1. Clin Lab Med 27 (2007) 893–908
Point of Care Testing
James H. Nichols, PhD, DABCC, FACB
Tufts University School of Medicine, Baystate Medical Center, Department of Pathology,
759 Chestnut Street, Springfield, MA 01199, USA
Point of care testing (POCT) is laboratory diagnostic testing performed
at or near the site where clinical care is delivered. POCT provides the advan-
tage of rapid test results with the potential for faster patient treatment. With
increasing pressure on physicians to see more patients and spend less time
with each patient, POCT has become a popular means of meeting the de-
mands for faster laboratory testing. POCT devices use small amounts of un-
processed specimen, so less blood is required, allowing the use of fingersticks
over the risk of phlebotomy. A wide menu of analytes is available, including
blood gas, electrolytes, pregnancy, cardiac, and infectious disease testing
(Box 1). The convenience of POCT has led to broad adoption of POCT
into clinical practice over the past 20 years. Current estimates indicate
that POCT encompasses nearly one third of the in vitro diagnostic testing
market and is growing at a rate of 9%, with annual sales of $7 billion world-
wide [1,2].
Federal regulations have facilitated the use of simple POCT devices. Al-
though the federal Clinical Laboratory Improvement Amendments of 1988
(CLIA’88) set minimum standards for validation and quality control of lab-
oratory tests, a separate category of simple testing called ‘‘waived’’ tests was
developed. CLIA ‘‘waived’’ tests are examinations or procedures that ‘‘are
cleared by the United States Food and Drug Administration (FDA) for
home use; employ methodologies that are so simple and accurate as to ren-
der the likelihood of erroneous results negligible; or pose no reasonable risk
of harm to the patient if the test is performed incorrectly’’ [3]. Although lab-
oratories adopting nonwaived testing must perform initial and ongoing de-
vice evaluation, document operator training and competency, subscribe to
proficiency testing, and develop a quality assurance program, including
daily performance of quality control, laboratories adopting waived tests
only need to enroll in the CLIA program, pay a biennial certification fee,
E-mail address: james.nichols@bhs.org
0272-2712/07/$ - see front matter Ó 2007 Elsevier Inc. All rights reserved.
doi:10.1016/j.cll.2007.07.003 labmed.theclinics.com

2. 894 NICHOLS
Box 1. Current clinical laboratory improvement amendments
waived category tests available
Diabetes testing
Glucose
Ketone
Hemoglobin A1c
Hemoglobin
Reproductive testing
Human chorionic gonadotropin (pregnancy)
Luteinizing hormone and Fern Test (ovulation)
Follicle-stimulating hormone (menopause)
Renal function
Urine dipstick
Microalbumin
Infectious disease
Streptococcus
HIV
Helicobacter pylori
Influenza A and B
Mononucleosis
Respiratory syncytial virus
Trichomonas
pH and amines (bacterial vaginosis)
Occult blood
Drugs of abuse testing
Therapeutic drug monitoring (lithium)
Lipids
Cholesterol
High-density lipoprotein
Low-density lipoprotein
Triglycerides
Brain natriuretic peptide
Liver function
Aspartate aminotransferase
Alanine aminotransferase
Coagulation (prothrombin time/international normalized ratio)
Tumor markers (bladder tumor-associated antigen)
and follow manufacturer’s test instructions. Because of these simple regula-
tory requirements, the number of CLIA waived tests has grown from 8 in
the original CLIA ’88 regulations to more than 40 tests today. Additionally,
the number of certificate of waiver (COW) laboratories has increased from

3. POINT OF CARE TESTING 895
20% to 58% of the nearly 180,000 CLIA-certified laboratories [4]. Most of
these are physician office practices.
This rapid increase in the use of POCT has led to concern about the qual-
ity and risks of POCT. Home blood glucose testing devices represent the
largest number of complaints filed with the FDA for any medical device,
with more than 3200 incidents, including 16 deaths [5,6]. Poorly maintained
urinometers and blood gas analyzers that are carried between patient rooms
can act as infectious reservoirs for nosocomial and antibiotic-resistant or-
ganisms [7,8], and blood glucose testing devices have been linked to trans-
mission of hepatitis B infection among patients at nursing homes in
California, Mississippi, and North Carolina [9]. A 2001 state survey of
COW laboratories found that 21% of laboratories were not performing
quality control as required, 12% failed to keep manufacturer’s package in-
sert, 21% failed to check the package insert for changes, 18% failed to re-
port results in units or as recommended in package insert, 6% were using
expired reagents, and 3% were not storing the reagents as recommended [4].
Although POCT devices may seem simple, these devices are not innocu-
ous. Consumers and operators of these devices need to be aware of the po-
tential risks and take steps to ensure appropriate test quality. This article
reviews several strategies to enhance the quality and integration of POCT
into patient care.
Point of care testing organization
Despite the illusion of simplicity, in practice, POCT devices can be af-
fected by several factors beyond the analytic process, including the environ-
ment and the operator. POCT presents challenges in managing the
preanalytic, analytic, and postanalytic processes similar to centralized labo-
ratory testing. Systematic reviews of the literature find that most laboratory
errors occur in the preanalytic and postanalytic phases of the testing pro-
cess, outside of the walls of the traditional laboratory [10]. This is the setting
where POCT is conducted, and there is ample opportunity for error.
Unlike the traditional laboratory where the bulk of testing is conducted
on a few analyzers by a core group of skilled and trained technicians, POCT
is conducted by a variety of clinical staff on multiple devices in many loca-
tions. An average hospital may have thousands of operators conducted test-
ing with hundreds of devices at more than 30 to 50 locations (Box 2). This
staff is focused on patient care and not on the nuances of instrument calibra-
tion and quality control. In fact, most clinical staff involved in POCT are
not trained in laboratory processes and do not know what quality control
is or even why controls are important. Getting all staff to perform POCT
the same way every time that the test is conducted presents a logistical chal-
lenge. Managing the volume of paperwork from training, test results, bill-
ing, quality control records, and other documentation can become

4. 896 NICHOLS
Box 2. Test operational features
Laboratory testing
One site
Limited instruments perform bulk of analyses
Limited staff with focus on sample analysis
Staff with laboratory training and experience
POCT
Multiple sites
Multiple devices
Multiple staff with focus on patient care
Staff with clinical training, not laboratory education
overwhelming. Laboratory professionals provide an important role as a re-
source of technical information and can assist in organizing a POCT pro-
gram, establishing policies, standardizing training, and supporting the
overall quality management of POCT whether conducted in a single-physi-
cian office or in a large health system.
The ‘‘laboratory director’’ on the CLIA certificate plays a key role in
managing POCT. Under CLIA’88, every site with a separate mailing ad-
dress must have a CLIA certificate if it is performing testing for patient
care. A laboratory director is responsible for all testing performed under
a CLIA certificate. Although some activities, like the daily review of quality
control, can be delegated to other qualified staff, the CLIA laboratory direc-
tor is ultimately responsible for all testing and quality of test results pro-
duced under his/her name. The consequences for noncompliance with
federal CLIA regulations can result in limitations of a site’s ability to per-
form testing and can sanction the laboratory director on the CLIA certifi-
cate, preventing that individual’s ability to bill Medicare for laboratory
services for periods of up to 2 years or more.
The laboratory director must be a physician, pathologist, or doctoral-
level laboratory scientist with laboratory experience and training; however,
the experience and training are not required for sites with a COW. Thus,
a doctor in a physician’s office practice can act as the laboratory director
for that office if the site only performs simple waived testing. For more com-
plex testing, the laboratory director must be a pathologist or a doctor with
some laboratory training and experience. The site can contract for external
consulting with a qualified laboratory director, but federal and state regula-
tions limit the number of CLIA certificates to three to five sites for any in-
dividual laboratory director. This ensures that the laboratory director has
time to spend at each site and is actively participating in and aware of the
testing conducted under his/her name.

5. POINT OF CARE TESTING 897
Although the limited testing performed in a small physician office gener-
ally can be managed between the laboratory director and one or two staff
members, management of POCT in larger institutions and hospitals requires
a team of staff to coordinate the testing. With multiple staff, devices, and lo-
cations, the volume of testing in hospitals requires a more formal POCT
program organization (Fig. 1). One CLIA certificate can cover all POCT
conducted within the hospital, with the laboratory director coordinating
the testing through the assistance of a dedicated staff member (POCT
coordinator) or team (POCT team led by a POCT coordinator). The
POCT coordinator or team handles the routine technical, training, and
troubleshooting tasks of ensuring that the POCT devices are functioning
properly and that the staff at each site is trained and competent to be per-
forming the tests. This team also is responsible for ensuring site compliance
with institutional policies and overall institutional conformity with federal
and state regulations. The laboratory director can delegate these tasks,
but should ensure control over the entire program by setting and reviewing
policies and procedures, as well as assisting in the clinical interpretation of
POCT results and consulting with physicians on unusual cases when the test
result does not match the clinical symptoms. Together, the POCT team, led
by the laboratory director and supervised by the POCT coordinator, acts as
an administrative group to orchestrate the POCT processes that will meet
patient and physician needs (see Fig. 1).
Standardization
POCT is not just a faster laboratory test. POCT devices are different
methodologies from core laboratory methods, and the test limitations and
Laboratory
Director
POCT POCT
Coordinator Committee
Unit Nurse Clinic Physician
POCT Contact Staff Contact Member
Nursing
Member
Purchasing
Member
Administration
Member
Fig. 1. Organization chart for POCT management in a hospital.

6. 898 NICHOLS
interferences can vary significantly. Glucose meters, for instance, can gener-
ate widely disparate results compared with core laboratory methods in pa-
tients who have ketoacidosis. This effect is noted in meters from many
manufacturers and is more than a matrix difference (ie, capillary versus ve-
nous sample). Most importantly, the differences are noted in the same spec-
imen and tend to resolve as the patient is hydrated and ketoacidosis declines.
Transcutaneous icterus devices generate comparable estimates to total se-
rum bilirubin, except when bilirubin is elevated (O12 mg/dL). These icterus
devices are contraindicated in premature infants, babies undergoing photo-
therapy, and certain ethnic groups with dark skin. Conversely, bilirubin and
glucose analysis using serum or plasma in a core laboratory do not have
these types of issues. Therefore, implementation of POCT devices must con-
sider the test limitations, and the quality assurance program should ensure
that the test is not used in patient populations that are contraindicated or
known to generate misleading results.
These cases illustrate the need for evaluating a POCT device in the spe-
cific patient populations in which the test is intended to be used. If limita-
tions and differences between POCT and core laboratory methods are
known before use in patient care, steps can be taken to prevent the misinter-
pretation of test results. For instance, prior knowledge of glucose meter is-
sues in patients who have ketoacidosis would raise concern about the use of
a glucose meter to screen patients in the emergency room. During triage,
routine screening of all patients could generate misleading results in patients
who have ketoacidosis. A physician should examine emergency patients for
symptoms of ketoacidosis before testing with a glucose meter. By examining
patients before testing, staff can ensure that this problem is prevented. An
alternative practice could screen patients for positive urine ketones before
the use of a glucose meter. Thus, implementation of POCT requires the
selection of devices that match patient care needs, as well as appropriate
deployment to ensure quality results and prevent known limitations.
Standardization of POCT technologies can help to improve quality in
multiple ways. Use of a single manufacturer or device may allow for sharing
of one policy and procedure across multiple sites. Training is simplified, be-
cause one common checklist can be used. Testing also is more consistent,
because staff who float between sites will not have to remember the opera-
tion of the same test from different manufacturers, each likely to have dif-
ferent testing protocols. Most importantly, test interferences and result
differences are minimized by limiting the number of unique devices in use.
In summary, standardizing to a single POCT technology (eg, a single glu-
cose manufacturer or single pregnancy test) is the most important step
that an organization can take to improve quality. By preventing sites
from randomly implementing POCT devices and narrowing each test to
a single device/manufacturer, testing will be uniform, and patients will expe-
rience the same test as they move from one site to another within an insti-
tution or health system. This ‘‘continuity of care’’ is a key goal in health

7. POINT OF CARE TESTING 899
care that is being stressed by the Joint Commission and the College of
American Pathologists (CAP) in their hospital and laboratory
accreditations.
A POCT committee consisting of multidisciplinary membership can help
to facilitate the standardization of POCT technologies in an institution by
providing a forum for review of new test requests, establishment of sys-
tem-wide policies, and discussion of POCT issues (see Fig. 1). Committees
composed of laboratory, physician, and nursing members provide balance
and viewpoints from different perspectives. The laboratory is knowledgeable
about test limitations and quality assurance/control processes. Nurses con-
duct the testing and have operational concerns to bring to the table. Physi-
cians use the POCT results in patient management and will have issues
regarding clinical interpretation of POCT. Additional members are useful,
depending on the issues being debated, and could include purchasing, ad-
ministration/budgeting, pharmacy, and hospital quality improvement. For
example, the POCT committee is important to resolving conflicts involving
POCT and depersonalizes the responsibility of decision-making from a single
individual to an entire committee. Selection of a device for hospital use may
involve evaluation of the device and review of the data by the POCT com-
mittee for approval/disapproval or limitation of use. The POCT committee
could review the data for a transcutaneous icterus device and limit its use to
the well baby nursery, because this device is known to not perform well in
premature infants (ie, preventing its use in the neonatal ICU). This would
be a committee decision to set a hospital policy of where and how the device
would be used. Physicians who are not comfortable with this policy could
address the committee, rather than directing comments to any single indi-
vidual. Therefore, the POCT committee assists in management by offering
a forum for discussion of issues and establishes consensus-driven decision
making.
Point of care testing and the environment
Unlike laboratory testing in the well-controlled and monitored environ-
ment of a core laboratory, POCT takes place in a variety of settings and
conditions. Many POCT kits contain reagents that are sensitive to heat,
cold, light, and moisture. Consumers need to be aware that storage and
use conditions can affect the quality of results. In most cases, however, com-
promised reagents still provide results, although perhaps not always accu-
rate ones.
Care must be taken in shipping so that tests kits do not freeze or become
overheated. Pregnancy tests contain protein antibodies that can be dena-
tured at high and low temperatures. Freezing during ground transportation
in the winter months and cooking the reagents during summer months can
affect test performance. Blood gas cartridges contain liquid reagents that are
calibrated to known levels of gases. Extremes of environment, freezing and

8. 900 NICHOLS
heating, can alter tonometered blood gas levels. On arrival in the clinic or
hospital, test kits should be checked for appropriate function by analyzing
specimens with known values, such as quality control solutions or previ-
ously analyzed patient samples.
Tests should be stored as recommended by the manufacturer under tem-
perature- and humidity-controlled conditions. Urine dipsticks contain
chemicals that are degraded by light, heat, and humidity. These tests should
be stored in dry cabinets and not near sinks, patient restrooms, or other
sources of moisture. Caps should be replaced and tightly covered after use
to prevent humidity in the air from contacting the dipsticks. Occult blood
cards also are sensitive to light, heat, and humidity. These cards should
be stored in a dark, dry cabinet away from windows, radiators, and other
sources of light and heat.
The environment also can affect POCT analysis, and staff should be
aware of potential environmental factors that can impact test results. Fluo-
rescent lighting, for instance, can affect color discrimination on urine dip-
sticks, so development is recommended under bright incandescent lighting
conditions. Visiting nurses who perform health care in patient homes often
use POCT devices. Care needs to be taken to protect the tests from the en-
vironment. Tests or kits left in the trunk of a car or back of an ambulance
can freeze in the winter and cook in the summer months. Devices like glu-
cose meters have internal checks within the device that prevent analysis if
the temperature or humidity is too low or high. These checks, however,
only monitor the electronics of the device and not the chemistry of the
test strips. Staff needs to be aware that the test strip and the device combine
to form a result, and quality requires managing the exposure of the strip and
device to environmental extremes. Blood gas devices are calibrated at sea
level. Performance of POCT at higher elevations, in helicopters, or in pres-
surized airline cabins can affect the calibration and bias patient results. The
manufacturer should be consulted if blood gas analysis is going to be con-
ducted in different locations or during mobile transport. Thus, a variety
of environmental factors that can affect POCT results should be managed
to ensure quality test results.
The point of care testing operator
Analytical technique can affect the quality of POCT results. Although
most core laboratory instrumentation is highly automated and nearly inde-
pendent of operator technique, POCT uses predominantly simple devices or
manual, visually interpreted colorimetric tests that are reliant on consistent
technique. Even when following manufacturer instructions, problems can
arise. Samples can be collected in the wrong anticoagulant, and delays in
analysis can lead to clots. Bubbles can be injected into analyzers, and blood
gas specimens can be exposed to air. Too much or too little sample can be
applied. Tests can be overtimed or undertimed. Staff can program devices

9. POINT OF CARE TESTING 901
with the wrong lot-specific calibration codes. Although some POCT devices
have internal control mechanisms to detect bubbles, clots, sample flow or
volume, and other common operator variables, these issues are primarily
unintentional and not recognized by staff during the testing process. This
is a prime opportunity for staff education and creates a continued need
for maintaining staff competency on a periodic, or at least annual, basis.
The large number of staff involved in POCT creates an even greater chance
for variability.
Manual and labor-intensive methodologies do not prompt staff from one
step to the next step, allowing for procedural errors and the opportunity to
take short-cuts. Although laboratory professionals consider POCT devices
to include glucose, pregnancy, rapid strep, and other ‘‘diagnostic’’ tests,
physicians and clinical staff are more familiar with medical devices, such
as scales and thermometers, that they consider POCT devices. The major
differences among scales, thermometers, and glucose meters are that staff
has fewer steps and decision making involved with medical devices. The pa-
tient stands on a scale, and the physician assumes that the device gives the
correct weight. Staff may need to zero the scale periodically, but the physi-
cian does not need to check expiration dates, monitor refrigerator tempera-
tures, check lot numbers and calibration codes, analyze quality control
specimens, determine whether quality control is successful, and troubleshoot
if quality control is not successful before obtaining a patient result. These
several actions may seem inconsequential to a laboratory-trained individual,
but are not routine at all for a clinician. These activities actually remove the
clinician from his/her primary responsibility of patient care.
Automation can reduce the potential for error. Devices that decrease the
number of steps required to obtain a test result, prompt operators, or reduce
the staff decision-making process can reduce the potential for mistakes.
Newer POCT devices are computerized with electronic data capture that
is capable of storing and transmitting results automatically to laboratory
and hospital information systems. These devices can capture the date,
time, operator identification, patient identification, meter serial number,
and test lot number/expiration dates with every patient test result and store
it in relation to the quality control performed on that device. Computerized
devices can store a list of trained operators and request operator identifica-
tion before allowing patient testing. If the identified operator is not on the
authorized list, the device prevents untrained individuals from performing
patient testing. Computerized devices also can require the analysis of two
levels of quality control every 24 hours. The device compares quality control
results against the expected target ranges and can interpret whether control
results are successful or unsuccessful. These features assist with regulatory
compliance by ensuring result documentation, performance of testing by
trained operators, and daily quality control; however, these features also
help staff to perform testing by prompting staff with each step of the analysis
and by interpreting quality control results and taking appropriate action

10. 902 NICHOLS
(allowing patient testing if successful and lock-up preventing patient testing
and requiring repeat control analysis if unsuccessful).
Automation of POCT devices also can help with data entry. Manual in-
put of multiple numbers for operator and patient identification presents an
opportunity for transcriptional errors. Computerized POCT devices have
barcode readers that allow automated reading of operator barcodes and pa-
tient barcoded wristbands. Barcoded data significantly reduce manual data
entry errors in institutions implementing these systems [11]. Barcodes also
have the potential to assist with positive patient identification if the device
can provide a confirmation of the patient’s name after scanning the identi-
fication number; however, few current POCT devices have the memory or
wireless connectivity to offer this advanced positive patient identification,
and this certainly is a feature to watch for in the next generation of devices.
Training with ongoing competency checks is fundamental to ensuring
quality test results. Staff operators of POCT devices should receive training
specific to the device being used. Familiarization of test technologies in nurs-
ing or medical school does not substitute for in-depth training on the
method intended to be used for patient care. A CAP Q-Probes survey of
hospital blood glucose programs that demonstrated the most significant
levels of continued improvement over time focused on operator training
[12]. These programs used standardized training materials, such as video-
tapes, as part of the training and repeated training and review of perfor-
mance at scheduled intervals. These programs also compared results
regularly between point of care devices and central clinical laboratory test-
ing and used computerized data capture in POCT devices to manage control
and patient data [12].
In summary, POCT is dependent upon operator technique. Training and
ongoing verification of competency are important. Current CAP and Joint
Commission regulations require ongoing competency by observation of
technique, written examination, analysis of quality control or specimens
with known values, demonstration of maintenance, recording of test results,
and evaluation of problem-solving skills. These skills should be checked
initially, at 6 months, and annually after training. Use of devices with
automated data management features can assist staff in appropriate test
performance and help with regulatory compliance.
Integration and communication
POCT is not an isolated process and should be integrated with patient
care pathways. The laboratory is blamed often for delays in patient manage-
ment, particularly in the emergency room, preoperative and procedural
areas of the hospital, and outpatient settings that are remote from a core
laboratory. POCT is seen as one means of obtaining faster test results and
reducing patient bottlenecks in the system. Unfortunately, just providing

11. POINT OF CARE TESTING 903
a faster test result does not guarantee improved patient outcomes. Manage-
ment pathways also must change to better use the faster result. Consider
point of care glucose testing where the physician has created a standing or-
der for testing every hour but then leaves the nursing unit to attend to other
patients. The advantages of obtaining a faster result are lost if the staff must
look for a physician to take clinical action. If staff had a management pro-
tocol available, they could take action immediately upon receipt of the test
result by altering insulin dosage or administering food or intravenous
glucose.
The link of POCT with patient outcome was examined in a study con-
ducted in the cardiovascular/radiology setting [13]. Patients were requested
to arrive 2 hours before procedure for preparation; however, despite arriv-
ing early, procedures frequently were delayed because laboratory results
were unavailable. These delays resulted in open operating rooms, changes
in physician scheduling, and stress and dissatisfaction for staff and patients,
with the laboratory being blamed. Before a procedure, patients required cre-
atinine and electrolytes to allow dosing of radiologic dyes, and coagulation
testing was required to assess for postprocedure bleeding tendency after re-
moval of indwelling catheters after the procedure.
POCT was seen as the optimal solution; however, implementation of
POCT did not result in the expected improvement in outcome (ie, meeting
scheduled procedure time). Improvement was noted only after changes
were made in the overall procedure scheduling and management. Intercom
systems that communicated between staff in the procedure rooms and staff
preparing patients allowed for better timing and preparation of patients
with rooms that were becoming available. POCT was only one of many
steps that needed to be accomplished before a procedure could be started.
A delay in any step could lead to delays in the final outcome, meeting the
scheduled procedure time. Once the patient preparation management path-
way was streamlined, significant improvements in meeting scheduled proce-
dure times were accomplished [13].
Therefore, implementation of POCT must be linked to changes in patient
management to improve outcomes. The cardiovascular/radiology example
illustrates that laboratory testing is only one component of a complex path-
way of care that ultimately leads to the patient outcome. Improvement in
one step of the pathway does not guarantee improved outcome without con-
sidering all of the other aspects of care, and, in this case, other sources for
delays.
Communication is fundamental to achieving the desired improvements.
All staff needs to understand the total pathway to relate their individual
role within that pathway of care. Unfortunately, physicians and laborator-
ians have different understandings of the role of POCT in the patient care
pathway. Physicians view POCT as the same test as core laboratory
methods, only faster, whereas laboratorians understand that POCT is a dif-
ferent methodology, with inherent precision and accuracy biases and unique

12. 904 NICHOLS
limitations. Both perspectives are required in the development of patient
care pathways and optimizing the delivery of patient outcomes.
Although physicians simply may want to use their same treatment cutoffs
and guidelines between core laboratory and POCT technologies, laborator-
ians understand that these treatment protocols may need to be modified
based on the technical performance of the POCT method selected and its
agreement with the core laboratory. As an example, POCT creatinine was im-
plemented in a hematology/oncology clinic to allow more rapid dosing of che-
motherapy and reduce patient wait times [14]; however, despite the POCT
and core laboratory using the same creatinase (enzymatic method), the
POCT method categorized more patients as having abnormal renal function
compared with the core laboratory. This would have resulted in significantly
different dosages of chemotherapy in the same patient depending on whether
POCT or core laboratory results were used. Ultimately, the pharmacy had to
change the management cutoffs based on the test method to ensure compara-
ble dosing between the core laboratory and POCT methods [14].
These test differences indicate the need to clearly communicate and dis-
tinguish the methodology of the test with the result. It is not sufficient to
write a ‘‘creatinine’’ result in the patient’s chart without distinguishing
whether the result was ‘‘POCT creatinine’’ or ‘‘core laboratory creatinine.’’
The adoption of electronic medical records emphasizes even more the need
to consider unique test methodologies when fields are established in the
medical record. Electronic records have the ability to be distributed and ac-
cessed widely in a health system, with staff adding test results from the core
laboratorydas well as physician office practices, inpatient POCT, and home
nursingdto the same record. Test results can be separated by name (eg,
POCT glucose, laboratory glucose, blood gas glucose); however, CLIA reg-
ulations also require the location and laboratory director of the test to be
linked to the final test result. Because locations with different addresses
can have unique CLIA certificates, a patient’s medical record in a large in-
stitution easily could have dozens of different test names (eg, inpatient
POCT glucose, laboratory glucose, Dr. Smith’s glucose, Dr. Jones’ glucose,
Dr. Miller’s glucose).
Because this could be confusing to the physician interpreting the test,
some institutions have simplified the complexity of this problem by separat-
ing testing into two test fields: POCT and core laboratory methods. Core
laboratory methods generally are resulted through an instrument interface
from a laboratory information system and automatically tagged with the
laboratory director and appropriate CLIA certificate. POCT results, how-
ever, can be entered electronically or manually. Electronic entry can be han-
dled the same as laboratory test results by automatically linking the
appropriate CLIA-required information. Manual data entry necessitates
the staff to remember to enter the appropriate information with every test
result. This task can be simplified by just requiring staff to select their loca-
tion from a dropdown screen before a test can be resulted (Fig. 2). This

13. POINT OF CARE TESTING 905
Fig. 2. Sample POCT result form for pH test reporting to a patient electronic medical record.
POCT result form contains fields for selecting positive or negative results from amniotic fluid
pH (with appropriate reference intervals) or free text fields for reporting numerical results
and comments. This POCT form requires selection of the site location linked to the site’s
CLIA certificate (Organization/CLIA#) before results can be verified and reported to the pa-
tient medical record. Staff enter the test result with any comments in the appropriate field,
and select the testing location from the dropdown menu to attach the appropriate CLIA certif-
icate to the POCT result. The patient’s electronic record will display only the test result; by
right-clicking the mouse, staff can view associated comments and test location/CLIA certificate
information required for regulatory compliance.
dropdown screen is linked electronically to the required information, cur-
rent CLIA certificate, and director and ensures that every test captures
the necessary information to interpret the test result and meet regulatory
compliance. By setting up the system to require the location with every re-
sult, staff is automatically prompted and cannot complete the task without
the necessary location information.
Clinical pathways and management protocols are a good means of assist-
ing physician interpretation and bridging the laboratory–clinical communi-
cation gap. Resources are available to assist the development of clinical
practices and pathways of care. The National Academy of Clinical Bio-
chemistry (NACB) has conducted a systematic review of the scientific liter-
ature linking POCT to patient outcome and published Laboratory Medicine
Practice Guidelines titled ‘‘Evidence-based practice for POCT’’ [15] (avail-
able at www.nacb.org). These peer-reviewed guidelines represent a consensus
of best practices from the literature.
Use of these guidelines helped to revise a chest pain pathway for the man-
agement of patients in the emergency department (Table 1). Before revision,

14. 906 NICHOLS
Table 1
Laboratory testing performed as part of an emergency department chest pain care pathway.
Testing has been streamlined and relies on the cardiac-specific troponin marker over creatinine
kinase. Revision of this pathway defines a 6-hour end point for patient disposition and de-
creases the number of phlebotomies and amount of blood
2001 2004
At presentation (hour 0) At presentation (hour 0)
Stat troponin Stat troponin
CK (reflex CK-MB) Automated complete blood cell count
Automated complete blood cell count Chemistry panel
Chemistry panel Electrolytes
Electrolytes Serum urea nitrogen
Serum urea nitrogen Glucose
Glucose
Serum hold tube
Hour 3
CK (reflex CK-MB)
Hour 6
Stat troponin qualitative (POCT)
Lipid panel (or fasting preferred)
Hour 9
Troponin
CK (reflex CKMB)
Repeat every 3–6 hours until discharge
Discharge or admission
Lipid panel (or fasting preferred)
patients with chest pain would receive ECG, physical, and laboratory testing
on presentation to the emergency department for glucose, electrolytes, cell
counts, urea nitrogen, and creatinine. Cardiac marker testing included initial
total creatinine kinase (CK) and cardiac-specific muscle/brain isoenzyme
(MB) fraction if total was elevated plus troponin. Extra tubes of blood
were collected and held in case additional testing was required. The total
CK/CK-MB was repeated every 3 to 6 hours, with troponin added every
9 hours until the patient was admitted or discharged. After review of the
NACB practice guidelines for cardiac markers published in 2002 in conjunc-
tion with the American College of Cardiology [16], the chest pain pathway
was streamlined so that the cardiac marker test consisted of just an initial
qualitative POCT troponin followed at 6 hours with a quantitative troponin
test. The revised protocol defined admission if any of the diagnostic tests
were positive (ECG or laboratory) and an end point for discharge at 6 hours
for two negative ECGs, two negative troponins, and a negative stress test.
The qualitative POCT provided a fast, initial result that the clinicians could
use to manage the patient rapidly on presentation to the emergency room,
followed by a more definitive laboratory troponin at 6 hours to decide on
discharge. Less blood was collected from patients, and fewer tests were con-
ducted (eliminated reliance on multiple timepoints of CK/CK-MB). This
pathway also assisted physicians in ordering the right test (POCT versus

15. POINT OF CARE TESTING 907
laboratory testing) at the right time in the patient’s care (admission versus 6
hours postadmission) and standardized clinical management, thereby reduc-
ing practice variation. By embedding this pathway into an electronic order-
ing system, test ordering can be standardized for patients with the same
diagnosis. This pathway improves consistency of care and enhances commu-
nication between the clinician and the laboratory, because the physician
knows when to order the right test for the patient and the laboratory now
knows why a test is being ordered and can relate the test back to the point
in a pathway of care for that patient. Recent revisions of the NACB cardiac
guidelines relating to POCT are included in the recent ‘‘Evidence-based
practice for POCT’’ guidelines, and all of the published NACB practice
guidelines are available through links from the National Guideline Clearing-
house at Agency for Healthcare Research and Quality (AHRQ) (www.
guideline.gov).
Summary
POCT offers the potential for fast test results and more rapid patient
treatment; however, concerns over the quality of test results and difficulties
in managing the documentation from multiple sites, operators, and devices
have created challenges to the widespread adoption of POCT. Practical
management of POCT requires an organizational structure with defined
staff roles in the supervision of testing and day-to-day operation. There
are multiple sources of potential error in POCT, including environmental
and operator factors. Development of an overall quality assurance program
for POCT should consider the entire preanalytic, analytic, and postanalytic
phases and use computerized device features to automate manual steps, sim-
plify the testing process, and reduce necessary decision making. POCT is
a different methodology from core laboratory testing, and the laboratory
needs to establish effective channels of communication with the physician
to distinguish test results, highlight test limitations, and assist with result in-
terpretation. Pathways of care and management protocols help with com-
munication and standardize practice. Resources are available through the
NACB Laboratory Medicine Practice Guidelines and National Guideline
Clearinghouse to help use POCT in the most effective manner for improving
patient outcome.
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