Who needs a CMS Form 116?
According to the United States Federal Law, every facility which deals with doing laboratory testings on humans (excluding basic researches and clinical trials) must comply with CLIA standards. To be legally allowed to perform this type of activities, 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 case a laboratory performs one of 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 operation data about a laboratory facility. It will be used for defining the type of certificate to issue and fees to charge.
As for the types of CLIA Certificates, they can be as follows:
- Certificate of Waiver
Certificate for Provider-Performed Microscopy Procedures (PPM)
Certificate of Compliance
Certificate of Accreditation
However, typically if the CMS Form 116 is filed for the first time as an initial application, the laboratory in most 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 as for 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 the type of CLIA Certificate applied for. For instance, supervising personnel of laboratory where nonwaived tests and PPM procedures are performed must comply with certain requirements as for educational and training background and experience. Therefore, in such a case, the confirmation of these requirements being met must be attached to a completed CMS-116 form.
When is CMS Form 116 due?
A process of the CMS-116 application revision is quite time-consuming, as it 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. And in about two weeks, the requested Certificate will be delivered.
The CLIA Certificate is valid for two years. To renew the certificate in a timely manner, it is necessary to file a new CMS-116 form with no less than nine months prior to 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 application should provide relevant information on the following items:
- Facility’s general information (type of application, name, address, email, name of director, etc.);
Type of requested certificate and appropriate testing (indicated further);
Type of laboratory;
Hours of testing;
Type of control;
Director affiliation with other laboratories;
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 in this online PDF document.