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August 2015

Q&A, 8/15

August 2015—Our laboratory is adding urine total protein to its Siemens Dimension EXL test menu. The test is being performed now at our reference lab on the Siemens Advia 1800. Our Dimension EXL method validation studies have revealed an average 40 percent positive bias over the Advia method. This bias is also evident in peer group evaluations for the quality control product we are using.

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What’s new in next-gen sequencing checklist requirements

August 2015—The first CAP accreditation checklist requirements specific to next-generation sequencing were published only three years ago. “In 2012, those 18 accreditation requirements were basically all new language that the College’s Next-Generation Sequencing Project Team developed and submitted for review,” says project team chair Karl Voelkerding, MD, of the University of Utah Department of Pathology and ARUP Laboratories.

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Checklists 2015: signposts are clarity, consistency

August 2015—It doesn’t come swathed in a ribbon on the showroom floor, but the 2015 edition of the CAP Laboratory Accreditation Program checklists is new, improved in style and substance, and ready to roll. More precise and consistent quality terminology, more consolidation of requirements into the All Common checklist, and increased clarity on how labs can demonstrate their level of quality are among the highlights of the 2015 edition.

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Pay is up in Medicare proposal, but final picture unknown

August 2015—After years of reading the latest news from the CMS with dread, pathologists and independent laboratories have some reason for revelry this summer as the agency’s proposed physician fee schedule offers an overall uptick in Medicare payment for 2016. Yet it is the final physician fee schedule, due in November, that will tell whether pathologists feel grateful toward the CMS when Thanksgiving rolls around.

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Letters, 08/15

August 2015—Breast pathology study: I read the letter by Diane Schecter, MD (July 2015), and I respect her right to remind readers that the findings from the breast pathology study published in JAMA (Elmore JG, et al. 2015;313:1122–1132) are similar to results published nearly 25 years ago.

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From the President’s Desk: Showing what is in our hearts

August 2015—The CAP Foundation See, Test & Treat program is one of the best things we do. I like that it is patient centric and volunteer driven. I like that it is multidisciplinary, collaborative, and community based. I like that it is quietly disrupting how underserved populations experience the health care system and how we relate to our clinical partners. And I like knowing that something that does so much good for everyone it touches is pathologist led—which means we are forever examining, growing, and improving it as only we can do.

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Cytopathology + More | ICD-10: finishing touches or finding the road?

August 2015—To gear up for the change from ICD-9, the Centers for Medicare and Medicaid Services has provided updates and training and has kept ICD-9 changes to a minimum in an effort to build a strong crosswalk to ICD-10. Last year, the U.S. was given one more year to prepare, but that will not be the case this year. In fewer than 75 days, on Oct. 1, the U.S. will convert to ICD-10 coding.

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Laboratory automation: more than moving from here to there

August 2015—Move it, monitor it, manage it: Hardware and middleware, modules, and interfaces dominate the developments from at least five manufacturers of systems in this year’s product guide to laboratory automation systems and workcells—Beckman Coulter, Siemens, Sarstedt, Inpeco, and Cerner. The guide also includes four systems from a company new to the guide—IDS in Kumamoto, Japan—and additions from Aim Labs, Ortho-Clinical Diagnostics, Roche, and Beckman Coulter.

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Cytopathology + More | Primary HPV screening, Pap-HPV cotesting: interim guidance and a retrospective study

August 2015—The Food and Drug Administration in 2001 approved the use of high-risk HPV testing to triage ASCUS Pap test results (reflex testing). Two years later the FDA expanded the indications for hrHPV testing to include its use as an adjunct to cytology in women over age 30 (cotesting). The rationale for age 30 as a cotesting cutoff point was that hrHPV is common in sexually active young women and most infections are transient and clear without medical intervention.

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