Cover Story

 CONTINUING EDUCATION

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LEARNING OBJECTIVES

Upon completion of this article, the reader will be able to:

1. Identify the goal(s) of POCT.
2. List sites where POCT is performed.
3. Name the POC Tests available to the healthcare field.
4. Explain the purpose of the POCT needs assessment.
5. State the evaluation criteria used to select POCT devices.
6. Explain how the use of POCT can lower economic costs.

 

Pieces of the POCT puzzle
Point-of-care testing: changing the way patient care is delivered

By Kristin N. Hale, BS, BA, and
Gerald J. Kost, MD, PhD, MS, FACB

Point-of-care testing (POCT) is defined as testing at or near the site of patient care.^1,2 The goal of POCT is to facilitate rapid diagnosis and faster treatment decisions to improve patient care and reduce morbidity and mortality.¹ POCT impacts every branch of the healthcare system, including hospitals, outpatients, and disaster and emergency situations. The ability of POCT to be utilized in all these respective locations has demonstrated the significant potential POCT has to positively impact and change the way healthcare is delivered to the patient population — ultimately, with the goal of improving patient care — wherever that may be.

POCT device design is a critical aspect for efficient POCT device performance.

While the beneficial use of POCT in the hospital and outpatient settings primed the transition of using POCT in emergency and disaster situations, the 2004 tsunami in Southeast Asia and Hurricane Katrina in the United States in 2005 exposed the lack of disaster medical preparedness worldwide.^1,2 The POCT was extensive and the disaster response immense, but results showed it was inadequate.¹ Compromised hospitals, roads, and communications hindered rescue efforts by first responders who carry POCT devices such as oxygen-saturation monitors (pulse oximeters), blood-glucose meters, and other small hand-held devices.^1,2 Furthermore, POCT instruments failed to effectively operate under the adverse environmental conditions of these respective disaster situations.² Regional catastrophes like these "newdemics"^3,4 lead to sequential magnified setbacks and, typically, communities lack the POCT resources to effectively handle the respective disaster situations.^1,2 These disasters not only highlighted the significant potential for POCT to positively impact disaster response and patient outcomes but also displayed the need for new sturdy, hand-held, and robust POC technologies capable of effectively operating in disaster situations. In the future, the versatile use of POCT will positively impact and change the way patient care is handled by doctors, medical personnel, and disaster and emergency responders.

What POC tests are available?

The use of POCT has become standard in nearly every sector of the healthcare field. The ability of POCT to be performed at the bedside of the patient to facilitate rapid diagnosis is efficacious to the patients, doctors, medical personnel, and laboratory technicians in saving valuable time from diagnosis to treatment.^1,2 Table 1 displays where POCT is used, including hospitals, outpatient sites, and disaster and emergency sites. The use of POCT at the site of patient care has primed the transition from not only using POCT in hospitals and for outpatients but also at disaster and emergency sites.

A variety of POC tests are available, including both in vitro and in vivo, which are utilized by hospitals, outpatients, and disaster sites. Many POCT in vitro instruments measure hematocrit using electrical conductance sensor (ECS), co-oximetry, or various other methods.¹ O₂ saturation can typically be measured utilizing fiber optics for multiple wavelength measurement.¹ The use of sensors for in vitro testing allows simultaneous measurement of several analytes quickly and effectively to facilitate evidence-based decisions for patients.¹ In vivo POCT devices for monitoring blood chemistry are typically limited and include analytes that vary rapidly, require fast response, or need frequent measurements.¹ These analytes primarily include oxygen saturation, blood glucose, blood gasses (PO₂ and PCO₂), pH, potassium, sodium, ionized calcium, hematocrit, and — to a lesser extent — urea, creatinine, and lactate.¹ The focus of development for these POCT devices has been for use in the hospital and intensive-care units.^6,7 Blood-glucose monitoring continues to be an area of interest for ongoing POCT-device development, especially for outpatients with diabetes who require monitoring on a regular basis. Development has been focusing on wearable or implantable blood-glucose devices to allow for efficient outpatient monitoring and management of diabetes to improve long-term patient care.¹ POCT development for various disaster sites and emergency situations has focused on developing pathogen-detection test clusters.⁸ These pathogen test clusters can be tailored to a respective disaster or emergency situation to test for prevalent pathogens in these respective situations. In order to develop the most effective and efficient POCT device, however, certain criteria must be considered, especially for POCT use in disaster and emergency situations.

POCT and needs assessment

POCT serves as a critical component of for hospital care, outpatient services, acute disaster response, and follow-up recovery; but, at present, POCT devices available in the consumer market and for routine use do not meet adequate standards for disaster conditions.⁸ During a disaster, emergency medical responders utilize the POCT to rapidly diagnose and treat victims.⁹ The specific pathogens present at a disaster site vary, however. To effectively facilitate the treatment of victims, emergency medical responders need POCT devices with specific-pathogen test clusters tailored to a respective disaster site.⁸ In order for POCT devices to be effective at facilitating evidenced-based medical decisions and improve patient outcomes, they need to be tailored to test for specific pathogens that have been shown to be present in a specific disaster scenario.

In an effort to close the gaps between current POCT technology and availability, a national needs-assessment survey that specifically focuses on pathogen detection and development of devices capable of withstanding harsh disaster conditions is currently being conducted. Clinical needs assessment serves as a tool for gathering information on POC devices, test clusters, and pathogens considered critical for diagnosis at a specific disaster site.⁸ The clinical needs-assessment survey utilizes "visual logistics" to specifically focus on what pathogens clinicians want to test for in a particular disaster scenario.⁸ By surveying experts in the field of disasters and emergencies, what is considered a priority and beneficial to POCT is clearly evident. The POCT Center at the University of California-Davis/Lawrence Livermore National Laboratory (LLNL), one of four National Institute of Biomedical Imaging and Bioengineering (NIBIB) POCT research centers, specifically focusing on infectious-disease detection would like to extend an invitation to all MLO readers to participate in our clinical needs-assessment survey; please see Table 2 for instructions.⁹ Through clinical needs assessment, the development of pathogen-detection test clusters and devices capable of giving rapid and reliable diagnosis will enable better patient care at a disaster site.

POCT selection and evaluation

POCT devices must meet specific standards, especially if the POCT instrument will be deployed to disaster and emergency sites that harbor harsh environmental conditions. The system performance of the POCT device must be considered. Results from POCT devices must be accurate, reproducible, stable, comparable, and fast.¹ Additionally, the performance of the POCT device should not be compromised if environmental extremes are encountered. In a recent study conducted by Dr. Louie and colleagues, results indicated that glucose test strips and blood-gas cartridges may not be able to withstand harsh environmental conditions often encountered at disaster sites.¹⁰ Thermal stresses adversely and inconsistently affected the performance of glucose-meter test strips and blood-gas analyzer cartridges.¹⁰ Without durable and robust POCT equipment, diagnosis and treatment of victims at disaster sites becomes increasingly complicated and hindered. In order to effectively and efficiently treat patients, current POCT technologies and devices must be improved and refined to meet not only hospital and outpatient conditions, but also those encountered in extreme disaster and emergency conditions.

POCT device design is a critical aspect for efficient POCT device performance. POCT instruments must be compact, durable, lightweight, portable, power efficient, robust, and hand-held.^1,10 POCT is specifically designed to be utilized at or near the patient and must, therefore, be deployable to any site the patient might be located, including disaster sites.¹⁰ Not only must the POCT device be able to operate in a hospital or outpatient locations, but also at disaster and emergency sites, where conventional amenities will not be present.

New POCT devices must meet current requirements for accreditation agencies, whether state, federal, or voluntary, and have simplified protocols for educating potential operators.¹ POCT devices held to the same standards present for hospitals ensures better patient care. Additionally, POCT devices must be accurate and the results comparable to established standards. During disaster situations, competent POCT operators are critical to facilitating efficient testing needed for rapid diagnosis and treatment. POCT devices supplemented with educational resources to achieve minimal operator training for effective device operation enable efficient patient care.¹

Connectivity, integration, and data-storage capabilities are important considerations and vital components for POCT device development.¹ POCT devices need to be easily operated and efficient at performing multiple tasks. By having the capability of integrating various pieces and components of information, patient care can be heightened by facilitating diagnosis and treatment. Another important consideration when designing a POCT device is specimen volume, type, and matrix.¹ The pathogens of interest for diagnosis and treatment must be identified and the best method to screen for them utilized in POCT device design.

Finally, medical efficacy in interpretation, diagnosis, and treatment will facilitate the most efficient patient care available at any site.¹ POCT results must be communicated in a way that facilitates rapid diagnosis and treatment. Decreasing therapeutic turnaround times will allow for doctors and medical personnel to offer the best level of patient care. Proper integration of all components of care from POC test results to correct diagnosis and treatment is critical to delivering effective patient care, and this notion of connectivity requires clear communication between multiple personnel to ensure the best level of patient care.¹

POCT cuts costs

Few countries can afford to renovate their facilities with the latest technological advances in medicine; however, it may be possible in low-resource countries to integrate the use of POCT devices to alleviate high economic costs.¹¹ In October 2007, NIBIB and the Department of Biotechnology (DBT) of the Ministry of Science and Technology of the Republic of India entered into an agreement to develop low-cost healthcare devices for underserved populations in India.¹² A workshop was held in November 2008 between NIBIB and DBT to identify key areas critical for device development.¹³ The workshop identified two areas for POCT-device development, including low-cost glucose monitoring and platform technologies for multiple diagnostic tests (such as infectious diseases and genetic screens).¹³ POCT blood-glucose instruments designed for use in underserved populations will focus on developing blood-glucose strips with extended shelf lives, robust devices, and reagents capable of effectively operating in less-than-ideal environmental conditions. Low-cost POCT will help bring evidence-based medicine to low-resource countries, bridging the current gap between developed countries (e.g., the United States) and underserved populations (e.g., India).

The effective use of POCT has the potential to lower economic costs by facilitating early detection and treatment.¹ This could lead to many advantages for patients, doctors, and medical personnel, and it could potentially reduce economic impact. A benefit to using POCT devices is that specimen type and reagent use are minimized.^1,10 This decreases the overall cost of diagnostic testing. In addition, rapid diagnosis and treatment facilitated by POCT reduces the time impact on both doctors and other medical personnel. A recent study conducted by Dr. G.F. Mendez, and colleagues evaluated the impact of using POCT to identify cardiac biomarkers in the Emergency Department (ED) in Mexico City.¹⁴ Results showed that POCT used in the ED effectively reduced turnaround-time (TAT) in patients with chest pain, while simultaneously reducing direct medical costs for patients when compared to conventional central laboratory.¹⁴

Another study by Dr. R. Tirimacco evaluated the development and use of an evidence-based cardiac-care network that utilized POCT to identify cardiac biomarkers to close the gaps between medical care available in metropolitan and rural/remote locations in Australia.¹⁵ Results displayed that POCT for troponin allowed for evidence-based cardiac care to assess the risk of patients, and it decreased both 30-day hospital readmissions and in-hospital deaths from acute coronary syndrome (ACS).¹⁵ Furthermore, this study displays how proper integration of POCT can effectively facilitate evidence-based medical decisions, decrease the time to diagnosis and treatment, while improving the level of patient care and reducing financial impact.¹⁵ Utilization of POCT for evidence-based medical care has the potential to heighten current standards of patient care, while possibly decreasing economic costs.

Globally, the use of POCT in low-resource countries is efficacious. By making POCT affordable, patient care not currently available in these areas can be increased to standards better comparable to areas with high resources.¹¹ POCT devices must be integrated into routine use in low-resource countries and because of the deployability and durability of POCT devices, they can be utilized at a variety of sites (see Table 1).¹⁰ Furthermore, POCT devices must be placed at the "point of need"¹¹ in developing countries, including primary-care facilities and community hospitals, which directly support emergencies and public-health preparedness.¹¹ By implementing widespread use of POCT globally, patient care will be standardized utilizing evidence-based medicine.

Conclusions

Proper development and integration of POCT has the potential to significantly impact the way healthcare is delivered globally. Surveying needs assessment will foster the development of new and innovative POC technologies capable of bringing care to the point of need, whether it is at hospitals, outpatient settings, or disaster sites. POC technologies have the potential to help reduce the economic costs on the healthcare system, while simultaneously heightening the standards of patient care by facilitating evidence-based medical decisions. Finally, proper integration of POCT information into diagnosis and treatment will effectively reduce mortality and morbidity rates worldwide.

Kristin N. Hale, BS, BA, and Gerald J. Kost, MD, PhD, MS, FACB, are from the Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR); Pathology and Laboratory Medicine, School of Medicine, University of California, Davis, CA.

Acknowledgments

From the University of California Davis/Lawrence Livermore National Laboratory Point-of-Care Technologies Center (National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health), The Point-of-Care Testing Center for Teaching and Research, and Pathology and Laboratory Medicine, School of Medicine, University of California, Davis, CA.

This article was supported by Award Number U54EB007959 (Dr. Kost, PI) from the National Institute of Biomedical Imaging and Bioengineering. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Biomedical Imaging and Bioengineering or the National Institutes of Health. Table and figures provided courtesy and permission of knowledge optimization, Davis, CA.

References

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