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POLICY:The Sysmex BEYONDCARE QUALITY MONITOR program uses a multirule approach to assess both the accuracy and the precision of your analyzer based on the results of your QC data. One of the rules uses evidence based quality control limits to determine the total allowable error of each QC parameter. The EBQC limits were developed using Six Sigma methodologies incorporating parameter-specific performance goals, bias, and coefficient of variation in order to achieve a relevant limit. EBQC limits are designed to flag “true” errors while minimizing “false” rejections. The application of these multirules along with the automatic troubleshooting process will help to determine any analyzer performance issues.
Daily QC
The CLIA ’88 document, enforced since 1993, states that calibration verification must be performed at least once every 6 months for nonwaived (moderate and high complexity) test systems. However, CLIA has an exception for automated hematology cell counters which states that calibration verification requirements are met if :
A calibration is performed only if calibration verification specifications are not met.
Sysmex PolicyCalibration Verifications:
Calibration Verification means testing materials of known concentration in the same manner as patient specimens to assure the test system is accurately measuring samples throughout the reportable range.
Calibration
Calibration is the process of testing and adjusting the instrument or test system readout to establish a correlation between the instrument's measurement of the substance being tested and the actual concentration of the substance.
The Sysmex BEYONDCARE QUALITY MONITOR program uses a comprehensive QC algorithm approach to assess the accuracy and the precision of your analyzer based on the results of your QC data. One of the algorithms uses evidence based quality control limits to determine the total allowable error of each QC parameter. The EBQC limits were developed using Six Sigma methodologies incorporating relevant limits. EBQC limits are designed to flag "true" errors while minimizing "false" rejections. The application of these comprehensive QC algorithms along with the automatic troubleshooting process will help to determine any analyzer performance issues.
Please provide a laboratory phone number near the Sysmex analyzer for Service and Technical Assistance Center to call when a QC concern is identified.
The contact details that we can use to notify the lab manager regarding an issue.
Summary Report
XN-10
QC Passed
Background Counts Passed
Controls Failed
Backgrounds Counts failed
XNBF QC Passed
XNBF QC Failed
Service Event
Calibrated(EBC)
Run QC
Have all controls finished analysis?
Selecting Reset wil restart the QC and Calibration Verification logic. Do you want to continue?
Are you sure you want to quit troubleshooting? Quitting will require a re-run of your standard QC preferences.
Selecting Confirm wil remove the analyzer from maintenance mode. Do you want to continue?