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April 2013

Put it On the Board, 4/13

April 2013—ACMG issues guidance on incidental findings: The American College of Medical Genetics and Genomics released last month its recommendations for reporting incidental findings in clinical exome and genome sequencing. An ACMG working group, working with 15 experts who served as external reviewers, specifies a set of disorders, the relevant associated genes, and certain categories of variants that should be reported, based on a consensus-driven assessment of clinical validity and utility.

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With NGS, new hope for managing thyroid nodules

April 2013—Faced with assessing one of the hundreds of thousands of patients who present with thyroid nodules each year, clinicians know that the initial diagnostic steps are straightforward. With fairly good reliability, using ultrasound examination, fine-needle aspiration, and cytologic examination, they can determine in about 70 to 80 percent of cases whether the nodule is benign or malignant. And good treatment options exist for those in the latter category.

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Missing transcripts, diplomas snag labs

April 2013—The paperless office may be just around the corner, and virtual reality may lie ahead too. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. For accreditation under CLIA, it’s not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas.

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HCV, CMV viral load—treatment, testing, timing

April 2013—Treatment for hepatitis C virus infection turned a corner in 2011 when direct-acting antiviral inhibitors were approved and combined with dual therapy—pegylated interferon and ribavirin. Cure rates shot up from about 45 percent to 70 to 75 percent. With antivirals that are even more potent in late-stage clinical trials now, “Use of oral antiviral therapy without interferon appears to be a real possibility for the near future,” said Mitchell L. Shiffman, MD, director of the Liver Institute of Virginia at Bon Secours Health System in Richmond and Newport News, in an Association for Molecular Pathology session at the 2012 annual meeting, where he spoke about viral load monitoring for HCV.

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Newsbytes, 4/13

April 2013—Computing for Good project proving great for African labs; Cerner purchases Labotix Automation, PureWellness; Six health IT companies forge interoperability organization; Liaison Technologies acquires Ignis Systems; Psyche Systems offers new LIS and updates another; AP-Visions marketing LIS to small hospitals and POLs; HL7 releases intellectual property as free offering

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Letters, 4/13

April 2013—Remembering Lee VanBremen, PhD: I read with interest the reminiscences about former CAP executive vice president Lee VanBremen, PhD (February 2013, page 12). It was my good fortune to serve on the CAP Board of Governors while Dr. VanBremen was the EVP. It became immediately apparent that he was a gentleman, highly intelligent, quiet, and reserved.

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Q & A, 4/13

April 2013—In the point-of-care test for the determination of prothrombin time and International Normalized Ratio by fingerstick in a physician’s office, are controls (normal and elevated) available for adequate QC determination? Are physician office labs not governed by the same basic principles governing formal clinical laboratories? Are they permitted to run tests without running QC? Are there potential legal ramifications for having obtained an incorrect result for a POC test performed in a physician’s office without the proper use of QC, leading to a catastrophic patient result?

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