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Experiences with a statistical quality control system (QCS) for coagulation diagnostics parameters.

E Spanuth1, J Breyer

  • 1Boehringer Mannheim GmbH, FRG.

Folia Haematologica (Leipzig, Germany : 1928)
|January 1, 1988
PubMed
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The Quality-Control-Service (QCS) provides statistical quality control for blood coagulation tests using PreciClot plasma. This system enhances the accuracy and precision of coagulation assays like prothrombin time and APTT.

Area of Science:

  • Clinical Chemistry
  • Hematology
  • Laboratory Medicine

Background:

  • Implementing robust quality control is essential for accurate blood coagulation testing.
  • Existing quality assessment programs may not offer continuous, integrated data analysis.

Purpose of the Study:

  • To introduce and evaluate the Quality-Control-Service (QCS) for statistical quality control of blood coagulation methods.
  • To assess the accuracy, precision, and interlaboratory reliability of common coagulation assays.

Main Methods:

  • Utilized PreciClot, a universal control plasma with normal and abnormal target values.
  • Collected and statistically analyzed daily quality control data from 75 participating laboratories over a 12-month period (1985).
  • Evaluated prothrombin time (PT/Quick), activated partial prothrombin time (APTT), fibrinogen assay, and thrombin time.

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Main Results:

  • Presented calculated results for PT/Quick, APTT, Fibrinogen, and Thrombin time.
  • Compared the accuracy and precision of these methods with historical ring trial data.
  • Demonstrated the utility of QCS as a monthly quality assessment program.

Conclusions:

  • The QCS system offers a valuable tool for ongoing statistical quality control in coagulation laboratories.
  • The study highlighted the interlaboratory reliability of the evaluated coagulation methods.
  • QCS provides enhanced information regarding the quality of routine coagulation tests.