Quidel Triage MeterPro, Руководство пользователя, Страница: 74 / 86

Page 74 of 86
A Patient ID is required for all patient tests performed. All QC sample and patient results are stored in the
meter’s memory and can be downloaded to a laboratory information system (LIS) or an external data
management software program for further viewing and printing of quality control reports.
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 Quidel
Triage tests.
The Quidel Triage tests have been designed to maximize Total Quality Assurance in any testing environment.
The combination of the QC features of the Quidel 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, Quidel 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 Ͳ 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 results, printing patient results, and recalling the last test run on
the meter when the last test is a patient sample,
„
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 NON Ͳ PATIENT RESULTS from memory or INSTALL
CODE CHIP.
2.
Out Ͳ of Ͳ Range Flags