le01.jpg (11657 bytes)Advances in point-of-care (POC) testing instruments can dramatically improve the way physicians do business. New devices that perform a broad menu of routine chemistry and hematology testing, along with built-in quality control and connectable data-management instruments, enable physicians to add to or improve an in-house laboratory, thereby saving time and offering better patient care.

In 1988, the Clinical Lab Improvement Amendment (CLIA) made regulatory compliance more difficult and costly for all types of lab testing systems, but existing POC devices were particularly hard hit. Most were not equipped to comply with the new, stricter regulations. Because of past regulatory difficulties, many physicians with office laboratories halted their in-housing testing in favor of sending patient samples to hospital or reference labs.

Though it’s routine for physicians to use outside laboratories for patient testing today, the practice can be costly. In a typical physician office setting, patient samples are obtained during an initial office visit or via an off-site blood drawing lab. The specimens must then be documented, prepared, packaged and sent by courier to a receiving lab. Each sample preparation step takes time, costs money and sometimes results in sample deterioration or even lost specimens.

The turnaround time on results can take several days. When test results do return, doctors must refocus their attention on the patient’s history, exam and test results, and then form a treatment plan — a process that can take 10 to 15 minutes per patient. Since physician time is costly, it’s wise to ensure most of it is spent seeing patients.

Meanwhile, patients are sent home to wait for a return visit or a phone call from office staff, a step that often negates the patient’s opportunity to ask the physician questions. This delay and lost opportunity can decrease patient satisfaction and may lead a patient to seek care elsewhere.

Physician office lab testing benefits
Primary care providers have started to recognize that the faster turnaround times afforded by point-of-care testing can reduce patient morbidity, increase efficiency and patient satisfaction and reduce the total cost per patient, according to Sheila Dunn, M.D., a physician office lab (POL) consultant with Quality America in Asheville, N.C. On-site testing allows physicians to receive results quickly for faster diagnosis and treatment protocols, Dunn said. Patients can receive physician counseling during their first office visit, when they are most receptive. If necessary, drug therapies and/or lifestyle changes can be implemented before the patient leaves the office, saving time and money for physicians and patients.

The financial picture for on-site POL testing certainly has brightened, according to Charles Root, Ph.D., president of a Chicago market research and consulting firm specializing in laboratory economics. His projections show that a well-run POL could produce an annual profit margin of 40 percent or more, with four to five physicians earning up to $200,000 per year. The actual amount would depend on payer mix, practice philosophy and the testing volume. Some solo practitioners with a POL cite as much as $50,000 in annual income from lab fees. Today only about 10 percent of U.S. physician offices perform their own testing, but that number is expected to grow as less expensive technologies become available.

Comparing costs
In most current POL settings, physicians rely on chemistry analyzers, which cost up to $60,000, and hematology instruments that run from $12,000 to $20,000. Tests run on these wet-reagent systems cost from 15 cents to $1 each, but they also require a highly skilled medical technologist to run the tests and perform QC checks. Quality control alone can constitute up to 30 percent of a lab’s total costs. Often, tests are run in batches, which means prolonged waits for physicians and patients.

A new generation of POC instruments offers physicians with in-house labs a cost effective and easy-to-use alternative to expensive analyzers. One such alternative is the Careside System from Careside Inc., in Culver City, Calif. It is comprised of the Careside Analyzer, its companion desktop automatic hematology unit, the H-2000, and the Careside Connect, a data acquisition and management system. The self-calibrating analyzer offers the broadest test menu of any POC instrument on the market, can run up to eight tests at a time and provides results in four to 12 minutes. It currently has 40 FDA-cleared or exempt tests in the categories of chemistry, electrochemistry, hematology and coagulation.

Together, the analyzer and its hematology unit, which sell for $19,000, run the 50 or so assays that comprise the majority of blood tests ordered by clinicians. The dry, cartridge-based system employs three measurements: spectral transmittance, reflectance and electrochemical — the same “gold standard” formats used by large hospital and reference lab analyzers.

At first glance, the $3 test cartridges seem to cost more than a typical wet reagent test, but “cost per test” analyses for traditional analyzers do not factor in the hidden expenses of daily quality control, expensive personnel and time-consuming batch testing. When a more accurate “cost-per-reportable result” measurement is utilized, small, fast POC instruments can prove profitable for even small medical practices.

Software on the analyzer governs testing of one patient at a time, interprets data, flags abnormal limits, performs QA/QC documentation and conducts all test ordering. The system captures most of the data required to comply with CLIA and contains a CLIA-compliant security system. After 30 minutes of training, non-technical personnel can operate the system.

The $3,000 Careside Connect data acquisition and management system collects and interprets data from any medical device with an active serial port. It then interfaces that data within the POL setting or to any clinical information system.

Technologically advanced point-of-care testing systems offer physicians group practices the opportunity to operate their own office laboratories as a profit center. These physician office labs can decrease costs, increase profitability and efficiency and, most importantly, improve patient care and satisfaction.

W. Vickery Stoughton is chairman and CEO at Careside, Inc., in Culver City, Calif.