The Westgard Rules

What's New on Westgard Web: April 2019

Posted by Sten Westgard, MS

Seven Lessons for Six Sigma Metrics
Our training in Six Sigma Metrics, finally available online. In seven concise lessons, you will learn the foundation, the metrics, and the application of tools like the Method Decision Chart, OPSpecs chart, and also Westgard Sigma Rules. Even new tools to quantitatively determine QC Frequency are covered.

Register and Enroll directly at the Westgard Course Portal

Or register through the Westgard.com online store
 

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Three Books to Make you Think Twice

We're living in an age of rapidly proliferating metrics, where we're trying to measure everything that can be measured, in the hopes that we could measure our way out of the current healthcare problems.
At some point, however, we need to be skeptical about adding each new measurement to our array. Three new books help us get a better handle on when and why measurements and indicators may or may not help.

When is a new measurement not worth the effort?
 

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Happy Medical Lab Week After-Party

Medical Laboratory Professionals Week was the last week of April.

A week is not enough to thank laboratories for all the critical work they do, so we at Westgard QC always like to embrace the "Lab Week After-Party" (or if you prefer, the Lab Week Hangover).

So don't let the fun end, keep it up here at Westgard Web.

We're grateful for all the professional who get our tests - and all patient tests - right the first time.
 

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Q&A: Should you panic about new CLIA goals?

The 2019 proposed changes for CLIA proficiency testing acceptability criteria have significant consequences for laboratories that adopt them as analytical performance specifications.

But do we need to panic about it yet?
 

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Announcing a new Partnership:
Technopath Clinical Diagnostics and Westgard QC

The Next QC Revolution: training and education worldwide

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Join me in June at ASCLS:
7 Things about 6 Sigma

Join me at the ASCLS/AGT annual meeting in Charlotte, NC, on Wednesday June 26, 2:00-3:00 pm.
This session will provide a rapid introduction to the Six Sigma Metric for laboratory testing, a practical quality management technique you can master without having to join a management cult. No green belts, black belts, or master black belts required. Just the tools to help you assess quality, optimize QC, redefine how many rules you use, how many controls you run, and how often you must run QC.

Register for this session at the ASCLS website

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CLMA Tidewater Workshop: A One Day Workshop on Six Sigma
Join me June 28 in Virginia Beach for a full day workshop on Six Sigma.
Learn the following:

1. Assess lab processes across the total testing cycle on the Six Sigma scale.
2. Calculate the sigma metric of your analytical methods.
3. Streamline the number rules and number of controls implemented in tests.
4. Optimize QC frequency based on patient risk sigma metric.
5. Confirm fitness for purpose of new instruments and methods.

The only full day Six Sigma Westgard workshop in the US this year

 

Join me in June at Virginia Beach

Posted by Sten Westgard, MS

Join me June 28 in Virginia Beach for a full day workshop on Six Sigma.
Learn the following:

1. Assess lab processes across the total testing cycle on the Six Sigma scale.
2. Calculate the sigma metric of your analytical methods.
3. Streamline the number rules and number of controls implemented in tests.
4. Optimize QC frequency based on patient risk sigma metric.
5. Confirm fitness for purpose of new instruments and methods.

Join us at the only full day Six Sigma Westgard workshop in the US all year

Join us in June at ASCLS

Posted by Sten Westgard, MS

Join me at the ASCLS/AGT annual meeting in Charlotte, NC, on Wednesday June 26, 2:00-3:00 for "7 Things you should know about 6 Sigma" A rapid introduction to the Six Sigma Metric approach for laboratory testing, a practical way to apply the quality management techniques of Six Sigma without having to join a cult. No green belts, black belts, or master black belts required. Just the tools to help you assess quality, optimize QC, redefine how many rules you use, how many controls you run, and how often you must run QC.

Lab Week 2019: Thanks for the Tests

Posted by Sten Westgard, MS

As I look back on Medical Laboratory Professionals Week of 2019, I reflect on all the medical care I received in the past year. When I look back on all the visits, procedures, and diagnoses that were given to me, I find that 100% of those decisions were guided by laboratory test results (more than the oft-quoted 70% of medical decisions being made based on test results). So thank you, to the nameless, faceless medical professionals who handled my results. I never met you. I never interacted directly with you. But every aspect of my health in the last year was dependent upon your commitment to quality. THANK YOU for treating my specimen like it was the most important patient in the world - and for treating each and every patient the same way. And not only thanks to the technologists who handled my tests, but to ALL the technologists out there who dedicate their profession to generating the right results for all patients. A week of recognition and celebration isn't long enough to reward you for what you do, but nevertheless I hope you feel more valued because of these past few days.

How I spent Lab Week 2019

I was blessed enough to spend the week in China during Laboratory Professionals Week: training, lecturing, q & a’ing. Celebrating one laboratory’s verification of performance Not just celebrating with labs but I hope empowering them to achieve even better results in the future.

Method Validation Matters

Posted by Sten Westgard, MS

https://www.evaluate.com/vantage/articles/news/snippets/healthineers-sinks-atellica-letdown

I'm late to the party on this story, but I think this illustrates an atrophy in our core laboratory skills. When a multibillion-dollar diagnostic manufacturer loses profitability due to the "longer than expected installations times" of its instruments, that's a telling sign we are losing our ability to validate and verify our methods.

For too long, labs have been out-sourcing these skills to the manufacturers, making that validation and verification phase part of the purchase of a new instrument. Or if they're not out-sourcing it, they are not training enough staff internally to handle the big instrument validation projects - where hundreds of tests need to come online in a very short period of time.

Our neglect of statistical training means we don't have enough skilled staff, either at the manufacturer or in laboratories, to complete the necessary validation / verification studies. Then it takes longer to get these instruments up and running. Certainly bad for profit, but possibly even worse for patients.

[An even worse scenario would be if the instruments are actually failing validation or verification... but we don't know that is happening here.]

It was pointed out that there isn't a pure causal relationship established in this article - that I'm being speculative about the reason installation is taking longer than expected.

There are other possibilities that could delay profitability, but most of them are less flattering to the manufacturer:

• The complexities of installing systems these days are much higher. But if that's true, isn't it foreseeable? Isn't it therefore possible for the company to either hire more staff for installation, or warn analysts that profitability will be delayed while installation is performed? If the company didn't know installation was going to be so complex, that's a failure of execution and implementation. If the company knew but pretended it wasn't going to happen, that's a failure of leadership and financial disclosure.
• A further follow-up, if the company is having problems installing 340-odd systems, what's going to happen when they scale up to the 1500+ systems that they claim they will achieve this year?

My speculation places the blame closer to the lab, for lacking the skills to be able to efficiently validate new instruments. That's something that's out of the control of the manufacturers, and less predictable. I'm trying to give the manufacturer more benefit of the doubt here. But if you prefer, we can go dark - and blame the manufacturer for all the problems.

Q & A: Should I Panic about CLIA Changes?

Posted by Sten Westgard, MS

The newly proposed changes in Proficiency Testing (PT) Criteria have made many people uncomfortable. We have received numerous messages worried about the implications, including a little bit of panic. While we provided a very critical review about the long-term impact, let's turn to the short-term future:

First, let's make sure we understand that these are proposed goals. Nothing is final yet. The public comment period ended in April (2019), so we're still waiting to hear from the committees about what will actually become adopted into the regulations. The committee will undoubtedly weigh the submitted public comments and they may possibly make modifications to the criteria.

Second, even if the goals emerge from the public comment period intact, I expect there will still be a phase-in period, so that it may be one or two years before these new goals get their real teeth. You won't have to achieve new analytical quality overnight.

Third, as stated explicitly in the proposed criteria, these new goals are only meant to be used for "PT scoring." If that is indeed all you are worried about, I don't expect that the new criteria will have a major impact to the labs. PT failure rates are low throughout the US, historically they've been in the 1 to 5% range. The CLIA committee performed explicit simulations and wanted to minimize failures to just 1 or 2%. So they are still building goals that 98-99% of current labs with current instruments can pass. So they are not intending to generate a radical change for PT pass rates.

The biggest change will be for Sigma-metrics. Because those are far more demanding of analytical performance. If labs apply these new CLIA goals for their sigma-metrics they will see their numbers drop, and the need for more rules, more controls, and more frequency of running controls, becomes a real possibility.

As our articles noted, the government is trying to dodge responsibility for such things by stating the goals are only for PT scoring. As if PT scoring has nothing to do with clinical care. Of course, that's absurd, but CMS just doesn't want to take responsibility to forcing labs to do more QC effort. They must explicitly calculate the financial impact of their regulations now, and if tightening goals means labs must spend more on QC, that means the regulations are more expensive, which, in the current US political climate, is toxic.

But as goals around the world are tightening, if analytical performance is not good enough, we will indeed need more QC effort and expense. While CLIA goals may only be "catching up" to where other EQA/PT and biological goals are now, this is part of a global trend toward more demanding performance specifications. Ultimately, this is a strong "nudge" to the manufacturer that they need to continue to improve their engineering, as well as motivation to laboratories to select only the best instrumentation.

So, as the Hitchhiker's Guide to the Galaxy states, don't panic. But do bring a towel....

New Course!! Six Sigma Metrics

Posted by Sten Westgard, MS

Our training in Sigma metrics, finally online!

Seven lessons on Six Sigma metrics.

You can register directly on our course portal at http://www.westgard.org/index.pl?op=show;isa=Program;iid=146582

Or you can also register through our online store  https://www.westgard.com/store/online-training/six-sigma-metrics-detail.html
(the online store allows you to use coupons, but allow 1-2 business days for enrollment processing)

Technopath Clinical Diagnostics and Westgard QC announce Strategic Partnership

Posted by Sten Westgard, MS

For decades, laboratories have been challenged with implementing standardised QC processes and naturally have looked to some of the solutions that were seen as synonymous with best practices for QC. However, given the latest generation of engineering, higher precision methods, more automated instruments and the proliferation of new instruments, new methods and new tests, many of the legacy solutions have quickly become outdated. Now more than ever, there is a greater need for more advanced, more efficient QC procedures.

Diagnostic testing accounts for <5% of total healthcare costs, but influences over 70% of all critical clinical decision making.
Busy laboratorians are time challenged, yet analytical quality demands continue to multiply as physicians and patients depend increasingly on test results for optimal diagnosis and treatment. Quality control (QC) procedures are an essential lab practice to ensure reported test results achieve the quality required for intended medical use. Crucial elements of a quality control system are the quality control materials used and the data management software to analyse the results. Equally important are the statistical rules that are implemented to provide a final independent check to detect performance changes potentially causing medically important errors.

Statistical Quality Control will not achieve optimal performance unless it is properly implemented.

Happily, there are alternative options to introduce more efficient and robust QC procedures into the laboratory. Consolidated multi-analyte quality control materials, such as the Multichem® range available from Technopath Clinical Diagnostics (Technopath), enable clinical laboratories to significantly reduce the cost of quality control.

JOIN THE QC REVOLUTION!

Technopath Clinical Diagnostics and Westgard Inc. announce strategic partnership to provide quality control training and
education services to customers around the world. handling requirements, reclaim storage space and minimise waste, leading to a more efficient quality control process. In addition, a new form of multi-rules called ‘Westgard Sigma Rules’ is available that adjusts the number of rules and control measurements to take into account the analytical Sigma-metric of the test method (see below for more information).

The result of these new developments is that laboratories are revolutionising their QC procedures and optimising their quality management systems.

Join The QC Revolution

Technopath and Westgard are combining forces, in a strategic partnership, to deliver the most advanced QC solutions and educational services on the market. Combining Technopath’s class-leading products with expert opinion and educational services from Westgard will allow laboratories around the world to get access to the most up-to-date information on advancements in quality control testing and analysis. As part of the partnership, Technopath will also become an official partner for the Westgard Sigma Verification of Performance Program.

Contact Technopath for more information: [email protected]

 

About Technopath Clinical Diagnostics

TECHNOPATH CLINICAL DIAGNOSTICS is a global leader in the development and manufacture of total
quality control solutions for clinical laboratories. In 2008, we launched the In-Vitro Diagnostic industry’s
first truly consolidated Immunochemistry Quality Control (QC) materials. Consolidating multiple tests into
one QC product enables clinical laboratories to significantly improve the efficiency and cost effectiveness
of quality control processes. Our IAMQC® software platform automates the handling and management of
QC data while facilitating laboratory accreditation requirements. Today our products are used by leading
laboratories in over 120 countries.

For more information on Technopath Clinical Diagnostics, visit www.technopathcd.com.

 

About Westgard Inc.

WESTGARD QC promotes the latest news, education, and tools in the quality control field. Our goal is
to bring tools, technology and training into today’s healthcare industry — by featuring QC lessons, QC
case studies and frequent essays from leaders in the quality control area. Westgard QC provides a unique
Sigma Verification of Performance program to laboratories seeking independent confirmation of analytical
performance.

For more information on Westgard QC, visit www.westgard.com