To evaluate the effectiveness of a customised endoscopy safety checklist in improving patient safety, identifying high‑risk conditions, reducing preventable complications, and enhancing team coordination in a high‑volume tertiary GI endoscopy unit in India.

This prospective single‑centre pilot study was conducted from September 2024 to the present. A customised endoscopy safety checklist was designed, incorporating critical parameters related to patient history, anticoagulation status, NPO duration, airway evaluation, anaesthetic considerations, and cardiopulmonary status. The checklist was completed pre‑procedure and verified independently by the endoscopy nurse, resident medical officer, and the endoscopist before scope insertion. All checklist entries and clinical outcomes were prospectively recorded. A total of 5460 endoscopic procedures were performed. Data were analysed for checklist compliance, high‑risk patient identification, adverse events, and avoidable complications. The study also recorded the single case in which the checklist was not implemented.

A total of 5460 endoscopic procedures were performed, and the checklist was implemented in 5459 cases, yielding a compliance rate of 99.98%. High‑risk factors were identified in 40 patients (0.73%), resulting in modification, delay, or abandonment of procedures to prevent adverse events. No adverse events occurred in any case where the checklist was used. One preventable fatal adverse event occurred in the single case (0.02%) where the checklist was not implemented.

Summary of Core Findings:

Total Endoscopic Procedures — 5460,  Checklist Implemented — 5459 (99.98%) compliance, Procedures WITHOUT Checklist — 1 (0.02%), High‑Risk Patients Identified — 40 (0.73%), Low‑Risk Patients Confirmed — 5419 (99.27%), Adverse Events WITH Checklist — 0  (0%), Adverse Events WITHOUT Checklist — 1 (Fatal haemorrhage post‑EUS‑FNA/FNB), Mortality WITH Checklist — 0(0%), Mortality WITHOUT Checklist — 1 (Preventable, related to unreported anticoagulant use)

Breakdown of High‑Risk Factors Identified:

Risk Factor — Count — % of High‑Risk Cohort — % of Total Procedures — Classification

Inadequate NPO Status (<6 hours) — 15 — 37.5% — 0.275% — ESGE aspiration‑risk criterion

Severe Trismus (<3‑finger mouth opening) — 11 — 27.5% — 0.202% — ASGE/ESGE difficult‑airway category

Ongoing Anticoagulant/Antiplatelet Therapy — 10 — 25% — 0.183% — ASGE high‑risk bleeding category

Severe Cardio‑Pulmonary Comorbidities — 4 — 10% — 0.073% — ASGE cardiopulmonary risk classification

Discussion: An Indian tertiary setting with high daily workloads, time constraints, inadequate documentation from referring clinicians, and limited patient awareness contribute to missed critical information during routine evaluations. The checklist functioned as a reliable error‑prevention tool, ensuring systematic confirmation of risk factors that may otherwise be overlooked.

Conclusions: Implementation of a customised endoscopy safety checklist achieved near‑perfect compliance and significantly improved patient safety by identifying high‑risk conditions and preventing avoidable procedural complications. No adverse events occurred in any case where the checklist was applied. The checklist promoted teamwork, standardisation of pre‑procedure evaluation, and improved communication among staff. Adoption of such structured checklists is strongly recommended for all diagnostic and interventional endoscopy units, particularly in high‑volume centres across India and similar healthcare environments.