[Clinic name]
Controlled document
[Address]
[Registration or licence number]
QM-RL inspection checklist
1The QM system
- Quality goals written down, measured and reviewed at least once a year.
- An organigram or table of responsibilities, with every safety-relevant process owned.
- Key processes described and available to every member of staff.
- The self-assessment documented for internal use, with its date.
2Risk and safety
- A risk strategy, and an error reporting system open to all staff, anonymous and without sanction.
- OP checklists for any procedure with two or more doctors or under sedation.
- Emergency equipment and training current, and the hygiene rules written down.
- A Schutzkonzept where children and young people are treated.
3The patient file
- Every entry made at the time, and no correction that hides the original.
- Files kept ten years after treatment ends.
- A patient's request to see the file answered without delay.
- Access to health data logged and limited by role.
4Licences and people
- Every doctor's Approbation and Kammer registration on file.
- The start of practice and every change reported to the Ärztekammer.
- Professional liability insurance in place for every doctor.
- For a clinic with beds, the § 30 GewO Konzession current.
5What a QM-RL inspector may ask
- Do you set practice quality goals and check how far you reach them? What to show, written goals, the measure for each, and the last self-assessment with its date.
- Who is responsible for what in this practice? What to show, an organigram or table, with a named lead for every safety-relevant process.
- How do staff report errors and near misses, and what happens next? What to show, a low-threshold, anonymous reporting route and the actions taken on recent reports.
- How is a correction to the patient file made? What to show, a file where every change shows the original and its date, as § 630f asks.
- How is the patient informed before treatment? What to show, the oral explanation recorded, in time, with copies of anything the patient signed.
- Who can see health data here? What to show, roles, access limits and a log of who read what, as § 22 BDSG lists.
- How do you use AI in care? What to show, where AI is used, and who decides.
AAppendix, KV QM check evidence map
- A.1KV ______ Letter dated ______ Deadline ______
- A.2Quality goals set ______ Evidence ______
- A.3Self-assessment on ______ Documented ______
- A.4Responsibilities in writing ______ Evidence ______
- A.5Error reporting system ______ Evidence ______
- A.6Complaints process ______ Evidence ______
- A.7Submitted on ______ By ______