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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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Extra-analytical quality indicators - where to now?

Ada Aita1, Laura Sciacovelli1, Mario Plebani1

  • 1Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy.

Clinical Chemistry and Laboratory Medicine
|December 19, 2017
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Summary
This summary is machine-generated.

Ensuring quality in clinical laboratory testing requires attention to all phases. Harmonizing quality indicators (QIs) and performance specifications improves laboratory accreditation and patient safety.

Keywords:
extra-analytical phasesharmonizationmeasurementpatient outcomesperformance specificationsquality indicators

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Area of Science:

  • Clinical laboratory science
  • Healthcare quality improvement

Background:

  • The extra-analytical phases of the total testing process (TTP) are vulnerable and require enhanced quality control.
  • Quality indicators (QIs) are crucial for documenting and improving TTP quality, and are essential for clinical laboratory accreditation.

Purpose of the Study:

  • To highlight the need for quality and harmonization in all steps of the clinical laboratory testing cycle.
  • To emphasize the importance of universal QIs, common terminology, and harmonized management procedures for TTP.

Main Methods:

  • Reviewing evidence on the vulnerability of extra-analytical phases in TTP.
  • Analyzing data from the Model of Quality Indicators program by the International Federation of Clinical Chemistry and Laboratory Medicine's Working Group.
  • Establishing performance specifications for extra-analytical phases based on QI data.

Main Results:

  • Wide consensus achieved on adopting universal QIs and common terminology.
  • Harmonized management procedures, including common metrics and reporting systems, are being adopted.
  • Performance specifications for extra-analytical phases have been defined based on the state of the art.

Conclusions:

  • Harmonization of QIs and performance specifications is fundamental for interlaboratory benchmarking.
  • Standardized QIs and specifications provide essential tools for continuous quality improvement in clinical laboratories.
  • Focusing on extra-analytical phases enhances the overall reliability of the total testing process.