CMS 116: Improved Standards for Clinical Laboratories

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Form CMS 116: Learning about Clinical Laboratory Improvement Amendments

If you are involved in conducting clinical laboratory tests, you should get familiar with when, why, and how to apply for CLIA Certification. Here are some details aimed at helping you file your CMS 116, which is the Clinical Laboratory Improvement Amendments Application for Certification.

Who needs a CMS 116?

According to the United States Federal Law, every facility which deals with laboratory tests on humans (excluding basic researches and clinical trials) must comply with CLIA standards. To be legally allowed to perform this type of activity, a laboratory facility has to be officially acknowledged as a clinical laboratory.

The results achieved by such facilities are to be used for establishing diagnoses, preventing and treating diseases, and making general health condition assessments. CLIA regulations should be fulfilled even in cases when a laboratory performs one of a few basic test free of charge.

What is the CLIA Application for Certification Form for?

The Clinical Laboratory Improvement Amendments Application for Certification has been created to collect operational data about laboratory facilities. It is used for defining the type of certificate to issue and fees to charge.

Types of CLIA Certificates include:
1. Certificate of Waiver
2. Certificate for Provider-Performed Microscopy Procedures (PPM)
3. Certificate of Compliance
4. Certificate of Accreditation

Typically if the CMS 116 form is filed as an initial application, the laboratory will be issued a Certificate of Registration. Right after an inspection is conducted, another type of certificate will be provided.

Is Form CMS-116 accompanied by other forms?

It is strongly recommended that the applying facility contacts their State Agency for additional requirements regarding supporting documentation, forms, or statements, as they vary from one state to another. In fact, this is true not only regarding the state of laboratory operation but also regarding types of CLIA Certificate. For instance, in locations where nonwaived tests and PPM procedures are performed supervising personnel must comply with certain requirements related to educational and training background and experience. In such a cases, documents confirming these requirements must be attached to a completed CMS-116 form.

When is CMS Form 116 due?

Revision of the CMS 116 application is quite time-consuming, and can take up to two months. Nevertheless, a laboratory facility can start its work as soon as their payment of a registration fee is credited. The requested Certificate will be delivered in about two weeks.

The CLIA  Certificate is valid for two years. To renew the certificate promptly, it is necessary to file a new CMS-116 form with no less than nine months before the effective certificate’s expiration date. And if the form is filed and payment made until the due date, the renewed Certificate will be received one month before the current Certificate’s expiration date.

How do I fill out the CLIA Application for Certification Form?

The CMS 116 application should provide relevant information on the following items:
1. Facility’s general information (type of application, name, address, email, name of director, etc.)
2. Type of requested certificate and appropriate testing
3. Type of laboratory
4. Hours of testing
5. Single/multiple sites
6. Type of control
7. Director affiliation with other laboratories
8. Owner/director’s signature and date

Where do I send CMS Form 116?

The completed Clinical Laboratory Improvement Amendments Application for Certification must be submitted to the local State Agency in the State where the laboratory testing will be performed. The full list of addresses and other contact information can be found here.