iv INTRODUCTION
Cholestech LDX System Procedure Manual
< TABLE OF CONTENTS
Introduction
Overview of a Quality Assurance Program
Quality assurance (QA) is a comprehensive set of policies, procedures and practices
necessary to ensure the quality of laboratory tests. Its purpose is to ensure that over the
long term, the laboratory provides reliable data that accurately reflect the patient’s status.
Quality assurance in a point-of-care laboratory covers nine basic areas:
1. Policies and standards that govern the laboratory cover elements that affect test
quality before (patient preparation, sample collection, etc.), during and after (data
transcription errors, etc.) the testing process.
2. Training: All personnel conducting tests should be properly trained and their training
documented.
3. Safety policies should be adhered to and a safe working environment provided.
4. Procedure manuals should contain operating protocols that are complete, up to date
and available to laboratory personnel.
5. Record keeping: All aspects of the quality assurance program should be documented
in writing as appropriate.
6. Calibration and instrument maintenance should be performed as needed.
7. Quality control may include initial verification of the test method, routine testing of
quality control materials and a written procedure for responding to “out of control”
test results. All quality control procedures and follow-up actions should be
documented.
8. Participation in proficiency testing programs is optional for CLIA-waived tests.
Proficiency testing may be performed and documented when required by local or
state regulations.
9. Laboratory inspections may be conducted by the appropriate organization to assess
quality assurance and suggest possible improvements.
A successful QA program assures that:
1. Policies and procedures are established in writing and followed by all personnel
involved in the testing process.
2. The test system performs properly at the time patient results are produced.
3. Written records are available to demonstrate that uniform procedures have been
established and are followed.
The material in this procedure manual can assist in assuring that the quality of test results
in the laboratory or at a testing site is satisfactory over time.
To Next Page
Loading...