Supplement 1: Dutch SPIEGEL-study: details of the incident reporting procedure (IRP)
Reporting
Caregivers were asked to report all incidents on paper forms after they were educated about aim and content of SPIEGEL. An incident was defined as: ‘any unintended or unexpected event which could have or did lead to harm for one or more patients receiving care’(1). To emphasize the reporting of every incident, including the minor incidents and near misses, dedicated ’reporting weeks’ were introduced. In these weeks extra attention was asked for reporting incidents. Reporters were explicitly asked to report ‘everything that should not have happened’,which was a practical translation of the formal definition of incident. In ‘normal’ weeks reporters were encouraged to always report incidents which caused actual harm to patients, but for practical reasons less emphasis was put on reporting all near misses. We tried to spread the reporting weeks equally over the year (interval about 4 months) and followed pragmatic planning criteria such as no overlap with holidays and no overlap with other important events in the practices. In the week preceding the reporting week the study team specifically reminded the practices of the coming reporting week by e mail and provided advertising material like posters and flyers. During the reporting week there was no specific action of the study team.
Screening
In every health care centre a multi-disciplinary committee of three to four persons was installed, representing the different disciplines in the health care centre. Together with management, the committee was responsible for the reporting procedure.
The committee members were asked to set up a confidential way of collecting and filing the reporting forms. The committee also screened and analysed the reported incidents. An important step in screening the incidents was the selection of incidents for analysis by determining a risk score from 0 to 4 for every incident reported. This risk score was based on estimating potential harm and frequency of occurrence. The higher the risk score, the higher the risk for patient safety.
Frequency/severity matrix
Estimated frequency of occurrence
-Weekly: incident occurs at least once every week
-Monthly: incident occurs at least once every month
-Yearly: incident occurs at least once every year
-<1 time per year: incident occurs less than once per year
Potential severity of harm caused by the incident
Catastrophic: Death or severe permanent harm and/or ICU admission necessary to treat life-threatening situation
Major:Minor, but permanent harm and/or severe temporary harm and/or hospital admission necessary and/or large extra costs
Moderate:Minor temporary harm and/ or extra treatment in hospital necessary (no admission) and/or conflict or breach of confidence between GP and patient and/or important extra costs
Small:Discomfort for the patient, such as long waiting time and/or irritation and/or extra treatment in primary care and/or extra costs
No:No harm/no consequences for the patient
Severity of potential harm caused by the incidentEstimated frequence of occurence / Catastrophic / Major / Moderate / Small
Weekly / 4 / 3 / 3 / 2
Monthly / 4 / 3 / 2 / 1
Yearly / 4 / 2 / 1 / 1
< 1 x Yearly / 3 / 2 / 1 / 1
Table: Risk scores by severity of potential harm and estimated frequency of occurrence
If there is no potential harm or no consequences for the patient: risk score 0
Committees were advised to analyse all incidents with a risk score of 2 or higher. The incidents with risk score 0 and 1 were stored in the incident database. For every incident with risk score 2 ‘short track analysis‘ based on PRISMA (22) was advised, for incidents with score 3 and 4 a more extensive analysis based on PRISMA and Root Cause Analysis-techniques (23) was advised.
Improvement measures and implementation
The committees were responsible for the development of improvement measures based upon the causes of the incidents. They were advised to consult the reporters or other front line experts about this step. The management of the health centres was responsible for the actual implementation of recommended improvement measures.
Preparation before implementing IRP
Before starting the actual reporting extensive attention was paid to obtaining full commitment of management and to informing and educating all potential reporters about the basic principles of patient safety, human fallibility and patient safety culture. The IRP committee-members followed a two-day, accredited training. The training addressed patient safety, safety management, thereporting procedure and more in detail two analysis methods: PRISMA (22) which stands for Prevention Recovery Information System for Monitoring and Analysis and Root Cause Analysis (23). All IRP committee members received a detailed workbook with a description of the IRP.
The participating health care centres were financially compensated for two working days of one GP per year. Pre implementation data were gathered by a questionnaire on “care as usual” about incidents and about expected results from all possible reporters by a questionnaire.
Feedback
Feedback about the results of the IRP during the study was given by a newsletter every three months. In this newsletter we reported on the results of the five participating centres to date. In addition, at the end of the study period a research ‘network meeting’ was organised in which the results were presented and discussed. The discussion was used as a source for qualitative data.