In rare instances, NIPT finds mother’s cancer

Sequenom Laboratories, providers of MaterniT21 Plus and other lab-developed noninvasive prenatal tests, is telling the public about a tiny proportion of cases in which its best-known test has revealed a genetic profile suggestive of cancer in the mother. The cases highlight the importance of ob-gyns working with laboratories to order follow-up testing as well as proper genetic counseling, Sequenom officials say.

My latest in the “Put It on the Board” section of CAP TODAY. Read the whole shebang.

Labs solve price, space squeeze to welcome TLA

After several years of watching their European counterparts have all the fun, a handful of American microbiology laboratories are going live with systems touted as providing total automation of diagnostic bacteriology. The systems automate how specimens are barcoded, plated, and inoculated, then move the plates on a track to an incubator, photograph them at a preset incubation time, discard or keep the plates as appropriate, and offer up the digital images for interpretation by medical technologists viewing them on computer screens.

Leaders at American microbiology labs making the move to total automation say it marks a profound transition that dramatically improves turnaround times but also can be wrenching, hindered by technical and management challenges that come with adopting state-of-the-art technology.

My feature story in the May edition of CAP TODAY. Read the whole shebang.

Door opens on direct access to genetic tests

The FDA’s recent move to give 23and­Me permission to market this country’s first direct-to-consumer genetic test, for Bloom syndrome, goes beyond the one in 107 Jews of Ashkenazi descent who are carriers of the rare disorder. At the same time as the agency gave the Mountain View, Calif.-based personal genetics company the go-ahead on its Bloom syndrome carrier test, the FDA also moved to classify autosomal recessive carrier status tests as class II medical devices and exempt them from premarket review.

“We’re excited that they have created a regulatory path forward for direct-to-consumer genetic testing,” 23andMe chief medical officer Jill M. Hagenkord, MD, tells CAP TODAY. “Historically, this kind of model hasn’t existed. We’ve had other over-the-counter, home-use tests like the HIV test. This is the first time we’re doing it for genetic testing.”

My latest in CAP TODAY’s “Put it On the Board” section. Read the whole shebang.

Pressing questions in POC glucose testing

Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, D.C. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

My cover story in the April edition of CAP TODAY. Read the whole shebang.

OK. Go.

Bob O'Reilly, 2004-2015

Bob O’Reilly, 2004-2015

It was nearly a decade ago that my ex-wife and I adopted Bob, and it has been one hell of a ride. He was a lover, a fighter, a tubthumper, the bearer of many names, a movie star and the star of a sermon (which, sadly, is not available online). He was, above all, so very present, typical of the Australian Shepherd‘s “velcro dog” tendencies.

Which has made it all the more difficult to bear his absence in the week since we put Bob to sleep, following his long struggle with canine renal failure. When doing training with Bob, among the commands I learned was one to release him from his sit, stay or down. “OK. Go,” I was taught to say in a nonchalant manner. The idea was — hey, you listened, you obeyed. Swell. Now you’re free. No big deal. Go ahead, run around.

OK, Bob. Go.

In that vein, let’s cap this off with a tune from Bob’s namesake.

FDA sheds light on digital pathology standards

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.

AMP outlines laboratory view on incidental findings

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.

Hear me now? Another audition for speech recognition

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.

Interface validation: abort, retry, succeed

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.

Labs entering risky payment game in the new year

This year will bring a host of regulatory, coding, billing, and payment changes that are going to challenge pathologists and laboratory administrators to move quickly or else face declining revenue and the grim specter of Medicare recovery audits. That was the somber consensus of three experts gathered for a December webinar hosted by The Dark Report.

“It will be a high-stakes game in 2015 because both government and private payers are stacking the deck against clinical labs and pathology groups,” Dark Report editor-in-chief Robert L. Michel said in a statement publicizing the webinar. “Across the nation, Medicare carriers and private health insurers are implementing myriad changes in coverage guidelines and reimbursement for both clinical lab tests and anatomic pathology services, in an effort to reduce their costs.”

The lede to my latest feature article in CAP TODAY. Read the whole shebang.

Digitized slides spur patient engagement, ‘allow for democratized medicine’

Regulatory and reimbursement hurdles are key factors blocking broader adoption of digital pathology. But the technology is already having an impact, enabling patients to grasp a firmer hold of the wheel in directing their care, said Keith J. Kaplan, MD, a pathologist and laboratory medical director in Charlotte, NC.

“This may be a little uncomfortable for some, but the idea is that digitized slides allow for democratized medicine and for patient and consumer access to their slides in an open and transparent fashion,” Dr. Kaplan said in a CAP TODAY webinar presented last month in collaboration with Ventana Medical Systems …

Lead item for CAP TODAY’s “Put It on the Board” section. The whole shebang.