The healthcare paradigm is moving rapidly toward point-of-care testing (POCT) in several areas. With this dramatic move, however, there are several issues to take under consideration. The benefits entail such things as increased timeliness of results and convenience for patients. Among the potential issues, however, are the possible costs of these tests, the reliability of the machines and the standards of quality and regulations hospitals must work to meet with the added equipment. Following are the thoughts of several experienced practitioners in the field of POCT, including Mark Crowther, MD, at McMaster University, Kim Gregory MT (ASCP), NCA, CLS, Associate Director, POCT at Massachusetts General Hospital and Lara Moody, MLT (ASCP), coordinator of POCT at Dartmouth-Hitchcock Medical Center in Lebanon, NH.
Q&A with Mark Crowther:
ADVANCE: What are some of the biggest challenges you face when designing/selecting a POCT system/device for your laboratory? (Quality standards, regulatory, ease of maintenance storage, general logistics)
Crowther: There’s an awful lot of people out there right now building what they’re calling “tricorders” in the finest of the Star Trek traditions. You have a small device which is able to do a wide variety of tests on a small sample of blood in a very timely fashion. Some of that technology is very interesting. However, the problems are going to be exactly the same. The first is that it’s not going to replace the laboratory, so it’s going to be an added cost to the system. Those systems might be inexpensive or expensive.
Second, there’s no reason to suspect that these machines are any more or less reliable than any other machine, so they’re going to require quality control. Cost and quality control, to me, are the two biggest issues that face any point-of-care test. From a clinical perspective, the biggest challenge is going to be getting clinicians to change their habits. What people don’t realize is that if I took a sample of blood from you and I ran it on ten different machines I would get ten numbers that are approximately the same but not identical. The numbers are not absolute, they’re a product of the testing system. So we’ll have people who get their electrolytes tested on one machine, and then at the same time get electrolytes run on a second, and then we’ll get a call from the ICU saying, “Why is this person’s result different?” And we’ll tell them, “Because it was run on two different machines.” They’ll ask, “Which one’s the correct value?” We’ll say both. They’ll say, “They can’t both be correct because they’re both different.” But they are both correct. Because no traditional laboratory test, other than a genetic test, is absolute. They’re based on the machine.
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ADVANCE: Would you say that, because the machines can offer different results, that they can create issues for hospitals as far as regulation standards?
Crowther: That gets back to the QC. The College of American Pathologists and other oversight bodies have very specific expectations about how quality control is delivered. Having a point-of-care-testing machine in your clinic, for instance, in a cardiology clinic located outside of a hospital, doesn’t free the clinician from the expectation that the machine is going to produce reliable results. The cardiology clinic working that outpatient laboratory, even if that outpatient clinic is not associated with the hospital, may not realize that if that machine produces a patient’s value and it’s inaccurate, that clinic is exposing itself to a liability because it has not participated in a QC program as you would expect.
ADVANCE: Can you select a specific medical/laboratory procedure you see potentially facing dramatic, positive change with the introduction of POCT technology in the future? Can you break down the nature of that change? (Particular area of practice, treatments)
Crowther: You can divide tests into two types. First, there’s the tests that we do bazillions of every day where having the results turned around more rapidly for a small group of patients might be useful. For example, developing systems that can be used at the bedside and can rapidly turn around the health status of a person undergoing surgery would be very useful. Having the results from our routine tests back in the span of a few minutes while the patient is being operated on would be extremely useful. To some extent, there have been a few point-of-care machines produced that can do that, but they all still have limitations.