ITC Hemochron Response Whole Blood Coagulation System - Manual (Page 27)

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QUALITY CONTROL (QC)
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recommends that medical and
laboratory instrumentation be enrolled in a quality assurance program adequate in maintaining accurate
and reliable performance of the equipment. Complete records of such quality control must be kept.
Routine quality control testing should be part of a comprehensive quality assurance program. This testing
should include:
• Testing system performance using Electronic System Verification tube or LQC.
• Testing test tube reagents in accordance with the Package Insert for each assay, using two levels of
liquid controls.
Self-Check
The HEMOCHRON Response instrument performs a “self-check” every time it is activated and a test is
performed. When a test is initiated by pressing START, system checks are automatically performed and include:
• Verification of adequate battery power to complete a 1500 second test.
• Verification that a tube has been inserted and that the test well is functioning properly. If any
rotation or temperature parameters are not appropriate, the test is terminated and an error
message is displayed.
• For barcoded tubes, the test type and expiration data are read. The test type will be displayed on
the screen. If the expiration date has passed, the test is aborted and an error message displayed.
Once a barcode is read, the user cannot change the test type.
• Verification that the test well is warmed to 37± 1.0 ºC. If this temperature is not achieved or is
exceeded, an appropriate error message will be displayed and testing is prohibited.
• Verification that the internal timers function correctly for each test. If the system timer and
assay timer disagree at the end of a test, a real-time clock error message is displayed and the
test result is not reported.
Operator Access to QC Procedures
If desired, operation of the instrument and running of quality control procedures can be restricted to
operators authorized by the supervisor (page 15). If an unauthorized operator attempts to run a QC
procedure, the message “Unauthorized Operator” is displayed.
Note: If QC Hide is enabled (page 17), a QC test result will be displayed as Pass/Fail without a
clotting time.
QC Intervals
If desired, the maximum allowable time between running ESV and/or LQC (the QC interval) can be
specified (page 16). If the specified QC interval is exceeded, the instrument will not run additional tests
until QC is performed and the results are acceptable.
QC Using ESV
The instrument should be tested at two levels once during any shift in which the instrument is utilized. An
ESV tube can be used to provide a three-level electronic verification of instrument performance, or LQC
products can be used.
Note: The ESV tube and HEMOCHRON LQC products are available from ITC.
To Use the ESV Tube:
1.
Press a START key to begin a test on a well. A beep will signal the start of the test. At the same
time, press the 100 second button on the ESV tube.
2.
Insert the ESV tube into the test well.
3.
A prompt is displayed if entry of an OID or PIN is required. Enter your OID or PIN and press YES.
4.
A prompt is displayed to enter the serial number of the ESV tube. The serial number of the last
ESV used is displayed.
Note: If needed, enter the ESV serial number (up to 9 characters) located on the back of the
ESV tube. Press BACKSPACE to undo an entry for retyping.
Printed From ITC Intranet