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).
Section I
In section I of this CMS-116 form, complete the basic information regarding your laboratory and director.
Section II
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.
Section III
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.
Sections IV-VII
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.
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.
Section IX
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.
Section X
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!
Thank you so much
Welcome:)
Hello, we are an Intern. Med. physician we will do Ua, Covid test. Sofia 2 Quidel, Rapid test INR
PT, Ptt testing should I get a waiver ?
Hello, yes you should get a CLIA waiver. Let us know if you have any other questions.
Do we need to get a clia waiver from every state for antigen testing?
If it is a CLIA Waived test, you would need a waiver in every state that the test is being read. If they are collected and shipped to a central location, you would only need a waiver for that location. Let us know if you have any other questions:)
Hi,
This website is great. Thank you. If I want to simply set up a pop up testing center where I administer waived antigen swab tests, do I need to obtain a certificate of waiver (and lab registration in CA) if I’ll be sending the tests to a lab for reading results? If not, can I just get started administering?
Hi Dan and thank you! I believe that in CA (assuming you are not performing the waived tests at the site but collecting specimens) you need a state specimen collection license in CA. However, if you are collecting specimens and running the specimen on the test at the site then you need a CLIA waiver and state lab registration. Also, we found this link helpful for it: https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVID-19Guidance.aspx
For a Change of Ownership for a CLIA Waiver, does Section VI require completion?
Hello Brenda, this depends on the state the laboratory is located in. However, we recommend that the entire application be completed. In what state the lab is located?
I have a few questions regarding completing Section VIII of CMS-116:
If we are a Mohs micrographic surgery practice and do only H&E and immunohistochemistry, do we list out “Hematoxylin” and “Eosin” separately under the “Analyte/Test” column even though those two things are run together during the processing of each slide? Do we need to list each component of an immunohistochemistry protocol as an “analyte/test” since these are multi-step protocols?
Also, how do we know which of these is defined as “M” (moderate complexity) or “H” (high complexity)?
Lastly, You mention “instrumentation” needs to be listed in this section, but since neither a microscope nor a cryostat fall under the category of “Analyte/Test” where would we list them?
Hello Charles, H&E can be listed as one test but provide as much detail as possible. You can find the complexity of the test by searching the FDA website (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm).
Also, we know that this requires a board-certified pathologist and usually is a high complexity test.
If you need more assistance, please feel free to submit a contact form to get in touch with our team for consulting or application help (https://www.lighthouselabservices.com/contact-form/).
Actually, board-certified dermatologists are capable and allowed to read their own histopathology. FYI, and per the CPT guidelines, any physician who uses/bills the Mohs codes MUST be both the surgeon and the pathologist (i.e. they must be the same person). Anything else is not considered Mohs surgery. Thus, the dermatologist is both the surgeon and pathologist.
This is because Dermatology training includes extensive training in dermatopathology.