The Westgard Rules

What's New: April 2015

Posted by Sten Westgard, MS

CMS goes off-off-label on BGMS

CMS took an unusual step on March 13th, 2015. They "temporarily withdrew" a memorandum issued on November 21, 2014 on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS). But then this withdrawn memo was also reissued as a draft, with additional draft clarifications. What's going on?

Has the CMS policy on BGMS fallen "critically ill"?

 

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The Top 5-and-a-half Best LabSafeQuality CompareGrades

When Ratings, Rankings, and Grades proliferate, confusion often reigns. For labs and healthcare institutions, there's the additional challenge of new metrics that are impacting reimbursement. Some of these new metrics may be unproven or dubious. Which raises the question: is the laboratory safe from these metrics? For that matter, why don't we see more ranking of laboratories, methods, and instruments? 

Is your method, instrument, and/or lab in the top best grade?

 

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Sigma-metrics across the Total Testing Spectrum

A recent paper accomplished a trifecta of sorts: measuring quality indicators not only in the PRE-analytical and POST-analytical phases of testing, but also in the analytical phase of testing. We convert the analytical Sigma-metrics to match the short-term Sigma results and compare the error rates of all the different phases of the testing spectrum.

When a laboratory in Egypt looks at their total testing process, where are the most errors found?
 

The Real Rili-BAEK: an official English Translation

Posted by Sten Westgard, MS

This year the German Rili-BAEK guidelines were updated and an official English language translation is now available. It was published in the March 2015 issue of the German Laboratory Medicine journal

The Rili-BAEK regulators are not shy about proclaiming the impact of their rules:

"From the viewpoint of the diagnostics industry, the Rili-BAEK guideline currently in effect has ushered in a noticeable improvement in the quality of medical laboratory services provided. In particular, this work has accomplished what was so difficult for all the previous initiatives, namely to create an awareness among laboratory operators for the necessity of a unified quality standard in medical laboratories. Today, no traditional medical laboratory can ignore the requirements of the Rili-BAEK guideline. Unlike mandatory accreditation according to DIN ISO EN 15189, as was implemented in France, the requirements are not leading to the mass extinction of laboratories – smaller labs in particular – nor is it accelerating the existing trend towards industry concentration.

"With the introduction of the Rili-BAEK guidelines, all the stakeholders came together to establish a rational and logical set of rules for a high uniform quality standard in laboratory medicine, thus avoiding the creation of a de facto useless 'paper tiger' riddled with compromises."

[Publication of the English version of the Rili-BAEK guideline - the diagnostics industry's view on the Rili-BAEK guideline and its ramifications on laboratory medicine in Germany, Martin Walger, J Lab Med 2015; 39(1):21

[editor's note: I'm not sure which 'paper tiger' they are referring to, but clearly the implication is that the German guidelines are superior to other sources of quality requirements.]

You can download the Rili-BAEK Official English Translation here - it was released in an issue of Laboratory Medicine with several additional commentaries like the one above. We've also put a copy in our own download section.

MLP Week: Bring Back the Bobble, Labs!

Posted by Sten Westgard, MS

It's that time of year again:

 

In honor of medical laboratory professionals and the week that celebrates their contributions, we are bringing back the Bobble Raffle.

For each of the 5 days of MLP week, we will be giving away one genuine plastic, authentically nerdy, James O. Westgard Bobblehead.

You can enter simply by sending an email to [email protected]. (void where prohibited, of course)

For those who have already won, we'd be happy to see pictures of the Bobble enjoying Lab Week with you and your staff.

 

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...

Free webinar: Simplify your IQCP

Posted by Sten Westgard, MS

Dr. James O. Westgard will be presenting a new webinar on IQCPs, sponsored by Thermo Scientific on April 22nd, 2015, from 2:00 to 3:30 pm Eastern. There will be an hour-long lecture followed by a half hour of open discussion and question and answer.

Simplify your IQCP: A Practical Approach to implementing your Individual QC Plan (IQCP)

This online webinar is accompanied by a "Start-up kit" of worksheets as well as a a set of Westgard Sigma Rules.

Topics include:

• Assessing performance objectively
• Choosing the right kind of quality control plan
• Implementing the right amount of QC
• Assuring results meet the clinical need of patients

You can Register for this webinar here