Abbott i-STAT 1 System Manual - Quality Control

QUALITY CONTROL

14

Art: 714376-00M 

Rev. Date: 31-Jan-12 

14-1

Overview 

This section describes the steps to be taken to verify the performance of the 

analyzer and cartridges. The rationale for the i-STAT cartridge and analyzer 

quality regimen is described in the Theory section of this manual. 

Customization

The quality control behavior of the analyzer can be customized via the Central 

Data Station or analyzer Customization Change function to:

• turntheexternalElectronicSimulatorreminderonoroff.

• prompttheoperatortousetheexternalElectronicSimulatorat

scheduled intervals.

• turntheinternalElectronicSimulatoronoroff,andselectthe

simulator test cycle intervals.

• disablefurthercartridgetestingwhentheinternalElectronic

Simulator test fails.

See the Customization section for default values.

Data Retention

Quality control data is transmitted to the Central Data Station.  If a Central 

DataStationisnotbeingused,thechartsattheendifthissectioncanbeused

to record liquid and electronic control results.

QUALITY CONTROL FOR i-STAT CARTRIDGES AND THE ANALYZER’S CARTRIDGE TEST CYCLE

Verify Performance of 

Analyzers Daily

VerifytheperformanceofeachanalyzeronsiteusingtheElectronicSimulator

(externalorinternal)onceadayonthedaystheanalyzersareinuse.Notethat

regulatory or accreditation requirements may dictate more frequent intervals. 

Verify Newly Received 

Cartridges

1. Verifythatthetransittemperaturesweresatisfactoryusingthefour-

windowtemperatureindicatorstripincludedintheshippingcontainer.

2. Fromeachlotineachshipmentofcartridges,analyzemultiplelevelsof

i-STATcontrols(andRNA

®

Medicalcontrolsiftestingforhematocrit)

using any verified analyzer.*

* This is not a manufacturer's system instruction; it is a suggestion to 

complywithregulatoryrequirements.

Check Refrigerator 

Storage Daily

Verifythatthecartridgesstoredintherefrigeratorarewithintheexpiration

dateprintedontheboxes.

Verifythatthestoragerefrigeratordidnotexceedthetemperaturelimitsof2to

8°C(35to46°F).Ifstorageconditionsareindoubt,usecontrolstoverifythat

the cartridges are performing properly.  This is especially important if freezing 

conditions are suspected at the back of the refrigerator.