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!