The Biostoffverordnung governs work with biological agents in Germany. It has its legal basis in the Arbeitsschutzgesetz and applies to any activity in which staff can come into contact with bacteria, viruses, fungi or parasites. A blood draw falls under it as a nicht gezielte Tätigkeit, because the agents that may be present in a given sample are not known in advance and are not the purpose of the work. That classification is why the ordinance applies to a pharmacy as soon as it opens a draw service.
The first duty applies before the first draw rather than after it. The employer carries out a Gefährdungsbeurteilung, records it in writing, and repeats it whenever anything relevant changes. The assessment assigns the activity to a protection level, and blood collection in an outpatient setting is normally placed at Schutzstufe 2.
The protective measures that follow from that level are taken in a fixed order:
- Technical measures come first, which means safer equipment before anything else.
- Organisational measures come next, once the technical options have been used.
- Only then comes persönliche Schutzausrüstung, which protects the individual but never substitutes for a safer piece of equipment.
The second duty is instruction, so staff are unterwiesen before they take up the activity and at least once a year afterwards, in spoken form, related to their actual workplace, and the instruction is documented. A written Betriebsanweisung has to exist for the activity, and occupational health provision has to be offered or arranged according to the rules that apply to the protection level. In daily work the ordinance also determines what happens after a Nadelstichverletzung, because such an incident is a reason to revise the risk assessment.
The relationship to TRBA 250 is often muddled in practice. The ordinance sets the duty and stays deliberately general, while the technical rule says how that duty is met in practice, down to safety cannulas and disposal containers. The ordinance is the obligation and the rule is the method, so following the rule is what lets an employer assume the obligation is satisfied.
For the pharmacy the output of all this is a working document rather than a folder, because the measures the Gefährdungsbeurteilung produces belong in the Standardarbeitsanweisung the team actually follows at the chair. Otherwise the assessment describes a pharmacy that does not exist.
This glossary entry is general information about German pharmacy law and practice. It is not legal advice. For binding guidance on your own pharmacy, contact your Landesapothekerkammer.
