The Clinical Laboratory Improvement Amendments (CLIA) regulations specify the requirements for becoming a lab director. Rigorous standards ensure labs have qualified directors for high- and moderate-complexity testing.

The lab director ensures CLIA compliance in the pre-analytic, analytic, and post-analytic testing phases. Let’s learn more about what a CLIA lab director is and what their requirements are.

CLIA Lab Director Duties

A CLIA lab director meets CLIA requirements regarding experience, education, and training. They’re also responsible for the lab meeting CLIA regulatory requirements, staffing the lab with qualified experts, and assisting the laboratory staff as needed. Even when a director delegates a task, the director remains responsible for how the job is performed and whether it adheres to CLIA standards.

CLIA Categorizations

A CLIA lab director’s duties and the requirements for attaining the job depend on the lab’s testing complexity. The FDA categorizes diagnostic tests into three levels of complexity: waived tests, moderate-complexity tests, and high-complexity tests. The complexity rating is based on seven criteria.

1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
5. Calibration, quality control, and proficiency testing materials
6. Test system troubleshooting and equipment maintenance
7. Interpretation and judgment

The FDA adds the scores of all seven criteria to get a test’s total score. A test with a score of 12 or less has a CLIA categorization of moderate complexity, and a score of 13 or more is high complexity.

Moderate Complexity Testing Requirements

Four pathways exist for a lab director to meet the requirements for supervising a moderate complexity lab:

1. Be a Doctor of Medicine (MD), Osteopathy (DO), or Podiatry (DPM) and

• Certified in anatomic or clinical pathology or
• Have lab training or experience of one year directing or supervising non-waived tests or
• Have earned at least 20 CME credits in lab practice or training equivalent to 20 CME credits earned during medical residency

2. Hold a doctoral degree in laboratory science and

• Be certified by an HHS-approved board or
• Have one year of experience directing or supervising non-waived tests

3. Hold a master’s degree in lab science and one year lab training or experience and one year experience supervising non-waived tests.
4. Hold a bachelor’s degree in lab science and two years lab training or experience and two years’ experience supervising non-waived testing.

High Complexity Testing Requirements

There are two ways a lab director can meet the requirements for supervising and running a high-complexity testing lab.

1. Be a licensed MD/DO/DPM and

• Be certified in clinical pathology or
• Have one year of lab training during medical residency or
• Have two years of experience directing or supervising high-complexity testing

2. Hold a doctoral degree in chemical, physical, biological, or laboratory science and be able to prove all the following:

• Be certified by an HHS-approved board
• Have two years of lab training or experience
• Have two years of experience supervising or directing high-complexity testing

Use lab management services by Lighthouse Lab Services to meet and maintain CLIA standards. Whether you want to fill a part-time or full-time lab director position, we can connect you with qualified professionals. Contact us today for a free consultation.

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