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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 for them?).

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 provider.

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 it?

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 cost?

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 per patient.

The types of tests commonly performed at the point of care both in hospital and physician office settings are shown in Table 1.

TABLE 1: Types of Point of Care Tests

Clinical Laboratory Tests

  • Chemistry tests for cholesterol, cardiac, liver, kidney, thyroid function
  • 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, infertility tests
  • Hematology tests for anemia, leukemia, infection, bleeding disorders
  • Immunohematology tests for blood grouping and typing in pregnancy


Physiological Tests

  • Electrocardiogram (resting ECG)
  • Holter monitoring (ambulatory ECG)
  • Exercise testing (cardiovascular stress test)
  • Ambulatory blood pressure (24 hour blood pressure monitoring)
  • 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

 POL  55%  87,500
 Other*  35%  
 Hospital  6%  8,800
 Referral  4%  5,500

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

 CPT  Service  Annual # Performed
 93000  Resting ECG  9,827,322
 93015  Stress Testing  1,036,384
 93230  Ambulatory ECG (Holter Monitor)  189,656
 94010  Spirometry, baseline  658,998
 94060  Spirometry, Post BD  546,526
 94760  Pulse Oximetry  1,031,990

Source: HCFA, 1996 Medicare Statistics


In an ambulatory health care setting, diagnostic tests help providers:

  • 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 monitoring.

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 (708-916-5600)

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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