Reader and Industry Forum

Using CLIA-Waived Technologies Builds Patients’ Trust

BY ARTHUR B. EPSTEIN, OD, FAAO

Although the healthcare environment is shifting and, in some cases, unstable, optometry is evolving rapidly. Progressive, contemporary optometrists are making advanced diagnoses for ocular diseases with in-office Clinical Laboratory Improvement Amendments (CLIA)-waived laboratory tests.

CLIA is a set of government-established guidelines for laboratory testing. The U.S. Food and Drug Administration (FDA) has deemed a CLIA-waived test to be accurate, safe, and unlikely to produce erroneous results, even in the hands of a non-clinician.

While a patient can administer a CLIA-waived test at home, an optometrist must acquire a waiver at each site to be able to administer the test. The Centers for Medicare & Medicaid Services (CMS) also requires all practices performing laboratory tests using “materials derived from the human body for the purposes of providing information for the diagnosis, prevention, or treatment of any disease” to meet certain federal requirements. Any clinic that performs tests for these purposes is considered under CLIA to be a laboratory and must register each test with the CLIA program (CMS, 2014).

The CLIA application is relatively straightforward. Simply access the CLIA application form—CMS-116—at www.cms.gov, complete the form, and mail it to the local state agency for the state in which your practice is located. State agency addresses, along with instructions for completing the form and other helpful information, can be located on the CMS web site.

Local Disparities

Unfortunately, there is a disparity in CLIA-waived testing from state to state. Some states prohibit some types of testing, so it is important to ensure that you are allowed to perform a specific test under your state laws. Contact your local optometry board or state agency by phone if you have any questions or need assistance to understand state regulations. Additionally, a practice looking to secure a waiver can leverage support from product vendors; certain vendors offer support lines dedicated to assisting a practice with the CLIA process.

A New Standard of Care

CLIA-waived testing has changed the standard of care in my practice. For example, my colleagues and I use a point-of-care diagnostic test to rule out or confirm adenoviral conjunctivitis in patients who have acute red eye. Others use a tear osmolarity test for dry eye patients, which produces an osmolarity measure that can be useful in gauging the severity of dry eye.

These new technologies can provide a concrete measurement that complements and enhances our understanding so that ultimately, patients feel more comfortable and confident in the care that they receive. There’s no question that the psychology of managing patients is as important as the medications and therapies that we choose. Using modern diagnostics and the improved trust that they create is one of the greatest benefits of CLIA-waived tests. CLS

For references, please visit www.clspectrum.com/references and click on document #231.

Dr. Epstein is the director of cornea-external disease and clinical research at Phoenix Eye Care, PLLC and the head of the Dry Eye Center of Arizona in Phoenix. He is a consultant for Alcon Laboratories, Inc., EyeEco, Nicox, Oculus, and TearScience. Dr. Epstein may be reached at artepstein@artepstein.com.