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.
In the laboratory, quality assurance involves the entire testing process: pre-analytical, analytical (testing), and post-analytical processes.
A well-prepared procedure manual provides a foundation for the lab’s quality assurance program.
Additional information on waived and PPM tests.
Checklists for waived and PPM testing compliance.
Learn the difference in how small, medium, and large volume labs are classified.
The different qualifications required of personnel working in a moderate complexity lab.
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.
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.
Length of time required for PT, test, and quality control records.
Notification requirements for changing the status of a laboratory.
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Clinical Laboratory Improvement Amendments (CLIA)