34 PROFICIENCY TESTING
Cholestech LDX System Procedure Manual
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7.1 Overview of Proficiency Testing
Under CLIA ‘88, all laboratories conducting tests classified moderately complex and highly
complex must participate in an approved proficiency testing (PT) program for each
specialty they perform testing in.
The purpose of this section is to discuss the importance of proficiency testing and describe
how proficiency testing is performed. When choosing the appropriate agency for your
testing, it is important to ask the agency if it is certified by CMS (Centers for Medicare and
Medicaid Services) to comply with CLIA ‘88 standard regulations.
What Is Proficiency Testing?
Although analyzing quality control specimens provides an “internal” check on the quality of
a laboratory’s results, proficiency testing serves as an “external” check. Outside agencies
send “unknown” specimens to subscribing laboratories. The laboratory performs the
required tests and returns the results to the agency. The data are analyzed and a summary
report is sent to the laboratory indicating the laboratory’s performance.
Why Is Proficiency Testing Necessary?
Proficiency testing assures the user of quality results and measures the performance of the
test system and operators relative to other laboratories using the same test system or a
reference method.
Testing may identify bias in a test system, which may not be apparent with an internal daily
quality control program.
Proficiency testing may be necessary for compliance with state or federal law (e.g., CLIA ‘88).
How Does Proficiency Testing Work?
Proficiency testing is one aspect of a quality assurance program. The method works in
conjunction with a daily internal quality control program. When properly controlled, it
indicates the laboratory’s accuracy performance on the test system being evaluated.
A number of agencies offer proficiency testing surveys. The surveys vary by the analytes
offered for testing, number of challenges per analyte, number of mailings per year, report
format, sample preparation and result evaluation.
1. Surveys are offered for most routine tests performed.
2. Under CLIA ‘88, proficiency testing is required three times per year, testing five
samples each time.
Proficiency Testing
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