ITC Hemochron Signature+ Whole Blood Microcoagulation System - Manual (Page 20)

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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. Quality
control testing of the HEMOCHRON Jr. Signature+ consists of the following operations:
• Testing system performance using Electronic System Verification Cartridges at two levels every eight
hours of operation.
• Testing cuvettes in accordance with the Package Insert for each assay using two levels of liquid
controls.
Self-Check
The HEMOCHRON Jr. Signature+ instrument performs a “self-check” every time it is activated and a test is
performed. When a test is initiated by inserting a cuvette, system checks are automatically performed and
include:
• Verification of adequate battery power to complete a full test.
• Verification of the test type on the screen display to insure that the LEDs used for identifying the
test are functioning properly.
• Verification that the cuvette temperature 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 sample is present and is of sufficient size to run test. This insures that the
pumps and sample sensing LEDs are functioning properly and that the cuvette is adequately
sealed. If these instrument and sample parameters are not appropriate, the test is terminated
and an error message displayed.
• Verification that the internal timers function correctly for each test. If the system timer and
assay timer disagree, a real-time clock error message is displayed and the test result is not
reported.
QC of Instrument Performance
The instrument should be tested at two levels once every eight hours of operation. Electronic quality control
cartridges (EQC Cartridges) can be used to provide a two-level electronic verification of instrument
performance, or liquid quality control products can be used.
QC Using EQC Cartridges:
1.
Insert the corresponding EQC Cartridge into the instrument. Enter an Operator ID (optional) for
the test. The instrument will beep once and display:
E-QC ……..TEST
Note: System verification checks are performed during this process. If a fault is encountered,
the instrument will beep several times and display the error message. Refer to the
Troubleshooting section for the procedure to resolve an error message.
2.
After a short interval, the instrument will beep once and alternately display:
Press E-QC …….. and …….. Start Now
3.
Press the Start button on the EQC Cartridge. The instrument displays the elapsed time (in
seconds) until the EQC Cartridge simulates an endpoint.
4.
When the EQC Cartridge simulates an endpoint, the instrument beeps twice. Final results of the
test, along with a PASS or FAIL designation, are displayed and saved in the database when the
cartridge is removed.
Note: If a printer is connected, the results are printed when the EQC Cartridge is removed.
5.
Compare the displayed time with the acceptable range for the EQC Cartridge and remove the EQC
Cartridge.
6.
Repeat the procedure using the other EQC Cartridge.