Selecting A New Analyzer For The Hematology Laboratory:The Experience at Ohiohealth Hospitals
Selecting A New Analyzer For The Hematology Laboratory:The Experience at Ohiohealth Hospitals
Selecting A New Analyzer For The Hematology Laboratory:The Experience at Ohiohealth Hospitals
Official Publication
Riverside Methodist Hospital; 2Grant Medical Center; 3Doctors North Hospital; 4Doctors West Hospital, Columbus, Ohio
ABSTRACT
INTRODUCTION
OhioHealth Hospitals of Central Ohio is a group of
4 hospitals located on different sites in Columbus, Ohio.
The hospital group is composed of Riverside Hospital, Grant
Medical Center, Doctors North, and Doctors West. The hos-
245
246
K. Moser et al
Evaluation Methods
Performance of each set of analyzers was evaluated based
on precision, carryover, sample stability, comparison of results
with those from current methods, and false-positive/negative
rates. Once collected, all data were analyzed by both the
instrument representatives and members of the task force.
Precision. The objective of the precision study was to verify that performance was within manufacturers stated limits
for each mode of operation. Within-run precision was determined for each of the instruments. The same sample from a
hematologically normal donor was used for each run on the
same instrument. Different samples were used for the different instruments. For the instruments with an automated
mode, aliquots of the sample were made into 10 (plain redtopped) tubes. In the automated mode, the 10 tubes were
placed onto the instrument rack and each was analyzed. For
the high- and midvolume systems with both automated and
manual modes, precision was also evaluated in the manual
mode. In the manual mode, precision was measured by analyzing 10 consecutive replicates of the sample, mixing by
inversion between aspirations. The mean, SD, and coefficient of variation (CV) were calculated for each parameter,
each mode, and each instrument.
Run-to-run precision was evaluated to provide documentation of the calibration stability of all parameters. Results
were determined by analyzing appropriate control materials
on a daily basis for a minimum of 10 days. Three levels of
control material, specified by the manufacturer, were used for
each analyzer daily. The mean, SD, and CV were analyzed
for each sample set.
247
ABX
Micros 60,
Pentra 60,
Pentra120 retic
Bayer
Advia 60,
Advia120 basic,
Advia 120
10 min/d
No
Yes, all systems
Yes, local
None daily
No
Pentra 120 & 60
Yes, local
7 min/d
Yes
Yes
Not evaluated
Not evaluated
Not evaluated
Issue
Maintenance/service/reliability
Routine maintenance
Maintenance by modem
Online help
Service
Downtime
Beckman Coulter
AcTdiff2,
HmX,
GenS
None daily
GenS only
GenS only/CD-ROM
3 experienced
representatives in
city
Very dependable; have
decreased service
contract level for
$ savings
Sample handling
System characteristics
Ability to handle high
volume of samples
Depth of product line
Calibration
Technology
Software
Rules-based technology
Online training
Usability
Autovalidation
Pentra120, 130/h;
others, 60/h
Advia120, 120/h;
Advia60, 60/h
Several systems
available
3 configurations,
Very good
1 with autosampler
Done by technologist
as needed, but at
least every 6 mo
Same technology
Less advanced
Same technology
No
CD4000, 5; CD3200, 4
No
Yes
Pentra120 with
10
retics, 6; Pentra 60, 5;
Micros 60, 3
No
No
Printing
Downtime procedure
Yes
All systems, 4
Yes
SE9500, 9; SF3000, 4
No
No
Easy
Need to do through
laboratory information
system
Flag printing
Other considerations
Nucleated red blood cell
enumeration
Automation
Slide-making/staining
~20 min/d
No
No
3 experienced
representatives
within 3 h of city
More than desired;
has improved
Ease of use
Reagents
Same across product line
Number of reagents
Sysmex
KX21,
SF3000,
SE9500
Yes, CD3200
No
Yes, CD3200 &
CD4000
Yes, Pentra120
No
Yes,Advia120
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K. Moser et al
GenS/SE9500
HmX/SF3000
AcT diff/KX-21
250 samples
200 samples
100 samples
Technologists Assessment
At the conclusion of the laboratory evaluation, each evaluator completed a survey. This helped the task force determine
how each analyzer met the needs of the individual laboratory
and focused on important operational issues such as ease of
operation, data terminal navigation, quality-control package,
instrument maintenance, sample throughput, and minimal
operator intervention. The staff technologists also filled out a
similar evaluation form that stressed these same issues.
RESULTS
System Evaluation
Precision. Within-run precision results are shown in Table 2
for each of the analyzers under evaluation. Results for the
closed-vial/automated sampling mode are shown for all systems.
For the high- and midvolume systems, results in the openvial/manual mode were similar. In both the automated and
manual modes, the SE9500 and GenS systems and the SF3000
and HmX were within the specifications stated by their manufacturers. The low-volume systems KX-21 and AcT diff gave
results in the closed-vial mode that were within specifications.
Run-to-run precision results (CV%) for the midvolume
systems are shown in Table 3. Data for the other systems are
similar. No specifications are published for run-to-run precision, but all results were within the ranges provided by the
control manufacturer. No calibration shifts or trends were
observed on any of the systems being evaluated.
Carryover. For all systems, the percentage carryover was well
within the manufacturers limits. Results are shown in Table 4.
Sample Stability. Sample stability results are shown in
Tables 5 and 6. Results shown are for a single representative
sample at both room and refrigerated temperatures for the
high-volume systems, GenS and SE9500. The difference
from time 0 is shown for 8, 24, 32, and 56 hours from initial analysis. These times were chosen as representative,
although additional testing was done at 4 and 48 hours.
Results are considered unacceptable if the difference from
time 0 is more than twice the manufacturers stated precision limit for the parameter. Unacceptable results are indicated on the tables. For the GenS, 6 results at room temperature and 3 results at refrigerated temperature at
24 hours or later were outside the limits. At 8 hours, 1 result
(mean corpuscular volume [MCV] at room temperature)
was outside the limit. For the SE9500, 16 results at room
temperature and 9 results at refrigerated temperature at
24 hours or later were outside the limits. At 8 hours, 2 results
at room temperature (hemoglobin [HGB] and mean platelet
volume [MPV]) and 2 results at refrigerated temperature
(platelets [PLT] and MPV) were outside the limit. It should
249
SE9500
Limits
2.40
0.70
0.60
0.70
0.20
1.10
1.10
3.00
1.50
1.00
1.50
1.00
1.50
1.50
1.10
0.50
0.80
1.3
2.7
7.9
9.8
29.6
4.00
2.00
3.00
8.0
8.0
20.0
25.0
40.0
Mid-Volume Systems
GenS
Limits
SF3000
0.85
0.51
0.22
2.50
0.80
0.80
NS
0.80
NS
NS
3.20
NS
5.00
2.70
2.70
3.00
1.40
1.30
0.56
1.90
1.37
1.10
2.00
1.38
0.78
0.50
0.43
Low-Volume Systems
Limits
HmX
Limits
KX21
Limits
AcT diff
Limits
1.90
0.70
0.40
0.90
0.30
0.90
1.00
3.00
1.50
1.50
1.50
1.50
1.50
2.00
1.20
0.90
0.60
2.50
2.00
1.50
NS
2.00
NS
NS
0.13
0.65
0.33
0.64
3.50
2.00
1.50
2.00
NS
NS
NS
1.17
1.16
0.72
2.50
2.00
1.50
NS
2.00
NS
NS
2.00
0.90
1.90
1.8
3.5
2.8
11.4
5.00
2.00
3.00
8.0
8.0
20.0
25.0
40.0
5.00
2.50
3.00
3.00
3.00
2.00
1.00
1.00
2.84
0.80
1.10
1.40
2.10
1.60
1.80
1.40
0.50
0.50
0.35
6.00
NS
NS
NS
NS
NS
NS
NS
3.46
0.95
1.38
1.34
3.70
20.83
5.00
2.50
3.00
3.00
3.00
2.00
NS
NS
Mid-Level Control
Low-Level Control
SF3000
HmX
SF3000
HmX
SF3000
HmX
1.0
0.8
0.5
0.8
0.3
0.9
0.8
1.1
2.5
0.6
1.6
4.8
5.2
4.2
1.9
0.8
1.4
0.6
0.4
1.5
1.4
2.6
1.1
1.2
1.0
2.4
3.8
5.5
0.8
1.2
0.4
1.2
0.4
1.2
1.2
3.6
3.1
1.5
2.2
3.6
3.2
10.9
1.7
1.2
0.5
1.1
0.3
1.0
1.1
3.2
0.9
0.7
1.2
2.5
4.6
5.6
2.2
1.0
0.9
1.1
0.7
1.0
1.5
12.6
2.0
3.3
3.8
5.3
5.3
11.8
2.7
0.9
1.0
1.0
0.3
0.7
0.9
2.6
1.1
1.0
1.4
2.5
7.5
5.2
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K. Moser et al
TABLE 4. Carryover*
High-Volume Systems
Parameters
White blood cells
Red blood cells
Hemoglobin
Hematocrit
Platelets
Mid-Volume Systems
Low-Volume Systems
SE9500
Limits
GenS
Limits
SF3000
Limits
HmX
Limits
KX21
Limits
AcT diff
Limits
0.1
0.0
0.0
0.0
0.0
1.0
1.0
1.0
1.0
1.0
0.0
0.3
0.0
2.0
1.0
2.0
NS
2.0
0.0
0.2
0.0
3.0
1.5
1.5
NS
1.5
1.0
0.3
0.0
2.0
1.0
2.0
NS
2.0
0.0
0.2
0.0
1.0
1.0
1.0
NS
1.0
0.0
0.2
0.7
2.0
1.0
2.0
NS
2.0
1.8
0.0
0.0
0.0
0.0
Technologists Assessments
The responses to the key-operator survey for the highvolume systems are shown in Table 9. Similar surveys were
used for the midvolume and low-volume instrument systems. All key evaluators rated the Beckman Coulter systems
higher overall. Surveys based on similar criteria were also
given to the staff technologists who ran the analyzers at each
hospital. Here again, Beckman Coulter instruments received
higher ratings than the Sysmex instruments.
DISCUSSION
At OhioHealth Hospitals, our goal is to equip our hematology
laboratories with instrumentation from a single manufacturer.
Change at 24 h
Parameter
RT
Refrig
RT
+0.2
0.0
0.0
+1.1
+2.7
+0.1
0.8
0.0
+0.04
+0.1
+10.9
+1.2
0.1
0.5
+0.2
0.02
0.1
+0.7
+2.3
0.0
0.8
+5
0.0
+0.6
+0.3
1.3
+0.8
+0.1
+0.1
6
+0.3
+0.5
0.6
+1.2
0.5
+0.2
0.2
+9
+0.4
+0.6
+2.5
1.2
1.1
0.1
0.1
Refrig
0.0
0.05
0.0
0.3
+0.4
+0.3
+0.3
18
0.1
+0.7
1.0
+1.9
0.7
0.2
0.0
Change at 32 h
RT
Refrig
Change at 56 h
RT
Refrig
2 Precision
Limit
+0.3
0.04
0.0
+1.1
+3.9
+0.3
1.0
0.0
0.04
0.0
0.3
+0.1
+0.3
+0.3
+0.2
0.06
0.1
+1.3
+4.7
+0.3
1.3
0.0
0.05
0.1
0.0
+1.2
+0.3
0.1
0.30
0.07
0.2
(NS)
1.5
(NS)
(NS)
+9
+0.3
+1.2
+2.8
1.4
1.1
0.2
0.1
3
0.1
+0.9
+1.3
+0.3
1.4
0.1
0.1
+4
+1.5
+1.5
3.9
+3.9
+0.8
0.6
0.2
PLT R
30
0.0
+1.1
+0.7
+0.8
1.6
+0.2
0.1
17
(NS)
0.8
5.2
5.2
6.0
2.8
2.6
NRBC
*RT indicates room temperature; Refrig, refrigerated; NS, no specification limits stated by manufacturer; PLT, platelet; NRBC, nucleated red blood cell.
Unacceptable results. Results are considered unacceptable if the difference from time 0 is more than twice the manufacturers stated precision limit for
the parameter.
Results flagged with PLT R flag.
251
Change at 24 h
RT
RT
Refrig
Change at 56 h
RT
Refrig
2 Precision
Limit
RT
0.26
0.08
+0.4
0.6
+0.4
0.3
0.4
0.07
0.01
0.0
+0.5
+1.3
+0.1
0.5
+0.04
+0.03
0.1
NA
+6.7
0.7
NA
+0.08
0.08
0.0
0.4
+0.8
+0.6
+0.3
0.16
+0.02
0.2
+3.9
+9.5
0.3
3.5
+0.02
0.08
0.0
0.4
+0.8
+0.60
+0.3
0.06
+0.01
0.1
+6.5
+15.2
0.1
5.1
+0.06
0.07
+0.1
0.2
+1.0
+0.7
+0.4
0.38
0.13
0.29
1.2
1.9
1.0
1.1
2
+0.1
+1.3
1.5
+1.1
0.2
+0.6
0.0
+27
+0.2
+0.9
+0.3
0.3
0.2
0.2
+0.0
NA
0.5
+1.2
3.4
+1.7
+0.7
+0.2
+0.8
+20
0.0
+1.2
+4.6
1.4
3.3
+0.5
0.2
+29
+1.2
+1.7
1.6
+0.5
+0.5
+0.4
+0.2
Atyp/Ab
Lymph
Aged
+19
+0.1
+1.4
+5.1
2.4
3.5
+0.5
+0.3
Imm Gran
+17
+1.6
+2.5
+4.0
+0.1
5.2
+0.9
+0.2
Atyp/Ab
Lymph
+24
0.2
+1.5
+5.7
1.2
5.1
+1.2
0.0
Atyp/Ab
Lymph
19
0.5
0.6
8.3
5.7
4.4
0.7
0.2
Aged
Refrig
Change at 32 h
Parameter
Aged
*RT indicates room temperature; Refrig, refrigerated; NA, data not available.
Unacceptable results. Results are considered unacceptable if the difference from time 0 is more than twice the manufacturers stated precision limit for
the parameter.
their campuses whereas the second was for their own observations. The team members were responsible for sharing all
information with their hospital staffs and bringing back the
information to the task force group. This process enabled the
staff technologists at all 4 hospitals to become involved with
the decision on a personal level. At the conclusion of the
evaluation, all technologists felt that their voices had been
heard. They now have a vested interest in the success of the
implementation.
At the conclusion of each phase, the recommendation of
the group was taken to the pathologists and medical directors.
The criteria and rationale for our decision were presented to
them. In each case, the pathologists and medical directors
were impressed with the thoroughness of the evaluation and
agreed completely with our recommendations. We included
the pathologists and medical directors in the process, as well,
and listened to their thoughts and concerns. We provided
them with additional in-services by the various technical
experts of the companies so that their questions would also
be answered. We made a final presentation of the technical
data to the laboratory directors. The findings showed comparable results between the 2 manufacturers. The operators
survey focused on the operational issues that were considered
important. This information was also presented to the laboratory directors.
At the conclusion of the process, we found that the technical evaluation data and the depth of product line were
252
K. Moser et al
SE 9500
GenS
1.00
1.00
0.99
1.00
1.00
1.00
0.98
0.99
0.88
0.98
0.98
0.99
0.98
0.97
0.98
0.99
0.78
0.49
0.98
0.99
0.21
0.17
Comparator: Manual Differential
0.92
0.93
0.92
0.93
0.50
0.60
0.85
0.84
0.09
0.13
CONCLUSION
When we needed new equipment for the hematology laboratories at OhioHealth Hospitals, we developed a comprehensive decision-making process that utilized participative
management techniques. Our objective was to partner with a
company that could provide outstanding support for us
HmX
0.99
1.00
1.00
0.99
1.00
1.00
0.99
0.97
0.98
0.82
0.99
0.98
0.91
0.93
0.93
0.93
0.04
0.07
0.92
0.96
0.00
0.06
Comparator: Manual Differential
0.91
0.91
0.91
0.91
0.54
0.58
0.80
0.82
0.00
0.17
AcT diff
0.98
0.98
0.99
0.97
0.91
0.98
0.98
0.97
0.97
0.98
0.99
0.97
0.98
0.96
0.91
0.94
Low-Volume Systems, N = 97
STKS*
GenS
SE9500
NE8000*
HmX
SF3000
CD3000*
AcT Diff
KX-21
228
19
1
12
0.950
0.950
0.996
0.613
0.960
225
17
3
15
0.850
0.938
0.987
0.531
0.931
166
18
1
75
0.947
0.689
0.994
0.194
0.708
225
17
3
31
0.850
0.879
0.986
0.354
0.877
240
9
2
25
0.820
0.906
0.992
0.265
0.964
227
10
4
35
0.714
0.866
0.983
0.222
0.958
81
6
2
7
0.750
0.920
0.980
0.460
0.900
69
10
0
17
1.000
0.802
1.000
1.000
0.810
84
2
4
6
0.330
0.980
0.950
0.250
0.890
253
Sysmex SE9500
Easier to learn: not Windows-NT based
Threw tubes: had to be adjusted by
service
Determining correct mode: software
does not prompt
Quieter; heat not an issue
Coulter GenS
Difficult to learn: based on icons that must be
memorized
Background on reticulocytes was out
Easier to run
Noisier; heat not an issue
Yes
Must know the file number to look up
Levy-Jennings charts
Easy
Easy. Can print only 1 copy of a patient
report
Easy
Yes
Very easy. Must know the lot number
Yes
Yes
Easy
No problems
Easy
Easy
Easy
Easy
No routine maintenance
None
No
Yes
Yes
No
Yes
254
K. Moser et al
the driving force and favored Beckman Coulter. The laboratory pathologists and directors as well as our staff
accepted our recommendation. We have found this
process to significantly improve our decision-making abil-