What the FDA giveth, the FDA may taketh away.

On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

Aside from offering patients another, less toxic treatment option, the FDA action seemed to portend a big boost to the surgical pathologist’s role in lung cancer care, says Philip T. Cagle, MD. He is medical director of pulmonary pathology at Houston Methodist Hospital and editor in chief of Archives of Pathology & Laboratory Medicine.

“Almost all of the lung cancer patients, one would expect, would be potential candidates for immunotherapy. They may get some other therapy first, but eventually they would be candidates for this,” he says. “The test is immunohistochemistry, and the good news about that is pathologists are already mostly set up to do IHC.…And they can bill and get reimbursed for immunohistochemistry, in contrast to a lot of the issues we have with molecular tests. There are many positives for pathologists, surgical pathologists, and cytopathologists to do this test themselves rather than simply collect tissue for the molecular lab. That’s the good news.”

My lead item in November’s “Put It on the Board” section of CAP TODAY. Read the whole shebang to find out some of the not-so-good news from the FDA.

At PAML patient service centers, patients fresh from a blood draw may spot a kiosk that asks, “How was your experience today?”

Responding is as easy as pushing one of four buttons with facial expressions that range from a broad smile to a major frown. The kiosk’s manufacturer, HappyOrNot, says about 20 percent of customers across a spectrum of industries will stop to register their level of satisfaction. For PAML, the rate is averaging 60 percent, and the results are transmitted wirelessly, says Rosalee Allan, senior vice president and chief operations officer at PAML (Pathology Associates Medical Laboratories, Spokane, Wash.).

“This sends us a dynamic report and we can tell by the hour what’s going on at our patient service center,” Allan says. The question patients are asked to answer can be changed on the fly to, for example, “How was your wait today?” during especially busy times of the day.

“We can find out what the dissatisfier is at this patient service center between three and five in the afternoon,” Allan says.

How Allan and her colleagues at PAML used this information to unravel the patient service center puzzle—more on that later—illustrates just one way that laboratories are using the power of data, properly analyzed, to achieve objectives. There are, experts say, two broad categories of ends to which labs today are applying analytics. In the first class sits laboratory operations. Here, the use of analytics is geared toward reducing unneeded test ordering or improving patient experience, turnaround times, and client service.

The second, broader category can be dubbed health system analytics. Some enterprising lab professionals are looking beyond the traditional confines of the laboratory to investigate how optimal use of analytics could prompt timelier patient interventions and avert costly episodes of care or help slash inappropriate use of high-priced medications.

My cover story in the November issue of CAP TODAY. Read the whole shebang.