Is the operating manual complete?

The last newsletter discussed the preparation of a risk assessment. The next step is to formulate an operating instruction based on this risk assessment (Section 14 of the BioStoffV). This must be made available to all laboratory employees and also serves as the basis for laboratory training. The content is comprised of various pieces of information. First, the hazards that can arise during the respective activities must be stated. This is supplemented by information on the biological agents used, as well as details of the corresponding risk group, known transmission routes, and health effects of exposure. The operating instruction also contains information on the necessary protective measures and rules of conduct in the laboratory. These consist of hygiene rules, such as disinfection measures, but also prophylactic measures, such as the correct handling of corresponding equipment. This also includes requirements for wearing personal protective equipment, such as laboratory clothing, safety goggles, respiratory protection, etc., which can vary accordingly depending on the potential hazards. Furthermore, the operating instructions must include measures for behavior in emergency situations, including how to deal with injuries and malfunctions, as well as first aid measures. It is important to regularly check that the relevant emergency telephone numbers are up to date. Finally, the operating instructions must contain information on the proper inactivation of biological agents used, as well as the correct handling of contaminated materials. The operating instructions should be clearly structured and written in understandable language. They must be updated immediately in the event of significant changes (Section 14 (1) Sentence 5 of the BioStoffV) and should be reviewed for up-to-dateness at least every two years (in accordance with Section 8 (6) Sentence 1 of the BioStoffV). A sample can be found in TRBA 500 (Appendix 2). The next newsletter will address operating instructions in genetic engineering facilities.