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.

Community hospitals keep time on tissue handling

The great promise of genomics and actionable cancer biomarkers relies on cancer tissues being handled in the right way so they are suitable for study. Reducing cold ischemia time and the total time that biospecimens spend in formalin is key to the process, say guidelines from the CAP and the American Society of Clinical Oncology on HER2 and on estrogen receptor and progesterone receptor testing in breast cancer specimens.

To hit the recommended times—less than an hour from excision to when the specimen is put in formalin, and between six and 72 hours of total formalin time—takes multidisciplinary coordination and reexamination of anatomic pathology processes. That was the experience of 30 community hospitals that took part in a seven-year National Cancer Institute project devoted to improving cancer care in the kinds of settings where most patients are diagnosed and treated.

The  lede for my feature story in the February edition of CAP TODAY. Read the whole shebang.

Kaiser Permanente to acquire Group Health

Kaiser Permanente’s announced acquisition of Seattle-based Group Health Cooperative is big, adding nearly 590,000 covered lives to Kaiser’s already extensive reach on the West Coast, in the Pacific Northwest, and beyond. Among the many things that remain unknown about the joining of the two integrated health care organizations is how the deal will affect Group Health’s laboratory operations.

Another item from this month’s “Put It on the Board” section. Read the whole shebang.

2016 may be year of action on laboratory-developed tests

During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

FDA officials, meanwhile, have been more circumspect in their public statements. In a recent meeting of the CDC’s Clinical Laboratory Improvement Advisory Committee, Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, described the agency’s potential action on LDTs in 2016 using the conditional “if.”

When the FDA released its proposed regulatory framework for LDTs in July 2014, it sparked criticism from virtually every side. What perhaps few expected was that 2015 would slip by without agency action on the matter.

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

When to fire up large multiplex PCR?

Multiplex PCR panel tests for viral and gastrointestinal pathogens as well as the rapid identification of bloodstream infections can detect more pathogens more quickly than traditional microbiology methods. The question that continues to bedevil is how to offer this newer breed of tests.

The panels, offered by manufacturers such as BioFire, Luminex, and Nanosphere, come with hefty price tags that have prompted difficult questions about their appropriate use. Should multiplex PCR panel tests be restricted in some way, reserved for the sickest patients or those whose immune systems are compromised? Or should the door be open for clinicians to order them as they see fit?

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

Qiagen touts one-stop shop for next-gen sequencing

Despite launching years after the next-generation sequencing systems from Illumina and Thermo Fisher, officials at the German molecular biology company Qiagen see an opening for their GeneReader NGS offering.

“Labs struggle with NGS adoption, whether it’s with fragmented workflows or the technical challenges,” says Jonathan Arnold, senior director of marketing at Qiagen, whose North American headquarters are in Germantown, Md. “We’re not launching a sequencer or a box, but launching a complete solution in itself.”

The lead item in  the December “Put It on the Board” section  of CAP TODAY.  Read the whole shebang.

For pathologists, 8% aggregate hike in Medicare pay

The final Medicare physician fee schedule for 2016 delivered on the Centers for Medicare and Medicaid Services’ July proposal of an overall increase in payment for pathologists and independent laboratories. The agency also fulfilled some pathologists’ fears by cutting payments for prostate biopsy services by 19 percent for the technical component and 18 percent for the global payment.

When a relatively good year on the Medicare pay side means treading water, laboratory consultants say it is all the more imperative for pathology groups to get the most out of their negotiations with private payers, hospitals, or accountable care organizations.

In the December CAP TODAY. Read the whole shebang.

Latest HbA1c debate examines race as nonglycemic factor

In 2010, the American Diabetes Association endorsed the use of hemoglobin A1c to diagnose type 2 diabetes, and fierce arguments over the wisdom of that move have ensued ever since. A 2013 debate at the American Association for Clinical Chemistry’s annual meeting featured a spirited dialogue on the merits of using HbA1c as a diagnostic marker, compared with the traditional—and still ADA-recommended—alternatives, fasting plasma glucose and two-hour plasma glucose.

Now the discussion is zeroing in on a narrower controversy within the HbA1c dispute—the role of race and ethnicity. African-Americans regularly have higher HbA1c values than do whites, even when they have similar fasting plasma glucose levels. Hispanics, too, have exhibited a similar HbA1c/FPG disparity, though amid a smaller body of research and to a lesser degree than is found among blacks. The questions are what this widely observed trend means and what to do about it.

Do higher HbA1c concentrations among blacks and Hispanics reflect socioeconomic or lifestyle factors, or are they driven by some as yet unidentified molecular or biological nonglycemic factors present in these patient populations? Should clinicians and laboratories set different diagnostic cutpoints for their black and Hispanic patients than for their white ones? Should laboratories seek race and ethnicity data to help overcome this apparent impediment to HbA1c interpretation?

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

Approvals mark ‘tip of the iceberg’ for PD-L1 testing

What the FDA giveth, the FDA may taketh away.

On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

Aside from offering patients another, less toxic treatment option, the FDA action seemed to portend a big boost to the surgical pathologist’s role in lung cancer care, says Philip T. Cagle, MD. He is medical director of pulmonary pathology at Houston Methodist Hospital and editor in chief of Archives of Pathology & Laboratory Medicine.

“Almost all of the lung cancer patients, one would expect, would be potential candidates for immunotherapy. They may get some other therapy first, but eventually they would be candidates for this,” he says. “The test is immunohistochemistry, and the good news about that is pathologists are already mostly set up to do IHC.…And they can bill and get reimbursed for immunohistochemistry, in contrast to a lot of the issues we have with molecular tests. There are many positives for pathologists, surgical pathologists, and cytopathologists to do this test themselves rather than simply collect tissue for the molecular lab. That’s the good news.”

My lead item in November’s “Put It on the Board” section of CAP TODAY. Read the whole shebang to find out some of the not-so-good news from the FDA.

Analyze this: data shines within and without

At PAML patient service centers, patients fresh from a blood draw may spot a kiosk that asks, “How was your experience today?”

Responding is as easy as pushing one of four buttons with facial expressions that range from a broad smile to a major frown. The kiosk’s manufacturer, HappyOrNot, says about 20 percent of customers across a spectrum of industries will stop to register their level of satisfaction. For PAML, the rate is averaging 60 percent, and the results are transmitted wirelessly, says Rosalee Allan, senior vice president and chief operations officer at PAML (Pathology Associates Medical Laboratories, Spokane, Wash.).

“This sends us a dynamic report and we can tell by the hour what’s going on at our patient service center,” Allan says. The question patients are asked to answer can be changed on the fly to, for example, “How was your wait today?” during especially busy times of the day.

“We can find out what the dissatisfier is at this patient service center between three and five in the afternoon,” Allan says.

How Allan and her colleagues at PAML used this information to unravel the patient service center puzzle—more on that later—illustrates just one way that laboratories are using the power of data, properly analyzed, to achieve objectives. There are, experts say, two broad categories of ends to which labs today are applying analytics. In the first class sits laboratory operations. Here, the use of analytics is geared toward reducing unneeded test ordering or improving patient experience, turnaround times, and client service.

The second, broader category can be dubbed health system analytics. Some enterprising lab professionals are looking beyond the traditional confines of the laboratory to investigate how optimal use of analytics could prompt timelier patient interventions and avert costly episodes of care or help slash inappropriate use of high-priced medications.

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