The skillset of laboratory professionals is well-suited to help POC testing improve patient outcomes
By Kim Futrell, MT(ASCP), MSHI
Throughout the United States, healthcare organizations have taken to heart the departure from fee-for-service medicine in favor of a shift to policies and practices that support a value-based and patient-centered approach to healthcare. For laboratorians and others with a focus on patient diagnosis and monitoring, this ongoing trend is also changing the way that patient testing is viewed—and especially the way that healthcare providers view testing performed at the point-of-care (POC).
Unquestionably, POC testing offers important advantages that can help to support value-based and patient-centered healthcare. But increasing demand for POC testing also calls for greater understanding of those benefits—as well as of the potential limitations that apply to POC methods.
Clinical laboratory professionals have the knowledge of laboratory testing needed to ensure that POC testing is implemented in the most opportune places, and that test results meet the quality standards of conventional laboratory testing. This article explores the role of laboratorians in guiding the development, selection, adoption, and use of POC diagnostics in the emerging context of a value-based, patient-centered healthcare system.
POC Testing in Value-Based Care
Both government and private payors are moving away from a system that reimburses healthcare expenses based on the volume of services delivered and toward a system in which payment is dependent on the quality of patient outcomes—value-based care. Such changes in the nation’s healthcare system are intended to improve access to care while also reducing the cost of care. This new paradigm is forcing healthcare organizations to redefine how they deliver patient care, and to consider how early and active care can support the prevention of disease and improve patient outcomes.
One of the reasons that POC testing is gaining in importance, in alignment with value-based goals, is that its rapid turnaround time allows for faster clinical decisionmaking that can improve patient outcomes and reduce overall spending. Better patient outcomes and reduced healthcare costs are key elements of value-based care. Particularly when staffing is limited, the fact that POC testing requires less infrastructure and offers immediate follow-up can lead to better patient outcomes.1
POC Testing and Patient Engagement
Advancing hand-in-hand with value-based care, patient-centered care requires healthcare professionals to take into account a patient’s opinions, beliefs, and life situation when designing their care plan. The ready availability of POC test results can help patients better understand their condition and lead to insights about how certain actions affect their health. While any intervention aimed at increasing a patient’s understanding and level of motivation positively influences patient attitudes, POC testing has been proven to improve both patient satisfaction and patient engagement.2,3
The ability of POC testing to speed up clinical decisionmaking and improve patient satisfaction and engagement makes it a good fit in value-based care settings. As healthcare organizations try to encourage patients to make decisions that improve their health and help them have a greater understanding of their health status, POC testing can be a tool that increases patient understanding and engagement.
Rethinking the Laboratory’s Role in POC Testing
The changing mindset of healthcare professionals in favor of exploring new paths for improving the nation’s healthcare system also presents an opportunity for laboratory professionals to reevaluate their role in value-based care. With greater utilization of POC testing a vital element of value-based care, laboratory professionals can play important roles by contributing their knowledge to POC testing implementation and oversight, helping to ensure that such testing contributes as much as possible to improving patient care.
In the past, laboratory professionals have sometimes avoided responsibility for managing POC testing programs—in part because of their inherent complexity, and in part because of the difficulty involved in controlling a large number of remote factors. Laboratorians may have paid a price for their lack of engagement in the field, as many have often complained that the profession does not get the respect it deserves, especially among healthcare administrators. Increased use of POC testing now opens the door for clinical laboratory scientists to partner with providers, together advancing POC testing to achieve its full potential in value-based care.
Not an Easy Undertaking
POC testing is a complex process with myriad challenges that make its implementation and oversight difficult. Since POC testing by definition takes place in many different settings and across many different health scenarios, laboratorians have not been wrong to judge that it would be difficult to control such a program from a central lab. Even the initial decisions about when and where a POC test should be implemented to improve patient outcomes and reduce downstream costs can be difficult. Moreover, by itself, simply putting a POC test in place is often not enough. To ensure the effectiveness of a POC test, it may be necessary to implement workflow or operational changes that will ensure the accuracy of test results and see that immediate action is taken based on such results.4
In addition, because POC testing is typically more expensive than the same test performed in a core lab, the cost benefits of POC testing sometimes become apparent only when they are evaluated across an patient episode, rather than by comparing the costs of the tests alone. Many studies have demonstrated the economic advantage of POC testing when patient outcomes are considered rather than only initial costs.5
In a large healthcare organization, POC testing typically involves scores of remote testing locations, hundreds of disparate devices with varying capabilities, and potentially thousands of diverse end-users who do not have a laboratory background (Figure 1). In such environments, ensuring the quality of testing and the competence of operators can be significant challenges.4 In fact, POC testing management has grown to a level of complexity that warrants a POC testing software integration and management solution.6
Lab Expertise Is Important
POC testing is not the same as core lab testing. Fortunately, clinical laboratory scientists have broad knowledge and familiarity with the principles of laboratory testing, which can be of great benefit in exercising oversight of POC testing. Tests for the same disease or marker performed in a core lab and a POC setting, for example, will likely employ an entirely different methodology, each having its own biases, precision, interferences, linearity, and reference range. Laboratory professionals have an in-depth understanding of testing methodologies and how a POC test method compares to testing performed in a central lab, and they understand the differences in interfering substances, specimen-handling requirements, patient preparation, and so on.
Those without a laboratory background might assume that the results of a POC test should align with the results of a test performed in a core lab. But in reality, this is rarely the case. POC tests for troponin and influenza, for example, are known to be less sensitive than equivalent central lab methodologies.6 For similar reasons, negative test results gathered from a rapid POC test for strep infection require lab confirmation.6
This type of knowledge is important when considering when and where to implement a POC test as well as in overall POC test management. It is vitally important to understand these types of testing details and to use that information to make wise decisions about when and where to implement POC testing to achieve the most patient benefits.1 Laboratory professionals have a clear understanding of which tests are applicable in various clinical scenarios. That expertise can be useful on a POC committee or in discussions with healthcare providers regarding where to implement POC testing. The knowledgebase of those trained in laboratory medicine aligns with the information that is needed to make decisions about where POC testing can be beneficial, and to properly oversee testing to ensure quality results.
The development of an individualized quality control plan (IQCP) is another area where laboratorians have an understanding that is beneficial for POC testing. Permitted by current regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), an IQCP offers labs the opportunity to tailor their QC procedures to match the risks represented by the types of testing they actually perform—including POC testing. Laboratorians can perform risk assessments to determine the frequency of QC that best fits their POC testing program and maintains a balance between costs and quality. Such analyses can enable POC directors to stop following older CLIA QC requirements that can overutilize POC testing materials with little benefit.7
Complicated Regulatory Requirements
Medical laboratory scientists have an in-depth knowledge of the regulatory requirements applicable to POC testing, which generally mirror the requirements that apply to central laboratory testing. For example, all glucose monitors are not equal, and FDA has voiced concerns about the use of glucose monitors to monitor critically ill patients.8 FDA has also classified influenza tests based on the difference in sensitivity and specificity between molecular reverse transcription-polymerase chain reaction (RT-PCR) and traditional influenza test kits.9 Laboratory staff are familiar with such regulatory distinctions, as they already affect day-to-day lab operations.
Laboratory personnel are also well-versed in the different requirements for CLIA-waived tests versus non-waived tests. Regulatory and accreditation bodies can differ in their requirements related to POC testing, such as the rules regarding device calibration verification and competency assessments for operators. With their training and experience, laboratory professionals are best qualified to train and oversee healthcare workers as end-users of POC tests, and to ensure that testing complies with regulatory requirements and produces quality test results (Table 1).
POC Integration and Data Management System
The growing field of POC testing will thrive when those with the most to contribute manage all aspects of POC testing in a systematic and professional manner within a comprehensive POC testing program. With the amount of data involved and the need to have results readily available, electronic integration with a POC testing data management system (DMS) is a crucial tool for a POC coordinator (Figure 2).
Electronic integration of POC devices allows for automation of results delivery and billing, and is vital for achieving real-time access to rapid results. There are several types of software available, with varying capabilities, but most such systems can help coordinators track POC testing across locations, manage POC devices, and perform end-user competency assessments. A POC DMS can help ensure quality testing and regulatory compliance.6
Benefits of an enterprise POC DMS include data handling and analytics, POC test tracking, workflow improvements, and flagging of incidents that need attention.11 In addition, a POC DMS can link to a learning system and help coordinate and track operator training.11 Overall, a POC DMS connects disparate devices, and provides operator oversight to improve efficiency, regulatory compliance, and workflow, as well as helping to manage costs.
The Lab’s Shifting Role
Alongside the rise of value-based and patient-centered healthcare, and the increased demand for POC testing, the role of the laboratorian is also shifting. While many laboratorians previously considered implementation and management of a POC testing program as a burden to be avoided, it has now become an opportunity to be seized and nurtured.
Laboratory professionals who possess training in POC testing are being encouraged to take a leadership role in implementing and managing POC testing. Such leadership should include creating a culture of understanding about the importance of proper POC testing procedures to obtain accurate results.12
Laboratory oversight of POC testing creates an opportunity for laboratory professionals to use their expertise to help improve patient care, and to gain greater visibility and respect as part of the healthcare team. Medical laboratory scientists can act as consultants and educators, and improve their status as valuable resources in healthcare.12
As decentralization of testing continues, the laboratory professional has an opportunity and a responsibility to step in and make sure POC testing is performed just as accurately as any other lab test.13 Laboratory professionals can help explain testing discrepancies, recommend POC testing devices, offer advice about which test is appropriate to order, and navigate POC testing vendor relationships (Table 2).
The ongoing shift of policies and practices in the direction of value-based and patient-centered healthcare is bringing testing closer to the patient. These trends virtually ensure that the volume of testing performed outside of the core laboratory will continue to grow. And as healthcare organizations change their models, the role of clinical laboratories—and how they serve their organizations—will also undergo change. Increasing sophistication and use of POC testing appears destined to play a major role in this new healthcare paradigm.
Although POC testing takes place outside the walls of a conventional laboratory, the essential principles are still those most familiar to laboratory-trained personnel. In POC testing, the intricacies that go into developing an accurate test result are compounded and harder to control and standardize because of wide variations in testing locations, devices, and operators. Because of these additional levels of complexity, healthcare organizations will be wise to include those with the most applicable skill set—laboratory professionals— in their selection and oversight of POC testing.
Laboratory professionals should see the rise of POC testing as an opportunity to get excited about the value that POC testing can bring to patient care in a value-based environment. POC testing offers laboratory professionals an opportunity to use their skills and training to ensure that testing is performed in areas where it can have the most positive influence on patient outcomes and that quality results are achieved. Laboratory professionals need to become involved and engaged in the management of POC testing in order to showcase the laboratory’s contribution to the healthcare team and to improve the overall contribution of the laboratory.
Kim Futrell, MT (ASCP), MSHI, is a product marketing manager at Orchard Software. For further information, contact CLP chief editor Steve Halasey via [email protected].
- Boppart SA, Richards-Kortum R. Point-of-care and point-of-procedure optical imaging technologies for primary care and global health. Sci Transl Med. 2014;6(253):253rv2; doi: 10.1126/scitranslmed.3009725.
- 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: 1016/j.cca.2013.04.025.
- Laurence CO, Gialamas A, Bubner T, et al. Patient satisfaction with point-of-care testing in general practice. Br J Genl Pract. 2010;60(572):e98–e104; doi: 10.3399/bjgp10X483508.
- St John A, Price CP. Benefits of point-of-care testing in the emergency department [online]. Brønshøj, Denmark: Radiometer, 2018. Available at: https://acutecaretesting.org/articles/benefits-of-point-of-care-testing-in-the-emergency-department. Accessed January 18, 2019.
- St John A, Price CP. Existing and emerging technologies for point-of-care testing. Clin Biochem Rev. 2014;35(3):155–167.
- Nichols JH. POCT Coordination: Managing Your Sanity as Your Program Expands Beyond the Horizon [webcast slides, online]. Nashville, Tenn: Vanderbilt University Medical Center, 2018. Available at: whitehatcom.com/pocwebmtgs/slides/dr_nichols_poct_coordination_110818.pdf. Accessed January 18, 2019.
- Paxton A. How POC testing is pushing the envelope [online]. CAP Today. April 2014. Available at: captodayonline.com/how-poc-testing-is-pushing-the-envelope. Accessed January 18, 2019.
- Chu UB, Heady TN. Improve point-of-care glucose measurements with staff outreach. Medical Lab Management. 2018;7(8):18–23. Available at: medlabmag.com/article/1514. Accessed January 18, 2019.
- Rapid Diagnostic Testing for Influenza: Information for Clinical Laboratory Directors [online]. Atlanta: Centers for Disease Control and Prevention, 2018. Available at: cdc.gov/flu/professionals/diagnosis/rapidlab.htm. Accessed January 18, 2019.
- Blick KE. The essential role of information management in point-of-care/critical care testing. Clin Chim Acta. 2001;307(1–2):159–168; doi: 1016/S0009-8981(01)00460-0.
- Mardis C, Gundler D. Keeping up with POCT regulatory compliance [online]. MLO. October 24, 2017. Available at: mlo-online.com/keeping-poct-regulatory-compliance. Accessed January 18, 2019.
- Nichols JH. The Nursing-Lab Relationship in POCT: The Good, the Bad, and the Ugly of Interdisciplinary Teams. [webcast slides, online]. Nashville, Tenn: Vanderbilt University Medical Center, 2018. Available at: whitehatcom.com/pocwebmtgs/slides/dr_nichols_nurse_lab_poct_relationship_082118.pdf. Accessed January 18, 2019.
- Shaw JLV. Practical challenges related to point-of-care testing. Pract Lab Med. 2016;4:22–29; doi: 10.1016/plabm.2015.12.002.