How does a clinic set up a Núcleo de Segurança do Paciente?

Under ANVISA's RDC 36/2013 the clinic's direção constitutes a Núcleo de Segurança do Paciente, names its members and a responsible professional, and the NSP writes and runs a Plano de Segurança do Paciente. The NSP notifies adverse events every month, by the 15th working day of the next month, and an adverse event that led to death within 72 hours.

Who needs an NSP

RDC 36/2013 applies to health services, public or private, and leaves out individual consulting rooms, clinical laboratories and mobile and home care services.¹ The direção constitutes the NSP, names its members and gives them the authority to carry out the plan, and may use an existing committee to do it. It must provide people, money and equipment, and a professional responsible for the NSP who takes part in the service's decision making.¹ RDC 63/2011 separately asks every health service, whatever its size, for patient safety measures such as patient identification, hand hygiene, safe medication, fall prevention and patient participation.²

What the NSP does

The NSP promotes risk management, finds non-conformities and proposes preventive and corrective action, writes and keeps current the Plano de Segurança do Paciente, implements the patient safety protocols and monitors their indicators, analyses incidents and adverse events and shares the results, notifies adverse events to the national sanitary surveillance system, and keeps those notifications for the sanitary authority.¹ The plan covers identification, hand hygiene, surgical safety, medication, blood, equipment, falls, pressure ulcers, infections, communication between professionals and services, and the participation of patients and families.¹

Notification runs through ANVISA's electronic tools, monthly by the 15th working day of the following month, and within 72 hours for an adverse event that led to death.¹ ANVISA monitors the data and publishes an annual report, and failing to comply is a sanitary infraction under Lei 6.437/1977.¹³

1. Constitute the NSP. The direção names the members in writing and gives them authority to act.
2. Name the responsible professional. Someone who takes part in the clinic's decision making.
3. Write the Plano de Segurança. Map the risks of the services you offer and the protocols that answer them.
4. Set up notification. Register with ANVISA's electronic tools, and set the monthly and 72 hour clocks.
5. Review every incident. Build the timeline from the record, decide the action, name an owner.
6. Report back to the team. Share the analysis with the direção and the professionals, as the RDC asks.

1. Date and time ______ Unit ______
2. Patient reference ______
3. What happened ______
4. Harm ______ Death ______
5. Notified on ______ Within 72 hours ______
6. Analysis by ______
7. Corrective action, owner and date ______
8. Shared with the team on ______

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Questions

Does a doctor's own consulting room need an NSP?

RDC 36/2013 leaves individual consulting rooms out of its scope. RDC 63/2011's patient safety measures still apply to every health service.

When must an adverse event be notified?

Monthly, by the 15th working day of the following month, and within 72 hours when the adverse event led to death.

Can an existing quality committee act as the NSP?

Yes. The direção may use an existing committee, commission or management structure to carry out the NSP's duties.

Sources

1. 1ANVISA, AnvisaLegis, 2013Resolução RDC nº 36, de 25 de julho de 2013, ações para a segurança do paciente em serviços de saúdeRead source
2. 2ANVISA, AnvisaLegis, 2011Resolução RDC nº 63, de 25 de novembro de 2011, Requisitos de Boas Práticas de Funcionamento para os Serviços de SaúdeRead source
3. 3Presidência da República, Planalto, 1977Lei nº 6.437, de 20 de agosto de 1977, infrações à legislação sanitária federal e sançõesRead source

Written by the wai team from ANVISA and the vigilância sanitária, the Conselho Federal de Medicina and the CRMs, and the Organização Nacional de Acreditação guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither ANVISA, the CFM nor ONA endorses wai or any software.