Point-of-Care Testing: Twenty Years' Experience

Abstract

Point-of-care testing (POCT) has expanded dramatically in the past 20 years with volume growth of 12% to 15% annually. What have we learned? Three features of POCT essential for a successful POCT program are: 1) a well-defined POCT organization, 2) robust connectivity, and 3) still more information regarding the relationship of POCT to clinical outcomes. The advances and limitations for each of these aspects are discussed in an up-to-date review of the POCT arena.

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560 LABMEDICINE j Volume 39 Number 9 j September 2008 labmedicine.com
Twenty years ago, with the development of the Clinical
Laboratory Improvement Amendments of 1988 (CLIA ’88),
the clinical laboratory industry embarked on a bold new experi-
ment in point-of-care testing (POCT). For laboratory profes-
sionals, this point in time is a hallmark since it is the time from
which the rapid development of POCT in the United States
is measured. The number of CLIA-waived tests in 1988 was
limited. By category, the number of waived tests has increased
from 8 in 1988 to more than 80 today.1 The Food and Drug
administration (FDA) lists more than 1,600 available waived
tests, and it is estimated that more than 520 million waived
tests are performed in physician office laboratories (POLs).2 A
recent survey, contracted by the Centers for Disease Control
and Prevention (CDC), estimates that, of more than 200,000
CLIA-certified laboratories, 54% are POLs, of which 4 out of
5 maintain a CLIA certificate of waiver, and largely perform
POCT.2
Point-of-care testing is also known as extra-laboratory, al-
ternate site, or near-patient testing. It typically refers to the per-
formance of a diagnostic laboratory test outside of a traditional
central laboratory and near the site of patient care, whether it is
inpatient settings or outpatient clinics. The worldwide volume
is rapidly expanding, with a 12% to 15% annual growth rate.3 A
2001 report estimated the U.S. POCT market to be $4.9 billion
and expected it to double in 5 to 10 years.4
Even with this widespread presence, many health care
professionals fail to understand the difference between a waived
test and a POC test. Waived tests are deemed by CLIA ’88 to
have low complexity with low risks for erroneous results and
no harm to the patient if performed incorrectly. They are also
typically easy to perform and do not require special training or
education.5
Point-of-care testing, on the other hand, describes the
location where a test is performed, typically close to a patient’s
primary care. Point-of-care tests, in fact, may be tests of moder-
ate- or even high-complexity if performed under the oversight
of a laboratory that is CLIA-certified for nonwaived testing,
and supervised by a qualified laboratory medical director. An ex-
ample might be a POC blood gas analyzer located in a neonatal
intensive care unit (NICU) managed through the main hospital
laboratory. If adequately covered by a CLIA ’88-defined labora-
tory director, the performance of testing on this instrument
may be considered a POCT.
POCT Faces Unique Challenges
The Role of Organization/POCT Committee
What have we learned about POCT in the past 20 years?
One aspect that is now clearly recognized is that POCT faces
some unique challenges compared with conventional testing.
Some POCT is performed only in POLs and may be managed by
1 or 2 individuals with a physician laboratory director. In larger
networks, testing may be performed at locations ranging from the
emergency room (ER), the operating room (OR), or intensive
care units (ICUs) in the hospital to satellite outpatient clinics.
The large majority of clinical staff members involved in POCT
are focused primarily on clinical care and are much more variable
in their familiarity with the testing process and quality control
requirements. Training and ongoing competency maintenance of
the staff performing POCT can be overwhelming to manage.
To successfully achieve POCT quality in such networks, a
multidisciplinary organizational approach is required. A clearly
defined organization must include designated authority, respon-
sibility, and accountability. Standard operating procedures and a
POCT quality program should be developed and carried out in all
areas. An example of an organizational chart for a POCT network
is shown in Figure 1.
Abstract
Point-of-care testing (POCT) has expanded
dramatically in the past 20 years with volume
growth of 12% to 15% annually. What
have we learned? Three features of POCT
essential for a successful POCT program
are: 1) a well-defined POCT organization,
2) robust connectivity, and 3) still more
information regarding the relationship of
POCT to clinical outcomes. The advances
and limitations for each of these aspects
are discussed in an up-to-date review of the
POCT arena.
After reading this article, readers should be able to discuss the current state
of point-of-care testing and discribe the role of a POCT committee, the
importance of information technology in the POCT arena, and the proven value
of POCT.
Generalist exam 90804 questions and corresponding answer form are
located after this CE Update article on page 564.
Point-of-Care Testing: Twenty Years’ Experience
Elizabeth A. Wagar, MD, FASCP, FCAP, Bushra Yasin, PhD, Shan Yuan, MD, FASCP, FCAP
(Department of Pathology and Laboratory Medicine, UCLA Clinical Laboratories, Los Angeles, CA)
DOI: 10.1309/9R9Y0V68Y3BA0KDN
Figure 1_An example of the point-of-care testing organizational chart
at a large health care network.

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labmedicine.com September 2008 jVolume 39 Number 9 jLABMEDICINE 561
Note that multiple areas of specialization are represented
as members of the POCT committee. In addition to a labora-
tory POC coordinator who serves as the liaison between the
laboratory and the clinical care areas, laboratory representatives
may include a technical consultant and an IT specialist. Admin-
istrative representatives from the hospital or other health care
institutions can evaluate financial aspects of a proposal. Physi-
cian members and nursing staff are important as representatives
of client groups and users. Any hospital with a high number of
diabetes patients may wish to include a diabetes specialist for
POC glucose testing.
An important feature of the POCT organization is a stan-
dard operating procedure for new test proposals. Such proposals
should include an application process in which the individual
requesting the test should provide, on a standardized form, spe-
cific information regarding clinical areas to be affected by the
new test, the number of tests that will be performed, suggested
vendors and financial analysis, and, most important, the POC
representative from the clinic or care area who will manage the
testing and serve as the responsible individual for all POCT
activities.6 Such a system provides the essential information
needed for evaluating the request and gives the POCT commit-
tee a starting point for discussions on whether the clinical utility
can justify the cost and logistic implications if the new test is
implemented.
Achieving Connectivity
A second major lesson learned in the past 20 years is the
value of good information technology (IT) in the POCT arena.
Connectivity is the key to managing testing that takes place at
many sites, including aspects such as quality control (QC), iden-
tification of testing personnel, and post-analytical transfer of
results to the patient’s electronic medical record (EMR). With
the POC market growing at an annual rate (12% to 15%) far
outpacing that of the traditional laboratory, it is easy to imagine
how information management is central to the use of POCT
in patient care.7 In a survey by Enterprise Analysis Corporation
in 2001, almost 60% of all POCT results never made it to the
patient record.8 This represents considerable potentially useful
clinical information as well as significant revenue loss from the
billing perspective.
Achieving connectivity has been hailed as the “millennium
challenge for point-of-care testing.”9 The Connectivity Industry
Consortium (CIC) attempted to identify the necessary ele-
ments for POCT-IT. These elements were incorporated into
the first Clinical and Laboratory Standards Institute (CLSI)
standard, known as POCT-1A, Point-of-Care Connectivity: Ap-
proed Standard, 2001. However, the complexity of the docu-
ment and the use of technical engineering terms eluded most
health care personnel. POCT-2P was developed in an effort to
make the guideline more user-friendly to clinical professionals.
According to a survey, vendors are generally enthusiastic about
POCT-IT.10 Within 1 year of the standard’s release, 5 vendors
offered compliant products. All vendors intended to incorpo-
rate the standards into most or all of their new products. Cur-
rently, among the available database management systems that
meet the requirements are the Remote Automated Laboratory
System (RALS), the Plus system from Medical Automation
Systems (MAS, Charlotte, VA), and the uick-Link System
from Telcor (Lincoln, NE). All are vendor-neutral and compat-
ible with devices from many manufacturers. RALS-Plus (MAS)
is the current leading vendor-neutral connectivity system for
POCT and is used by more than 1,300 U.S. hospitals.11
Since the development of these systems, additional fea-
tures have further enhanced the use of POCT connectivity.
New instrumentation now has 2-way (host query) interfacing
capabilities. Additionally, to improve laboratory management
of POCT, instrumentation has quality control and user lock-
out functions that provide hard controls over its use at distant
testing sites. Currently, wireless interfacing capabilities are avail-
able and in actual use at some institutions. With the addition
of hard controls and wireless flexibility, oversight can be better
managed by the POC coordinator.
Long Way to Go
The third conclusion that can be drawn after 20 years of
POCT is that we still have a long way to go in proving good
clinical outcomes related to patient-adjacent testing. Although
it seems to intuitively make sense that better patient care is
a result of immediate test results, the proven positive clinical
outcomes remain elusive. A few patterns have evolved, however,
which suggest scenarios in which POCT has proven valuable for
patient care.
Proven Value of POCT
The most obvious of these scenarios is POCT for diabetic
patients. Early studies indicated that POC glucose testing was
associated with decreased lengths-of-stays for patients with
ketoacidosis and improved cost management of diabetic pa-
tients.12,13 Larger studies included the Diabetes Control and
Complications Trial, which demonstrated reductions in long-
term complications of diabetes for insulin-dependent patients
who used self-testing to maintain tight control of blood glucose
concentrations.14
In 2001, the use of tight glycemic control in the intensive-
care environment encouraged further use of POC glucose test-
ing for inpatients. This algorithm demonstrated a reduction
in morbidity or mortality in ICU patients with or without a
history of diabetes. Blood glucose levels were normalized, even
in nondiabetic patients at 80 to 110 mg/dL.15,16 This has led to
a marked increase in the use of POC glucose testing. At UCLA,
with partial implementation of tight glycemic control, the
volume of POC glucose testing increased by 100% in a 1-year
period (unpublished data). However, a recent study also per-
formed at UCLA indicates that tight glycemic control employ-
ing POC glucose testing was consistently associated with lower
average glucose levels and a trend toward decreased lengths-of-
stays, costs, and mortality.17
A second area where POCT seems intrinsically of clinical
value is in the coagulation (warfarin, Coumadin) therapy clinic.
International normalized ratio (INR) is used to standardize the
results from the prothrombin time (PT) and to monitor antico-
agulation prophylaxis in patients with deep-venous thrombosis,
heart valve replacement, atrial fibrilliation, and other indica-
tions according to current clinical guidelines, Close monitoring
of the use of warfarin has become of primary importance given
the risk factors associated with inappropriate therapy. Recently,
the Joint Commission (JC) has added anticoagulant monitoring
as a new patient safety initiative (patient safety goal 3E) to be
fully implemented by January 2009, adding prominence to PT/
INR testing algorithms.18
Theoretically, anticoagulation testing is an attractive can-
didate for POCT given widespread monitoring in outpatient
clinics and significant negative outcomes if the therapy is poorly

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managed. It is estimated that 85% to 95% of noninpatient-
related INR testing is conducted in the general practice setting.
But has POCT for PT/INR really proven itself in terms of
positive clinical outcomes? A correlation between INR level
and event rates demonstrates how thromboembolic and hemor-
rhagic event rates compare with a primary outcome measure
such as INR. However, the events may be rare as shown in
Figure 2.19
A problem with PT/INR testing in POC is the reliability
of INR in the comparison of POC methods with conventional
PT/INR reagents and testing platforms. Mean results in several
studies differed significantly for multiple paired comparisons of
methods.20-22 Surveys have shown a difference in displayed INR
of more than 20% between 2 POCT instruments, greater than
the World Health Organization (WHO) recommendation of a
10% limit for clinical relevance.23
There are many other clinical outcome models that might
be considered, from multiple analyte POC systems (I-Stat, East
Windsor, NJ) to rapid testing for infectious diseases (HIV,
influenza, streptococcus A antigen testing). However, what is
distilled from the best data is that 2 factors contribute signifi-
cantly to the potential for positive clinical outcomes: 1) clinical
algorithms appear to drive the use of the POCT results, and
2) POCT results translate into immediate diagnostic or thera-
peutic care recommendations. The 2 scenarios described as ex-
amples, POC glucose testing and PT/INR testing, are far from
perfect. However, understanding how these 2 factors contribute
to clinician demand for POCT can help laboratory profession-
als address the needs of their health care institution in a better
manner. When kept in mind during a new POCT proposal,
they also can contribute to better decision-making.
Finally, the cost of POCT requires a few comments. Al-
though one of the fastest growing segments of laboratory test-
ing, POCT has expanded during an era of pressure to cut costs.
Several studies have attempted to measure why this is occurring
and how it has been justified. Because billing is often a difficult
element to link to POCT, it is less complete. While this is sav-
ing many millions of dollars for providers and patients, it is
recognizing the cost of the procedures inaccurately. Also, stud-
ies have shown that the cost-per-test in the central laboratory is
much lower than POCT.24 Another study of 445 institutions
showed that although central laboratory testing for glucose
was approximately 25% of POCT, costs varied depending on
low-volume versus high-volume testing sites.25 Similar major dis-
crepancies are noted, for example in HIV testing, again showing
list prices of 4 to 5 times for POC HIV tests versus the central
laboratory per test cost.26
Thus, the perspective varies for payer POCT costs (which
may not even see the costs because of inadequate billing) versus
the producer of laboratory services (the typical primary pur-
chaser of POCT services).27
In summary, the world of laboratory medicine has changed
considerably in the past 20 years and nowhere is this more
evident than in POCT. We have learned how to better orga-
nize our POCT organizations and determined the key players
required for an effective POCT network. Also, we have expe-
rienced an expansive development of connectivity for POCT.
More than 1,300 hospitals now use RALS-Plus (MAS). Finally,
we are better defining the scenarios for using POCT by ana-
lyzing clinical outcomes. Although imperfect, scenarios that
provide defined algorithms for use and require immediate clini-
cal diagnostic and therapeutic actions provide the best use of
advanced POC technologies. LM
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Figure 2_Event rate for thromboembolic events and hemorrhagic
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