1. Purpose & Scope

This SOP defines the structured process for identifying, reporting, investigating, and responding to incidents and adverse events at Newcastle Cosmetic Doctor (NCD). It ensures transparent reporting, learning, and compliance with AHPRA, NSW Health, ACSQHC, and TGA expectations. ^{1 2 3}

2. Definitions & Classification

An 'incident' is any unintended event that could have or did result in harm, deviation from protocol, or regulatory non-compliance. 'Adverse events' include infection, bruising, vascular occlusion, delayed nodules, laser burns, or medication error. Classification follows the NCD Adverse Event Grading Matrix (1–5: Minor to Sentinel). ^{2 4 5}

3. Roles & Responsibilities

The treating clinician must initiate immediate patient care and notify the Governance Manager. The Governance Manager logs the incident, informs the Medical Director, and ensures timely escalation and documentation. The Medical Director determines regulatory notification requirements and oversees RCA (Root Cause Analysis). ^{1 2}

4. Immediate Response & Containment

Provide first aid and urgent care (e.g., vascular occlusion management, anaphylaxis protocol, laser injury first response). Document clinical findings, interventions, and follow-up plan. Notify the Medical Director within 24 hours of a moderate-to-severe event. ^{2 3 6}

5. Incident Notification & Reporting Pathways

Internal reports use the NCD Incident Form and log in the Clinical Risk Register. External notification occurs to AHPRA (practitioner issue), HCCC NSW (patient complaint), or TGA (device/medicine problem) as per statutory timelines. ^{1 3 7 8}

6. Investigation & Root Cause Analysis (RCA)

The Governance Manager coordinates RCA using evidence-based frameworks. Contributing factors (human, equipment, environment, communication) are analysed; CAPA (Corrective and Preventive Actions) are defined with due dates and owners. Findings feed into the CQI Plan. ^{2 9}

7. Communication with Patients & Transparency

Patients are informed promptly of adverse events, investigations, and outcomes. Communication follows NSW Open Disclosure principles, respecting patient privacy and the Australian Charter of Healthcare Rights. ^{10 11}

8. Regulatory Notifications & Timelines

Serious events must be reported to regulators: TGA within 10 business days (devices or medicine), AHPRA within 7 days (practitioner impairment or restriction), and HCCC upon complaint receipt. All external correspondence is logged in the Governance Register. ^{1 3 7 8}

9. Documentation, Records & Privacy

Incident files include forms, RCA outcomes, photos, consent, and correspondence. Records are stored securely with restricted access under APP 6 and NSW privacy law. Aggregated data informs risk dashboards and annual reports. ^{12 13}

10. Continuous Improvement & Governance Review

Quarterly governance meetings review incident trends, RCA themes, CAPA completion, and regulatory correspondence. Lessons learned are disseminated to staff and incorporated into policy updates and training. ^{2 9 14}

Sources

1. Ahpra/Medical Board of Australia, Guidelines for practitioners who perform cosmetic medical and surgical procedures (2025)., viewed 28 October 2025, https://www.ahpra.gov.au/Resources/Cosmetic-surgery-hub/Cosmetic-procedure-guidelines.aspx ↩
2. ACSQHC, National Safety and Quality Health Service (NSQHS) Standards (2nd ed.)., viewed 28 October 2025, https://www.safetyandquality.gov.au/standards ↩
3. NSW Health, Clinical Governance and Patient Safety Framework (PD2017_043)., viewed 28 October 2025, https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2017_043.pdf ↩
4. World Health Organization (WHO), Patient Safety Incident Reporting & Learning Systems., viewed 28 October 2025, https://www.who.int/publications/i/item/9789241511636 ↩
5. Therapeutic Goods Administration (TGA), Database of Adverse Event Notifications (DAEN)., viewed 28 October 2025, https://www.tga.gov.au/safety-and-shortages/database-adverse-event-notifications-daen ↩
6. NHMRC, Infection Prevention & Control Guidelines (2019)., viewed 28 October 2025, https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019 ↩
7. Health Care Complaints Commission (HCCC) NSW, Complaints and notifications., viewed 28 October 2025, https://www.hccc.nsw.gov.au/ ↩
8. SafeWork NSW (2025), Incident notification, viewed 28 October 2025, https://www.safework.nsw.gov.au/notify-safework/incident-notification ↩
9. Institute for Healthcare Improvement (IHI) (2015), RCA²: Improving Root Cause Analyses and Actions to Prevent Harm, viewed 28 October 2025, https://www.ihi.org/library/tools/rca2-improving-root-cause-analyses-and-actions-prevent-harm ↩
10. NSW Health, Open Disclosure Policy (PD2020_042)., viewed 28 October 2025, https://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2020_042.pdf ↩
11. ACSQHC, Australian Charter of Healthcare Rights., viewed 28 October 2025, https://www.safetyandquality.gov.au/our-work/partnering-consumers/australian-charter-healthcare-rights ↩
12. Office of the Australian Information Commissioner (OAIC), Australian Privacy Principles., viewed 28 October 2025, https://www.oaic.gov.au/privacy/australian-privacy-principles ↩
13. NSW Government, Health Records and Information Privacy Act 2002., viewed 28 October 2025, https://legislation.nsw.gov.au/view/html/inforce/current/act-2002-071 ↩
14. RACGP, Clinical Governance and Quality Improvement Toolkit., viewed 28 October 2025, https://www.racgp.org.au/clinical-resources/clinical-guidelines ↩