How do you set up Risikomanagement and a Fehlermeldesystem in a practice?

The QM-RL makes risk management, error management with a reporting system, and OP checklists for procedures with two or more doctors or under sedation into minimum standards no practice may waive. Reports are voluntary, anonymous and without sanction, and every one is worked through to a preventive action whose effect is checked.

What the minimum standards ask

Risk management identifies and analyses every risk in care, from the patient's and the staff's view, uses reports from the error reporting system, and sets an individual risk strategy that recognises, assesses, handles and monitors risks, with structured risk communication.¹ Error management is part of it. The Fehlermeldesystem is low-threshold and open to every profession, reports are voluntary, anonymous and without sanction, and each one leads to recommendations whose effect is evaluated.¹

OP checklists are used for procedures with two or more doctors or under sedation, developed for the practice, aimed at preventing mix-ups of patient, procedure and side, and checking the equipment.¹ None of these may be waived on grounds of size.¹

Hygiene, emergencies and medication

The QM-RL also asks the practice to regulate emergency management, hygiene, medication safety, pain, falls, and the prevention of abuse and violence.¹ § 23 of the Infektionsschutzgesetz obliges the head of every medical practice to take the measures current science requires against healthcare-associated infections, and requires hygiene plans in facilities for ambulatory surgery and day clinics.²

1. List the risks. Walk each process from booking to follow-up and note what could harm a patient or a colleague.
2. Rate and own each risk. Likelihood, severity and a named owner for every risk on the list.
3. Open a reporting route. Anonymous, without sanction, open to every member of staff, on paper or digital.
4. Review reports on a fixed day. Each report analysed in the team meeting and turned into one preventive action.
5. Check the action worked. Set a date to confirm the change did what it was meant to.
6. Build the OP checklist. Where two or more doctors operate or sedation is used, a checklist for identity, side and equipment.

1. Report number ______ Date of event ______
2. What happened ______
3. What could have happened ______
4. Contributing factors ______
5. Preventive action ______ Owner ______ Due ______
6. Effect checked on ______ Result ______

Copy template

Logging as a safeguard

§ 22 BDSG lists logging among the measures for health data, so it can be checked later who entered, changed or deleted personal data.³ The same log gives a risk review its timeline.

Questions

Can a single-handed practice skip the Fehlermeldesystem?

No. Risk management, error management and the reporting system are minimum standards the QM-RL exempts from its waiver.

Must error reports be anonymous?

The QM-RL says reports should be voluntary, anonymous and without sanction, so staff report what they see.

When is an OP checklist required?

For procedures with two or more doctors or under sedation, developed for the practice and involving everyone in the procedure.

Sources

1. 1Gemeinsamer Bundesausschuss, 2026Richtlinie über grundsätzliche Anforderungen an ein einrichtungsinternes Qualitätsmanagement (QM-RL), Volltext, BAnz AT 19.08.2026 B4Read source
2. 2Bundesministerium der Justiz, Gesetze im Internet, 2026§ 23 IfSG, Nosokomiale Infektionen, ResistenzenRead source
3. 3Bundesministerium der Justiz, Gesetze im Internet, 2026§ 22 BDSG, Verarbeitung besonderer Kategorien personenbezogener DatenRead source

Written by the wai team from Gemeinsamer Bundesausschuss, the Kassenärztliche Vereinigungen and the Länder guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the G-BA, any KV nor any Land authority endorses wai or any software.