The development of the Patient Safety Events Reporting and Learning system (Sistema de Notificación y Aprendizaje para la Seguridad del Paciente, SiNASP) was based on analysis of exiting notification systems, expectations and demands from main stakeholders and the legal context related to these systems. Once the system had been defined and the electronic program had been developed, a pilot test was performed. The steps of the development process are shown on Fig. 1.

Fig. 1.

SiNASP development process.

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A scientific literature review was conducted to identify lessons learned from existing RLS, focused on articles that discussed the impact of the systems, the assessment of the most important characteristics and expert recommendations. Visits to countries with leading national notification systems (Denmark, England and Wales) were performed to learn about characteristics and workflow of the systems.

In the first step of the project, a meeting was held with the Regional authorities and national experts as well as two focus groups with 16 representatives members of patients associations to know their opinions expectations and position regarding a RLS.

Their suggestions were used as a basis to define the SiNASP main attributes. On a second stage, scientific societies were consulted by an online questionnaire, about the viability of implementing and pros and cons of a system with those attributes.

The taxonomy of SiNASP was developed according to the information collected in previous phases, the WHO International Classification for Patient Safety (ICPS)15 and aiming to get a compatible taxonomy with other RLS running in the NHS (Andalucía, Bask Country, ISMP-Spain16 and SENSAR17) and from some leading international systems (National Patient Safety Agency,18 Veterans Administration19 and Joint Commission International).20

The terms included were mapped using the WHO ICPS framework as the guiding structure, to identify the common contents in the different notification systems. The common terms in most systems were selected for the SiNASP taxonomy. A detailed assessment of the rest of the terms was performed in order to select only the ones providing relevant information. The usefulness of the information was balanced with the goal of developing a questionnaire that was simple and quick to fill out (requirement identified by healthcare professionals in prior phases of this work).

Conclusions from literature review and visits to relevant notification systems were very similar and can be summarized by the characteristics of a successful reporting system: non punitive, confidential, independent, expert analysis, timely analysis of cases, systems oriented, responsive and capable of disseminating and implementing recommendations.21

The legal experts, taking into account the Spanish legislation, recommended the development of a RLS voluntary, confidential, preferably anonymous, non punitive, oriented to learning and focused on incidents that did not produce harm to patients.15

Characteristics and main results from the pilot test are summarized on Table 2. The general evaluation of the system was positive, and the agreement with the basic attributes of it was high.

SiNASP was developed by the Spanish Ministry of Health for the Health Regions that required a RLS with the goal to improve Patient Safety through the analysis of incidents and learning process at local level.

The basic principles of SiNASP were: voluntary reporting, no punitive consequences to professionals involved in the incidents, confidentiality of information, analysis of incidents and implementation of improvements performed at hospital level, systemic orientation for the analysis of incidents and anonymous reporting or nominative with anonymization (or de-identification, meaning that the software automatically eliminates this information after a 2 weeks period).

SiNASP has a pyramidal structure: 1) The healthcare organizations are responsible of the management, analysis of the incidents and improvement proposals; 2) The Health Regions are responsible for the periodic analysis of aggregated data in order to identify patterns and risks and to elaborate recommendations for all the organizations in the region; 3) The Spanish Ministry of Health has a similar role than the regions but with a broader scope, including all the hospitals participating in the system.

Reportable incidents to SiNASP are all kinds of patient safety incidents (events or circumstances which could have resulted, or did result, in unnecessary harm to a patient)16, excluding sabotages which are understood as serious offenses, deliberate deviations from norms or rules to harm either the patient or the system. These events have obvious legal implications and limited use from a learning point of view.

The process to manage a safety incident within a healthcare organization follows the steps shown in Fig. 2. Incidents are detected either by direct observation (the professional is involved or directly observes the incident) or indirect information (the incident is identified by a third party or by any documentation that reflects it). The inclusion of non-healthcare professionals, patients and family members as reporters is still under discussion.

Fig. 2.

Process to manage a patient safety incident within a healthcare facility.

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An adaptation of the “Severity Assessment Code” (SAC)22 is used to classify all incidents based on their associated risk. The SAC score guides the selection of the analysis method for the incident: Incidents with low and medium risk are commonly analyzed by monitoring of trended aggregated incident data, while for incidents with high and extreme risk, a deep analysis is recommended thought a root cause analysis or a similar method.

Finally the development of a risk reduction plan is needed, specifiying the actions to be accomplished, staff in charge, calendar and indicators to monitor the plan. Feedback to professionals includes the submition of a semi-automatic email to the reporter when the incident is received (if the reported included his/her contact details), phone calls in those cases where a deep analysis is required, periodic reports (with aggregated data, examples of incidents and the risk reduction plans developed), meetings to discuss about safety incidents, etc.

The SiNASP software (https://www.sinasp.es) has a public area including the reporting questionnaire accessible to healthcare professionals through a code and a private area for the managers of the system, where individual incidents are managed and aggregated information is analyzed in order to developed feedback reports.

The reporting form has four sections: incident (characteristics and type of incident), patient (consequences for the patient and patient characteristics), contributing factors and risk reduction actions (Table 3). The form includes open and close questions with several response categories that facilitate the subsequent analysis of data thought groups, classifications and filters; some of the questions are mandatory. The form also includes specific questions for some incident types (for example for medication incidents) that show up in the form only after some alternatives have been selected, what reduces the perceived workload for the reporter.

The SiNASP software includes an indicator scoreboard that provides information to facilitate the management of the system at different levels (Table 4).

Since incident RLS are relatively new in the healthcare arena, the development and use of indicators to monitor these systems imply some difficulties, such as the lack of background information to establish the standard for the indicators. For this reason, SiNASP's indicators provide objective data about the functioning of the system, but there is no value judgment associated to it. Indicators’ results can be analyzed mainly by comparative analysis (the organization receives information about its own results compared to the anonymous results from all the rest of the organizations using the reporting system) and trending analysis (observing the evolution of its own results).

The implementation process includes an on-site training process for the reporting system managers, supporting documents and tools to facilitate the local management of the incidents, the internal training process and the implementation into the organization. An on-line training course is available to all healthcare workers from organizations using SiNASP, which provides basics topics on Patient Safety and information to the reporting process in SiNASP.