PREMIER Error Management

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"The biggest mistake you can make in life is to always be afraid to make a mistake."

Dietrich Bonhoeffer

Objectives

Basic reporting of errors and critical incidents is important to provide transparency about the experimental work performed in a laboratory. The aim is to learn from mistakes and avoid them in the future.

Background

In a complex environment, as it is the case in basic experimental research, a not to be underestimated number of errors occur every day, which can negatively influence the quality of the work, waste materials and working time and put people at risk.

The reporting of critical incidents in clinical medicine has long been an internationally recognized instrument for improving patient safety, and is required by law in many countries. The basic principle of CIR (Critical Incident Reporting) in clinical medicine is that safety can be improved by learning from incidents that could have harmed or have harmed patients rather than ignoring such incidents.

In basic biomedical research, such a concept was completely lacking until now, although a number of critical incidents and errors can occur in the complex environment of a research laboratory with its state-of-the-art machinery, multi-professional and often international staff with different expertise, complicated assays and potentially harmful chemicals. These have the potential to negatively impact data integrity, test results, animal welfare, personnel safety, or the integrity of expensive reagents or machinery. Unfortunately, these errors and critical incidents of variable severity are currently reported only sporadically or are not reported at all. Sometimes such events are even covered up for fear of negative consequences.

To create a transparent error culture it is therefore essential to communicate such incidents properly and to create an awareness of how to deal with errors or critical incidents. To achieve this, there are different possibilities, for example with the help of an error reporting list or using an open source tool, the LabCIRS.

Tasks / Actions

In order to create a lab specific action plan, the first step is an assessment, which will be carried out by the PREMIER team. The assessment will determine the status quo of the laboratory in regard to existing quality tools. Here you find the general tasks / actions that are necessary to implement the module.

Error reporting list

When introducing error management, many employees are afraid of being punished for errors. The head of an organization / laboratory must counteract this fear by ensuring that a transparent error culture is important. To ensure that errors are reported by employees, the preservation of anonymity is the top priority.

The entries in an error list, which can be posted in the laboratory, need to be anonymous. It must be ensured that the errors reported are regularly analysed and discussed, for example in meetings, in order to take appropriate countermeasures to avoid the reported error in the future.

Example for an error reporting list

No.	Date	Error / Critical Incident	Cause of error	(Counter-) Measure	Evaluation
					Measure	Responsibility	Date
1.
2.
3.

LabCIRS (Critical Incident Reporting System for Laboratories)

The LabCIRS is an anonymous error reporting system developed by the Department of Experimental Neurology at the Charité together with the QUEST Center at the BIH and is made available to the Charité - and to the entire scientific community.

With the development of the LabCIRS, we provide researchers with structured measures for recording, analyzing, reporting and ultimately avoiding critical incidents in experimental biomedicine. The software is administered in a standardized manner on an internal server at the Charité, so that the program can be accessed via any computer within the Charité intranet using a web browser. Every interested laboratory facility of the Charité can apply for its own access, which is managed by the facility itself. Thus LabCIRS functions in every laboratory or department as an independent error reporting system, in which the reported critical events and errors are processed only within the respective organization (e.g. working group or department).

The success of the LabCIRS depends largely on the safeguarding of anonymity and confidentiality. This concerns both the identity of the reporting party and the identity of the persons involved in the specific CIRS case. The protection of the identities of these persons is therefore an absolute priority. For this reason, each participating institution is assigned a general user account, which all employees use equally for registration and for writing error reports. The institution's own LabCIRS area is managed by a person, the "reviewer"; this person can be a scientific employee, laboratory manager or another person. The reviewer will be notified of incoming error reports via e-mail. He or she evaluates the incoming error reports and, if necessary, initiates appropriate (immediate) measures.

LabCIRS for laboratory facilities at the Charité

Access to LabCIRS for laboratory facilities at the Charité:

LabCIRS is available on the Charité intranet. Employees of the Charité can request access by clicking on the "Register" button.

The QUEST Center at BIH is responsible for the service.

Questions can be directed to: labcirs-admin@charite.de.

LabCIRS for the scientific community

LabCIRS is an open-source software and can be used by every laboratory. The source code is available on GitHub.

Recommendation

A structured error management with a laboratory critical incidence system is an effective self-assessment activity, which can be implemented relatively easily. Beyond helping in the recurrence of reported errors, it is a powerful tool to introduce a non-punitive error culture.

References

• LabCIRS tool for reporting critical incidents
• Plos Biology article about the LabCIRS
• Article in the laboratory journal by Ulrich Dirnagl
• LabCIRS on GitHub
• Discuss at PREMIER forum