• 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.

    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.

    Lab Classifications
    Learn the difference in how small, medium, and large volume labs are classified.

    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.

    Changing the Status of a Laboratory
    Notification requirements for changing the status of a laboratory.