Facility or practice conditions
Independent clinical laboratories need Alabama licensing even when they perform only waived tests.
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State filing guides
CLIA waiver applications and requirements by state.
Ask about my application — no payment todayA federal Certificate of Waiver does not answer every state licensing or personnel question. Each state summary links to official sources, explains the requirements found there and identifies what still needs confirmation for your facility. District of Columbia and Puerto Rico are listed separately within this directory.
“Federal application procedure” describes the application materials we found; it does not mean “no additional requirements.” Extra documents, state permits, practice exemptions and unresolved questions are identified separately. A source check is not a completed facility review or a promise of approval.
National intake, state-specific preparation
All 50 states have sourced review questions. 33 states also have structured packet templates: 31 common-route states plus Florida and Pennsylvania. The newly expanded templates cover initial, fixed-site physician or practitioner offices testing their own patients with exact waived systems. Other operations need a separate scope review.
A template is preparation support. A person must confirm current state requirements, device evidence, documents, destination and authorization before filing.
Start with your clinic’s factsRequirement type by state
Select a state to open its guide.
50 of 50 state guides · 2 additional jurisdictions
Federal application procedure
Alaska's published CLIA application procedure uses Form CMS-116.
Sources checked 2026-09-10
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Federal application procedure
Arizona identifies CMS-116 for initial CLIA applications.
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Federal application procedure
Arkansas directs new CLIA applicants to CMS-116.
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State authorization required
California requires state registration for waived-only clinical laboratories alongside CLIA certification.
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Federal application procedure
Colorado's CLIA instructions direct applicants to CMS-116 and the state program.
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Agency clarification needed
Connecticut's waived-only licensing exemption needs clarification before a filing route is stated.
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Federal application procedure
Delaware's CLIA FAQ directs applicants to email the CMS-116 application pages.
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Facility or practice conditions
Florida removed its separate clinical laboratory facility license; personnel requirements remain a separate question.
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Federal application procedure
Georgia repealed separate state clinical laboratory licensing on July 1, 2021.
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Facility or practice conditions
Hawaii requires an ownership disclosure with CLIA and a facility-specific state permit assessment.
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Federal application procedure
Idaho's initial CLIA procedure uses CMS-116.
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Federal application procedure
Illinois explicitly identifies CMS-116 for a waived-only application.
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Additional application documents
Indiana requires two enclosures in addition to CMS-116 for initial waiver applications.
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Federal application procedure
Iowa's waiver application uses a director-signed CMS-116.
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Federal application procedure
Kansas publishes the CMS-116 application and director-signature instructions.
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Facility or practice conditions
Kentucky's physician own-patient exemption depends on how the laboratory operates.
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Additional application documents
Louisiana requires CMS-116 and its separate list of tests performed.
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Facility or practice conditions
Maine provides exemptions for specified practitioners and practice arrangements.
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State authorization required
Maryland requires a state permit or Letter of Exception as well as CLIA authorization.
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Additional application documents
Massachusetts exempts waived-only laboratories from state lab licensing but requires a test list with CMS-116.
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Federal application procedure
Michigan uses CMS-116 for the initial waiver application.
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Federal application procedure
Minnesota directs CLIA applicants to the federal application process.
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Federal application procedure
Mississippi's CLIA program publishes CMS-116 and its submission contact.
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Federal application procedure
Missouri states that it does not require laboratory licensure.
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Federal application procedure
Montana publishes the CMS-116 application procedure for CLIA certification.
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Additional application documents
Nebraska requires CMS-116, ownership information and a test list.
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State authorization required
Nevada administers a separate laboratory authorization process.
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Facility or practice conditions
New Hampshire's professional-office exemption can change the laboratory licensing route.
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State authorization required
New Jersey has a state Clinical Laboratory License process alongside CLIA.
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Federal application procedure
New Mexico's Health Care Authority publishes the CMS-116 application route.
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Facility or practice conditions
New York has different POLEP and CLEP routes; one instruction cannot cover every practice.
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Federal application procedure
North Carolina publishes an email route for signed CMS-116 applications.
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Agency clarification needed
North Dakota's additional test-list and personnel requirements need a case-specific check.
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Federal application procedure
Ohio's initial CLIA process uses CMS-116; blood-lead testing has a separate program.
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Federal application procedure
Oklahoma publishes a CMS-116 submission route for clinical laboratories.
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Federal application procedure
Oregon publishes a dedicated waived-testing certification route.
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State authorization required
Pennsylvania requires a state clinical laboratory permit package as well as CMS-116.
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Facility or practice conditions
Rhode Island's physician own-patient exception has specific conditions.
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Agency clarification needed
South Carolina requires a state application packet whose contents need confirmation.
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Federal application procedure
South Dakota identifies the federal CLIA application route for laboratories.
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Facility or practice conditions
Tennessee's waived-only license and testing-policy scope needs confirmation for a standalone clinic.
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Additional application documents
Texas uses CMS-116 plus Form 3225, an additional form rather than a separate laboratory license.
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Additional application documents
Utah lists ownership disclosure alongside the CMS-116 application.
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Agency clarification needed
Vermont's CLIA administration is routed through New Hampshire; a statutory fee needs clarification.
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Federal application procedure
Virginia's published CLIA procedure calls for an original signature and postal submission.
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State authorization required
Washington's Medical Test Site process integrates CLIA authorization.
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Federal application procedure
West Virginia directs initial applicants to CMS-116.
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Federal application procedure
Wisconsin provides CMS-116 and current federal application instructions.
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Federal application procedure
Wyoming publishes the CMS-116 application route.
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Additional jurisdictions
District of Columbia and Puerto Rico are outside the 50-state source review.
Manual review required
A reviewer must confirm the current requirements before a filing route or price is stated.
Current source review needed
Ask about District of ColumbiaScope inquiry only. No payment or case acceptance.
Manual review required
A reviewer must confirm the current requirements before a filing route or price is stated.
Current source review needed
Ask about Puerto RicoScope inquiry only. No payment or case acceptance.
Need help with your CLIA route?
Tell us where your clinic operates and what you need to prepare or change. You can ask before you know your exact test system. We review the next facts needed before proposing any paid scope.
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Business inquiries only. Do not send patient information, test results, dates of birth, government identifiers, credential numbers, or documents.
From test research to your application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.