Clinical lab testing and CLIA get some clarification at Vision Expo

Article

hich clinical tests meet clinical laboratory improvement amendments (CLIA) compliance? Furthermore, which routine tests have CLIA waiver approval? If these questions have stumped you, you're not alone, and it's likely you are one of the many who see CLIA as one big mystery.

Las Vegas-Which clinical tests meet clinical laboratory improvement amendments (CLIA) compliance? Furthermore, which routine tests have CLIA waiver approval? If these questions have stumped you, you're not alone, and it's likely you are one of the many who see CLIA as one big mystery.

How to manage adenoviral conjunctivitis

To help unravel the mystery, Dr. John Rumpakis, OD, president and CEO of Practice Resource Management provided some tips at Vision Expo West to a room full of competent optometrists and eyecare providers who were looking for a refresher on CLIA and a better understanding of just what it is.

Brought about in 1988 as a way to set standards of quality for laboratory testing, all clinical labs that perform tests on the human body must receive a CLIA certificate of compliance. But that's just the start. And while the topic is multifaceted, Dr. Rumpakis offers these tips:

• CLIA tests must be based on medical necessity. The basis of patient care should be about what the patient truly needs - rather than what the physician wants to bill for.

•  "What is the only thing that can be held against you during an audit?" asks Dr. Rumpakis. "Your medical records. What is the only thing you can use in your defense? Your medical records." Keep air-tight records and your case will be easy when facing an auditor.

• You can't bill the carrier unless there's a specific reason for it. Coverage for services is dependent on the purpose of the exams.

• In general, lab tests are not revenue-generating events for a practice. But with CLIA-waived procedures, it's a different story.

As for the initial questions, while the first would take too much room to fully list, the second is a trick question.

"There is no such thing as a routine clinical exam when it comes to CLIA," Dr. Rumpakis said. "All tests have to be rooted in some sort of patient-based need and not performed automatically." Yes, trick questions still show up on exams.

Newsletter

Want more insights like this? Subscribe to Optometry Times and get clinical pearls and practice tips delivered straight to your inbox.

Recent Videos
Jessilin Quint, OD, MBA, FAAO, outlines her AOA's Optometry's Meeting 2025 presentation on nutrition and its impact on ocular health.
Carolyn Majcher, OD, FAAO, detailed a talk she gave alongside Mary Beth Yackey, OD, at Optometry's Meeting 2025.
Shelby Brogdon, OD, details opportunities for practices to answer the patient's concerns from the chair before they hit the internet for their contact lens needs.
Christi Closson, OD, FAAO, shares her excitement for the new Acuvue Oasys MAX 1-Day multifocal for astigmatism
Karen R. Hoffman, OD, shares how customizable scleral lenses can transform vision for patients with complex corneas, achieving 20/20 outcomes and enhanced comfort.
Janna Pham, OD, shares key takeaways from a corneal tomography session she presented alongside Travis Pfeifer, OD; and Matthew McGee, OD.
Jacob Lang, OD, FAAO, details early symptom relief demonstrated in as early as day 1 during AOA's Optometry's Meeting 2025.
When Langis Michaud, OD, MSc, FAAO, FSLS, FBCLA, FEAOO, began fitting scleral lenses 20 years ago, there was limited knowledge about conjunctival characteristics, scleral shape, and lens behavior.
Ioussifova details what sets Johnson & Johnson's new lens apart from the rest, which was launched at the American Optometric Association's Optometry's Meeting 2025.
Alongside Rachel Steele, OD, Rafieetary outlines what to look for in blurred disc margins and the importance of acting fast and sending patients to the ED when needed.
© 2025 MJH Life Sciences

All rights reserved.