuhan Union Hospital achieves Sigma VP

In March, Westgard QC was pleased to award the Sigma Verification of Performance to Wuhan Union Hospital in China.

What's New: January 2017

Posted by Sten Westgard, MS

Here's what's happening on Westgard Web this month:

7 Tips for Better Sigma in '17


Want World Class Quality? You have to ask for it by name. We see more and more labs, hospitals, and health systems doing this - asking for performance data and Sigma-metrics from their prospective vendors. But it's not as easy as it seems. You need to specify the goals, the decision levels, the imprecision time frame, and more. If you want to get an honest picture of performance from your vendors, you need to be in control of the tender / bidding process.

Here's some gentle advice about adding Six Sigma to the tender process

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A Sigma-metric analysis of a Vitros 5600, an Hitachi 7170, and a Roche Cobas 8000.


What happens when a hospital has multiple analyzers, "closed systems", "open systems" and "mixed systems"? When we use different analyzers, reagents, and calibrators, can we assume the results will always be comparable? NO. No, we can not.

Can wet and dry chemistry provide comparable results within the same healthcare system?
 

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ISO 9001:2015 Quality Management Systems

Dr. Paulo Pereira begins a series on ISO standards that apply to the medical laboratory. ISO standards dominate more and more of the globe, and laboratories even within the US need to take a closer look at what is required to implement them. ISO 9001 had a significant update in 2015 and Dr. Pereira examines what those changes are and what they mean for medical laboratories

Do you need to adopt "Risk-based thinking"? ISO says so
 

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Quality Healthcare Medical Service of Hong Kong achieves Sigma Verification

Quality Healthcare Medical Service (QHMS) becomes the first laboratory in Hong Kong to achieve Sigma Verification of Performance.



QHMS Sigma Verification of Performance
 

What's New: December 2016

Posted by Sten Westgard, MS

Here's what's new on Westgard Web:

Validating Qualitative Assays

While the protocols for method validation of quantitative assays are well-established, the studies required for qualitative assays are less well understood.  Dr. Paulo Pereira, our new contributing editor, provides a needed overview of the validation requirements for qualitative tests. 

Are we positive (or negative) that we know how to validate a qualitative method?

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In case you missed it... Westgard and Westgard on YouTube


For those who weren't able to attend the Westgard and Westgard workshop at the AACC/ASCLS convention in Philadelphia, the video is now on YouTube.  Here's your chance to see how many jokes my father can make at my expense.

Is it ever possible that your father will stop embarrassing you in public? So far I can only answer "NO"

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A Sigma-metric analysis of an AU 5800.


Earlier this year, a Belgian laboratory performed a series of validation studies for the analytical performance verification of a Beckman Coulter AU 5800. The additional twist is that it compared two distinctly different instruments from the same vendor, an AU 5800 and a DxC Unicel.

Does buying all your instruments from the same manufacturer always guarantee the comparability of results?

 

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Prodia Labs achieve Sigma Verification

The first laboratories in Indonesia - three of them, in fact - achieved Sigma Verification of their chemistry performance in November.



Prodia Laboratories Sigma Verification of Performance
 

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Zhongshan Hospital achieves Sigma Verification

In November, the first hospital in Shanghai, Zhongshan Hospital, was able to receive the Verification of their Sigma performance, guided by the assistance of our local partner, QuaLab.



Zhongshan Hospital Sigma Verification of Performance
 

What's New: October 2016

Posted by Sten Westgard, MS

Here's what's new on Westgard Web...

Still bothered by Bias

One of the perennial debates about quality is what to do about bias. Metrologists would prefer that it didn't exist. They want to stamp it out whenever and wherever it is found. It's a laudable mission, but what if the methods on the marketplace are currently unable to be standardized, harmonized, and/or calibrated so that the bias is pushed to zero?  A recent Clinical Chemistry study found unacceptably large biases in 4 out of 5 common immunoassays: cobalamin, folate, ferritin, TSH, and Free T4. 

When methods have major bias, are Sigma-metrics more forgiving?

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AB...C. And Bias exists with Cortisol, too

Yet another study in Clinical Chemistry took a deep dive into the bias present in different patient cohorts for common Cortisol methods. When there are significant differences in males, females, (pregnant and non-pregnant), laboratories and clinicians need to make sure they don't make one judgment on a method when there are multiple dimensions to consider.

If Bias is Bad for females, but okay for males, should we accept the method? (Isn't that biased?)
 

 

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INVITRO Labs achieves Sigma Verification

The first laboratory in Russia, INVITRO Labs headquartered in Moscow, achieved verification of their chemistry performance in early October.



INVITRO Laboratories Sigma Verification of Performance
 

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Guizhou Provincial People's Hospital achieves Sigma Verification

In mid-October, the first hospital in China was able to receive their verification of Sigma performance. Located in Guiyang City of Guizhou Province, this hospital commenced work earlier this year and finished their training and verification in short order.



Guizhou Provincial People's Hospital Sigma Verification of Performance

 

50,000!

Posted by Sten Westgard, MS

Earlier this week Westgard Web reached another milestone: 50,000 laboratory professional members.

That's a lot of interest in quality. That's a lot of dedication to the profession. (Or that's a lot of people seeking cures for their insomnia).

To celebrate, we're running a special discount at westgard.com for the next 50 hours. Anything ordered online will be 50% off for the next 50 hours.

That's HALF OFF. The Best deal you're going to see at westgard.com for the foreseeable future.

 

What's New: July 2016

Posted by Sten Westgard, MS

Quexit? TE-xit? or IQCP-exit?

Every so often reality delivers a vicious refute to the myth of continuous forward progress. Recent events have shown us there is always a very real possibility that countries and societies will choose instead to take a step backward. This is happening not only in the politics of the world, but even in the policies of our laboratories.

Are we moving forward or leaping backward in Quality?

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IQCP: The Users Respond.



More than 200 labs responded to our survey on IQCP implementation. What was most striking was the difference between US labs and labs from around the rest of the world. There's a very big difference between the IQCPs here inside the US and those from the rest of the globe.

The US IQCP Survey Results
The Global IQCP Survey Results
The Survey Comments
 

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Sigma metric analysis of Sysmex XN2000


We've been looking at a number of hematology instruments recently. It's time to take a closer look at one of the leading new instruments from Sysmex.

Hematology Sigma-metrics on a Sysmex XN 2000
Hematology State of the Art Performance Requirements

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When Manufacturers Mislead

A recent white paper released by a major manufacturer contains at least one serious mistake. Or is it purposely misleading? When it comes to Sigma-metrics, can we trust manufacturers to tell us the truth?

When a manufacturer present Sigma-metrics, how do you verify that they have made the right calculations?
 

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An Outside Review of an IQCP

We asked a group of IQCP experts to review our sample IQCP for a POC device from last month. What do you think they found?

Would you expect that a external review of your IQCP would find twice or three times as many hazards than you did?
 

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What's New: June 2016

Posted by Sten Westgard, MS 

Here's new this month at Westgard Web:

Are you being Theranos-ed? Or are you Theranos-ing others?

The Theranos scandal is proving to be an object lesson for the laboratory industry. While this story has now reached "let's-make-a-movie" proportions, there's some data analysis that still hasn't been done, as well as a few lessons yet to be learned by labs and the diagnostic industry.

Thuffering Theranos! Can this get any worse?
 

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Making Quality Great (again?)...I'm with Quality. What are the politics of making Quality Progress?


Another slew of MU has hit the journals.  The MU-TE debate continues in publications and online postings. But there are some reasons for hope...

Some Dismay, but with less Disagreement.

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Welcome Innovative Diagnostics Singapore to Sigma VP


Innovative Diagnostics has become the first (and fastest) private laboratory in Singapore to achieve the Verification of Performance. (Sigma VP).

Innovative Diagnostics verified not only chemistry, but also immunoassay, hormones and tumor markers.
 

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The First Sigma VP Lab Colloquium 


On May 27th, the member labs of the Westgard Sigma Verification of Performance (Sigma VP) Program gathered for their first annual meeting in Singapore.

Sharing Best Practices, Setting New Goals, Exploring New Possibilities for Collaboration. Sigma VP is not just for benchmarking anymore.
 

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