By Gary Tufel

Some physicians, and particularly physician groups, are finding that doing part or all of their lab testing in-house is a good way to improve patient care and enhance the bottom line. Physician’s office labs (POLs) range from the basic to the elaborate; some even do testing for other doctors. The compact size of many lab instruments makes testing in POLs feasible even in smaller offices. In addition to offering speedier test results and the opportunity for increased profits, POLs lessen the chances of lost or deteriorated samples. Lost or deteriorated samples are a possibility when samples are sent to off-site labs, according to Debby McLemore, BA, MT (ASCP), who has been managing and supervising POLs for the past 18 years.

 Biosite’s Triage BNP Test is performed on the Triage MeterPlus.

Lisa Wikstrom, physician office segment director for Biosite Inc, (San Diego) says POLs run the gamut. Those that operate under a moderately complex (nonwaived) Clinical Laboratory Improvement Amendments (CLIA) license often comprise around three doctors. “Our experience indicates that a pediatric practice needs at least three doctors to have enough patients to warrant the requirements associated with a moderately complex license,” says Robb Morse, support and marketing manager, blood lead products, ESA Inc (Chelmsford, Mass). “Whether to have a POL depends on the number and type of tests performed and the access to reimbursement.” Physicians who opt for POLs like the immediate access to results and the additional revenue. Those who decide against them usually do so because they just want to treat patients, and also because cost-benefit analyses may show them not to be beneficial, Morse says.

McLemore has relied on several benchtop analyzers in POLs, and her lab uses every inch of space in the converted exam room it occupies. Some of the instruments, though suitcase-sized, are multifunctional and high-volume, and therefore space-efficient.

Why POLs?
POLs in and of themselves are not profit centers to the extent that they used to be, says Ron Blasig, director of marketing for Abaxis Inc (Union City, Calif). But they make physicians more profitable indirectly by streamlining the testing process, which positively impacts staff efficiencies and increases patient satisfaction. Faster lab results enable physicians to review patient files and discuss results earlier face-to-face with the patient. Physicians save the time they would normally have taken before or after business hours to review lab tests. The POL profit picture is no longer based exclusively on reimbursement, but in combination with these other very important factors, Blasig says.

The decision to have a POL or not starts with the desire to provide better patient care, and includes an examination of the financials behind it, says Wikstrom. And the CLIA requirements, mandated by the government in 1988, also play a role in the decision. Many manufacturers can provide guidance through the CLIA setup process. Don DuBois, general manager of HemoCue Inc (Lake Forest, Calif), says that CLIA is the biggest factor for doctors in determining if they want to set up their own labs. “It’s pretty easy to have a CLIA-waived lab, and most POLs are waived,” he says. That status is desirable because there’s little inspection, only a small staff is required, and test results are obtained quickly. Some POLs are moderately complex, says DuBois, but he knows of very few that are high-complexity.

In the 1980s, before CLIA, most companies made sure their POL instruments were error-free with established quality control (QC) procedures, says Blasig. But the analyzers tended to be big and very hands-on. CLIA imposed inspections and more rigorous requirements for QC and personnel; this resulted in more testing referred out to commercial and hospital labs.

“Now, physician office testing has come full circle,” Blasig says. New microelectronic and microfluidic instruments are smaller and easy to use, and offer excellent performance and quality control; therefore, more physicians are setting up POLs. “Physicians have to be efficient to see more patients and provide more services. POLs enable them to effectively manage their patient loads and provide a value-added service to gain new patients and hold onto existing ones. Patient satisfaction is very much on physicians’ minds.”

The POL/Reference Lab Relationship
Are reference labs worried about POLs? DuBois says lab testing is a cooperative effort. POLs are good for physicians’ offices because they give quick results, but reference labs have much more complex testing to do. Clas Runnberg, director of marketing and business development for HemoCue AB in Sweden, says that the revenue value of POLs is relatively small, even though the volume may be high, so reference labs aren’t worried. In some ways, POLs actually free up reference labs. For example, if a patient presents with fatigue but no other symptoms at a doctor’s office, a simple hemoglobin test can tell the physician whether it’s safe to send the patient home rather than to an emergency room.

And Wikstrom says, “POLs aren’t necessarily taking volume away from reference labs.” She sees POLs as a way for doctors to provide more responsive patient care.

Testing Handled by POLs
Some labs focus on one POL test. For those that do blood lead testing, ESA has two blood lead testing platforms: one designed for the clinical laboratory, and one for the POL. The primary exposure path to lead poisoning is dust and chips from lead paint, Morse says. Typically, although paint has not been made with lead for years, children who live in older buildings ingest the lead from paint peeled from walls and windowsills. The market for ESA’s LeadCare instrument is pediatricians; in the United States, testing is mandatory for all Medicaid children at 1 and 2 years of age, and several states have additional requirements that apply to some or all of their pediatric population. The LeadCare system is widely used in states that are “lead friendly”—that is, those that require stringent lead testing for children and reimburse for it, Morse says. Where private health care fails, many public health departments are stepping in, he says. Lead poisoning has decreased greatly, but there are pockets of the country that are 20 years behind the curve. Lead testing, sponsored through the Centers for Disease Control and Prevention, carries reimbursement for doctors who perform it.

A thriving POL market is cardiology. Wikstrom says Biosite’s main POL focus is on a diagnostic test to identify congestive heart failure patients: the Triage BNP Test, a blood-based immunoassay that measures BNP. “Heart failure can be a very challenging diagnosis, because the symptoms can be confused with lung disease and a number of other causes. BNP allows diagnosis to be made in the doctor’s office,” Wikstrom says. The Triage BNP Test measures approximately six drops of whole blood or plasma, and needs only about 15 minutes to provide results.

“Patients in the early stages of heart failure can be asymptomatic,” Wikstrom says. “When a patient is feeling fatigued, he or she may go to the doctor’s office; or if they’re short of breath, they may go to the ER. In either case, the Triage BNP Test, which is moderately complex, is used for diagnosis and assessment of disease severity. The instrument used in both places is the same. It’s about the size of a telephone, easy to use, and walks the user through the process.”     

Early detection of kidney damage, cardiovascular disease, and other major diseases is the future of the POL, DuBois says. Diabetes exists in epidemic proportions, so testing for it will be huge, he says. HemoCue is introducing a quantitative urine analyzer for detecting small amounts of albumin, DuBois says. The test offers evidence of kidney disease, and may be a marker for cardiovascular disease. This instrument should also qualify as CLIA-waived, he says. In addition, Runnberg says HemoCue offers a glucose device that is accurate enough to be used as a diagnostic and screening device and has been given a special CPT code. “It’s not just another meter,” he says. Lily Sunkin, marketing manager for HemoCue Inc, adds that the CPT code means additional reimbursement for users: $5.48 versus $3.27. That, combined with its multifunctionality, makes the instrument even more attractive to POLs. Runnberg notes that diabetes can lead to renal failure, which costs Medicare about $13 billion annually, about 5% of its total budget. This past January, Medicare expanded its coverage and reimbursement for diabetes screening, Sunkin says.

 The Piccolo from Abaxis performs routine blood tests on whole blood samples.

At Abaxis, the main POL product is the Piccolo‚ Point-of-Care Chemistry & Electrolyte System, says Blasig. Piccolo processes whole blood, serum, or plasma samples in self-contained, single-use reagent disks, and features fully automated processing and onboard data handling. It incorporates a process called iQC (Intelligent Quality Control), which checks the analyzer, the reagent disk, and the sample during each run to verify correct electronic and chemistry performance. He says the Piccolo enables any caregiver to perform routine blood tests on whole blood samples and obtain laboratory-equivalent results within minutes.

The Piccolo, originally designed for use in the space shuttle and introduced into POLs about 2 years ago, uses a 3-in-diameter disk with a bar code reader on top, and is about the size of a toaster. The disk goes into the analyzer (just like a CD player), the bar code is read, and complete chemistry panel results are provided in 12 minutes. The Piccolo is self-calibrating and meets the Clinical and Laboratory Standards Institute (formerly NCCLS) EP 18 guidelines for quality control. “Anybody can operate it,” Blasig says.

Many POL instruments are rated “moderately complex.” Testing personnel must have at least a high school diploma or equivalent with “documented training” appropriate for testing performed by the lab, McLemore notes.

ESA’s system of blood lead testing is one of those classified as moderately complex, says Morse. However, “All medical device manufacturers targeting a POL audience have the same goal: Increase the number of labs that can use their devices. So to service the POL market, products have to be waived. That’s the most important aspect,” Morse explains. Adds McLemore, the more tests that are run, the less expensive it gets and the more revenue is realized. Products with waived status are usually more desirable for labs, because those products tend to require less paperwork, and take less time away from patient care. Even in POLs licensed to run moderately complex tests, little decision-making and experience is required to operate the instruments. To justify the added responsibilities associated with a moderately complex CLIA license, labs must have high test volumes, Morse says.

To obtain waived status for their products, manufacturers apply for it and undergo testing and procedures; anything not approved is not waived. A key element in obtaining waived status is demonstrating a low risk of error for the product. Once approved, the final hurdle is a small clinical trial.

HemoCue’s hemoglobin 201 and glucose 201 instruments are used in large hospital labs as well as POLs. HemoCue’s approach is to manufacture products that are CLIA-waived, because they can be used in all lab complexity levels, but are easier to use than moderate- or high-complexity products. “We don’t want to restrict our market,” says DuBois. “We design them as simplistically as possible to meet waived status.”

Gary Tufel is a contributing writer for Clinical Lab Products.