QM according to DIN EN 15224 / ISO 9001
Just google this keyword! Dozens of lawyers specialising in medical law will eloquently explain the central role of this formula. In patient law (BGB § 630h) states: „(1) An error on the part of the treating party shall be presumed if a general treatment risk has materialised which was fully controllable by the treating party and which has led to injury to the life, body or health of the patient.“
In paragraph (5), the formula for gross negligence is further tightened: „(5) If there is gross negligence and this is fundamentally capable of causing injury to life, limb or health of the kind that actually occurred, it is presumed that the negligence was the cause of this injury.“ This also applies to delayed or omitted measures. The first question the judge asks is whether everything reasonable was done to fully control the process. There are no „unavoidable“ errors.
With these rules, the legislator wants to reduce the burden of proof for patients. Shocking events such as operations on the wrong side, swabs left in the abdomen, organs removed by mistake or incorrect histological diagnoses are not just tragedies for those affected. They are failures on the part of those treating them. Firstly, because they have such serious consequences. Secondly, because we know exactly how they could have been avoided. They are events that should never happen - never events.
And yet they do happen. They will not diminish if we enter them in a register or pillory the perpetrators.
„Fully controllable risk“ is the appropriate translation for Never Event. The ideal is a fully controlled process. Safety is a quality feature. Unwanted events should not occur, let alone serious ones. And what seems unavoidable today can perhaps be avoided tomorrow.
The advantage of formulating „fully controllable risks“ lies in the resulting recommendation for action. We must closely examine the process in which a risk has materialised. What's more, we need to examine processes prospectively to see where errors are possible and what influences lead to them - whether technical or human. If we know from experience where the dangers lurk or where we can only imagine them. We have to insert our safety barriers at the critical control points. The magic letters are HACCP and FMEA.
U. Paschen, 2026-03-23
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