Compliance
RSSArticles
-
OHRP Holds Workshop on ‘Pervasive’ Data
The unprecedented level of digital data available across an expanding electronic landscape poses complex challenges for IRBs as they attempt to provide ethical insight and ensure participant privacy. Some of these data are collected in clinical care, but the public also is generating data through health monitoring devices, GPS location systems, social media, and information collected and shared on mobile apps.
-
Focus on the Differences Between IRBs and HRPPs
As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program.
-
Single IRB Common Rule Changes Arrive in January
Academic institutions are grappling with ensuring their IRBs are prepared for the January 2020 deadline to move multisite research to a single IRB. This deadline looms over all policy and procedural changes.
-
Provider Stress Can Trickle Down to Affect Patient Safety
The healthcare industry can be stressful for everyone involved, with clinicians sometimes suffering greatly from the workload, time demands, bureaucracy, and the emotional nature of their work. Minimizing stress is important for the health of the caregivers, but also to maintain patient safety. When staff are exhausted, experiencing depersonalization from their work and feeling less effective, they are more likely to fail to follow practices that support high-quality, safer care.
-
CMS Issues 2020 Final Rules for Inpatient and Long-Term Acute Care
The Centers for Medicare & Medicaid Services issued its final rule in August to update the Medicare payment policies for hospitals under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System for fiscal year 2020. Changes were made to the rural hospital wage index, all-cause readmissions, and interoperability.
-
Physician Not Liable for Alleged Complications After Gallbladder Removal
This successful defense case reveals potent methods for defeating medical malpractice claims. On the substance, the defendant physician successfully challenged one of the necessary elements that an injured patient must prove when alleging medical malpractice: causation. Causation includes factual and legal aspects, where the physician’s actions must have been a “substantial factor” in contributing to the patient’s harm, but there may be an intervening action or event that cuts off the physician’s liability. If the risk of injury exists, even when a procedure is performed correctly, then simply because an injury occurred does not mean that the physician was negligent.
-
Negligent Thyroid Surgery Results in $2.2 Million Verdict
One of the primary lessons from the case for physicians and care providers is that assistant physicians, including residents, may be subject to liability for failing to provide services within the standard of care as well, and that standard does not change for a resident still in training.
-
MSU Expands Risk Management, Adds Additional Safeguards
Michigan State University has expanded its risk management program after the arrest and conviction of Larry Nassar, a former USA Gymnastics national team doctor and osteopathic physician at the university, for the sexual abuse of minor patients. The university recently signed an agreement with the U.S. Department of Health and Human Services to make further improvements.
-
Oncology Unit Improves Safety and Culture With Focus on Relationships
An oncology unit at a Washington, DC, hospital has improved patient safety by focusing on “relationship-based care,” a model that aims to help nurses focus more on caring for and connecting with other people. The 5E Medical Oncology/Hematology Unit at MedStar Washington Hospital Center recently received AMSN Premier Recognition In the Specialty of Med-Surg (PRISM) Award. The unit had made strides in recent years in improving quality and safety on the unit as well as the overall culture.
-
Hospital Addresses Stress With Healthy Healer Program
A Colorado hospital is addressing stress by reminding clinicians that it is OK to take a moment for themselves and focus only on the patient care at hand. Craig Hospital created its Healthy Healer program two years ago to help nurses address their stress in a positive way, encouraging them to be more at ease during patient interactions and better able to focus on providing proper care. The program has been expanded to include physicians and other clinicians.