This Guideline is an official statement of the European Society of Gastrointestinal
Endoscopy (ESGE). It provides guidance on the collection and handling of tissue samples
during endoscopy of the lower gastrointestinal tract. The Grading of Recommendations
Assessment, Development and Evaluation (GRADE) system was adopted to define the strength
of recommendations and the quality of evidence.
Introduction
Continuous quality improvement and patient safety in gastrointestinal (GI) endoscopy
are overarching priorities of the European Society of Gastrointestinal Endoscopy (ESGE)
and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA).
Consistently with these societal priorities, ESGE has developed and disseminated quality
indicators to improve both the efficacy and safety of GI endoscopy procedures [1 ]
[2 ]. Moreover, the patients we serve expect us to provide a safe, rigorous, and standardized
approach to the performance of both diagnostic and therapeutic GI endoscopy procedures.
Since Haynes et al. published their landmark study in 2009 [3 ], reporting that a surgery safety checklist (the World Health Organization [WHO]
Surgical Safety Checklist) significantly reduced postoperative surgical mortality
and inpatient adverse events, there has been a growing body of evidence demonstrating
the importance of surgical safety checklists in the operating theatre [4 ]
[5 ]. Studies have shown that safety checklists in the operating theatre enhance a team
approach, flatten hierarchies, improve team communication and nontechnical skills,
and contribute to the safe delivery of patient care [4 ]
[5 ]. Taken altogether, this has led to the uptake and routine use of surgery safety
checklists in operating theatres around the world.
ESGE and ESGENA believe that these same principles apply to the field of GI endoscopy.
This is particularly relevant given the burgeoning volume of endoscopic procedures
that are increasingly interventional and technically advanced, coupled with an aging
patient population with more comorbidities. Considering this evolution in endoscopic
practice, patient safety must not be compromised and measures to maintain and improve
safety in GI endoscopy should continually be sought [6 ]. Given the above, the introduction and use of GI endoscopy safety checklists has
gained traction in recent years [6 ]
[7 ]
[8 ]
[9 ]
[10 ].
Despite the recognized importance of GI endoscopy safety checklists, there are limited
data on their implementation or actual use in practice in GI endoscopy units around
the world. Moreover, there are still no high-level data showing that endoscopy safety
checklists improve patient safety in the GI endoscopy unit, including rates of mortality,
adverse events, or endoscopy completion. This evidence base is difficult to obtain
given the relative rarity of severe adverse events in GI endoscopy. In a recent systematic
review and narrative synthesis on checklist feasibility and impact on GI endoscopy,
Bitar and colleagues reported that endoscopy team communication and teamwork significantly
improved with the implementation of a GI endoscopy safety checklist [10 ]. Although most published studies evaluating safety checklists in the GI endoscopy
setting have not reported on associations between checklist implementation and clinical
outcomes, it may be extrapolated that with improved team communication, medical errors
may be reduced and adverse events thereby prevented [10 ]
[11 ].
Methods
To identify published biomedical literature on this topic, a Pubmed/MEDLINE search
was performed using “surgery,” “endoscopy,” “gastrointestinal endoscopy,” “digestive
system endoscopy,” “gastrointestinal endoscopic examination,” “safety,” and “checklist”
as MeSH terms.
What is a GI endoscopy safety checklist?
What is a GI endoscopy safety checklist?
Analogously to surgical safety checklists, GI endoscopy safety checklists comprise
three distinct, yet equally important phases: “Sign in,” “Time out,” and “Sign out”
[3 ]
[10 ].
The “Sign in ” phase occurs once the patient enters the endoscopy room. This phase includes:
Introduction to the patient of the endoscopy team (including names and roles) and,
where relevant, including the anesthesiologist
Verification of patient identity
Completion and verification of the appropriate informed consent form(s)
Documentation of the patient’s American Society of Anesthesiologists (ASA) score.
GI endoscopy units that use moderate sedation/general anesthesia may also document
the patient’s Mallampati score [12 ]
A review of pertinent medical/surgical comorbidities (including cardiopulmonary risks,
presence of cardiac pacemakers/defibrillators, and/or other implantable medical devices),
A review of medication use (including anticoagulant/antiplatelet medications)
A review of known drug allergies, including any difficulties with previous sedation/anesthesia
A review of dental status (e. g., loose teeth, dentures, bridge)
A review of known communicable patient infections (e. g., hepatitis B virus [HBV],
hepatitis C virus [HCV], human immunodeficiency virus [HIV], tuberculosis [TB], COVID,
etc)
Confirmation of the pre-endoscopy preparation (e. g. nil per os and/or correct bowel
preparation)
The “Time out ” phase occurs immediately prior to the induction of moderate sedation/general anesthesia
or insertion of the endoscope in nonsedated procedures. This phase includes:
Confirmation of the planned GI endoscopic procedure(s) (including indications, aims,
and potential limitations)
Confirmation that all required/appropriate endoscope(s), endoscopic accessories, and
ancillary equipment are available and functioning correctly
Confirmation of functioning intravenous access, where indicated
Confirmation that the appropriate patient monitoring equipment is prepared and functioning
correctly (including pulse oximetry, blood pressure, and cardiac monitor)
Confirmation that information on relevant comorbidities and on limitations concerning
patient sedation and airway management has been shared amongst the endoscopy team
Confirmation that antibiotic prophylaxis and/or pre-endoscopic retrograde cholangiopancreatography
(ERCP) nonsteroidal anti-inflammatory drug (NSAID) has been given if clinically indicated
The “Sign out ” phase occurs after the completion of the endoscopic procedure(s), but prior to the patient’s exiting
the endoscopy room. This phase includes:
Confirmation that all histological samples taken during endoscopy are present, correctly
labelled, documented, and cross-checked by both the endoscopist and the assisting nurse
Confirmation that the endoscopy report is accurate, including post-procedure patient
instructions and any follow-up procedures that may be indicated.
Safety checklist implementation
Safety checklist implementation
With respect to the practical implementation of the GI endoscopy safety checklist,
ESGE and ESGENA recommend that a single individual from the endoscopy team takes the
lead [6 ]. This same individual should continue to have the lead throughout the day’s endoscopy
procedure list, and can be the endoscopist or the endoscopy nurse. However, as with
all aspects of GI endoscopy, from patient consent to technical outcome, the ultimate
responsibility resides with the lead endoscopist. Irrespective of who leads the checklist
process, it is important that the entire endoscopy team is actively engaged in and
contributing to all three phases of the GI endoscopy safety checklist. For example,
during the “Time out” phase, no competing activities should be undertaken in the endoscopy
room and distractions minimized (e. g., by locking the door to prevent interruptions
and/or queries about other patients).
As the field of GI endoscopy rapidly becomes more akin to “endoscopic surgery,” ESGE
and ESGENA strongly recommend the implementation of safety checklists as part of the
standard practice for all GI endoscopy procedures. This will require adapting and
adopting successful checklist strategies from the surgical operating theatre but making
them specific and relevant to GI endoscopic practice. We here provide a generic GI
endoscopy safety checklist for use ( [Fig.1 ]). This safety checklist can be adapted as dictated by local needs and requirements
and translated into local languages. Once a generic GI endoscopy checklist has been
successfully implemented, endoscopy units may wish to further devise procedure-specific
checklists (e. g., for ERCP, endoscopic ultrasound [EUS], percutaneous endoscopic
gastrostomy [PEG]) to enhance safety practices.
Fig. 1 European Society of Gastrointestinal Endoscopy and European Society of Gastroenterology
and Endoscopy Nurses and Associates ( ESGE-ESGENA) Gastrointestinal Endoscopy Safety Checklist. This checklist is not intended
to be comprehensive and can be adapted to local gastrointestinal endoscopy practice.
To be successful, checklist implementation requires a considered approach with education
and engagement from key stakeholders. It should be noted that paper-based checklists
may be initially easier to implement, but their data are more difficult to evaluate
and report. Electronic checklists may be included in the electronic GI endoscopy reporting
systems; these enable easier data evaluation for quality assurance and/or scientific
purposes and provide more definitive medicolegal documentation.
Overcoming potential barriers
Overcoming potential barriers
ESGE and ESGENA realize there may be barriers to the implementation and routine use
of endoscopy safety checklists in GI endoscopy. These barriers may include a lack
of patient safety culture, negative attitudes/resistance to change, and additions
to the endoscopic procedure leading to inefficiencies, as well as a perceived loss
of medical autonomy. These barriers were also faced by the surgical community and
lessons can be learned for GI endoscopy. Barriers to checklist adoption can be minimized
by having a clear checklist training strategy for endoscopists, endoscopy nurses,
and managerial teams, so there is a unified understanding of the benefits of checklists,
not only for safety and quality but also for GI endoscopy unit efficiency. Mandating
checklists without an implementation strategy that has been created in concert with
the end-users may hinder this process. Moreover, if GI endoscopy safety checklists
are not well designed with content validity, and therefore contain irrelevant items,
they will be perceived as a waste of time and as a simple “tick-box” exercise.
These potential barriers will need to be overcome with hard work and demonstrated
senior leadership by both the endoscopists and the nursing staff of the GI endoscopy
unit. Thus, to facilitate the implementation of an endoscopy safety checklist, we
recommend formal education of the entire GI endoscopy team on the importance of patient
safety and endoscopy quality; the endoscopy checklist is one tool in the armamentarium
for delivering this. Such practical measures of implementing safety checklists will
feed into a culture of patient safety in the GI endoscopy unit over time.
Recommended also are: endorsement from senior endoscopy unit leadership by championing
the checklist; a training plan for the entire GI endoscopy team; a target for the
checklist adherence rate (e. g. ≥ 80 %); support for those who adopt and routinely
use the checklist; debriefing for those who are noncompliant; continued reassessment
and audit; and targeted feedback on checklist use [6 ]
[10 ]. It may be helpful to follow a PDAS (Plan, Do, Act, Study) cycle framework as recommended
by Bitar et al. [10 ].
These facilitating activities will need to be emphasized and optimized if we, as GI
endoscopists and endoscopy nurses, are to be successful in advancing patient safety
in the GI endoscopy unit and thereby improving the overall quality of patient care.
