Draft guidance issued by the Food and Drug Administration in February lays out the agency’s expectations for the technical specifications of whole-slide imaging devices used in digital pathology.

While the FDA document does not cover the more controversial area of what clinical data companies would need to submit to gain marketing approval for whole-slide imaging devices in primary diagnosis, Liron Pantanowitz, MD, says the agency’s move is significant. He is a member of the CAP’s Digital Pathology Committee and associate professor of pathology and biomedical informatics at the University of Pittsburgh Medical Center.

Also from the “Put It on the Board” section this month. Read the whole shebang.

The American College of Medical Genetics and Genomics’ controversial 2013 recommendations on the reporting of incidental findings on select genes was the first attempt to address the matter in the clinical setting. But the ACMG’s recommendations pose significant challenges that labs undertaking next-generation sequencing must be prepared to address, said a special report written by an Association for Molecular Pathology working group.

My latest in the March “Put It on the Board” section. Read the whole shebang.

When Pete Fisher, MD, says his name aloud, the speech-recognition system he uses spits out the words “deep fissure” on the screen. And there are times when he says “note that” and “note fat” pops up instead. Despite the occasional hiccups, he loves the software and the freedom it affords him to do his work without being bound to a transcriptionist’s timetable.

My latest feature article in CAP TODAY. Read the whole shebang.

When you go looking for problems, you’re bound to find them. That truism is especially pertinent in the arena of interface validation, as the team at New York’s North Shore-LIJ Health System discovered recently.

The laboratory professionals there were charged with helping to implement the first phase of a joint venture with New York City’s Health and Hospitals Corp. (HHC), in which North Shore-LIJ would serve as the massive public health system’s primary reference lab. Their job was to interface through middleware and validate, in just eight months, 840 HHC tests coming from 21 of that system’s sites. Meanwhile, the North Shore-LIJ team has had to contend with validating the plethora of electronic health record systems at more than 300 physician clients’ offices, as well as a customized smartphone application. North Shore-LIJ Laboratories has long performed interface validations, but they learned just how arduous it can be when so many have to be performed at once.

My latest cover story in CAP TODAY. Read the whole shebang. You can also check out the items I wrote for the “Put It on the Board” section on cervical cancer screening, genomic testing, regulation of lab-developed tests, and testing-related diagnostic errors.