Abstract
Background and study aims Patient safety incidents (PSIs) in endoscopy, although infrequent, can lead to significant
morbidity or mortality. There is no commonly agreed strategy to investigate PSIs.
We describe a three-tiered approach to investigation to facilitate appropriate action,
shared learning, and timely disclosure to patients as mandated in the UK health system
by the Duty of Candor (DoC).
Methods PSIs were identified prospectively over a 3-year, 7-month period in a large teaching
hospital. Level of investigation was agreed by a group of three senior clinicians.
Levels of investigation comprised: 1) rapid desktop review; 2) departmental “mini-root
cause analysis” (mini-RCA, developed internally); and 3) hospital-level RCA or mortality
review.
Results Of 63006 procedures there were 73 reported cases of significant harm. Eleven resulted
in death. Thirty PSIs were related to hepatobiliary endoscopy, 17 to lower gastrointestinal
endoscopy, and 26 to upper gastrointestinal endoscopy. Hospital-level RCA was performed
in six cases, mini-RCA/mortality review in 14, and 53 were examined by the endoscopy
lead. Findings were presented in an endoscopy user group (EUG) meeting. There was
learning in relation to informed consent, pre-procedural radiology reviews, pre-procedural
treatment, escalation planning, teamwork and communication, preparation of equipment,
and recognition of delayed complications. Open and honest communication with patients
and relatives was facilitated.
Conclusions The introduction of an endoscopy-tailored investigation tool, the mini-RCA, as part
of a three-tiered approach, facilitated investigation, appropriate action, learning,
and disclosure after PSIs.
