ANVISA, CFM and ONA adverse event reporting procedure template

1Purpose

1. 1.1This procedure sets out how [Clinic name] reports, investigates and learns from incidents and near misses, so that each one leads to a change that sticks.
2. 1.2Staff report without fear of blame, and the clinic looks for causes in its systems before it looks at individuals.

2What to report

1. 2.1Any event that harmed or could have harmed a patient, a visitor or a member of staff, including near misses.
2. 2.2Medication errors, missed or delayed results, records shared in error, and any breach of patient data.

3Reporting

1. 3.1Adverse events are notified monthly by the 15th working day of the following month, and a death within 72 hours, under RDC 36/2013.
2. 3.2The report records what happened, when, where, who was involved, and what was done at once.
3. 3.3Where a patient was harmed, the patient is told, given an apology and kept informed of what the clinic finds.

4Investigation

1. 4.1[Name, role] grades each incident by severity within [2] working days, and decides the level of review.
2. 4.2The review uses the record and the audit trail to establish what happened, in order, with times and names.
3. 4.3The review names the causes, the actions, an owner and a date for each action.

5Learning

1. 5.1Each incident and its actions are discussed at the next governance meeting, and the discussion is minuted.
2. 5.2What changed is shared with every member of staff, and checked [3] months later to confirm it held.

6Review

1. 6.1[Name, role] reviews this document every [12] months, and sooner after an incident, a complaint or a change in the regulator's requirements.
2. 6.2Each review is recorded with the date, the reviewer and what changed, and the previous version is kept.
3. 6.3Staff are told of each change, and their acknowledgement is recorded.

7Where this sits in the ANVISA, CFM and ONA framework

• Patient safety and adverse eventsRDC 36/2013 art. 4, Núcleo de Segurança do Paciente (NSP) constituído pela direção
  RDC 36/2013 art. 10, notificação mensal até o 15º dia útil do mês seguinte
  RDC 36/2013 art. 10, parágrafo único, óbito notificado em até 72 horas