Beckman Coulter COULTER ACT 5diff - 4.3 INTERPRETING AND USING CELL CONTROL DATA

PN 177196BB
4-9
QUALITY ASSURANCE
INTERPRETING AND USING CELL CONTROL DATA
4
4.3 INTERPRETING AND USING CELL CONTROL DATA
A Objectives
When you have completed this topic, you will be able to:
B Explain the statistics associated with the control files and graphs.
B Review numeric and graphic control data for errors and make appropriate corrections.
B Establish running means and expected ranges for parameters without assay values or for
which you want to use your own values and ranges.
B References
1. In the Online Help System or the Instructions for Use manual, refer to Reviewing Control
Results
under Heading 7.3 RUNNING CELL CONTROLS.
2. Basic Concepts of Quality Control, PN 4235526
C Special Instructions
This material can be covered in front of the instrument, particularly if you are helping the
trainee interpret their control data, but it can also be covered in a classroom setting.
D Topic Notes and Tasks
1. Interpreting cell control data can be divided into two activities: checking the results of
one control run and checking the results of many control runs collected over time.
2. When you are running controls before running patient samples, your first concern is to
address why the results of the immediate run did not fall within the expected range.
Refer to WHAT TO DO WHEN A CBC/DIFF CONTROL IS OUTSIDE ITS EXPECTED
RANGES in this section.
3. As data in your control file accumulates, you can also:
a. Check for a change (shift or trend) developing over time, or for results spread too
widely (increased 2 SD and CV).
b. Use the data to refine your controls’ target values and ranges.
c. Use the data to define a target value and ranges for any parameters without assigned
assay values.
4. Graphing control data facilitates monitoring instrument performance and aids in
troubleshooting.
a. It allows you to easily view -
1) Trends, shifts, and outliers.
2) “In control” and “out of control” results.
3) Subtle developing problems.
b. Different types of changes on the graphs suggest different sources for error.
c. Refer to USE GRAPHS TO DETECT PROBLEMS AND POINT TO SOLUTIONS in
this section.