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December 2017

Hopes, fears as users switch to new troponin

December 2017—The questions that arise over the use of highly sensitive cardiac troponin are as riveting as, if less historically fraught than, the Jefferson-Hamilton debates over the shape of their newborn country. Who should lead—the states or a strong central government? Cardiologists or the emergency department? What cutoffs represent the right balance between admissions, referrals, and sending patients home? And will Lin-Manuel Miranda ever write a smash musical about this cardiac assay?

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In hemostasis, two hot-button testing issues

December 2017—Having validation data to support the use of age-adjusted D-dimer cutoffs with the D-dimer assay your laboratory uses is a must, and know well the limitations of point-of-care prothrombin time/INR testing. That advice and more was shared in a “Hot Topics in Hemostasis” session at CAP17, presented by Russell Higgins, MD, and Karen Moser, MD.

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‘Connectathon’ opens door to interoperability in digital pathology

December 2017—With the FDA having approved whole slide imaging for primary diagnosis this year, one obstacle to full acceptance of digital pathology remains: lack of interoperability. To topple that barrier, the Digital Pathology Association, the CAP through its Digital Pathology Committee, and DICOM Working Group 26 convened in October, during the Pathology Visions conference, the first Connect­athon for digital pathology.

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HbA1c shows its mettle in predicting diabetes risk

December 2017—The longitudinal Framingham Heart Study, which first identified the concept of risk factors and made serum LDL cholesterol a household name, could help increase the celebrity status of HbA1c, with the Oct. 26 publication of a new study in Diabetes Care. International and national organizations since 2010 have recognized HbA1c as a valid way to diagnose abnormalities in glycemia and diabetes mellitus. But there has been less consensus on its use as a screen for elevated diabetes risk.

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From the President’s Desk: Family matters, 12/17

December 2017—Most of us look forward to the holidays. We are excited about renewing old connections or making new ones, getting together with family and friends, having special meals, attending comforting services, gathering together to exchange gifts or just talk. We look forward to the comforts of predictability. The corny Dad jokes that must be retold. Family stories, those true and nearly true, are relived together and, for the younger members of the family, may be heard for the first time. Familiar, treasured television shows are seen for the umpteenth time. Beautiful lights, shows, pageants, and parades dazzle all, young and old.

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Higher pay for therapeutic apheresis, bone marrow aspiration

December 2017—For 2018, CMS estimates a one percent overall decrease in pathology reimbursement. Pathologists will receive payment increases for therapeutic apheresis and diagnostic bone marrow aspiration services in 2018. At the same time, reimbursement for flow cytometry services will continue to decrease following phased-in reductions set by the Medicare program last year, but the CAP was successful in lessening the impact of cuts to those services in 2018.

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Are point-of-care PT/INR devices safe and effective?

December 2017—Safety issues related to point-of-care PT/INR testing surfaced in recent years, among them a 2016 voluntary class 1 recall of Alere’s INRatio and INRatio2 monitor systems. “Prior to that, the company that manufactured the device had received thousands of complaints about it,” says Russell Higgins, MD, of the University of Texas Health Science Center at San Antonio.

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Class act in Ohio expands pool of phlebotomists

December 2017—After two rounds of a new program to train high schoolers in phlebotomy, OhioHealth is seeing the fruits of its efforts. It has hired 19 of its trainees and a third course, set to begin next month, has 20 high school seniors enrolled. Just when OhioHealth’s phlebotomy staffing needs were expanding, laboratory services leaders were growing increasingly dissatisfied with the quality of the training students were receiving at most of the phlebotomy programs in the Columbus area.

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Anatomic Pathology Abstracts, 12/17

December 2017—Gene mutations in HPV-negative penile squamous cell carcinoma: The majority of penile squamous cell carcinomas are caused by transforming human papillomavirus infection. The etiology of HPV-negative cancers is unclear, but TP53 mutations have been implicated. Archival tissue from 108 invasive squamous cell carcinomas from a single pathology institution in a low-incidence area were analyzed for HPV-DNA and p16INK4A overexpression and for TP53 mutations by Ion Torrent next-generation sequencing.

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Clinical Pathology Abstracts, 12/17

December 2017—Chimeric antigen receptor T-cell therapy assessment and management of toxicities: In August, the FDA approved the gene therapy Kymriah (tisagenlecleucel) for pediatric and young adult patients with a form of acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a breakthrough in the treatment of leukemia and lymphoma, but it is associated with unique acute toxicities, such as cytokine-release syndrome and CAR-T-cell-related encephalopathy syndrome.

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Molecular Pathology Abstracts, 12/17

December 2017—Refining subgroups of pediatric gliomas using molecular markers: Pediatric high-grade and diffuse intrinsic pontine gliomas are a rare and heterogeneous group of tumors that show diverse histology, location, and prognosis. Although little was known regarding the development of these tumors, recent genomic studies have begun to elucidate their biological underpinnings. The authors conducted a study to further understanding of such gliomas by breaking them into subgroups.

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Newsbytes, 12/17

December 2017—Hospital cyberattack a brief setback with lasting gain: A cyberattack that paralyzed the computer systems at a rural West Virginia hospital last summer could have brought the laboratory’s work to a screeching halt. But that didn’t happen, thanks, in part, to the downtime procedures in place throughout the laboratory and the low-tech nature of the lab’s pathology operations.

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Put It on the Board, 12/17

December 2017—FDA announces IMPACT authorization and path for authorization of other tumor profiling tests: The FDA on Nov. 15 authorized Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The IMPACT test uses next-generation sequencing to identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a tumor.

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