CLIA WAIVED TESTING During the ’90s, new federal rules made many physicians think twice about starting in-office labs. But doctors have grown less intimidated by the rules, and today, in-office labs are quickly becoming an indispensable feature of many physician practices. The biggest increase is among “waived” labs, which perform easy-to-administer, fairly low-risk tests: ovulation, blood glucose, dipstick or tablet reagent urinalyses, rapid strep tests, and the like. Waived labs are attractive because they’re subject to only minimal requirements under CLIA, the Clinical Laboratory Improvement Amendments of 1988. But doctors are also establishing labs that do more complex testing like CBCs, PSAs, routine chemistry panels, and antibiotics susceptibility tests. These moderate- to high-complexity labs must adhere to a stricter set of federal requirements, including routine inspections. Based on the typical average number of tests run in an office who usually runs these test, operating a CLIA waived lab in your office could be very profitable: Machine Increased Profit Per Year DCA Vantage $12,595 INratio2 PT/IR $23,088 Coaguchek XS Coming Soon Cardiochek P-A $12,698 Multistix Pro $44,706 BD Veritor Coming Soon AimStrip Coming Soon What Do CLIA Waived Tests Mean? There are some kinds of lab tests that are considered to be CLIA waived. When a test is CLIA waived, it means that the test itself is so simple and accurate in itself that it is impossible to produce incorrect results in conducting them. A test can also be CLIA waived if it is proven that it does not do any harm to the human body. In addition, a test becomes automatically CLIA waived if the Food and Drug Authority has approved its use at home. The specific tests that are deemed to be CLIA waived are: 1. Non-automated urinalysis using dipstick or tablet reagents 2. Ovulation tests 3. Urine pregnancy tests 4. Fecal occult blood 5. Hemoglobin-copper sulfate 6. Erythrocyte sedimentation rate 7. Blood glucose monitoring utilizing devices specifically for home use 8. Spun microhematocrit 9. Hemoglobin testing done through devices with self-contained features and which give readout results via direct measurement Laboratories that give CLIA waived tests have to renew their certification every two years and they have to conduct their tests in a controlled environment. The CMS (Centers for Medicare and Medicaid Services) does not conduct inspections of laboratories that offer CLIA waived testing except in case of complaints. To learn more about how to get a CLIA waived Certificate, go to https://www.cms.gov/clia/ and click on “How to Apply for a CLIA Certificate“ WHY VESSEL We recognize the needs of the individual and offer a vast collection of medical supplies to the average consumer to deal with their unique medical needs. CONTACT 6000A-1 Pelham Rd Greenville, SC info@vesselmedical.com For media inquiries, please contact Kristina Loughrey, KLoughrey@divmedinc.com. Download Brand Guidelines here. 1-866-451-6337 1-800-207-6946 info@vesselmedical.com Mon. - Fri. 8AM - 5PM EST RECENT POSTS 4 Ways to Prepare Your Practice for the Upcoming Flu Season August 30, 2021 What You Need to Know About the 2021-2022 Upcoming Flu Season July 29, 2021 Vessel Medical Introduces Lab in a Box: Cutting Edge All-in-one Equipment That Can Turn a 600 Sqft Room into a COVID-19 Testing Lab October 27, 2020 © 2021 Copyright Vessel Medical | All rights reserved August 30, 2021 What You Need to Know About the 2021-2022 Upcoming Flu Season July 29, 2021 Vessel Medical Introduces Lab in a Box: Cutting Edge All-in-one Equipment That Can Turn a 600 Sqft Room into a COVID-19 Testing Lab October 27, 2020 CATEGORIES A more Efficient Practice Allergy Allergy Shots BR Video System Burdick ECG Chemistry CLIA Waived Current Trends Diabetes Enovachem Injection Kits Equipment exercise Flu Flu Season General Medical Supplies Generate More Revenue Hematology Immunoasay In-House Lab Integra Miltex Lab Lifestyle Lung Diseases Monthly Specials NDD News Nikomed Others Overstock Flu Vaccine People Post Profitable Lab Running a Efficient Practice Sport Uncategorized WordPress zika virus META Log in Entries feed Comments feed WordPress.org