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Cholestech LDX System Procedure Manual
< TABLE OF CONTENTS
Procedure Manual Overview
This procedure manual has been designed to instruct Cholestech LDX users in how to
comply with good laboratory practices and assist in complying with applicable regulations.
The Cholestech LDX System Procedure Manual covers:
• Setup and Maintenance: Procedure to properly run an optics check and record the
values for the Cholestech LDX System. In addition, the section provides specific
information about recording laboratory environmental conditions.
• Specimen Collection and Handling: General procedures that are applicable to obtaining
a suitable specimen and running a test on the Cholestech LDX System.
• Quality Control: Discusses laboratory activities designed to ensure that each test system
is working properly and that the test results satisfy quality standards.
• Safety: Allows you to file your safety guidelines as recommended by OSHA.
• Training: A checklist as a guideline to train personnel on the Cholestech LDX System.
After the training is completed, you may use the Certificate of Training for the
Cholestech LDX System and the Certificate of Training for Fingerstick Blood Collection to
document training.
• Material Safety Data Sheets: A copy of Cholestech Corporation’s MSDS for the
Cholestech LDX test cassettes. You can add additional MSDSs as required.
• Proficiency Testing Guidance: Discusses the importance of proficiency testing, how
testing is performed and lists agencies offering proficiency testing.
• Glossary of Terms: An alphabetical list of common laboratory terms.
• Master Forms: Master forms are provided for you to print as needed.
An icon, characterized as a letter within a shape, will appear at the beginning of each
section. These icons indicate the following:
Foreword
I
R
O
The information in the following section is “For Information Only.”
The information in the following section is “Recommended” by the Manufacturer.
The information in the following section is recommended to comply with OSHA and
CLIA ‘88 Moderately Complex Laboratory Regulations, as well as regulations that
apply to users in certain states.
If you need assistance using the manual, please call us at 800-733-0404.
Please Note: The following procedures are outlined as a guide, not a substitute for
complying with state or federal regulations relevant to your site. Cholestech Corporation
does not guarantee that following this guide will result in certification or meeting state or
federal regulations. For further information regarding regulations, please refer to your state
or federal agencies.
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