Contents

Draft: Adverse Events

This is a draft page which will replace the existing version on your site in February 2026. See Upcoming Changes.

This policy has been updated to align with the National Adverse Events Policy 2023 and recent RNZCGP guidance on adverse events. Definitions and processes have been updated to align with HQSC requirements.

Adverse reactions are now reported via the national pharmacovigilance database, a joint system managed by Medsafe and CARM.

Management of SAC 1 and 2 events to HQSC is via the national reporting tool within specified timeframes.

Policy

This policy covers events that result in harm or potential harm, to a patient while receiving healthcare. It should be read in conjunction with the Open Disclosure policy.

Test Medical Centre Cornerstone records, responds to, and learns from adverse events and near misses in line with the National Adverse Events Policy 2023.

An adverse event is any unexpected harm to a patient as a direct result of healthcare. Near misses that could have caused harm to a patient, but didn't, are also treated as adverse events and managed through the same process, to identify where systems or processes can be improved.

We have clear processes for reporting, reviewing, and learning from all levels of harm. We recognise harm as negative consequences to patient or whānau as a result of health care, rather than from an underlying disease or injury. Harm may be physical, psychological, cultural, or spiritual.

When managing an adverse event or near miss, we are guided by the principles of the National Adverse Events Policy 2023.

To ensure adverse event management improves patient and whānau safety, prevents harm, and supports healing, we:

• report adverse events to the appropriate bodies within required timeframes
• provide and follow processes to categorise adverse events and near misses and respond to them appropriately

  Each adverse event or near miss is assigned a Severity Assessment Code (SAC) rating according to the level of harm the patient has experienced. This determined how the event should be managed.

  • SAC 1 and 2 events: Severe or major harm, e.g. death or severe loss of function.
  • SAC 3 and 4 events: Moderate or minor harm, e.g moderate loss of function or requiring increased care.

  Source: Te Tāhū Hauora | HQSC Severity Assessment Code (SAC) rating and triage tool for adverse event reporting

• focus on open communication, healing relationships, and repairing harm in our response
• promote a no-blame culture and and support our team to continuously improve* at the pora
• review our adverse events response to identify what has been learned.

Occupational health and safety events, service interruptions (e.g. fires, floods or IT failures), and employee issues are not considered adverse events and are managed under separate policies.

Roles and responsibilities

ACTION: Tell us who has roles and responsibilities for adverse event management in your organisation.

We have designated roles and responsibilities to ensure accountability for adverse event management:

• All team members are responsible for identifying and reporting events, providing an appropriate emergency response, and notifying an appropriate person at the practice as soon as possible.
• The clinical director and practice manager are responsible for ensuring the event has been entered into the incident register, establishing the SAC rating, and overseeing the adverse event management process within appropriate timeframes.
• The clinical governance group analyses why events happened, leads the learning review of SAC 1 and 2 events, and identifies where learning or quality improvement are needed.
• The equity champion provides advice and guidance to ensure the restorative process is culturally responsive.
• The health and safety lead ensures health and safety reporting processes are followed, if applicable.

Adverse event reporting process

All adverse events (including near misses)

1. Take immediate action to prevent harm and notify appropriate people.
   • Take immediate safety actions to prevent further harm.
   • Notify an appropriate person as soon as possible. Escalate immediately if serious harm has occurred.
   • Add to incident register and document in the PMS.
2. Discuss the harm with the patient and whānau (begin open disclosure).
   • Begin open disclosure by discussing what has happened, or what might have happened, with patient and whānau as soon as practicable.
   • If patient and whānau aren't ready to engage, ensure they have contact details so they can engage when ready.
   • Consider what is needed to ensure communication is culturally safe.

   See Open Disclosure: Step 1 for details of preparing for the initial conversation

3. Establish a provisional SAC harm rating.
   • Establish a provisional SAC harm level. Base this on:
     • initial discussion of harm with patient and whānau
     • Severity Assessment Code rating and triage tool for Healing, Learning, and Improving from Harm
     • Primary Care SAC examples 2024

Identify whether the event is, or might be, an adverse reaction to a therapeutic product, e.g. medicine, vaccine, medical device, etc.

Manage the event according to the provisional SAC category and type of event as outlined below.

Adverse reactions

• Report all adverse reactions, or suspected adverse reactions, to therapeutic products to:

  Adverse reactions could be from:

  • prescription and non-prescription medicines
  • devices such as inhalers, insulin pens, contraceptive implants
  • medicinal cannabis products
  • vaccines
  • complementary or alternative medicines (e.g. rongoā, herbal remedies)
  • dietary supplements.
  • National pharmacovigilance database (Medsafe/CARM), using the online Adverse reaction reporting form.
  • IMAC (for immunisation-related events) using the online form, or via your immunisation coordinator.
• Follow the internal process for the event's provisional SAC rating and manage it as an adverse event.

SAC 1 and 2 events (severe and major)

All SAC 1 and 2 events require mandatory reporting and formal review.

Action

1. Immediately notify leadership and the clinical governance group when a potential SAC 1 or 2 event is identified.
2. Advise the PHO for support and guidance. Agree roles for review, cultural guidance, and communication.
3. Submit Part A "Learning from Harm" report of harm to Te Tāhū Hauora | HQSC within 30 working days of becoming aware of the event, using the national portal.

Review

1. Conduct a structured learning review into what happened, and what made it difficult to keep the patient safe in this case.
   • Choose a formal review method and appoint a review team.
   • Create a terms of reference that considers the principles of the National Adverse Events Policy 2023.

     There are eight guiding principles for managing adverse events. They focus on healing, learning, and restoring trust rather than appointing blame.

     • Patient/whānau protection: Working in partnership to understand and learn from harm.
     • Culturally responsive practice: Acknowledging and supporting each person's values and beliefs
     • Equity: Addressing inequities as part of the review process
     • Open communication: Timely and transparent communication with patients and whānau.
     • Restorative practice: Bringing everyone affected together to share their perspectives (not all criteria are required in general practice)
     • Safe reporting: Developing a culture where people feel safe raising concerns or reporting events.
     • System accountability: Having processes and systems that identify and address issues.
     • System learning: Identification of learning opportunities and improvement.

     Source: Healing, learning, and improving from harm: National adverse events policy 2023

     Note: The National Adverse Events Policy 2023 sets national expectations, and needs to be integrated into local systems. Some specific parts of these principles don't yet apply to general practice.

   • Debrief with involved staff and provide support.
   • Review what happened, focusing on system failures and learning rather than assigning blame.
   • Identify key learning points and prioritise actions to improve care.

   Use the Te Tāhū Hauora | HQSC learning review template to guide the learning review.

2. Determine a final SAC rating based on the actual harm experienced.
3. Submit Part B "Learning from Harm" review and the final anonymised report to Te Tāhū Hauora | HQSC within 120 working days of notification, using the national template and upload process.

Open disclosure

• Allocate a key contact person for patient and whānau to use for questions, updates, and support.
• Engage regularly with patient and whānau throughout the review to ensure the process, findings, and actions meets their needs and preferences.
• Share a draft report with patient, whānau and involved staff and invite feedback, corrections, and additional perspectives before the report is finalised.

For full requirements and communication approaches, see Open Disclosure.

Share and learn

• Provide regular progress updates to patients, family/whānau, and team until actions are completed.
• Share key learnings and improvements locally through the PHO, peer groups, and clinical education forums.
• Consider sharing anonymised learnings nationally through clinical networks where this may support wider system learning.
• Support team members to complete Te Tāhū Hauora | HQSC Learning from Harm education (if available) and apply learning in quality improvement activities.

SAC 3 and 4 events (moderate or minor)

• Manage SAC 3 and 4 events by following the internal incident management process. These events do not need to be reported to Te Tāhū Hauora | HQSC.
• Review clusters of similar events together where possible to identify patterns and system issues.
• Implement and document actions for improvement. Assign responsibility and timeframes, and evalulate whether changes are effective and sustainable.
• Record all SAC 3 and 4 events in the incident register, and discuss them as part of clinical governance to identify quality improvements.

Follow the incident management process to manage SAC 3 and 4 adverse events. See Incidents.

Related policies

• Open Disclosure
• Clinical Governance

Other types of events managed by separate policies:

• Health and Safety
• Human Resources
• Fire
• Business Continuity

Resources

• Te Tāhū Hauora | HQSC:
  • Healing, Learning, and Improving from Harm: National Adverse Events Reporting Policy 2023
  • Healing, Learning, and Improving from Harm: User Guide
  • Severity Assessment Code (SAC) rating and triage tool for adverse event reporting
  • Primary Care SAC examples 2024 (and A3 printable)
  • Harm (adverse) event submission portal
  • How to engage with consumers following an adverse event
• Medsafe (CARM): Adverse Reaction Reporting
• IMAC: Vaccine incident report and reflection form

Keywords: adverse events, adverse reactions, sentinel events, significant event, reportable events, notifiable events, accident