Disclaimer: This article was updated on Jan. 2, 2022, to provide new information.
Are you thinking about opening a clinical laboratory? If so, and you’ve identified your test menu, instrumentation, and have hired a Laboratory Director, you’re now ready to obtain a CLIA certificate. “What are the next steps in the process to apply for a CLIA license?” is something you may ask. We are here to help!
Here is a brief overview of how to apply for your CLIA certificate:
First, download the CMS-116 Clinical Laboratory Improvement Amendments (CLIA) application form (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf).
In section I of this CMS-116 form, complete the basic information regarding your laboratory and director.
In proceeding to section II, you will need to know what type of CLIA Certificate you are requesting: e.g., a Certificate of Compliance, which involves regional CLIA and state-specific oversight, OR a Certificate of Accreditation, whereby you’d be seeking accreditation through an agency such as COLA or CAP. The form contains a list of the approved Accrediting Bodies with whom you can enroll your laboratory should you choose the Certificate of Accreditation route.
In Section III, list the type of laboratory you are starting; for example, is your facility a Physician Office Lab or an Independent Reference Lab? Mark the appropriate checkbox associated that most closely matches your facility.
In the next Section (IV), list the hours of the laboratory and days of the week that the facility will be open; only list the days and times that your lab will be staffed and operational. If your facility is not applying for multiple sites, waived testing, or PPM testing, please check the ‘no’ boxes that are provided in Sections V, VI, and VII, and skip ahead to Section VIII.
In Section VIII, list each analyte and device/instrument that will be used in the laboratory; for example: “Influenza A, QuantStudio 12K Flex” (analyte, device/instrument). Do this for each analyte and/or device/instrumentation that you have in your lab so that Section VIII provides a comprehensive look at your analytes and instrumentation for CLIA to review. The space that is provided can be limited, but the form includes a checkbox that should be marked if you need additional space and would like to attach more pages in order to detail all of your analytes and devices/instruments in the same format described above.
Section VIII is also where the specialty/subspecialty should be marked according to your test menu, along with the annual volume you are estimating for each specialty. If you have decided to request a Certificate of Accreditation, please list the Accrediting Organization in that same-named specific column next to each subspecialty; if you are seeking a Certificate of Compliance, leave the Accrediting Organization column blank for all specialties. Once you have estimated each specialties’ annual volume, total these numbers and enter the Total Estimated Annual Test Volume to complete Section VIII.
In the next Section (IX), list the Type of Control regarding the lab’s ownership: nonprofit, for profit, or government, and check the appropriate box under the correct designation.
You will need your Laboratory Director to complete or provide you with his/her other CLIA Laboratory Directorships and those labs’ CLIA Numbers for section X. Typically, the application is signed and dated by the Laboratory Director, but an owner may sign it instead.
The Final Step
Now that the application is complete, it will need to be mailed to the proper State agency with the Laboratory Director’s resume, diploma/transcripts, board certifications, applicable state license(s), and the lab’s Accrediting Agency’s enrollment letter (if applicable due to seeking a Certificate of Accreditation).
We recorded a step by step video of filling out CMS-116 form process that may be more explanatory for you. You can WATCH IT HERE.
Still having trouble with the completion of the CMS-116 form? Reach out to us! We have Credentialing Specialists available to assist you that can address your questions and/or complete the application process for you!