TITLE: Instrument Correlations – CS-2500 vs. CA-660

PRINCIPLE: To comply with CAP standard COM.04250, “If the laboratory uses more than one non-waived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results.” And standard COM.04300, which states: “Acceptability criteria are defined for comparability of instruments/methods used to test the same analyte, with documentation of corrective actions when criteria are not met.”

PERSONNEL

Medical Technologists and Technicians

SPECIMEN COLLECTION/TREATMENT:

Patient Preparation:	No special patient preparation required by Laboratory personnel.

Type of Specimen:	3.2% Sodium citrate anticoagulated whole blood. Specimen must be filled to meet the minimum fill line on the tube. Specimen requirements are the same as for PT/PTT policies. Follow all the same protocols.

Handling Precautions: Handle all specimens using Standard Precautions.

REAGENTS AND EQUIPMENT:

CS-2500 and CA-660 analyzers which have been maintained and quality control material run as specified in QC program for Coagulation.

Reagents/Detergents/Diluents/QC which is required in order to perform testing

CALIBRATION:

N/A

QUALITY CONTROL:

Performed according to analyzer protocol

STEPWISE PROCEDURE:

Comparisons of PT/PTT/FIB/D-Dimers are run during New Lot/Reference Range studies and then again approximately six months later to verify agreement between analyzers.

During our New Lot studies a minimum of 20 specimens are run on each analyzer for PT/PTT/FIB/D-Dimer. Data is plotted for comparisons of current versus new lot of reagents, to verify our patient reference range and to verify established tolerance limits between the two analyzers.

All data is now entered into the computer with the EP Evaluator program. PT: < 10%, PTT: < 20%, Fibrinogen's: < 20% and D-Dimer: <20% to meet our limits of acceptance. Data is reviewed by the Sr. Tech or designee and stored in the binder for Instrument Comparisons.

CALCULATIONS:

Initial tolerance limits were established for each test, PT, PTT and FIB. The EP Evaluator is used to plot and print-out data for review.

REPORTING AND INTERPRETING RESULTS:

Results are recorded and reviewed by the Sr. Technologist or designee. Results of comparisons should agree within tolerance limits established.

PROCEDURAL NOTES:

None

LIMITATIONS OF PROCEDURE:

None

REFERENCE:

CAP Inspection All Common Checklist, 04.21.2014, Quality Management, General Issues; p. 14-15.