Executive Summary

This Clinical Risk Register & Escalation Framework forms the central risk governance hub within Newcastle Cosmetic Doctor’s quality management system. It connects directly to the Continuous Quality Improvement (CQI) Plan, Governance & Operations Policy, and the Incident Management & Adverse Event SOP. It provides a structured, defensible process for identifying, grading, mitigating, and escalating risks across injectables, laser/energy devices, and topical medicines. The framework aligns with AHPRA’s Cosmetic Procedure Guidelines (2025), NSQHS Standard 1 (Clinical Governance), TGA medical device and pharmacovigilance requirements, Safe Work NSW obligations, and ISO 14971:2019 principles of medical device risk management.

1. Purpose & Scope

The purpose of this framework is to establish a unified system for identifying, assessing, and controlling clinical and operational risks at Newcastle Cosmetic Doctor (NCD). It applies to all cosmetic medical and energy-based procedures including anti-wrinkle injections, dermal fillers, bio-stimulators, PDO threads, laser rejuvenation, tattoo removal, skin resurfacing, RF, HIFU, and topical product use or dispensing. The framework ensures transparency, defensibility, and compliance with national governance standards. ^{1 2 3 4}

2. Governance Framework

Risk management oversight is provided by the Medical Director and Governance Manager. Clinical leads are responsible for maintaining local risk registers within their domains (Injectables, Laser, Topicals). Quarterly governance meetings review high-rated risks, corrective actions, and audit outcomes. Serious risks trigger immediate escalation to external regulators such as AHPRA, the TGA, or SafeWork NSW, in line with statutory reporting duties. ^{1 3 7 8}

3. Risk Register Structure & Classification

Risks are classified using a 5x5 matrix based on likelihood and consequence, rated from Low (1–4) to Extreme (20–25). Each entry includes a risk owner, control measures, review frequency, and escalation threshold. Categories include: Patient Safety, Medicines & Devices, Infection Control, WHS, Privacy & Data, Advertising Compliance, and Environmental Safety. High-severity risks are reviewed monthly; medium risks quarterly; and low risks annually. ^{4 8 11}

4. Section A — Injectables

Risks include vascular occlusion, infection, anaphylaxis, and medication errors. Preventive controls include credentialing, emergency preparedness, batch traceability, and adherence to the NCD Vascular Occlusion Protocol and Anaphylaxis SOP. Escalation of moderate-to-severe adverse events requires notification to the Medical Director within 24 hours and reporting to AHPRA or the TGA when indicated. ^{1 3 4 7 8}

5. Section B — Lasers & Energy Devices

Risks include ocular injury, burns, pigmentary change, and equipment malfunction. Risk control measures include appointment of a Laser Safety Officer (LSO), use of protective eyewear, plume evacuation systems, signage, and adherence to AS/NZS 4173 and ARPANSA radiation standards. Serious or repeated device faults trigger reporting to the TGA under ARTG and DAEN requirements. ^{8 11 19 20}

6. Section C — Topical Medicines & Skincare Products

Risks include allergic reactions, misuse of compounded preparations, and incorrect classification between cosmetic and therapeutic goods. Controls include pharmacist collaboration, ingredient verification, patch testing, and compliance with the Therapeutic Goods Advertising Code. Adverse reactions are recorded in the Incident Management Register and, if serious, reported to the TGA. ^{2 3 4 20 25}

7. Escalation Pathways & Reporting Thresholds

Incidents are triaged by severity. Level 1–2 (minor/moderate) incidents are managed internally and logged in the risk register; Level 3–4 (major/critical) incidents require escalation to the Medical Director and may involve AHPRA, HCCC, TGA or SafeWork NSW notifications. A debrief and root cause analysis must be completed for any Level 4 event, with corrective actions documented. ^{1 3 7 8 11 19}

8. Documentation, Review & Audit

Risk registers and escalation outcomes are stored within NCD’s governance repository. Monthly summaries are tabled at management meetings. Annual audits review risk ratings, control effectiveness, and compliance with NSQHS standards. Lessons learned inform revisions to SOPs, training modules, and staff credentialing. ^{2 4 8 25}

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/News/2025-01-31-Guidelines.aspx ↩
2. Therapeutic Goods Administration (TGA), Australian Regulatory Guidelines & DAEN Adverse Event Reporting., viewed 28 October 2025, https://www.tga.gov.au/reporting-issues ↩
3. ACSQHC, National Safety and Quality Health Service (NSQHS) Standards (2nd ed.)., viewed 28 October 2025, https://www.safetyandquality.gov.au/standards ↩
4. NSW Health, Clinical Governance and Patient Safety Framework (PD2017_043)., viewed 28 October 2025, https://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=PD2017_043 ↩
5. SafeWork NSW, Work Health and Safety Act & Regulation., viewed 28 October 2025, https://www.safework.nsw.gov.au/legal-obligations/legislation ↩
6. ISO, ISO 14971:2019 – Medical Devices Risk Management Framework., viewed 28 October 2025, https://www.iso.org/standard/72704.html ↩
7. ARPANSA, Laser and Optical Radiation Safety., viewed 28 October 2025, https://www.arpansa.gov.au/understanding-radiation/radiation-sources/more-radiation-sources/lasers ↩
8. WHO, Patient Safety and Risk Management Framework., viewed 28 October 2025, https://www.who.int/teams/integrated-health-services/patient-safety ↩
9. ACCC, False or misleading claims, viewed 28 October 2025, https://www.accc.gov.au/consumers/advertising-and-promotions/false-or-misleading-claims ↩
10. NHMRC, Guidelines for Infection Control and Clinical Practice., viewed 28 October 2025, https://www.nhmrc.gov.au/about-us/publications/australian-guidelines-prevention-and-control-infection-healthcare-2019 ↩