How to apply for a CLIA certificate? Filling out CMS-116 form

[@chicagolandtradinginc909]

@ lighthouse Lab Services i am applying for a CLIA WAIVER in state of Illinois but i myself can be list an owner and Director? i don't have any type of credentials, Neither i have a background of medical Experience. So what proof i have to send them with form CMS 116.

[@blisslimoservice1732]

im trying to get an answer as well since I hve no credentials eaither.. did you find an answer to this?

[@Jeremiibonner09]

Thank you for the information I'm a certified phlebotomist and I've started a mobile phlebotomy Service ..I really need help with filling out this application ..I'm not sure if I need a laboratory director can someone please reach out to me I just want to make sure I'm doing things by compliance.

[@simplysunshine30215]

When u say ,start a validation, and validation study for the lab what are you referring to.can u explain

[@miriamouma2699]

Thanks for this useful information. I'm a RN planning to open a CLIA lab in MA. Can I serve as owner and Director per CLIA guidelines?

[@johnguo4217]

Thank you very much for the tutorial. I am not sure what can I fill in VI for detection kits?

[@moejamal1448]

Have you figured that out yet?

[@courtneyhilson9366]

Very helpful video, thank you. I’m a registered nurse planning to open a mobile Covid testing business in TX. Can I serve as owner and lab director per Clia guidelines?

[@LighthouseLabServices]

Thanks Courtney! We're glad that it's helpful. To answer your question, it depends on the kind of testing you're doing. If you're doing point-of-care or rapid testing, then you could actually apply for a CLIA waiver via a CMS 116 form (which can be found with an online search for free). On this form, you'd be able to list yourself as the lab director. If you're doing testing that would be categorized as moderate or high complexity, you would need other personnel to fulfill the additional CLIA roles, as well as someone who would meet the qualifications for lab director.

[@schillerambroise6426]

What does one pick as a medical supplier?

[@ambrosiodelafe6514]

Thanks for this useful information. My Question is , For Research Sites, what type of laboratory Facility should I pick?

[@donnavarela3796]

Can the owner be a lab director since I have a cpt-1. Or who can be a ab director what type of license does a lab director need to have

[@LighthouseLabServices]

Hi Donna, this requirement can differ depending on which state you're located in. If you reach out to us at [e-mail] with some more background info, we can help you further!

[@courtneyhilson9366]

Very helpful video, thank you. I’m a registered nurse planning to open a mobile Covid testing business in TX. Can I serve as the director of laboratory as well per CLIA guidelines?

[@eyvettlawson2315]

Did you get started?

[@latauruscampbell7514]

Yes you can.

[@rasheemamcknight1348]

DO YOU HAVE TO HAVE A NURSE TO OPEN UP ONE

[@a.z777]

Yes

[@marthajacobs8601]

No you do not

[@latauruscampbell7514]

In certain states, it depends.

[@allysoncollins9924]

I am a Medical Assistant I work at a School doing covid testing a swabber but I would like to have my own covid site I have a Nurse Practioneer and a staff in place, so is this what I need to fill out this form and start from there?

[@LighthouseLabServices]

Hi Allyson, the CMS-116 is typically a good start, but depending on what state you are in, you may have to file an in-state application as well.

[@simplysunshine30215]

Hello 👋if you apply for a clia waiver certificate do u need a physician's to authorize for bill? Or is it whom the director is will bill.

[@pattyn421]

Hi there😊 I currently live in Fort Lauderdale Florida and work as a registered nurse I want to start my own mobile Covid testing business here. After completing the cams-116 form what would be the next step? Does your lab offer classes or step by step directions towards achieving this? Thank you

[@LighthouseLabServices]

Hi Patty, there are a couple resources we can provide to help you out with this: First, this link has contact info for Florida's Agency for Health Care Administration, info on Non-waived Lab Testing Personnel Requirements, and the Florida CLIA Laboratory Application: www.lighthouselabservices.com/state-license/florida/ Second, this link will take you to our "Start a Lab" page, which includes a lot of great info on the process of getting your lab up and running: www.lighthouselabservices.com/consulting/start-a-laboratory/

What if I'm a phlebotomist who is running my own mobile phlebotomy business?

[@LighthouseLabServices]

If you are only performing specimen collection and you are not manipulating the sample you do not need a CLIA certificate. However, several states including NJ, NV, and TN (to name a few) do require a Specimen Collection license.

[@LighthouseLabServices]

@ The state of Florida requires a CLIA license for any type of diagnostic testing; it sounds as though you are likely performing point-of-care/rapid testing, which is likely classified as Waived testing by the state of Florida. If this is the case, you'll need to apply for a Certificate of Waiver; you must possess this in order to conduct any testing, and you will need to cease all testing being performed until you receive it, or you otherwise are imposing significant risk to your business and operation from a regulatory compliance standpoint. You'll be able to find a form online by searching for "CMS 116 application". You will need to list a Laboratory Director, but there are no specific qualifications or credentials that need to be held by this individual in order to fulfill this role for Waived testing as per the state of Florida. We can assist with the filing of the application if you’d like; if so, I'll put you in touch with the appropriate person here at Lighthouse, who will get you a contract for this service and provide you with more information on what is included and the cost. Further, should the state of Florida determine that the testing you are performing is actually classified as Moderate or High Complexity instead of Waived, there will be many other requirements with regard to personnel, documentation, policies and procedures, etc. that will apply. We are well-equipped to assist you with all of this, if needed, and I can connect you with someone here to discuss if you would like to learn more about our services either now or in future.

[@ShahinMg]

Hi, what if my independent lab is in Canada? Can I still apply for CLIA waiver?

[@LighthouseLabServices]

Hi Shahin, there is a CLIA certification process for international labs. You would only need to pursue this process if your lab is obtaining specimens from the United States, however.

[@LifeisGood-2024]

hOW TO FILL IT OUT WITH HEALTH CARE ANGECY?

[@LighthouseLabServices]

Hi, thanks for your question! Which health care agency are you seeking to complete this form with? If you'd like to reach out to us at [e-mail] to provide some more background information, we can provide a free initial consultation to get you started!

[@MA-eh4zp]

If I am a Pharmacist, can I list myself as the Lab Director for my business? I am trying to implement COVID Testing for my patients.

[@LighthouseLabServices]

That depends on a couple things, such as the state you are in and the COVID testing complexity level (waived, moderate, or high).

[@MA-eh4zp]

@@LighthouseLabServices I am in Illinois and the COVID testing is waived at the moment due to the emergency authorization act.

[@momentsoflife4460]

@@MA-eh4zp what’s the requirements to start a Covid lab in Chicago? Can you share with me the links to the application, where to get the equipment from, and how much does it cost to start a full blown lab, and finally how quickly can I be operational? We are a small nonprofit mental health clinic and would like to start this COVID lab to help our clients. Thank you for sharing this amazing vid and answering my questions.

[@ddellaa09]

Thanks for the video. You mentioned that section V is almost always a "no" answer. What about a mobile laboratory doing concierge rapid covid testing which may require home, office or event visits? Will V.1 be a yes?

[@LighthouseLabServices]

Hi Dee, thanks for watching! You are correct, V.1 would be a yes in that instance, and then you would have to provide a VIN number in the space below as well.

[@enjoyurjourney6222]

@@LighthouseLabServices A VIN # such as your car VIN?

[@LighthouseLabServices]

@@enjoyurjourney6222 Yes, it would be the VIN for the truck or van being used as the mobile lab.

[@enjoyurjourney6222]

@@LighthouseLabServices Thank You

[@LighthouseLabServices]

@@enjoyurjourney6222 You're welcome!

[@stasskribnik3141]

Do I need to have some sort of level of education to perform Covid testing ?

[@LighthouseLabServices]

It depends on the state that the testing will be performed in, as well as the testing complexity being performed, which determines qualifications for CLIA roles (such as Testing Personnel). You can learn more on our website at www.lighthouselabservices.com/application-processing/

[@everlenemc]

No one is explaining mobile unit, why?

[@LighthouseLabServices]

If you'd like more info on the definition of a mobile unit, feel free to contact us directly at [e-mail]!

[@friscod3864]

if I am doing mobile lab (DOT physical) what address should i put? thank u

[@LighthouseLabServices]

Hi Frisco, most, if not all states require a mobile unit to be tied to a physical, brick-and-mortar location.

[@friscod3864]

I do not have an exact location. Can I used po box or a virtual address that I can receive my email without actually being present? Thank you for responding ❤️

[@Exposing21]

@@friscod3864 did u find the answer?