- An unfortunate event resulting from carelessness, unawareness, ignorance, or a combination of causes
- An unexpected bodily event of medical importance especially when injurious <a cerebrovascular accident>
- An unexpected happening causing loss or injury which is not due to any fault or misconduct on the part of the person injured but for which legal relief may be sought
- falling or striking on something <incident light rays> <incident radiation>
- An occurrence or event, generally an untoward, or unwelcome occurrence, e.g. a complication of an existing disease, a mishap affecting a patient in hospital.
A Sentinel Event is defined by The Joint Commission (TJC) as any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not related to the natural course of the patient's illness. Sentinel events specifically include loss of a limb or gross motor function, and any event for which a recurrence would carry a risk of a serious adverse outcome. Sentinel events are identified under TJC accreditation policies to help aid in root cause analysis and to assist in development of preventative measures. The Joint Commission tracks events in a database to ensure events are adequately analyzed and undesirable trends or decreases in performance are caught early and mitigated. Wikipedia
incidents include death, injury, or other harm to patients, staff, and
visitors. They also include financial losses due to damage to equipment,
systems, and facilities. Our focus is on investigation of incidents in which
medical devices, building systems, information technology, or other
technology-related aspects of healthcare delivery may have been contributing
factors. Our ultimate objective is to decrease risk for the organization by the
reducing the likelihood that such events will recur.
- Multifactorial causes
- Mechanical or material failure
- Design issues
- Labeling, packaging or manufacturing errors
- Software deficiencies
- Device interactions
- User/systemic errors
Health facility adverse event investigation
When the Quality / Risk Manager receives a report of a quality issue, user difficulty or malfunction of a medical device, the Health Care facility will respond to the event in several ways relevant to the incident and the resources available to the facility. It is also important to record the event and be able to track it to assess the rate of occurrence. It is recommended that if the incidence rate becomes unacceptable or the response from the device supplier is not consistent with solving the issue an incident report is then sent to the TGA.
The investigation action plan should include directions for:
- Preserving and impounding evidence (actual device,
error codes in device memory, control settings, batch/serial numbers &
- Assembling an investigation team (i.e. clinicians,
biomedical engineers, risk manager etc.);
- Collecting and reviewing all related information
(patient & device) including interviews with attending personnel at the
time of the event;
- Assessment of any injury or damage; and
- Reporting the event to the supplier and the TGA .
emergency measures to minimize and care for injury to, discomfort of, and
threat to life of patients or personnel (e.g., thermal burns, electric
shock, contusions, lacerations, fractures, cardiac arrhythmias,
interruption of normal respiration, loss of consciousness).
appropriate action to minimize damage to equipment and the environment.
the attending clinician who has legal responsibility for the patient.
Impound all equipment attached or contiguous to the injured party in the
same room or areas.
not disconnect or change the relative physical positions of equipment or
connecting cables, except as absolutely necessary to avoid further injury
and preserve any disposable products that may have been involved (e.g.,
drapes, electrodes), as well as their packaging materials.
When an accident or serious adverse event occurs in your facility, you want to know how it occurred, the root cause analysis (RCA) findings, whether the incident must be reported, and how to prevent recurrence. For many types of accidents, retaining a third-party investigator is critical to restoring operations, minimizing interdepartmental conflict, and maintaining staff confidence in the affected technology. An immediate action plan is necessary.
Mandatory Medical Device Reporting
The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
- You have a legal duty to take reasonable care of your own health and safety.
- You must also take reasonable care not to put other people (fellow employees, students and members of the public) at risk by what you do or don't do in the course of your work.
- You must report any injuries or illnesses you suffer as a result of doing your job (the College may need to change the way you work).
- You have a duty to report all accidents or near misses experienced at work.
What is a "Root Cause Analysis"?
A Root Cause Analysis (RCA) is a method of investigation. The purpose is to identify organisational deficiencies that may not be immediately apparent and which may have contributed to the cause of the event. A RCA report also includes risk reduction strategies to reduce the chance of a similar event occurring again.
General Process for Performing and Documenting an RCA-based Corrective Action
- Define the problem or describe the event to prevent in the future. Include the qualitative and quantitative attributes (properties) of the undesirable outcomes.
- Gather data and evidence, classifying it along a timeline of events to the final failure or crisis.
- In data mining Hierarchical Clustering models, use the clustering groups instead of classifying: (a) peak the groups that exhibit the specific cause; (b) find their upper-groups; (c) find group characteristics that are consistent; (d) check with experts and validate.
- Ask "why" and identify the causes associated with each sequential step towards the defined problem or event. "Why" is taken to mean "What were the factors that directly resulted in the effect?"
- Classify causes into two categories: causal factors that relate to an event in the sequence; and root causes that interrupted that step of the sequence chain when eliminated.
- Identify all other harmful factors that have equal or better claim to be called "root causes." If there are multiple root causes, which is often the case, reveal those clearly for later optimum selection.
- Identify corrective action(s) that will, with certainty, prevent recurrence of each harmful effect and related outcomes or factors. Check that each corrective action would have reduced or prevented specific harmful effects.
- Identify solutions that prevent recurrence with reasonable certainty; are within the institution's control; meet its goals and objectives; and do not cause or introduce other new, unforeseen problems.
- Implement the recommended root cause correction(s).
- Ensure effectiveness by observing the implemented solutions in operation.
- Identify other possibly useful methodologies for problem solving and problem avoidance.
- Identify and address the other instances of each harmful outcome and harmful factor.