Hospital
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Small IRB Revises Forms, Updates Policies and Procedures to Obtain FWA and Reach Next Level
A small university's human research protections program overhauled its processes to bring it up to the requirements of the Common Rule and Federalwide Assurance.
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FDA’s Draft Guidance on eRecords Could Have Unintended Consequences
The FDA’s draft guidance on the use of electronic records and electronic signatures encourages systems to improve quality and efficiency, and expands the use of a risk-based approach in validating and establishing audit trails for electronic systems. But it’s the validation part of the proposed guidance that could introduce a new problem.
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Assent Is Not Consent: Children in Clinical Trials Are Not Little Adults
The classic admonition in pediatric medicine is “children are not little adults,” implying in part that you cannot just scale down adult care and treatment. Does this phrase resonate as well in human research trials involving children, particularly around issues of consent for the former and assent for the latter?
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ICMJE Underlines Ethics on Importance of Data Sharing
The International Committee of Medical Journal Editors published an editorial in June 2017, saying there is an ethical obligation to share interventional clinical trial data. Beginning July 1, 2018, manuscripts with clinical trial results that are submitted to the committee's journals must contain a data-sharing statement.
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Quality Payment Program Delaying Some Requirements
CMS is attempting to lower the burden of the Quality Payment Program for small practices and other clinicians, with a proposed rule that would update the physician payment programs created as a part of the Medicare Access and CHIP Reauthorization Act. The changes could be important for hospitals and health systems with affiliated physician practices.
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Changes to Readmissions Rule Will Help, But No Panacea
CMS has proposed a change that would have it consider a hospital’s proportion of dual-eligibles when determining penalties under Medicare’s Hospital Readmission Reduction Program (HRRP), a change welcomed by hospitals that have long argued dual-eligible patients are more expensive for hospitals and skewing readmissions figures for safety-net hospitals.
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Communication Challenges Can Threaten Quality
Language barriers may be commonly recognized as threats to quality of care and patient safety, and hospitals routinely provide resources to overcome that barrier. But communication challenges can come in many forms and hospitals often are blind to them, leading to serious risks, one expert cautions.
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Smartphone Alerts for Lab Results Speed ED Discharge
Delivering lab results immediately to a specially provided smartphone helps physicians discharge patients significantly faster from the ED, according to recent research.
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Board Members Involved in Quality Can Be Quality Resource
Quality improvement leaders should strive for a working relationship with hospital boards of directors and help the members gain the knowledge necessary to be meaningful champions of quality initiatives. However, that does not mean that board members should be expected to participate in the day-to-day efforts to improve quality and patient safety.
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The Epidemiology of Violence: Knowledge Is Power
As hospital violence has become a national issue and the subject of a possible federal regulation, researchers are showing that interventions using the basic epidemiologic principles of measurement and feedback can reduce unit-level violence by patients against healthcare workers.