General Hematology Calibration Procedure Guideline

Cal-Chex, Cal-Chex A Plus

Streck provides this template for laboratories to • C

 ontrol materials reflect an unusual trend or shift,
incorporate into their internal protocol. or are outside of the laboratory’s acceptable
limits, and other troubleshooting means of
Streck assumes no responsibility for protocols correcting the unacceptable control values fail to
generated from this template. identify and resolve the problem.
Principle • T
 he laboratory has determined that the test
Multi-parameter hematology analyzers require system’s reportable range for patient test results
routine calibration checks and/or adjustments in should be checked more frequently.
order to produce accurate results. Calibration can
be accomplished with the use of fresh whole blood Calibration must be considered the last step in a
samples which have been assayed by reference troubleshooting sequence. Frequent unnecessary
methods. A more direct and convenient approach is to recalibrations can mask an underlying problem with
use a calibrator material assayed with system specific the instrument’s performance.
values traceable to a reference method. Streck Safety
calibrators are stable suspensions of erythrocytes,
leukocytes, and platelets. Assigned values are derived Standard Universal Precautions apply.
from replicate analysis on whole blood-calibrated Calibrator Storage and Stability
hematology analyzers.
Refer to product IFU (Instructions For Use)
Clinical Laboratory Standards Institute (CLSI) defines
calibration as the process of testing and adjusting Pre-Calibration Procedure Checklist
the instrument or test system readout to establish a Date
correlation between the instrument’s measurement Operator
of the substance being tested and the actual Instrument
concentration of the substance. Serial Number & Software Version
Calibration verification is the testing of materials of
known concentration in the same manner as patient 1.  Perform all required maintenance.
specimens to assure the test system is accurately
measuring samples throughout the reportable range. 2.  Verify all reagents have not reached the
expiration date and there is ample volume
When to Calibrate to complete the precision and calibration
Calibration should take place in accordance with the procedures.
recommendations outlined in the instrument operator 3.  Record calibration information:
manual, typically once every 6 months or whenever Lot #
any of the following occur: Exp. date
• A
 ll of the reagents used for a test procedure 4. 
 Verify that background counts are within the
are changed to new lot numbers, unless the acceptable limits.
laboratory can demonstrate that changing reagent
lot numbers does not affect the range used to 5. 
 Print current calibration factors from the
report patient test results, and control values instrument.
are not adversely affected by reagent lot number
changes. Precision Check
Prior to calibration, it is prudent to ensure proper
• F
 ollowing a major preventive maintenance or instrument performance through a precision check. It
repair/replacement of critical parts that may is recommended to use a normal patient sample less
influence the test’s performance. This includes than 4 hours old for the purpose of this check.
sending a test system to the manufacturer for
repairs. 320612
2016-05
Precision Procedure: b. If the recovered mean values are close to
the system specific tolerance limits and
• R
 un the sample consecutively in a replicate file, your control data indicates an adjustment is
at a minimum 11 times. warranted, proceed with accepting the new
• D
 iscard the first run and obtain a mean, SD and calibration factors.
CV for all parameters that can be calibrated. • C
 alibration of the specific parameter(s) should
• E
 valuate the results. The CV% should fall within be done in accordance with the procedure in
the acceptable limits of your specific analyzer; your instrument manual. Calibration may not be
limits can be referenced in the Performance required for all parameters.
Characteristics/Specifications section of the • O
 nce calibration is complete, verify calibration
instrument operator manual. by analyzing the calibrator 3 times in the patient
• If any parameter’s CV% exceeds the limits, refer mode. Compare the means of the results to the
to the troubleshooting or diagnostics section of ranges on the calibrator assay sheet to verify the
the operator’s manual as necessary. Repeat the adjustment is appropriate.
precision check. • P
 rint the new calibration factors and retain with
• D
 o not proceed with calibration if your instrument records as documentation along
the precision study does not pass. If with the calibration verification runs.
troubleshooting does not bring the CV% to within
Quality Control Verification
acceptable limits, you may need to contact
service for your analyzer. Following calibration, it is recommended to run
controls and verify results are within range prior to
Note: The differential parameters are not calibrated and any differential performing patient testing. Print the post-QC results
adjustments are made by the instrument field service representative.
for your records.
Calibration Best Practices
• Remove vials of calibrator from refrigeration and It is good laboratory practice to review QC data and
warm to room temperature (18 °C to correlate the individual lab results to an interlaboratory
30 °C) for 15 minutes before use. peer group prior to calibration. Determine the percent
• Refer to Mixing Procedure in IFU and for a video deviation from assay and/or the peer group. Verify
demonstration, visit www.streck.com/mixing. any differences in calibrator recovery mirror the
differences observed in QC data for each parameter
• P
 rime the instrument by aspirating 2 normal blood being adjusted. Monitor proficiency testing results for
samples. Disregard results. ongoing calibration verification as well.
• F
 ollow the instructions for calibration in the References
instrument operator manual. Each instrument Clinical Laboratory Standards Institute, H26-A2, Validation, verification
has specific requirements for the file to use and and quality assurance of automated hematology analyzers. Approved
number of runs to be performed. Standard - Second Edition.

• Calculate the mean for each parameter. Clinical Laboratory Standards Institute, H15-A3, Reference and selected
procedures for the quantitative determination of hemoglobin in blood.
• C
 ompare the results from your instrument to the Approved Standard - Third Edition.
assay targets:
Clinical Laboratory Standards Institute, H07-A3, Procedure for
a. If the recovered mean values are within the determining packed cell volume by the microhematocrit method.
Approved Standard - Third Edition.
system specific assayed tolerance limits, and
your control data does not indicate a change
is warranted, the instrument does not require
calibration. It may be helpful to correlate your
lab control means with a peer group for this
assessment. 320612
2016-05