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Key Definitions

Term	2025 definition	Examples
Medical error	Failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim.	Wrong-drug syringe swap; wrong-side nerve block.
Near miss	Error that had the potential to cause harm but did not reach the patient owing to chance or timely interception.	Residual needle cap found before injection.
Preventable adverse event	Patient harm arising from error or system failure.	Post-op overdose due to prescribing fault (attending = Type 1), or infusion pump mis-set by nurse (team = Type 2), or stock-out of antidote (system = Type 3).
Unpreventable adverse event	Complication not related to error; unavoidable despite best care.	Anaphylaxis to correctly administered antibiotic.
Disclosure (duty of candour)	Prompt, open explanation to patient/family, apology, outline of next steps. Required by HPCSA Ethical Rule 25 & SA National Guideline for Patient Safety Incident Reporting (2022).

Severity Assessment Code (SAC)–national Priority Matrix

SAC	Harm	Notify	Investigate / report
1–catastrophic / serious permanent harm or death	e.g. retained instrument, wrong-patient surgery	Management immediately; provincial office + SAPS within 24 h	Formal RCA¹ complete ≤ 60 working days; submit to province.
2–moderate harm	Unplanned surgery, LOS↑ > 72 h, serious ADR	Management < 24 h	Local RCA; actions logged ≤ 60 days.
3–minor / no harm	First-aid only, LOS↑ ≤ 72 h, near miss	Management < 24 h	Concise investigation; departmental review ≤ 60 days.

• ¹Root-Cause Analysis using London/Contributory Factors Framework and Just-Culture algorithm.

PSIRF = Patient Safety Incident Response Framework

(NHS England, first published Aug 2022; full adoption required in trusts by Sept 2023)

What it is

• A national policy that replaces the 2015 Serious-Incident Framework.
• PSIRF is not a list of events you must “investigate”; it is a method for deciding how to respond to any patient-safety incident so that learning and improvement, rather than blame, are prioritised.

Four Aims (the Cultural shift)

1. Compassionate engagement with patients, families and staff.
2. Proportionate, systems-based responses (one size no longer fits all).
3. Insight through human-factors-informed analysis.
4. Improvement–embed findings into QI programmes

Core Steps in the PSIRF Pathway

Step	Purpose	Typical tools
1 Identify the incident (incl. near miss)	Real-time safety huddle, electronic reporting portal.
2 Triage → choose a learning response	Learning response options: • Immediate “hot debrief” • Rapid desktop review (≤ 14 d) • Patient-safety investigation (systems-focused, ≠ root-cause “hunt”) • Independent external review (rare)	SAC level, harm/recurrence potential, patient/family wishes.
3 Analyse with human-factors lens	After-Action Review, Systems Engineering Initiative for Patient Safety (SEIPS), London Framework.
4 Engage & share	Compassionate duty-of-candour meeting; draft report shared with those affected.
5 Improve	Translate recommendations into SMART actions; add to trust QI plan; monitor KPIs.	Run-chart, audit, simulation.

Key Differences from the Old Serious-Incident Framework

Old SIF (2015)	PSIRF (2022)
“Investigate everything” → backlog, variable quality.	Proportionate responses based on risk & learning value.
Focus on root cause / blame an individual.	Systems thinking & Just-Culture questions.
Little patient/family involvement.	Mandatory compassionate engagement throughout.
Action plans often shelf-ware.	Actions linked to existing quality-improvement workstreams & tracked.

Where Anaesthetists Encounter PSIRF

• SAC 1 drug error → triage within hours; likely full patient-safety investigation.
• Near-miss airway fire → rapid review; lessons fed into theatre briefing checklist.
• M&M meeting now draw on PSIRF reports rather than traditional RCA write-ups.
• Memory aid: I-T-A-E-I
  • Identify ▶ Triage ▶ Analyse ▶ Engage ▶ Improve–covers the whole PSIRF cycle.

Approach to Any Adverse Event

Use SAFESTAR for Any Clinical Incident

• (one word, eight steps; covers patient care and governance duties)

Letter	Action	What you do	Timing / follow-up
S	Stop further harm / Secure the patient	Airway–breathing–circulation check, halt the offending process, isolate any contaminated lines, call for senior help.	Immediately
A	Assess & assign SAC level	Measure vital signs, review notes, confirm drug/device, decide SAC 1 / 2 / 3 (or near-miss).	Within minutes
F	Fix / mitigate now	Give antidote, extra monitoring, move to PACU/HDU, adjust treatment plan, document orders.	Within first hour
E	Explain (duty of candour)	Apologise, give factual explanation to patient ± family when stable, outline next steps; record the discussion.	Same day
S	Submit incident report	Complete eQuate/Datix form, keep syringes/labels, upload to secure server; tick “near-miss” if appropriate.	≤ 24 h (SAC 1 within 24 h to province/SAPS)
T	Team debrief & secure records	Brief theatre/PACU staff, capture statements, save monitors & logs, activate PSIRF “learning response”.	≤ 48 h
A	Analyse (RCA / human-factors review)	Use London or fish-bone tool, identify system barriers that failed, agree SMART actions.	SAC 1 formal RCA ≤ 60 days; SAC 2 ≤ 60 days; SAC 3 concise review
R	Review & re-audit	Implement fixes (label change, checklist step, education), set audit date, share learning at M&M and on QI board; feed into hospital & national databases.	Re-audit 3–6 months; monitor KPIs quarterly

Why SAFESTAR Works

• Covers the whole PSIRF pathway—immediate safety ➔ proportionate investigation ➔ organisational learning.
• Maps to HPCSA duty-of-candour and SA National Guideline reporting timelines (24 h notification, 60 day RCA).
• Easy to recall under stress; each letter is a discrete, examinable action.

Medication Labelling & Standardisation

Requirement
Generic name displayed in upper-case, Tall-Man lettering where look-alike (e.g. morphine vs HYDROmorphone).
Colour code ISO 26825:2020–14 standard drug classes (e.g. blue = opioid, yellow = induction agent).
Font ≥ 9 pt sans-serif; contrast ≥ 70 % (ISO requirement).
Language–English mandatory; bilingual label permitted.
Date/time drawn-up & initials on syringe or additive label.
Storage–segregate look-alike vials; use pre-filled labelled syringes where available.

Translating Incidents into Safer practice–practical Checklist for Departments

1. Encourage reporting–senior staff model openness; no-blame language.
2. Allocate time–10 min at end of weekly M&M for new reports.
3. Run monthly “theme analysis”–e.g. airway, drug, equipment.
4. Select top risk–conduct mini-RCA, devise SMART² intervention.
5. Implement & monitor–run-chart displayed in coffee room.
6. Celerate success–positive feedback to reporters; certificates for safety champions.

Medication Safety & Drug-error Prevention

Hierarchy of Safeguards

Rank (1 = highest certainty of benefit)	Intervention	2025 consensus strength*	Key details for theatre implementation
1	Read the label aloud before drawing-up / injecting	Strongly recommended	Pause-point; verbal read-back if second person present.
2	Standardised labelling (ISO 26825:2020; Tall-Man lettering)	Strongly recommended	Generic name ≥ 9 pt; colour band by class; date/time & initials on syringe.
3	Every syringe labelled immediately after draw-up	Strongly recommended	Use pre-printed, colour-coded labels or machine-readable flag label.
4	Organised drug drawer/ work-space (fixed layout)	Strongly recommended	High-alert drugs segregated; infusions separate from bolus meds.
5	Independent double-check (person or barcode) before administration	Recommended	Mandatory for paediatric high-alert boluses & vasoactive infusions.
6	Electronic incident reporting of every IV medication error or near-miss	Recommended	Use PSIRF portal; audit trends quarterly.
7	Inventory management to eliminate look-alike / sound-alike (LASA) vials	Recommended	Pharmacy & theatre team joint formulary review.
8	Avoid similar packaging / presentation	Recommended	Select alternative brands or over-label if substitution unavoidable.
9	Prefilled, ready-to-use syringes for emergency meds	Possibly recommended	Pharmacy-supplied phenylephrine 100 µg mL⁻¹ etc.
10	Syringes drawn-up & labelled by same anaesthetist who will administer	Possibly recommended	Reduces hand-over confusion.
11	Colour coding by pharmaco-class	Possibly recommended	Follow ISO standard; not a substitute for reading label.
12	Coding by syringe position / needle colour	Insufficient evidence	May aid some clinicians but risks complacency.

• Strength adapted from Jensen et al. (BJA 2004) and updated with APSF/ASA statements 2018-2024.

APSF Operating-room Medication-safety Bundle (endorsed by SASA 2023)

• Standardisation
  • Pharmacy-prepared ready-to-use high-alert drugs in adult & paediatric concentrations.
  • Smart infusion pumps with hard limits + drug library.
• Technology
  • Mandatory barcode scan of vial and syringe before draw-up/administration in every anaesthetising location; auto-populate AIMS record.
• People & culture
  • “Just culture” reporting of near-misses; monthly learning huddle.
  • Peri-operative clinical pharmacist on ward rounds & list briefings.
  • Case-specific pre-prepared drug packs (e.g. obstetrics PPH kit).

ADR / Drug-error Classification (ABCDE mnemonic)

Class	Description	Typical example
A–Augmented	Dose-related, predictable	Hypotension from excessive propofol.
B–Bizarre	Idiosyncratic, non-dose, rare	Anaphylaxis to cefazolin.
C–Chronic	From prolonged therapy	Adrenal suppression with > 1 week etomidate infusion.
D–Delayed	Appears after use for years	Halothane-induced hepatitis.
E–End-of-use	Withdrawal	Clonidine rebound hypertension.

Protocols

Accidental Intra-arterial Injection / Cannulation

1. Keep arterial catheter patent (0.9 % saline infusion).
2. Confirm diagnosis (flashback, ultrasound, ABG).
3. Systemic anticoagulation–IV heparin 50 units kg⁻¹ bolus then infusion 500–1000 units h⁻¹ (contra-indications permitting).
4. If traumatic/non-iatrogenic: baseline angiography ± cultures; start broad-spectrum antibiotics if contamination suspected.
5. Relieve arterial spasm–intra-arterial Ca-channel blocker (verapamil 5 mg) or papaverine; consider brachial plexus/stellate block.
6. Restore flow–catheter-directed thrombolysis (t-PA) or surgical thrombectomy when ischaemia persists.
7. Treat sequelae–debridement, iloprost for digital ischaemia, chronic pain referral, physio/OT.
8. Documentation & incident report (SAC classification).

Extravasation Injury–Immediate Management Checklist

1. STOP infusion; keep cannula in situ.
2. Aspirate residual drug gently through cannula.
3. Mark / photograph affected area; measure circumference.
4. Elevate limb; apply warm or cold compress according to drug class.
5. Drug-specific antidote (e.g. hyaluronidase for vinca alkaloids; phentolamine for vasopressors).
6. Consult plastics / burns team early for vesicants or extensive injury.
7. Document fully in notes and electronic incident system.

Links

• Never ever events
• Death on table
• Practice management
• Practice guideline
• Risk
• Morbidity and mortality in Anaesthesia

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Past Exam Questions

Management of a Substitution Drug Error During Anaesthesia

During an anaesthetic for a laparotomy, you discover that you made a substitution drug error. The patient received 7.5mg of morphine through the epidural catheter shortly before the end of the procedure. At the end of surgery, the patient is extubated, is awake, pain-free, and has a respiratory rate of 14 per minute.
List the important points in managing this incident. (10)

Quality Improvement in Surgical Site Infections

a) Name a quality improvement method whose steps you would use. (1)

b) Briefly describe your approach using one of the accepted quality improvement tools available, explaining the steps. (9)

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References:

1. Kothari D, Gupta S, Sharma C, Kothari S. Medication error in anaesthesia and critical care: A cause for concern. Indian J Anaesth. 2010 May;54(3):187-92. doi: 10.4103/0019-5049.65351. PMID: 20885862; PMCID: PMC2933474.
2. Lake, C. and Beecroft, C. (2010). Extravasation injuries and accidental intra-arterial injection. Continuing Education in Anaesthesia Critical Care &Amp; Pain, 10(4), 109-113. https://doi.org/10.1093/bjaceaccp/mkq018
3. Jensen LS, Merry AF, Webster CS, et al. Evidence-based strategies for preventing drug-administration errors during anaesthesia. Br J Anaesth. 2004;93(1):15-30. Available from: https://pubmed.ncbi.nlm.nih.gov/15096243/ pubmed.ncbi.nlm.nih.gov
4. International Organization for Standardization. ISO 26825:2020–Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during anaesthesia. Available from: https://www.iso.org/standard/76678.html iso.org
5. Anesthesia Patient Safety Foundation. APSF Recognizes Best Practices for Safe Medication Administration during Anesthesia Care. 2018. Available from: https://www.apsf.org/article/apsf-recognizes-best-practices-for-safe-medication-administration-during-anesthesia-care/ apsf.org
6. South African Society of Anaesthesiologists (SASA). Guidelines for the Safe Use of Procedural Sedation and Analgesia in Adults 2020-2025. Available from: https://www.sasaweb.com/wp-content/uploads/2022/07/SASA-Adult-Sedation-Analgesia-Guidelines-2020.pdf sasaweb.com
7. SASA. Medication-labelling and look-alike/sound-alike (LASA) alert: Heparin vs Oxytocin. Risk Bulletin Nov 2023. Available from: https://www.sasaweb.com/wp-content/uploads/2023/11/RBU-Drug-Labelling-Nov-2023.pdf sasaweb.com
8. Lokoff A, Maynes JT. The incidence, significance and management of accidental intra-arterial injection: a narrative review. Can J Anaesth. 2019;66(5):576-592. Available from: https://pubmed.ncbi.nlm.nih.gov/30877587/ pubmed.ncbi.nlm.nih.gov
9. Ward C, et al Management of Accidental Intra-Arterial Injections. WFSA ATOTW 498; 2023. Available from: https://resources.wfsahq.org/wp-content/uploads/atow-498-00.pdf resources.wfsahq.org
10. Infusion Nurses Society. Infusion Therapy Standards of Practice (9th ed.). 2024. Available from: https://www.ins1.org/publications/infusion-therapy-standards-of-practice/ ins1.org

Summary or mindmap:

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Copyright**
© 2025 Francois Uys. All Rights Reserved.

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