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Draft guidance issued by the Food and Drug Administration in February lays out the agency’s expectations for the technical specifications of whole-slide imaging devices used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

Traveling with Lee Sandlin

Lee Sandlin died earlier this month. What a tremendous loss. He was a fantastic writer, and I was lucky to make his acquaintance. Here’s an obit by Michael Miner in the Chicago Reader, the longtime home for his singular brand of narrative nonfiction.

A celebration of his life and work was held recently at Chicago’s Sulzer Library and his wife, Nina (@nsandlin) — a good friend of mine from our days together at the late, great American Medical News —  asked me to contribute some thoughts. Here they are below. I post them here principally for the opportunity to share a bit of Lee’s writerly genius, and to encourage you all to read as much of his work as you can, as soon as possible.

To read is to place your trust in the hands of another, typically a stranger. When you read, the general rule is that most of what you know, what you believe about a subject, what you feel and hear and see in the mind’s eye, is shaped by your guide, the author. There was no better guide than Lee Sandlin.

The road he led you down may have been full of pit stops and detours, but every one was worth all the while. In a world where the written word is defiled by inattentiveness and, worse yet, artlessness, he kept a great faith with himself and with his readers. And, boy, did his prose show you how to go. In “Wicked River,” he wrote:

There were no beacons or lighthouses or channel buoys on the river then; there were no official markers of any kind. Here and there someone would occasionally paint a warning or an arrow on a prominent rock to alert voyageurs to danger — but these were often the work of pirates, to trick boats into going aground. Nor were there any reliable maps. In that era, mapmaking, even at its best, was a mixture of supposition, obsolete or garbled information, and pure fantasy; the first rule of travel in the American interior was that only a fool trusted a commercial map.

But the voyageurs didn’t care. What did they need a map for? The land was so wild it was essentially impassable; anyone who didn’t go by the river didn’t go at all. In effect, the river served as its own map. A voyageur who needed to consult it had only to climb the nearest hill. There the route was unfolded, in all its blue-misted splendor: the great dragon tail of the river uncoiling through forested valleys and across the tallgrass prairies and into the vast shrouded swamps, glittering with ten thousand sunflecks, blurred by drifts of drizzle, blazing with reflected herds of brilliant cumulus, on and on toward the horizon. As far as the eye could see, the river was the only road.

I would give a pinky finger to write sentences so pure, so authoritative, so precise, so true. I feel lucky to have read them, and doubly fortunate to have had the opportunity to share with Lee how much they meant to me, thanks to my friendship with his lovely wife, Nina.

One could call writing like Lee’s majestic, or lyrical, those book-review workhorse words. Posh! I say. When we see nonfiction writing like this again (as will surely be rare), I suggest we call it Sandlinesque. That will be a true compliment. Thank you, Lee, for letting us travel with you. On and on, toward the horizon!

Massive transfusion: a question of timing, detail, a golden ratio

Here it was, the kind of massive postpartum hemorrhage case for which the team at Duke University Medical Center had spent months preparing. The multidisciplinary group had agreed on which laboratory tests would be done in such a case, determined which blood products would be delivered, and decided which members of the OB team would be sent racing to retrieve the potentially life-saving package.

For the two labor-and-delivery nurses designated as runners, the quickest way to get down to the blood bank was the elevator. The elevator was working, but the nurses’ badges did not allow them access to it.

“They had to run all the way down the hall, then all the way down the stairs. It took much longer,” says Evelyn Lockhart, MD, a pathologist who specializes in transfusion medicine and led the Duke team in implementing a massive transfusion protocol for postpartum hemorrhage.

“It was a surprise to us all,” Dr. Lockhart says. Fortunately, the only harm associated with the inaccessible elevator was a couple of winded nurses. That is because the elevator flap came as part of a simulation, and no woman’s life was in danger. It turned out that access to the elevator was restricted to emergency department personnel. That changed soon enough, before any real-life obstetric massive transfusion protocols, or MTPs, were initiated.

The story illustrates an essential truth in the world of massive transfusion, experts tell CAP TODAY. While a randomized clinical trial likely to be published could help answer persistent questions about which blood component ratio can best reduce the mortality rate in massive transfusion cases, experts say that fine-tuning the timely communication, processing, and delivery elements of the MTP are just as essential as determining what “golden ratio” of blood products to prepare.

My cover story from the December issue of CAP TODAY. Read the whole shebang.

How LIS tweaks can enhance efficiency, patient safety

So, you have a great idea that will improve laboratory workflow and reduce errors? Chances are the change will depend on automation of some sort, and will involve the LIS. But upgrades to laboratory information systems may not come fast enough, and the middleware may not be available to accomplish what you need. Then the question becomes how to customize the LIS to achieve your aims.

That is what the six-member pathology informatics team at the University of Pittsburgh Medical Center Health System has had to do—work on their own, with middleware providers, and with their LIS vendor to meet the demands of their laboratory colleagues.

“That’s the philosophy we have. Our users ask, and we aim to deliver,” Liron Pantanowitz, MD, tells CAP TODAY. An associate professor of pathology at the University of Pittsburgh School of Medicine, Dr. Pantanowitz also directs cytopathology at UPMC Shadyside, heads UPMC’s pathology informatics fellowship program, and is associate director of Pitt’s Pathology Informatics Division.

Dr. Pantanowitz and his colleague Anil V. Parwani, MD, PhD, detailed several innovative UPMC projects in a CAP ’14 session, “Customizing the Laboratory Information System to Improve Patient Safety and Workflow in the Pathology Laboratory.” These include using the LIS to drive improvements in anatomic pathology quality control, synoptic reporting, and specimen tracking, while exploring the promises—and challenges—of digital pathology and next-generation sequencing.

My latest feature article. Read the whole shebang.