The Westgard Rules

What's New on Westgard Web: November 2011

Posted by Sten Westgard, MS<

Re-emerging Issues in QC today

To repeat or not repeat? the question itself keeps coming up again and again. We all recognize the theoretical problem with repeating the control, but in practice, most labs are chronic repeaters. Dr. Westgard discusses why some QC problems persist, and what approaches to deal with them are best.

Included in this essay is a discussion of multiplex QC. In the new field of molecular diagnostics, labs are rediscovering some of the same problems with tight control limits and multiple analytes. Dr. Westgard discusses whether new multirules are needed for multiplex tests.

Can't we just move on from multirules?

Traceability: Why it Matters

Traceability, Standardization, Harmonization, Comparability. Even within the laboratory, these are not terms and concepts that inspire a lot of excitement. But as the world gets smaller, and health records get more connected, reliable, comparable tests results matter more and more. Whether or not we want to be involved, we are already part of the struggle for standardization and harmonization.

At Halloween, did your method Trick or Traceable?

Is QC Quality Compromised?

Non-commutable controls, matrix effects, non-harmonized methods, consensus means, artificially wide manufacturer ranges, repeated controls, lot-to-lot variation. How many ways can the implementation of quality control can be compromised? The answer might depress you.

If Lean has "7 wastes", does QC have "7 corruptions"?

Westgard at AMP, Webinar on healthcare reform

Posted by Sten Westgard, MS

Dr. James O. Westgard, PhD, will be at the AMP (Assosciation for Molecular Pathology) 2011 Annual Meeting in Grapevine, Texas:

Wednesday, November 16, 2:00 - 3:00 pm: Industry Workshop for SeraCare Life Sciences. Dr. Westgard will present Risk Analysis QC Plans for Laboratory Developed Tests (LDTs).

Thursday, November 17, 2011, 2:45-3:45 Workshop: Applying Statistics to Multianalyte and Multitarget Testing. Dr. Westgard will be presenting on the Evolution of QC Practices and Development of Multiplex QC Procedures.

Hope to see you there!

Also, Sten Westgard will be presenting as part of an Abbott-sponsored webinar, November 16th, 1:00 pm Central, on the Significance of Six Sigma in Health Care Reform 

Hope to hear from you on the webinar!

Adverse Events In Hospitals: US Error Rates in Medicare

Posted by Sten Westgard, MS

Here's an eye-opening report from the Office of Inspector General from the Department of Health and Human Services: Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries

So what's your best guess on the frequency of adverse events?

POC INR: don't rely on the "r"?

Posted by Sten Westgard, MS

A recent Clinical Laboratory Strategies article:Anchoring POC Quality in Clinical Decision-Making and the related study: Novel analysis of clinically relevant diagnostic errors in point-of-care devices, KM Shermock, MB Streiff, BL Pinto, P Kraus, an dPJ Pronovost,  (J Thromb Haemost 2011;9:1769-1775) have an interesting observation about the use of the correlation coefficient to accept method performance.

They looked at Hemochron POC devices, analyzing 1518 paired INRs. The correlation between the POC and laboratory measurements ranged between 0.84 and 0.91.

The authors stated, "Traditional, quarterly, quality assurance studies emphasize correlation analysis." So this study has good news, right?

The psychology of the irrational laboratory

Posted by Sten Westgard, MS

Why do some numbers and statistics in the laboratory attract more attention than others?

While we consider ourselves scientists who make decisions based on rational cost-benefit analyses, an objective look at some of our priorities often reveals the opposite. Labs often make decisions and set priorities based on the emotions of the moment, rather than a cold analysis of the data.

Let's put it another way. There is an infamous quotation attributed to Stalin: "When one man dies it is a tragedy, when thousands die it's statistics."

Do labs respond more to individual tragedies or their own statistics?