• Determine the test complexity in the laboratory
• Apply for the appropriate CLIA certificate
• Identify resources needed to complete enrollment with an accreditation organization

Clinical testing performed on human specimens for the purpose of diagnosis, treatment, monitoring and evaluation of wellness is covered under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The regulations require that each testing site or laboratory obtain a separate and appropriate CLIA certificate for the testing performed. The regulations, however, do define exceptions that allow a single CLIA certificate for multiple testing sites. One of these exceptions is for temporary testing sites and mobile laboratories. This Primer addresses the unique requirements for mobile laboratories, such as ambulances.

COLA’s Laboratory Director course will prepare participants to meet the CLIA requirements for Laboratory Director, promote successful management of laboratory operations and effectively oversee required staff.  Participants enrolling in COLA’s Laboratory Director course will benefit from self-paced modules delivered through a blended online learning environment. The course will provide the learner with ease of accessibility and material that is concise and practical.

The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116. This form should be completed and mailed to the address of the local State Agency (PDF) for the state in which your laboratory resides.