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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.

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Put It on the Board

April 2014—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.

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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.”

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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.

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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.

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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.

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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.

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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.

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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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From the President’s Desk: Member survey meets our need to know, 4/14

April 2014—Soon CAP members will receive the online Practice Characteristics Survey, designed to provide evidence of the value we contribute to health care and the many ways we serve our patients. This is the ninth time since 1994 that we have conducted this survey, which informs our policy, advocacy, and planning for member services. If every CAP member makes a commitment to complete and return the survey, the results will greatly refine and enlighten our work to serve, promote, and represent your best interests. But every is the key word. Each member has a role in building a robust response rate that will give our findings the depth and level of credibility that inform and educate.

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A lot to like about laboratory-provider links software

April 2014—It’s not a race, but you gotta keep pace or risk losing face (and customers and revenue). While this rhyme isn’t an axiom, for vendors of laboratory-provider linking software, it might as well be. “It seems like a new health care initiative, best practice, or regulation is announced every year,” says Tim Kowalski, president and CEO of Halfpenny Technologies. “That makes it crucial to choose laboratory vendor partnerships and solutions that are designed to withstand this ever-changing industry.”

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Q & A Column, 4/14

April 2014—I have a question about the meaning of the word “guideline” versus “procedure.” Checklist requirement ANP. 11670 Specimen—Gross Examination says the following: “Documented instructions or guidelines are readily available in the laboratory for the proper dissection, description, and histologic sampling of various specimen types (e.g. mastectomy, colectomy, hysterectomy, renal biopsy, etc.).” This leads me to question whether the word guideline means the same as procedure. Procedures need to be signed bi­ennially. Does the same apply to guidelines? The formatting is different for procedures. Could guidelines also mean references?

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Newsbytes, 4/14

April 2014—CommonWell executing pilot phase of interoperability project: Competition is considered a positive force in business, but when patients are the consumers, cooperation sometimes trumps competition. For the founding members of the CommonWell Health Alliance, all major players in the competitive arena of health information technology, enabling clients to share patient data across disparate care settings and competing electronic health record systems is viewed as a common-sense move that boosts cost-effectiveness and benefits patients.

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Clinical Pathology Selected Abstracts, 4/14

April 2014—Intervention to improve timing of vancomycin levels: Samples drawn for therapeutic drug monitoring are sometimes drawn too early, which can cause inaccurate results that lead to a potential dosing error. One approach to reducing such errors is to create an information technology tool to assist clinicians in determining the best timing for a sample draw. The authors conducted a study at Brigham and Women’s Hospital, Boston, in which the investigators used both an educational and electronic intervention to reduce the number of vancomycin collection timing errors. The information technology-based intervention provided educational instructions to nurses.

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Anatomic Pathology Selected Abstracts, 4/14

April 2014—Clear cell papillary renal cell carcinoma: diagnosis and immunohistochemical profile: Clear cell papillary renal cell carcinoma is a recently recognized renal neoplasm composed of cells with clear cytoplasm lining cystic, tubular, and papillary structures. These tumors have immunohistochemical and genetic profiles distinct from clear cell renal cell carcinoma and papillary renal cell carcinoma. The authors studied morphologic and immunohistochemical features (cytokeratin 7 [CK7], carbonic anhydrase IX [CAIX], CD10, alpha-methylacyl-CoA racemase [AMACR], smooth muscle actin, desmin, and estrogen and progesterone receptors) in 55 tumors from 34 patients, eight of whom had end-stage renal disease.

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