Rev AM-4
The Supervisor can select the QC Frequency for performing external liquid control
samples. When it is time to perform external QC samples, the user must test the external
liquid controls and obtain acceptable results before patient samples can be tested. When
QC samples have been successfully performed, the user is allowed to perform tests on
patient samples. If QC samples are not within an acceptable range, a
QC Lockout function
prevents testing of patient samples. If desired, the supervisor in a central lab setting can
bypass this function. If test device controls are out of range, a QC Lockout function is
activated and patient test results are blocked from viewing and printing. This prevents
unacceptable results to be communicated to and used by the physician.
Additionally, if test devices are expired, a QC Lockout function is activated and prevents
testing using expired test devices.
Quality Control Samples
It is still valuable to apply the traditional approach to quality control by testing quality
control samples. These controls will check the total integrity of the system. The interval for
analyzing these controls, however, can be extended due to the many other Total Quality
Assurance features inherent in the Triage tests.
The Triage tests have been designed to maximize Total Quality Assurance in any testing
environment. The combination of the QC features of the Triage tests reduce the impact of
procedural errors, ensure reagent integrity, and assure that patient results are accurate
each and every time a test is performed. Based on the current CLIA guidelines and other
regulating bodies, Biosite Incorporated makes the following QC recommendations:
• Run two levels or POS and NEG external liquid control samples as appropriate with
each new lot of reagents and once every thirty days with continued use of the same
reagent lot number
•
Run the QC Device daily
Notes Regarding Software Controls
1. User ID Access
• To prevent untrained persons from performing a test, a User ID (1-9 digits in length)
must be entered before access is given to the RUN TEST function if the User ID
bypass is OFF. If a User ID Bypass is ON, then anyone can analyze a test.
• The User ID Bypass is controlled by the SET PARAMETERS function, which
requires a Supervisor Code Chip module for access.
• Access is available to anyone wanting to RECALL RESULTS from memory or
INSTALL NEW CODE CHIP.
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