The range of analyzers available to the clinical laboratory today has grown from simple to stunning, with nearly every need for function, size, capacity, and price met by at least one model. Both routine and unusual diagnostic tests can be performed, alone or via multifunction instruments, whether the analysis setting is the central laboratory, the clinic, the critical care unit, or the bedside. Although most conceivable product niches are filled, manufacturers continue to compete by improving ease of use, speed, reliability, and cost per test.
It is this fierce competition for a saturated market that works to the advantage of clinical laboratories. In order to obtain a respectable share of the market when most relevant technologies have already matured, analyzer manufacturers cannot rely on major innovations to sell most of their products. When “new and improved” cannot be a company’s sales-driving slogan, improved must do the job alone. This has resulted in ongoing investment by analyzer manufacturers in understanding and meeting the needs of laboratories, with results that have not been seen elsewhere in health care: exactly what the buyer wants is likely to be available off the shelf, at a competitive price.
The competition that creates a vast range of analyzer choices benefits the laboratory’s productivity, capabilities, and budget, but it can have one adverse effect: the process of equipment acquisition becomes far more complex than it would be if there were fewer choices. The number of models available for a given analyzer type may be so large that several people must serve on a purchasing committee, sharing the task of narrowing down the choices.
Even when that job has been completed (or the time allotted to finishing the work has run out), the committee members may not be certain that they have seen everything on the market. Is there a less expensive analyzer out there, or one that is smaller, more durable, more advanced, or better at handling this laboratory’s volume? Would another model work better with the facility’s information systems and automation plans? Would the staff prefer different features, or be more productive if the analyzer had additional capabilities? Will a smaller, quicker, or better new model be introduced next month?
Defining Analyzer Needs
No matter how daunting it seems to sort through the analyzers on the market today, this job is worth the effort. Buying the model promoted by the laboratory’s usual vendor may be the simplest solution, but it may not bring the laboratory what it really needs, no matter how important the manufacturer’s reliability is to the laboratory’s future satisfaction with the purchase.
Likewise, relying on the recommendation of a colleague who works in another laboratory is unwise; the inside scoop from someone who uses the analyzer is valuable, but the needs of the other laboratory may be too different to permit useful comparisons to be made. Unless the colleague’s working environment matches one’s own closely in terms of procedural volumes, staffing levels, capital budget, patient population, facility layout, information technology, and growth plans, that colleague’s recommendation can serve only as the beginning point of a search for equipment, not its end.
A buying decision can be made with confidence not because the purchasing committee has seen everything on the market, but because it has seen everything that meets its predefined criteria. Much time and effort will be saved—and the analyzer chosen will be a better fit for the facility—if the purchasing process begins with a complete assessment of needs.
At a minimum, the analyzer buyer should have in hand a price range; a volume projection for the next several years; a description of the installation site and its available space; an understanding of who will use the analyzer; an evaluation of turnaround times (including whether this analyzer will be expected to handle stat orders); and an idea of what the laboratory hopes to gain from the purchase in terms of productivity, accuracy, and staff satisfaction.
Once the laboratory’s ideal analyzer has been described (based on the needs assessment), it will be much easier to find the right product. Because of competition in the analyzer market, that ideal analyzer is quite likely to exist in reality. As a starting point in finding the perfect fit for the facility, consult the charts that follow. In response to a CLP survey, prominent manufacturers of all types of analyzers have indicated what their products do best. This will allow those planning a purchase to identify analyzers not only by function and specimen type, but by intended use location, procedural volume, automation capability, testing speed, price, and training requirements.
As the survey responses show, most analysis categories have been expanded in recent years at both ends of the volume scale. One trend has favored the introduction of high-capacity analyzers that can handle growing test volumes while providing rapid turnaround of results. These models continually become faster and more readily automated, with an emphasis on reducing both staffing needs and costs per test. Initial purchase prices may be high, but these are workhorse analyzers that can pay for themselves with years of reliable, rapid, low-cost operation.
At the other end of the scale has been the proliferation of analyzers for use at the point of care. This trend has favored the introduction of models for bedside, unit, and office use. Because a facility may need them in multiple locations, manufacturers have emphasized their low cost and ease of use; in addition, the models have become steadily smaller. While they are not generally intended for high-volume applications (and may be less durable than the central laboratory’s analyzers), they can still provide reasonably prompt test results.
Automation and Connectivity
The survey results highlight two other trends of recent years in the demand for analyzers: an increasing reliance on laboratory automation and a growing need for connectivity (both within and outside the facility). The primary force driving automation is, of course, the shortage of staff time that affects many, if not most, clinical laboratories.
When there are staff positions that the laboratory cannot fill, the next step that is often taken to cope with the lack of available staff time is to shift as much of the work as practical to automated instruments and automation systems. By automating routine activities, the laboratory can make every minute of staff time count by saving it for tasks that require experienced judgment (and other human capabilities).
The push for automation has had major effects on analyzers, which are now available for use in fully automated settings with robotic tracks, for automation through the laboratory information system or middleware, and as stand-alone units (walk-away automation). Many manufacturers produce the same kind of analyzer in automation-ready versions that will work in any of those three ways, as well as in a less expensive nonautomated form for low-volume, intermittent, or point-of-care use.
Automated analyzers have been able to manage test functions for many years; depending on the test and specimen types, these functions could include pipetting, dilution, uncapping, aliquotting, adding beads, staining, slide making, mixing, incubation, well washing, and preparation for the next test or batch.
Newer analyzers can automate not only the testing process, but quality-control routines and regular maintenance as well. Reagent levels can be monitored automatically and replenished as needed. Results of many types can be interpreted by the analyzers that generate them (with flags raised as necessary to solicit human intervention).
After automation, the second most important way to save staff time is, in many settings, to enhance connectivity as much as possible. On a whole-facility basis, this is often accomplished using interfaces that connect instruments and information systems; if the laboratory can afford to do so, it can be simpler to hire a company to handle this job as one integrated project. Naturally, many laboratory budgets do not support custom interface programming and large connectivity projects. For them, the connectivity capabilities built into a new analyzer can be lifesavers, enhancing capabilities to a degree that far outweighs the small cost that connectivity adds to the analyzer purchase.
The analyzer’s ability to import admission-discharge-transfer (ADT) patient data from the hospital or laboratory information saves technologists time by reducing data entry and other recordkeeping; it also reduces the possibility of errors in identifying the specimen or the patient and decreases the chance that test results will be assigned to the wrong medical record. The complete charge capture that ADT connectivity enhances also ensures that the facility will be billing a payor for every test that it performs.
In addition, an interface between the analyzer and the laboratory information system permits the kind of administrative analysis that can enhance efficiency and productivity. Tracking the analyzer’s activity can help the laboratory predict periods of peak demand for particular kinds of testing, helping it staff accordingly. It also can be useful in improving workflow, distributing work more evenly, and indicating when backup equipment might be required.
For laboratories involved in outreach work, the greatest push for analyzer connectivity is coming from referring physicians. Because they are responding to regulatory pressures and financial incentives by installing electronic medical record (EMR) systems in droves, they are likely to lean heavily in favor of referring work to laboratories that can provide test results directly to the EMR. As usual, the makers of analyzers have responded to a market need. Analyzers are now available that can solve this problem by sending results directly to the physician’s EMR, with little to no involvement of the technologist on the laboratory side or the clerical staff on the physician’s side.
Because the outlook for laboratories indicates ongoing pressure to handle higher testing volumes with shrinking staffs and declining reimbursement, there is no doubt that analyzer manufacturers will continue to fine-tune their products to suit these demands. For many laboratories, this means that each upcoming analyzer purchase will represent another chance to become better at coping with the pressures that it must face.
Kris Kyes is technical editor of CLP.