6.1. Off Study Criteria • All protocol interventions are complete • Death • Request of the Patient/Parent • Discretion of the Study PI 7.0 SAFETY AND ADVERSE EVENT REPORTING REQUIREMENTS 7.1. Reporting Adverse Experiences and Deaths to St. Jude IRB Only “unanticipated problems involving risks to participants or others” referred to hereafter as “unanticipated problems” are required to be reported to the St. Jude IRB promptly, but in no event later than 10 working days after the investigator first learns of the unanticipated problem. Regardless of whether the event is internal or external (for example, an IND safety report by the sponsor pursuant to 21 CFR 312.32), only adverse events that constitute unanticipated problems are reportable …show more content…
Unexpected Adverse Event: • Any adverse event for which the specificity or severity is not consistent with the protocol-related documents, including the applicable investigator brochure, IRB approved consent form, Investigational New Drug (IND) or Investigational
Several errors and hazards can be identified as possible factors leading to the sentinel event. The ER appeared to be terribly understaffed that day with only one ER physician, one RN, one LPN, and a secretary.
November, 1999 brought about a release of a report prepared by the prestigious National Academy of Science’s Institute of Medicine (IOM) making medical mistakes and their magnitude of the risks to patients receiving hospital care to common public knowledge. The IOM concluded that between 44,000-98,000 deaths occur annually because of medical errors. Among a general agreement was that system deficiencies were the most important factor in the problem and not incompetent or negligent physicians and other caregivers (Sultz & Young, 2010). An excellent example of a system deficiency that leads to a crisis and sentinel event was the highly publicized overdose of Heparin to Dennis Quaid’s newborn twins in 2007.
Attached is a copy of the EPIC glossary. I included the entire glossary only because the Event and Type of the 10/4/14 and 10/15/14 spreadsheet are abbreviated explanations of what actually occurred within the patient's medical record.
Patient death or serious disability associated with a medication error, and the use or function of a device in patient care in which the device is used or functions other than as intended (AHRQ, 2009).
Review of the Utah and Minnesota Incident reporting mandates provided various state statutes and reporting responsibilities to the state’s government and regulatory agencies. Reports of adverse events must be reported in various methods among states. For example, Utah and Minnesota require each individual facility, hospital, outpatient centers, and clinics, to report the adverse events that occur at the particular facility. Specifically, in Minnesota if the Boards that regulate physicians, nurses, podiatrist, physician assistants, and/or pharmacists are aware of an adverse event, the specific board holds the responsibility to report the events to the Minnesota Department of Health. Adverse events consist of defined elements within states in the categories of surgical, product or device, patient protection, case management, environmental, and potential criminal events, essentially providing events that produce irreversible patient harm. However, differences among these two states exist as Utah provides more specific descriptions in the case management events involving
Although the outcome proved the NPCT intervention of DSME education and medical management were effective, something other than the interventions used could have caused other results but not confounded results. The use of multiple locations and a larger randomized sample size may have helped avoid obstacles such as time, fuel, cost and transportation issues and allowed for generalizability. Different outcomes could have been achieved if individualized education plans were completed separately for the insulin dependent and non-insulin dependent patients (Jessee & Rutledge, 2012). Some factors that were not included in this study were the patient history, educational level, and other health risk factors of
B required as his health deteriorated. The LPN, however, made the error of not notifying the staff of Mr. B’s condition. She again, made the error of simply silencing the patient’s alarms and walking away. Furthermore, according to policy, Mr. B was to be provided supplemental oxygen and continuously monitored, including the use of ECG, throughout the recovery period, for which he did not have. These numerous hazards and errors eventually led to a code situation and ultimately the death of Mr. B. This death, as it turns out, was a result of a simple medication error for which the team must now implement a change to prevent similar errors from occurring again in the future.
The Canadian Paediatric Adverse Events Study reviewed 8 academic pediatric centres and 14 community hospitals looking at the epidemiology of adverse events (EAs), which are decisions made by health professionals that result in unexpected occurrences and consequently, unfavourable outcomes.
A Payment that is denied for reasons that are not clear to the hospital. The hospital may have information that proves an error in the denial.
There are errors and hazards in care that occurred in the Mr. B scenario. One error was the emergency room physician’s failure to recognize the signs and symptoms of deep vein thrombosis (DVT) that Mr. B was presenting. If not treated early, a DVT can become a pulmonary embolism, a fatal condition that Mr. B unfortunately developed. Another error in care that happened in the Mr. B scenario is the nurses’ failure to monitor Mr. B’s ECG and respirations. Early detection of critical ECG and respiratory changes could have initiated medical interventions that would have saved Mr. B’s life. One hazard is the emergency room nurses’ heavy patient load at the time of Mr. B’s sentinel event. Another hazard is having a licensed
A medication error refers to an error (of commission or omission) at any step along the pathway that begins when a clinician prescribes a medication and ends when the patient actually receives the medication. Preventable adverse drug events result from a medication error that reaches the patient and causes any degree of harm. It is generally estimated that about half of ADEs are preventable. Medication errors that do not cause any harm—either because they are intercepted before reaching the patient, or by luck—are often called potential ADEs. An ameliorable ADE is one in which the patient experienced harm from a medication that, while not completely preventable, could have been mitigated. Finally, a certain percentage of patients will experience ADEs even when medications are prescribed and administered appropriately; these are considered adverse drug reactions or non-preventable ADEs (and are popularly known as side
Research shows that half of life-threatening or fatal adverse-drug events (ADEs) are preventable and a lot of these ADEs result from prescribing errors or co-prescription of drugs known to have drug-to-drug interactions.
Medical records reviewed included Request for Authorization (DWC Form RFA) dated 07/20/17, Primary Treating Physician’s Progress Report (PR-2) dated 07/20/17, Mitchell, Utilization Review Request for Additional Information (RFAI) dated 07/26/17, and Mitchell, UR Notice of Retrospective Authorization
Wrong site, wrong procedure, and wrong patient errors are avoidable safety issues. Nearly 1.9 trillion dollars are spent on medical errors each year in the United States (Catalano & Fickenscher, 2008). Between 1995 and 2007, 691 wrong-site surgeries have been reported to The Joint Commission's Sentinel Event data repository (AHC Media LLC, 2008). In 2003 in response to the outcry for better patient safety The Joint Commission
Reporting errors can strengthen the processes of care and also enhance the quality of care. To effectively avoid further errors that can cause harm to patients, improvements must be made on the incidents or events reported in reporting system. Reporting errors can help the organizations better understand what happened, identify the factors that cause the occurrence of errors or incidents, determine its frequency and predict whether it could happen again and find an intervention to prevent or to