Pathology and POCT in the Emergency Department

Vol. 14 •Issue 7 • Page 82
Pathology and POCT in the Emergency Department

Although appropriately applied POC technologies can help tame the frenzied environment of the emergency department, the core lab concept must not be abandoned.

Uncontrolled bleeding. Shortness of breath. Chest pain and heart attack. Loss of vision. Severe abdominal pain and persistent vomiting. Emergency medicine is like no other specialty in terms of the wide range of severe conditions that are rushed in on a daily basis.

The commonly visualized emergency room scene involves an ambulance racing up to the facility, a gurney rushing through the hallway and several people frantically working against the clock to save someone’s life. Although many cases seen in a typical emergency department (ED) are not quite so dramatic, a unique critical element requires efficient lab testing and swift results.

Back in the Day

In the old days—before decentralized computers were introduced to the lab in the 1980s—specimens were collected in rounds using a phlebotomy team. There were no computers, so techs had to do manual logs. They would gather all the samples together in a batch for a particular type of test and put them in racks to perform a “test run.” It was a batch environment with paper reporting, and it was not very efficient, explains Kenneth E. Blick, PhD, professor, Department of Pathology, University of Oklahoma Health Sciences Center and Medical Center, Oklahoma City.

“We would send paper reporting to the chart once daily–hand-written information, using very primitive technology,” he tells ADVANCE. “That is the way it was not that long ago, before we got computers, barcodes, etc., in the lab. The problem was that we had patients queuing up in the ER who were not getting results. So, here we were in the lab with racks of samples sitting around everywhere and not able to deal with the fact that our batch processing might be causing delays in patient care. Meanwhile, such delays may be causing the hospital to be on divert because there is no place to put patients.”

Need for Speed

Although computer and other technologies have infiltrated the clinical lab at an incredible rate since then, delays in laboratory services still exist and cause patient delays in many hospitals throughout the United States. Some labs have specimens queuing up in front of the instrument because they don’t have very rapid throughput. So, a physician’s natural response to a laboratory that provides that kind of service for critical information on critically ill patients is to order tests stat. The idea is that the priority specimen is to be placed in front of the queu.

“One time at our lab we had about 50 percent of our tests ordered stat,” recalls Dr. Blick. “A lot of times [physicians] wouldn’t get the results in time, so they would call the lab. In many cases there was a problem with the sample, and the sample would be set aside and end up sitting in a rack again to be dealt with later. So, we had all these batch processes, lots of calls coming into the lab, lots of distractions for the technologists, lots of pouring off samples into other tubes, mislabeling and the potential for lots of errors. That is just sort of the way the laboratory used to function.”

But technology now allows healthcare professionals to do testing in real time in highly automated core labs as well as in real time at the patient’s bedside, essentially eliminating batch testing. Indeed, POCT has new technologies such as bio-sensors and immunosensors, and is performed on very stable devices that have auto quality control (QC), internal checks and various rules within the software to make sure that the measurement is correct.

“These generally small and highly sophisticated,” says Dr. Blick. “Oftentimes, minimal training is required, but manufacturer’s guidelines must be followed. But despite the highly sophisticated instruments, many laboratorians do not feel that nurses are capable of performing the testing.”

Such devices now available at the point of care can do a lot of the critical care analytes, which can be absolutely essential and can save the patient’s life, says Dr. Blick. If a patient comes in with an acute disease, he could die at any moment. Thus, the physician often needs that critical information within minutes rather than hours.

“We can’t wait an hour or two to find out if a person has a major artery in his left ventricle blocked,” says Dr. Blick. “It is just not acceptable anymore to wait around for hours to get troponin results, for example. If we can’t get the lab results back in 30 minutes to an hour from sample to results, then we need to look at ways we can; and in many cases that requires POCT.”

Departmental Differences

The ED staff at Johns Hopkins Hospital performs only glucose testing at the point of care, as they have a stat lab that does the majority of their critical care testing, hematology, chemistry, blood gases, etc. According to Karen Dyer, MT(ASCP), POCT coordinator, Department of Pathology, Johns Hopkins Hospital, there is little difference in POC methodology in the ED compared with other areas.

“It is the same glucose meter throughout the hospital,” says Dyer. “It is the same methodology throughout all the laboratories—there just may be different versions of it.”

The uniqueness lies not in the methodology of the testing, but the environment in which the testing is performed. Perhaps the most significant inimitability of the ED is the tremendous need for rapid, acute critical tests.

“The laboratory tends to be focused more on the quality of the things that they get—specimen labeling, handling, etc.,” says Dyer. “The ED tends to just want the number and they want it now. They are not as concerned about the QC being done. They just see it as they need their value ASAP to treat their patient.”

Primary Trend

Many experts concur that ED nurses and physicians simply do not have the time to be concerned with QC. That is particularly true at Johns Hopkins Hospital, an inner-city hospital that sees a lot of trauma come through. In addition, because it is an inner-city location, a lot of patients tend to use the hospital as their doctor, as more people are using the ED for primary care. This is a growing trend, say experts.

“Primary care is taking place at the ER because people do not have insurance, and our population is getting older and sicker,” claims Dr. Blick. “So, we better be gearing up in laboratories to provide potentially life-saving, real-time information to more effectively manage patients presenting to the ED with potentially life-threatening diseases.”

Compliance Concerns

As hospitals are seeing an increasing number of patients, the compliance issue becomes even more convoluted and can cause some serious apprehension when it comes to POCT in the ED. Laboratorians are generally hesitant to embrace POCT based on the embedded fear that it is uncontrolled testing. But POCT vendors are putting mechanisms in place to control who exactly is running the test, helping to ensure that the laboratory still has the control over near-patient or decentralized testing.

“Most of the POC technology now has control mechanisms, like QC lockout, in which only certified operators can use the instrument,” says Joe Baugh, MT(ASCP), i-STAT senior product manager, Abbott Point of Care. Baugh contends that the responsibility of establishing QC should be taken on by the manufacturers.

“It is the responsibility of industry to make sure that these things are completely automated,” he says. “For example, the i-STAT instrument will run QC on itself without any user intervention. It is our responsibility as vendors to figure out what we are going to do to automate the process.”

Dr. Blick agrees that compliance issues can be minimized if the facility has smart devices that are very stable, self-calibrating and have internal QC.

“If the device is interfaced whereby the order all the way through to the results validation is handled with a scripted interface, then all the nurse really has to do is collect a couple of drops of whole blood and put it on the device,” he tells ADVANCE.

Some argue, however, that the bulk of the compliance responsibility—making sure the testing is done properly—falls on the clinical laboratory.

“The manufactures can only do so much in terms of operator lockout, but it always seems that people find a way to bypass these things,” says Dyer. “The manufacturers are doing the best they can and they are very responsive to our needs, but it pretty much falls on us to make sure those operating the tests are doing what they are supposed to be doing.”

But achieving full compliance is a team effort that should isolate neither the vendor nor the laboratorian. According to one expert, four groups must work together to ensure that compliance actually works. It is a partnership between vendors, the lab technologists that oversee POCT, the IT people and the nurses performing the tests.

“The team approach to medical care—people all working together—is unfortunately, in some cases, a novel concept,” says Dr. Blick. “We’ve got all of these silos—the lab silo, ER silo, etc.—but we should be working together because we can provide the information to the physician when he needs it, and by doing so can potentially help save lives.”

Direct Impact?

POCT obviously can deliver faster turnaround time (TAT) in the ED, but some argue that having the test result faster does not necessarily impact the treatment of the patient. Experts are quick to point out that it is merely a matter of perspective, and that opinions may vary depending on the specialty of the particular expert.

“The clinician will tell you that the faster turnaround time allows them to make a decision, especially in the ED,” stresses Baugh. “For example, if I have a 10 minute blood gas or a 10 minute troponin, then perhaps I don’t have to go back and visit that patient an hour later. But I also see the argument from the laboratory side, which says there is no empirical data to show that this makes a significant difference.”

It also depends upon how one is measuring the impact of treatment. If looking at total ED length of stay (LOS), the impact may not change much, according to some experts. But LOS is just one aspect of the equation. Therapeutic TAT must be considered as well.

“If you do not have an ED laboratory, then POCT cardiac markers can have a significant impact on the therapeutic TAT and, potentially, patient outcome,” declares Dr. Petersen.

Another factor in the equation is physician availability. If the physician is available at the patient’s bedside while the test is being run, there should be an immediate decision on treatment.

While POC technology provides significant benefit, the overall process of the ED must be addressed to reach the full potential.

“If there are other problems in moving the patient through the ED, then POCT may not have a significant impact,” cautions Dr. Petersen.

Some contend, however, that hard evidence shows that timeliness of laboratory data has a direct impact on making the diagnosis, processing and triaging the patient. According to Dr. Blick, that impact is quantifiable and is three to seven minutes per percent outlier.

“We did a 13 hospital study, and the data is in,” he tells ADVANCE. “We found for every percent outlier for turnaround time on potassium results can cause as much as an additional three minutes of wait in our ED. It appears from this that the lab is a critical department if you want to have a smooth operating hospital that manages patients in real time. Thus, we have to conclude that if you don’t manage your specimens in real time, you can’t manage your patients in real time, either.”

The lab is the purveyor of information for treating ill people, continues Dr. Blick, and it is imperative that such information gets into the right hands as quickly as possible.

“The lab has 70 to 80 percent of the information needed for taking care of critically ill patients and the physicians must have that data up there to make clinical decisions,” Dr. Blick says. “We are the linchpin for the practice of evidence-based emergency medicine, whether it is in critical care areas or in the EDs.”

The Looking Glass

Many predict that POCT will be much more prevalent in the ED as vendors bring out more immunoassays, helping to relieve from the laboratory some of the burden of various stat tests.

“Chemistry is very well aware that there is a problem with employees and with people going into the med tech field,” says Baugh. “We are going to work in conjunction with the laboratory to help move the most stat critical tests to a POCT platform and relieve some of the burden of staffing the laboratory.”

In addition to the staffing shortage, other elements of the modern healthcare situation may drive the need for POCT in the ED, explains Dyer.

“Unless the current healthcare environment improves, more people are going to be using the ER as their doctor,” she says. “It is a double-edged sword; the lab gets busier, so the turnaround slows down. Therefore, clinicians are going to want more at the point of care.”

Final Thoughts

Although experts are confident that POC in the ED will continue to grow, many admit that POCT should be done only when it makes sense.

“You don’t usually do POCT on non-critical patients,” contends Dr. Blick. “A lot of testing we do in the hospital is to monitor therapy and see if the patient is responding. There is no need to have an emergency approach to do that kind of testing, which is where the core lab really shines.”

The advantage of sending a specimen to a highly automated core lab is that add-on tests can be done, in addition to more sophisticated testing and a larger menu of tests. Core lab testing offers the ability to add on tests as clinicians drill down into the diagnosis, says Dr. Blick.

“Having the specimens in a refrigerated stockyard in an automated core lab allows the ER doctor to electronically add on a test and have the result in 15 or 20 minutes, even if it is an immunoassay on a very sophisticated immunoassay instrument,” he says. “So, there is still going to be a great future for core lab testing, but only when it is highly automated and very efficient. The labs that are not automated and not very efficient in getting the results back in real time are simply not going to survive.”

Todd Smith is an associate editor.