CoaguChek Professional Monitoring Systems
Training Manual
31
CoaguChek
IQC and EQA Guidelines
This section provides detail on the quality control systems available as an integral part of the
CoaguChek systems, and quality assurance processed that are available from third party providers.
It is intended as a guide to help with the management of a quality control process, and assist with
meeting regulatory compliance requirements as applicable to the end user.
Please note also that quality control recommendations by national associations or local hospital
guidelines take precedence over manufacturer recommendations.
Internal quality controls (IQC) and external quality assessment (EQA) are two components of a
quality assurance programme. IQC is used to ensure consistency of INR results over a period of
time. EQA is used to identify the degree of agreement between INR results in different centres.
IQC for the CoaguChek Systems
The CoaguChek XS Plus and Pro have a number of built in quality control functions:
• A Check of the electronic components and functions every time the meter is powered on
• A check of the test strip temperature while a test is in progress
• A check of the expiry date and lot information on the test strip based on the code chip data
• A two-level, on board quality control test and patient result determination within a single test
chamber
The CoaguChek XS PT Test strips
The CoaguChek XS PT Test strips also have built in quality control functions:
• The reagents integrity is checked on each strip on the same channel that the sample goes through.
• Strips are refused which are exposed to:
• High temperature
• Humidity
• Light
• (or any combination of the above)
Summary of Contents for CoaguChek XS Plus
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Page 67: ...Accuracy and precision in oral anticoagulation monitoring I know my value...
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