TRBA 250

TRBA 250 is the Technische Regel für Biologische Arbeitsstoffe that covers activities in healthcare and welfare. It is drafted by the Ausschuss für Biologische Arbeitsstoffe and published by the Bundesministerium für Arbeit und Soziales. For a pharmacy that has decided to draw blood, it is the document that turns a general legal duty into a list of things that must actually be present in the room and in the routine.

A technical rule is not a statute and creates no duty of its own, because the duty comes from the Biostoffverordnung. What the rule adds is a description of the state of the art, and with it a presumption that an employer who follows TRBA 250 may assume the requirements of the ordinance are met. An employer who departs from it is not automatically in breach, but has to demonstrate that the chosen alternative reaches the same level of protection, and has to have written that reasoning down beforehand. In practice that proof is demanded at the worst possible moment, after something has already gone wrong.

The provisions that matter to a draw station are specific:

• Cannulas with an integrated safety mechanism are required wherever blood is taken, so the sharp end is shielded before the hand moves.
• Recapping a used cannula is not permitted under any circumstances.
• A puncture proof and break proof Kanülenabwurfbehälter has to stand within reach of the person drawing.
• Gloves, hand hygiene and surface disinfection are covered to the same level of detail.
• The handling of samples and of waste is set out for daily work under Hygiene bei der Blutentnahme.

The paper duties belong with the equipment, which means a written Betriebsanweisung for the activity and a documented Unterweisung of every member of staff involved, repeated at least once a year. These are the parts most often missing, because they cost time rather than money and nobody notices their absence until an inspection or an incident.

That is the practical weight of TRBA 250, because it is the standard the supervisory authority and the accident insurer use when they reconstruct a Nadelstichverletzung. A pharmacy that can show safety cannulas, a container in the right place, a signed instruction record and a rule it can quote is in a very different position from one that improvised.