Lab Name Department of Pathology
Address Automated Hematology
Blind Duplicate Patient Testing on the HmX
Author: Document Number: Equ30-42
Heidi Hanes 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: HEA.2620 Effective: _____________
Version 1.0
PURPOSE
This procedure provides instruction for using patient specimens as an additional
quality control process for both the primary and secondary modes on the GenS
and HmX Hematology Analyzers.
POLICY
They are:
The new high and low patient specimen is run through both the primary and
secondary mode of the HmX. This acts both as a QC for the secondary
mode and a correlation of the two modes.
Both specimens are run through the primary mode only at designated times
throughout the shifts.
Samples are run the following morning until new patient controls are chosen
from the morning run.
Refrigerate samples when not in use.
NOTE: The same samples will be used on both the GenS and the HmX
instruments each day.
SAMPLES
Use the following table to select patient samples for use as blind duplicates:
Sample Type WBC HGB
3 3
High 5.0-10.0 x 10 /mm 12.0-15.0 mg/dL
Low 10.0-15.0 x103 /mm3 7.0-10.0 mg/dL
PROCEDURE
Step Action
1 All monitored parameters of blind duplicates should agree within + 2 SD
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HEA.2620 Version 1.0
Lab Name Department of Pathology
Address Automated Hematology
with back up method.
If Then
Any parameter Rerun
exceeds limits
Still out Run on alternative method to determine if an
instrument problem or sample problem
If Then
Same results on Sample problem
both instruments Mark “Sample Deterioration”
Attach to Hct result.
Different results Instrument problem
Run on alternate instrument until
problem resolved
Call Coulter Service.
Consistent problem Inform QC tech.
with Blind
Duplicates
RESULTS
A. The parameters below are monitored on the HmX to ensure proper instrument
function and correlation between instruments and modes. Each parameter
should agree within the following ranges:
High Low
WBC ± 0.6 ± 1.4
RBC ± 0.20 ± 0.20
HGB ± 0.4 ± 0.4
HCT ± 2.0 ± 2.0
MCV ± 3.0 ± 3.0
PLT ± 60.0 ± 60.0
B. Control decisions are as follows:
If Then
All parameters on the high and low Proceed with patient testing
samples read within ± 2 SD when
compared to the results of each
original run
OR
One parameter of either the high or
low reads with ± 2-3 SD when
compared to the results of the
original run and all others are within
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HEA.2620 Version 1.0
Lab Name Department of Pathology
Address Automated Hematology
+ 2 SD.
Any parameter on either the high or Do not proceed with patient testing
low sample reads greater than + 3 Repeat sample.
SD If Then
Acceptable Proceed with patient
testing
Still out Use back up
methods
Results still the Sample deterioration,
same on proceed with patient
backup testing
Results Indicates instrument
acceptable on problem, use back
backup up instrument
Inform QC tech or
supervisor
A single parameter on both high and Repeat test on each sample:
low is greater than + 2 SD
If Then
Acceptable Proceed with patient
testing
Still out Use back up
methods
Results still the Sample deterioration,
same on proceed with patient
backup testing
Results Indicates instrument
acceptable on problem, use back
backup up instrument
Inform QC tech or
supervisor.
C. Run 5C controls.
If Then
Similar problems with 5C as with Call Coulter Hotline
patient controls Use back up instrument
5C controls acceptable Run 10-12 patients on back –up
instrument and compare results.
If Then
Parameters Proceed with patient
match testing
Monitor moving
averages
Moving Call coulter Hotline
averages show Use backup
same problem instrument
Inform QC Tech and
Supervisor of any
unresolved or
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HEA.2620 Version 1.0
Lab Name Department of Pathology
Address Automated Hematology
recurring problems.
D. Handling insufficient or deteriorated samples:
If Then
Insufficient sample remaining Go to function MEM
Go to Test
Use test modes to ensure correct
method (workload) assignment
Enter CBC
Enter blind dup acc. number, B-
Acc No.
At prompt, enter 0.0-QNS for all
parameters and accept.
Sample deteriorated Attach onto Hematocrit, “Sample
Deteriorated”
Both high and low samples become Select 2 new samples from
deteriorated before 24 hours are previous run
completed Follow protocol for selection of new
blind patient duplicates
Follow Procedure A-C above.
REFERENCE MMC Laboratory QC Policy
Approval Signature:__________________________ Date: ______________
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HEA.2620 Version 1.0