AMP puts a cost — and value — to sequencing procedures

Amid excitement about the groundbreaking work of unlocking the human genome’s secrets to speed diagnosis and target oncologic treatment comes the unpleasant reality that much of this labor now goes unpaid. Getting the American Medical Association’s editorial panel to publish nearly two dozen new genomics-related CPT codes for molecular pathology was a vital step, as was having those codes accepted in the Medicare clinical laboratory fee schedule.

In CAP TODAY’s “Put It on the Board” section this month. Read the whole shebang.

Why Sonora Quest gave itself high marks for LIS conversion

For laboratory chief information officer David N. Moore, July marks a first anniversary worth celebrating. Twelve months ago, his employer, Phoenix-based Sonora Quest Laboratories, flipped the switch on its new laboratory information system, effectively turning it on site-wide with one click—and with barely a hitch or a glitch.

The lede to my piece in July’s “Newsbytes” section. Read the whole shebang.

Keep close eye on payments to physicians

Recent legal developments should give laboratories new cause to tightly monitor efforts to win physician referrals, attorney Jane Pine Wood said at last month’s Executive War College meeting.

In April, the federal government reached a settlement with cardiovascular-disease testing labs Health Diagnostic Laboratory and Singulex to resolve allegations that they violated the False Claims Act by paying doctors in exchange for patient referrals. The U.S. Justice Department also alleged the companies billed Medicare and Medicaid for medically unnecessary testing. HDL agreed to pay $47 million to settle the matter, while Singulex will pay $1.5 million.

My latest contribution for “Put It on the Board.” Read the whole shebang.

RFID keeps lab’s supplies on hand, just in time

Sharon Cox, MT(ASCP)SM, has a passion for the correct count.

Charged with managing the laboratory supply inventory as core lab supervisor at Saint Francis Health System in Tulsa, Okla., she knows the right tally matters. Get it wrong and the lab can wind up with too little of what is needed. That can mean big overnight shipping charges when things run out unexpectedly. To avoid that outcome, the lab may order more supply than necessary, which leads to a different kind of problem.

“All those reagents you have sitting in the refrigerator—that’s just wasted money sitting there that could be better used by the health system,” Cox said last month during a talk at the Executive War College in New Orleans.

My feature article in the June edition of CAP TODAY. Read the whole shebang.

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.

Update: I forgot I had taken this brief video of Bob cavorting at the beach. What a find!

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.