Lab Name
Address
Department of Pathology
Manual Hematology
Hematology Inter- and Intra-instrument Comparisons
Author:
Heidi Hanes
Document Number:
Equ30-40
Effective (or Post)
15-June-2010
Date:
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.0015
Version 1.0
Effective: 6/25/2007
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.
WBC
RBC
HGB
HCT
MCV
PLTS
Analyte Reference Range
5.0-10.0
4.0-5.0
13.5-16.5
40-46
80-100
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
Inter- and Intra-instrument Comparisons
HEM.0015, Version 1.0
Page 1 of 3
Lab Name
Address
Step
1
2
3
4
5
6
Department of Pathology
Manual Hematology
Action
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.
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
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.
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
Review the study results by the Manager. Document the review appropriately.
File the paperwork appropriately.
PROCEDURE B
Semiannual intra-instrument comparison on the 3200 analyzers in the open and
closed modes
Step
1
2
3
Action
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.
Ensure the specimens are thoroughly mixed off-line by placing the tubes on a
tube rocker for two (2) minutes.
Analyze the specimens again for WBC, RBC, hemoglobin, hematocrit, MCV,
and platelet count in the open mode on the 3200 analyzer. Minimize the
Inter- and Intra-instrument Comparisons
HEM.0015, Version 1.0
Page 2 of 3
Lab Name
Address
4
5
Department of Pathology
Manual Hematology
amount of time between the analyses.
Repeat steps 1-3 of Procedure B for the other 3200 analyzer.
Repeat steps 2-6 of Procedure A.
REFERENCES
RELATED
DOCUMENTS
CAP Hematology-Coagulation 04/06/2006 checklist - HEM.28000,
.28666, .29332, and .30070
HEM.0016 Inter-and Intra-Instrument Comparison Data
Approval Signature ___________________________________
Inter- and Intra-instrument Comparisons
HEM.0015, Version 1.0
Date: ___________
Page 3 of 3