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Endoscopy 2024; 56(02): 100-101
DOI: 10.1055/a-2215-5713
Editorial

Navigating the path to patient safety in endoscopy…going beyond the procedure!

Referring to Ravindran S et al. doi: 10.1055/a-2177-4130
Ian M. Gralnek
1   Gastroenterology, Emek Medical Center, Afula, Israel (Ringgold ID: RIN61172)
2   Technion Israel Institute of Technology The Ruth and Bruce Rappaport Faculty of Medicine, Haifa, Israel (Ringgold ID: RIN58880)
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Continuous quality improvement and patient safety in gastrointestinal (GI) endoscopy are overarching priorities of endoscopy services. Our patients expect us to provide a safe, standardized, and rigorous approach to the performance of GI endoscopy, especially in this era of increasing procedural complexity. To improve patient safety during endoscopy, measures such as pre-endoscopy checklists are recommended and have been implemented in many endoscopy units around the world [1]. Yet, despite our best efforts, endoscopy procedural adverse events, or “patient safety incidents” (PSIs) occur. However, PSIs that occur before and/or after the endoscopy procedure itself (defined as “nonprocedural patient safety incidents” [nPSIs]) are rarely tracked and documented, and usually not on a nationwide level [2] [3].

In this issue of Endoscopy, Ravindran and colleagues, using a cross-sectional qualitative study design, extracted and analyzed endoscopy-specific PSIs from the National Reporting and Learning System (NRLS) database [4]. The NRLS database contains records of all reported safety incidents in England and Wales. PSIs were defined as “any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving healthcare” [5]. The aim of their study was threefold: within the context of the overall endoscopy service, to characterize nPSIs contributing to “significant harm” (moderate and severe harm, or death); to identify potential contributing human factors; and to identify goals for safety improvement. To achieve these aims, the investigators performed “incident analysis” to identify the factors that contributed to the incident, including human factors, thereby informing the prevention of future nPSIs. Human factors include environmental, organizational, and human characteristics that may influence performance [6].

“Overall, the investigators reported that delays in care, development of cancer, and delays in cancer diagnosis accounted for more than half of all nPSIs.”

The investigators identified and analyzed 1181 endoscopy-related PSIs of significant harm from 2017 to 2019. Of these, 539 (45.6%) were nPSIs. Of the nPSIs, 71.2% were classified as leading to moderate harm, 24.1% to severe harm, and 4.5% to death; 13% of nPSI outcomes could not be classified owing to a lack of data. With further characterization of the nPSIs, over 80% fell into five main incident categories: (i) patient follow-up and surveillance (nearly 25% of all nPSIs); (ii) access to care and booking; (iii) quality of endoscopy; (iv) specimens and histopathology; and (v) peri-endoscopy care.

The investigators then took a deeper dive into these five main nPSI categories to try to better understand what specifically was related to these incidents. nPSIs in the category “patient follow-up and surveillance” appeared to be related to failures or delays in following up a significant endoscopic finding that required surveillance. “Access and booking” nPSIs were primarily related to delayed/no access to outpatient endoscopy procedures. Most “quality in endoscopy” and “specimens and histopathology” nPSIs reflected a failure or delay in interpreting and/or acting upon a significant endoscopic or histopathologic finding. Lastly, the most common “peri-endoscopy care” incidents were related to inadequate management of a pre-existing condition. Overall, the investigators reported that delays in care, development of cancer, and delays in cancer diagnosis accounted for more than half of all nPSIs.

So what does this study reveal to us? What can we learn? This study opens our eyes to the reality that patient safety in endoscopy is not only limited to the time of the endoscopic procedure itself. Patient safety encompasses the entire patient journey through endoscopy. Patient safety in endoscopy should be considered to include the process that occurs prior to the endoscopic procedure (e.g. patient access to endoscopic care, availability of endoscopy procedures, availability of advanced therapeutic endoscopy procedures, waiting times for endoscopy), as well as what happens after the patient is discharged from the endoscopy unit (e.g. histopathology sample handling, timely turnaround in receiving histopathology results, correct and timely response to histopathology results, access to a follow-up gastroenterology clinic and/or endoscopy procedures for endoscopic surveillance where indicated), and how this impacts patient outcomes. This is a paradigm shift in patient safety in GI endoscopy as these important issues encompass the entire patient journey.

How can these data be used to further improve patient safety in endoscopy? The investigators derived potential contributory factors that may have led to nPSIs within each of the five main incident categories. These factors included errors by act or omission; local preconditions that led to incidents; supervision and management deficiencies; and organizational influences. Driver diagrams were then created to help identify areas of deficiency to target with specific interventions, referred to as “exemplar interventions.” Lastly, “key enablers” were developed from the driver diagrams and exemplar interventions to identify key areas to address in improving patient safety in endoscopy from an overall systems perspective. This included interventions targeting the structure of care (e.g. electronic systems, workforce planning) and the process of care (e.g. standard operating procedures, training, communication, and teamworking). These are fully detailed within the manuscript and provide additional information that goes beyond the scope of this editorial. This is a very technical manuscript and therefore I encourage you to fully read the entire study, including the supplementary materials.

The investigators are to be congratulated on their work. This study is unique in endoscopy-related research, using social science/qualitative research methodology in an attempt to drill down into the evaluation of nPSIs. As with any study there are limitations. These include using PSI reports that were anonymized and may have been variable in their detail and quality, thereby leading to the need to impute assumptions by the investigators. More than 10% of nPSI outcomes could not be classified owing to a lack of data. Moreover, there may have been detection bias because only safety incidents that are detected are reported in the NRLS database and therefore the full representation of all patient incidents may have been underestimated.

So where do we go from here? To me, this study is “hypothesis generating” and I hope this will encourage other endoscopy/quality improvement-focused investigators to evaluate and report similar patient safety data, whether this be at their own institution or at a larger national level if these data are accessible. Moreover, now that these investigators have identified the baseline nPSIs and where deficiencies exist, it will be important to implement key interventions and then re-evaluate post-intervention to see if the interventions truly reduce nPSIs. The primary take-home message from this study is that patient safety in GI endoscopy goes well beyond the actual time of the endoscopic procedure. Therefore, as endoscopists, we must begin to think this way and begin to more comprehensively evaluate the entire patient journey through endoscopy. Where we find deficiencies, we will need to create interventions to fix those deficiencies. Our patients will expect nothing less from us.



Publication History

Article published online:
20 December 2023

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Refers to:

Patient safety incidents in endoscopy: a human factors analysis of nonprocedural significant harm incidents from the National Reporting and Learning System (NRLS)Endoscopy 2024; 56(02): 89-99
DOI: 10.1055/a-2177-4130