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CIRS Guidance - Part 1: Introduction & Definitions

A.  Introduction

This recommendation for action marks a milestone in international cooperation and efforts to promote patient safety. For the first time, Germany’s Coalition for Patient Safety, Austria’s Platform for Patient Safety, and the Swiss Patient Safety Foundation jointly propose a recommendation for action.

The experts involved in the development of this recommendation provide concrete suggestions for the introduction and successful implementation of reporting and learning systems in inpatient healthcare institutions. It is, however, up to the respective competent experts in the institutions to examine this recommendation with regard to the specific needs on the ground and to decide whether it can be adopted unchanged or adapted. The individual design of this recommendation according to local, professional, operational, legal and situational circumstances is the responsibility of the institution.

This recommendation is primarily aimed at managers of inpatient healthcare institutions and employees in quality and clinical risk management departments. Hospital leaders make the decisions on the introduction and operation of an internal critical incident reporting system (CIRS). On the other hand, employees in quality and clinical risk management are responsible for the practical implementation. In addition, the recommendation is aimed at informing persons and institutions that are active in promoting quality assurance of inpatient care at the political level. It goes without saying that it is also aimed at all other interested employees of healthcare institutions; however, the comprehensive knowledge of this recommendation is not absolutely necessary for their cooperation in internal CIRS.

CIRS is currently one of the most important instruments for identifying risks, errors, and critical events and their triggering factors. Through this reporting and learning system, safety-relevant events, often caused by complex processes, are identified.  A systemic analysis of these events is the basis for the development of preventive measures. CIRS helps reduce adverse events. It has proven itself both nationally and internationally and is recognized as an integral part of quality and risk management in healthcare facilities.

Reporting and learning systems serve to improve patient safety through the following:

> Identifying safety-relevant problems, latent errors, and unsafe processes, procedures, and methods, as well as improvement potentials;

> Providing employees with knowledge of preventive measures that other information systems (ie claims reporting, patient complaint systems) cannot provide;

> Providing a larger number of cases and greater diversity of topics and thus more learning possibilities than damage reporting systems;

> Raising awareness of risks and solutions;

> Supporting the development of a long-term safety culture;

> Supporting cross-facility learning from errors and risks.

Because the use of reporting and learning systems is voluntary, CIRS has the following limitations:

> CIRS is only a diagnostic tool for the identification of risks and events and their causes. It never guarantees the elimination of errors.

> CIRS is an instrument of clinical risk management (CRM), which is able to identify some of the risks and events from the employee's perspective. Risk identification, analysis, and assessment must be supplemented by other established methods and instruments of risk management.

> CIRS does not provide representative data of the number or type of reported events, their origin, or the involved teams or professional groups from which conclusions about the frequency of events and actual risks can be drawn. However, the number of reports can be interpreted to measure acceptance of the system.

> Repeated reports on a topic can point to serious problems, but also focus attention on specific processes.

> Reports in CIRS reflect the subjective view of the reporter.

> CIRS does not replace obligatory reporting routes, for example, in the case of damages claims.

A central prerequisite for the successful implementation and operation of a reporting and learning system is the existence of a CIRS concept and an open proactive safety culture. The CIRS concept must be integrated in the processes and structures of operational quality and risk management, including the following aspects: regulation of confidentiality, guaranteeing freedom from sanctions, ensuring necessary resources, describing CIRS decision-makers' participation in decision-making committees, and clarifying the process for reporting. Furthermore, the CIRS concept should stipulate that the reporting and learning system provides information that must be incorporated into the PDCA cycle in quality management. The PDCA cycle is a continuous cycle with step-by-step system improvement based on careful planning, implementation, and analysis of measures to ensure effectiveness as well as subsequent system modification.

Another important aspect for the successful operation of a CIRS is the self-organized and self-controlled learning culture in an organization. Learning culture is based on experience and depends on prerequisites such as mutual trust and transparent communication, the role of leadership, and a shared vision for improving patient safety. Safety culture must be planned and supported in an organization. This can be achieved if there are established planning and implementation processes in the organization in which individual employees and teams are involved. This participation is particularly important for involving individuals in decision-making and changing systemic processes.

The following aspects are essential for the successful operation of a reporting and learning system:

> Active and visible commitment of the leadership;

> Sustainable implementation and clear clarification of roles and responsibilities;

> Incorporation of learning into the risk management and quality management strategy;

> Learning at the level of the individual, the group, and the organization (networking);

> Systemic case analysis and systematic knowledge generation and dissemination;

> Management of knowledge (self-directed, self-organized learning);

> Disseminating information to all employees, timely feedback;

> Promoting commitment and strengthening a collegial and proactive attitude of the employees.

A high level of motivation is the basis for the success of CIRS. When employees feel that they can shape their work environment, that they are valued for critical comments and reports, that reports are sensitively circulated, that they themselves do not suffer any disadvantages from the collaboration, and that the reports reveal visible changes for more patient safety and for themselves, they will use the reporting and learning system. CIRS must also be equipped with the appropriate human and financial resources so that it can be effective.

B.  Definitions

Reporting and learning system -

A reporting and learning system is an instrument of clinical risk management through which employees can report anonymously or confidentially. It is used to analyze system-related errors, risks, critical events, and near-misses in healthcare facilities. Based on the analysis results, risks are identified and improvement and preventive measures are derived.

Events to be reported -

The "events to be reported" are all errors, risks, critical events and near-misses in the care of the patients if at the time of the reporting no harm to the patient is recognizable.

It is also useful to explicitly motivate the employees to report on the successful handling of errors and solutions for critical situations.

The term "care" refers to all activities that are directly and indirectly related to the healthcare of patients. Care includes both clinical activities, such as nursing, medicine, and physiotherapy, as well as supporting activities, such as in the laboratory, patient transportation, technical infrastructure, or administration.

Technical failures to the infrastructure (such as water pipes, electricity, alarms, information systems, or telecommunication systems) can also lead to significant dangers for the patients and are also included in the group of events to be reported in the CIRS if a patient risk is possible.

Also included are all risks and events that could endanger employees and visitors

Each institution should define clearly, simply and practically, which events or circumstances should be reported in the CIRS. This is an important prerequisite for the use of a reporting and learning system and for the motivation to report. The definition of the desired report content should be known to all employees and be available at any time.

Events that have resulted in damage to the patient generally require a processing separate from the CIRS. Since the majority of the reporting and learning systems work with anonymous (or anonymized) reports and these reports are often published in the internal CIRS, events without harm to the patient should be captured in the reporting and learning system and events with damage should be captured in a separate damage reporting system. In practice, this means that both reporting systems must be set up separately with regard to the input and processing of the reports. In order to distinguish the term "damage" from "events to be reported," “damage” should be defined as a temporary or permanent health impairment of the patient (or of an employee or a visitor).

Source: Aktionsbündnis Patientensicherheit, Plattform Patientensicherheit, Stiftung Patientensicherheit (Hrsg., 2016): Einrichtung und erfolgreicher Betrieb eines Berichts- und Lernsystems (CIRS). Handlungsempfehlung für stationäre Einrichtungen im Gesundheitswesen, Berlin (available for download at

MedRisk Report by Mindy Nunez Duffourc