Clinical Laboratory Improvement Amendments (CLIA)

Clinical Laboratory Improvement Amendments

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of clinical trials and basic research). A clinical laboratory is defined by CLIA as any facility which performs laboratory testing on specimens obtained from humans for the purpose of providing information for health assessment and for the diagnosis, prevention, or treatment of disease.

Learn how to obtain a CLIA certificate with this resource from the Centers for Medicare & Medicaid Services (CMS).

Laboratory test results have a significant influence on medical decisions. Given the importance of laboratory test results federal regulations and programs are in place to help assure quality is achieved so patients and physicians can be confident test results are accurate and reliable.

CLIA oversight is primarily administered by Center for Disease Control and Prevention’s (CDC) Division of Laboratory Systems (DLS). DLS’s focus and goal is to improve the quality and safety of clinical and public health testing and practice. Visit DLS for resources and training opportunities.

Quality Assurance
In the laboratory, quality assurance involves the entire testing process: pre-analytical, analytical (testing), and post-analytical processes.

Preparing a Procedure Manual
A well-prepared procedure manual provides a foundation for the lab’s quality assurance program.

Waived and PPM Tests
Additional information on waived and PPM tests.

Testing Tips
Checklists for waived and PPM testing compliance.

Personnel Requirements

The different qualifications required of personnel working in a moderate complexity lab.

Inspections
CLIA inspection regulations address both basic and specific inspection requirements. All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements.

Physician Office Laboratory Director Duties
The director is responsible for the overall administration and operation of the lab, including hiring personnel who are competent to perform testing and record/report results promptly, accurately, and proficiently.

Recordkeeping Requirements
Length of time required for PT, test, and quality control records.

Laboratory Certificate Types
Learn about the three laboratory certificates that labs can apply for.