Newly reported survey data that show widely varying international practices on managing critical values may demonstrate the need for a new guideline—already in development—to help laboratories formulate evidence-based policies.

The new data from European labs were presented during a session at the American Association for Clinical Chemistry’s Annual Meeting and Clinical Expo in Chicago (“Critical Result Management Practices: Global Perspectives and Recommendations for Best Practices”). The session also provided a preview of a forthcoming draft guideline from the Clinical and Laboratory Standards Institute that represents the organization’s first formal attempt to advise laboratories around the world on critical values reporting.

My feature article in the September issue of CAP TODAY. Read the whole shebang.

Time is running short for laboratories to figure out how they will comply with a federal regulation that for the first time requires all U.S. labs to give patients their test reports within 30 days of request.

With the Oct. 6 deadline for complying with the mandate fast approaching, leaders at two laboratories shared how they are wrestling with the regulation during a July 31 webinar hosted by G2 Intelligence.

A process that at first blush may seem fairly straightforward—patient requests test results, lab hands them over—gets complicated fast. How does a patient request the test reports? How does the lab that conducted the test verify the identity of a patient, or of a patient proxy, who may live in another state? And how should labs handle patients’ access to sensitive test results relating to sexually transmitted infections, or life-changing diagnoses?

My latest in CAP TODAY’s Put It on the Board section. Read the whole shebang.

Payment rates declining. Bad debt rising. Test orders falling. Diagnostic equipment manufacturers checking in on test-volume commitments. A wrenching transition from fee-for-service care to population-based medicine. These are a few of the trends that laboratories across the country are seeing and that keep lab directors up at night, heavy lidded, checking their email, illuminated by the glow of their smartphones.

Strategies that once reliably yielded success in the laboratory business are no longer sufficient, says W. Stanley Schofield. He is president of NorDx, which operates 11 labs and 23 patient service centers and is owned by the MaineHealth system, also affiliated with four other health care organizations in the state. Schofield is cofounder and managing principal of the Compass Group, a 501(c)(6) business league whose 24 lab members represent more than 300 of the nation’s most prestigious hospitals and health systems.

Labs are being called upon to simultaneously add value, cut costs, and improve the quality of the work they do, Schofield says. Moreover, the pressure is on for laboratories to show how their performance compares with that of their peers.

“Today, labs are known for, and their value is seen to be in, delivering accurate test results in a timely fashion,” Schofield tells CAP TODAY. “In the future, the value of the laboratory is that it will help manage that the right test was done on the right patient for the right reason, and that the right cost will be available. And that they manage the data, rather than just report the data. That is one of the huge transitions that labs have to go through right now, and that we are preparing for.”

My cover story in the August issue. Read the whole shebang.

Proposed revisions to the American Medical Association’s Code of Medical Ethics would remove language that supports direct billing and condemns clinicians who charge markups for laboratory or pathology services. The changes could weaken efforts to rein in billing practices that CAP leaders argue are not in the best interest of the patient and that the AMA currently defines as unethical.

“The importance of this is that many states utilize the AMA’s code of ethics as their code of ethics for things related to medicine. . . . So, if you change the AMA code of ethics that these laws are based on, then people can make the argument that since these ethics principles have changed, perhaps these laws need to be changed,” Daniel C. Zedek, MD, tells CAP TODAY. He is an alternate delegate to the AMA House of Delegates for the CAP and is director of dermatopathology at the University of North Carolina School of Medicine.

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

Before the Affordable Care Act was passed, and before the notion of an ACO became a Medicare reality, Richard J. Cote, MD, was among those in medicine who saw the writing on the wall regarding health care payment.

Dr. Cote recalls his thinking as he joined the University of Miami Miller School of Medicine in 2009 to become chair of its Department of Pathology.

“President Obama had just been elected. There was a great push for creating a comprehensive health care system across the country to insure uninsured people,” Dr. Cote tells CAP TODAY. “What was very clear to me, even before the ACA came into being, was that this push was going to accelerate the at-risk model of reimbursement and that there was also going to be very much a downward pressure on reimbursement for all medical services, including pathology, which we’ve clearly seen take place. And there was going to be a move to better coordinated management of care.”

Dr. Cote and his laboratory colleagues at UM are preparing for this transition away from the traditional, and still predominant, fee-for-service payment model. They say the health-system–owned laboratory must move beyond its established role to show how it will help cut costs while improving care and outcomes.

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

With the dismissal of residents from training programs having led to well-known tragedies, the most recent in pathology just a year ago, attention is being paid to the importance of ensuring residents’ well-being and properly handling remediation, probation, and dismissal.

The Accreditation Council for Graduate Medical Education has strengthened its requirements for what kind of information residency programs must share about residents’ performance. The ACGME’s common program requirements, last revised in June 2013, say “a program director must provide timely verification of residency education and summative performance evaluations for residents who may leave the program prior to completion.”

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

A trillion base pairs of sequence here, a trillion there. Pretty soon, you’re talking about a lot of information—and it all needs to be managed. That’s the dilemma facing Mayo Clinic and other health care organizations leading the personalized medicine revolution that relies on compiling and analyzing patients’ genetic code to better diagnose, predict, and treat disease.

“We generated 90 trillion base pairs of sequence last year,” says Eric Wieben, PhD, director of Mayo’s Medical Genome Facility in Rochester, Minn. “Gathering big piles of data is the easy part. It’s trying to transform the data into knowledge that’s the hard part.”

My latest in CAP TODAY’s Newsbytes section. Read the whole shebang.

Despite an explosion of research into cancer biomarkers and professional guidelines that urge testing for certain genetic mutations that help detect disease, anticipate its course, or predict response to treatment, many cancer centers are out of sync with oncology testing recommendations.

Payment policies, regulatory oversight, clinician preferences, and varying access to testing technology are among the factors that contribute to discrepancies in cancer care.

So says Jan A. Nowak, MD, PhD. And he is worth hearing out on the subject, as did an audience of hundreds of pathologists, oncologists, and others at this year’s Cancer Biomarkers Conference in Houston.

“Adoption of biomarker cancer testing is not high among cancer centers,” Dr. Nowak told the crowd. “It seems high to us because . . . we go to the meetings and we talk to each other, and we’re doing this stuff. But then there are the people who are not going to the meetings, not talking about it, and not doing it.”

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

The constant churn of information technology applications is creating new security and financial risks that health care organizations—including laboratories—must systematically address, IT experts say.

Organizational mergers, acquisitions, and the replacement of lab information systems, electronic health record systems, and other solutions often lead to a “legacy system junkyard” of little-used yet costly applications, according to Steve Davis. He is manager of enterprise archive and decommission at Dignity Health, a San Francisco-based health system with 40 hospitals in California, Arizona, and Nevada, and hundreds of outpatient clinics in 17 states.

In 2013, Davis helped lead an IT application decommissioning project at Dignity Health that resulted in the archiving, purging, or storing of 62 applications, the recovery of more than five terabytes of data, and the decommissioning of 390 servers. That has helped save the health care system $4.5 million—so far. The Dignity Health team plans to retire a total of 192 applications and sees a potential for saving nearly $10 million over five to six years.

My latest in the Newsbytes section in CAP TODAY. Read the whole shebang.

“There are known knowns; there are things that we know that we know,” then-defense secretary Donald Rumsfeld famously said in response to a question at a 2002 news briefing.

“We also know there are known unknowns. . . .” he added. “But there are also unknown unknowns, the ones we don’t know we don’t know.”

Rumsfeld—the principal subject of a new documentary, The Unknown Known, by Oscar-winning director Errol Morris—was addressing the case for war against Iraq. But when it comes to the case for improving the use of laboratory testing, the “known known” is fairly clear.

Overutilization is widely understood as a problem that blights American medicine, with lab testing no exception to the rule.

But there also is a “known unknown” in the world of test utilization—the extent of underuse, its effect on care and costs, and how to deal with it. How often do clinicians fail to order the tests that would improve diagnosis, prognosis, or management? And how can pathologists and their colleagues in the laboratory take action to improve test ordering if they lack the complete patient picture that would allow them to help clinicians spot the instances in which ordering more tests is the right answer?

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

A shrinking pool of cash to pay for medical care, the decline of private practice medicine, and recently enacted federal legislation will combine to put the squeeze on medical laboratories. That was the stark and sobering message delivered to the hundreds of administrators, pathologists, and other lab professionals who gathered in New Orleans in late April and early May for the Executive War College.

The bearer of the bad news was Robert L. Michel, editor-in-chief of The Dark Report, which hosts the annual meeting. Michel said the biggest threat facing labs is implementation of the Protecting Access to Medicare Act of 2014. The legislation, signed into law April 1, contains a one-year delay in big Medicare physician pay cuts due to the sustainable growth rate formula. But it also includes major changes to the Medicare clinical laboratory fee schedule that will pose a huge challenge to labs, Michel said.

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

Clinical trial data and a Food and Drug Administration panel’s full-throated endorsement stand to reshape cervical cancer screening practice recommendations in the U.S.

The FDA’s Microbiology Devices Advisory Committee in March voted 13-0 in favor of a new indication for Roche’s Cobas human papillomavirus test that would allow the assay to be used as a primary screen for cervical cancer in women 25 and older. At this article’s deadline, the FDA had not yet acted on the panel’s advice but the agency usually heeds its advisory committees’ recommendations.

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

A back-page section in CAP TODAY that I’ve been working to beef up is called “Put it On the Board.” I usually contribute a fairly well reported lead news item of a few hundred words.

Back in January, I examined the need for faster, simpler tests to diagnose infectious diseases. In February, the story looked at explosive growth in the field of genomics and how difficult it is to translate benchside discoveries into bedside treatments. And last month I reported on how labs will be affected by a new federal regulation giving patients the right to their test reports.

And, yes, it appears that Ken “Hawk” Harrelson’s home-run call did inspire the section’s name.