Tools, Technologies and Training for Healthcare Laboratories

CLIA Final Rule

Part II: Perplexity about Complexity and Personnel

Final5 CLIA. Part II:
Perplexity about Personnel and Complexity

We're pleased to have this article by Dr. Sharon Ehrmeyer, PhD, well known for her grasp of CLIA and regulatory affairs. Dr. Ehrmeyer offers us her view of the new CLIA rules. In particular, she clarifies how these new rules will impact personnel requirements and qualifications in the laboratory. (preview)

As discussed in Part 1 of this series, the long awaited Final CLIA Rule was published in the Federal Register on January 24, 2003. The Final Rule did away with the use of the terms high complexity and moderate complexity and established one set of "quality assessment" standards for non-waived tests. Now instead of separate quality requirements for moderate and high complexity testing, there is only one set for non-waived testing. Readers may now have the impression that there is only one set of personnel requirements for non-waived testing as well. NOT TRUE! Personnel qualifications still are related to test complexity, thus you have every right to be "perplexed" or confused.

Laboratories still need to meet the personnel requirements identified for moderate and high complexity testing. The only change in the Final Rule is for the director qualification in the high complexity category.

This discussion provides a review the current personnel qualifications for testing under CLIA and identifies the appropriate sections in the CLIA regulations for each position. Details for each position, including specific responsibilities and requirements for directors in specialty and subspecialty areas, can be found in the most current codified edition (12/29/01), which contains all changes subsequent to the initial requirements identified in the February 28, 1992 Federal Register: The latest qualifications (01/24/03) for high complexity test director are available at:

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