Qualifications. Do not send any money with your application. Send the completed Form CMS-116 to the appropriate State Agency http //www. 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. Note that for a Certificate of PPM Certificate of Compliance or Certificate of Accreditation an individual can only serve as the director for no more than five Reminders - Before submitting the Form CMS-116 Include the current or estimated annual test volume. Cms. gov/Regulations-and-Guidance/ Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed a fee remittance coupon will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate and if applicable the compliance survey or validation fee. Cms. gov/Regulations-and-Guidance....
Open form follow the instructions
Easily sign the form with your finger
Send filled & signed form or save
How to fill out the CMS-116 online
Filling out the CMS-116 form online is essential for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This guide provides step-by-step instructions to ensure users complete the form accurately, facilitating a smooth application process.
Follow the steps to successfully complete the CMS-116 online.
- Press the ‘Get Form’ button to access the CMS-116 online and open it in your preferred form editor.
- Begin by filling out Section I: General Information. Indicate whether this is an initial application, a survey, or a change in certificate type. Provide your facility name, anticipated start date, and CLIA identification number, if applicable.
- In Section II: Type of Certificate Requested, select the appropriate certificate based on the highest level of test complexity your laboratory will perform. Make sure to understand the requirements for each certificate type.
- Complete Section III: Type of Laboratory by selecting the option that most accurately describes your facility, such as hospital, independent lab, or mobile laboratory.
- In Section IV: Hours of Laboratory Testing, list the days and hours when testing will be performed. Use the HH:MM format and check the box if the laboratory operates 24/7.
- Proceed to Section V: Multiple Sites if applicable. Indicate whether you are applying for a single certificate that covers multiple testing locations, and provide details for each location as required.
- For those applying for a Certificate of Waiver, focus on Section VI: Waived Testing. List the waived tests to be performed and their estimated annual test volume.
- If applying for a Certificate for Provider Performed Microscopy Procedures (PPM), complete Section VII: PPM Testing, marking the procedures to be performed and estimating their annual volumes.
- Complete Section VIII: Non-Waived Testing if applying for a Certificate of Compliance or Accreditation. Identify non-waived tests by including their details and estimated volumes.
- Fill out Section IX: Type of Control, specifying the ownership type of the laboratory. This information helps categorize your facility correctly.
- Conclude by detailing any affiliations of the laboratory director with other laboratories in Section X and ensure to read and sign the consent statement carefully.
- After verifying all information, save the form, and prepare for submission as per the instructions provided. Remember not to send payment with the application.
Complete your CMS-116 application online and ensure your laboratory is certified under CLIA.
Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Related content
Form #. CMS 116. Form Title. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA)...
o The “Related Links” section contains a link to the CMS-116 CLIA Application Form...
Apr 28, 2010 - CMS Manual System. Department of Health &. Human Services (DHHS). Pub...
Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
If you believe that this page should be taken down, please follow our DMCA take down process here.