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February 2014

Q & A Column, 2/14

February 2014—We are thinking about using a reference laboratory for HER2 FISH testing of breast carcinomas with an arrangement in which that lab performs the technical component and we perform the interpretation. A “frequently asked question” from 2011 on the CAP Web site seems to say that we must perform bright-field ISH proficiency testing to be in compliance, since we are not performing the hybridization and cannot refer PT to another laboratory. Can you clarify the PT requirement, if any, for this situation? The vendor we are dealing with has offered to establish its own FISH PT program.

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Put It on the Board, 2/14

February 2014—When are genomic tests useful? IOM seeks answers: Collaboration among key stakeholders to set clear evidentiary standards is needed to determine the clinical utility of genome-based testing in cancer care, according to a wide variety of experts participating in an Institute of Medicine workshop. Between 1969 and 1989, genomic biomarkers were mentioned in fewer than 50,000 National Library of Medicine publications. But between 2000 and 2010, more than 250,000 articles mentioned biomarkers, said a December 2013 IOM report, “Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.”

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Clinical Pathology Selected Abstracts, 2/14

February 2014—Comorbidity-adjusted life expectancy: a new tool to aid cancer screening strategies: Controversy surrounds how best to use cancer screening tests in the elderly and at what age to stop screening. The benefits of early cancer diagnosis and treatment decline with age because many elderly people are more likely to die of a comorbid condition or other cause than of cancer. This impacts the survival benefits of early cancer detection. One must also consider the harms of screening, including complications of further testing and treatment for a disease that may not be symptomatic in a patient’s lifetime.

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Breast cancer answers, short and long

February 2014—When it comes to breast cancer, medical oncologists have two “wish lists” for their pathologist colleagues. Here’s the short list of test results they need when they sit down with a patient, courtesy of Melody Cobleigh, MD. “ER, PR, HER2,” says Dr. Cobleigh, professor of medicine and the Brian Piccolo Chair for Cancer Research, Rush University Medical Center, Chicago. It’s a direct, unassailable answer. But so, too, is saying that the assassination of the Archduke Ferdinand caused World War I.

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Diabetes debate: HbA1c or glucose?

February 2014—If it were a boxing match, the debate over whether hemoglobin should be used to diagnose diabetes would place the odds-on favorite in the “Yes” corner. In the “No” corner would be the underdog. At least based on the mainstream consensus since 2010, HbA1c for diagnosis is well established as an alternative to measuring glucose.

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Powering down on excessive test use

February 2014—Utility companies can generate electricity in many ways—fossil fuel, nuclear reaction, solar panel, wind turbine. Which power source is preferable depends on the circumstances and the work that needs to be done. Generating optimal laboratory utilization is much the same. Providing an efficient and effective combination of tests for diagnosing hematologic neoplasms requires a different approach from achieving appropriate repeat ordering of chemistry tests in ICU patients. Delivering only the necessary blood components to cardiovascular surgery patients may take different tactics from curbing orders of expensive molecular genetic send-out tests.

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Handling a reagent recall, step by strenuous step

February 2014—Recalling a reagent is about more than just removing a product from laboratory shelves. It’s about retracting test results and thus affecting diagnoses and treatment plans. It’s about questioning patient outcomes and revisiting past decisions. “So much of what laboratories do is central to making a diagnosis and determining treatment,” says John Harbour, MD, regional medical director of HealthPartners Laboratories, medical director of the Bon Secours St. Mary’s Hospital Laboratory, and president of Monument Pathologists Inc., Richmond, Va.

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IT drives clinical, financial gains in hospital labs

February 2014—For “quants”—people who love all things numeric or algorithmic—information technology is its own reason for being. But for those with responsibility for clinical outcomes and the bottom line in the clinical laboratory, IT is much, much more. Innovative uses of IT are providing myriad new solutions with measurable paybacks in quality improvement and cost reduction.

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