5.3.01 Report on Adverse Events

Goal and purpose

Identification and reporting of serious adverse events (SAEs) to the responsible parties. The reports are intended to initiate measures to assess the resulting damage at an early stage in order to take countermeasures and initiate a case analysis.

Application

All clinics, departments and areas of the hospital

Description of the process

3.1 General considerations

Errors and complications are unavoidable in medicine. They are one of the painful disappointments of medicine that is geared towards healing and relief. Intensive efforts have always been made to find the causes of errors and to eliminate them for the future. To this end, incidents and adverse events are regularly reported and discussed at hospital meetings and ward rounds.
In medicine, however, personal blame is assigned too quickly or the event is considered so typical for a treatment case that no further conclusions are drawn from the event itself. The growing responsibility of hospital management and the organisation responsible for treatment in the hospital often necessitates a rapid response in order to prevent the recurrence of errors and complications. The documentation of the event must be deepened and secured. The event must be reported to the liability insurance company. In some cases, it is advisable to inform the public or the organisation in a preventive manner. In order to fulfil these organisational obligations, the management must be informed of such incidents at short notice.

A cross-clinic overview of adverse events is not currently standard practice, but is necessary to counter the accusation that such events are being covered up.

The timeliness of reporting must not be diminished by waiting to see whether damage occurs or is claimed by the patient concerned.

Events are reported regardless of whether errors or complications were caused or could have been avoided. The term "adverse event", which originates from clinical research, deliberately leaves the question of causation open. The temporal coincidence is sufficient to carefully analyse the event to determine the cause. The concept of unbiased individual case reporting has been applied with great success in many areas (aviation, reactor safety) but also in medicine (e.g. anaesthesia). The procedure that can be followed in a hospital is described here.

3.2 Subject of the report

In principle, every adverse event can and must be reported to superiors within a department. It should be examined whether the cross-clinic reporting system should be limited to serious adverse events. The general acceptance and capacity for processing the reports is a consideration here.

A report must always be drawn up if the observed event is temporally related to a treatment. The report must be made regardless of whether personal or organisational responsibility can be identified.

The following adverse events are considered "serious":

- Death
- Resuscitation
- Return to the extracorporeal circuit
- Return to the operating theatre
- Transfer to an intensive care unit due to life-threatening condition
- Significant extension of the hospital stay

if they occur unexpectedly in the course of treatment or become necessary unplanned.

The same applies to events where there was a serious risk that one of the aforementioned SUEs could have occurred (previously: near miss):

- Medication errors
- Use of a medical device (appliance)
- Drug side effects
- Incidents during anaesthesia, surgery or radiotherapy
- Differences between pre- and postoperative diagnosis
- Differences between clinical and pathological diagnosis

3.3 Scope of the report

The report on an SUE must contain at least the data on the form attached in Annex 1. Further information on the event can be provided informally if this does not delay reporting.

Reports can also be submitted anonymously. Further processing of an anonymous report must be strictly confidential. A copy of the reports on adverse drug reactions, poisonings, incidents during the use of medical devices and transfusion reactions should also be given to Quality Assurance.

3.4 Who reports?

The physician who administered the treatment in which or as a result of which the SAE occurred is responsible for reporting the SAE.

Any other person involved in the treatment may report in his/her place if the responsible physician is unable to attend or is suspected of not fulfilling his/her obligation. The head of a complication conference (incident or mortality meeting) must decide whether an event discussed there should be reported as a SAE.

If damage reports are received by the legal department or claims are made to the public liability insurance, the legal department should check whether a report on a SUE is necessary. If no report has been submitted to date, the legal department should initiate the report.

Anonymous reports are accepted and followed up by the quality assurance department.

3.5 Other reporting obligations

The reporting of adverse drug reactions, poisoning, incidents during the use of medical devices and transfusion reactions is regulated by law. Please refer to the special regulations.

3.6 Collection and processing of reports

3.6.1 Recording the reports

Reports on sUE are sent to Quality Assurance and recorded. The reports are given consecutive numbers followed by the year. Reports on adverse drug reactions, poisonings, incidents and near misses in the use of medical devices and transfusion reactions that are received by Quality Assurance are recorded in the same way as reports on AEs.

If the number of reports requires it, the quality assurance department should suggest statistical processing.

3.6.2 Passing on the reports

The reports remain with Quality Assurance and are strictly confidential. Quality Assurance is only authorised to pass them on to third parties if the Executive Board so decides.

The Quality Assurance department reports to the Medical Director on SUEs in individual cases if a criminal offence is suspected, if immediate action is required to prevent the damage from increasing or if there is an imminent threat of recurrence. All other SUEs are reported to the Medical Director in a quarterly report in the first week of the quarter.

Quality Assurance proposes in the report for which SAEs a case analysis is deemed necessary. The Medical Director commissions the incident and event conference of the clinic/department to analyse the case. If the SAE is of general significance for the hospital or if the necessary impartiality for the case analysis is lacking, the Medical Director can also commission Quality Assurance or an expert in an anonymised form.

3.6.3 Dealing with anonymous reports

Anonymous reports are immediately communicated confidentially to the persons named therein as being involved with a request for comment. The case itself and the names of the persons named may not be passed on under any circumstances until a statement has been made and the facts of the case have been finalised. The presumption of innocence has absolute priority in all further investigations.

3.6.4 Case analysis

The case analysis is carried out according to a structured procedure. The persons responsible for analysing the case should not be able to initiate disciplinary measures.
The result must be summarised in a report. The report must contain
- a description of the process as it appears after the analysis
- Statements on the identified causes
- proposed corrective actions.

Quality assurance takes the case analysis report to the report of the sUE. If corrective measures are proposed, quality assurance follows up on their implementation.

The reports on the case analyses are submitted to the Medical Director in the quarterly report with recommendations for corrective measures.

3.7 Corrective measures

Corrective measures can consist, for example, of process-organisational measures, restriction of responsibilities, intensification of monitoring, improvement of the competence of the persons involved.

3.8 Report forwarding to reporting register

The management must decide whether and in which cases reports of adverse events are passed on to cross-institutional organisations. Reference should be made here to the CIRS-V experience of the patient safety action alliance.

3.9 Reports from other organisations

Each year, Quality Assurance compiles an anonymised list of all SUEs and other reports (see 3.5), possibly by cause and with recommendations for corrective measures.
The list of SUEs is supplemented by SUEs reported by other comparable hospitals (cases of damage, liability claims, e.g. from hospital association data, court judgements or press publications). The list does not claim to be exhaustive and is for information purposes only.

4 Documentation

Report form on a serious adverse event during hospital treatment
List of internally reported sUE
Quarterly reports and ad hoc reports to Medical Director Annual report on sUE in own organisation and other comparable institutions.

5 Responsibility, qualification

Submission of the report:	Doctor responsible for the treatment, any other observing person
Collection and evaluation:	Quality assurance
Case analysis:	ZEK of the clinic/department, expert appointed by the Medical Director, quality assurance
Regular reporting to the Medical Director	Quality assurance
Decision on case analysis	Medical Director
Tracking of corrective measures	Quality assurance, QM coordinator of the clinic/department
Collection of other UE reports	Quality assurance

6 Notes and comments

7 Applicable documents

7.1 Literature

Patient Safety Action Alliance
Recommendations for the introduction of Critical Incident, Reporting Systems (CIRS), Practical tips for hospitals, November 2007

7.2 Terms

Serious adverse event (sUE):
Unexpected death during hospital treatment or resuscitation
Unplanned return to the operating theatre
Return to the extracorporeal circuit
Not insignificant extension of the hospital stay

8 Systems

Appendix 4: Quarterly report to the Medical Director
Appendix 5: Annual report on AEs