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    NEW! Risk Analysis Guidelines Analysis

    Get an overview of ISO standards 15189, 14971, and 22367 and CLSI guidelines EP18, EP22, and EP23. With Risk Management coming into medical laboratories, now is the time to learn these important Risk Analysis concepts recommended by these documents.

    Introduction to Risk Analysis

    New standards and guidelines for Quality are heading toward the lab, based on Risk Management principles. Learn all about them now.

    Quality Management and Design of Analytical Systems (An Introduction)

    Quality Planning and Design are part of a larger systems approach to analytical management. in this new six lesson course, participants will review current guidelines for quality and learn to use QC Design tools to customize their procedures and achieve the quality required by their tests.

    Basic QC Practices

    Our most popular course, covering the fundamentals of quality control in the laboratory.

    Basic Method Validation

    This course teaches all the experiments and calculations needed for a basic validation of a new instrument. Linearity, Reportable Range, Comparison of Methods, Correlation, Replication, Interference, Recovery, Detection Limit and Reference Range studies are explained and demonstrated. Educational online tools allow participants to enter data and view results immediately.

    Secrets of Method Validation Streaming Video course

    A short animated slide show, narrated by Dr. Westgard, explaining the Inner, Hidden, Deeper, Secret Meaning of Method Validation

    "Westgard Rules" and Levey-Jennings short course

    Everything you ever wanted to know - and were afraid to ask - is included in this online course. All the rules, combinations, and interpretations are included. Online graphing tools allow you to enter data and see the interpretation.

    Westgard QC, Inc. was the first company to offer accredited online courses through both the AACC and ASCLS. More than a thousand participants from over 30 countries have taken our online courses.

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September 04, 2012


Kathleen Freeman

I think this is a great question… my opinion, we need to keep going back to the clinical use of the results to determine if the quality requirement/standard is appropriate.

In working with clinicians (and other pathologists) with TEa/quality requirements, I've found that they often have unrealistic goals based on how they'd LIKE to interpret a test….so some education and compromise is needed to let them know what the current state-of-the-art is with regard to instrument performance.

Likewise, manufacturer's need to pay attention to what specifications the user requires and try to get the instrumentation performance in the needed range!

Hassan Bayat

Of course choosing “right goals” is a critical issue.
- Any goal is chosen, it must be clear for both sides: laboratories and physicians. Physicians must be aware of the TEa the laboratory is working within, and also be informed about the number of the results that are in the chosen TEa. For example, if a laboratory’s TEa for glucose is 10% and the laboratory’s sigma is 2 (that unfortunately accepted by current rules!), it means that 5% of glucose results are more than 10% away from the correct value. If a physician knows this, then s/he will be able to make better decisions about the patients. But it seems that a lot of physicians aren’t informed of quality goals and sigma number of the laboratories’ performance, and this makes them, as Sten Westgard says, think of the laboratory results as an absolute vale an not a probable value.
- Clinical guidelines must address, and be based on, the required quality goals and needed sigma number. Only the laboratory results that are produced complying the needed TEa and sigma, could be interpreted the way that a guideline says.
- “The 1999 Stockholm consensus hierarchy" addresses the way to choose quality goals. But:
 It is not clear that this statement talks to whom: laboratories or authority organizers? (Of course laboratories have to refer to rules that authority organizations establish.)
 Using “the behavior of the physicians” as a source for establishing quality requirements can result in a loop. The physicians’ behavior is based on the current quality of the assays, at least to some degree. Therefore, the physicians make their mind based on the quality of our performance, and then behave based on that idea, and then we consider the physicians’ behavior as quality requirements for our performance. In short, this means accepting the current performance as the best performance!

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