Pathologists’ errors get new scrutiny as medical tests soar in use, importance

dna-208x300Pathologists are the medical specialists whom few patients ever meet, but they play increasingly important roles in treatment decisions. Some new reports raise concerns about systematic errors in the path lab.

The New York Times painted a surprisingly distanced picture of the work of pathologists in a recent report on these medical doctors who are trained to interpret an array of laboratory tests and often microscopic materials to determine the care for complex diseases.

The paper found that the specialists and their labs mislabeled and mixed up patient samples and results, as well as sometimes contaminating them—yes, rarely, but with potentially significant harms. Erroneous results could lead to misdiagnoses, resulting in patients getting wrong or ineffective treatment, especially for cancers, experts say.

To be sure, the mix-ups and contamination occurred in just a fraction of instances examined by researchers, with one recent published study finding 34 of 13,000 biopsies (reported in their study as .26 percent) by a major path lab fully switched up and another 87 of the 13,000 of them partially mixed up (.67 percent). That same study found slightly higher rates in other independent labs, which also reported 3 percent of samples contaminated.

Those figures might seem favorably low. But consider: pathology labs process millions of tests like these, especially for cancer, each year. Experts estimate that doctors submit more than 800,000 prostate biopsies to path labs each year, and mix-ups or errors—including those that result in lawsuits—end up costing the country almost $880 million annually.

Here’s what’s more worrisome still, the New York Times says, without alarm:

[Pathology lab errors] may be happening more often than doctors realize. There is no comprehensive data on how often pathology labs mix up cancer biopsy samples, but a few preliminary studies suggest that it may happen to thousands of patients each year.

Some safety advocates suggest that samples could be better identified and tracked using patients’ DNA, an advance that would jack up the price per test by $300. This method isn’t foolproof. And other experts interviewed by the paper say that a key challenge may be for pathologists simply to fess up to problems and make a concerted effort to remedy them.

In my practice, I see the big harms that patients suffer while seeking medical services, including significant woes tied to misdiagnoses or failure to detect cancers. A little less than a third of cancers are misdiagnosed, even as doctors tell 1.3 million or so Americans each year they’ve got the dread-inducing disease. Misdiagnoses can create a cascade of other costly, painful, and invasive tests and procedures, not to mention taking a bad psychological toll on patients.

I wish I could express greater confidence about pathologists’ work, which occurs in volumes that only grow by the day. I’ve likened the challenging job to being something like a combined wallpaper inspector and art critic, in which fallible “experts” are supposed to look through microscopes at myriad swirls of color daily, to discern tiny differences among them, then to interpret their meaning with acuity.

Alas, as we know from other areas of medical practice, doctors and hospitals struggle with tasks much more basic: Safety experts have zinged them for failing to ensure that patients get correctly identified and given something as fundamental as a correct ID bracelet to match them and their health records and any procedures they might need. A phlebotomist may follow a checklist carefully to ensure that the tube of blood she draws from you is correctly labeled but if it goes to a big lab where a bar code is misread or a sample is mishandled, precautions go for naught—and patients can suffer and be harmed.

This woe will only increase in significance as we advance more into an era of personalized, targeted, or, ironically, precision medicine, in which genetic testing will expand exponentially and determine even more what drugs and treatments we get for various diseases, especially cancer.

Patients already are tapping into genetic tests, some of them to determine ancestry and with minimal health benefits. Health individuals also increasingly are mapping their genomes, perhaps to detect mutations linked to disease. It’s fascinating to see the reactions to a new study about the practical results of fit folks’ genomic curiosity, with some news reports deeming the efforts “alarming,” while others seeing it as “not as scary as feared.” The stories all seem to indicate that, for now, such lab work “might not be that useful” in most patients’ care.

Still, it is clear that, especially with technology as a driver, these are sunny, boom times for medical labs and pathologists, their expert arbiters, as tests increase and improve. There are dark clouds building on the horizon, including patients understandable anxiety during the current health insurance debates as to whether genetic testing information in their medical records may cause them to lose coverage under reinstated scrutiny of preexisting conditions. Pathologists, other doctors, hospitals, and medical labs need to step up their efforts even more to ensure the safety, accuracy, cost, accessibility, and effectiveness of medical tests.

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