Top court clarifies autopsy’s place in Texas law

The Texas Supreme Court has decided, in the case of Christus Health Gulf Coast v. Carswell, that a hospital-provided autopsy falls under the scope of the state’s medical liability statute. The plaintiff, Linda Cars­well, alleged that professionals at Christus St. Catherine Hospital in Katy, Tex., defrauded her by refusing to request that an autopsy for her husband—who died as a hospital inpatient—be performed by the county medical examiner’s office. The autopsy was instead performed by a hospital-contracted pathology group. Carswell’s attorneys alleged this was done as part of an effort to hide some medical error-related cause of death.

My lede to an item in this month’s “Put It on the Board” section.  The whole shebang.

Missed UTIs? ‘Enhanced cultures’ suggest so

The long-held belief that urine is sterile is facing a serious challenge from new research combining sequencing techniques and an enhanced urine culturing protocol to uncover an array of uropathogens hitherto unseen in microbiology laboratories.

The notion that urine, indeed the entire bladder, is sterile is one medical students are still taught and “it’s a pretty deeply entrenched dogma,” says Linda Brubaker, MD, a urogynecologist and professor of obstetrics and gynecology and urology at Loyola University Chicago Stritch School of Medicine. She and a team of Loyola colleagues have worked for years to learn more about urinary microbiota and in the process demonstrated that currently standard urine culturing techniques fail to spot an alarmingly high proportion of uropathogens that may well be clinically relevant. Their findings were presented in June at the American Society for Microbiology’s Microbe meeting.

“What we’re going to do is replace the dogma that clinical care is based on,” Dr. Brubaker says. “There is a great deal of excitement because this is a vast unknown. It’s like discovering a tribe in the middle of the Amazon. We never knew these people were here, or how they eat, or how they live. We have to understand this [bacterial] community now—how it maintains health, how it deals with perturbations, like when patients are catheterized and a certain number of patients will get infections. Not all of them do. We may learn why some do and some don’t.”

My cover story in the August issue of CAP TODAY. Read the whole shebang.

Structured illumination microscopy used to detect nephrotic kidney disease

Structured illumination microscopy, or SIM, offers an alternative to electron microscopy in viewing details that are below the resolution limit of standard light microscopy. SIM was applied recently to analyze renal podocyte substructure in nephrotic kidney disease, and the findings corresponded with those obtained using electron microscopy (Pullman JM, et al. Biomed Opt Express. 2016;7[2]:302–311).

That is important, says lead author James Pullman, MD, PhD, because electron microscopy, or EM, techniques require specially trained technicians and a time-consuming process of preparing, imaging, and analyzing a single sample using EM. SIM also gives protein localization by immunofluorescence the high resolution of EM.

Also in this month’s “Put It on the Board” section. The whole shebang.

Michel: The good, bad, and ugly that labs need to know

Robert Michel’s opening remarks at the Executive War College, which can be seen as a kind of state of the union address for laboratory medicine, focused on the trends in the industry and the opportunities and dangers they create.

“Fraud and abuse. That’s the ugly,” Michel began. “Folks who are doing lab medicine the right way aren’t really aware of what’s been happening outside the walls of their laboratories.”

From July’s “Put It on the Board” section of CAP TODAY. Read the whole shebang.

Laboratory 2.0: Changing the conversation

Bundled payments, physician employment, and unconventional competitors are cannibalizing the volume-based business model that for decades has defined laboratory medicine. And labs have little room within their customary confines—the three percent of health system spending they directly account for—to play a central role in American medicine’s transformation.

TriCore Reference Laboratories CEO Khosrow Shotorbani, MT(ASCP), put the matter succinctly to a group of laboratory leaders and other health care experts who met in Santa Fe, NM, this spring to tackle the conundrum of how to move from volume to value.

“The question is,” Shotorbani said, “how do we survive in the future? If there is no margin, there is no mission.”

Altering the discourse and, ultimately, the practice of laboratory medicine is the ambitious goal of the invite-only brainstorming sessions among two dozen heavy hitters in health care. The think-tank-style venture, dubbed Project Santa Fe, includes leaders from five of the most innovative clinical laboratory operations in the country: TriCore; the Henry Ford, Geisinger, and Kaiser Permanente Northern California health systems; and New York’s Northwell Health (formerly known as North Shore-LIJ Health System).

The project brings to mind the R&D that took place just 30 miles away in Los Alamos, NM, where more than 70 years ago the scientists of the Manhattan Project raced to beat the world’s totalitarian powers in developing a nuclear weapon. Project Santa Fe participants, too, see themselves in a contest where time is of the essence. What’s needed to beat the clock before fee-for-service dies, they say, is an enterprising, aggressive strategy that aims for a wholly new understanding of the laboratory’s role in medicine. Call it lab 2.0.

The lede for my  cover story in the July issue of CAP TODAY. Read the whole shebang.

Eco effort cuts biohazard waste, saves money

An environmental initiative at the Cleveland Clinic laboratories has increased recycling by 20 percent and reduced biohazardous waste hauling charges by an estimated $10,000 a year. The effort succeeded by expanding the categories of items that could be tossed in recycling bins instead of into biohazard containers, and by working to educate laboratory professionals through a “know where to throw” campaign.

Another item  from “Put It  on the Board.” Read the whole shebang.

Guidance seen as sign of FDA openness to digital pathology

The Food and Drug Administration has issued final guidance for industry and agency staff on how to assess the technical performance of whole-slide imaging devices. During a Digital Pathology Association webinar on the FDA action, experts said the guidance is another strong sign of the agency’s working to detail the standards manufacturers will need to meet to earn approval for WSI’s use in primary diagnosis.

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

Logistics hurdles overcome for single Pap-HPV report

Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

That was the conclusion that leaders at Northwestern Memorial Hospital’s cytopathology laboratory came to in concert with their ob-gyn colleagues after changes were made to cervical cancer screening and management guidelines. At Northwestern, the high-risk HPV/genotyping and the cervical cytology results are combined into a single report that is sent to clinicians through the electronic health record system.

My lead piece in this month’s “Put It on the Board” section of CAP TODAY. Read the whole shebang.

In late flu season, early signs of new tests’ impact

The 2015–2016 influenza season is shaping up to be lighter than physician offices and hospitals have seen in recent years, with fewer flu positives reported, a lower death count, and a smaller share of flu-like illnesses among outpatients.

Last year’s flu season, by contrast, was “very hectic,” says MAJ Charlotte Lanteri, PhD, deputy chief of microbiology at Brooke Army Medical Center at Fort Sam Houston in San Antonio, Tex. It is not just the lower number of patients presenting with flu-like symptoms in the medical center’s inpatient and outpatient settings that has made for a quieter season so far, she says. Also contributing to the peaceful, easy feeling at Fort Sam Houston—at least as regards the flu—is the medical center’s implementation of a rapid molecular test for influenza A and B.
My latest cover story in CAP TODAY. Read the whole shebang.

Case raises uncertainty on autopsy’s legal status

Should a hospital-provided autopsy be considered health care? It’s a question the Supreme Court of Texas will decide this spring, and its answer to that question will make a big difference—in the millions of dollars—to the claimants, Christus Health Gulf Coast v. Carswell. It could also have an impact on the medical liability coverage available to pathologists who perform autopsies in the Lone Star State.

My lede for the top item in this month’s “Put It on the Board” section in CAP TODAY.

Lab shoots for better phlebotomy service, satisfied patients

Try running a race and tying your shoes at the same time. That is the kind of challenge laboratories face when they endeavor to refine their processes while providing all the usual services clinicians and patients expect. When laboratory leaders at Brigham and Women’s Hospital in Boston surveyed the landscape of their phlebotomy operations, they spotted many opportunities for improvement through Lean Kaizen events as well as technology that reduces the risk of human error.

On the outpatient side, patients showing up for blood draws encountered long waits, felt confused about when a phlebotomist would see them, and were even in the dark on the main outpatient phlebotomy area’s operating hours.

On the inpatient side, blood draw times varied widely from phlebotomist to phlebotomist, it often took more than half an hour after phlebotomists started work for them to draw their first patient, and the rate of preanalytical errors such as wrongly labeled specimens was too high.

Across inpatient and outpatient operations, the Brigham team—led by Milenko Tanasijevic, MD, MBA, and Stacy Melanson, MD, PhD—measured the phlebotomy capacity required at different times of the day and week and found that suboptimal staffing contributed to delays in collection and, consequently, longer patient waits and turnaround times.

Theirs is a multiyear project that has achieved dramatic improvements, among them a 76 percent reduction in average patient wait times and a 41 percent cut in specimen labeling errors.

My lede. Read the whole shebang    in this month’s CAP TODAY.

Cutting cultures: the move to all molecular in virology

For laboratories performing virology testing, taking advantage of molecular testing’s superiority to traditional testing methods is a no-brainer. But leaders in the University of Michigan’s clinical microbiology laboratory have found that the push to go all molecular for virology testing must be tempered by attentiveness to clinician preferences and a collaborative approach that’s likelier to make the journey a success.

So says Duane Newton, PhD, clinical microbiology director at the University of Michigan Health System in Ann Arbor. Compared with a high of nearly 6,000 viral cultures performed in-house during the 2009–2010 fiscal year, the Michigan clinical microbiology laboratory performed fewer than 1,000 viral cultures during 2014–2015, and that figure appears to be dropping to “essentially zero” in this fiscal year.

My lede. Read the whole shebang in the March issue of CAP TODAY.