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July 2014

New analyzers, assay applications, and tools, tests, and solutions to come

July 2014—In this year’s roundup of chemistry analyzers for mid- and high-volume laboratories, three appear in our guide for the first time. Randox received FDA clearance this year for the latest edition of its RX series, the RX Daytona Plus, a fully automated, random-access benchtop analyzer that’s capable of running 270 photometric tests per hour or 450 tests per hour with the optional ion selective electrode unit.

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AML molecular testing a map with many paths

July 2014—When it comes to molecular testing for acute myeloid leukemia, the approach seems more Montessori than military school. There are some basic steps physicians should take, to be sure. Cytogenetics still shepherds patients into three prognostic groups: favorable, intermediate, and unfavorable. And several gene mutations—NPM1, CEBPA, FLT3, and KIT—alone or in combination, and with various cytogenetic associations, provide additional prognostic and therapeutic guidance.

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Slashing send-out costs with lab formularies

July 2014—A glance at most hospital laboratory spreadsheet makes it clear: Where laboratories could reduce high-cost reference testing for inpatients and unreimbursed send-out testing for outpatients, the savings would be striking. But voluntary education programs geared to improving test ordering practices are known to have their limits. Could a mild form of, well, coercion be helpful?

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Lab gets a jump on pay-for-value world

July 2014—Before the Affordable Care Act was passed, and before the notion of an ACO became a Medicare reality, Richard J. Cote, MD, was among those in medicine who saw the writing on the wall regarding health care payment. Dr. Cote recalls his thinking as he joined the University of Miami Miller School of Medicine in 2009 to become chair of its Department of Pathology.

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PT referral rules bring regulatory relief for labs

July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.

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From the President’s Desk: Collaborating when and where it matters, 7/14

July 2014—I recently attended my first meeting as a member of the American Society of Clinical Oncology. I joined ASCO because I’ve been so impressed with the members I’ve met and the way they contribute to our work. I learned a lot and enjoyed the company, which means that I plan to attend their meetings whenever I can and hope many of you will do the same.

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Clinical Pathology Selected Abstracts, 7/14

July 2014—Effects of fish oil in recent-onset rheumatoid arthritis: a patient study: The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaneonic acid (DHA), which are found in fish oil, can suppress synthesis of the omega-6 proinflammatory eicosanoids prostaglandin E2 and leukotriene B4. The effects of fish oil as a dietary supplement in rheumatoid arthritis have been studied in randomized, controlled trials for patient-assessed pain, morning stiffness, number of painful or tender joints, and non-steroidal anti-inflammatory drug consumption.

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In amyloidosis, timely diagnoses lag therapy gains

July 2014—G-G-G-E♭. Also known as da-da-da-DUM. Also known as the opening to Beethoven’s Fifth Symphony. It’s a simple motif, heard repeatedly in the piece (not to mention across the centuries), yet no less thrilling for that fact. Maria M. Picken, MD, PhD, finds herself repeating an equally straightforward motif when she speaks about amyloidosis, and it, too, is worth hearing again: The disease is not being diagnosed early enough, and sometimes not at all. That theme has been a steady refrain of hers over the years, and it runs throughout a recent interview with CAP TODAY, so much so that she worries readers will respond with, Oh no, here she goes again.

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Anatomic Pathology Selected Abstracts, 7/14

July 2014—Assessing IHC biomarkers for basal-like breast cancer against a gene-expression profile gold standard: Gene-expression profiling of breast cancer delineates a particularly aggressive subtype referred to as basal-like. This subtype comprises approximately 15 percent of all breast cancers and afflicts younger women. It is refractory to endocrine and anti-HER2 therapies.

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Put It on the Board, 7/14

July 2014—Ethics of laboratory billing at stake in AMA’s code: Proposed revisions to the American Medical Association’s Code of Medical Ethics would remove language that supports direct billing and condemns clinicians who charge markups for laboratory or pathology services. The changes could weaken efforts to rein in billing practices that CAP leaders argue are not in the best interest of the patient and that the AMA currently defines as unethical.

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Newsbytes, 7/14

July 2014—The benefits of building versus buying lab software: Like many in the field of pathology informatics, John Sinard, MD, PhD, does not believe that one-size-fits-all when it comes to laboratory software systems. But unlike many of his peers, he does not choose to live with the discrepancies or purchase a new product.

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