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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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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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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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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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Cytopathology + More | Telecytopathology’s potential starting to be seen

August 2015—There is a growing body of literature referencing the uses of telecytopathology in clinical care. Telecytopathology is the interpretation of cytopathology material at a distance using digital images. It can be subdivided into three basic applications: rapid on-site evaluation (ROSE), primary specimen diagnosis, and second opinion consultation. Although there is a long history of attempts at implementing telecytopathology for broad clinical use, it still has limited but important applications in patient care.

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Lab studies new steps in urine and anemia screening

August 2015—Despite the demonstrated value of implementing reflex testing algorithms to improve patient care and avert wasteful spending, the road from conceptual understanding to plan-in-action can be rocky. A pathologist at one academic medical center recently talked about his experience with reflex testing algorithms in the areas of urine screening and preoperative anemia screening. His story illustrates the barriers to change as well as the enviable outcomes that could potentially be achieved.

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IOM report on diagnostic errors expected this fall

August 2015—The Institute of Medicine is expected to release in September a consensus study on diagnostic error in health care that will offer recommendations for policymakers, payers, medical institutions, physicians, and patients aimed at preventing harmful mistakes. This will come after nearly two years of studying the U.S. health system and reviewing the perspectives of stakeholders such as the CAP.

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Clinical Pathology Abstracts, 8/15

August 2015—Characteristics and antibiotic use associated with short-term risk of C. difficile infection in hospital patients: Clostridium difficile infection is recognized as the leading cause of infectious nosocomial diarrhea. Since molecular testing has improved the sensitivity and specificity of C. difficile infection (CDI) diagnosis, most hospitals discourage repeating a negative test within seven days. However, there is a rare possibility that a patient may have repeat CDI testing that is positive within 14 days after an initial negative finding.

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Anatomic Pathology Selected Abstracts, 8/15

August 2015—Quality of diagnostic staging in patients with bladder cancer: a process-outcomes link: Muscle sampling is often used as a surrogate for staging quality in patients with bladder cancer. The association of staging quality at diagnosis and survival was examined among patients with bladder cancer. The clinical records of all individuals within the Los Angeles Surveillance, Epidemiology, and End Results registry with an incident diagnosis of nonmuscle-invasive bladder cancer in 2004–2005 were reviewed.

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Molecular Pathology Selected Abstracts, 8/15

August 2015—Studying clonal dynamics in response to cancer therapy using barcoding: The emergence of resistance to targeted cancer therapeutics is a significant problem clinically and is generally believed to result from genetic alterations in tumor cells. Whether resistance exists within a subpopulation of a tumor prior to treatment or develops de novo during treatment is a fundamental question that may significantly impact therapy.

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Put It on the Board, 8/15

August 2015—To meet TAT goals, Vanderbilt builds ED lab: In a move expected to help meet accreditation standards on testing turnaround times for stroke and chest pain patients, Vanderbilt University Medical Center’s emergency department will gets its own satellite laboratory this month.

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Newsbytes, 8/15

August 2015—How one pathologist made use of artificial intelligence: Like many pathologists, Jay J. Ye, MD, PhD, longed to spend less time preparing reports and more time interpreting slides and rendering diagnoses. Rather than dedicating half of his workday to what he considers secretarial tasks, the dermatopathologist wanted to devote the lion’s share of his hours in the lab toward applying the knowledge and skills he developed during his years of medical training and practice.

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