ITC Hemochron Signature Elite Whole Blood Microcoagulation System - Manual (Page 36)

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QUALITY CONTROL (QC)
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and other regulatory agencies
recommend 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 Signature Elite consists of the following operations:
• Testing system performance and verifying system temperature using internal Electronic System
Verification 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 Signature Elite 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 °C ±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.
Verification of Instrument Temperature
Instrument temperature is automatically checked whenever EQC is carried out. The instrument temperature
check verifies that a temperature of 37 °C ±1.0 °C is maintained during the test.
Note: If the temperature reading is out of range, please contact ITC Technical Support at
(800) 631-5945 or (732) 548-5700.
QC of Instrument Performance
The instrument should be tested at two levels once every eight hours of operation. Automatic internal Electronic
Quality Control (EQC) can be used to provide a two-level electronic verification of instrument performance, or
liquid quality control products can be used.
Note: HEMOCHRON Configuration Manager is used to specify Automatic EQC, to specify the required
interval for performing EQC, and to program EQC Level 2 for either 300 seconds or 500 seconds (see
page 58).
Important: If Auto EQC is selected, ensure that cuvettes are routinely removed from the instrument
after completing a test. If EQC is run while a cuvette is inserted, the message Detector Blocked is
displayed and the EQC test fails.
EQC is performed automatically if Automatic EQC is specified and if the HEMOCHRON Signature Elite
instrument is plugged into the AC/DC Power Module. EQC results are stored to the database and displayed for
five minutes (or until Cancel is pressed).