Many nurse practitioner owned practices will need to perform some sort of point of care test at one point or another. These tests may include anything from a rapid strep test, COVID test, a urinalysis, or even a hematocrit check. Most niche side practices will probably do a point of care test in the initial stages of patient care. But before you perform these, you must obtain a CLIA waiver to maintain federal compliance.
What is a CLIA waiver?
The Clinical Laboratory Improvement Amendments (CLIA), was a law passed by congress to standardize laboratory testing and provide oversight for all laboratory testing done in the country. It was passed to standardize laboratory testing and enhance patient safety.
But what does this mean for a small practice owner? It means you need to obtain a certificate from the U.S. Department of Health and Human Services if you plan on doing any kind of laboratory testing in your practice, even routine labs. However, you do not need one if you are just drawing labs and sending them out to a third party testing facility.
Types of CLIA certifications
There are various types of CLIA certifications, ranging from general waivers to more advanced forms that permit providers to run extensive lists of laboratory tests. If you run a private practice specializing in general medicine or a niche that is generally non-invasive, you most likely will need a CLIA certificate of waiver.
The CLIA certificate of waiver is what most NPs need. This allows a facility to legally examine a person through a waived test to assess health, diagnose conditions, and determine treatment. These tests can range from INRs to hematocrita, influenza, and everything in between. A list of CLIA waived tests can be found here. This CLIA certificate of waiver is obtained by submitting an application and paying a fee.
If you plan on purchasing chemistry and blood analyzers so you can do CBCs, CMPs, TSHs, lipids, and so forth in your practice, you must apply for permission to perform moderate to complex testing, which is beyond the scope of this article. You can find more information about more complex certifications here. This process usually takes quite a bit of work and typically requires a laboratory director to oversee testing operations.
How do I get a CLIA certificate of waiver?
To apply for your CLIA waiver, you first need to print off Form CMS-116 and complete it according to these instructions. Be sure you select “Certificate of Waiver” on the application, as that is all you need to perform point of care testing in your practice. Additionally, if you plan on providing mobile testing, then be sure to select the appropriate regulatory exception, which is question 1 under section V. If you are doing this via the mobile route and don’t have a physical office location, use your home address.
After you complete the application, you need to mail the form to your local state agency for processing. You can expect processing time to be anywhere from two to four weeks. You should receive an email confirming your certification. After you receive the certificate in the mail or through email, you can now legally perform CLIA waived point of care testing.
You do need to renew your CLIA waiver every two years. You can do this through your state agency. It’s advisable to begin the renewal process three months out from the expiration date to ensure that there is no lapses between certification periods.
The CLIA waiver for a small nurse practitioner practice is simple to obtain. The application is straight forward and can be completed in 15 minutes. Seriously, it’s a piece of cake! Get this done during the startup phase of your practice and put it behind you. Once you get this done, you can focus on more important aspects of business ownership like marketing, brand development, and patient acquisition.
29 Responses
Just got my email notification of CLIA approval pending the $180 fee… after 2 weeks .
Just follow Justin’s instructions…. You can’t go wrong!!
Thanks for the comment! It is very simple!
It is also my understanding that you have on file a process and records of how and when you test your equipment.
Would be wise to have some basic records on this, but a rapid strep test does not require any type of equipment testing. Really depends on the test.
What type of certification would you need to have medications in your clinic ? I would like to open an urgent care and want to have some basic meds in house. Thanks
It ultimately depends on your states laws but you shouldn’t have an issue administering medications in a practice setting as that is covered under your license. No additional certification is needed.
Hello,
Now that we’ve been awarded independent practice in Massachusetts, I’m wondering if that means we no longer need a physician signature for the CLIA waiver application/renewal? This is specific to a home health agency.
You probably would not, but that is going to be up to your states CLIA and when they impliment the changes on their forms. Just call them and ask.
I’m a DNP, CRNP-NP-C in PA. I have applied for a clia waived to do urine dipsticks for CDL exams and the state keeps kicking back my application stating I need a lab director and I am not qualified.( they send me the requirements for a clia director). I’ve been rejected twice. How do you suggest I move forward. My emails keep getting forwarded to the same individual in the state office that rejects me. This is holding me back from a potential contract to do CDL physicals that can be extremely profitable since i became a CME and am listed on the national registry. Any info would be greatly appreciated
You are applying for a moderate complexity CLIA certificate… You are just filling out the application wrong. You don’t need a lab director for urine dipsticks….
Hi Justin, We are also finding a similar issue in PA it seems like the wording for the requirements of lab directors here are a doctorate degree and relevant experience even for waived testing. Do you have any guidance?
I do not have any specifics. Just look up the CLIA requirements for a lab supervisor for moderate complexity testing. There really is no way around it.
Hi Karen, We also are in PA looking to do the same thing, Did you get approvals on this? & if you did how did that come about?
The wording on PA’s heath sites seems to say that a lab director must have a doctoral degree & necessary experience even for exempt tests? Is this why you were being denied and were you able to find a solution to get approvals?
Hi Stephanie,
No I have not been able to obtain the clia waiver. PA is not being open to granting one without a medical director as per THEIR criteria. I went as far as CMS and they kicked it back to the state.
I have a doctorate and 30 years of experience having oversite of clinics performing clia waived testing and yet they will not accept. It does not look like they are going to move forward with full practice authority anytime soon as well so I am moving to a FPA state.
Bye PA
Did you have any luck??
Hi Stephanie
i was wondering if you ever had any success with obtaining the clia waiver in PA?
I would greatly appreciate any feedback
Thanks
Karen
Karen,
We have a similar situation and are working with a consultant to figure it out. Would like to connect and compare notes. I can be reached at the attached email.
Jeff
Hi Jeff
Just wondering if you ever resolved the clia waiver issue in PA?
I am still struggling to obtain in PA
Thanks
Karen
Hi Jeff
I was wondering if you ever had any success in obtaining the clia waiver in PA and if so, how you accomplished it, I would greatly appreciate any feedback
Thanks
Karen
Thanks for the informative post. Could you please help with these 2 questions: I noticed the section that asks for analyte, test name, and manufacturer. I assume analyte is just what the test is for, test name is the FDA name of the test, and then manufacturer is which company made the test. How did you decide between the different manufacturers that the FDA approved for each specific test? I’m not sure what to write for the manufacturer. Also, if you are using a single certificate to cover multiple locations, do you need to write each location on the application or can you add more later? If you are able to help with these questions, that would be greatly appreciated. Thank you for your valuable time and have a nice day.
I just put a test down and go. Tests change based off availability… It isn’t realistic to update that every single time you switch brands… In terms of location, I would imagine each location needs to be listed.
Hello colleagues
Just wanted to circle back to the issue with PA in regards to obtaining a clia certificate of waiver. I know a few of us were experiencing difficulty in obtaining due to the wording of the state requirements.
Does anyone have any updates regarding this issue?
Thanks
Karen
Any recommended vendors for clia testing equipment/supplies?
Just any standard medical supplier like McKesson or Henry Schein
Do I need a waiver or certificate if I’m only obtaining the specimen in house then sending to Access Medical Labs?
No license needed for collection
Do I need a clia waiver for prp injections that aren’t billed through insurance?
Nope
Just to confirm… if I am doing urine dips, strep and flu testing and not accepting insurance is a CLIA waved certificate required?
Yes, any point of care test requires a CLIA waiver