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“You can get past the dead end. You can break through the ceiling. I did and so have countless others.”

Understanding CLIA Waivers for the Nurse Practitioner Practice

Medicine Corona Test Throat Swab  - Tho-Ge / Pixabay

Many nurse practitioner owned practices will need to perform some sort of point of care test at one point or another. These tests could include anything from a rapid strep test, rapid COVID test, a urine dip, or even a hematocrit check (I use this often at my men’s health practice). At some point or another, most niche side practices will probably do a point of care test. But before you do these, you need something called a CLIA waiver, so you remain “compliant.”

The Clinical Laboratory Improvement Amendments, or 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 essentially. What does this mean for a small practice owner like yourself? 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 a simple strep test. You do not need one if you are just drawing labs and sending them out, just FYI.

There are various types of CLIA certifications ranging from a CLIA waived certification to a full-blown laboratory certification where you do every test imaginable (CBCs, troponins, hormones, immunological tests, etc…). For the vast majority of you though, the only certification you need to worry about is the CLIA waived one.

If you plan on purchasing chemistry and blood analyzers so you can do CBCs, CMPs, TSHs, Lipids, and so forth in your practice, then you need to apply to do moderate to complex testing and that is beyond the scope of this article. You can find more information about that HERE. It takes quite a bit of work and requires a laboratory director to be able to do moderate to complex testing in your office. With that said, this does not apply to most of you.

The CLIA certificate of waiver is what most of you will 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 hematocrits to influenza and everything in between. A list of CLIA waived tests can be found HERE. This CLIA certificate of waiver is supposed to make doing point of care testing “safer” for the patient, but I do not see the logic in it. All you need to do is submit an application, pay $180, and now you can “legally” perform point of care testing “safely.” I think they just like the $180 fees personally…

Regardless, the process to obtain a CLIA certificate of waiver is very straight forward. Do not get overload paralysis or analysis paralysis about this! There is nothing to it and it does not require an inspection to obtain nor maintain.

To apply for your CLIA waiver, you first need to print off Form CMS-116 and complete it according to THESE INSTRUCTIONS. Remember, be sure you just 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, then just 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 2-4 weeks. I have never had it take longer than 2 weeks personally. Usually you will receive an email confirming your certification.

After you receive the certificate in the mail/email, you can now “legally” perform CLIA waived point of care testing “safely!” Congratulations! Personally, I am not sure why we need this to “legally” perform a urine dip or a rapid strep test safely, but what do I know? Sounds like a way the government can get more money from us more than anything, but I digress…

Now remember, you do need to renew your CLIA waiver every 2 years. You will do this through your state agency. I would advise renewing this at least 3 months before it expires just to be on the safe side.

That is it folks! The CLIA waiver for a small nurse practitioner practice is really not that big of deal. Do not waste much mental energy on this. 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. You need to be focusing on marketing, not your CLIA waiver!

16 Responses

    1. 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.

  1. 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

    1. 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.

  2. 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.

    1. 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.

  3. 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

    1. 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….

      1. 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?

        1. 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.

    2. 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?

      1. 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??

  4. 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.

    1. 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.

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