This version of the form is not currently in use and is provided for reference only. Download this version of Form CMS-116 for the current year.
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.
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.
Form Details:
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.