Template:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Final thoughts and additional resources/Final thoughts

5. Final thoughts and additional resources

5.1 Final thoughts

The physician office laboratory (POL) has come a long way since its humble origins in the 1800s, using urinalysis to diagnose patient afflictions. The modern POL has a wider range of testing options thanks to evolutions in technologies such as molecular diagnostics. Yet they are also more regulated today (at least in the U.S.) than their ancestors, with the likes of the Clinical Laboratory Improvement Amendments (CLIA) framing test complexity and the requirements that come with each level of complexity. Laboratory testing is not all that is regulated either, with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) dictating how data and other information generated from testing must be protected. Add to that concerns about ensuring financial reimbursement for testing, maintaining competent staff, implementing and reviewing standardized procedures, tracking specimens, and reporting results in a timely and accurate fashion; this can leave the enterprising physician office doubting whether a POL is worth the effort.

However, the promise of caring for a patient's needs at or near the point of care—and the benefits that come with that—remains strong. Yes, pharmacy laboratories have increasingly sprung up in the last 10 years, taking away some of the momentum of the POL, but the physician isn't found at the pharmacy. Patients will continue to visit their physician, and many will continue to get value from having some level of laboratory testing at the physician office. This is usually represented by a set of specific tests that lend themselves well to being conducted relatively easily and interpreted rapidly. Types of urinalysis, blood analysis, clinical chemistry, and immunological analysis—particularly those that are CLIA-waived—are most likely to be employed in the POL for a number of conditions, diseases, or analytes, including pregnancy, cholesterol, thyroid-stimulating hormone, and mononucleosis.

This testing requires thoughtful workflow preparation and management that takes into account not only the order of operations but also the flow of information. Data and information management practices are important to the POL, and if their workload justifies it, the POL may require software solutions like laboratory information systems (LIS) and electronic health records (EHRs). However, implementing such systems isn't necessarily straightforward, requiring additional considerations about budget and usefulness. Decisions on such software implementations, as well as the testing the lab conducts and how it's conducted, requires knowledgeable personnel who have been trained in information systems and testing protocols. How the laboratory is classified with CLIA will determine whether or not a laboratory manager is a hard requirement; however, in all cases someone should be taking the lead on POL operations. Are processes and procedures properly documented? Is there a quality management process in the POL? Does the lab participate in proficiency testing? These and other aspects of the POL must be addressed, regardless of the POL's CLIA classification.

In the end, a POL still serves an important role within the sphere of clinical laboratory testing. As molecular testing options continue to expand to the point of care, the POL will likely see additional opportunities to expand its test menu. This was seen with the emergence of the COVID-19 pandemic and the demand for rapid molecular testing that came with it, which made clear that a quick diagnosis at the physician's office, among other locations, is valuable to patient management and treatment. But the POL's continued utility and success will largely hinge upon effective setup and management, which in turn requires knowledgeable and motivated people to ensure the POL's long-term success.