What is the purpose of CLIA waiver?

The purpose of a CLIA Certificate of Waiver is to ensure that laboratory standards are met which ensure timeliness, accuracy, and reliability of laboratory test results for patients. Diagnostic testing allows healthcare providers (doctors, nurses, etc.) to monitor and/or check for a variety of diseases and conditions.

What is a CLIA application?

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed. NOTE: If you have any questions regarding the completion of the CMS-116 form, contact the appropriate State Agency (PDF).

What is CLIA and what is its purpose?

The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. CMS oversees all lab testing (except some research) done on humans in the U.S. through CLIA.

What is the role of a laboratory director?

The laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of competent personnel, equipment, safety, laboratory policies, quality assurance, all testing (including proficiency testing) and test reports.

Who can be a lab director in California?

(a) As used in this chapter, laboratory director means any person who is any of the following: (1) A duly licensed physician and surgeon. (2) Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following: (A) A duly licensed clinical laboratory scientist.

How long does it take to get California CLS license?

Minimum one year of post-baccalaureate clinical training as a CLS. Minimum one year of work experience as a CLS performing high complexity testing in hematology, chemistry, blood bank, and microbiology. Training or work experience must be comprehensive to cover all areas of the clinical laboratory.

What does it mean to be CLIA approved?

CLIA is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.

What are three types of CLIA licenses?

Types of CLIA Certificates Certificate of Waiver. ... Certificate for Provider Performed Microscopy Procedures (PPM) ... Certificate of Registration. ... Certificate of Compliance. ... Certificate of Accreditation.

Get Lab 183 2007-2024

(date) clinical laboratory, located at (name of laboratory) (street address) CLIA number: State ID number (if known): As the director or co-director, I assume all directorship responsibilities for CLIA and State of California purposes. I understand that as a director of this laboratory, I am responsible for the accuracy and reliability of all testing performed by the laboratory and for ensuring that the laboratory meets all applicable CLIA and state requirements as stipulated in both federa.

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