Note: This series contains translated excerpts and summaries from the original German-language guidance.[1] The content, organization, and names of the parts and subparts in this series are not identical to that of the original guidance.

Previous: Part 3: Establishment of a Reporting and Learning System: General Principles and Organization

Part 4: Establishment of a Reporting and Learning System: The CIRS Teams and Officers

I. The Central Team

Duties:

  • Anonymize and ensure confidentiality of reports: It may be useful if a person who is independent of the CIRS Team and has the necessary expertise performs anonymization at a central location.
  • Find out what happened: If necessary and possible, contact the reporting person to obtain information needed to clarify facts.
  • Obtain more information. The Central Team needs specialist knowledge of the clinical processes of the Local Teams.
  • Perform cause analysis
  • Propose measures and estimate the feasibility of implementation as well as the time, costs, and personnel needed for implementation
  • Coordinate with management, chief physicians or nursing staff to make decisions
  • Implement, track, and possibly extend preventive measures throughout departments. If necessary, delegate the implementation and tracking of measures to the clinical risk management.
  • Give feedback on measures to the reporter (if not anonymous), the team, and/or the entire institution.
  • Regularly organize and assist training on the reporting and learning system.

Qualifications:

The Central Team should be multi-professional and have clinical expertise and experience.

The following specific skills are important prerequisites for an effective CIRS team:

  • Strong communication abilities
  • Expertise in clinical risk management and quality management
  • Competencies in patient safety and systemic case analysis
  • Skills in process and project management
  • Knowledge of patient protection laws

The following skills are desired in central CIRS team members:

  • Knowledge of medical and hospital technology, as well as technical security, administrative procedures (order management, patient administration, etc.), and economic constraints.
  • Other non-technical skills such as analytical and systemic thinking, experience with difficult communication situations, and perseverance and assertiveness.

Selection:

The Central Team should be named directly by the top management. The team members should be announced and trained before CIRS is implemented.

The Central Team should be fixed, but able to accommodate expansion after CIRS is implemented. The bigger the hospital, the more complex the CIRS organization will be. It will be important to define local structures in order to ensure fast communication, an effective flow of information, and an independent and system-oriented processing and evaluation of reports.

The Role of Management:

The representation of several hierarchical levels and a variety of professional groups in the Central Team is beneficial; however, it is debatable whether management, particularly those involved in disciplinary matters, should be on the CIRS teams.

Advantage: Recommendations for preventive measures would be easier to implement. Many facilities have good experience with the participation of nursing managers and senior physicians in the CIRS team.

Disadvantage: Employees may be less likely to report, because of fears that their managers would become aware of their “near-misses.”

Potential Solution: A meaningful limitation on the activity of management personnel in the CIRS Team would be to limit their access to the original reports, thereby eliminating potential conflict with their managerial duties. A general recommendation cannot be given, because team composition depends on the safety culture of the institution.

II. The Local Teams

The members of the Local Teams are the contacts for local employees and for the Central Team. The tasks of the local teams depend on the processes of their departments or clinics and the specific expertise of the members.

Duties:

  • Inform colleagues about CIRS
  • Motivate colleagues to use CIRS
  • Inform the Central Team about department or clinic procedures when more information is needed
  • Conduct cause analysis in the clinic or department
  • Recommend local measures and cooperate in the development of joint proposals for solutions if risks or safety-relevant events require cooperation between departments or clinics.

The distribution of tasks between the Central Team and the Local Team may be limited differently depending on the size of the institution, number and location of departments or clinics, and number and location of their personnel resources. The Local Teams should be trained on the foundations and structures of CIRS and their specific tasks before the start of system.

Qualifications

The Local Teams in the clinics/departments may be different sizes depending on the setup of the clinic/department. Like the Central Team, the Local Team is staffed with multi-professionals and with employees from different hierarchical levels.

Selection

The criteria for the selection of its members should be their acceptance by management and staff and their identification and experience with the institution. Whether the department head may be a member of the team is, like the composition of a central team, controversial. While committed managers can demonstrate an open approach to mistakes and facilitate the implementation of measures, department heads are able to impose sanctions, which could endanger the safe reporting and decrease employees’ willingness to report.

III. CIRS Officers

The top management also ensures that CIRS Officers have no conflict of interest between clinical responsibility (management of a specialist department, nursing or technical service) and maintaining the confidentiality of CIRS. A regular communication with CIRS is established between the facility’s top management and the Central CIRS Representative. There is a steering committee through which the CIRS Officers report on CIRS and the management makes the necessary decisions.

For the members of the Central Team, CIRS Officer rights and obligations are as follows:

  • They have access to all existing clinical IT systems such as internal audit, but no access to personal or commercial systems. Access to individual medical records must be justified.
  • They have access to documents on the organization of a department, but no access to personnel records or similar employee documents.
  • They can call on employees and possibly external experts when processing CIRS reports.
  • They have access to all levels of management and especially top management in urgent cases. Reports that indicate urgent need for action are passed to management in a timely manner.
  • They are integrated into the institution’s regular communication system.
  • They work together with other internal bodies and external organizations, including other institutions and regional or national patient safety organizations.

Next: Part 5: Establishment of a Reporting and Learning System: The Decision-Making Phase

[1] 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 www.aps-ev.de)

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