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 –

  • Do not live close to health care providers (a significant issue in rural communities).
  • Lack the transportation they need to make trips for medical care, and hesitate or are unable to ask friends and family for assistance; this is an especially prevalent state of affairs for more vulnerable populations, such as seniors. 
  • Are economically disadvantaged, and rely heavily on health clinics for healthcare.
  • Are simply overwhelmed by the day-to-day struggles of work, family, and life, and do not seek or follow-up on healthcare visits as they deal with what they consider to be more pressing priorities at the time.

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

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.

  • Improved clinical outcomes. Reduced time from testing to treatment has the potential to get patients better faster, and help ensure patients are not lost to follow-up.
  • Improved health economics. There are many factors that go into evaluating the health economics of diagnostics, but there is considerable evidence suggesting that in many different arenas, point-of-care testing can reduce healthcare costs versus reference lab testing.
  • Improved healthcare operations. Even the best hospital in the U.S. has limits to the number of patients it can provide care to at any given time. Managing hospital resources, whether measured in beds, physician time, or some other metric matters to patients and payors. POCT can help improve the follow of patients by making each visit more efficient and eliminating unnecessary follow-up appointments.
  • Staging patients for emergency treatment. May patients with symptoms will present first at a primary care facility. Even if clinical symptoms alone suggest rushing to the ER, additional POCT diagnostic information can give providers and emergency personnel information they can use prior to hospital admission, and potentially mitigate the damage being caused by a significant event that requires immediate attention.
  • Therapeutic development. POCT can be extremely valuable in clinical trials, by improving subject recruitment and the ability assess subject health. Janet Woodcock, Director, Center for Drug Evaluation and Research recently noted that an absence of point-of-care tests was hindering the development of new therapeutics for infectious diseases.