Handling a reagent recall, step by strenuous step

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Assuming the reagent is still in stock, the second step is to immediately communicate with all laboratory staff that the reagent has been recalled and should not be used.
And then the investigation begins. “You don’t know how significant the recall will be to the patient until you dive into it a bit,” Dr. Harbour says. “So you want to start the investigation as soon as possible and make sure you have the right people at the table.”

Within 24 hours, the response team should complete a quick preliminary assessment of the manpower needed to respond to the recall, as well as the number of patients affected.

The magnitude of patient impact is gauged by an important team member: the data miner. This person should be trained to quickly access the laboratory’s electronic or manual medical records system to identify the affected patients and their physicians during a specified date range.

“For the two-and-a-half-year window we had a few years ago, we really relied on the electronic system, and we were able to mine that data fairly effectively. But if you’re in a manual system and faced the same sort of recall, that would be more difficult.” Some hospitals limit data mining to the evening hours, when the extensive mining won’t slow down the whole system and interfere with patient care.

Risk management personnel—often nurses—should be brought on board early in the process. They often work with a hospital attorney, Dr. Harbour says. “People in risk management think differently than people in laboratories. Whereas I want to tell everyone everything as quickly as possible and make sure no one is hurt, risk management is trained to look at it the other way around: How can we take care of the patient, but also deal with the risk?”

An effective team should also include subject-matter experts who can read the vendor’s description of the recall and gauge the potential patient impact. “If the recall would cause you to see a five percent change [in a test result], is that a clinically important difference?” In particular, clinicians and pathologists can often lend a greater appreciation for the implications of a certain type of recall. “If this is a cardiac marker, for instance, does it really matter? Physicians order these tests all the time, and they can give you very quick insight into how impactful a minor variation might be.” In many cases, expert feedback determines the pace of the response team.

Finally, he says, clerical support is key. “You’ll need to figure out how you would handle an eight-patient recall versus a 15,000-patient recall. There are very different logistics involved. I mean, just think about that. Fifteen thousand letters,” he says.

Companies overseeing the recall sometimes, though not always, reimburse laboratories for the cost of replacing recalled lots with new material. Sometimes companies defray the laboratory’s cost of mailing letters to clinicians. But recalls can be potent time wasters, and there’s not often a way to reimburse for lost productivity.

In the wake of recent recalls, Dr. Harbour says, he has signed thousands of letters—one letter to the physician of each patient affected by the recall. He wasn’t reimbursed for his time, or his lab manager’s time, or for the subject-matter experts who assessed the patient impact. “I can sign letters pretty fast. I’m not one to put a streak as my signature, but you just sit down and you work your way through a pile for a half hour. And then you go to the next pile.” It takes a while, he says, but he’d rather invest energy in the process than risk implying to clinicians that the recall isn’t a big deal. “I want them to know that I looked at this carefully.”

Physicians are then tasked with the cumbersome chore of examining individual patient records to determine if a skewed test result might have affected past care, whether it might affect ongoing care, and whether the patient should be notified. Because most clinical practices are already pressed for time, laboratories field the same question from physicians time and again: “What do you think I should do?”

Unfortunately, labs can rarely provide a straightforward answer, Dr. Harbour says. In years past, his laboratory has offered to collect new patient samples and retest, depending on which reagent was recalled. But without access to patient records, laboratories are not often in a position to recommend an across-the-board statement on how clinicians should proceed.

“The physicians are the ones who need to review the medical records and decide whether or not a minor or moderate or major test variation would have changed the course of therapy or whether it could change the patient’s current therapy today,” Dr. Harbour says. “Some patients will have recovered totally and the test result may no longer be meaningful. And so [the clinician] may choose not to say anything, and just put the letter in the file.”

The process tends to proceed most smoothly when there is ample trust between physicians and laboratories. “The physician you’re talking to has to trust your laboratory, whether you become aware of a problem you caused or whether you’re notified of a problem by a vendor—that you’ll be in touch with physicians as soon as possible, convey the significance of the problem, and help them get the patient redrawn if needed.”

But even when such trust exists, tempers can flare. “There are times when physicians will get upset and feel that the extra work is being dumped on them, when in reality it was dumped on the laboratory and maybe even on the vendor,” Dr. Harbour says, recalling a time when a physician was notified about 85 patients who might have been affected by a recall. “They said basically, ‘This is a huge amount of work! How can I do all my current patient work and do this, all because of somebody else’s problem? I don’t have the staff, the FTEs, to be able to pull all these charts and review them. You need to do that.’ I understood their frustration, and I said, ‘I understand where you’re coming from. Let’s try to find a way to work our way through this. What can I do to help you? But I can’t do it for you.’”

Fortunately, lab tests aren’t the only deciding factor in patient diagnosis and treatment, Dr. Harbour acknowledges. “It’s the history, it’s the physical, it’s the physician’s understanding of all the different parameters going on with a given patient. A single test is not the only thing you’re hanging your hat on.”

Nevertheless, recalls present an easy target for laying blame. “When samples get mixed up, or are borderline interpreted, people might be likely to think about suing,” Dr. Harbour says. And that’s when a strong recall response plan can make all the difference.n
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Ann Griswold is a writer in San Francisco.