Issue: Volume XXV No. 6 - April 16, 2018

Discovery of Pathology Errors Shows Quality Flaws

MOST PATHOLOGISTS WOULD AGREE THAT PATIENTS AND THEIR PHYSICIANS have every right to expect a timely, accurate lab test result. Stated differently, patients and physicians implicitly trust that a pathology laboratory in the United States will not make errors in specimen processing (technical component) and diagnosis (professional component). For these reasons, the recent federal Centers …

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NC Hospital Reviewing Path Lab Deficiencies

CEO SUMMARY: Discovery of multiple diagnostic errors occurring in an anatomic pathology department triggered a complaint investigation and a 54-page report from the federal Centers for Medicare and Medicaid Services. The report shows that Wake Forest Baptist Medical Center is reviewing more than 9,000 pathology cases to identify incorrect cancer diagnoses. Last month, the medical …

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CMS Report, News Stories Describe Pathology Issues

CEO SUMMARY: In response to information the pathology lab staff provided to the hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, the Wake Forest Baptist Medical Center is taking corrective action to fix serious deficiencies in its anatomic pathology laboratory. In reports issued in February …

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Georgia Micro Lab Slashes TAT by Almost Two Days

CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass spectrometry and MALDI-TOF for bacterial infections, cutting turnaround times from 104 to …

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Legal Briefs Explain Problems with PAMA Implementation

CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the …

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Attorney Says Labs Face Increased Legal Liability

CEO SUMMARY: For many reasons, including cuts to lab test prices that health insurers pay, narrow networks, and more competition for lab test referrals, a significant number of lab companies are seeking ways to increase market share. These methods include the use of new laboratory test arrangements and innovative strategies for pricing lab tests. But …

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Response to FDA’s Gottlieb on Reducing Regulatory Burden

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible …

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April 16, 2018 Intelligence: Late Breaking Lab News

Add Estonia to the growing list of nations that will now provide genetic information to its citizens. On March 20, the government rolled out an initiative that, in its first phase, will generate genetic information for 100,000 of its 1.3 million residents. This data will address an individual’s genetic risk for specific diseases. The University of …

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