Lab 144a 2025

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

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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.
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.

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