Issue: Volume XXVI No. 10 - July 22, 2019

Houston Errors Are Every Clinical Pathologist’s Fear

Due to medical errors, three patients died in three Houston hospitals in a short period of time. Each adverse event led to inspections by the federal Centers for Medicare and Medicaid Services (CMS) and sanctions as tough as revocation of deemed status for participation in the Medicare program. That these events came so closely together, …

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FDA Clears Aperio’s Digital Pathology System

CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed paraffin …

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Outside US, Digital Path Moves Ahead Rapidly

CEO SUMMARY: Implementation of digital pathology and whole-slide imaging systems in the United States lags behind that of other countries for two reasons. One is a more acute shortage of pathologists in those countries and the other is a less restrictive regulatory environment. In some locations outside the United States, pathologists have adopted fully-digital operations, …

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Bill Would Delay PAMA Reporting for One Year

CEO SUMMARY: For all laboratories that must report private payer price data under the Protecting Access to Medicare Act (PAMA), a new bill in congress would delay the next round of data reporting for one year and require the National Academy of Medicine to recommend ways to improve the data collection and market-rate setting processes …

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By 2025, Millennials Will Dominate Lab, Pathologist Workforce

CEO SUMMARY: Within five years, members of the millennial generation will make up 75% of the physician workforce in the United States, rising from about 24% in 2017. That three-fold increase represents a strong demographic trend that will require changes in the steps all clinical laboratories and pathology groups take when seeking to attract and …

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CMS Sanctioned Three Houston Hospitals, Labs

CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process in patient monitoring and communication of critical lab values.” State and …

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July 22, 2019 Intelligence: Late Breaking Lab News

Another clinical laboratory company disclosed a major breach of its patients’ protected health information (PHI). On July 15, Clinical Pathology Laboratories (CPL), a division of Sonic Healthcare, issued a press release and disclosed that it estimated as many as 2.2 million of its patients may have had their data exposed in a breach at Retrieval Masters …

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