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Hospitals might face quandaries over when they must report clinicians to the National Practitioner Data Bank (NPDB), but it is important to remember queries to the NPDB also are required. Failure to follow protocol could put the facility in peril.
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Hospitals enjoy substantial protection when reporting physicians to the National Practitioner Data Bank (NPDB) in many situations, with laws protecting against retaliatory lawsuits as long as the hospital was required to report and followed appropriate protocols. However, there are situations in which reporting to the NPDB is not required but might still be the right thing to do when leaders are concerned about a clinician’s threat to patient safety. In those circumstances, the protection against liability is not ironclad.
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CMS explains the new 2021 methodology for its Hospital Quality Star Ratings uses “a simple average of measure scores to calculate measure group scores and Z-score standardization to standardize measure group scores” in five measure groups.
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Hospital leaders had criticized previous ratings because they believed the methodology used to create them was flawed and produced inconsistent results that made the ratings misleading and not useful to consumers.
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Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.
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Whether institutions are the IRB of record or the relying IRB, setting up a seamless process involves many time-consuming processes — and it can take years. One of the obstacles to an efficient IRB reliance effort is handling the technological details.
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It is unlikely IRBs will see many studies with one enrolled participant (the N=1 study design), but they should be prepared for this type of protocol. The single-subject study design can be applied to chronic conditions like cystic fibrosis or to ultra-rare diseases.
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One hot topic during a recent webinar on diversity in clinical trials centered around whether researchers should use race in a clinical trial. Using race as a variable is never neutral and never scientific, one expert noted.
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Structural racism is a powerful construct that may influence participation in clinical research studies, panelists of a recent webinar noted.
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Diversity in clinical trials involves more than just including more minority participants, panelists said at a recent webinar. It is a commitment from leadership that addresses the diversity topic within every aspect of the clinical trial process.
