SEGURANÇA DO PACIENTE: RDC nº 36/2013 - Parte 2 - Núcleo de Segurança do Paciente (NSP)

Understanding the Core of Patient Safety: Resolution No. 36/2013

Introduction to Patient Safety and Resources

• The session is led by Professor Juliana Melo, focusing on Resolution No. 36 from Anvisa regarding patient safety.

• An e-book on comprehensive patient safety studies is available for download, containing updated theories and practice questions.

• The website "emfrenteenfermagem.com.br" offers various nursing resources, including legislation and health policies.

Establishing the Patient Safety Core

• The discussion continues from a previous lesson about the core of patient safety as outlined in Article 4 of the resolution.

• Health service management must establish a patient safety core and appoint its members to ensure effective operations.

• Management is responsible for granting authority and responsibility to core members for executing patient safety plans.

Mandatory Nature of Patient Safety Cores

• All health services, whether public or private, must have a patient safety core; this includes clinics and specialized diagnostic services.

• The establishment of these cores is not optional; they are mandatory across all healthcare settings.

Utilizing Existing Structures

• Health service management can utilize existing committees or teams to fulfill the responsibilities of the patient safety core instead of creating new ones.

• This approach allows for efficient use of resources within healthcare units while maintaining focus on patient safety initiatives.

Specific Guidelines for Public Services

• In public outpatient services, either individual cores can be created per service or shared among multiple units based on local management decisions.

• The complexity and type of services offered will dictate how these cores are structured within public health systems.

Strategic Alignment with Healthcare Management

• It’s recommended that hospital-based patient safety cores be directly linked to management with regular meetings involving various departments (e.g., nursing, pharmacy).

• Ensuring that all relevant sectors collaborate enhances commitment towards achieving optimal patient safety outcomes.

Resource Allocation for Effective Functioning

• For continuous operation, health service management must provide necessary human resources, financial support, equipment, supplies, and materials essential for the functioning of the patient safety core.

Nucleus of Patient Safety: Structure and Responsibilities

Financial and Structural Aspects

• The nucleus must encompass all financial aspects, including necessary funding for actions and equipment to ensure effective operation. A responsible professional should lead this nucleus and participate in decision-making instances within the health service.

Composition of the Patient Safety Nucleus

• It is essential that the Patient Safety Nucleus consists of a multidisciplinary team, minimally including doctors, pharmacists, and nurses trained in quality improvement concepts and patient safety tools. This ensures comprehensive risk management in healthcare services.

Leadership and Expertise

• Members of the Patient Safety Nucleus should have a strong understanding of work processes within their unit and possess leadership qualities. The composition may vary by institution but should always seek professionals with these profiles.

Collaborative Roles

• The nucleus should include representatives from infection control, risk management, quality assurance, hospital pharmacy, nursing services, among others. Existing committees related to patient safety can also contribute constructively to this nucleus's efforts.

Principles and Guidelines for Operation

• According to Article 6, the Patient Safety Nucleus must adopt principles such as continuous improvement in care processes, systematic dissemination of safety culture, integration of risk management processes, and ensuring best practices in health service operations.

Core Competencies of the Patient Safety Nucleus

Risk Management Actions

• The nucleus is tasked with promoting actions for risk management within healthcare services by identifying risks effectively and implementing necessary interventions based on evaluations communicated across teams.

Multidisciplinary Integration

• Developing actions that facilitate integration among various specialties is crucial for enhancing collaboration within healthcare settings while promoting mechanisms to identify non-conformities in procedures or equipment usage.

Educational Role

• An important function includes educating professionals on identifying non-compliance issues while ensuring proper use of medical equipment following established protocols aimed at guaranteeing patient safety standards are met consistently.

Development of Safety Plans

• The nucleus is responsible for creating, implementing, disseminating, and maintaining an updated patient safety plan which serves as a foundational document guiding safety actions within healthcare services. Monitoring associated indicators is also part of this responsibility.

Training Programs

• Establishing barriers against incidents through preventive measures is vital; thus developing training programs focused on patient safety quality becomes essential for ongoing education among healthcare professionals about incident data analysis related to adverse events during service delivery is critical too.

Patient Safety Plan Overview

Role of the Patient Safety Core

• The Patient Safety Core is responsible for notifying the National Health Surveillance System about adverse events resulting from healthcare services. All adverse events must be reported, and this core will manage these notifications.

Notification Process

• All notifications of adverse events are stored and made available to ANVISA (National Health Surveillance Agency) or any relevant health authority when required. This ensures that the healthcare team remains updated on health alerts and risk communications issued by health authorities.

Development of the Patient Safety Plan

• The Patient Safety Plan in healthcare services is developed by the Patient Safety Core, establishing strategies and actions related to risk management based on activities performed within healthcare services. Planning involves identifying, analyzing, evaluating, monitoring, and communicating risks systematically.

Integration with Risk Management Processes

• The safety plan must integrate various risk management processes within healthcare services and include protocols established by the Ministry of Health regarding patient identification, hand hygiene, surgical safety, medication administration safety, blood component safety, equipment usage safety, fall prevention, pressure ulcer prevention, and infection control measures.

Importance of Effective Communication

• Effective communication among professionals and between different healthcare services is crucial. It also encourages patient and family participation in care provision while promoting a safe environment for all involved in patient care.

Key Components of the Patient Safety Plan

Documenting Priorities

• The Patient Safety Plan serves as a document expressing the importance of patient safety within an organization. It outlines priorities for implementing safety practices in risk management along with process designs that connect leadership with frontline care professionals based on training needs and evaluations of patient safety culture.

Risk Management Strategies

• This plan identifies significant risks associated with patient care and describes strategies defined by healthcare services to manage these risks effectively while aiming to prevent incidents throughout all phases of patient assistance from admission to discharge. Additionally, it emphasizes that the Patient Safety Core is responsible not only for creating but also for developing and updating this plan regularly according to regulatory requirements set forth by ANVISA Resolution No. 36/2013.

Monitoring Adverse Events

Monthly Reporting Requirements

• Monitoring incidents and adverse events falls under the responsibility of the Patient Safety Core which must report these incidents monthly by the 15th business day using electronic tools provided by ANVISA. This reporting includes any incident resulting in harm during health assistance activities as mandated by resolution guidelines aimed at enhancing patient safety planning efforts through systematic data collection on adverse occurrences.

Health Notification and Patient Safety Regulations

Notification of Adverse Events

• Health notifications regarding deaths must be reported within 72 hours of occurrence, emphasizing the importance of timely reporting.

• The National Health Surveillance Agency (ANVISA) is responsible for monitoring adverse event data reported by health services and publishing annual reports analyzing these notifications.

Responsibilities and Deadlines

• Health services have a deadline of 120 days to establish Patient Safety Centers and develop safety plans, with an additional 150 days to begin monthly reporting of adverse events post-publication of the resolution.

• Establishing a Patient Safety Center is mandatory; failure to comply can lead to sanitary infractions, including potential criminal charges.

Compliance and Enforcement

• Local, municipal, or state health surveillance agencies are tasked with enforcing compliance with existing sanitary regulations through oversight of these centers.

• Non-establishment of a Patient Safety Center constitutes a sanitary infraction that may result in civil, administrative, or criminal liabilities.

Additional Resources

• For further information on patient safety topics, resources such as e-books are available at specific websites.