The Ever-evolving POC Diagnosis Space

The Ever-evolving POC Diagnosis Space

By Edmunds Reineks , Medical Director/Section Head, Point of Care Testing, Cleveland Clinic

Edmunds Reineks , Medical Director/Section Head, Point of Care Testing, Cleveland Clinic

Edmunds Reineks has the experience of leading several high volume, critical clinical testing operations, including directing the Cleveland Clinic’s automated chemistry core laboratory and enterprise point of care testing program. A former former U.S. Navy officer and nuclear engineer, Mr. Reineks holds the esteemed position as a CLIA laboratory director, PhD scientist in pharmacology. He is a key consultant in development of diagnostic tests and devices, quality & compliance, data mining/ utilization, and diverse, highly-regulated, critical operations for many companies.

Edmund Reineks, an extremely seasoned and successful professional, exclusively talks to HealthcareTech Outlook for a special edition of Patient Engagement.

In the light of your experience what are the trends and challenges you’ve witnessed happening with respect to the Point of Care (POC) Diagnosis space?

Every year, there is more POC testing in more environments. In some respects, I attribute this growth to unrecognized negative externalities that shift the cost-benefit curve in the direction of more consumption. Care providers in the clinic are often unaware of the drawbacks associated with POC testing, which can include higher analytic cost per test, organizational compliance risks, and (sometimes) lower quality test results. However, the clinical team is usually aware of and primarily focused on the benefits, which typically include gains in workflow efficiency, improved patient satisfaction, and greater clinician control in providing care. Manufacturers of POC testing devices are working to reduce some of the drawbacks (competing on pricing for consumables, and improving the robustness of the testing process), and this is a contributing factor to the growth. But the regulatory environment that applies to healthcare organizations that perform patient testing is increasingly burdensome.

Could you elaborate on some interesting and impactful project/initiatives that you’re currently overseeing?

We have spent almost 18 months in the implementation phase of a middleware connectivity solution for a spectrum of POC devices which span our healthcare system. This allows POC testing devices to be connected to important clinical systems, primarily the electronic health record and our ADT (admission/discharge/ transfer) system. Overall, the project has taken much longer than 18 months; it has been almost three years since we first vetted the idea, researched the paths to acquisition and implementation, obtained strategic internal funding, and identified a vendor through an RFI/RFP mechanism. The POC management team has benefitted from our improved monitoring and workflow. Dozens of POC testing locations, such as emergency departments and ICUs, are no longer manually entering patient test results (reducing errors and speeding their processes), results quickly reach patient charts, and the POC management team has insight into near real time testing trends and issues. We have dispensed with our previous hodge-podge of middleware systems. We have modernized and standardized our processes, and improved compliance and quality through effective deployment and management of our new middleware system.

Another recent example was implementation of POC Hemoglobin A1c (HgbA1c) testing in primary care settings. Clinical champions saw POC HgbA1c testing as a mechanism to achieve Accountable Care Organization (ACO) goals for managing patients with diabetes. Patients who were non-compliant with testing for monitoring (i.e. not going to the lab for a blood draw), could be tested right in the office when POC HgbA1c became available. But the analytical costs per HgbA1c test are almost 10- fold higher for a POC HgbA1c vs. a lab-based HgbA1c, without a reimbursement difference. We are gathering data to determine if the expected improvements in diabetes management outcomes are being realized; the results of that analysis will contribute to any decisions about continuation or expansion of this testing program. This example is a small slice of Population Health Analytics that will be taking place in the next few years.

What are some of the points of discussion that go on in your leadership panel? What are the strategic points that you go by to steer the company forward?

A guiding principle in most decisions is prioritizing the needs of patients. But there can be disagreement about how to best meet those needs. From the perspective of our POC program, it is not our goal to expand our footprint – we are critical of new requests for testing, because most clinical areas are unaware of the compliance challenges in following CLIA (Clinical Laboratory Improvement Amendments) law and maintaining accreditation. But physician champions in many clinical settings often provide insight and can make a compelling case for adding POC tests to their services, so we continue to grow.

Can you draw an analogy between your personality traits, hobbies and how they reflect on your leadership strategy?

My leadership strategy is most influenced by my first career as an engineering division officer in the US Navy. My ship was nuclear powered, so we had very little room for error in our operations. In general, the leadership experience I gained as a commissioned officer in the Navy emphasized attention to detail and an understanding of responsibility and authority. Working in the nuclear field reinforced those principles, but also contributed to my understanding of critical operations, safety and quality. “Expect what you inspect,” a motto that was drilled into me as a junior officer, has applicability in a wide range of settings, far beyond the military. The routine of doing a job right because it is important, documenting your processes, and remaining inspection ready, applies in healthcare as much as it did in the military. The well-being of others is at stake, and there is little tolerance for sloppiness, ignorance, or inattentiveness. And though I got an early start on developing leadership skills in the service, I can’t claim that I mastered those skills as a junior military officer; leadership, much like medicine, must be practiced. Mastery may be more an aspiration than an accomplishment.

How do you see the evolution of the Point of Care Diagnosis arena a few years from now with regard to some of its potential disruptions and transformations?

“At home self-testing” has grown and this trend will likely continue, with improvements in the robustness of testing platforms, reduced costs of at-home POC testing, and better connectivity with decision support and notification systems. Although patients with diabetes have been self-testing at home for many years, this practice will likely expand into other areas of chronic disease management with the availability of new tools and improvements in convenience.

What would be the single piece of advice that you could impart to a fellow or aspiring professional in your field, looking to embark on a similar venture or professional journey along the lines of your service and area of expertise?

The practice of medicine and delivery of healthcare in the US are constantly evolving. People entering a field that contributes to diagnostic processes (mainly pathology and radiology) should develop a broad skillset, continually educate themselves and remain adaptable. While some diagnostics practitioners are anxious about competition from technologies such as artificial intelligence, it is likely that as more information becomes available about a patient and their condition, integration of all this new information will require even more input from experts to provide meaningful information to front-line care providers and their patients. Getting actionable information to the right place at the right time will remain a complex challenge in healthcare that diagnostics experts will have to address.

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