Background: Near-misses are errors that have the potential to cause an
adverse event but fail to do so because of chance or because they are
intercepted. By 2021, Sri Lanka had only established systems for
maternal and blood transfusion services. Methods: A new, holistic
near-miss reporting system was developed and piloted at a large tertiary
hospital in 2022 to guide subsequent nationwide implementation. During
the pre-interventional phase, national-level consultative meetings
(n=20), key informant interviews (n=10) and focus groups (n=22) were
convened with purposively selected representatives of professional
colleges, academia, medical administrators, and senior staff of the
participating hospital to identify existing methods of reporting
near-misses. A near-miss reporting format and guidelines were designed
with input from national-level consultative meetings. Training on the
new system for medical and nursing officers, periodic reminders to
staff, and dissemination of preventive measures for patient safety
incidents were implemented as interventions. A pre-post evaluation was
conducted to identify the effect of the new system, and stakeholders’
views on potential for nationwide implementation. Results: Eight
near-misses were reported three months following implementation,
compared to none prior to implementation. Study participants expressed
satisfaction with the new system’s user-friendliness, clarity,
non-punitiveness, voluntary nature, and confidentiality protection. The
system was perceived to be suitable for national implementation
following refinements. Conclusions: This evidence-based near-miss
reporting system, combined with the complementary activities implemented
in the pilot setting, should now be introduced into additional hospitals
before national implementation to further enhance its design, support
from stakeholders, and quality and safety impact.