[Clinic name]
Controlled document
[Address]
[Registration or licence number]
KOIHA inspection checklist
1Opening
- Confirm the route, a report to the 구청장 for a 의원, a permit from the 시도지사 for a hospital.
- File the 개설신고서 with floor plans and licences, and keep the 개설신고증명서.
- Report every change of site, name, departments or doctors.
- Register under the 의료해외진출법 before attracting patients from abroad.
2Records
- Every 진료기록부 records symptoms, diagnosis, treatment and the date and time, and is signed.
- 진료기록부 kept 10 years, 환자 명부 5, 처방전 2.
- A separate 접속기록 for every addition or amendment to an electronic record.
- Patients can see their record and receive a copy.
3Health information
- Separate PIPA consent for health information, apart from other consents.
- Every transfer abroad on a ground PIPA article 28-8 allows.
- A leak reported to patients and the PIPC within 72 hours.
- Written consent before surgery, transfusion or general anaesthesia.
4Certification
- Decide whether 인증, the foreign patient accreditation, or both apply to you.
- Apply at least two months before the survey you want.
- Trace patients through the record before KOIHA does.
- After 인증, keep the self review and the mid-cycle visit in the diary.
5What a KOIHA inspector may ask
- Show me this patient's 진료기록부. What to show, a signed record with symptoms, diagnosis, treatment and the date and time.
- Who amended this entry, and when? What to show, the separate access log the 의료법 requires for every amendment.
- Which doctors work here, and what can each one see? What to show, the staff list matching the 개설신고, and access limited by role.
- How did the patient consent to their health information being used? What to show, a separate consent for health information, and when it was given.
- How do you answer patients who write in other languages? What to show, replies in the patient's language, checked by a person.
- Can a patient have a copy of their record? What to show, how a request is handled, and how fast.
- How do you use AI in care? What to show, where AI is used, what patients are told, and who decides.
AAppendix, Standard readiness log, one row per standard
- A.1Domain ______ Standard ______
- A.2Owner ______ Evidence ______
- A.3Where it lives ______
- A.4Patient traced on ______ Gap found ______
- A.5Action ______ Due ______