Managing Adverse Patient Outcomes: steps required for Office-Based Procedures

This is a reminder of the key obligations and does not replace the Standard of Practice itself. Registrants are expected to read and comply with the full document.  

All CPSM registrants performing office-based procedures (including vasectomy, cosmetic/aesthetic procedures, fillers, botulinum toxin/neuromodulators, laser and light-based therapies, and platelet-rich plasma therapy) must be aware of, and follow, their responsibilities when an adverse patient outcome occurs.

Recognizing an Adverse Patient Outcome

An adverse patient outcome is defined as an unanticipated significant outcome, by misadventure, complication, or patient reaction, that requires higher-level care by an alternate CPSM registrant. This includes, but is not limited to:

• Transfer to hospital, or unanticipated hospital follow-up, related to how the procedure was performed or how the patient responded
• Third-degree burns, disfigurement, or impairment of vision
• Extreme pain or discomfort causing significant, ongoing functional limitation
• Intra-arterial injections causing thrombosis, tissue ischemia, necrosis, or embolism with risk of blindness
• Injection or infusion of the wrong material than originally intended

Required Steps

1. Disclose openly and honestly

Inform the patient of the adverse outcome promptly. You must comply with the CPSM Standard of Practice – Good Medical Care (Section 9. Disclosure of Harm to a Patient).

2. Establish a care plan to mitigate harm

 Registrants who perform, authorize, or are most responsible for a  procedure must ensure a care plan is established to mitigate the effects of the adverse outcome in a satisfactory manner.

3. Notify the Assistant Registrar of Quality

When becoming aware of the adverse patient outcome, the medical director of the clinic must provide to  the Assistant Registrar of Quality:

o   Notice within one working day of becoming aware of the adverse patient outcome.

o   A written report within two weeks.

 4. Document

Document the event, disclosure, and care plan in the patient's record.

Procedural Reinforcement – Preventing Adverse Outcomes

As a reminder, registrants must:

·         Work only within their limits of competence and scope of practice.

·         Ensure the medical clinic is equipped for Basic Life Support, with staff appropriately trained and certified.

·         Have resuscitation equipment, medications, and appropriate antidotes (e.g., hyaluronidase for filler-related ischemia) present when performing injections.

·         Maintain a policy for emergent complications, including anaphylaxis and acute embolic events.

·         Obtain informed consent prior to every procedure, verbal or written.

If you have any questions, please contact the Quality Department at  204-774-4344.

Resources

Standard of Practice - Performing Office-Based Procedures

o   See Appendices 1–3 on fillers/botulinum toxin, PRP, and laser safety) for more details