The Value of Expanded CLIA-Waived Point of Care Testing
Improved patient access to testing. Certificate of Waiver (“CoW”) clinical laboratories – physician office labs, health clinics, and other facilities at the point-of-care that run only CLIA-waived tests – comprise nearly 70% of clinical laboratories in the U.S. Increasing the number of available, innovative CLIA-waived tests could greatly expand access to beneficial point-of-care diagnostic testing (“POCT”) by opening up a wide range of new testing options for patients at CoWs labs. Just imagine the potential benefits that could come from expanded POCT that aids in diagnosis and treatment of infectious disease, heart damage, stroke, and other conditions, both serious and mild. More options at CoWs translates to more access to beneficial POCT for patients.
Access to healthcare, including diagnostic testing, is a significant issue for many Americans who –
For these people, making even one trip to see a medical professional can be difficult, which makes it important to get the most out of each visit. Increased CLIA-waived POCT adds patient value to each visit by offering healthcare providers access to near-immediate tests results that can aid in-office diagnosis and development of treatment plans when a patient is in the exam room. If a medical provider needs to send out samples for analysis, this not only can delay diagnosis and treatment – it adds more steps to the healthcare process, increasing the probability that a patient is lost to follow-up and doesn’t receive the best possible care (see figure, below).
Improving Access to Point of Care Testing through Sound Science & Regulatory Reform
Coalition for CLIA Waiver Reform
For any given patient, diagnosis and initiation of treatment in the physician’s office or clinic could lead to better management of serious illness, or catch illnesses earlier allowing for better treatment or preventive care to prevent small problems from becoming large ones.