Lab 144a 2025

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The document is a Clinical Laboratory License Application for laboratories located outside of California, issued by the California Department of Public Health (CDPH). It provides instructions for completing the application, including payment details, mailing address, and required supporting documents. The application requires information about the laboratory's ownership, director, and any changes since the last application. It emphasizes the need for original signatures and outlines options for laboratory oversight.

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2019	4.8 Satisfied (96 Votes)
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How to get a lab certificate?

How to get a clinical lab certification Get an associate degree or 60 semester hours of education. Complete a NAACLS-certified technician course. Earn at least six months of clinical laboratory experience. Pass the medical laboratory technician certification test.

What is the difference between a public health lab and a clinical lab?

Clinical laboratories assist clinicians with individual patients; public health laboratories support the health officer whose patient is the community.

What is the difference between waived and non-waived lab testing?

Waived testing may be performed at the POC or in a centralized facility. Non-waived testing is subcategorized as moderately complex and highly complex. The majority of non-waived POCT is moderately complex. The facility must be diligent regarding adherence to the manufacturers operating/testing instructions.

What does CLIA stand for in a laboratory?

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, , etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.

What does waived mean in testing?

By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some tests, etc.

What does waiving test mean?

Waived tests include test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria. While CLIA requires waived tests to be simple and low-risk, they are not completely error-proof.

What is an example of a waived laboratory test?

As defined by CLIA, waived tests are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. Examples of waived tests include: dipstick urinalysis, fecal occult blood, pregnancy tests, and blood glucose monitoring.

Lab 144a 2025

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