Posted by Sten Westgard, MS

So here's a Normalized Method Decision chart for a cholesterol method.

Which method would you choose?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

I just wanted to share some pictures of a trip taken back in late April.

The Asian Society of Continuing Medical Education was kind enough to invite me to present in a workshop titled "Assuring Quality, Standardization, and Efficiency in the Laboratory 2012"  In Delhi and Mumbai.

Group picture, Mumbai

More pictures, after the jump.

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?

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.

Posted by Sten Westgard, MS

Heads up. There's a new abbreviation in town: IQCP

Can you guess what IQCP means?

1. Information Quality Certified Professional
2. Individualized Quality Control Plan
3. Intelligent Quality Control Plan
4. Incoherent Quality Control Plan
5. Ill-conceived Quality Control Plan

The answer, after the jump...

Posted by Sten Westgard, MS

Recently, a user submitted a question about the mandatory use of the 10_x rule on chemistry analytes as mandated by ISO 15189 through NABL:

"Specific criteria of accreditation of NABL India (for ISO 15189) say that 10x should be considered as a violation for clinical chemistry  and Immunoassay parameters. However we understand that Westgard rules consider it as a warning only. Please advise."

So, the central question is, does ISO 15189 mandate the use of the 10_x control rule?

A guest post by Nils Person, PhD, FACB

I recently read the essay "The QC We Really Do" with great interest and found the information very useful.  However, there was one topic that I was concerned about. It had to do with re-calibration in response to QC rule failure. The essay indicated that re-calibration is a common response to QC rule failure.... and I am not sure that is a good strategy. .

Posted by Sten Westgard, MS

We see the Bail Outs of the bankers and wall street. We see the cutbacks and austerity of governments in Greece and Ireland as their governments struggle to make good on the debts run up by their out-of-control banks.Private risks made into Public losses.

But is the laboratory immune from the problem of "Too Big to Fail"?

Posted by Sten Westgard, MS

The National Oil Spill Commission released a preliminary chapter of its report today. This is the commission charged with finding out what went wrong with the Deepwater Horizon / Macondo oil rig in the Gulf of Mexico that blew up in 2010 and spilled 4 million barrels of oil and killed 11 workers.

Whenever there are big stories in the media, we like to take a look at them to see if we can learn anything, find any connection between the disaster and our own situation in the medical laboratory community. But from a distance, it's hard to see any similarities between oil rigs and labs, right?

Right?

Posted by Sten Westgard, MS

We want your control chart data!

We've always had an "open door" policy on the website, welcoming your questions and your data. At times, we may not be so explicit in inviting you to contact us with your observations, comments, inquiries, and frustrations, but we do want to hear from you.

Now, we're asking for a more specific set of data from you - for your problem methods, show us a few months of QC data, ideally with notations such as new control lot, new reagent, recalibration, etc.

From Dr. Carmen Ricos, on behalf o the SEQC-Analytical Quality Commission:

Sten Westgard, MS

Is it time for a tighter quality requirement for glucose meters?

Fresh on the heels of Dr. George Klee's review of setting performance specifications, as well as the recent FDA public meeting on glucose meter quality, Dr. Klee and Dr. Brad Karon of the Mayo Clinic and Dr. James C. Boyd of the University of Virginia recently published a study that used simulation modeling to determine performance criteria for glucose meters:

"Glucose Meter Performance Criteria for Tight Glycemic Control Estimated by Simulation Modeling", Brad S Karon, James C. Boy, and George G. Klee, Clinical Chemistry 56:7; 1091-1097 (2010)

Posted by Sten Westgard, MS

Attending the AACC/ASCLS convention predictably results in one frustration. Walking through the poster sections, you find that many of the method validation abstracts are only performing within-run precision studies.

What's so bad about that?

Repeat after me: it's not about the repeatability...

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

In the iconic western film, The Magnificent Seven, there is a famous scene about marksmanship. [Quick set up: The Magnificent Seven are - you guessed it, seven - gunmen hired to protect a peasant village from a much larger group of bandits] Early in the film, the heroic gunmen detect three bandit scouts and want to capture them. In an abrupt exchange of gunfire, two bandits are killed, but the third bandit mounts his horse and attempts to escape. As the bandit flees, one of the gunmen, Britt, steadies his pistol and takes aim. The escaping bandit gallops farther and farther away. But just as he is about to disappear behind a hill, Britt shoots, hitting the bandit square in the back, killing him. The youngest of the gunmen, Chico, shouts:

    Chico: (in awe) That was the greatest shot I've ever seen!

    Britt: (sternly) The worst! I was aiming at the horse.

This scene reminds us that even when what one person thinks is great performance may not be acceptable by another person's standards. Indeed, what appears like an accomplishment may actually be an error.

And what, you may ask, does this have to do with Six Sigma?

Sten Westgard, MS