The breadth of outreach services now being offered to physicians by clinical laboratories has expanded beyond the basics to include nearly any test that can be ordered, with the exception of diagnostic procedures so specialized that the typical laboratory is not equipped to run them. Nonetheless, having such wide capabilities does not necessarily mean that a laboratory’s outreach program will derive the bulk of its revenues from them, despite their ability to attract referrals from specialists. Instead, the bread-and-butter tests are those that every primary care physician orders every day: basic cultures, urinalysis, chemistry, hematology, and screening for common chronic conditions.

The Outward Push

The pressure on hospital laboratories to obtain outreach customers has been building ever since it began with a rude awakening 25 years ago. At that time, Medicare’s Prospective Payment System changed the financial status of most hospitals by decreeing that a single payment for inpatient care would be made, based on the patient’s diagnosis. Suddenly, every additional test ordered for an inpatient Medicare enrollee was no longer earning money for the hospital; instead, it was costing the institution more. So was every additional day of an inpatient’s stay, so staying in the hospital for tests (once a common reason for admission) promptly became obsolete.

Administrators pushed laboratories to meet the sometimes contradictory goals of completing ordered tests as quickly and cheaply as possible. They also expected medical staff to cut inpatient testing to the bone, especially as private payors followed Medicare’s lead in skewing reimbursement rates to favor outpatient testing. Over the ensuing years, inpatient census averages dropped steadily as both admissions and lengths of stay decreased. Excess bed capacity was often converted for skilled nursing or rehabilitation, which were less likely to generate laboratory orders.

Nonetheless, the laboratory, with fewer inpatients to serve, had to remain prepared to cover the same range of tests as before, so it could rarely decrease its capabilities. The new ambulatory-surgery centers and outpatient clinics opened by many hospitals at this time took up some of the slack, but some instruments were often idle even if laboratory staff remained busy due to personnel cuts. Finance departments looked at laboratories and saw capabilities standing ready but not always fully used; they asked many laboratories to look outside the hospital for new revenue sources. Outreach business was (and still is) often the most viable answer to the problem of unused capacity.

The challenge, of course, is to compete for high-volume outreach business, since so many facilities are capable of doing the work. Customer service skills and state-of-the-art information handling go far toward bringing in new outreach customers and retaining established ones, but another key factor is the degree to which the laboratory is equipped to handle the work itself. The instruments and tests that follow can hone an outreach program’s competitive edge by making it possible to complete the work quickly, at a low cost per test, and with the least possible commitment of scarce staff time.

On the Market

BD Biosciences, San Jose, Calif, makes the BD™ HLA-B27 system for BD flow cytometers, including some that use the Mac® OS X operating system. The kit includes reagent and setup materials, along with everything needed for quick detection of the HLA-B27 antigen. The antigen is associated with ankylosing spondylitis, Reiter syndrome, inflammatory bowel disease, and psoriatic arthritis, making this test part of the diagnostic workup for a number of prevalent disorders. If it is paired with the BD FACS™ Loader option, the test can be run as an efficient walkaway procedure. The test uses erythrocyte-lysed whole-blood specimens and employs a qualitative, two-color, direct immunofluorescence method. Samples are analyzed automatically, and a detailed report is issued.

The COULTER® LH 755 Hematology Workcell from Beckman Coulter Inc, Fullerton, Calif, is intended to make high-volume hematology testing simple. In one workcell, it integrates advanced technology and automation capabilities to ensure accurate, reliable results. According to the company, its smearing technique (slide on slide) produces the best slide quality. Custom protocols and flexible stain options are available, along with a body-fluid application, the LH 750. Random-access testing means that presorting and batching are unnecessary, and stat samples can be given priority. Barcode use is optional, and an automated slide-preparation module is also a time-saver. AccuCount technology reduces false-positive results, along with the need for confirmatory testing.

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bioMérieux Inc, Durham, NC, offers BacT/ALERT 3D microbial detection using an automated system. This newest version of the classic colorimetric BacT/ALERT (in use for more than 15 years) handles blood, sterile body fluids, platelet quality-control testing, and mycobacterial cultures. A modular design saves space, and touch-screen operation makes the system easy to use. Automated identification and susceptibility testing can now fit readily in settings where this might not otherwise be practical. According to the manufacturer, the system has the lowest extant false-positive rate and quickest response time. Immediate bottle recognition eliminates handling errors, and flexible data management lets the system integrate easily into existing workflow.

Likewise valuable for adding new capabilities to small spaces is the Mini Incubator, available from Globe Scientific Inc, Paramus, NJ. This low-cost model is intended for microbiology and hematology, the company says, and has three shelf levels despite its small size. The corrosion-resistant chamber is visible through the door’s large viewing area, and a pilot light is visible so heating can be verified easily. The outside of the incubator measures only 28.5 x 28 x 33.5 cm, but the interior space available is 23 x 20 x 20 cm, yielding a chamber capacity of 9.2 L. The unit weighs 8.3 kg and has a temperature range of 5°C above the ambient temperature to 60°C, with a stability of ±0.6°C and a uniformity of 0.7°C (both at 37°C).

Instrumentation Laboratory, Lexington, Mass, manufactures the ACL™ 7000 Coagulation Analyzer for running fully automated d-dimer, heparin, and APCR-Leiden tests, among others, at low cost. Advanced optical technology is used in combination with the company’s HemosIL™ reagent line; together, they provide users with easy operation and high accuracy, dependability, and flexibility, the company says. The test menu includes clotting, chromogenic, and immunologic work, and a bidirectional interface permits automated testing using a host computer. An integral barcode reader and onboard quality control further increase efficiency. Other helpful features include autodilution, stored calibration, patient and quality-control databases, an alphanumeric keypad, and an optional external printer.

The QUANTA Lite™ CCP3 IgG ELISA, offered by INOVA Diagnostics Inc, San Diego, is used to differentiate rheumatoid arthritis from other possible diagnoses. This test, the company says, is more informative than the older tests that detect only rheumatoid factor because that is also found in many patients who actually have infections or forms of autoimmune disease other than rheumatoid arthritis. Because this disorder is both quite common and relatively easily mistaken for other diseases, the detection of the third-generation cyclic citrullinated peptide that this test allows is important in securing optimal and early treatment for patients. The semiquantitative ELISA uses serum, citrated plasma, or EDTA plasma and carries a CLIA designation of high complexity.

Inverness Medical Professional Diagnostics, Princeton, NJ, produces the Osteomark NTx Serum/Urine ELISA, which uses a standard format that requires no creatinine testing or correction. The company describes the test as simple and convenient, with no need for specialized instruments. Results (expressed as bone-collagen equivalents) are ready in about 2 hours and are highly reproducible, with low same-patient variability. Since a third of postmenopausal women (and about one of eight older men) are at risk for osteoporosis, a way of predicting the likelihood of bone loss is very valuable to clinicians who treat patients over 50 years old.

The COBAS Integra® 800 system is made by Roche Diagnostics, Indianapolis. It is intended to improve the efficiency of chemistry testing and reduce its cost, in part by emphasizing the best use of resources. In addition, it eliminates manual operations that are not necessary, the company says. System-control mechanisms (including Pipetting Integrity Check) are automated to reduce sample handling and the need to rerun tests. Maintenance, reconstitution, and startup are automatic, and the complete test menu is available around the clock. Barcode scanning tracks 68 reagent cassettes onboard at 8°C; the system can hold 150 samples and 3,000 disposable cuvettes. The system uses four technologies: photometry, turbidimetry, fluorescence polarization, and ion-selective potentiometry.

Siemens Medical Solutions Diagnostics, Tarrytown, NY, provides the Clinitek Atlas Automated Urine Chemistry Analyzer. In its carousel configuration, this benchtop instrument is a fully automated means of conducting high-volume urine testing using Siemens’ dry-pad technology. It loads 490 tests at a time and uses a continuous reagent roll to decrease handling. Sample preparation is simplified though built-in sensing of liquid levels and automatic adjustment to suit the sample’s volume. The company describes the instrument as easy to operate, with simple keypad functions and a menu-driven system that make it simple to learn to use it. A modular design also makes the unit easy to add to track-based automation systems.

VersaTREK, manufactured by TREK Diagnostic Systems, Cleveland, uses one platform for four tests: mycobacteria, mycobacterial susceptibility, blood culture, and sterile body fluids. The modular system’s design focuses on ergonomic factors, making it possible for the user to reach all bottles and drawers from one position. At no time is it necessary to stoop, bend, or stretch while using the system, the company says. A unique agitation method called VorTrexing is described as superior to shaking or rocking for aerobic organisms because it mixes air into the broth. A miniature stirring bar is inside each aerobic bottle, and a magnet below it keeps the bar moving throughout the test cycle.

Long-term Business

Even as the common outreach tests ordered by physicians change over time in response to new diagnostic capabilities, the reasons for ordering those tests remain stable. Some patients will always need screening for risks such as diabetes, autoimmune disease, or osteoporosis, while others will need one-time identification of infectious pathogens. Others will need ongoing testing to ensure that prescribed medications are working as expected, to see whether the patient’s liver and kidneys are tolerating long-term treatments of various types, and to monitor the course of many chronic illnesses.

As a result of these needs, two factors combine to create a healthy outreach market. First, patients often prefer to provide a specimen at the physician’s office during or after a scheduled visit, instead of making a trip to a national chain’s testing facility.

Second, physicians who want to respond to this preference for on-site sampling don’t necessarily want to invest in the staff or equipment to provide actual on-site testing, particularly as self-referral regulations become more uncertain. They may be comfortable with providing simple, single-step test kits for influenza or occult fecal blood, but they often do not wish to deal with complex instrumentation or testing that calls for regular quality control.

By obtaining specimens in their offices, but sending them to the laboratory for testing, they can keep patients happy while minimizing their own headaches. The outreach program that does the best job of getting reliable results back to them quickly will have their ongoing business.

Kris Kyes is technical editor of CLP.