Clinical Laboratory Improvement Amendments (CLIA) Application for 2026

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  1. Click ‘Get Form’ to open the Clinical Laboratory Improvement Amendments (CLIA) Application in our editor.
  2. Begin with Section I: General Information. Fill in details such as 'Initial Application', anticipated start date, and facility name. Ensure your email address is valid for future notifications.
  3. Proceed to Section II: Type of Certificate Requested. Select the appropriate certificate type based on the complexity of tests performed at your laboratory.
  4. In Section III: Type of Laboratory, check the box that best describes your facility type, ensuring accurate representation.
  5. For Section IV: Hours of Laboratory Testing, list the operational hours in HH:MM format or check if testing is available 24/7.
  6. Complete Sections VI to VIII regarding testing types and estimated annual test volumes. Be specific about each test performed and its corresponding manufacturer.
  7. Review all sections for completeness before submitting. Incomplete applications cannot be processed.

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The objective of CLIA is to ensure quality laboratory testing. In 1988, Congress passed CLIA regulations to establish quality standards for all testing laboratories to ensure that all patient test results are: Accurate. Reliable.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) was passed to ensure the accuracy, reliability, and timeliness of patient results. This regulation applies to all clinical laboratories that perform testing on human specimens, regardless of their size or number of employees.
CLIA applies to, and requires certification of, all facilities that perform any 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 (see 42 U.S.C. 263(a)).
The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review

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