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Experience with quality control in clinical chemistry.

D Stamm

    Zeitschrift Fur Lebensmittel-Untersuchung Und -Forschung
    |May 1, 1986
    PubMed
    Summary

    Statistical quality control in clinical chemistry has improved analytical reliability and methods. A new concept uses method-independent reference values for enhanced quality assessment in Germany.

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    Area of Science:

    • Clinical Chemistry
    • Laboratory Medicine
    • Quality Management

    Background:

    • Statistical quality control (SQC) has significantly enhanced the reliability of clinical chemical analyses since its introduction.
    • SQC has driven improvements in analytical methods, reagents, calibration materials, control specimens, and equipment.
    • Reliable analytical results have fostered advancements in theoretical concepts within clinical chemistry.

    Purpose of the Study:

    • To provide an overview of quality control developments in the Federal Republic of Germany from 1964 onwards.
    • To describe the uniform basic quality control program implemented in Germany since 1971 and discuss experiences with it.
    • To introduce a new quality control concept based on method-independent reference values.

    Main Methods:

    • Description of the uniform basic quality control program, including internal (precision and accuracy control) and external (interlaboratory surveys) procedures.
    • Determination of assigned values for accuracy control specimens under routine conditions by independent, highly qualified laboratories.
    • Development of a new quality control concept utilizing method-independent reference method values.

    Main Results:

    • The established quality control system provided valuable data on analytical result reliability and data structure.
    • Experience with the system led to the development of a new concept replacing method-dependent assigned values with method-independent reference values.
    • Quality control requirements, including acceptable imprecision and deviation, are defined based on clinical decision-making impacts.

    Conclusions:

    • Statistical quality control is crucial for ensuring the reliability of clinical chemical analyses.
    • The evolution of quality control in Germany, from assigned values to reference method values, reflects a progression towards more robust analytical assessment.
    • Defining quality requirements based on clinical needs ensures the practical utility of laboratory results in patient care.

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