CLIA Requirements

CLIA Requirements

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CLIA program applies to entities ranging from physician office laboratories to large commercial laboratories. CLIA certificates vary based on the complexity and risk of the tests performed. Types include Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures (PPMP), Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation. Each certification corresponds to different testing complexities, from simple tests with a low risk of error to highly complex analyses. 

Frequently Asked Questions

How does a laboratory obtain CLIA certification?

To obtain CLIA certification, laboratories must first register with the Centers for Medicare & Medicaid Services (CMS) by completing the CMS-116 form and submitting it to their state's CLIA office. After assessing the application, CMS assigns a CLIA number to the laboratory and determines the type of CLIA certificate required based on the complexity of tests performed.

Are there specific personnel requirements under CLIA?

Yes, CLIA stipulates specific personnel qualifications for various roles within a laboratory, including the lab director, clinical consultant, technical consultant, and testing personnel. The requirements include specific education, training, and experience based on the complexity of the laboratory tests performed.

What are proficiency testing requirements under CLIA?

Proficiency testing (PT) under CLIA involves external checks on a laboratory's accuracy by comparing its test results with those from other laboratories. Labs performing moderate to high complexity testing must enroll in a CMS-approved PT program for each specialty and subspecialty in which they perform tests.

How often are CLIA inspections conducted?

The frequency of CLIA inspections depends on the type of certificate a laboratory holds. Laboratories with certificates of compliance or accreditation generally undergo inspections every two years. However, frequency can vary based on previous inspection results and compliance history. Failing a CLIA inspection can result in numerous consequences, including civil penalties, the submission of a plan of correction (a document that describes actions that will be taken to correct deficiencies) to CMS, mandatory cessation of specific laboratory tests or services, or suspension, revocation, or limitation of the CLIA certificate.

Can a laboratory perform tests not specified on its CLIA certificate?

No, laboratories can only perform tests that are categorized under their specific CLIA certificate. Performing tests outside the scope of their certification can lead to sanctions and potential loss of the CLIA certification.


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