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Versions Form popularity Fillable & printable
CMS-116 2020 4.8 Satisfied (191 Votes)
CMS-116 2017 4.2 Satisfied (71 Votes)
CMS-116 2015 4.1 Satisfied (56 Votes)
CMS-116 2014 4.4 Satisfied (459 Votes)
CMS-116 2010 4.2 Satisfied (38 Votes)
CMS-116 2007 4 Satisfied (38 Votes)
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The CLIA application (Form CMS-116) collects information about your laboratory's operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility's laboratory operation.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Certificate of Waiver. Certificate for Provider-Performed Microscopy Procedures (PPMP) Certificate of Registration. Certificate of Compliance. Certificate of Accreditation.
2:53 12:00 How to Complete a CMS 116 Application - YouTube YouTube Start of suggested clip End of suggested clip Process. Section 1 general information section 1 contains fields to enter a facility's demographicMoreProcess. Section 1 general information section 1 contains fields to enter a facility's demographic information the first part of this section describes the purpose of the application.
2:53 12:00 How to Complete a CMS 116 Application - YouTube YouTube Start of suggested clip End of suggested clip Process. Section 1 general information section 1 contains fields to enter a facility's demographicMoreProcess. Section 1 general information section 1 contains fields to enter a facility's demographic information the first part of this section describes the purpose of the application.
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A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.
CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.
1:05 19:02 How to apply for a CLIA certificate? Filling out CMS-116 form - YouTube YouTube Start of suggested clip End of suggested clip So on section 1 of this form you will need to list your lab directors. First and last legal names asMoreSo on section 1 of this form you will need to list your lab directors. First and last legal names as well as their middle initial as well as their credentials.
What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.
CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.

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