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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.

« Q&A: Two questions, Three graphs, and the 4:1s rule | Main | What's New: June 2013 »

June 17, 2013


Hassan Bayat

By sure, if our tests are traceable, then the patient’s results will be traceable. Though it’s very nice and also very necessary, but it’s not enough.
If it’s supposed that a specific patient be treated the same way regardless of the health-care institute or the practitioner s/he refers, we need a lot more than just the labs’ results being standardized/harmonized via traceability to a reference method and/or material.
To get uniformity in the patients care demands:
 Establishing reference methods and materials as the pivotal point so that all the other activities would be referenced to them.
 Establishing “Allowable Uncertainty” that could be tolerated in calibrating field methods.
Consider that when we claim a method is traceable, it means that we have calibrated that method via an unbroken chain of methods/materials against the “Master” of the available methods and materials i.e. the reference method/material. But such a claim does not say anything about the degree of the completeness of this process. To offer “Reliable” traceability we have to establish “Uncertainty Standards”, determine calibration uncertainties, and compare those against the standards to judge about the acceptability of the calibrations.
 Establishing “Clinically-acceptable” allowable total errors (as have been done for different analytes since long years ago).
 Determining “performance characteristics” of the assay methods to calculate the maximum probable error that a result might contain i.e. “Total Error”.
Total error would be the combined effect of three partners: A) Certain Bias (the same traditional bias), B) Probable Bias that is the result of calibration uncertainty and also inevitable shifts in calibration, and C) method’s variation (again the traditional CV).
 Programing QC activities based on the quality standards and performance characteristics (the long-life approach recommended by Professor J. O. Westgard).
 Researchers must use assay methods with specifications mentioned above, i.e. methods that are reliably traceable, and strictly Quality Controlled, to get traceable conclusions.
 Expert organizations must use only such traceable evidence to prepare traceable guidelines/care-maps that contain traceable reference ranges/cut-offs.
 Laboratories must assay the patient’s specimens using “reliably traceable” and “strictly controlled” methods equal to those used in the researches to produce traceable results.
 And, physicians must interpret the results and make decisions using traceable care-maps to practice traceable medicine.
As we see, uniformity in patient care needs a lot more than just labs to be traceable. It’s necessary that all the people and the activities related to the health care issue to be traceable. In short, to have a traceable health care system, every body and every activity must be “engaged” and “gaged”.
Hassan Bayat, DCLS, Sina Lab (Qaem-shahr, Iran)

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