Biosite Triage MeterPro - Page 83

M-4Rev F
care & maIntenance
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
preventstesting 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
foranalyzing 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validUserID(1-16
characters 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.
 • Topreventunauthorizedpersonsfromaccessingpatientinformation,avalidUser
ID must be entered before access is given to the RECALL PATIENT RESULTS
functions if the User ID bypass is OFF. If a User ID Bypass is ON, then anyone can
recall patient data. RECALL PATIENT RESULTS functions include recalling patient
M-4