Point Of Care Testing:
Issues, Answers and Future Challenges
(Part 1 of a 2-part series)
by Dr. Sheila Dunn
Reprinted with Permission from Physicians Marketplace
This is the first article
in a twopart series addressing new technology for point of care testing
(POCT). The decision to implement "nearpatient" testing involves
an analysis of economic and regulatory issues...and, there are no "one
size fits all" answers.
The two most important issues surrounding POCT are: 1.)
Regulatory requirements (CLIA in POLs and JCAHO/CAP in hospitals), and
2.) The economic impact of POCT (these tests cost more than their megalab
counterparts. Can you afford to do them? Will managed care plans pay
This first article in this series addresses the current
state of POCT and explores the regulations for this type of testing.
Next month's article will address clinical and economic issues which
determine, for the most part, whether POCT is feasible for a particular
Consider the following scenarios: One of the hospitals
where you are on staff uses a chemistry instrument that gives 4 test
results from a drop of fingerstick blood in 2 minutes. Another hospital
where you are on staff requires these same tests to be sent to the central
lab where results are available in hours. Can you persuade the second
hospital to adopt this test?
The ER at the local hospital uses a 5 minute test to
determine whether a patient has suffered a myocardial infarction. Is
this test available for office use? Will regulations allow you to do
HMOs require diabetic patients to be tested for Hemoglobin
A1c which you send to a local reference lab. Results are returned in
a few days. Can you do this test in your office? What are the regulatory
requirements? Can you come out ahead ñ or even break even on
The POCT Revolution
With myriad new testing devices on the market for both hospital and
physicians' office use, it's no wonder physicians have so many questions.
During the last two decades, innovations in technology put advanced
diagnostic tests within the reach of health care providers, enabling
them to give patients fast, accurate information about their health
status. Before that, most testing took place in settings with sophisticated
equipment and highly educated technical personnel.
In most US hospitals, a large portion of diagnostic testing
has moved from large central locations (e.g., the laboratory) to patient
rooms, emergency rooms and intensive care units. Although initially
skeptical of the accuracy of POCT instruments and test kits, clinicians
now embrace nearpatient testing that expedites proper treatment; decreases
patient morbidity; reduces length of stay; and lowers the total cost
The types of tests commonly performed at the point of
care both in hospital and physician office settings are shown in Table
TABLE 1: Types of Point of Care Tests
Clinical Laboratory Tests
- Chemistry tests for cholesterol, cardiac, liver, kidney,
- Drugs of abuse testing, therapeutic drug level monitoring
- Tests to detect infectious disease (strep throat,
sexually transmitted diseases, allergies, ulcers)
- Tests on urine and other body fluids, pregnancy tests,
- Hematology tests for anemia, leukemia, infection,
- Immunohematology tests for blood grouping and typing
- Electrocardiogram (resting ECG)
- Holter monitoring (ambulatory ECG)
- Exercise testing (cardiovascular stress test)
- Ambulatory blood pressure (24 hour blood pressure
- Pulse oximetry (during outpatient surgery or exercise)
- Spirometry (pulmonary function)
Prevalence of POCT: Clinical Laboratory Tests
More than half of all practicing physicians in the US perform officebased
lab testing ranging from simple urine tests to "hightech"
blood immunoassays for infectious disease. About onethird of visits
to primary care practitioners involve laboratory tests. Group practices
perform more testing than solo practices (60% versus 45%). Although
laboratory services account for less than 5% of the total healthcare
dollar, test results leverage much of providers' decision making such
as hospital admittance, referrals, and medications.
Figure 1. Lab Testing, By Type of Laboratory
158,000 Total Labs
* Includes clinics, long term care, surgery
centers, industrial facilities, schools, etc.
Prevalence of POCT: Physiological Tests
Physiological tests are used widely by physicians to diagnose and monitor
cardiac and pulmonary disease. In 1996, almost one million resting ECGs
were performed in physicians' offices in the US (Table 2).
TABLE 2: Selected Physiological POCT
|| Annual #
|| Resting ECG
|| Stress Testing
|| Ambulatory ECG (Holter Monitor)
|| Spirometry, baseline
|| Spirometry, Post BD
|| Pulse Oximetry
Source: HCFA, 1996 Medicare Statistics
In an ambulatory health care setting, diagnostic tests
- screen for a disease in certain highrisk populations
(e.g., glucose tests for diabetes); or
- more accurately confirm a suspected diagnosis (e.g.,
tests for strep throat or H. pylori for ulcers); or
- determine the progression of a disease (complete blood
counts for cancer, anemia or infection, as well as chemistry tests
for hepatic/liver function or cardiac/heart function); or
- monitor drug therapy (e.g., prothrombin time
test for anticoagulant levels).
Each provider uses a battery of tests to diagnose, monitor
or screen for diseases in his/her particular patient population. Test
mix and complexity differ in each POCT setting, based on the severity
of illness and case mix of patients examined.
In the hospital setting, POCT tests are often "stat",
i.e., rapid results are mandatory for immediate diagnostic intervention.
Examples are electrolytes, some cardiac assessment tests including ECGs,
renal and liver function tests, prothrombin time, and therapeutic drug
Regulations for POCT
All laboratory testing performed for the purposes of
diagnosis, monitoring, or treatment is regulated federally by the Clinical
Laboratory Improvement Amendments of 1988. CLIA requirements range from
onerous for very complicated tests (termed highly complex) to virtually
nonexistent for the simplest tests (waived).
Most tests designed for point of care use are in the
leastregulated waived CLIA category. A waived test does not have specified
quality requirements for the end user; rather, manufacturer's instructions
must be followed. Facilities that only perform waived testing pay a
fixed fee of $150.00 every two years.
Each physical location where testing occurs must have
its own CLIA license. Exceptions are those testing sites under the same
contiguous roof, such as different departments in hospitals.
Some states have their own regulations for lab testing,
such as Florida, Maryland, and Pennsylvania. These states do have quality
requirements for waived tests. Check with your state Department of Laboratories
if you wish to begin testing (Table 3).
TABLE 3: Agencies That Regulate POCT
- Health Care Financing Administration - call for state
Departments of Laboratories (410-786-3407)
- Joint Commission on Accreditation of Health Care Organizations
Further, many hospitals and provider networks choose
to be accredited by an organization such as the Joint Commission on
Accreditation of Health Care Organizations, which may also have more
stringent standards for this type of testing. (Table 3)
States and agencies that do have quality requirements
for waived tests likely require written procedures and daily or weekly
quality control testing. The latter needs to be taken into account when
determining the economic feasibility of testing in very low volume situations.
On the other hand, physiological testing such as ECGs
are rarely regulated. Although standards exist for mammography, most
other physiologic tests performed at the point of care are either performed
by providers, supervised by providers or by a licensed/registered technician
and no nationwide quality standards exist as they do for lab testing.
For those who wish to test at the point of care to achieve
better patient outcomes or superior patient satisfaction, regulatory
issues should be a nonissue.
So exactly when is a $5 glucose test less expensive than
a $0.50 glucose test? Next month's "Medical Practice Newswatch"
explores the clinical and economic factors surrounding POCT.
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