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July 2018

Small groups, big answers in HER2 testing

July 2018—Take the new ASCO/CAP guideline for HER2 testing. Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. The previous guidelines turned out to be tough acts to follow—a bit like following Sean Connery in the role of James Bond—even as the new one benefits from new data.

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Look, wait, buy: labs share instrument plans

July 2018—“Robbie,” the autonomous service robot that transfers specimens for Florida Hospital’s central laboratory, may not quite be ready for his gold watch. But after five years of faithful service delivering samples between the different esoteric testing units, he’s nearing the end of his natural lifespan with signs of wear.

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In memoriam: Harold H. Harrison, MD, PhD (1951–2018)

July 2018—Harold H. Harrison, MD, PhD, 67, Pennsylvania state commissioner in the CAP Laboratory Accreditation Program and a member of the Inspection Process Committee, died suddenly June 6 of cardiac causes. Dr. Harrison joined the Geisinger Health System in Danville, Pa., in 2007 where he was director of clinical pathology and director of Geisinger Regional Laboratories.

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For pain care and more, PGx testing at Avera Health

July 2018—Putting pharmacogenetic testing into play at Avera Health was years in the making. It took time to operationalize it at an affordable cost. Today, it has wide physician acceptance and is seen as a strong benefit for patients. “Pharmacogenetics is what will differentiate Avera in a new era of ACOs and personalized medicine, and will ultimately lead to a model for transforming health care,” says Trisha Lauterbach, MS, MLS(ASCP)CM, laboratory operations manager at Avera Institute for Human Genetics (AIHG), Sioux Falls, SD.

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Direct oral anticoagulants and APTT, PT results: The risk of normal results in patients on therapy

July 2018—With the introduction of direct oral anticoagulants (DOAC) there is a paradigm shift in the use and understanding of screening coagulation tests to determine a patient’s bleeding risk. In patients on DOAC therapy, clinicians cannot rely on normal activated partial thromboplastin time (APTT) and prothrombin time (PT) results to reflect the patient’s level of anticoagulation.

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Put It on the Board

High-sensitivity troponin I assay available in the U.S.
July 2018—Beckman Coulter Diagnostics received 510(k) clearance from the Food and Drug Administration for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI, and the entire Access family of immunoassay systems. Access hsTnI demonstrates less than 10 percent CV at the upper reference limits for men and women and detects troponin in more than 50 percent of the healthy population. In an independent study, Access hsTnI detected more than 99 percent of troponin values for healthy men and women (Pretorius CJ, et al. Clin Biochem. 2018;​55:​49–55). “Beckman Coulter’s high-sensitivity cardiac troponin I assay can measure very low cardiac troponin concentrations with excellent precision. This test may help physicians with both the early diagnosis of myocardial infarction and future risk stratification in and outside the acute coronary syndrome setting,” Peter Kavsak, PhD, associate professor, Department of Pathology and Molecular Medicine, McMaster Uni­versity, said in a statement.

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Clinical Pathology Abstracts

Trends in perioperative RBC transfusion from index cases in five surgical specialties
July 2018—In recent years, greater attention has been given to patient blood management. While contemporary national guidelines recommend restrictive red blood cell transfusion, it is not known whether such transfusions have decreased in surgical patients. Approximately 11 million RBC transfusions are performed annually, and two-thirds of those are for patients in the perioperative period.

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