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

June 1, 2009
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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.

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

Site Location Hospital bedside   Critical care workstations
Hybrid laboratory instrument sites
Near-patient testing locations
Patient-focused care centers
Patient monitoring stations
Procedure sites
Satellite laboratories Outpatient   Clinics and specialty care centers
Homes
Patient-focused care facilities
Physician offices
Urgent care centers
Wellness testing areas Disaster and emergency rescue

  Emergency ground vehicles
Helicopters
Military field operations and battlefields
Ships, submarines, and other vessels
Space shuttles and space stations
Points of disaster and emergency rescues

 

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.

Participate in clinical needs-assessment
survey

  1. Visit UC Davis-LLNL POCT website:

    http://www.ucdmc.ucdavis.edu/pathology/poctcenter/
    .
  2. The Clinical Needs Assessment survey link appears in the top right
    corner of the navigation bar. It is the first item under POC Technologies
    Center. Please click on “Needs Assessment Survey.”
  3. Follow the instructions on the screen.
    Note: Your progress will be saved after pressing the “next”
    button at the end of each page. Your progress online is managed through your
    Web-browser cookies, and your identity is maintained using your IP address.
    For this reason, please try to complete the survey on the same computer and
    do not delete the cookies on your Web browser prior to completion of the
    online survey.
  4. Thank you for your time and input on the survey!
    Note: Please contact, Keith Brock, Research Specialist, at
    530-752-8471, e-mail
    [email protected], for any
    comments or questions to better facilitate your participation in the
    Clinical Needs Assessment Survey.

Table 2: “Survey Monkey”
instructions

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

  1. Kost GJ, Tran NK, Louie RF. Point-of-care testing: principles,
    practice, and critical-emergency-disaster medicine. In: Meyers RA, ed.
    Encyclopedia of Analytical Chemistry
    . 2008; DOI:
    10.1002/9780470027318.a0540.pub2.
  2. Kost GJ, Tran NK, Tuntideelert M, et al. Katrina, the tsunami and
    point-of-care testing: optimizing rapid response diagnosis in disasters.
    American Journal of Clinical Pathology
    . 2006;126:513-520.
  3. Kost GJ, Minear M, Siegel PM, et al. Knowledge, education, mind
    connectivity: using telemedicine to achieve a global vision for
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  4. Kost GJ. Newdemics, public health, small-world networks, and
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  5. Kost GJ. Guidelines for point-of-care testing: improving patient
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  11. Kost GJ. Point of need, global outreach, and a universal companion.
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  12. NIH and India partner to develop low cost medical technologies. News
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    http://www.nibib.nih.gov/NewsEvents/Releases/Archive/2007OctNovDec
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    Accessed on May 19, 2009.
  13. NIBIB and India hold joint workshop on low-cost diagnostic and
    therapeutic medical technologies. e-Newsletter
    2009;3(1). Available at:

    http://www.nibib.nih.gov/NewsEvents/Newsletters/March09
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    May 19, 2009.
  14. Mendez GF, Castillo P, Galicia G, et al. Point-of-care testing
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