Details of UMKU Business Permit

Parameter: All

Authority: Minister/Head of the Agency

Requirements:

1. Facilities/Infrastructure
   Duration: -
2. Administration:
   • Self-assessment
   • Recommendation from the Provincial Health Office
   • Hospital Business Permit
   • Accreditation Certificate
   • Recommendation from professional organizations
   • Profile of Assisted Reproductive Technology Services in Hospitals
   Duration: -
3. Equipment
   Duration: -
4. Human Resources:
   • Practice Permit
   • Clinical Authorization Letter
   • Membership Letter from the In Vitro Fertilization Association of Indonesia
   • Membership Letter from the Indonesian Human Embryology Association
   Duration: -
5. Organization:
   • Director's Decree regarding the Establishment of Assisted Reproductive Technology Services for Non-Natural Pregnancy or Non-Natural Conception
   • Director's Decree Regarding the Duties and Functions of Each Implementer
   Duration: -
6. Special Requirements (Standard Operating Procedures for Assisted Reproductive Technology Management approved by the Hospital Director):
   • SOP for Assisted Reproductive Technology Services Registration
   • Patient Satisfaction Form
   • SOP for Handling Patient Dissatisfaction in Services
   • SOP for Adverse Events
   • SOP for Medication Storage
   • SOP for Medication Administration
   • SOP for Infection Risk Management
   • SOP for Cross-Infection Prevention
   Duration: -
7. Quality Assurance Documents:
   • Periodic Meeting Reports
   • Periodic Assisted Reproductive Technology Service Reports
   • Performance Reports for each IVF Clinician
   • Bi-Annual Protocol Evaluation Meeting Reports
   • Internal Audit Reports for Twin Pregnancy Rates
   Duration: -

Obligations:

1. Service Standards
   Duration: -
2. Internal and External Quality Control
   Duration: -
3. Activity Reporting
   Duration: -