Standard Operating Procedure

Subject COBAS Integra 400 Plus Routine Operation

Index Number Lab-1597
Section Laboratory
Subsection Regional/Affiliate
Category Departmental
Contact Elizabeth Kamprud
Last Revised 7/17/2017

References
Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers
for Medicare and Medicaid Services (CMS) and/or COLA.

Applicable To
Employees of the GLMC, Gundersen Tri-County Hospital laboratories and Gundersen St. Joseph’s
Hospital laboratories.

Detail
PRINCIPLE:
The Roche/Hitachi Cobas 400 Plus is a fully automated, software-controlled system for clinical
chemistry. It is designed for quantitative in vitro determinations using a large variety of tests for
analysis. It is ready to use 24 hours per day. The Cobas Integra 400 Plus:
1. Is fully automated
2. Is modular
3. Is computerized
4. Uses serum/plasma/whole blood
5. Performs in vitro quantitative tests on a wide range of analytes
6. Performs photometric assays and ion-selective electrode measurements on Integra 400 Plus
modules.

CLINICAL SIGNIFICANCE: N/A

SPECIMEN: N/A

REAGENTS/MATERIALS: N/A

EQUIPMENT INSTRUMENTATION: N/A

QUALITY CONTROL: N/A

Implementation
PROCEDURE:
Review inventory. Remove any expired reagents. Replace any diluents or wash reagents. Replace
activator every 4 days or if low. Check cuvette supply, waste container and paper supply. If the ‘Service’
icon is yellow, click to reveal due service actions. Click on ‘Perform’ to do the service actions.

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 Standard Operating Procedure

1. Review Calibration/Status screens.

2. Order QC for in-use reagent cassettes.
3. Pour necessary calibrators and controls into Cobas cups.
4. Check calibration and QC for error messages. Troubleshoot and repeat as necessary,
documenting corrective action.
5. Calibrations are saved on disk and stored in a file.
6. Load specimens in appropriate racks. Use designated racks for specimen/tube type. Load racks
when analyzer status is in operating mode or press START.
7. Semiannual cross checks between analyzer where applicable. Refer to Lab-0170 Quality Control.
8. Refer to Roche Diagnostics Cobas Integra 400 Plus Operator’s Manual for detailed instruction.

CALCULATIONS: N/A

INTERPRETATION: N/A

LIMITATIONS: N/A

REVIEW AND CHANGES:

This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as
the maximum review date. Review will be done by the Technical Leader, Supervisor, Manager, Medical
Director or designated person. Changes require retyping document or form and review by the Medical
Director.

REFERENCES: N/A

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