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April 2014

Letters, 4/14

April 2014—HER2 testing guideline update: Karen Titus’ article “New guideline takes on tough HER2 cases” (October 2013) nicely captures the deliberations behind the new HER2 testing guideline, issued by the American Society of Clinical Oncology and the CAP last October. But as her article makes clear, the new guideline leaves open a question—and I would like to suggest an answer. That answer is based on new studies of molecular diagnostics, to which my institution and several others are contributors, and my own experience as a practicing medical oncologist.

Put It on the Board, 4/14

April 2014—Third cervical cancer screening paradigm may be on the way: 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.

Pens, pencils, Post-its—setting out to save on supplies

April 2014—The Department of Laboratory Medicine and Pathology is one of the largest departments at Mayo Clinic, with approximately 3,250 employees who work in 61 specialty labs at seven locations across Rochester, Minn. Throughout this large department, about 300 employees are designated to order supplies for their work units, which consist of laboratory and support staff. Before 2008, there was no standard process for ordering office supplies, which led to inefficient practices and escalating costs over time.

Taking aim at overuse: daily labs, high-cost send-outs

April 2014—As reimbursement models change, achieving better test utilization will become a survival strategy. And in the hard work to improve test use, the computerized physician order-entry system appears to be the work tool with the winning record. Inpatient laboratory tests at Massachusetts General Hospital fell by 21 percent between 2002 and 2007, despite a seven percent increase in the number of discharges. Per discharge, inpatient tests dropped by 26 percent (Kim JY, et al. Am J Clin Pathol. 2011;135:108–118). Kent B. Lewandrowski, MD, associate chief of pathology and director of laboratory and molecular medicine at MGH and professor of pathology at Harvard Medical School, calls the number of inpatient tests per discharge “a global benchmark,” saying, “It rolls up all of our individual utilization initiatives.”

How POC testing is pushing the envelope

April 2014—It can be hard to remember a time when GPS was not available in cars, the Web didn’t exist, and only eight diagnostic tests were classified as waived and able to be performed at the point of care. But after CLIA’s enactment in 1988, those were some basic realities of location and speed.

HPV primary screening for cervical cancer—an interview with Ritu Nayar, MD

April 2014—Dr. Nayar, professor of pathology at Northwestern University Feinberg School of Medicine in Chicago, is co-chair of the Cytopathology Education and Technology Consortium, president of the American Society of Cytopathology, and a member of the CAP Cytopathology Committee. She spoke with CAP TODAY recently about the FDA advisory committee’s recommendation on cervical cancer screening.

Microbiology automation: finding the right mix

April 2014—Talk to a few microbiology laboratories about why they feel the need to automate and you hear common themes: people, space, quality, and, most of all, time to detection. Microbiology may be late to join the bandwagon, but whether laboratories are making partial or full-scale moves to automate, they are dramatically making up for lost time, in all senses of the phrase. That’s because turnaround time savings are no longer measured in minutes. “Our goal is to be able to give some of these answers out in one to four hours rather than 24 hours, or much longer for some culture-based methods,” says Randall T. Hayden, MD, director of clinical and molecular microbiology at St. Jude Children’s Hospital in Memphis.

Can an old drug be taught new pharmacogenetic tricks?

April 2014—Despite warfarin’s continued presence near the top of the FDA’s list of adverse drug events and the availability of competing agents, the drug continues to be a mainstay of anticoagulant therapy, particularly among general practitioners. Its narrow therapeutic window and intra- and interpatient variability require regular measurement of the international normalized ratio. This, along with the large genetic component to warfarin response, principally contributed by variants in the genes VKORC1 (–1639G ➞ A) and CYP2C9 (*2 and *3), led many to hypothesize that pharmacogenetics could improve warfarin safety.

In encephalitis case, next-gen sequencing is the star

April 2014—In what may be a first for the burgeoning field of next-generation sequencing, this powerful new technology was used to identify the cause of encephalitis in a teenage boy who had been critically ill in the intensive care unit for several weeks. Diagnosis suggested a specific treatment. Within two weeks of initiating therapy, the boy had recovered and was discharged. It is becoming common practice to use NGS to detect mutations that can help select drug therapy in cancer cases and to find genetic variations responsible for inherited diseases. However, NGS has not previously been considered a useful tool in critical care situations, where a short turnaround time is crucial.

Tuning in to hypotensive transfusion reactions

April 2014—Most pathologists are trained to think of hypotensive transfusion reactions as rare events, and for the most part they are. But one pathologist’s experience suggests these reactions may be underreported, and perhaps on the rise. Greater recognition of these events could provide valuable information and help improve patient outcomes. “People often report these reactions as possibly related to transfusions, but the challenge to the pathologist is that the transfusion reaction workups are negative, for the most part. So they’re in a quandary as to whether the drop in blood pressure was because of the transfusion or other causes,” says Richard M. Scanlan, MD, clinical professor, vice chair of laboratory medicine, and director of the transfusion medicine service at Oregon Health and Science University (OHSU).

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