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Medical Laboratory Evaluation

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What is Proficiency Testing?

The Need For CMS Proficiency Testing Procedures

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) applies to all facilities that perform tests on human specimens. To ensure the quality of these tests, the law requires that most facilities participate in proficiency testing (PT) procedures as an external quality control. Physicians who perform any testing procedures in their offices, therefore, are subject to these CLIA regulations.

Complying With CLIA Regulations

CMS (Center for Medicare & Medicaid Services formerly the Health Care Financing Administration or HCFA) is the federal agency primarily responsible for implementing CLIA 88. Under the law, the number of steps in each test procedure and the degree of difficulty to achieve the final result are used to categorize all tests, or "analytes," as either waived, moderate- or high-complexity. Varying quality assurance (QA) and quality control (QC) standards apply to tests based on their complexity. Facilities that perform moderate- or high-complexity testing are subject to announced inspections biennially and must participate in a CMS-approved proficiency testing program.

Tests classified as "waived" are exempt from federal regulation, including the inspection and PT requirements. However, some states, third-party payers and other regulators require proficiency testing procedures even for federally-waived procedures; to help labs meet this requirement, MLE offers economical waived CMS test order options.

All non-waived tests are categorized as either moderate- or high-complexity, and referred to as "regulated or non-regulated analytes." Regulated analytes refer to the specific tests for which PT enrollment is mandatory. The law requires that PT programs approved by CMS must provide five samples or "challenges" for each of these tests in three shipments per year. As a CMS-approved proficiency testing provider, MLE is required by law to submit your results for the regulated analytes to the federal government or another agency acting on its behalf. The phrase "non-regulated analytes for PT purposes" refers to those tests that are not specifically listed in Subpart I of the CLIA regulation. However, all testing procedures, including non-regulated analytes and those in the provider-performed microscopy (PPM) category, are subject to a quality assurance regulation at the time of a laboratory inspection. This means that the facility must have a system for verifying the accuracy and reliability of its tests at least twice a year. Proficiency testing is a convenient and cost-effective way to comply with this CLIA requirement.

In short, proficiency testing is the practice of testing specimens of unknown values sent from an outside source—most commonly, a proficiency testing program. After submitting the results of your proficiency testing procedures, you receive data comparing your lab's performance with that of other laboratories performing the same procedures using identical or similar methods. Through the proficiency testing process, participants can identify procedural problems and take corrective action before patient results are affected.

 

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