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CLIA Requirements - Dhmh - dhmh maryland 2025

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The document outlines required updates to the Infectious Agents Culture/Detection Form (DHMH 4676) and Serological Form (DHMH 4677), including the addition of the legal authority's name for test orders, changes in terminology from 'Submitter' to 'Health Care Provider', and modifications to demographic options. It also references COMAR regulations for legal authority.

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Is CLIA certification required for clinical trials?

All laboratory testing performed on humans in the United States, including research testing under the circumstances described here, is subject to the regulations called the Clinical Laboratory Improvement Amendment (CLIA). CLIA regulations require laboratories to be certified.

Who needs a CLIA certificate?

CLIA Certificate Application Process: Clinical laboratories and facilities performing clinical laboratory testing must apply for and receive both a state registration or license and a federal CLIA certificate.

What are CLIA requirements?

CLIA generally requires all facilities that perform even one applicable test, including waived tests, on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings to meet

What are the requirements for CLIA medical technologists?

To work in a high complexity testing laboratory, testing personnel are required to have at least an associates degree and a current state license, where applicable. Depending on the testing performed, personnel may be required to have higher levels of education, up to a doctorate.

What are the requirements for CLIA lab director for waived testing?

For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.

What is the difference between CLIA certification and FDA approval?

Only research laboratory testing is exempt from CLIA. The purpose of the CLIA regulations is to establish quality standards, strengthen federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test resultsno matter how simple the testno matter how small the laboratory.

CLIA Requirements - Dhmh - dhmh maryland 2025

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