Note: This series contains translated excerpts and summaries from the original German-language guidance. The content, organization, and names of the parts and subparts in this series are not identical to that of the original guidance.
Part 7: Operation of a Reporting and Learning System
After CIRS implementation, the primary goal is to improve patient safety through the successful operation of a long-term reporting and learning system.
I. Creating A Positive Reporting and Safety Culture
CIRS is based on a positive culture for handling errors. Employees should understand that reporting and evaluating errors is a tool for learning, not punishment. Management can promote this positive culture by being active role models. Current research shows that leadership is a decisive factor for the successful operation of CIRS. Here are some examples of how to provide active support and motivation at management level:
- The hospital management incorporates CIRS when planning the hospital’s goals.
- There is a management steering committee with defined structures and processes that discusses CIRS and the resulting preventive measures.
- Managers at all levels can report at specified intervals on the status of CIRS, for example, as a regular agenda item at the chief physician meetings.
- Managers decide measures for prevention and ensure implementation of those measures.
- Employees are regularly informed about the current status of CIRS, for example, though bi-annual employee information sessions and training on report input.
- Employees regularly receive appreciation or feedback from their superiors or hospital management regarding their participation in CIRS and the resulting measures.
- The manager, i.e. the chief doctor of a department, regularly reports on an event that he has entered into CIRS.
- There are incentives for active participation in CIRS.
Missing or inadequate management support leads to demotivation and a decrease in reporting by employees. CIRS will continue to be supported and utilized only when the added value and benefits of CIRS are clear to both executives and employees. Demonstrable senior management support, for example, making concrete improvements as a result of reported events and their analysis, is especially important for CIRS success and sustainability, because it leads to risk reduction, greater safety, more efficient operations, and cost savings.
Another key factor to the long-term success of CIRS is the participation of employees in the overall process. Employees will only continue to enter reports in CIRS when they learn that because of their reports, something actually happens. It is therefore necessary that they receive feedback regarding both received reports as well as the derived and implemented measures.
CIRS is an essential element of overall clinical risk management. In order to achieve a sustainable improvement of patient safety, it requires constant support, stable structures, reliable teams, and resources in all areas of patient care during, and especially after, the system is introduced. In addition to identifying risks and critical events, CIRS is an instrument for developing internal safety culture. Through open communication about systemic errors and near misses, it is possible for the staff and teams at the facility to learn to deal proactively with safety events. An internal CIRS system should not only be anonymous, but confidential in order to encourage an open attitude towards discussing mistakes, near misses, and critical events.
II. Motivating Employees for Long-Term Investment and Use
Reporting and learning systems are sharing schemes based upon the input by the employees. The employees are the experts in clinical processes and know their faults and weaknesses. Despite comprehensive training and information, it is important to react to worries and uncertainties at an early stage so that employees continue reporting. For example, uncertainty often exists with regard to the following questions and statements:
- Is my report really anonymous? Can it be traced back to me?
- Who really gets my report?
- Our boss says, “We don’t make mistakes . . . I report nothing in CIRS.”
- Why should I report? It doesn’t change anything.
- Yet another new task! What do I actually get from it?
Practical experience and studies show that only a fraction of the detected errors, critical events, and near misses are actually reported in a well-established reporting and learning system. This so-called “underreporting” or diminishing report volume can result from an unfavorable design of the reporting and learning system, lack of or inadequate feedback, or confusion about what constitutes a critical event and what should be reported.
The following guidance should contribute to increasing reporters’ motivation and willingness to report:
Individual level – Employees are willing to report if they are convinced that their reported observations lead to positive changes, are accepted by colleagues, and are appreciated by supervisors.
Organizational Level – The visible embedding of a reporting and learning system in the institution is critical to employee motivation. The security of being able to anonymously and/or confidentially report errors and near misses without fear of sanctions increases confidence in the system and improves safety culture.
System Level –Transparent communication about the organization’s internal CIRS process is a key element for the system’s credibility and the employees’ trust. This means that employees need to know what to report, how, when, and by whom the reports are processed, how improvements are implemented, and how newly generated knowledge is disseminated
In addition, the following strategies can be used to increase the willingness of employees to participate: (1) publication of recommended and implemented improvement measures, (2) rewards for reporting, and (3) participation in patient safety campaigns such as the International Patient Safety Day on September 17.
III. Processing Individual CIRS Reports and Identifying Systemic Problem Areas
After successful implementation and operation of CIRS, the focus should be on the analysis of identified problem areas and the implementation of improvement measures. This requires a timely screening of all incoming reports, a systemic analysis of individual reports, and, at the same time, a systemic assessment of the common problem areas identified by CIRS reports. For example, a systemic evaluation of all incoming reports in a particular time frame could be made by comparing current reports with previous reports on a similar subject or with similar system factors.
In everyday practice, there are generally not enough human and financial resources available to systematically analyze each report and develop and implement appropriate corrective measures. In any CIRS, there are also reports that do not contain sufficient information for analysis. One recommendation is to develop criteria for selecting CIRS reports for individual analysis. This could be, for example, all reports of events with potentially severe patient injury or a high-level risk index and / or events that are described as frequently occurring. The criteria should be reviewed after a predetermined period with respect to their efficacy.
In order to maintain and preserve reporting motivation, actions that result from CIRS reports must be identified. Therefore, identification of problem areas, systemic analysis that leads to implementation of improvement measures, and dissemination of that knowledge is as effective for employee motivation as the publication of individual reports and feedback.
IV. The Role of CIRS Officers
The role of the CIRS officers is critical to the successful operation of a reporting and learning system. In practice, the CIRS officers do not always have sufficient resources and are faced with limited ability to make decisions. Ideally, CIRS officers have defined decision-making powers and established communication channels with clear escalation levels, through which they can reach decisions if necessary. Their decision-making authority could fall short, for example, if they don’t have the ability to set meetings, implement cost-neutral improvement measures, and coordinate with different departments.
CIRS Officers should have the following qualities and expertise:
- They know the organization, its processes, and management structure and, in return, are known personally by the employees.
- They are aware of the employees’ uncertainties and “common” arguments raised against the use of CIRS.
- They know the concept, structure, and the processes and rules in the reporting and learning system “inside out.”
- They can display all process steps and responsibilities in a transparent manner.
- They know the literature and publications on CIRS.
- They can present examples of reports, including derived measures, if necessary.
- They can identify the level of a report’s usefulness.
- As team leaders, they take control and bring topics forward in the facility.
V. Controlling the Reporting and Learning System
The designated central CIRS person is responsible for internal communication and organization, as well as controlling the CIRS process. This means that the CIRS controlling department should also be located in the central clinical risk management department.
Checklists can be used to check CIRS structures and processes as well as report management criteria.
Below are examples of requirements for ensuring quality of CIRS structures and processes during the ongoing operation of the system.
- Appoint CIRS representatives and CIRS team members, as well as representatives who will serve in the absence of the original representatives and members
- Observe the CIRS implementation schedule
- Establish report processing and analytical teams
- Establish a steering committee to ensure that CIRS is included as monthly agenda item
- Discuss CIRS at monthly station / team meetings
- Publish recent reports
- Monitor use of the reporting portal
- Regular meetings between the CIRS staff and the central CIRS team
- Ensure communication of CIRS results to all employees
- Create and distribute monthly or quarterly reports
- Create examples of requirements for complete report processing, including:
- Accept and anonymize reports within a defined period
- Process reports promptly
- Document CIRS team recommendations
- Upon completion of the analysis, decide and document responsive measures
- Ensure that the responsive measures are understandable and comprehensible.
- Select a person to be in charge of and determine a target date for the implementation of defined measures
- Confirm that the target date set for the adopted measures was met.
Using Statistics to Measure CIRS Effectiveness
In order to measure CIRS results and examine the use and effectiveness of the system, it is advisable to define and regularly collect and document key figures. The number of reports is only a minor figure. The real benefit of the reporting and learning system can only be based on the number of derived and implemented measures.
An example of key figures includes:
- Number of reports per month, total hospital
- Number of reports per quarter, total hospital
- Number of reports per reporting group per month
- Number of reports per reporting group per month – single representation
- Number of reports per reporting group per year
- Number of helpful reports (total and with derived measures), number of measures (total and implemented), total hospital
- Number of usable CIRS messages (total and with derived measures), number of measures (total and implemented) per reporting group
- Number of reports by category, total hospital
- Number of reports by risk level, total hospital
If possible, the key figures should be easily generated for each clinic and each reporting group (including a graphical representation) using the electronic system. When using key figures and statistical data from the reporting and learning system, it must always be emphasized that these data provide information about reported events and not about was has happened – they do not allow any conclusions to be drawn about the actual frequency of safety-related events in the facility.
 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 http://www.aps-ev.de)