Form CMS-116 Clinical Laboratory Improvement Amendments (Clia) - Application for Certification

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Form CMS-116 Clinical Laboratory Improvement Amendments (Clia) - Application for Certification

What Is Form CMS-116?

This is a legal form that was released by the U.S. Department of Health and Human Services - Centers for Medicare and Medicaid Services on September 1, 2017 and used country-wide. As of today, no separate filing guidelines for the form are provided by the issuing department.

FAQ

Q: What is the CMS-116 form?
A: The CMS-116 form is the application for certification under the Clinical Laboratory Improvement Amendments (CLIA).

Q: What is the purpose of the CMS-116 form?
A: The purpose of the CMS-116 form is to apply for certification as a clinical laboratory under CLIA.

Q: What does CLIA stand for?
A: CLIA stands for Clinical Laboratory Improvement Amendments.

Q: Who needs to complete the CMS-116 form?
A: Clinical laboratories that perform tests on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease need to complete the CMS-116 form.

Q: What information is required on the CMS-116 form?
A: The CMS-116 form requires information such as laboratory location, director qualifications, and types of testing performed.

Q: Are there any fees associated with the CMS-116 form?
A: Yes, there are fees associated with the CMS-116 form. The fee depends on the type of certification sought.

Q: How long does it take to process the CMS-116 form?
A: The processing time for the CMS-116 form varies, but it typically takes several weeks to several months.

Q: What are the benefits of CLIA certification?
A: CLIA certification ensures that clinical laboratories meet quality standards in order to provide accurate and reliable test results.

Q: Are there any penalties for not having CLIA certification?
A: Yes, there can be penalties for operating a clinical laboratory without CLIA certification, including fines and possible closure of the laboratory.

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Form Details:

  • Released on September 1, 2017;
  • The latest available edition released by the U.S. Department of Health and Human Services - Centers for Medicare and Medicaid Services;
  • Easy to use and ready to print;
  • Yours to fill out and keep for your records;
  • Compatible with most PDF-viewing applications;
  • Fill out the form in our online filing application.

Download a fillable version of Form CMS-116 by clicking the link below or browse more documents and templates provided by the U.S. Department of Health and Human Services - Centers for Medicare and Medicaid Services.

Download Form CMS-116 Clinical Laboratory Improvement Amendments (Clia) - Application for Certification

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  • Form CMS-116 Clinical Laboratory Improvement Amendments (Clia) - Application for Certification

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