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How to fill out the CMS-116 online
This guide provides clear and comprehensive instructions for completing the CMS-116 application for certification under the Clinical Laboratory Improvement Amendments (CLIA). Whether you are a new applicant or making changes, these steps will help you navigate the online form confidently.
Follow the steps to complete the CMS-116 form accurately.
- Click ‘Get Form’ button to access the CMS-116 application and open it in your editor.
- Fill out the general information section, including selecting 'Initial Application' or other relevant reasons, and provide your facility name, CLIA identification number, effective date, and contact information.
- Indicate the type of certificate requested by checking one of the options provided. This section determines the level of testing your laboratory will be performing.
- Select the type of laboratory that most accurately describes your facility from the list provided.
- Detail the hours of laboratory testing by specifying the times each day when testing occurs, using the HH:MM format.
- If applicable, declare whether you are applying for a single site CLIA certificate to cover multiple testing locations and provide necessary details.
- Complete the sections on waived testing, PPM testing, and non-waived testing by specifying the tests performed and estimated annual test volumes.
- Check the type of ownership control for your laboratory from the available options.
- If the director of your laboratory serves as director for any other separately certified laboratories, provide their information in the specified section.
- Sign and date the application at the bottom, ensuring that all entries are completed legibly.
- Submit the completed CMS-116 form to the appropriate state agency as per the instructions without enclosing any payment.
Begin your online documentation process now to ensure your laboratory meets CLIA requirements.
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CLIA stands for the Clinical Laboratory Improvement Amendments, which set standards for laboratory testing, while CMS refers to the Centers for Medicare & Medicaid Services, which oversees Medicare programs. CLIA focuses on testing accuracy, whereas CMS ensures healthcare providers meet the necessary billing guidelines through forms like CMS-116. Understanding these distinctions helps healthcare providers navigate compliance.
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