For Laboratory Directors

As a laboratory director (PDF), you are responsible for the overall operation and administration of your laboratory. This includes: 

  • Ensuring compliance with all applicable CLIA regulations. 
  • Employing qualified personnel who are competent to perform their duties. 
  • Overseeing overall laboratory performance, even if you delegate some tasks. 

To serve in this role, a laboratory director must meet specific educational, experience, training, and continuing education (CE) requirements. More information about HHS-Approved Certification Boards (PDF). 

Laboratory Director Requirements

Laboratory directors must meet certain requirements depending on the type of testing their laboratory performs.  

To direct a laboratory that performs

Information about Requirements

High Complexity Testing
§ 493.1443
Moderate Complexity Testing
§ 493.1405
Provider-performed Microscopy (PPM) Testing
§ 493.1357
Waived Testing

There are no federal education or experience qualifications required for the laboratory director. However, laboratory directors must: 

  • Hold a CLIA Certificate of Waiver 
  • Ensure laboratory personnel are properly trained and follow manufacturers’ instructions to perform the test(s) correctly and get accurate results. 

Continuing Education (CE) 

Continuing education (CE) credits for Laboratory Director qualifications should cover the laboratory director responsibilities defined at § 493.1407 and § 493.1445. 

Free courses covering some of the laboratory director responsibilities are available on the CDC website at Laboratory Director University. 

Page Last Modified:
08/28/2026 11:52 AM