Compliance
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Surgeon Sues Health System for ‘Forced Referrals’
A Florida health system is facing a whistleblower lawsuit from a surgeon alleging the system violated federal law by requiring him to perform surgery and refer patients within its own facilities. The surgeon claims the health system fired him for not complying with the policy. The mandatory self-referrals violate the Physician Self-Referral Law and other statutes, the lawsuit claims.
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Can Telemedicine Deliver High-Quality Geriatric Care to Rural EDs?
More than 100 U.S. EDs that have achieved some level of credit through the Geriatric Emergency Department Accreditation (GEDA) program. These EDs have taken specific steps to better meet the needs of older patients who present to the ED according to Geriatric Emergency Department Guidelines, established in 2013. However, recognizing that smaller, rural hospitals often do not have the training or resources to meet GEDA standards, researchers are determining if telemedicine technology can be leveraged to make this accreditation available to these facilities.
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The Case Manager’s Toolbox: The Essential Skills of an Effective Case Manager, Part 1
RN case managers and social workers are key advocates in the delivery of quality healthcare. Their broad skills and training allow them to assess patients’ needs and work well with families and other members of the healthcare team. Negotiating, collaborating, communicating, team-building, precepting, educating, and consulting are the basis of what a successful case manager brings to the care setting each day. This month will begin a discussion of the skill sets every case manager and social worker should possess to be as effective in the role as possible.
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Consent Library Is Consistent With Quick Access to Better Wording
Dedicated editors help a research program manage an informed consent library of terms that can be included in consent forms as a substitute for medical/scientific language.
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Protocol Activation Model Leads to Reduction in Time-to-IRB Approval
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018.
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Consent Calendar for Continuing Reviews Can Save IRB Meeting Time
The consent calendar is a century-old tool, but it can work well in saving time during IRB meetings. Typically, IRBs review each study up for continuing review, discussing and voting for each, separately. But that might not be the most efficient way to handle these on the board meeting agenda.
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IRB Devises Efficient, Time-Saving Annual Review Process
Continuing review might have gone away for many studies, but a research protection program’s responsibilities have not. This is why many IRBs have devised an alternative annual review process that combines workflow efficiency with enhanced research protection. One model for this regular review is an annual status report. Minimum risk, expedited review, and some additional studies do not need to go through the annual continuing review by the IRB, but they can be monitored through this review.
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IRBs Can Work on Ground Floor With Start-Up Technology Firms
New companies using cutting-edge technology can enter the research arena, but they might lack resources and a knowledge base that academic research organizations take for granted. IRBs can help companies fill some of those knowledge and experience gaps by forming a collaborative relationship and working with them from the beginning of the study design process.
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New Tech Research Raises Ethical Challenges for IRBs and Investigators
Some new technology companies that are developing novel human subjects research face challenges and design issues that have never been explored. Companies engaging in cutting-edge technological services and solutions can raise public concerns for what they do on the business side, but there is less public awareness of privately funded research.
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Wrong Person Receives Bill, OCR Secures $2.175 Million Fine
Sentara Hospitals in Virginia and North Carolina agreed to take corrective actions and pay $2.175 million to settle potential HIPAA violations stemming from a complaint alleging the organization sent a bill to an individual containing another patient’s PHI. OCR determined Sentara mailed 577 patients’ PHI to wrong addresses.