20 QUALITY CONTROL
Cholestech LDX System Procedure Manual
I
R
O
For Information Only
Recommended Optional Information
< TABLE OF CONTENTS
6. If results for all levels of quality control material are within established ranges, patient
samples may be tested and the results reported.
7. When you change lot numbers of control materials, you will need to repeat
this procedure.
3.5 Cholestech LDX System Quality Control Log
We have provided you with a log sheet that can be duplicated and used for your records when
you test quality control materials on the Cholestech LDX System. (See
Master Forms
section.)
3.6 When Results Are Outside Acceptable Control Limits
If results of one or both levels of control tested are outside established ranges:
1. Check that the expiration date for the test cassette and quality control materials have
not passed.
2. Verify that the lot number on the control vial and the assay sheet are the same.
3. Retest the control level that is out of range using a new sample from the same control
vial. Pay careful attention to possible errors in technique.
a. If the control is within acceptable limits, patient samples may be tested and results
reported.
b. If the control is outside acceptable limits, retest with a sample of control from a
new vial.
• If results are in range, continue testing patient samples.
• If the control is still outside acceptable limits, contact Cholestech Technical
Service at 800-733-0404. Do not use the Analyzer for testing patient samples
until the problem is resolved.
3.7 Quality Control Remedial Action
Use this space if you wish to document a course of remedial action should any erroneous
results occur. The action will be initiated if a patient has received test results during the
time in which the instrument control results were out of range.
Procedure
R
R
O
To Next Page
Loading...