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The CLIA Certificate of Waiver
By Dinah Monahan
 Directors of rural centers have to be jacks-of-all-trades. We counsel, train, plan, write proposals, and clean toilets. Add to those tasks the need to stay on top of state and federal requirements, and it all can be a bit dizzying. So we may let some things slip. Getting a CLIA certificate of waiver for pregnancy testing may be one of those things. It was for me. After checking into what had to be done, we found that getting certified was simple and allowed us to run the tests ourselves.
When we were sending the tests to an outside lab, the client would go home and await the results. After we started doing the tests in-house, we realized that we were able to counsel the client as she waited for the results. We also found it advantageous to know the test results before the client did. I encourage other centers to get their CLIA waivers so their volunteers can do the tests.
"CLIA" stands for Clinical Laboratory Improvement Amendments of 1988. The federal government requires CLIA certification for PCCs when the lay counselors do the actual pregnancy tests. There are four types of CLIA certificates: (1) Certificate of Waiver. This is for agencies that are performing any basic tests with a diagnosis, for example urine tests, blood glucose, etc. PCCs fall in this category. (2) Certificate for Provider Performed Microscopy Procedures. This is for any agency performing tests that require the use of a microscope to diagnose. (3) Certificate of Compliance. This for any agency that is non-waivered, performing moderate complexity tests. (4) Certificate of Accreditation. This is for accreditation for hospitals.
To get the three necessary forms, go online to www.cms.hhs.gov/clia. You need forms CMS1513, CMS116, and CMS209. Your state may require additional forms. Contact your state health department to find out.
First, read through all the forms. On Form 116, fill out sections I and II. Section II tells you what else to complete, according to the type of certificate you are applying for. The forms generally are easy to fill out. If you have any questions, call your state health department.
Where the form asks for the "director's signature," it means your medical director. If your center isn't a medical clinic, ask a sympathetic doctor to be on your advisory board in that capacity. All he needs to do is sign the CLIA application and write a standing order for your clinic to perform pregnancy tests on women who come to you seeking tests. This standing order must be posted visibly in any site where you perform tests.
When you send in the application, your state health department will send you a bill for $150 for two years. Thereafter, you reapply and pay every two years.
Originally we were intimidated by this prospect. It turned out to be so simple that we were amazed. So, step up to the plate, get your CLIA Waiver Certification, and get started.
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