According to Section 2 of the German ordinance on biological substances (Biostoffverordnung, BioStoffV), biological agents are microorganisms that may cause sensitising or toxic effects or other health-damaging effects as a result of an infection. If biobank employees work with the SARS-CoV-2 pathogen, the risk assessment may need to be adjusted. The Committee on Biological Agents (ABAS) has classified the SARS-CoV-2 pathogen as risk group 3 and protection level 2.
What is a risk assessment?
According to Section 5 of the German occupational safety and health act (Arbeitsschutzgesetz, ArbSchG) and Section 4 BioStoffV, employers must have risks in the workplace assessed by qualified personnel before beginning with any activities. The assessment can be performed by employees who have been trained as biosafety officers, for example. A risk assessment determines the measures required for a safe working environment. Risks must be avoided or minimised. Existing risk assessments for the individual areas of a biobank can serve as the basis here for documentation of the risks. A responsible person must consider all of the activities and work processes foreseen at the biobank.
Should the activities change, the risk assessment must be updated accordingly. Even without any changes, a risk assessment must be performed at least every two years, updated as necessary and the identified measures implemented (Section 4 BioStoffV).
The Technical Rules for Biological Agents (TRBA) 400 offer support here and give practical examples. The ABAS has also published a step-by-step guide on its website featuring further examples. It has identified the following seven steps to perform and update a risk assessment:
- Define the work areas and activities
- Determine the risks
- Assess the risks
- Define specific, state-of-the-art occupational safety measures (technical, organisational, personal and behavioural) according to the S-T-O-P principle
- Implement the measures
- Review the effectiveness of the measures
- Update the risk assessment (specifically, adjust in case of changes to the operational conditions as per Section 3 ArbSchG).
In the following presentation, Bettina Meinung (QM Core Team, GBN) shares tips for preparing a risk assessment. She delivered this presentation during a GBN webinar on handling infectious samples held on 29 April 2020. See here for the full webinar documentation.
Changing a risk assessment: who to contact
If a risk assessment needs to be updated, biobank employees should first contact the responsible member of staff at the site (department of biosafety or occupational safety). Many sites already have a form template for this – GBN will also be making a template available soon.
Operating instructions
Employers are also obliged to instruct employees on the individual workstations and to provide operating instructions (Section 12 ArbSchG and TRBA 250 (7.2)). Operating instructions are among others drawn up for biological agents and hazardous substances and indicate potential risks and the protective measures foreseen. They can also be combined with hygiene plans.
More information and links:
- German ordinance on biological substances (Biostoffverordnung, BioStoffV)
- Resolution of the Committee on Biological Agents (ABAS) dated 19 February 2020 (last updated on 1 October)
- German occupational safety and health act (Arbeitsschutzgesetz, ArbSchG)
- Technical Rules for Biological Agents (TRBA) 400
- ABAS guidelines on preparing a risk assessment
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