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Allegheny General Hospital in Pittsburgh has determined that the cause of an outbreak of pulmonary infections in 12 patients may be contaminated bronchoscopes that werent properly sanitized. Of the 12 patients, one patient died.
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There was a kinder time in the world. Nations were relatively at peace, and the future held nothing but blue skies and harmony. While our own industry is as stable as any, changes in reimbursement, shifting of physician loyalties, and profit compression have changed the way we operate our facilities. Or they should.
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If implemented, recent recommendations from the Department of Health and Human Services Office of Inspector General (OIG) would result in millions of dollars in payment reductions for hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs). OIGs report recommends that the Centers for Medicare & Medicaid Services (CMS) set uniform rates for outpatient services provided in ASCs and HOPDs.
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Schwetz named acting director of OHRP; Books help prepare for FDA inspections; NEJM retracts study after authors point to forgery;
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Its as simple as typing in an Internet URL, entering a few keywords, and hitting return across any persons computer screen comes a nationwide listing of clinical trials under way at various research institutions. Some sites even offer matching services. Could use of these listing services be considered recruitment?
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As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, theres general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects.
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Although some researchers are doing a better job of presenting informed consent documents in language that subjects can understand, too many still rely on jargon and overly technical language that can stymie people with limited literacy.
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It would seem that two recent publications by the Office of Inspector General (OIG) indicate a desire by the agency to be less stringent when it comes to the use of inducements for clinical trial participation involving Medicare and Medicaid patients.
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One of the major changes promoted in the Institute of Medicine (IOM) report Responsible Research: A Systems Approach to Protecting Research Participants, is a call for federal legislation expanding protections to all human subjects involved in research, regardless of funding or setting.
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State health policy experts and pharmaceutical company officials are anxiously awaiting the U.S. Supreme Courts decision on a controversial Maine program designed to help residents unable to afford prescription drug coverage get lower-cost medications.
