Beckman Coulter COULTER ACT 5diff User Manual

PN 177196BB
4-10
QUALITY ASSURANCE
INTERPRETING AND USING CELL CONTROL DATA
5. When troubleshooting a problem with control results, keep the following factors
in mind:
6. The package insert for the COULTER A
C
•T 5diff CONTROL PLUS states that your
instrument is considered well maintained and operating correctly if before the current
cell control lots expire, the laboratory does one of the following on the new lots of cell
control:
a. Confirms recovered mean values are within the assay limits.
b. Establishes its own mean values and acceptable ranges and periodically re-evaluates
those means.
7. Performance specifications for your instrument are located under
Heading 3.2
PERFORMANCE SPECIFICATIONS
, in the Online Help System or the Instructions for Use
manual.
8. If the trainee needs more basic information on quality assurance, suggest Basic Concepts
of Quality Control, PN 4235526, as a reference.
a. Contact your Beckman Coulter Representative to order a printed copy.
b. This book is designed for someone with little or no quality assurance experience.
The following information and a self-evaluation is included:
1) Fundamental components of a quality assurance program
2) Definitions of common terminology
3) How to read a package insert
4) Difference between a control and a calibrator
5) Why calibration is necessary
6) How to determine if a control is “in” or “out”
7) What to do if a control is “in”
8) What to do if a control is “out”
9) Outliers
10) Trends
11) Shifts
12) Interlaboratory Quality Assurance Program (IQAP)
13) A glossary
Problem Affect on Results Concerns
Statistical
Outlier
Generally affects only one
parameter (and any
associated parameters) on
one vial of control.
The frequency of outlier occurrences should be carefully
monitored. A high frequency of outliers could indicate an
underlying problem with the instrument, control material,
or Operator technique.
Control Generally affects only one
level or vial of control.
Any change in the control material can cause the control
to be out. Controls must be handled carefully as
instructed on the package insert. If control material is
treated roughly, stored improperly, or used beyond the
expiration date, results may be outside the limits.
Instrument Generally affects more than
one level or vial of control.
Any change to the instrument regarding the test system
may cause controls to be out.

Beckman Coulter COULTER ACT 5diff Specifications

General

Brand	Beckman Coulter
Model	COULTER ACT 5diff
Category	Laboratory Equipment
Language	English