With connectivity, point-of-care testing is on the front line when it comes to diagnosing and managing chronic diseases

By Peter Koerte, PhD

Across the globe, studies of healthcare delivery systems have led researchers to the inescapable realization that fragmented patient care is not a sustainable way to manage patient health in the face of growing economic pressures.1 The United States, for example, spends more on healthcare than any other high-income nation, yet it is well known that Americans have a lower life expectancy and graver health outcomes than residents of many other countries. Such disparities can be attributed, in part, to the failure of encounter-based medicine to meet the growing demands of a population that is heavily afflicted with chronic disease.2

In response to such trends, healthcare delivery systems in the United States and elsewhere are in the midst of a fundamental shift toward patient-centered care, while at the same time making use of a growing body of patient data to devise improved methods of managing population health. At the heart of both movements is an increasing willingness to use patient satisfaction and quality of care as the key performance indicators that define the success of both healthcare delivery systems and individual providers.

Peter Koerte, PhD, Siemens Healthineers.

Peter Koerte, PhD, Siemens Healthineers.

The importance of such new metrics doesn’t stop with hospitals and doctors. The payor community has also taken to patient-centered measurements to provide a foundation for the development of value-based reimbursement systems that effectively determine how—and how much—healthcare providers will be paid for their services.

Taken together, all of these transitions in the healthcare sector trend in the direction of organizing delivery systems so that they can provide care for the whole patient rather than merely offering treatments during symptomatic episodes. In the realm of clinical diagnostics, such market trends are blazing the path toward increased implementation of point-of-care (POC) testing—a field that embraces both technologies and testing strategies designed to provide faster test results and enable quicker clinical decisions.3

POC testing makes it possible for clinicians to obtain quantitative observations of patient status in a manner that complements central lab testing, but with greater frequency and convenience, and often at significantly lower cost when the overall costs of care are considered. When the results of POC testing are organized into a longitudinal record, it becomes possible for clinicians to discover trends and patterns that can be difficult to appreciate from a single encounter. In the context of emerging patient-centered and value-based delivery systems, it is understandable that clinicians would lean favorably toward POC testing methods that can improve both patient satisfaction and quality of care by providing more immediate results for chronic, critical, and infectious diseases—all of which benefit from quicker decisionmaking.4

A key element that will be needed if healthcare delivery systems are to unlock the full potential of POC testing, however, is connectivity. POC testing can be widely deployed and geographically dispersed, and is readily capable of revealing actionable data applicable to a specific patient. But to collect and analyze such data on a scale that can be applied to an entire served population requires more than just localized testing.

When POC testing is connected with automated data analysis systems, decision support tools can be created to foster earlier detection and intervention, helping to provide care in ways that are more convenient for the patient and physician, to improve population health outcomes, and to lower costs—the so-called ‘triple aim’ defined by the Institute for Healthcare Improvement.5

POC Testing in Perspective

It can be challenging to define precisely what is meant by the term ‘point-of-care testing.’ The technologies and clinical applications encompassed by the field continue to expand, and both the regulatory requirements and list of individuals permitted to conduct POC testing are undergoing constant change.6 This article will focus on the segment of POC testing that includes diagnostic testing and therapeutic monitoring specific to chronic conditions, as conducted by trained healthcare professionals outside the central laboratory. Concentrating on this segment will permit discussion of accountability for the implementation of POC testing in healthcare environments outside of, but overseen by, the central laboratory.

In their quest to offer more immediate test results, clinicians may not always understand or appreciate the importance of defined testing protocols and quality controls for the operation of a clinical laboratory. However, clinical laboratorians do understand the importance of these factors, which are essential for ensuring that each patient’s reported test results are correct and accurate the first time, and every time. The need to provide such unfailing accuracy may be one reason that POC test development is among the most active areas of the in vitro diagnostics industry. And there is more to come from POC test developers, as technological capabilities are continuing to advance at a pace that is way ahead of the rate at which new technologies are being adopted.7

Recent advances in POC testing connectivity may provide a way to break this logjam, by offering laboratories the capabilities needed to address accountability for POC testing, which is often perceived as a barrier to adoption.8,9 The latest advances in connectivity make it possible for central laboratories to grow their business by embracing POC testing, without sacrificing oversight of the key quality controls of importance for diagnostic decisionmaking and patient outcomes.

In most healthcare institutions, it is the central laboratory that is ultimately responsible and accountable for POC testing. Nevertheless, clinical laboratory managers frequently voice a common set of concerns that inhibit their overall interest in managing POC testing. Perceived barriers to implementing POC testing often include reticence to take responsibility for such factors as quality control, adequate staff training, and oversight for accreditation purposes.10

Such hesitancy on the part of laboratorians is understandable, as effective patient outcomes ultimately depend on quality diagnostic information, whether from a central laboratory or a POC testing site. Missed or incorrect diagnoses contribute to wasteful spending, and can also be costly to patients in terms of their health outcomes and quality of life. Since it is widely believed that diagnostic testing accounts for just 2% to 3% of healthcare costs, but drives nearly 70% of clinical decisionmaking, there is a significant responsibility on laboratorians and POC testing operators to deliver quality results.11

Figure 1. The challenges of POC testing.

Figure 1. The challenges of POC testing.

Such pressures on POC coordinators arise from the most basic challenge that connectivity aims to address: the need to connect POC testing instruments to a single user interface in order to provide more effective oversight. A typical healthcare organization may encompass dozens of POC testing sites and departments, together housing hundreds of instruments operated by thousands of clinicians (see Figure 1).

Meanwhile, POC coordinators often reveal that they do not have access to even the most basic information about their own organizations—such as how many POC testing devices are within their health system. In part the result of ongoing hospital and health system consolidation, the challenge of keeping track of an organization’s widely dispersed POC devices is expected to continue, as analysts and hospital associations do not foresee any slowing of consolidation in the near future.12

Overcoming Barriers to POC Testing

To overcome the barriers to implementing POC testing, hospital administrators are focusing their attention on the connectivity capabilities that make it possible for POC testing sites to contribute to the growing realm of informatics—the process of turning data into useful information. Connectivity features can help POC coordinators address a wide range of practical considerations involved in managing a POC testing site, while informatics can help to deepen a health system’s abilities to improve patient care. Together, connectivity and informatics are critically important for the long-term success of a POC testing program.

Despite the fundamental importance of connectivity as a feature of POC instruments, purchasers often fail to confirm that the systems they are putting in place can in fact connect with one another. With many POC instruments on the market from a variety of vendors, it is not uncommon for different departments within an institution—or even different POC testing sites within the same department—to purchase different types or brands of instruments that cannot readily communicate with one another. Such unintended outcomes are often the result of uncoordinated purchasing among units that are merely trying to meet their specific testing demands within predetermined budget limitations.

When it comes to selecting and implementing instruments for a testing site, POC coordinators occupy an important position with significant responsibilities. POC devices from different manufacturers usually have unique user interfaces that may be specific to that brand, or even to the individual instrument. While such devices may have similar capabilities and feature sets, they rarely share the same look, feel, or approach to operations.

Figure 2. Connectivity is fundamentally important to the success of a POC testing program.

Figure 2. Connectivity is fundamentally important to the success of a POC testing program.

POC coordinators must be trained to recognize and use the different software interfaces of all POC devices belonging to an institution—even when the institution has a large variety of such instruments. They must understand each instrument’s functionality and limitations. They must manage the instruments’ quality control, usage, and inventory. And they must ensure that their system’s security vulnerabilities are continually addressed by performing software updates on a regular basis. With all of these tasks to manage, it is understandable that the key concerns of POC coordinators are quality control, adequate staff training, and oversight to support accreditation (see Figure 2).

To arm POC coordinators with the tools necessary to carry out such oversight and reporting responsibilities, manufacturers of POC systems are introducing capabilities that give central laboratories greater control over the factors most applicable to their levels of oversight (see Table 1). For instance, it is easier for POC coordinators to maintain their institution’s instruments—and to oversee the operators performing POC testing—when the data from every instrument is connected to a single user interface. Open connectivity solutions enable POC coordinators to connect instruments from several manufacturers to their existing information technology (IT) networks, and also provide the option to automatically validate and transfer patient results to electronic medical records.

Further, by leveraging built-in informatics capabilities, POC coordinators can make meaningful use of system information to improve efficiencies and positively affect the POC testing program. Using reports derived from the data captured by each POC instrument, for instance, coordinators can review workload analytics to determine overall testing demand, to assess whether a particular analyzer is underutilized, to identify performance issues for a particular analyzer, or to take steps for better inventory control.

Once equipped with open connectivity and an informatics solution, POC coordinators can rest assured they have the tools necessary to address common quality concerns. Further, with access to data collected at the front line of patients’ healthcare journey, the idea of the central laboratory becoming a resource to help address population health challenges becomes less abstract.

Rethinking Disease Diagnosis and Management

Industrywide adoption of fee-for-value payment models may lie in the near future for the US healthcare delivery system. By 2018, the US Department of Health and Human Services intends to have linked 90% of Medicare reimbursement to value-based payment models that incentivize the management of population health. In addition, a number of commercial payors have developed contracts that similarly reward healthcare providers for delivering high-value care rather than a high volume of services.13

Table 1. How connectivity is addressing common POC testing challenges. Click to expand.

Table 1. How connectivity is addressing common POC testing challenges. Click to expand.

Population health goals can be addressed at any point in the healthcare continuum. To achieve the greatest success at improving the health of both individuals and the population as a whole, however, it is generally best to engage as early in the disease process as possible, by stratifying the population according to their level of risk for disease. The next step is to leverage low-cost, convenient, early detection methodologies to support the earliest possible intervention—a practice that is generally associated with lower costs and better outcomes.

Using the connectivity of POC systems to collect, organize, and leverage available information is a key enabler for improving the health of a defined population.

In line with such population health goals, healthcare delivery systems are looking for innovative methods of care delivery and shifting their approach toward patient-centered programs designed to prevent and address the most common and costly conditions affecting the nation. According to the US Centers for Disease Control and Prevention, the US population is undergoing a major shift in the leading causes of death, with decreasing incidence of infectious diseases and acute illnesses, and increasing incidence of chronic diseases and degenerative illnesses.14 Treatment of patients with chronic conditions now accounts for 86% of the nation’s healthcare budget.15

Additionally, it is anticipated that by 2030 older adults will account for 20% of the US population.3 Two out of three older Americans are afflicted with chronic conditions such as diabetes or heart disease, which are costly to treat. Thus, the anticipated influx of older Americans entering the Medicare system will result in a greater need for patient care for those suffering from chronic conditions.

While the increasing rate of chronic disease represents a critical need for patient care in the short term, the health system costs associated with such diseases are considered preventable. Such diseases are often attributed to risk factors associated with lifestyle choices such as smoking, excessive drinking, or other risky health behaviors.16 In the long term, POC testing that results in earlier intervention may reduce the incidence of chronic diseases as well as the costs associated with treating them.

POC Testing Effects on Patient Care

POC testing is becoming increasingly available to patients by way of nontraditional testing sites such as pharmacies and physicians’ offices, making POC testing one of the fastest areas of growth in the medical field.17 For central laboratories that manage the operations of nontraditional testing sites, such rapid growth offers a unique opportunity to expand the clinical offerings and testing capabilities of the laboratory while leveraging laboratorians’ skilled expertise to add value to the health system and to patient care.

The increasing number of POC testing sites makes it feasible for healthcare providers to serve patients more efficiently, diagnosing and monitoring chronic conditions before they become critical. These capabilities can also help healthcare providers to overcome some of the key barriers that have previously made it difficult to serve certain populations.

Among aging populations, for instance, a major barrier to patient care is health literacy—ensuring that patients understand the health information provided to them so that they can make appropriate decisions pertaining to their care plan.18 Central laboratory testing does not always provide a convenient process to ensure that patients with chronic conditions receive the information they need. Not only do such patients need to travel to the laboratory for testing—often on a regular basis so that they can be monitored—they must also return to their physician’s office to discuss their care plan or receive follow-up care.2

By contrast, a number of studies have demonstrated that POC testing can benefit patients with chronic conditions such as diabetes who are at risk for cardiovascular diseases. Among such patients, POC testing has been shown to bring about a reduction in HbA1c levels as a result of the testing, medication changes, and patient education that can take place during a single visit.19–22 Other studies of POC testing have also demonstrated improved HbA1c outcomes that are presumed to result from more informed consultation with a healthcare provider.3,19,23

Initial evidence about the relationship between POC testing and patient satisfaction has been positive. In one study, patients managed by general practitioners for diabetes, hyperlipidemia, or anticoagulant therapy expressed overall satisfaction with POC testing, including the process of collecting blood samples, and viewed POC testing as strengthening the relationship with their general practitioner.24 In another study comparing physician office POC testing with past visits that did not offer onsite testing, patients ranked the overall level of satisfaction with their office visit a 3.96 out of 4.25

With the emergence of value-based reimbursement plans that have adopted patient satisfaction and quality of care as key performance indicators, it is logical that the capability of providing quicker test results and care decisions would be attractive reasons for adopting POC testing. As patients gain exposure to such capabilities in a variety of POC testing sites, they will likely come to expect the same level of turnaround time for all of their test results, thereby creating even greater demand for POC testing.6


Growth in demand for POC testing is on the horizon. The latest POC systems are armed with connectivity infrastructure and informatics solutions designed especially for organizing and analyzing POC data. Such analytics can assist in the development of clinical decision support tools for identifying at-risk patients early in the disease process. But central laboratories are still best positioned to oversee POC programs, and to leverage their expertise to ensure quality results.

Recent advances in POC testing connectivity offer capabilities for addressing the issue of accountability, which is often perceived to be a barrier to the adoption of POC testing. Making use of these capabilities, central laboratories no longer have to sacrifice their oversight of quality controls in POC testing sites.

Through data collection on the front line of patient care, central laboratories in close collaboration with physicians can continue to add value by leveraging their expertise with sophisticated informatics to identify as early as possible those patients in the population who are at risk or in need of health intervention. POC testing contributes to this process, enabling the medical community to most appropriately allocate its resources in order to improve outcomes and reduce overall costs.

Peter Koerte, PhD, is president of the point-of-care diagnostics business area at Siemens Healthineers, Norwood, Mass. For further information, contact CLP chief editor Steve Halasey via [email protected].


  1. St John A, Price CP. Existing and emerging technologies for point-of-care testing. Clin Biochem Rev. 2014;35(3):155–167.
  1. Squires D, Anderson C. US Health Care from a Global Perspective: Spending, Use of Services, Prices, and Health in 13 Countries [online]. New York City: The Commonwealth Fund, 2015. Available at: www.commonwealthfund.org/publications/issue-briefs/2015/oct/us-health-care-from-a-global-perspective. Accessed August 8, 2017.
  1. St John A. The evidence to support point-of-care testing. Clin Biochem Rev. 2010;31(3):111–119.
  1. The hospital readmissions reduction (HRR) program [online]. Baltimore: Centers for Medicare & Medicaid Services, 2015. Available at: www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/hrrp/hospital-readmission-reduction-program.html. Accessed August 8, 2017.
  1. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood). 2008;27(3):759–769; doi: 10.1377/hlthaff.27.3.759.
  1. Camacho-Ryan O. Monitoring point-of-care testing compliance. Clinical Laboratory News (February 1, 2016). Available at: www.aacc.org/publications/cln/articles/2016/february/monitoring-point-of-care-testing-compliance. Accessed August 8, 2017.
  1. Malone B. Spotlight on point-of-care testing [online]. Clinical Laboratory News (October 1, 2012). Available at: www.aacc.org/publications/cln/articles/2012/october/point-of-care-testing. Accessed August 8, 2017.
  1. Siemens Healthineers acquires Conworx Technology GmbH to deliver open connectivity for 100+ point-of-care instruments [press release online]. Tarrytown, NY: Siemens Healthineers, 2016. Available at: https://usa.healthcare.siemens.com/press/pressreleases/healthcare-news-2016-11-07-2. Accessed August 8, 2017.
  1. New Siemens RapidComm System release delivers workflow innovation for point of care [press release online]. Tarrytown, NY: Siemens Healthcare, 2014. Available at: www.siemens.com/press/en/pressrelease/?press=/en/pressrelease/2014/healthcare/diagnostics/hdx201403020.htm&content[]=hdx&content[]=h&content[]=hc&content[]=hcdx. Accessed August 8, 2017.
  1. Shaw JLV. Practical challenges related to point of care testing. Pract Lab Med. 2016;4:22–29; doi: 10.1016/j.plabm.2015.12.002.
  1. Rohr UP, Binder C, Dieterle T, et al. The value of in vitro diagnostic testing in medical practice: a status report. PLoS One. 2016;11(3):e0149856; doi:10.1371/journal.pone.0149856.
  1. Health Care 2020, Part 4: Consolidation. Westchester, Ill: Healthcare Financial Management Association, 2016. Available at: www.hfma.org/healthcare2020. Accessed August 8, 2017.
  1. Better, smarter, healthier: in historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value [press release online]. Washington, DC: Department of Health and Human Services, 2015. Available at: https://wayback.archive-it.org/3926/20170127185400/https://www.hhs.gov/about/news/2015/01/26/better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html. Accessed August 8, 2017.
  1. The State of Aging and Health in America 2013. Atlanta: Centers for Disease Control and Prevention, 2013. Available at: www.cdc.gov/aging/pdf/state-aging-health-in-america-2013.pdf. Accessed August 8, 2017.
  1. Chronic disease overview [online]. Atlanta: Centers for Disease Control and Prevention, 2017. Available at: www.cdc.gov/chronicdisease/overview/index.htm. Accessed August 10, 2017.
  1. The four domains of chronic disease prevention [online]. Atlanta: Centers for Disease Control and Prevention, 2015. Available at: www.cdc.gov/chronicdisease/resources/publications/four-domains.htm. Accessed August 8, 2017.
  1. Wagner EA, Yasin B, Yuan S. Point-of-care testing: twenty years’ experience. Lab Med. 2008;39(9):560–563; doi: 10.1309/9r9y0v68y3ba0kdn.
  1. Koh HK, Berwick DM, Clancy CM, Baur C, Brach C, Harris LM, Zerhusen EG. New federal policy initiatives to boost health literacy can help the nation move beyond the cycle of costly ‘crisis care.’ Health Aff (Millwood). 2012;31(2):434–443; doi:10.1377/hlthaff.2011.1169.
  1. Eeg-Olofsson K, Eliasson B, Zethelius B, Svensson AM, Gudbjörnsdottir S, Cederholm J. HbA1c reduction and risk of cardiovascular diseases in type 2 diabetes: an observational study from the Swedish NDR [online abstract 415-P of poster presented at the 2012 annual meeting of the American Diabetes Association]. Available at: www.abstractsonline.com/plan/viewabstract.aspx?skey=465c09cc-e66a-403c-a619-0f648526bd73&ckey=89a308da-61f7-4ed8-82ef-a5a7168ff33a&mkey=0f70410f-8df3-49f5-a63d-3165359f5371. Accessed August 8, 2017.
  1. Grieve R, Beech R, Vincent J, Mazurkiewcz J. Near patient testing in diabetes clinics: appraising the costs and outcomes. Health Technol Assess. 1999;3(15):1–74.
  1. Petersen JR, Finley JB, Okorodudu AO, Mohammad AA, Grady JJ, Bajaj M. Effect of point-of-care on maintenance of glycemic control as measured by A1c. Diabetes Care. 2007;30(3):713–715; doi: 10.2337/dc06-1909.
  1. Ferenczi A, Reddy K, Lorber DL. Effect of immediate hemoglobin A1c results on treatment decisions in office practice. Endocr Pract. 2001;7(2):85–88; doi: 10.4158/ep.7.2.85.
  1. Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care. 1999;22(11):1785–1789.
  1. Laurence CO, Gialamas A, Bubner T, et al. Patient satisfaction with point-of-care testing in general practice. Br J Gen Pract. 2010;60(572):e98–e104; doi: 10.3399/bjgp10x483508.
  1. Crocker B, Lewandrowski EL, Lewandrowski N, Gregory K, Lewandrowski K. Patient satisfaction with point-of-care laboratory testing: report of a quality improvement program in an ambulatory practice of an academic medical center. Clin Chim Acta. 2013;424:8–11; doi: 10.1016/j.cca.2013.04.025.