OPTIMedical OPTI CCA-TS, Руководство оператора, Страница: 74 / 271

Operator’s Manual – OPTI CCA-TS 4-3
4 CALIBRATION AND QUALITY CONTROL
procedure as proposed by the FDA, “Federal Register” 39, No. 126, 24136-24147.
In the case of BUN (urea), OPTI Medical Systems recommends correlation against the end-point
coupled enzyme method described by Sampson and Baird, et.al., in Clinical Chemistry 26: 816-
826, 1980.
4.5 QC Recommendations
Two standard Reference Cassettes (SRC) should be used as a control for the OPTI CCA-TS
analyzer. The level 1 and level 3 SRCs represent high and low samples. The SRCs contain a
stable optical sensor simulator which is measured by the device in exactly the same manner
as any other cassette and provides assurance that all measured parameters by the analyzer are
consistent. The results obtained should fall within limits contained in the SRC barcode.
NOTE: Hospitals should develop their own policy and procedures on the number of QC samples
to be run on a daily basis as mandated by the regulatory agency under which they
operate.
After receipt of a shipment of cassettes and at monthly intervals thereafter, validation should be
performed by analysis of OPTI CHECK or OPTI CHECK PLUS Blood Gas Controls or other
equivalent material as recommended by OPTI Medical Systems. These materials should provide
target values for pH, P CO
2
, and all other measured parameters over a range of measurement
values typically seen in each testing site laboratory. The results obtained should fall within limits
defined by the day-to-day variability as measured in the user’s laboratory facility.
OPTI Medical recommends the following as a minimum testing frequency of QC materials:
Control Frequency
SRC level 1 At least 1x per day in operation
SRC level 3 At least 1x per day in operation
OPTI Check or OPTI Check Plus Liquid
Controls
1 month intervals and with each new shipment
of cassettes.