Lab Name Department of Pathology

Address Manual Hematology

Author:
Heidi Hanes / Document Number: / Equ30-40
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.

Hematology Inter- and Intra-instrument Comparisons

Document: HEM.0015 Effective: 6/25/2007

Version 1.0

PURPOSE

This procedure provides the instructions for inter- and intra-instrument comparisons for checking correlation of patient results between hematology analyzers at least semiannually. Comparisons are required between the Sapphire and the 3200 analyzers in the closed mode and within the 3200 instrument in the open and closed modes.

INSTRUMENTATION

Abbott Diagnostics Cell-Dyn Sapphire and 3200 hematology analyzers

SPECIMENS

A minimum of five (5) fresh patient specimens collected in EDTA anticoagulated vacuum tubes 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. Refer to the following chart for reference ranges of acceptable specimens to be used.

Analyte / Reference Range
WBC / 5.0-10.0
RBC / 4.0-5.0
HGB / 13.5-16.5
HCT / 40-46
MCV / 80-100
PLTS / 150-450

NOTE: All specimens must fall within the criteria.

PROCEDURE A

Semiannual inter-instrument comparisons between the Sapphire and the 3200 in closed mode

Step / Action
1 / Analyze a minimum of five (5) patient specimens for WBC, RBC, hemoglobin, hematocrit, MCV, and platelet count, on the Sapphire, 3200 (Core lab), and 3200 (Cancer Center lab) analyzers. Minimize the amount of time between the analyses on the three 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, ±
WBC / 0.4
RBC / 0.1
Hemoglobin / 0.25
Hematocrit / 1.25
MCV / 2.0
Platelet / 25
3 / o  If 100% 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 100% specimen acceptability is achieved, no further action is necessary.
o  If <80% specimen acceptability is achieved for any analyte, 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 100% 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 Abbott Diagnostics, if necessary.
4 / Record which analyzers were used, location of analyzer (OPC or Core Lab), what mode the specimens were run in (3200 only) and the results and findings on HEM.0016 Inter- and Intra-Instrument Comparison Data
5 / Review the study results by the Manager. Document the review appropriately.
6 / File the paperwork appropriately.

PROCEDURE B

Semiannual intra-instrument comparison on the 3200 analyzers in the open and closed modes

Step / Action
1 / Analyze a minimum of five (5) patient specimens for WBC, RBC, hemoglobin, hematocrit, MCV, and platelet count in the closed mode on the 3200 analyzer.
2 / Ensure the specimens are thoroughly mixed off-line by placing the tubes on a tube rocker for two (2) minutes.
3 / Analyze the specimens again for WBC, RBC, hemoglobin, hematocrit, MCV, and platelet count in the open mode on the 3200 analyzer. Minimize the amount of time between the analyses.
4 / Repeat steps 1-3 of Procedure B for the other 3200 analyzer.
5 / Repeat steps 2-6 of Procedure A.

REFERENCES CAP Hematology-Coagulation 04/06/2006 checklist - HEM.28000, .28666, .29332, and .30070

RELATED

DOCUMENTS HEM.0016 Inter-and Intra-Instrument Comparison Data

Approval Signature ______Date: ______

Inter- and Intra-instrument Comparisons Page 1 of 3

HEM.0015, Version 1.0