The Westgard Rules

The Other Healthcare Shoe Drops (Or doesn't)

Posted by Sten Westgard, MS

In case you haven't heard yet, the Supreme Court of the US did not strike down the individual mandate of the Affordable Healthcare Act (ACA, somewhat derisively known as "Obamacare").

From Chief Robert's opinion: ""We do not consider whether the Act embodies sound policies. That judgment is entrusted to the Nation's elected leaders. We ask only whether Congress has the power under the Constitution to enact the challenged provisions."

The ruling: http://www.supremecourt.gov/opinions/11pdf/10-7081b2d.pdf

The opinions (very long, a set of essays for the ages, really):
http://www.supremecourt.gov/opinions/11pdf/11-393c3a2.pdf

Does this really clear things up? Well, there are still a lot of other details that need to be worked out. The individual mandate provision hasn't even kicked in yet, that's 2014. So while this is one major decision, it's not the whole story on healthcare reform. Each time we think we've reached a defining moment, we realize that there are more defining moments to come.

How does this impact the laboratory? Expect more "More with Less" in the future. More testing, Fewer funds. More weight given to those test results, fewer resources and staff to run them. Accountable Care Organizations (ACO) and the bundling of payments will raise the stakes on the test results, as those results will not only determine the patient's fate, but increasingly also the health system's payment.

The politics are far from over - this will just unleash a new round.

What's New on Westgard Web: June 2012

Posted by Sten Westgard, MS

=WOULD YOU DRIVE YOUR CAR THE SAME WAY YOU RUN YOUR QC? =

They call it 'inattentional blindness' in cognitive science. In car
accidents, it happens when drivers look but don't see an oncoming
danger. Does this type of behavior happen in the laboratory, too?

When it comes to QC, are we asleep at the wheel?
 http://www.westgard.com/qc-drive.htm

ANOTHER LOOK AT LABORATORY ERROR RATES, 2012

A new study looks at the frequency of errors in laboratory processes
across the Total Testing Process. Are pre-analytical errors still
predominant?

Does monitoring quality indicators automatically improve quality?
 http://www.westgard.com/sigma-metrics-lab2012.htm


WILL MOLECULAR DIAGNOSTICS REPEAT OUR QC MISTAKES?

A new field with explosive growth and complexity. A "traditional"
approach with rigorous implementation requirements. Can statistical QC
and Molecular Diagnostics mix? Is this new field condemned to make the
same mistakes with QC that other areas of testing have made?

Can we do QC for NGS, microarrays, and other new tests?
  http://www.westgard.com/molecular-quality-control.htm

Westgard workshops and books at AACC/ASCLS Los Angeles

Posted by Sten Westgard, MS

At this year's AACC/ ASCLS meeting in Los Angeles, there are more opportunities than ever to attend a workshop with Dr. Westgard (or myself). There's even a special event where you can receive a signed, complimentary book!

Click the links below to find out more or register for these events.

Tuesday only, July 17th: At the SeraCare (Booth #804), Dr. Westgard will be signing copies of Basic QC Practices, Basic Method Validation, and Six Sigma Risk Analysis. For a limited number of visitors, these books will be FREE! (First-come, first-served, Tuesday only).

Tuesday, July 17th, 7:00 am: Sigma-metric Driven Quality Managment in the Clinical Laboratory
 Dr. Westgard, Dr. Litten of Winchester Medical Center, Winchester, VA and Dr. Khosrow Adeli, University of Toronto, Ontario, will discuss Six Sigma tools and their applications in real laboratories.


Tuesday, July 17th, 6:00 pm: Quality control for the Future series: Risk Management EP23 for Laboratories
Dr. Westgard and Dr. Curt Parvin of Bio-Rad Laboratories will discuss the new Risk Analysis techniques.


Wednesday, July 18th, 6:00 am: Vitamin D Testing - Bringing Performance and Quality to the Lab
Dr. Hossein Sadrzadeh of Cedar-Sinai Medical Center LA, Cynthia Johnson of the University of Minnesota Medical Center, will show data from their studies of new authomated 25-OH D immunoassays. Sten Westgard will place performance in context with Sigma-metrics, evidence-driven quality requirements, and provide recommendations for QC and reporting optimization in the laboratory.

Westgard QC will also be exhibiting at Booth 951. We will be demonstrating software, displaying our reference manuals, and debuting a new book (whose title and topic will remain a mystery for now...) And of course the infamous "Westgard Wear" raffle will be held.

[note: as you might expect, Dr. Westgard's lecture at the Abbott Diagnostics industry workshop will be sponsored by Abbott Diagnostics. Dr. Westgard's lecture at the Bio-Rad industry workshop will be sponsored by Bio-Rad. Dr. Westgard's appearance at the SeraCare booth will be sponsored by SeraCare, etc.]

Pop Quiz: Which Glucose method is acceptable?

Posted by Sten Westgard, MS

Here's a range of statistics describing the performance of a glucose method. Try to pick: Which one has acceptable performance?

1. method with combined uncertainty 3.69%
2. method with combined uncertainty 6.79%
3. method with expanded uncertainty 7.38%
4. method with expanded uncertainty 13.58%
5. method with 3.78 Sigma

Which method would you pick?

Think QC Again - in Japanese!

Posted by Sten Westgard, MS

Recently, the journal In Vitro Diagnostics Global News a publication of CGI KK and in association with CAP Today, has begun publishing a series of translations of Westgard articles into Japanese:

The title of the series is Think QC Again, an important message regardless of language or country.

Pop Quiz: when is a standard not a standard?

Posted by Sten Westgard, MS

As we wait for more details about EP23 and how CMS and CLIA will actually enforce the implementation of Risk QC, the latest morsels to emerge are quite tantalizing.

On the CLSI website, a Q&A has been posted. Here is one interesting bit:

"3. Is there a planned format for documenting the EP23 QCP to present to surveyors?
There is no specific format that is required for the presentation of a QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard."

This is an interesting question and an even more intriguing answer. The new standard will have "nothing standard" about its implementation. Presumably labs that use the workbooks sold by CLSI will be able to fulfill any requirements for proper design of Individual QC Plans.

So why won't there be a standard QC Plan format?

Basic QC: now in Korean!

Posted by Sten Westgard, MS

We recently had the pleasure of working with Koonja Publishers in South Korea.

They have translated the Basic QC Practices, 3rd edition manual into Korean and are now making it available for sale: http://koonja.co.kr/shop/goods/goods_view.php?goodsno=14152

Here's a glimpse of the cover:

This is an official, authorized translation. This book has previously been translated into Spanish.

Thanks to Koonja for this important project.