Labs Face Challenges With POCT

Keeping an eye on the big picture can be difficult when you’re in the frame, but in health care it’s a common way to operate, which explains why point-of-care testing (POCT) has become so prevalent despite the high costs to the lab. In the big picture, POCT produces better patient outcomes through faster turnarounds and more efficient delivery of health care. This ultimately translates to reduced overall expenses for treatment as well as the capacity to handle more patients and generate more revenue.

But drilling down to another level—say, pixels—these programs create money and management issues for the lab. POCT, however, is not only here to stay, its use is likely to expand. Therefore, labs must meet the challenges these programs present—in some cases with technology, in others with more resources—for the greater good.

Too Many Tests
Glucose testing is probably the most predominant form of POCT used by health care institutions today, and subsequently, its use is one of the most advanced. Not only is it ubiquitous at the bedside, but patients, such as those diagnosed with diabetes, are frequently responsible for self-testing to monitor their condition.

Experts predict this type of use will become more common in the future. It has long been a standard for pregnancy tests, commercials for which dot television programs and advertise these products’ ease and accuracy. But like home pregnancy tests, it is sometimes recommended that confirmation be made by testing by a medical professional. Hemoglobin, strep, urinanalysis, blood gases, and cardiac biomarkers, like troponin, are tests commonly run in health care institutions by trained operators.

But as new tests are introduced, it is important for the lab to be consulted on additions to the POCT program. Just because a test is available does not mean it is the best way to reach a diagnosis.

“The hospital should have a specific philosophy. Unless there is a clear clinical need for a result within a seconds time frame, then the test may not be worth it,” says Dennis Dietzen, PhD, DABCC, assistant director, core laboratory and metabolic genetics lab, St Louis Children’s Hospital (Missouri). He states that often the problem may not be the time to result, but rather the physician’s availability to see the result, analyze it, and implement treatment. “There is lots of complexity in a chaotic setting, and there should be an unquestionable clinical benefit,” he says.

Assessing a Test’s Value
Often, the request for a test will come from a physician or group of physicians who have been exposed to it through a conference or journal. “The anecdotal experience leads them to assume they want the test too,” Dietzen says. But before adding a rubber stamp, the St Louis lab will assess the test’s value based on outcomes, using evidence-based criteria.

“Sometimes the lab’s opinion is ignored, but generally we work together to see if the test is actually needed or if the central lab can be utilized in a better fashion to get them what they need,” Dietzen says.

Similar systems work well in a number of institutions. The Geisinger Health System (Danville, Pa) relies on a laboratory technical advisory committee to help select new tests and devices. In addition to the obvious representatives (that is, the lab and physicians), it includes representatives from other affected departments, such as information technology and systems management, according to Jay B. Jones, PhD, the institution’s director of chemistry and Geisinger Regional Laboratories.

At the University of California, Los Angeles (UCLA), a formal application process for new tests is used to determine anticipated test volume, on-site coordinators, documentation, and collection, says Elizabeth A. Wagar, MD, FASCP, FCAP, laboratory medical director of the UCLA Clinical Laboratories.

Too Many People, Too Little Compliance
POCT coordination, documentation, and collection are issues not to be taken lightly. Though some of this responsibility is often delegated outside of the lab, it is still the lab that remains responsible for oversight. “POCT, in many centers, is under a separate license, but is still under the purview of the lab,” says Alan Wu, PhD, DABCC, professor, laboratory medicine, at the University of California, San Francisco (UCSF).

Not only does this mean management of personnel and inventory, but it also includes compliance, which is the most difficult aspect. “CLIA [Clinical Laboratory Improvement Amendments] mandates quality control, but it is difficult to get compliance outside of the lab,” Wu notes.

Nurses are most frequently the ones responsible for conducting the tests, though respiratory therapists (RTs), anesthetists, and other medical personnel may be recruited. “Very rarely is it someone from the lab,” says George Cembrowski, MD, PhD, associate professor, division of medical biochemistry, at the University of Alberta Hospital (UAH of Edmonton).

These personnel, busy with multitasking and saving lives, do not have the time, patience, or desire to deal with quality control. “Nurses tend to feel it [quality control] is a waste of time,” Cembrowski says, echoing other laboratory leaders.

It is the responsibility of POCT coordinators to make sure that compliance is not ignored and that everyone is following quality-control protocols. But as the tests expand, this can be difficult.

“We have roughly 3.2 FTEs [full-time employees] who run the glucose program, work with 300 RTs on blood gases, and manage ACT [activated clot testing] in surgical suites,” Cembrowski says. UAH is part of Capital Health, a network that includes 13 hospitals and two primary care centers. Glucose POCT is a standard of care with 10,000 nurses using 1 million glucose strips per year.

Carry a Big Stick—or Lock Them Out
“You want to have a POC coordinator who carries a big stick,” Dietzen advises. He recommends that this person have the support of management so that when someone is not performing a test to specification, the supervisor will handle it.

But people and politics being what they are, manufacturers have stepped in to help monitor and control compliance, and that solution is connectivity. Cembrowski would like to see each POC device have a computer that will recognize approved users and lock itself if the operator is unknown or unqualified because of poor quality control.

Connectivity can also help gather and analyze relevant information, making compliance easier to monitor and document. “There is a big bottleneck getting the information into the LIS [laboratory information system] and electronic medical records. The result is used immediately on the floor, but it then needs to be entered manually into the system, which introduces time constraints and increases the possibility of error,” says Dietzen, who believes this will have a negative effect on the retrospective analysis of data.

He suggests that newer equipment offer features, such as remote docking stations, that will enable the electronic transfer of information. “Ideally, these systems will be wireless,” he adds. Dietzen recognizes that this may require a capital outlay, but it would be worth it to assist in program management.

Too Much Money
Of course, frequently it is the lab that absorbs these costs without necessarily seeing any return. “If the lab can bill for POCT, then it can offer a revenue stream. But frequently, these tests are performed in-house and not credited to the lab,” UCLA’s Wagar says.

But the lab is not only absorbing the costs of results produced at the point of care, it is absorbing increased costs because POCT tests are generally more expensive. According to Tom Graham, CFO, AMC Registry Inc (Upper Arlington, Ohio), the cost of a POC test can be $3 to $5 more than one that is performed in the core lab.

“Blood glucose is cheaper if run in the lab. The tests cost more, and nursing time is expensive. Considering expense alone, the tests cost $12 to $16 when run by a nurse versus almost half of that in the lab,” UAH’s Cembrowski says.

These costs have limited the use of POC in Canada, according to Cembrowski. “The Canadian system relies on cost as a driver more so than in the United States. So we look at the expense from a lab perspective and not the total cost of stay,” Cembrowski says.

“Cost is always an issue. Turnaround isn’t always enough to justify the additional cost,” UCSF’s Wu adds.

Dietzen does not believe that the cost of POCT and its disposables will ever be cheaper than centralized testing. However, in clinical situations where its value is proven, such as when moving a patient out of the emergency department (ED) and into a cath lab more quickly, the expense can and should be justified. “Unless there is a clear clinical value, the test is not worth it,” Dietzen reiterates.

Counting Beans
Proving the value may not be as difficult as it would seem. “The problem in most labs is that when they move from centralized to POC testing, they ask for cost justification. What they should consider is revenue justification,” says AMC’s Graham, who walks through an example:

• A hospital with 30,000 annual ED visits can expect 7% of these, or 2,100 patients, to arrive with acute coronary symptoms.
• These 2,100 patients will be tested for troponin, which the core lab will turn around in 120 minutes versus 10 minutes with POCT.
• Using the 10-minute POCT will therefore save 110 minutes per patient.
• The 110 minutes per 2,100 patients add up to 231,000 minutes, or 3,850 hours, during which new patients can be seen.
• If the average length of stay in this ED is 3.5 hours, then 1,100 additional patients can be seen in the freed 3,850 hours.
• If the admission rate is 17%, then 187 of the 1,100 patients will be admitted to the hospital.
• If the average revenue generated per patient is $8,000, then the hospital will see an additional $1,496,000 in revenue, nearly $1.5 million.

Graham compares this figure to the expense of offering POCT for troponin:

• Assuming that each of the 2,100 patients with acute coronary symptoms will undergo three troponin tests per guidelines, the lab will purchase supplies for 6,300 tests.
• At $5 more per POCT, the incremental cost of testing at bedside will be $31,500.
• Adding an FTE to manage the program with an annual salary of $70,000, the hospital will spend $101,500 to offer troponin as a POCT test in its ED.
• Subtracting this amount from the estimated additional revenue, the hospital is left with $1,394,500 of extra income.

Tom Graham

“Even if this prediction is only 10% accurate [additional revenue of $149,600], the effect is budget neutral,” Graham suggests. Those are numbers that he believes CEOs cannot ignore. “The CEO needs to maximize the return for the hospital,” he says, suggesting that whether or not the laboratory gets credit for it is often not an issue.

That is because even greater value comes from the improved health care that results, providing patients with better outcomes. Using troponin as an example again, faster results are directly correlated to outcome. “The old saying is that during a heart attack, time is muscle,” AMC Registry’s Graham says, adding that not many core labs can turn around a result within the recommended upper limit of 60 minutes. “POCT allows door-to-reportable results in 15 minutes,” he says.

POCT can also improve interaction with the patient. Geisinger’s Jones notes that a POCT program for monitoring Coumadin through the pharmacy using prothrombin times resulted in better outcomes. “We have eight sites that perform POCTs. The pharmacist ushers the patient in and does the finger-stick, speaking with him and assessing his status while the results are processed. The interaction is better, and the patients have exhibited fewer strokes since monitoring began,” Jones says.

As health care systems become more stressed, POCT will be used to create relief. “There is a need for more patient testing outside the hospital. Most health care institutions have been innovative, but more and more will have less money to fund these projects,” Cembrowski says.

Other POCTs can be expected to follow the progress of glucose tests. They will get faster, require a smaller sample, and become almost idiot-proof. These advances, along with the ability to easily transfer results, will enable labs to continue to meet the stringent demands of POCT programs and serve the greater good.

Renee DiIulio is a contributing writer for Clinical Lab Products.