17 hours ago Injury or death unrelated to trial. Accidental injuries and death are sometimes seen in subjects enrolled in clinical trials. These cases should not be considered for compensation. The Rule 122 DAB does not provide for compensation for such cases, but does provide for free treatment at the expense of the sponsor. >> Go To The Portal
It is essential to have your patients describe the details of the accident in depth. This is an important part of the evaluation, as it provides a context for their physical complaints and may give clues to the correct diagnosis. Some important questions to ask are: Was the patient the driver or a passenger?
If the incident involves an in-patient at the hospital, their medical records will reflect the treatment and diagnosis of the injury. However, for others, it might be required to follow up and record their injury diagnoses.
However, relatives of patients in clinical trials would be handsomely compensated in case of the death of the patient. With Rule 122 DAB in place, every cancer patient dying in a drug trial will be assured of compensation.
In order to record the most accurate account of the incident, maintain an objective tone. Do not include assumptions or assign blame; just write down the facts. Where possible, include direct quotes from the patient and/or other involved parties. The higher your quality of writing, the more valuable your patient incident report will be.
Accidental injuries and death are sometimes seen in subjects enrolled in clinical trials. These cases should not be considered for compensation. The Rule 122 DAB does not provide for compensation for such cases, but does provide for free treatment at the expense of the sponsor.
Once suspicion has been aroused that an unexpected serious event has a reasonable possibility of being causally related to a drug, the AE should be reported to FDA through MedWatch, to the company that manufactures the product, or to the registry coordinating center. (See Chapter 11.)
All SAEs must be reported to the IRB within 5 business days as "reportable new information."
Investigators are required to report promptly “to the IRB… all unanticipated problems involving risks to human subjects or others,” including adverse events that should be considered unanticipated problems (21 CFR 56.108(b)(1), 21 CFR 312.53(c)(1)(vii), and 21 CFR 312.66).
According to CDISC CDASH standards, death should not be recorded as an adverse event (AE) or serious AE, but should be recorded as the outcome of the event. The condition that resulted in the death should be recorded as the AE/SAE.
All team members are required to participate in the detection and reporting of any error, medication error, near miss, hazardous/unsafe condition, process failure, injuries involving patients, visitors and staff or a sentinel event.
Reporting Timeline If the internal SAE resulted in harm or death to the subject that was definitely caused by study participation the SAE should be reported to IRB-HSR within 24-hours. In addition, the appropriate Dean and Office of Risk Management should be notified within 24-hours.
Serious Adverse Event (SAE): Any adverse event that: • Results in death. • Is life threatening, or places the participant at immediate risk of death from the. event as it occurred. • Requires or prolongs hospitalization.
The event is serious and should be reported to FDA when the patient outcome is:Death. ... Life-threatening. ... Hospitalization (initial or prolonged) ... Disability or Permanent Damage. ... Congenital Anomaly/Birth Defect. ... Required Intervention to Prevent Permanent Impairment or Damage (Devices) ... Other Serious (Important Medical Events)
Examples of Non-compliance that must be reported to the IRB include (but are not limited to): Performing non-exempt human subject research without obtaining prospective IRB approval. Implementing protocol modifications without obtaining prospective IRB approval.
A serious reportable event (SRE) is an incident involving death or serious harm to a patient resulting from a lapse or error in a healthcare facility.
Events that result in harm to subject's rights, safety or welfare must be reported to the IRB within 5 business days of knowledge of the event. Events that result in harm to the integrity of the data must be reported to the IRB within 10 business days of knowledge of the event.
Two clinical decision rules, the NEXUS Low-risk Criteria (NLC) and the Canadian C-Spine Rule (CCS), have been well validated to help determine the need for cervical spine imaging.#N#The NLC (Table 3) states that radiography is unnecessary in patients who demonstrate all five characteristics spelled out in the rule. The NLC’s sensitivity and specificity was found to be 99.6% (95% CI 98.6-100) and 12.9% (95% CI 12.8-13.0), 5 respectively.#N#The CCS (Figure 1) identifies patients who are in need of radiography. Its sensitivity was found to be 99.4% (95% CI 96-100) and its specificity 45.1% (95% CI 44-46). 6
Direct trauma, rapid deceleration, and other mechanisms may lead to chest wall injuries, including rib fractures, cardiovascular contusion, aortic injury, pulmonary contusions, lacerations, or pneumothorax.#N#Risk factors for severe thoracic injury include high speed, no seat belt use, extensive vehicular damage, and steering wheel deformity. Inquiring about contact with the steering wheel, chest pain, palpitations, or trouble breathing is also important to the history. A complete visual inspection should be done, looking for a paradoxical movement of the chest wall, and identifying all wounds on the chest and back. The exact location, appearance, number, and type of wounds should be noted and well documented.#N#Auscultation for absent or diminished breath sounds may indicate a pneumothorax or hemothorax.#N#Palpation of the chest wall should be done carefully, feeling for subcutaneous emphysema or bony crepitus.#N#An electrocardiogram should be performed in all patients with anterior chest trauma, pain and tenderness directly over the mid-anterior chest, and in those patients with a history or active signs and symptoms suggestive of cardiac disease, as well as in the elderly. Findings concerning for cardiac contusion include unexplained persistent tachycardia, new bundle branch block (with right BBB being the most common), or dysrhythmia. These patients should be admitted for cardiac monitoring.
Epidural hematomas present in 5% to 10% of patients with severe head injuries. A brief loss of consciousness at the time of the accident or an alteration in behavior may be the only clue to an epidural or subdural hematoma. Other signs and symptoms, such as headache, dizziness, unsteady gait, lack of awareness of surroundings, nausea, and vomiting may develop gradually.#N#The classic presentation is a patient who loses consciousness from the initial concussion, gradually recovers over a few minutes, and enters the “lucid interval” where they may be neurologically intact. Accumulation of blood form the lacerated artery may compress the brain and cause a shift, leading to a declining level of consciousness and eventually a second loss of consciousness with herniation and death. There can be a very short window of opportunity to intervene; this is considered a true emergency.
Post-traumatic headaches are estimated to occur in 25% to 78% of patients with a mild traumatic brain injury (TBI); in the United States, 45% of TBIs are caused by MVAs. 1,2 The differential diagnoses of these headaches range from benign etiologies such as post-concussive syndromes, tension, or migraine, to more serious and potentially life-threating ones such as epidural hematomas, subdural hematomas, or injuries of the carotid or vertebral arteries.#N#It is incumbent upon us to seek out details that may cause concern in the history and exam.#N#The post-MVA headaches that we see most commonly in the urgent care center are tension headaches, which can be related to simple cervical strains. Often, these present as a persistent throbbing headache; unfortunately, this is nonspecific and odes not rule out a more serious cause which can present in a delayed fashion. Therefore, the examiner should look for concerning physical signs, such as extensive bruising and hematomas of the scalp, as well as a hematoma or bruit over the lateral neck.
A negative neurological examination indicates a low likelihood of significant neurologic injury, but the history, physical, and plain films are not sensitive enough to rule out a potentially unstable injury when the index of suspicion is high. This may, of course, require transfer to an ED.
Symptoms include pain, spasm. loss of range of motion, and, often, and occipital headache. The pain is usually midline or paraspinous, and may be referred to the shoulders, periscapular region, or occiput. Over should always be concerned about missing an injury to the vertebral column or the spinal cord.
Cervical strain – frequently referred to as whiplash – occurs with the abrupt flexion/extension movement of the cervical spine. Abrupt movement from one side to the other and rotational trauma can be involved. Symptoms include pain, spasm. loss of range of motion, and, often, and occipital headache.
An incident is an unfavourable event that affects patient or staff safety. The typical healthcare incidents are related to physical injuries, medical errors, equipment failure, administration, patient care, or others. In short, anything that endangers a patient’s or staff’s safety is called an incident in the medical system.
Improving patient safety is the ultimate goal of incident reporting. From enhancing safety standards to reducing medical errors, incident reporting helps create a sustainable environment for your patients. Eventually, when your hospital offers high-quality patient care, it will build a brand of goodwill.
Using predictive analysis, healthcare facilities can improve the quality of patient care and reduce workplace mishaps. Around 60% of healthcare leaders have confirmed that adopting predictive analytics has improved their efficiency considerably.
Clinical risk management, a subset of healthcare risk management, uses incident reports as essential data points. Risk management aims to ensure the hospital administrators know their institution performance and identify addressable issues that increase their exposure.
#2 Near Miss Incidents 1 A nurse notices the bedrail is not up when the patient is asleep and fixes it 2 A checklist call caught an incorrect medicine dispensation before administration. 3 A patient attempts to leave the facility before discharge, but the security guard stopped him and brought him back to the ward.
Even the World Health Organisation (WHO) has estimated that 20-40% of global healthcare spending goes waste due to poor quality of care. This poor healthcare quality leads to the death of more than 138 million patients every year. Patient safety in hospitals is in danger due to human errors and unsafe procedures.
Usually, nurses or other hospital staff file the report within 24 to 48 hours after the incident occurred. The outcomes improve by recording incidents while the memories of the event are still fresh.
Reviewing incidents helps administrators know what risk factors need to be corrected within their facilities , reducing the chance of similar incidents in the future.
Staff did not consider 62 per cent of incidents as reportable, due to unclear incident reporting requirements. Because of this, the first step to incident management in any healthcare facility is writing strong, clear reporting requirements. Then, staff can submit reports that help correct problems of all types.
Using resolved patient incident reports to train new staff helps prepare them for real situations that could occur in the facility. Similarly, current staff can review old reports to learn from their own or others’ mistakes and keep more incidents from occurring. Legal evidence.
Every facility has different needs, but your incident report form could include: 1 Date, time and location of the incident 2 Name and address of the facility where the incident occurred 3 Names of the patient and any other affected individuals 4 Names and roles of witnesses 5 Incident type and details, written in a chronological format 6 Details and total cost of injury and/or damage 7 Name of doctor who was notified 8 Suggestions for corrective action
Patient incident reports should be completed no more than 24 to 48 hours after the incident occurred.
Even if an incident seems minor or didn’t result in any harm, it is still important to document it. Whether a patient has an allergic reaction to a medication or a visitor trips over an electrical cord, these incidents provide insight into how your facility can provide a better, safer environment.
A no-harm incident means that something happened to a patient or another person but no discernible injury or illness resulted. For example, a patient could be given a blood transfusion meant for another patient but no harm was done because the blood was compatible.
Realizing this serious Public Health Issue happening globally, the WHO in 2004 came out with a theme of “Road Safety is No Accidents” to highlight the urgency to tackle the issue on a priority basis.[11] It is high time for us to look into the various issues of the RTA in this perspective so that corrective and preventive measures can be undertaken in an urgent manner so that further damages can be lessened.
The data for fatal accidents presented to the Parliament by the Ministry of Road Transport and Highways for year 2008 shows that 119,860 people perished in mishaps that year and the national and state highways accounted for nearly half of all road accidents.[3] Deaths due to road accidents in 2009 were reported to be 126,896 and in 2010 it increased to 133,938 which is about 5.5% over and above the previous year's deaths. Tamil Nadu, Andhra Pradesh, Maharashtra, Karnataka, and Rajasthan have accounted for 11.5%, 10.5%, 7.1%, and 6.8%, respectively, of total “Road Accident” deaths in the country.[4] The trend is alarming and is leading to a frightening situation day by day.
Most drivers continue to be acting like maniacs in a tearing hurry and error in judgment often leads to major accidents. Reckless driving, over speeding, decline to follow traffic rules, and drunken driving are main reasons for road accidents.
The road accidents are happening most often due to the reckless and speedy driving of the vehicles, not obeying or following traffic rules, the attitudes of the “right of the mighty” bigger vehicles toward the smaller vehicles, overburdened or overcapacity hauling of public and transport vehicles, poor maintenance of the vehicles, drunk and driving, driver fatigue, and above all the appalling condition of the already chocked roads with every in ch encroached by unauthorized persons and properties [Table 2].
The statistics also show that most of the road accidents in the highways are due to drunken driving only. Globally, some 480,000 deaths and 20 million of people get injured by drunken driving every year. In most high-income countries about 20% of fatally injured drivers have excess alcohol in their blood, i.e., blood alcohol concentration (BAC) in excess of the legal limit. In contrast, studies in low- and middle-income countries like India have shown that between 33% and 69% of fatally injured drivers and between 8% and 29% of nonfatally injured drivers had consumed alcohol before their crash.[8]
Driver fatigue is a very dangerous condition created when a person is suffering symptoms of fatigue while driving, often resulting from the hypnotic effect especially during nighttime driving either falling asleep at the wheel or so exhausted to make serious- and fatal-driving errors. The increasing number of traffic accidents due to a diminished driver's vigilance level has become a serious problem for society. Statistics show that 20% of all the traffic accidents and up to one-quarter of fatal and serious accidents are due to drivers with a diminished vigilance level. Furthermore, accidents related to driver's hypo-vigilance are more serious than other types of accidents, since sleepy drivers often do not take correct action prior to a collision.[10]
Well-maintained vehicles with good breaks, lighting, tyres etc. will reduce accidents.