Hospital Management
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FDA Gene Therapy Draft Calls for Long-term Follow of Subjects
The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events.
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Consistency Is a Challenge, but Necessary With Multiple Institutional IRBs
Research institutions that undergo accreditation preparation quickly learn that having separate policies and procedures for each IRB is a problem.
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Newly Accredited Program Has Made Policies and Procedures Easier to Follow
When the human research protection program at the University of Florida decided to undergo accreditation with the Association for the Accreditation of Human Research Protection Programs, officials revised policies and procedures, making them consistent across IRBs and easy to follow.
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Tackling AAHRPP Accreditation Requires Time, Focus, Documentation
Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.
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Does Use of Biospecimens From Children Require Reconsent When They Are Adults?
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions.
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Hip Replacement Guarantee Required Solid Metrics
Geisinger health system’s decision to offer a lifetime guarantee on total hip replacements could only be made after reaching quality metrics that would make any hospital proud. -
Patient and Family Councils Make a Difference
A strong quality improvement infrastructure can be the perfect setting for developing a patient and family advisory council, says Libby Hoy, founder and CEO of Patient and Family Centered Care Partners in Long Beach, CA, which works with hospitals to encourage patient and family participation. -
Volunteer Advisors Round in ED to Reduce Falls, Improve Care
In 2012, leaders at Health Central Hospital in Ocoee, FL, were concerned that the patient voice was not heard and thought overall patient care and satisfaction could be improved by listening to them more. -
After One-time Training Fails, Long-term Approach Developed
A Texas hospital has learned that a checklist and one-time training do not always yield lasting results, so it developed a systematic, long-term approach to a vexing problem related to patient handoffs. -
Best Practices to Avoid Negligent Credentialing Claims
Among other things, adopt and implement a robust credentialing process on the front end. It is better to avoid appointing a physician than to have to remove a physician once he or she is appointed.