13.3 Adverse event reporting

The 2023 National Adverse Events Policy: Healing, Learning and Improving from Harm by Te Tāhū Hauora | Health Quality & Safety Commission (HQSC) guides the reporting, review, and improvement of patient safety in New Zealand's health settings. It emphasises healing, learning, and system safety improvements, replacing the 2017 policy with broader definitions of harm and mandatory reporting requirements for serious events.

• Definition of adverse events: Adverse events cause or could cause harm to patients, often revealing system gaps, and can include physical, psychological, cultural, or spiritual harm. Near misses, which do not cause harm but could have, are also important for safety improvements.
• Severity Assessment Codes (SAC): SAC 1 events involve severe harm or death requiring lifesaving intervention, while SAC 2 events cause major harm needing significant intervention. These events must be formally reported and reviewed.
• Events outside the framework: Operational disruptions like fires or IT failures and health and safety incidents involving staff accidents fall outside this policy and are managed through other protocols.
• Core principles of the 2023 policy: The policy focuses on healing those affected, learning from incidents to understand system failures, and improving safety to prevent future harm.
• Key changes from 2017 policy: The update includes a system safety focus recognising complex causes, a broader harm definition including non-physical harm, emphasis on open communication, mandatory reporting of SAC 1 and 2 events, and expanded learning resources.
• General practice expectations: Practices should align local policies with the 2023 policy, report all SAC 1 and 2 events to Te Tāhū Hauora | HQSC, foster open communication, and use provided resources to support implementation. Full compliance may take time, with some criteria pending additional tools.
• Reporting adverse reactions: If an adverse event also involves a therapeutic product reaction, it must be reported to Medsafe and managed internally. All SAC 1 and 2 events must be reported to Te Tāhū Hauora | HQSC. Reporting suspected reactions to medicines, devices, vaccines, and complementary products is encouraged even if causality is uncertain.
• Managing SAC 1 and 2 events: These events require formal learning reviews, timely reporting to Te Tāhū Hauora | HQSC, and submission of the College’s General practice review tool for SAC 1 and 2 events [SB1] to support continuous improvement and certification compliance. Practices can seek support from PHOs or allied health organisations.
• Learning and resources: The Te Tāhū Hauora | HQSC’s Learning from Harm Education Programme offers online modules and workshops to help practices apply the policy confidently. The College has developed an Adverse Events Policy and Procedures Guide for General Practice, and a General practice review tool for SAC 1 and 2 events to assist practices in meeting expectations of the National Adverse Events Policy 2023. A short College video is also available, offering an overview of adverse events and transitioning to the National Adverse Events Policy 2023.

An adverse event is defined by Te Tāhū Hauora | Health Quality & Safety Commission (HQSC), as an event that results in harm to a patient, or has the potential to result in harm (near miss).

Key characteristics of adverse event:

• There is an unintended or unforeseen outcome
• Typically results in harm (physical, psychological, cultural, or spiritual)
• Often reveals gaps in systems, processes, or communication
• Sometimes, the same incident can be both an adverse event and an adverse reaction.

Near-miss events

• A near miss is an event that could have caused harm, but did not, either by chance or timely intervention.
• Even without harm, near misses provide valuable opportunities to learn and improve safety systems.
• Practices are encouraged to log and review near-miss events regularly, as they may highlight risks that could lead to more serious incidents if left unaddressed.

Definitions

The Severity Assessment Code, commonly known as SAC classifies the severity of actual harm or potential harm to a patient. The quality check tool focusses on adverse events classified as:

• SAC 1: Severe; death or harm causing severe loss of function and/or requiring lifesaving intervention
• SAC 2: Major; harm causing major loss of function and/or requiring significant intervention

NB: For a full list of definitions, refer to page 15 of Healing, learning and improving from harm: National adverse events policy 2023

Events Not Managed Within the National Adverse Events Reporting Framework

While some incidents may be significant, they fall outside the scope of the 2023 National Adverse Events Reporting Policy. These events should be managed through other appropriate channels:

1. Operational Disruptions: Events such as fires, floods, property damage, IT failures, or service delivery interruptions are not considered adverse events under the national framework. These should be addressed through the practice’s health and safety protocols or business continuity plans.
2. Health and Safety Incidents: Serious incidents involving team member accidents or injuries must be reported to agencies such as WorkSafe New Zealand and the PHO. Reporting requirements may vary depending on the contracted provider or back-to-back agreement.

In 2023, Te Tāhū Hauora | HQSC, introduced a new national policy to guide how adverse events are reported, reviewed, and used to improve patient care across all health settings in Aotearoa New Zealand.

The National Adverse Events Policy 2023: Healing, learning and improving from Harm policy replaces the 2017 version and places greater focus on healing, learning, and system-level safety improvements.

Purpose of the Policy

The National Adverse Events Policy 2023 aims to:

• Promote safe, high-quality care
• Support healing for those affected by harm
• Encourage learning to prevent future incidents
• Create a consistent, transparent approach to reporting and responding to harm across the health system

Core principles of the the National Adverse Events Policy 2023

The policy is structured around three key themes:

1. Healing: Listening to and supporting everyone affected by an adverse event, including patients, whānau, and healthcare teams.
2. Learning: Understanding what happened, how safety is usually maintained, and why it broke down in this case.
3. Improving: Using lessons from the event to make the system safer and strengthen care for everyone.

Key changes in the 2023 National Adverse Events Policy

Compared to the previous 2017 policy, these changes include:

• System safety focus – Recognising that adverse events often result from complex system interactions, not just individual mistakes.
• Broader definition of harm – Expanding harm to include psychological, cultural, and spiritual aspects, not just physical.
• Greater emphasis on relationships – Encouraging open, honest communication and restoring trust with those affected.
• Mandatory reporting of serious events – All SAC 1 and SAC 2 events must be reported and formally reviewed.
• Expanded learning opportunities – Teams are supported to learn from SAC 1 and 2 events using HQSC guidance and resources.

Relevance to general practice

General practices are essential in early identification and reporting. The National Adverse Events Policy 2023 policy sets national expectations, which general practices must begin integrating into local systems. The next section will outline how general practices can implement the policy, including supporting resources, timelines, and expectations.

What is expected of general practices?

General practices are expected to begin aligning with the National Adverse Events Policy 2023 by:

• Understanding the new approach to adverse event management and reporting harm events.
• Starting the transition process to the National Adverse Events Policy 2023 now, recognising that full implementation will take time.
• Updating local policies and procedures, such as the adverse events policy and the open disclosure policy, to align with the National Adverse Events Policy 2023.
• Reporting and reviewing all SAC 1 and 2 harm events to Te Tāhū Hauora| HQSC
• Promoting a culture of open communication and continuous improvement within the practice

What is not yet required to be met by General Practice?

In collaboration with Te Tāhū Hauora | HQSC and with discussions the PHO Quality Improvement Network (QIN), one principles and certain criteria in the 2023 National Adverse Events Policy are currently on hold and not yet required for general practice compliance.

Principle and criteria on hold:

• 1.5: Independent consumer representation– on hold due to lack of infrastructure and pending SAC1/2 review funding resolution.
• 2.4: Engagement of cultural support networks in reviews – on hold until formal networks are established.
• 5.1-5.3: Restorative practice capability and iwi partnerships - subject to a 5-year transition period and capability support.
• 7.6: Regional service interconnection analysis – on hold pending development of a process for wider sharing of learnings.

These are awaiting sector-wide implementation support and practices should remain informed of future updates from Te Tāhū Hauora | HQSC.

The College will continue to monitor developments and provide updates to help practices stay aligned with any change in expectations.

Suggested steps for implementation:

1. Inform the team about the new policy at a practice meeting and discuss its relevance.
2. Watch the informational video understand the updated definitions of harm and the policy’s system safety focus.
3. Review and update policies, including:
   • The adverse events policy and procedure, using College resources.
   • The open disclosure policy, ensuring it supports open, honest communication with patients, whānau, and team members in a culturally appropriate way.

1. Communicate changes to the team to ensure they:
   • Understand the new policies and procedures.
   • Know their role in the event of harm or a near miss.
   • Have access to the finalised documents.

The College’s supporting resources

The College has developed the Adverse Events Policy and Procedures Guide for General Practice to help practice teams align with the National Adverse Events Reporting Policy 2023. While the content may be adapted to suit each practice’s unique context, it is essential that all core compliance requirements are retained.

In accordance with the National Adverse Events Policy 2023, if an incident is both an adverse reaction (to a therapeutic product) and an adverse event, the adverse reaction must be reported to Medsafe and the incident managed internally as an adverse event. If the event is rated SAC 1 or 2, It needs to be reported to Te Tāhū Hauora| HQSC

Events classified as Severity Assessment Code (SAC) 1 or 2 must also be reported to Te Tāhū Hauora | HQSC (see Sections 4 and 5 below for details).

Therapeutic Product Reporting : How to report to Medsafe

Previously, suspected adverse reactions to therapeutic products (e.g. medicines or vaccines) were reported to the Centre for Adverse Reactions Monitoring (CARM) in Dunedin by healthcare professionals, patients, and whānau.

As of October 2023, these reports must be submitted to the new national pharmacovigilance database, maintained by Medsafe. Information on how to report an adverse reaction are provided on the NZ Pharmacovigilance Centre website.

What should be reported?

Any suspected adverse reaction to a therapeutic product should be reported, whether confirmed or not.

This includes reactions to:

• Prescription and non-prescription medicines
• Medicine-associated therapeutic devices such as inhalers, insulin pens, contraceptive implants
• Medicinal cannabis products
• Vaccines
• Complementary and alternative medicines (e.g. rongoā, herbal remedies)
• Dietary supplements

NB: Reporting is encouraged even if the link to the product caused is uncertain.

Under the National Adverse Events Policy 2023, general practices are required to formally report and review all events classified as Severity Assessment Code (SAC) 1 or 2.

This section outlines what that means, when to report, and how to manage the process.

What are SAC 1 and SAC 2 harm events?

Severity Assessment Codes (SACs) are used to rate the seriousness of harm.

• SAC 1: Severe; death or harm causing severe loss of function and/or requiring lifesaving intervention
• SAC 2: Major; harm causing major loss of function and/or requiring significant intervention [SB1]

SAC 1 and 2 harm events require a formal learning review and mandatory reporting to Te Tāhū Hauora| HQSC. Use the Primary care SAC examples to help categorise SAC events in general practice.

What to do if a SAC 1 or 2 harm event occurs

• Use the Te Tāhū Hauora user guide: National adverse events policy 2023 in section 8 to follow the national events policy 2023 and process.
• Practices must adhere to the reporting timelines provided in National Adverse Events Policy 2023.
• Contact your PHO or allied health organisation for additional support/guidance on reporting and conducting a review.
• If the practice has not already updated their policy and procedure to align with the National Adverse Events Policy 2023, the Colleges resources in section 8 can be used to help develop these. [SB2]
• Submit the required documentation to Te Tāhū Hauora | HQSC within the required timeframes.
• In preparation for a Foundation Standard assessment, complete the General practice review tool for SAC 1 and SAC 2 events tool and upload it to Smartsheet for the next assessment.

General practice review tool for SAC 1 and 2 events

Te Tāhū Hauora | HQSC and the College have jointly developed the General practice review tool for SAC 1 and 2 events to support practices that have completed the reporting of a SAC 1 or SAC 2 harm event. This tool enables assessors to evaluate how the practice responded to the event and provides a structured framework for practices to reflect on their processes, identify areas for improvement, and drive continuous quality enhancement.

NB: Completing this tool is mandatory for practices who have finalised the reporting of a SAC 1 or 2 harm event.

Quick Summary: SAC 1 and 2 Reporting

• Must be reported to Te Tāhū Hauora | HQSC
• Requires formal learning review
• Use College and HQSC tools and resources
• Complete the General practice review tool for SAC 1 and 2 events

As part of quality assurance and continuous improvement, general practices are assessed against the Foundation Standard. This includes how they manage adverse events.

Practices that are not due for recertification will not be assessed against the National Adverse Events Policy 2023 until their next scheduled assessment.

However, per Clause 1.4 of the Foundation Standard Terms and Conditions, a practice is still expected to update relevant policies and procedures as soon as reasonably practicable after notification of the change.

The College’s expectation is that all practices should work toward compliance with the National Adverse Events Policy 2023 in the next 6 months[SB1] [HB2] . If a SAC 1 or 2 event occurs in the meantime, practices should follow the suggested steps in section five above. They should contact their PHO or allied health organisation for guidance and support, if needed, with the reporting and the formal review process.

What practices will need to show for Foundation Standard certification compliance:

• An adverse events policy and procedure that aligns with the National Adverse Events Policy 2023
• An updated open disclosure policy and other updated documents/registers in alignment with the National Adverse Events Policy 2023
• If a SAC 1 or 2 event has occurred, the completed General practice review tool for SAC 1 and 2 events [SB3] needs to be provided for the next Foundation Standard assessment

To support implementation of the National Adverse Events Policy 2023, Te Tāhū Hauora | HQSC created the Learning from Harm Education Programme.

This programme is designed to help healthcare teams, including general practices to build confidence in applying the policy.

The programme includes self-paced online modules and virtual or in-person workshops covering system safety, adverse event management, and open communication.

General practices are encouraged to participate to build confidence, support policy compliance, and promote a culture of learning and transparency.

How to access Te Tāhū Hauora | HQSC’s education programme

Full details about the Learning from Harm Education Programme are available in the Te Tāhū Hauora user guide: National adverse events policy 2023, page 11.