[Clinic name]
Controlled document
[Address]
[Registration or licence number]
ANVISA, CFM and ONA inspection checklist
1Licence and registration
- A current licença sanitária, displayed where the public can see it.
- A responsável técnico and a substitute named to the vigilância.
- The clinic and every branch registered with the CRM, the certificate renewed each year.
- A diretor técnico in place, exercising the role in person.
2Records
- Every entry dated, timed and signed, with the doctor's CRM number.
- A Comissão de Revisão de Prontuários, coordinated by a doctor.
- Records kept at least 20 years from the last entry.
- Patients can see their record and receive copies.
3Safety
- A Núcleo de Segurança do Paciente and a written Plano de Segurança.
- Adverse events notified monthly, and deaths within 72 hours.
- Complaints examined, recorded and investigated.
- A data incident procedure on the ANPD's three working day clock.
4Toward ONA
- Written procedures that match what the clinic does.
- Tracers of real patients, with the record and the patient's account compared.
- Indicators reviewed in improvement cycles.
- Consent for telemedicine and AI recorded in the prontuário.
5What an ANVISA, CFM and ONA inspector may ask
- Who is the responsável técnico, and who is the diretor técnico? What to show, the names, their CRM registration, and the notice given to the vigilância and the CRM.
- Show me how the prontuário is kept. What to show, entries with date, time and signature, reviewed by the committee, kept at least 20 years.
- Which doctors work here, and are they registered? What to show, the corpo clínico list, each doctor's CRM registration and specialist title on file.
- How are adverse events found, analysed and notified? What to show, the NSP's records, the analyses, and the notifications made on time.
- How was this patient told about telemedicine or AI, and did they agree? What to show, the term of agreement in the electronic record, and the AI use noted in the prontuário.
- Can I follow one patient from first contact to follow-up? What to show, the booking, the messages, the note, the payment and the follow-up for one patient.
- How do you use AI in care? What to show, where AI is used, and who decides.
AAppendix, Licença sanitária plan
- A.1City ______ Body ______
- A.2Activities licensed ______
- A.3Responsável técnico ______ Substitute ______
- A.4CNES number ______ CMVS or LSF number ______
- A.5Architecture approved on ______
- A.6Licence issued on ______ Revalidation due ______
- A.7Displayed at ______