What incidents should be reported and recorded?

Adverse Nursing Event Logging

A personal data breach is a security incident resulting in the accidental or unlawful destruction, loss or alteration of, or unauthorized disclosure of or access to, personal data processed by a controller.

Article 33 of the GDPR imposes an obligation on controllers of personal data to notify the competent supervisory authority of personal data breaches where they are likely to constitute a risk to the rights and freedoms of individuals.

The controller must assess the level of risk of a personal data breach and notify the supervisory authority where such a risk exists, and in addition where the risk is high the controller must also communicate the breach to the data subjects in accordance with Article 34 of the GDPR.

Notifying the supervisory authority of a breach affecting personal data is part of the proactive responsibility established in the GDPR, and the fact of notifying it does not necessarily imply the opening of an administrative procedure. In fact, notifying in due time and form is evidence of the organization’s diligence, while failing to comply with this obligation is classified as a breach.

What is the difference between incident and Near Miss?

Also according to that publication, the incident can be: incident without damage, incident with damage (adverse event), or near miss(1) …. Therefore, the near miss should be understood as a potential adverse event and not as a near miss.

Who should report patient safety incidents?

Who can report incidents or adverse events to medical devices? All healthcare professionals who, in their professional practice, suspect that an incident or adverse event to a medical device has occurred in a patient, within the scope of the National Institute of Neoplastic Diseases.

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What means is used in Spain to notify a personal data security breach?

In the case of Spain, the Control Authority to be notified is the Spanish Data Protection Agency (AEPD), both for the private and public sector, except for public bodies1 of the Autonomous Communities where there is an Autonomous Control Authority.

Types of event notification

The objective of the incident notification and management systems is to turn them into opportunities to learn and improve and to transform them into concrete actions that minimize their impact or occurrence.

For this reason, we make this instrument available to professionals and citizens so that they can voluntarily and anonymously report risks or incidents related to patient safety that occur in their environment. It will take no more than 10 minutes to complete.

Remember that for proper incident management it is necessary to describe clearly and concisely what, how, why and where the events occurred and what immediate actions were taken.

Reported incidents will be analyzed by a group of experts from the unit or center involved in order to identify and establish improvement actions. Likewise, incidents that can be generalized to other centers will be analyzed by a group of experts at regional level.

What is event notification?

A strategy that allows the collection of data on adverse events occurring in the healthcare setting, from which patient safety can be improved. They are a part of the “safety culture” where adverse events are understood as an opportunity to learn and improve.

What is the difference between an incident and an accident?

An accident is an undesired event that occurs suddenly and causes damage, whether to people, installations or machinery. An incident, on the other hand, is an occurrence at work that may or may not cause damage.

What is patient near miss?

Refers to a woman who was near death, but survived a complication during pregnancy, delivery or within 42 days after the end of pregnancy.

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Incident and adverse event

For a service to work optimally, it is necessary to have an efficient incident management, capable of solving any problem or adversity effectively, in the shortest possible time.

The ITIL4 methodology provides an incident management process (Incident Management) that allows the proper functioning of an organization, making internal and external customers feel secure and have the feeling that there is total control over any situation or incident.

AXELOS is the official ITIL body, created by the British Government Cabinet Office to implement the Best Practice methodologies used worldwide by industry professionals in IT service management. These include ITIL.

In this article, we look at one of the integral parts of that ITIL4 framework: incident management. One of the changes found in this new edition is that the processes are now called practices.

As we pointed out before, we should talk about incident management framed within the service management practices.  To understand how the incident process works under the ITIL methodology, it is necessary to know the meaning of some concepts such as what are the incidents, the time scale, the incident models and the serious incidents. Many of these concepts in their definition come from the previous versions of ITIL.

How are incidents reported?

The resolution that receives the motion for trial is notified by the daily statement and not by writ of summons, as is the general rule for notification of this type of resolutions. Articles 48 and 323 of the Code of Civil Procedure are pronounced in this sense.

How can an adverse incident report be made?

In Mexico, there is an online system for reporting adverse incidents, accessing CEMAR (Commission of Evidence and Risk Management), which belongs to the executive direction of Pharmacopoeia and Pharmacovigilance, in addition, the topic of technovigilance can be consulted, including the legal framework and, likewise, …

How are adverse incidents classified?

Adverse events and incidents can be classified as follows: Serious adverse event: unintended event that could have led to death or serious deterioration of the health of the patient, operator or anyone directly or indirectly involved, as a consequence of the use of a medical device.

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Incident Notification

Within an Information Security System based on the ISO 27001 standard, we find events and weak points in the organization, these must be notified to the person in charge so that he/she can initiate a correct management.

The process by which the weak points are communicated must be perfectly documented by means of a formal procedure that must be available to all the workers of the organization and all the parties that are considered appropriate.

For all this it is necessary to create a person to be the point of contact, that is to say, it must be a responsible person, with capacity and availability to be able to manage all the events that happen, in addition it must be a person known by all the employees of the organization.

The different weak points detected by the employees of the organization or by third parties must be communicated as soon as possible to the person in charge associated to the corresponding system.