Month: May 2017

New Business Models for Pathology, Clinical Labs

EXPERTS OFTEN PROCLAIM THAT THE U.S. HEALTHCARE SYSTEM is slow to change and slow to adopt the management approaches, operational innovations, and new technologies that other industries use. One example is adoption of the quality management techniques that W. Edwards Deming and the Japanese developed by the 1970s. Today, these are described as Lean, Six …

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Cautious Optimism Seen At Executive War College

CEO SUMMARY: Among the major themes to emerge from the more than 60 sessions and 100 speakers at this year’s Executive War College on Lab and Pathology Management were the accelerating pace of integrated care, the growth of precision medicine, and use of big data to guide physicians. Other issues centered on labs’ need to …

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Cyber Thieves Hit UK Hospitals During Ransomware Attack

AT LEAST 48 HOSPITALS, PHYSICIANS’ OFFICES, and ambulance companies in Britain’s National Health Service were among the many victims of a cyberattack Friday that affected tens of thousands of computers in as many as 150 countries, The New York Times reported. Hackers used malicious software developed by and stolen from the U.S. National Security Agency, …

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Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for …

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CEO Describes Characteristics Of the Clinical Lab 2.0 Model

CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Project Santa Fe, which wants …

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Digital Pathology Systems Will Create Opportunities

CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision to clear this system for sale earlier this month, and informed by their …

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May 15, 2017 Intelligence: Late Breaking Lab News

There is a new development in one of the whistleblower lawsuits filed against several lab companies that offered specialty cardiology tests. Earlier this month, the Department of Justice announced a settlement with Quest Diagnostics involving its acquisition of Berkeley HeartLab, which was acquired by Quest in 2011. The DOJ said that Quest agreed to pay …

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