CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Ann Griswold, PhD
February 2014—Recalling a reagent is about more than just removing a product from laboratory shelves. It’s about retracting test results and thus affecting diagnoses and treatment plans. It’s about questioning patient outcomes and revisiting past decisions.
Dr. Harbour
“So much of what laboratories do is central to making a diagnosis and determining treatment,” says John Harbour, MD, regional medical director of HealthPartners Laboratories, medical director of the Bon Secours St. Mary’s Hospital Laboratory, and president of Monument Pathologists Inc., Richmond, Va.
Consequently, a recall can challenge a patient’s trust in his physician, a physician’s trust in her laboratory, and a laboratory’s trust in its vendors. It’s a major event. And unfortunately, Dr. Harbour says, the number of these events has increased dramatically in recent years.
A structured approach to reagent recalls can help save time, and sanity, by streamlining the laboratory’s response and restoring confidence in the laboratory test reporting process.
If practice makes perfect, Dr. Harbour’s laboratory has had ample opportunity to be so. “Unfortunately, our ‘practice’ is real life,” he says. “We’ve had enough recalls that we’re starting to get the process down rote.”
Almost anything can be recalled, he says: single reagents, calibrator materials, computer programs that support electronic reporting. Depending on the nature of the recall, the impact on patient care can range from barely perceptible to pervasive.
“If it’s a reagent glitch, it could result in a test result being too high, too low, negative when it should be positive, or positive when it should be negative.” Similarly, a programming error could prevent the report from getting to the clinician, or could send an incomplete report to the clinician. “If the physician didn’t know to look for part two or part three of the report, they might just go with the information on the first part,” he says. As a result, recalls can affect thousands of patients over a period of several years, or a few patients over the course of a week.
Generally, tests that are urgently needed—complete blood counts, chemistry tests, for example—aren’t often recalled, Dr. Harbour notes. “It’s the more esoteric tests, immunology, chemistry, drug levels, and so forth, that tend to be affected.”
When that happens, a laboratory can likely use another reagent or instrument to complete the test. Alternatively, patient samples can be redirected to another laboratory nearby. “Bon Secours uses a certain vendor for our chemistry analyzer, for example,” Dr. Harbour explains. “If we have a problem, we can send patient samples to the University of Virginia Medical Center or the local hospital, which use different vendors and wouldn’t be affected by the recall. We do have a natural backup in that sense.”
But in the most unfortunate of circumstances, a wide-reaching recall could affect a staple product or platform used by multiple labs in town. That calls for a plan C. “If a routine test like coagulation got recalled, that would be hard because everybody in town is using the same thing and many labs purchase enough coag reagents to last an entire year,” Dr. Harbour notes. In that case, a relationship with a referral lab would be key.
A successful response to a recall, Dr. Harbour says, largely depends on having a plan in place ahead of time—and on establishing a well-defined response team, usually led by the laboratory director. “It’s never a good idea to create a procedure to deal with a problem as the problem occurs. That’s one thing. The second thing is to ensure that you identify the types of expertise you need.”
A few years ago, Dr. Harbour’s laboratory was notified that a certain test reagent may or may not be affected by the presence of an antibody, and it was unpredictable whether the antibody might cause the test result to go up or down. “So here we were in a situation of telling physicians, ‘If you had a result on your patient with this reagent, during this two-and-a-half-year window, the results may or may not be correct. The test result might be high, it might be low, we don’t have a way of knowing.’ The vendor just didn’t have enough information with enough patients in variable settings to be able to tell me clearly what to expect.” In the end, Dr. Harbour established a relationship with a referral laboratory that could retest patients affected by the recall.
In that event, as with any recall, the first step is to stop using the reagent, Dr. Harbour says. “To do that, you need a bench-level staff member who knows where the reagents are stored, which ones are next in line to be used, and which lots are affected. You need someone who can say, ‘Gee, are we even using this reagent anymore? Did we use it in the past? Or have we not started using it?’”