Brazil Hospital ANVISA Inspection Checklist

Comprehensive Brazil hospital ANVISA inspection checklist for sanitary vigilance.

  • Industry: Healthcare
  • Frequency: Monthly/Quarterly
  • Estimated Time: 60-90 minutes
  • Role: Gerente de Qualidade/CCIH
  • Total Items: 30
  • Compliance: RDC ANVISA, NR-32, PPRA

Licenças e Documentação

Licenses

  • Alvará Sanitário válido?
  • Responsável Técnico cadastrado?

Controle de Infecção

Infection control

  • CCIH constituída e ativa?
  • Insumos para higiene das mãos?

Gerenciamento de Resíduos

Waste management

  • PGRSS implementado?
  • Segregação de resíduos correta?

Farmacovigilância

Pharmacovigilance

  • Sistema de notificação de eventos?
  • Rastreabilidade de medicamentos?

Pre-Assessment Information

Initial assessment documentation and patient/facility identification

  • Assessor Name / Credentials
  • Assessment Date
  • Department / Unit
  • Assessment Type (Routine/Annual/Complaint)
  • Previous assessment findings reviewed?

Infection Prevention & Control

Verify infection control practices per CDC and Joint Commission standards

  • Hand hygiene compliance observed?
  • Appropriate PPE available and properly used?
  • Isolation precautions properly implemented?
  • Sharps containers available and not overfilled?
  • High-touch surfaces properly disinfected?

Patient Safety & Identification

Verify patient safety protocols and identification procedures

  • Two patient identifiers used before procedures?
  • Fall risk assessment completed?
  • Call light within patient reach?
  • Bed in lowest position with brakes locked?

Medication Safety & Management

Verify medication handling and administration practices

  • Medications stored securely and at proper temperature?
  • Controlled substances properly secured and counted?
  • No expired medications in stock?
  • High-alert medications properly labeled?

Environment of Care & Safety

Verify facility environment meets safety standards

  • Fire exits clear and unobstructed?
  • Emergency equipment functional and accessible?
  • Spill kits available and stocked?
  • Electrical cords and outlets in safe condition?

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