Lab Name Department of Pathology

Address Manual Hematology

Coagulation Inter-Instrument Comparisons

Author:
Heidi Hanes / Document Number: / Equ30-44
Effective (or Post) Date: / 15-June-2010
Review History / Date of last review: / NA
Reviewed by: / Heidi
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.

Document: HEM.0060 Effective: 8/28/2007

Version 1.1

PURPOSE

This procedure provides the instructions for inter-instrument comparisons for checking correlation of patient results between coagulation analyzers at least semiannually. Comparisons are required between the Stago STA Compact Analyzers.

INSTRUMENTATION

Stago STA Compact Analyzers

SPECIMENS

A minimum of five (5) fresh patient specimens collected in 3.2% Sodium Citrate anticoagulated vacuum tubes that have the correct blood:anticoagulant ratio (9:1) is required. The selection of normal patient specimens is preferred. Ideally, specimens should be less than four (4) hours from collection time. Ensure that there is enough blood volume in each specimen to perform the required studies. Do not use hemolyzed specimens. Refer to the following chart for reference ranges of acceptable specimens to be used.

Analyte / Reference Range
PT / 11.0-15.0 seconds
PTT / 24.0-35.0 seconds
Fibrinogen / 200-450 mg/dL
D-Dimer / 0.22-0.48 µg/mL

NOTE: All specimens must fall within the criteria.

PROCEDURE

Semiannual inter-instrument comparisons between the Stago STA Compact Analyzers

Step / Action
1 / Analyze a minimum of five (5) patient specimens for PT, PTT, Fibrinogen and D-Dimer. Minimize the amount of time between the analyses on the two different analyzers.
2 / For each analyte, compare each specimen’s results from each analyzer and verify that they agree within the acceptability criteria (based on the normal control quality control material) given below:
Analyte / Criteria, ±
PT / 0.2 seconds
PTT / 1.0 seconds
Fibrinogen / 15 mg/dL
D-Dimer / 0.03 µg/mL
3 / o  If ³80% specimen acceptability is achieved for all analytes, no further action is necessary.
o  If 80% specimen acceptability is achieved for any analyte, analyze another five (5) specimens for that analyte and compare those results to the acceptability criteria. If ³80% specimen acceptability is achieved, no further action is necessary. If <80% specimen acceptability is achieved for any analyte after the second set of 5 specimens, institute instrument/analyte troubleshooting. After successful troubleshooting, as determined by acceptable quality control results, analyze another five (5) specimens and compare those results to the acceptability criteria. If ³80% specimen acceptability is achieved on the second set of specimens, no further action is necessary. If not, continue to troubleshoot and confer with Management and Stago, if necessary.
4 / Record patient ID, the results and findings on HEM.0061 Inter-Instrument Comparison Data.
5 / Review the study results by the Manager. Document the review appropriately.
6 / File the paperwork appropriately.

REFERENCES CAP Hematology-Coagulation 04/06/2006 checklist - HEM.37050, 37232

RELATED

DOCUMENTS HEM.0061 Inter-and Intra-Instrument Comparison Data

Approval Signature ______Date: ______

Inter-Instrument Comparisons Page 1 of 2

HEM.0060, V 1.1