How to run a laboratory: CLIA-waived office-based lab requirements

As the transition from fee-for-service healthcare to outcomes-based medicine accelerates, many physicians are assessing their practices from a population management standpoint. They’re concluding that offering point-of-care (POC) testing right at their practice can help to drive better outcomes.

For example, many medical practices are now taking a population-based approach with patients who have diabetes or take warfarin. This includes adding office-based programs and policies beyond the standard physician visit that support improved outcomes for these groups of patients. These changes include requiring increased monitoring of blood glucose or INR levels.

But if you ask patients to take a more active role in their own care via increased testing, won’t that adversely affect patient satisfaction? On the contrary, physician office lab testing supports improved patient satisfaction, an important performance metric in today’s value-based care environment. 1 , 2

You may also find that providing POC testing in your office supports increased operational efficiency. With results in hand sooner, you can move on to diagnosis and treatment promptly. This helps to encourage better patient compliance and, ultimately, better health outcomes. Managed appropriately, testing can also serve as an additional revenue stream for the practice.

Know your practice, know your goals

Once you’ve determined that offering physician office lab testing in your practice would help you improve the quality of care your patients receive, you’ll need to start digging more into the logistics and requirements of your potential point-of-care (POC) testing venture.

Your answers to the following questions can help you determine the financial feasibility and optimal approach when implementing a new laboratory:

Your answers to these questions can guide your path through learning about the regulatory and staffing requirements of running your own lab.

Further Reading

CLIA 101: Answers to your most common questions about CLIA-waived tests