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Imagine being in the position of publicly critiquing a competing hospital's compliance with Joint Commission requirements. Would you be able to be completely objective? Even if you were, would your colleagues really trust your ability to be impartial?
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Joint Commission standards require the organized medical staff oversee the quality of care, treatment, and services rendered by physicians and other licensed independent practitioners. This includes monitoring the quality of services provided by hospital-based practitioners such as radiologists and pathologists.
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Just 14 weeks after The Joint Commission approved an interim action that allowed pharmacists to retrospectively review ED medication orders to comply with element of performance (EP) 1 for standard 4.10 of medication management, the action was suspended.
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Hospitals may become more liable to infection-related lawsuits as patients gain greater access to information and expect higher standards of care to prevent infections once considered inevitable, a legal scholar warns.
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Now that IRBs have both the final guidance on unanticipated problems and adverse events from the Office for Human Research Protections (OHRP) of Rockville, MD, and the draft guidance from the Food and Drug Administration (FDA), their duties in handling these issues should be clear, right?
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In April, 2007, the Food and Drug Administration (FDA) issued its draft "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection."
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When IRB members weigh risks and benefits of an oncology clinical trial, they need to put risks and benefits in perspective for this particular population, or else they'll err by being too cautious, an expert suggests.
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For IRB offices to run smoothly, employees need to work well together and count on each other when the work overflows.
