pt01.jpg (9077 bytes)Little more than a decade ago, most physicians had in-office laboratories at their disposal, along with all the attendant benefits — quick turnaround time, better patient service, staff efficiencies and financial advantages. After implementation of the Clinical Lab Improvement Act (CLIA), many physicians opted to rely on outside reference laboratories for test results, sacrificing the benefits of a physician office lab (POL) because of concerns about the cost and hassle of regulatory compliance.

Today, however, the outlook is brightening for physicians who want to be able to do in-office testing. Some solo practitioners with a POL can cite as much as $50,000 in additional annual income from lab fees.

One key factor in the improved outlook for physician office labs is the vast technological improvement in point-of-care (POC) testing devices. While early POC devices offered only limited test menus that could not supplant physicians’ in-office need for routine tests, doctors now have at their disposal an instrument with a broad menu of these tests and results delivered in as little as four minutes. This instrument, the Careside Analyzer, is accurate, cost-effective, easy to use and simplifies CLIA compliance.

The instrument also provides several intangibles. Physicians have long recognized the medical advantages of getting quick test results, which enable them to immediately proceed to treatment. In a time of clamor for a Patient’s Bill of Rights, the ability to provide comprehensive lab results at the point of care eliminates the potential for medical errors that can accompany shipping samples to an outside facility. Moreover, delivering quick results obviates the need for worried patients to wait several days to find out what, if anything, is wrong with them — and what can be done about their condition.

Comprehensive, cost-effective
The Careside Analyzer is an alternative to the expensive and complicated desktop or floor systems employed in more POL settings. How can this be, given that the instrument is barely more than one cubic foot in size and sells for less than $14,000?

First, it can perform 38 FDA-cleared or exempt chemistry, electrochemistry and coagulation tests, far more than any other available POC instrument. Coupled with its companion H-2000 analyzer for hematology tests, the Careside System encompasses more than 50 assays and the great majority of commonly ordered tests. (Immunochemistry tests will soon be added to the menu.)

Second, the dry, cartridge based system with unit-dose testing provides results accuracy equivalent to those from larger, more costly instruments that use bulk wet reagents.

Third, even when per-cartridge cost is figured in, testing in this fashion is cost competitive with traditional POL setups. Any accurate measure of the true cost of providing lab results must look beyond a simplistic cost-per-test metric to consider the actual cost per reportable result. When this more accurate cost measure is used and when staff efficiencies from an easy-to-operate instrument are considered — the lab can become a profit center for even small medical practices.

Staff efficiencies are realized in several areas. With an instrument capable of running up to six tests at a time and delivering results in no more than 12 minutes, staff and patients are spared the inefficiencies of lab results delivered days later and communicated to the patient by telephone. Repeat office visits can be eliminated and therapy initiated when it is most effective, at the time the patient first meets with the caregiver. POC testing eliminates lost samples that can often require retests, while also eliminating the danger of medical errors that can result when patients’ samples are inadvertently mixed up by a courier or reference lab.

The Careside’s easy to use technology also can reduce office-staffing costs. Rather than requiring a highly trained, medical technician (as with more complex devices), the instrument can be operated by high school-educated, non-technical personnel with only 30 minutes of training. The touch-screen user interface accesses an embedded PC that automates many steps and requires minimal operator decision-making. Whole blood specimens necessitate only a semiquantitative transfer of sample to the testing cartridge, because channels within each cartridge automatically control sample preparation and application to the reagent.

The instrument’s companion data management system can transfer information to in-office computers and other information systems. The data screen provides numerous information fields, including date and time, patient information, test requisition, data retrieval, reference intervals and alert ranges. Built-in flexibility to perform individual tests or customized panels also makes it easy for POLs to meet the cost-control requirements of managed-care payers, who increasingly resist reimbursing for preset, overly broad panels.

CLIA compliance and the future
But what of those CLIA regulations that led so many physicians to drop their labs a decade ago? The Careside Analyzer provides most of the information and processes necessary for CLIA compliance. This includes testing documentation and sophisticated, embedded quality-control capabilities unique among POC devices. Reusable quality-control test cartridges can lower QC costs and simplify quality control performance. The instrument also aids in overall quality assurance by documenting and controlling the pre-analytical, analytical and post-analytical testing phases. For instance, the instrument automatically checks reagent integrity on every cartridge prior to performing a test.

Many observers believe that in addition to POL settings, the accuracy and greater ease of testing access will eventually enable sophisticated POC devices to replace some hospital core laboratories. Physicians are already adopting these devices for the POL setting. We may well see the day when high-volume, routine testing in some hospitals moves from centralized labs to the point of care. It’s a logical step toward better meeting patients’ and providers’ need for quicker, cost-efficient lab results in a time frame and setting when they can make the greatest contribution to better medical care.

Thomas H. Grove, Ph.D. is executive vice president and chief technology officer at Careside, Inc. in Culver City, Calif.

For more information on the Careside Analyzer, call 888-698-2273.