Canadian Association of Gastroenterology Consensus Guidelines on Safety and Quality Indicators in Endoscopy

Abstract

Several organizations worldwide have developed procedure-based guidelines and/or position statements regarding various aspects of quality and safety indicators, and credentialing for endoscopy. Although important, they do not specifically address patient needs or provide a framework for their adoption in the context of endoscopy services. The consensus guidelines reported in this article, however, aimed to identify processes and indicators relevant to the provision of high-quality endoscopy services that will support ongoing quality improvement across many jurisdictions, specifically in the areas of ethics, facility standards and policies, quality assurance, training and education, reporting standards and patient perceptions.

Full text

Can J Gastroenterol Vol 26 No 1 January 2012 17
Canadian Association of Gastroenterology consensus
guidelines on safety and quality indicators in endoscopy
David Armstrong MB BChir
1
, Alan Barkun MDCM
2
, Ron Bridges MD
3
, Rose Carter LLB (Hons)
4
, Chris de Gara MB MS
5
,
Catherine Dubé
MD
3
, Robert Enns MD
6
, Roger Hollingworth MD
7
, Donald MacIntosh MD
8
, Mark Borgaonkar MD
9
,
Sylviane Forget
MD
10
, Grigorios Leontiadis MD
1
, Jonathan Meddings MD
11
, Peter Cotton MD
12
, Ernst J Kuipers MD
13
,
Roland Valori
MD
14
; on behalf of the Canadian Association of Gastroenterology Safety and Quality Indicators in
Endoscopy Consensus Group
1
Division of Gastroenterology, McMaster University, Hamilton, Ontario;
2
Division of Gastroenterology, McGill University, Montreal, Quebec;
3
Division of
Gastroenterology, University of Calgary, Calgary, Alberta;
4
Faculty of Medicine & Dentistry;
5
Division of General Surgery, University of Alberta, Edmonton,
Alberta;
6
University of British Columbia, St Paul’s Hospital, Vancouver, British Columbia;
7
The Credit Valley Hospital, Mississauga, Ontario;
8
Division of
Gastroenterology, Dalhousie University, Halifax, Nova Scotia;
9
Faculty of Medicine, Memorial University, St John’s, Newfoundland and Labrador;
10
Division
of Gastroenterology & Nutrition, McGill University, Montreal, Quebec;
11
Department of Medicine, University of Calgary, Calgary, Alberta;
12
Department of
Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA;
13
Department of Gastroenterology & Hepatology,
Erasmus MC University Medical Centre, Rotterdam, The Netherlands;
14
Gloucestershire Royal Hospital, Gloucestershire, United Kingdom
Correspondence: Dr David Armstrong, Division of Gastroenterology, McMaster University Medical Centre, HSC-4W8F, 1280 Main Street West,
Hamilton, Ontario L8S 4K1. Telephone 905-521-2100 ext 76404, fax 905-521-4958, e-mail armstro@mcmaster.ca
Received for publication October 2, 2011. Accepted October 4, 2011
SPECIAL ARTICLE
©2012 Pulsus Group Inc. All rights reserved
D Armstrong, A Barkun, R Bridges, et al; on behalf of the
Canadian Association of Gastroenterology Safety and Quality
Indicators in Endoscopy Consensus Group. Canadian Association
of Gastroenterology consensus guidelines on safety and quality
indicators in endoscopy. Can J Gastroenterol 2012;26(1):17-31.
BACKGROUND: Increasing use of gastrointestinal endoscopy, particu-
larly for colorectal cancer screening, and increasing emphasis on health
care quality, highlight the need for clearly defined, evidence-based pro-
cesses to support quality improvement in endoscopy.
OBJECTIVE: To identify processes and indicators of quality and safety
relevant to high-quality endoscopy service delivery.
METHODS: A multidisciplinary group of 35 voting participants developed
recommendation statements and performance indicators. Systematic litera-
ture searches generated 50 initial statements that were revised iteratively
following a modified Delphi approach using a web-based evaluation and vot-
ing tool. Statement development and evidence evaluation followed the
AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE
(
Grading of Recommendations, Assessment, Development and
Evaluation) guidelines. At the consensus conference, participants voted
anonymously on all statements using a 6-point scale. Subsequent web-
based voting evaluated recommendations for specific, individual quality
indicators, safety indicators and mandatory endoscopy reporting fields.
Consensus was defined a priori as agreement by 80% of participants.
RESULTS: Consensus was reached on 23 recommendation statements
addressing the following: ethics (statement 1: agreement 100%), facility
standards and policies (statements 2 to 9: 90% to 100%), quality assurance
(statements 10 to 13: 94% to 100%), training, education, competency and
privileges (statements 14 to 19: 97% to 100%), endoscopy reporting stan-
dards (statements 20 and 21: 97% to 100%) and patient perceptions
(statements 22 and 23: 100%). Additionally, 18 quality indicators (agree-
ment 83% to 100%), 20 safety indicators (agreement 77% to 100%) and
23 recommended endoscopy-reporting elements (agreement 91% to
100%) were identified.
DISCUSSION: The consensus process identified a clear need for high-
quality clinical and outcomes research to support quality improvement in
the delivery of endoscopy services.
CONCLUSIONS: The guidelines support quality improvement in endos-
copy by providing explicit recommendations on systematic monitoring, assess-
ment and modification of endoscopy service delivery to yield benefits for all
patients affected by the practice of gastrointestinal endoscopy.
Key Words: Digestive system; Endoscopy; Guideline; Health care; Quality
assurance
Les lignes directrices consensuelles de l'Association
canadienne de gastroentérologie sur les indicateurs
de sécurité et de qualité en endoscopie
HISTORIQUE : L’utilisation croissante de l’endoscopie gastro-intestinale,
notamment dans le cadre du dépistage du cancer colorectal, et l’accent
grandissant mis sur la qualité des soins mettent en lumière la nécessité
d’établir des processus probants clairement définis pour étayer l’amélioration
de la qualité en endoscopie.
OBJECTIF : Déterminer les processus et les indicateurs de qualité et de
sécurité pertinents pour la prestation de services d’endoscopie de qualité.
MÉTHODOLOGIE : Un groupe multidisciplinaire de 35 participants
ayant droit de vote a élaboré des énoncés de recommandations et des indi-
cateurs de rendement. Des analyses bibliographiques systématiques ont
permis d’obtenir 50 énoncés initiaux qui ont été révisés de manière itéra-
tive conformément à la méthode Delphi modifiée au moyen d’une évalua-
tion virtuelle et d’un outil de vote. L’élaboration des énoncés et l’évaluation
des données probantes respectaient les lignes directrices AGREE (acro-
nyme anglais d’appréciation de lignes directrices, de recherches et
d’évaluations) et GRADE (notation de recommandations, d’appréciation,
d’élaboration et d’évaluation). À la conférence consensuelle, les partici-
pants ont exprimé leur vote de manière anonyme à l’égard de tous les
énoncés, au moyen d’une échelle de six points. Les votes virtuels sub-
séquents ont permis d’évaluer les recommandations relatives à des indica-
teurs de qualité spécifiques et individuels, à des indicateurs de sécurité et à
des champs de déclaration d’endoscopie. Le consensus a été défini a priori-
par une entente entre 80 % des participants.
RÉSULTATS : Les chercheurs sont arrivés à un consensus à l’égard de
23 énoncés de recommandation portant sur les points suivants : l’éthique
(énoncé 1 : entente 100 %), normes et politiques de facilité (énoncés 2 à
9 : 90 % à 100 %), assurance qualité (énoncés 10 à 13 : 94 % à 100 %),
formation, éducation, compétence et privilèges (énoncés 14 à 19 : 97 % à
100 %), normes de déclaration d’endoscopie (énoncés 20 et 21 : 97 % à
100 %) et perceptions des patients (énoncés 22 et 23 : 100 %). De plus, ils
ont repéré 18 indicateurs de qualité (entente de 83 % à 100 %), 20 indica-
teurs de sécurité (entente de 77 % à 100 %) et 23 éléments de déclaration
d’endoscopie recommandés (entente de 91 % à 100 %).
EXPOSÉ : Le processus consensuel a permis de déterminer un besoin clair
de recherches cliniques et d’issues de qualité pour étayer l’amélioration de
la qualité dans la prestation des services d’endoscopie.
CONCLUSIONS : Les lignes directrices appuient l’amélioration de la
qualité en endoscopie en fournissant des recommandations explicites sur la
surveillance, l’évaluation et la modification systématiques de la prestation
des services d’endoscopie qui seront bénéfiques à tous les patients touchés
par la pratique de l’endoscopie gastro-intestinale.

Armstrong et al
Can J Gastroenterol Vol 26 No 1 January 201218
Q
uality in digestive endoscopy has been central to the emphasis on
quality care in gastroenterology worldwide. Publications, both in
the gastroenterological and surgical literature, have primarily addressed
issues of procedural and technical quality and of procedural and pro-
cess safety (1-8). However, recognition of the need for greater patient
focus in health care has led to greater interest in patient access to
procedures, in the appropriateness and timeliness of procedures, and in
patient comfort and satisfaction.
Guidelines or position statements on various aspects of quality indi-
cators, safety indicators and credentialing for endoscopy have been
developed by the British Society of Gastroenterology (BSG) (1), the
American Society for Gastrointestinal Endoscopy and the American
College of Gastroenterology (2,4), the Organisation Mondiale d’Endoscopie
Digestive/World Organisation of Digestive Endoscopy (OMGE/OMED)
(3), the International Agency for Research in Cancer (9) and the
Canadian Association of Gastroenterology (CAG) (5-8). However,
these guidelines are all procedure-based and, while they are very import-
ant, they either do not address patient needs or do not provide a frame-
work for adoption in the overall context of endoscopy services.
The Global Rating Scale (GRS) was developed from the patients’
perspective as a quality improvement tool relevant to the entirety of
endoscopy service delivery (10); it was based on quality and safety
indicators developed by the BSG (1) and was designed for the English
National Health Service in the context of a nascent colorectal cancer
screening program. The GRS has been credited with a marked
improvement in the quality and availability of endoscopy services in
England, and has been adopted in other parts of the United Kingdom.
However, although the general principles of the GRS are broadly
applicable, specific elements of the GRS and the associated BSG qual-
ity and safety indicators are not, necessarily, directly applicable to
other health care systems. The development and implementation of
endoscopy quality guidelines relevant to different jurisdictions should
be based on the needs of the patients and the realities of clinical prac-
tice evaluated by providers and users familiar with the relevant health
care environment.
AIMS
The primary aim in developing the present consensus guidelines was to
identify processes and indicators relevant to the provision of high-
quality endoscopy services and to achieve consensus on broadly applic-
able standards and key indicators that will support continuing quality
improvement for endoscopy services across many jurisdictions (1,10).
The literature review and guideline development addressed only the
most commonly performed endoscopic procedures: esophagogas-
troduodenoscopy and colonoscopy. However, the principal issues
addressed in this process are also applicable to more specialized endo-
scopic procedures, although specific indicators relevant to these pro-
cedures fall beyond of the scope of the current project.
METHODS
Initial stages and identification of the consensus group
The guideline development process was performed in accordance with
the Appraisal of Guidelines, REsearch and Evaluation (AGREE)
guidelines (Figure 1) (11).
The goals of the consensus process were defined by the steering
committee (DA, AB, RB, RC, CD, RE, CG, RH and DM) and
endorsed by the CAG. The voting participants, invited by the steering
committee, were selected to ensure multidisciplinary expert input from
gastroenterologists, surgeons, nurses and administrators, as well as
individuals with expertise in endoscopy, colorectal cancer screening,
quality and patient safety (Appendix); two participants (MB and SF)
joined the steering group as leads to two of the working groups. Four
international experts (BP, PC, EK and RV) and a nonvoting moder-
ator (JM) were also invited. No patients participated; however, con-
sensus participants were provided with a summary of focus-group
sessions conducted in a multicentre, qualitative research study that
identified patient-derived quality indicators for endoscopy services.
Systematic literature searches
Systematic literature searches of PubMed were performed using the
search terms: “colonoscopy”, “quality of healthcare”, “quality control”,
“colorectal neoplasms”, “rectal neoplasms”, “adenomatous polyps”,
“colonic polyps”, “intestinal polyps”, “digestive system neoplasms”,
“diagnosis”, “diagnostic errors/adverse effects”, “diagnostic errors/stan-
dards”, “safety”, “mortality”, “complications” and “adverse events”.
Searches were limited to articles published in English since 1990. Case
reports were excluded. Additional searches (using the same search
terms) were used to identify relevant abstracts from Digestive Disease
Week 2007, 2008 and 2009, and United European Gastroenterology
Week 2007 and 2008.
These searches identified 2475 articles. The citations and abstracts
were assigned in batches to pairs of assessors from the steering commit-
tee; a dedicated, purpose-designed, online voting system was used to
identify relevant articles on the basis of the article title and abstract.
All conflicts were resolved by consensus. After two rounds of
reviewing, 817 references were retained and the complete articles were
uploaded to an online literature review site, used by the steering com-
mittee to develop draft statements. Additional literature searches were
conducted during the statement development process, as needed.
Development of statements and iterative voting process
Fifty initial statements were developed, based on the literature review,
analysis of the GRS and input from the steering committee; these were
intended to be broad in nature rather than highly specific and they
were used as a framework for continued development. An online sys-
tem enabled the 35 voting participants (Table 1) to engage in three
rounds of votes during the development process. At each voting
round, participants voted on the importance and content of all state-
ments using a 6-point scale (‘disagree strongly’, ‘disagree with major
reservation’, ‘disagree with minor reservation’, ‘agree with major reser-
vation’, ‘agree with minor reservation’ and ‘agree strongly’) and com-
mented on the wording and validity of the statements. Results were
compiled by the CAG to ensure voter anonymity.
Round 1 vote: Using the 6-point scale, participants rated the extent
to which they agreed that each of the 50 initial statements was import-
ant and relevant to the quality or safety of endoscopy. After reviewing
the results of this round of voting, the steering committee reduced the
number of statements to 22 and made iterative changes to the remain-
ing statements to incorporate participants’ comments.
Round 2 vote: Participants voted to indicate the extent of their agree-
ment with each of the 22 statements using the 6-point scale. After this
round of voting, the 22 statements were assigned to nine working
groups for further refinement and development of the evidence base
before a third round of voting. The nine working groups were con-
vened to address the following topics: quality indicators, safety indica-
tors, endoscopy reporting standards, ethics, credentialing, quality
assurance legislation, GRS development, patient perceptions of endos-
copy quality and guideline dissemination. The conclusions of the
working groups were then reported back to the steering committee.
Round 3 vote: Participants again voted to indicate the extent of their
agreement with each of the statements, using the 6-point scale. After
the third round of voting, the statements were revised and two addi-
tional statements were added. The resulting 24 statements were
reviewed by the working groups, who allocated relevant references to
each statement to enable evidence grading.
Grading of evidence
Evidence grading was performed by two independent evaluators (GL
and KK) using a modified Grading of Recommendation Assessment,
Development and Evaluation (GRADE) process (Table 2) (12). This
process involved two steps: assessment of the methodological quality
of individual studies and assessment of the overall level of evidence
behind each statement. Each step was performed independently by the
two evaluators and disagreements were resolved by consensus.
The overall level of evidence across studies for each statement was
assessed using a Summary of Findings table (13). The GRADE system

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 19
classifies the quality of evidence into one of four levels – high, moder-
ate, low or very low. Evidence based on randomized controlled trials
begins as high-quality evidence, but may be decreased due to study
limitations (identified through the risk of bias evaluation), inconsis-
tency (heterogeneity), indirectness, imprecision or other considera-
tions such as reporting bias. Evidence based on case-control or cohort
studies starts as low-quality evidence, but may be further decreased (for
the same reasons as for randomized controlled trials) or increased if the
magnitude of the treatment effect is very large, if there is evidence of
a dose-response relationship or if all plausible biases would decrease
the magnitude of an apparent treatment effect (12). The grading was
subsequently reviewed and approved by all consensus members.
Consensus meeting and final voting
At the three-day consensus meeting, held in June 2010, each section
was introduced by a member of the relevant working group who sum-
marized the relevant literature and key issues. Each statement was
subsequently discussed by the consensus group under the direction of
the nonvoting moderator. A statement about withdrawal of consent
was incorporated into a more general statement on consent (state-
ment 1). Thus, the final vote included 23 statements.
Following discussion, all voting participants used electronic keypads
to record two separate anonymous votes on each statement. The first
vote asked whether participants believed the statement should be imple-
mented, and the second asked the extent to which they agreed with the
overall recommendation for implementation (Table 2). In voting on the
strength of recommendation, participants were asked to consider desir-
able and undesirable effects, patient values and preferences, the quality
of the evidence and the judicious use of resources (12).
After the meeting, voting participants used the online system to
identify specific, individual quality indicators, safety indicators and
mandatory endoscopy reporting fields that they would recommend,
again using a six-point scale for each item: ‘disagree strongly’, ‘disagree
moderately’, ‘disagree slightly’, ‘agree slightly’, ‘agree moderately’ and
‘agree strongly’.
For each vote, a recommendation was considered to have been
adopted by consensus if 80% or more of participants selected ‘agree
slightly’, ‘agree moderately’ or ‘agree strongly’.
Ethics and financial support
The consensus process and meeting were administered by the CAG,
supported by Canadian Partnership Against Cancer/Partenariat
Canadien Contre le Cancer and Canadian Institutes of Health Research/
Instituts de Recherche en Santé du Canada: Institute of Nutrition,
Metabolism, and Diabetes. All members provided conflict of interest
statements before the meeting. Honoraria for participation were pro-
vided for international experts and participants who were not mem-
bers of the CAG. Travel and accommodation were provided for all
participants. After review of all disclosures, it was determined that
there should be no limitations placed on any participant (14).
TABLE 2
Categorization of evidence, classification of
recommendations and voting options
Grade of evidence
High: Further research is very unlikely to change our confidence in the
estimate of effect
Moderate: Further research is likely to have an important impact on our
confidence in the estimate of effect and may change the estimate
Low: Further research is very likely to have an important impact on our
confidence in the estimate of effect and is likely to change the estimate
Very low: Any estimate of effect is very uncertain
Category of recommendation
“Do it” or “don’t do it”: Indicates a judgment that most well-informed people
would make
“Probably do it” or “probably don’t do it”: Indicates a judgment that the
majority of well-informed people would make but a substantial minority
would not
First vote – should this statement be implemented?
Strong recommendation in favour – do it
Weak recommendation in favour – possibly do it
Weak recommendation against – possibly don’t do it
Strong recommendation against – don’t do it
Second vote – how much do you agree with the overall
recommendation for implementation?
Agree strongly
Agree moderately
Agree slightly
Disagree slightly
Disagree moderately
Disagree strongly












Figure 1) Guideline development process
TABLE 1
Details of participants participating in the final round of
voting (n=35)
Specialty
Gastroenterology 28 (80)
Surgery 3 (8.6)
Endoscopy nurse 1 (2.9)
Other 3 (8.6)
Country of employment
Canada 32 (91.4)
Other 3 (8.6)
Endoscopic practice
Perform upper endoscopy 31 (88.6)
Perform colonoscopy 30 (85.7)
Perform ERCP or other advanced procedures 17 (48.6)
Location of endoscopic practice
Academic health centre 23 (65.7)
Hospital setting 31 (88.6)
Out-of-hospital facility 12 (34.3)
Data presented as n (%). ERCP Endoscopic retrograde cholangiopancre-
atography

Armstrong et al
Can J Gastroenterol Vol 26 No 1 January 201220
CONSENSUS STATEMENTS
SECTION 1: ETHICS
Introduction
Informed consent must be obtained from a patient before any endo-
scopic procedure is performed. This statement provides the legal and
ethical background to this position.
Statement 1. For a patient to give a physician informed consent
to perform an elective endoscopic procedure, the patient must be
advised, in a timely fashion, of all relevant information about the
procedure, its risks, benefits and alternatives, if any, and be given
an opportunity to ask questions that the physician must answer.
Evidence grade: Low/very low
Strength of recommendation: Do it, 91%; possibly do it, 6%;
possibly don’t do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 65%; agree moderately, 29%; agree slightly, 6%)
Discussion
This statement describes the minimum required to document accept-
able provision of informed consent, consistent with Canadian law. It is
necessary to obtain informed consent in a way that satisfies the
patient’s expectation of full, informed consent based on individual
needs for information to address personal concerns. The patient can be
provided with information or instructions (eg, for bowel preparation)
in several formats, including videotapes (15-17), brochures, informa-
tion sessions led by allied health care professionals (nurses or assist-
ants) or computer-assisted instructions/interactive software (18).
However, these forms of communication do not obviate the need for a
conversation with the endoscopist; it is the endoscopist who should
obtain informed consent. Trainees may obtain consent if they are to
perform the procedure and if disclosure is complete. However, in one
study, up to one-third of trainees obtaining consent for colonoscopy
had not disclosed the risks of perforation and hemorrhage (19).
Ultimately, it is the supervisor who is responsible for ensuring that
complete information is provided and that questions have been appro-
priately answered.
For an elective procedure, disclosure should allow the patient suf-
ficient time to understand the information, reflect on it, ask questions
and decide whether to proceed or to select an alternative. In an emer-
gency situation, informed consent should be obtained as soon as pos-
sible. For direct-access endoscopy, the patient may be sent information
before the procedure, although, in one study, 37% of patients would
have preferred meeting a gastroenterologist before the colonoscopy
and 20% said that they received the most useful information after tak-
ing the bowel preparation (20). In all cases, full verbal disclosure,
documented in the patient record, is still required before the procedure
(Box 1).
BOX 1
Full disclosure for informed consent:
Required elements for review
•Indicationfortheprocedure
•Natureoftheprocedure
•Needforpreparation
Risks and benefits of preparation
Alternative preparations
•Patients’concernsaboutdiscomfortandpain
•Benefitsandlimitationsoftheprocedure
Full disclosure of risks
▪Procedure-specificrisks(eg,bleeding,perforation,needforsurgeryor
stomatomanagecomplications)(21,22)
▪Risksofmissedlesions(23)
▪Risksofsedation,ifadministered(24,25)
•Alternativestotheprocedure
Option of no investigations or treatment
Potential alternative therapies including risks and benefits
•Sedationoptions
Risks,benefitsandadverseeventsofalloptions
▪Nosedation
▪Conscioussedationanddeepsedation/generalanesthesia
▪Alternativesincludinghypnoticrelaxation,music,electro-acupuncture
andnitrousoxide
The choice of sedation (or no sedation) should be a shared deci-
sion, made on a case-by-case basis, between the attending physician/
endoscopist and patient, based on the patient’s expectations of com-
fort, the patient’s medical condition, and complexity and duration of
the procedure. Regardless of the type of sedation recommended,
patients should understand that they may decline sedation.
The consent process should account for the patient’s competence
and understanding. Language, cognitive ability, severity of illness, pain
and analgesia may affect a patient’s capacity to understand and con-
sent to a procedure. Provision of informed consent is not a guarantee
that the patient has understood the information provided; recall of
informed consent is often suboptimal. In one study, 50% of patients
could not recall important information on their procedure’s indication
or risks or when consent was obtained (26). Effort should be made to
ensure that the patient has the capacity to consent and to maximize
their understanding of the information provided, possibly by comple-
menting oral with written information.
Consent must be given without coercion; this implies that consent
can be withdrawn at any time. However, it is possible that a patient
under sedation may not be fully cognizant of their request to halt a
procedure and the associated risks; nonetheless, if a patient requests
that the procedure be stopped, the endoscopist should review his or
her technique, the patient’s comfort and the need to continue.
Procedure cessation may put the patient at risk of increased complica-
tions and may not be appropriate.
SECTION 2: FACILITY STANDARDS AND POLICIES
Introduction
Endoscopy facilities must meet or exceed defined standards of quality
for operating standards, appropriateness of procedure, and technical
and personnel resources. Facilities also must have policies in place that
ensure best practice before, during and after endoscopic procedures.
Statement 2. Endoscopy facilities should meet or exceed defined
operating standards, in all domains, consistent with accreditation
under the appropriate national or regional standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 91%; possibly do it, 6%; don’t
do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 85%; agree moderately, 12%; disagree slightly, 3%)
Discussion
Operating standards may be endorsed locally by many endoscopists
and endoscopy facilities, but adoption of appropriate standards is not
universal and approved; accepted national guidelines are unavailable
in many jurisdictions. Although endoscopic facilities differ greatly
with respect to structure, size and procedural case loads, operating
standards should apply uniformly, regardless of the facility’s size, design
or location. It is, however, recognized that standards may be achieved
by different means in different facilities.
In many jurisdictions, accrediting bodies do not have specific dir-
ectives for endoscopy facilities. If endoscopy facilities are to be
included in hospital accreditation programs, comprehensive directives
must be specified to ensure that high-quality care becomes

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 21
the standard. Ideally, accreditation of hospital and out-of-hospital
endoscopy facilities should be governed by comparable processes to
support continuous quality improvement programs, with regular
review in all cases.
The adoption of standards and procedures to ensure safety and
quality should also support appropriate resource use; indicators of
appropriate utilization include no-show rates, adequacy of prepara-
tion, nurse-to-patient ratios, safe working environment and appropri-
ate flow of patients. Quality assurance activities should be defined
from a patient perspective, and should target indicators of procedural
completeness and accuracy, opportunities for patient feedback, and
evidence of continued change and reassessment to demonstrate
improvement (see section 3 below). Quality and safety standards
should also address endoscope reprocessing, conscious sedation, mon-
itoring protocols and resuscitation equipment. Although documented
transmission of infection from endoscopic equipment is extremely
rare (27), the United States Food and Drug Administration recom-
mends that all institutions have a written program and appropriate
administrative organization for endoscope processing, handling and
storage (28). Every facility providing endoscopic services should
ensure the ongoing availability of protocols, equipment, and trained,
competent personnel necessary for the provision of safe and effective
conscious sedation.
Statement 3. Endoscopic procedures are performed for an
appropriate, clearly documented indication, consistent with
current, evidence-based guidelines.
Evidence grade: Low/very low
Strength of recommendation: Do it, 97%; possibly don’t do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 85%; agree moderately, 6%; agree slightly, 6%; disagree
slightly, 3%)
Discussion
The indication for every procedure should be documented in the pro-
cedure report, and the indication should be consistent with accepted
guidelines. National or regional guidelines are preferable; however, if
none are available or applicable, locally relevant guidelines should be
developed.
Consensus guidelines provide explicit statements of appropriate
indications for endoscopic procedures (29,30), and there is evidence
that the diagnostic yield of endoscopy is significantly increased if pro-
cedures are performed for appropriate indications (31,32). Regrettably,
reports indicate that 11% to 39% of endoscopic procedures are per-
formed for inappropriate indications (31,33), and that surveillance
endoscopies may be performed at inappropriate intervals (34) or
unnecessarily (35-37). However, guidelines should not be the only
determinants of procedural appropriateness; for example, esophagas-
troduodenoscopy may be an inappropriate initial step in dyspepsia
management, but it may become appropriate if initial medical therapy
fails (29). Similarly, a colonoscopic surveillance interval may, appropri-
ately, be shorter than recommended if, for example, bowel preparation is
poor. However, in all cases, the reason for deviation from guidelines or
accepted indications should be clearly documented.
Statement 4. Endoscopy facilities should have the technical and
personnel resources required by national and/or regional standards
to complete all planned procedures safely and effectively.
Evidence grade: Low/very low
Strength of recommendation: Do it, 91%; possibly do it, 6%; pos-
sibly don’t do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 69%; agree moderately, 26%; agree slightly, 6%)
Discussion
Published, evidence-based guidelines do, on occasion, specify the
technical and personnel resources needed for procedures, such as
endoscopic reprocessing and urgent endoscopy, in the event of a major
gastrointestinal bleed (28,38). The importance of experienced ancil-
lary personnel for procedural quality and efficiency is highlighted, for
example, by reports of higher polyp detections rates at screening
colonoscopy in the presence of more experienced nurses (detection
rate of 46% with more than six months of experience versus 40% with
six months or less; OR 1.26 [95% CI 1.09 to 1.46]) (39) or of efficiency
gains of up to 30% when additional personnel were available to gain
intravenous access and administer medications (40).
A skills mix review (41) can identify the personnel resources
necessary for a particular institution or facility, based on types of pro-
cedures performed, types of sedation offered and need for out-of-hours
emergency services.
Statement 5. Endoscopy facilities should implement and monitor
the effect of preprocedure policies that ensure best practice.
Evidence grade: Low/very low
Strength of recommendation: Do it, 97%; possibly don’t do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 86%; agree moderately, 9%; agree slightly, 3%; disagree
slightly, 3%)
Discussion
Preprocedure assessment should encompass the risks of sedation, the
preparation and the procedure, including documented assessments of
patient age, comorbidity, American Society of Anesthesiologists clas-
sification, significant medical issues, medications (including type of
bowel preparation) and potential complications of bowel preparation
(such as dehydration). Relevant policies and guidelines should be
implemented (Box 2).
BOX 2
Preprocedure guidelines that should be implemented
•Antibioticprophylaxisguidelinesforpreventionofinfectiveendocarditis;
eg,AmericanHeartAssociation(42)andBSGguidelines(43).
•Antithromboticagentguidelinesonmanagementofantithromboticagents
forendoscopicprocedures;eg,AmericanSocietyforGastrointestinal
Endoscopyguidelines(44)statethatanticoagulantagents(eg,warfarin,
unfractionatedheparin,low-molecular-weightheparin)andantiplatelet
agents(eg,acetylsalicylicacid,clopidogrel,ticlopidine,glycoproteinIIb/
IIIa receptor inhibitors) increase the risks of procedure-related bleeding.
Preproceduralassessmentshouldencompassthebenefits,risksand
urgencyoftheprocedure,thebleedingrisksassociatedwith
antithrombotictherapyandtheprocedure,andthethromboembolicrisk
of stopping therapy.
•Surveillanceschedules(eg,Barrett’sesophagus,ulcerativecolitis)
•Diabetesmellitusmanagementguidelines(45,46)
•Anesthetic/sedationriskguidelines(47)
•Allergyordrugsensitivityguidelines(48)
•Proceduralpause(48)
Statement 6. Endoscopy facilities should implement and monitor
the effect of intraprocedural policies that ensure best practice.
Evidence grade: Low/very low
Strength of recommendation: Do it, 94%; possibly do it, 3%; pos-
sibly don’t do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 85%; agree moderately, 9%; agree slightly, 3%; disagree
moderately, 3%)

Armstrong et al
Can J Gastroenterol Vol 26 No 1 January 201222
Discussion
Intraprocedural policies are important to achieve and maintain max-
imal patient safety and comfort and optimal examination quality (Box 3).
Completion of colonoscopy, with complete cecal visualization, is
essential for detecting lesions in the proximal colon. Endoscopists with
a higher cecal intubation rate have a higher rate of colonic neoplastic
lesion detection (49). Documentation of cecal intubation using still
image or, preferably, video recording (50) of the appendiceal orifice
and ileocecal valve, should be confirmed by the endoscopy assistant/
nurse. Terminal ileum biopsy should be performed only if indicated
clinically. Right iliac fossa transillumination and finger indentation
are inadequate to confirm cecal intubation (51). Cecal intubation
rates greater than 90%, documented in several case series (52-54),
should be standard of practice for symptomatic patients and intubation
rates should exceed 95% for screening colonoscopies (1,3).
Conscious sedation (intravenous benzodiazepines, with or without
narcotics, or propofol) may improve endoscopy completion rates (55)
but is resource intensive. An evidence-based sedation protocol can
improve practice quality and reduce sedation-related adverse events
(56,57).
Poor bowel preparation is associated with longer procedure time
(58), greater patient discomfort (58), lower colonoscopy completion
rates (55), and higher risks of adverse events and missed lesions. A
standardized tool such as the Ottawa Bowel Preparation scale (59) or
the Boston Bowel Preparation scale (60) should be used to assess bowel
preparation quality and process changes should be implemented if
inadequate bowel preparation is prevalent.
Endoscopy facilities should institute a policy to record the colonos-
copy withdrawal time as a surrogate for a thorough examination.
Longer withdrawal times are associated with greater detection rates for
advanced neoplasia (adenomata of 10 mm or larger, lesions with vil-
lous change, high-grade dysplasia or cancer) (61) and advanced neo-
plasia detection is improved by a protocol specifying a minimum
withdrawal time of 8 min (62).
BOX 3
Intraprocedural policies that should be implemented
•Verified,objectivephotoorvideodocumentationofcecalintubation
•Regularmonitoringofsedationlevel(eg,implementationofanevidence-
based sedation protocol)
•Regularmonitoringofrelevantphysiologicalparameters(bloodpressure,
pulse,oxygensaturation,etc)
•Routineevaluationofbowelpreparation(ie,astandardizedtoolsuchas
theOttawaBowelPreparationscale[59]ortheBostonBowelPreparation
scale[60])
•Documentationofwithdrawaltimeduringcolonoscopy–aminimumof
8minisideal(withdrawaltimeiscorrelatedwithathoroughexamination)
•Regularmonitoringofpatientcomfort
•Dualobservationduringexamination(endoscopistandnurse)
Statement 7. The endoscopy facility should implement and
monitor the effects of policies for the discharge of patients that
ensure best practice.
Evidence grade: Very low
Strength of recommendation: Do it, 97%; possibly do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 89%; agree moderately, 9%; agree slightly, 3%)
Discussion
Clear specific discharge policies (Box 4), should be implemented
and should accommodate differences in patients’ responses, particu-
larly, to sedation. Elderly patients (70 years of age and older) and
those with oxygen desaturation, hypotension, bradycardia and those
needing reversal agents require longer recovery times (63). A list
of criteria such as the Aldrete score (respiration, oxygen saturation,
consciousness, circulation and activity levels) should be used to deter-
mine readiness for discharge (64,65). The half-life of reversal agents
tends to be shorter than the half-life of sedatives; therefore, reversal
agent effects may wane before those of the sedative. Discharge poli-
cies should specify patient transportation requirements and activity
restrictions after the procedure, with respect to the type and dose of
sedation.
Patient satisfaction with discharge processes should be assessed
regularly, for example, using standardized postdischarge surveys.
BOX 4
Policies for discharge of patients that should be
implemented
•Standardcriteria(eg,Aldretescore[64,65])todeterminereadinessfor
discharge
•Resultofdischargetoolenteredonthepatient’srecord
•Regularmonitoringofpatientsatisfactionwithdischargeprocess
•Standardsfor24hactivityrestrictionsforpatientswhoreceivesedation
Statement 8. Endoscopy facilities should ensure that there is a policy
in place to notify patients of the need, and appropriate interval, for
follow-up.
Evidence grade: Low/very low
Strength of recommendation: Do it, 76%; possibly do it, 18%; pos-
sibly don’t do it, 3%; don’t do it, 3%
Level of agreement with recommendation: Agree, 90% (agree
strongly, 39%; agree moderately, 42%; agree slightly, 9%; disagree
slightly, 6%; disagree moderately, 3%)
Statement 9. All patients, on discharge, are given written informa-
tion regarding the procedural findings, plans for treatment and
follow-up, worrisome symptoms to watch for, and steps to be
taken.
Evidence grade: Very low
Strength of recommendation: Do it, 97%; possibly do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 86%; agree moderately, 6%; agree slightly, 9%)
Discussion
On discharge, written details of the procedure should be provided for the
information of the patient and of any physician providing subsequent care
(eg, for complications). Provision of a procedure report reduced patients’
postprocedure anxiety, improved their recall of findings and recommenda-
tions and improved adherence to recommendations (66).
The facility’s policies should specify the information to be provided in
the discharge report (Box 5), the details of follow-up arrangements
that have been or will be made and the person responsible for arran-
ging the follow-up plan.
BOX 5
Discharge report – key elements
•Descriptionofkeyfindings,interventions,complicationsandsedation
•Descriptionofsymptomsofpotentialcomplications
•Instructionsonactionstobetakenifsymptomsofcomplicationsarise
•Contactdetailsintheeventthatcomplicationsarise
•Instructionsonresumptionofanticoagulants
•Instructionsforfollow-up(why,when,whereandwithwhom)
SECTION 3: QUALITY ASSURANCE
Introduction
Maintaining and enhancing the quality and safety of endoscopy servi-
ces should be a continuous process that measures aspects of endoscopic

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 23
performance, implements changes based on these measurements, mon-
itors the effect of these changes and evaluates these effects to achieve
new standards (Figure 2).
Statement 10. Endoscopy facilities should maintain a comprehen-
sive quality improvement program incorporating formal, regular,
scheduled review of performance reports.
Evidence grade: Low/very low
Strength of recommendation: Do it, 85%; possibly do it, 9%; pos-
sibly don’t do it, 3%; don’t do it, 3%
Level of agreement with recommendation: Agree, 94% (agree
strongly, 76%; agree moderately, 12%; agree slightly, 6%; disagree
slightly, 6%)
Statement 11. Endoscopy facilities should appoint a review
committee to monitor and report back to management on
adherence to and implementation of quality standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 79%; possibly do it, 21%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 71%; agree moderately, 24%; agree slightly, 3%; disagree
strongly, 3%)
Discussion
In some jurisdictions, quality assurance activities are legislated and,
in many jurisdictions, a quality assurance committee’s proceedings
are protected from disclosure if it is constituted according to applic-
able regional, territorial, state or national legislation and regula-
tions (66-77). Thus, endoscopy quality assurance committees must
be developed within the appropriate legislative framework to over-
see the performance of the endoscopy facility and all of its person-
nel. The potential conflicts arising from the disparate perspectives
of different stakeholders can be resolved if quality in endoscopy is
addressed from the perspective of the patient. In developing the
GRS for evaluation of endoscopy, two patient-centred quality
dimensions were devised (10): the “Clinical Quality and Safety”
dimension addressed six items related to appropriateness of the
procedure, information and consent, safety, patient comfort, qual-
ity and prompt communication of results, while the “Quality of
Patient Experience” (customer care) dimension addressed six items
related to equality, timeliness, patient choice, privacy and dignity,
aftercare and the ability to provide feedback to the endoscopy
service.
A quality improvement and assessment tool such as the
GRS provides a framework to support evaluation of service
delivery by identifying specific indicators, consistent with
high-quality endoscopy that should be auditable (ie, relevant
outcomes for which there are no set standards) or measurable
(ie, relevant outcomes for which there is an established
standard).
Statement 12. Endoscopy facilities should systematically and
regularly review current indicators of quality for all endoscopic
procedures and implement appropriate responses.
Evidence grade: Low/very low
Strength of recommendation: Do it, 88%; possibly do it, 9%; don’t
do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 88%; agree moderately, 9%; disagree strongly, 3%)
Statement 13. Endoscopy facilities should systematically and
regularly review current indicators of safety for all endoscopic
procedures and implement appropriate responses.
Evidence grade: Low/very low
Strength of recommendation: Do it, 91%; possibly do it, 9%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 82%; agree moderately, 15%; agree slightly, 3%)
Discussion
Quality indicators and safety indicators for endoscopy were considered
sufficiently distinct that two working groups were charged with identi-
fying measurable or auditable outcomes that would support quality
improvement. After the consensus meeting, participants voted on
their endorsement of each quality and safety indicator identified by
the working groups (Boxes 6 and 7).
BOX 6
Indicators of quality in endoscopy
Indicator
Comment
Consensus,
%
Indicator related to entire endoscopy facility
1.Participationinarecognizedqualityassuranceprogram 97.2
Indicators related to the technical performance of the procedure and
appropriateness
2. Completion of procedure 100.0
 Documentedinspectionofduodenum,cecumorterminal
ileum
3. Appropriateness of procedure 97.2
Performed for an appropriate indication
4. Completeness of procedure 97.2
 Inspectionofallrelevantareas,acquisitionof
appropriate biopsies and completion of all appropriate
interventions
5. Withdrawal time 85.6
 Asaminimum,rapidwithdrawalprecludescomplete
inspection;especiallycolonoscopy
6. Adenoma detection rate 100.0
 Requiresreconciliationofpathologyandendoscopy
reports
7. Polyp detection rate 91.4
 Asurrogatemarkerforacarefulexamination
8. Appropriateness of endoscopic intervention 97.2
 Interventionsareperformed,oreschewed,appropriately,
according to the indication and findings
9. Completion of endoscopic intervention 97.2
Standard
Dene
outcomes
Measure
outcomes
Monitor impact
of changes
Implement
changes
Feedback
results
Continuous
quality
improvement
Figure 2) Continuous process of quality improvement
Continued on next page

Armstrong et al
Can J Gastroenterol Vol 26 No 1 January 201224
 Interventionsareperformedtocompletion(eg,
polypectomy)
10. Appropriateness of biopsy 94.3
 Biopsiesareperformed,oreschewed,appropriately,
according to the indication and findings
Patient-centred indicators of quality
11.Qualityofpatientexperience 97.2
There is a formal assessment of the patient’s
experience,preferablyusingastandardtool
12. Sedation dosage 82.8
 Systematicoveruseorunderuseofsedationisidentified;
usage is correlated with outcome
Indicators relevant to quality of preparation before procedure
13. Quality of bowel preparation 97.2
 Assessedformally,usingavalidatedtoolor,ata
minimum,astandardscale(eg,poor,fair,good)
14. Appropriateness of antithrombotic management 91.4
Consistent with accepted guidelines
15.Appropriatenessofantibioticprophylaxismanagement 82.8
Consistent with accepted guidelines
Indicator relevant to quality of communication regarding results
16. Completion of endoscopy reporting 97.2
 Procedureresultsreportshouldbecomplete,withall
relevantinformationincluded,andshouldbeavailable
immediately
Indicator of procedural quality relevant, predominantly, to colonoscopy
screening and surveillance programs
17. Interval cancer incidence 97.2
 Requiresreconciliationofendoscopyreportandhealth
records
Indicator of technical competence related, predominantly, to the
endoscopist
18. Number of procedures performed annually 97.2
A marker for maintenance of competence
Quality and safety indicators should be recorded systematically; the
American College of Surgeons National Surgical Quality Improvement
Program (78) is a potential model for a safety monitoring system,
although it is labour intensive and would require modification for use
in endoscopy.
BOX 7
Indicators of safety compromise in endoscopy
Indicator
Comment
Consensus,
%
Indicators of increased risk of complications
1. Use of reversal agents 88.6
An indication of inappropriate sedation practice
2. Sedation doses in patients older than 70 years 82.8
Evaluation of sedation use in susceptible patients who
have greater risk of comorbidities
Indicators related to an increased risk of immediate complications
3. Need for cardiopulmonary resuscitation 97.2
For any cause – with assessment of causal relationship
4. Allergic reactions 80.0
For documented or undocumented allergens
5. Laryngospasm or bronchospasm 80.0
For any cause – with assessment of causal relationship
6.Hypoxia(oxygensaturation<85%) 88.6
For any cause – with assessment of causal relationship
7.Hypotension:<90/50mmHgorfallof≥20%frombaseline
For any cause – with assessment of causal relationship
88.6
8.Hypertension:>190/130mmHgorriseof≥20%from
baseline
80.0
For any cause – with assessment of causal relationship
9. Symptomatic metabolic complications 80.0
 Symptomatichypoglycemiaorhyperglycemia;
symptomaticdisturbanceoffluidand/orelectrolytestatus
10. Perforation 100.0
Occurring during or after procedure
11. Immediate postpolypectomy bleeding 94.3
This may have been treated successfully during the
procedureoritmaybepersistentand/orrequiring
transfusion
12. Severe persistent abdominal pain 91.4
 Requiringfurtherevaluationbutnotprovenasperforation
13. Impaction of instrument 94.3
 Includestherapeuticaccessories,eg,snareorbasket
14. Instrument malfunction 77.1
 Includesendoscope,accessoriesorancillaryequipment
(eg,processor,monitor,lighting,computer,etc)
15. Admission or transfer to an emergency department 94.3
Includes transfer from endoscopy unit for any reason
other than the underlying gastrointestinal condition
Indicators related to an increased risk of late complications
16. Infection 88.6
 Includingacute(eg,Clostridium difficile,abscess,
endocarditis)andchronic(eg,hepatitisC)infections;
presentation may be early or delayed
17. Gastrointestinal bleeding within 14 days of the procedure 88.6
 Upperorlowergastrointestinalorigin:eg,postpolypectomy
or postbiopsy
18.Unplannedhospitalizationwithin14daysoftheprocedure
For any cause – with assessment of causal relationship
94.3
19. Unplanned contact with health care provider within
14 days of the procedure
91.4
 Foranyreason–eg,forabdominalpainorinfection–
with assessment of causal relationship
20. Death within 30 days 94.3
For any reason – with assessment of causal relationship
and evaluation of mortality attributable to the underlying
gastrointestinal condition
Adverse events should be reviewed by the facility’s endoscopy
quality review committee to determine the indication for the proced-
ure and decision as to the level of attribution (eg, definitely, probably,
possibly or unlikely to be due to the procedure), as recommended for
good clinical practice in clinical research (79), the severity of the
event and the appropriateness of the procedure. Changes should be
implemented as appropriate and the impact of changes made should be
reviewed within an acceptable time frame (such as three to six
months).
Indicators of safety compromise may be monitored by phone call
follow-up, questionnaire mail back or review of hospital admissions.
At a minimum, relevant clinical events and near misses should be
recorded, systematically, through a safety learning report system to
identify risks, reduce the likelihood of complications, improve safety of
the service and reassure patients and physicians.
SECTION 4: TRAINING, EDUCATION, COMPETENCY
AND PRIVILEGES
Introduction
To provide high-quality endoscopy services, endoscopy staff’s skills
must meet predefined standards. This requires that endoscopy facilities
provide staff with the opportunities to evaluate, maintain and improve
their skills on a regular basis while accommodating the disparate needs
of patients, trainees, trainers and the facility.

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 25
Statement 14. Endoscopy facilities should provide high-quality
education programs or opportunities for all staff.
Evidence grade: Very low
Strength of recommendation: Do it, 86%; possibly do it, 14%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 66%; agree moderately, 26%; agree slightly, 9%)
Discussion
Endoscopy facilities should provide continuing training and compe-
tency assessment for all staff in all their areas of activities, including
clinical policies, patient monitoring, administration of intravenous
medications, endoscope handling and maintenance, use of accessories,
emergency procedures, decontamination, patient recovery, communi-
cation skills and new technologies. The benefits of nurse training, for
example, include improved polyp detection rates (39) and non-
pharmacological management of pain and anxiety.
This statement does not imply that the facility should pay for all
education opportunities or support ‘growth opportunities’ that are not
congruent with the facility’s needs. It does, however, imply that all
staff members have the opportunity to evaluate and maintain skills
relevant to their position.
Statement 15. All endoscopy facility personnel in training
should be supervised and their performance monitored regularly
until they have achieved competency to perform specified
routine and/or emergency procedures according to appropriate
current standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 97%; possibly do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 94%; agree moderately, 3%; agree slightly, 3%)
Statement 16. All endoscopy facility personnel engaged, directly
or indirectly, in endoscopy service delivery should be trained and
certified as having competency to perform specified routine and/
or emergency procedures according to appropriate current
standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 97%; possibly do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 91%; agree moderately, 6%; disagree strongly, 3%)
Discussion
Competency is the minimal level of skill, knowledge and expertise
derived through training and experience required to perform a task or
procedure safely and proficiently, without assistance or supervision
(80). Endoscopists must be competent to perform endoscopic proced-
ures safely and to interpret and manage findings correctly. Competency
for specific procedures should be assessed by objective measures with
full documentation of the number and type of procedures performed.
Methods for determining competency should include guidelines on
the role of observers, number of cases observed and criteria assessed.
Competency assessment should encompass proficiency in common
therapeutic interventions, cognitive competency (ie, how to manage
the patient overall) and technical competency.
Minimal levels of endoscopic competency should be defined, con-
sistent with the OMGE/OMED guidelines on credentialing and quality
assurance in digestive endoscopy (Box 8) (3). The minimum numbers
of procedures recommended by many professional associations as
thresholds for evaluation of competency, may be markedly lower than
numbers required for documentation of proficiency (81,82).
BOX 8
Competencies required by end of training (OMGE/OMED) (3)
•Successfulcompletionofarecognizedmedicalorsurgicaltrainingprogram
•Abilitytointegrateendoscopyintotheclinicalmanagementplan(bethis
medical,surgicalorreferralforspecialtyservices)
•Understandingofindications,contraindicationsandrisksrelatedto
procedures
•Abilitytoclearlydescribetothepatient,inlayman’sterms,detailsofthe
procedureincludingattendantrisksand,thus,toobtaininformedconsent
•Soundknowledgeofendoscopicanatomy
•Familiaritywiththetechnicalandsafetyfeaturesoftheendoscopeand
accessories and an understanding of proper endoscope reprocessing and
infection control
•Abilitytoaccuratelyidentifyandinterpretendoscopicfindings
•Understandingofpharmacology,administrationandrisksofsedation/
analgesia
•Abilitytoperformprocedurescompetently,includingcommonmethodsfor
tissue sampling and therapy
•Abilitytodiagnoseandmanagecomplicationspromptlyandcompetently
•Abilitytorecognizelimitationsofendoscopictechnologyandoftheirown
skill in management or therapy of endoscopic findings
•Abilitytodocumentfindingsandcommunicatethemwithpatientsandother
health care providers
•Abilitytomaintainarecordofkeyperformanceindicators
Statement 17. Endoscopists should regularly review their endo-
scopic practice and outcome data with the aim of continuous
professional development.
Evidence grade: Low, very low
Strength of recommendation: Do it, 94%; possibly do it, 6%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 66%; agree moderately, 29%; agree slightly, 3%; disagree
slightly, 3%)
Discussion
Under the auspices of a properly constituted quality assurance committee
(see statements 10 and 11) (66-77), endoscopists should review their
endoscopy practice data regularly including the number and type of
procedures, and standard quality and safety indicator outcomes (eg,
completion rates, unplanned events, comfort scores, patient satisfac-
tion). Practice audits (83-86) to facilitate maintenance of competence
should be complemented by a formal annual evaluation of endos-
copy performance. Any serious unplanned event or series of events
should be reviewed by the endoscopist and quality assurance committee
with documentation of deficiencies, discrepancies and any consequent
actions. Audits can detect poor performance/inadequate numbers and
can improve outcomes such as colonoscopy completion rate (52,87-89).
Unverified self-reporting is not encouraged as a formal perform-
ance indicator, although this does not preclude self-reflection based on
structured practice audits directed at personal learning programs.
Verifiable databases, generated from electronic reporting systems or
web-based practice audits, have greater validity for documenting, but
these do require that endoscopy facilities have tools available to mon-
itor outcomes.
Statement 18. Endoscopists should be granted privileges to per-
form specified procedures based on a formal evaluation of their
competence consistent with appropriate current standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 100%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 91%; agree moderately, 9%)

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Can J Gastroenterol Vol 26 No 1 January 201226
Statement 19. Endoscopists’ privileges should be subject to for-
mal, regular, scheduled review to ensure that renewal is based on
documented competence to perform specified procedures consist-
ent with appropriate current standards.
Evidence grade: Low/very low
Strength of recommendation: Do it, 94%; possibly do it, 3%; pos-
sibly don’t do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 89%; agree moderately, 9%; disagree slightly, 3%)
Discussion
Health care institutions are legally responsible for ensuring that indi-
viduals who perform procedures are competent (3). Endoscopy privil-
eges are granted or renewed by health care institutions, including
hospitals and out-of-hospital endoscopy facilities, to competent indi-
viduals based on regional and national guidelines and regulations.
Policies guiding the granting of endoscopic privileges should be
applied uniformly for all endoscopists; privileges should be granted
separately for each endoscopic procedure, based on competence deter-
mined according to current standards (5-8). Each institution should
specify appropriate standards, monitor adherence to standards and
update standards, as needed.
When applying for privileges, the applicant and training program
director must provide details of training undertaken for each endo-
scopic procedure requested. Each application should be reviewed by a
clinician who is knowledgeable about the relevant procedure; proced-
ural competence should be documented from direct observation of the
applicant’s performance at the privileging institution or by the training
program director.
Endoscopic privileges should be granted for a finite period to per-
mit regular re-evaluation of the applicant’s performance and compe-
tency; procedural volumes should also be evaluated because, for
example, colonoscopic complications have been associated with pro-
cedures performed by lower-volume endoscopists (90). Renewal of
privileges should be based on defined policies for addressing poor
performance.
SECTION 5: ENDOSCOPY REPORTING STANDARDS
Introduction
A completed, comprehensive endoscopy report is an essential element
of a quality endoscopy service. Traditional, narrative reporting is asso-
ciated with marked variations in the documentation of positive find-
ings, pertinent negative findings and other procedural details. Effective
communication of procedural findings and successful practice audit
and quality improvement processes are virtually impossible in the
absence of a standardized, ideally electronic, endoscopy report format.
Statement 20. Endoscopic procedures should be reported in a
standardized electronic format, including mandatory reporting
fields, to provide full documentation of all necessary clinical and
quality measures.
Evidence grade: Low/very low
Strength of recommendation: Do it, 82%; possibly do it, 15%; don’t
do it, 3%
Level of agreement with recommendation: Agree, 97% (agree
strongly, 76%; agree moderately, 15%; agree slightly, 6%; disagree
strongly, 3%)
Discussion
Deficits in endoscopy reporting include marked variability in the def-
initions of inflammation in ulcerative colitis (91), as well as marked
differences in the completion of different report elements such as
lesion identification and removal (84% of reports), sedation procedure
(75%), demographic data (69%), procedure interpretation (58%),
patient history (57%) and procedure quality (40%) (92).
Electronic reporting offers a data collection method that can be
more complete and cost-effective – but no more time-consuming –
than handwritten reports or free-text dictated reports (93). Although
electronic reporting is initially more expensive than handwritten or
dictated reporting (94), the overall costs become comparable after five
years, and cost-benefit outcomes are better after three years, in part,
because automatic electronic transmission of reports reduces costs,
administrative workload and communication delays.
Standardization of electronic reports, including mandatory
reporting elements (Box 9) and accepted grading systems (Box 10),
permits standardization of the data capture and long-term storage (at
least 10 years) needed for audit and quality improvement processes.
While electronic data (eg, digital transcripts of dictated reports) are
preferable to handwritten reports, they are inferior to a full, structured
electronic report.
BOX 9
Required endoscopy report elements
Report field
Comment
Consensus,
%
1. Type of procedure 100.0
 Esophagastoduodenoscopy,colonoscopy,etc
2. Date and time of procedure 100.0
3. Name of endoscopist 100.0
Including trainee and supervisor
4. Name(s) of assistant(s) 91.4
 Endoscopynurse,respiratorytechnician,etc
5.Ageandsexofpatient 100.0
6. Indication(s) for procedure 100.0
Consistent with guidelines for appropriate indications
7. Comorbidities 91.4
Assessed using American Society of Anesthesiologists physical
statusclassificationsystem(95),Mallampatiscore(96),etc
8. Type of bowel preparation 91.4
Including timing and adherence to prescribed regimen
9. Type and dose of sedation used 100.0
Including incremental dose adjustment
10. Other medication and related information 97.2
 Administrationroute,reversalagents,antispasmodics,
allergies,etc
11.Extentandcompletenessofexamination 100.0
 Confirmedbyindependentobserverand/or
photodocumentation;withdrawaltime(colonoscopy)and
retroflexionmanoeuvres
12. Quality of bowel preparation 97.2
 Assessedformally,usingavalidatedtoolorstandardscale
(59,60)
13. Relevant findings 97.2
 Usingrelevant,standardizeddescriptionsandvalidated
scales
14. Pertinent negatives 97.2
 Usingrelevant,standardizeddescriptionsandvalidated
scales
15. Adverse events and resulting interventions 100.0
 Usingrelevant,standardizeddescriptionsandvalidated
scales
16. Patient comfort 100.0
 Usingformaldescriptorsand,ifpossible,avalidatedscale
17. Diagnoses 100.0
Using standard terminology and validated scales
18. Endoscopic interventions performed 100.0
Using standard terminology and descriptors
19. Details of pathology specimens 100.0

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 27
 Numberandlocationofbiopsies;number,sizeandlocation
of polyps
20. Details of follow-up arrangements 97.2
Identify person responsible for booking further tests and
follow-up
21.Appendedpathologyreport(s),whenavailable 94.3
 Requiresreconciliationofendoscopyandpathologyreports
22. Management recommendations 100.0
 Includingmedication,testsandfollow-up
23.Informationprovidedtopatientand/orfamily 91.4
 Descriptionoffindings;contactdetailsintheeventofan
emergency
BOX 10
Grading systems appropriate for electronic
reporting forms
•Patientstatus:AmericanSocietyofAnesthesiologistsphysicalstatus
classificationsystem(95),Mallampatiscore(96)
•Bowelpreparation:BostonBowelPreparationscale(60)orOttawaBowel
Preparation scale (59)
•Refluxesophagitisseverity:LosAngelesclassification(97,98)
•Barrett’sesophagusdiagnosisandextent:PragueC&Mcriteria(99)
•Crohn’sdisease–SES-CDactivityscore(100)
•Ulcerativecolitisdiseaseactivity:Mayoscore(101,102)
•Bleedinglesions–Forrestclassification(103)
•Esophagealvarices–gradesize(104,105)
•Readinessfordischarge:Aldretescore(64,65)
Statement 21. Endoscopy facilities should implement policies to
monitor and ensure the timeliness and completeness of procedure
reporting.
Evidence grade: Low/very low
Strength of recommendation: Do it, 100%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 91%; agree moderately, 6%; agree slightly, 3%)
Discussion
An important aspect of clinicians’ competency relates to the timely
provision of a completed procedure report. Receipt of a procedure
report improves patients’ adherence to follow-up appointments and
therapies (66). Optimally, the endoscopy report should be available on
the day of the endoscopy, either as a modified, patient-centred version
or as the formal report, supplemented by a patient-centred summary.
When relevant, pathology results should accompany the final endos-
copy report but this can be a technical challenge because it requires
linkage of separate databases. Patient concerns regarding their test
results should be addressed in a timely manner although the nature
and timeliness of the response may, legitimately, vary among institu-
tions, depending on local needs and resources.
SECTION 6: PATIENT PERCEPTIONS
Introduction
Patient-centred care is predicated on a satisfactory patient experience
in endoscopy, as in all other areas of health care delivery; thus, assess-
ments of endoscopy quality must include domains that are important
to patients.
Statement 22. Endoscopy facilities should ensure that the services
they provide are patient-centred.
Evidence grade: Moderate to very low
Strength of recommendation: Do it, 85%; possibly do it, 12%; don’t
do it, 3%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 71%; agree moderately, 26%; agree slightly, 3%)
Discussion
Acknowledgement of the patient’s perspective on all aspects of endos-
copy service delivery and responsiveness to their concerns necessitates
a collaborative relationship between the clinician and the patient to
address the quality of the patient’s experience and the appropriateness,
accuracy and safety of the procedure. Patients’ perspectives on quality
endoscopy care were reviewed at the consensus conference based on
the results of focus groups held in French and English Canada for
adults who had undergone or were scheduled to undergo a colonos-
copy. Focus group participants’ discussions of the total colonoscopy
experience, defined as all factors and events occurring before, during
and after the day of the procedure, yielded several major quality
themes, including communication: quantity and quality; comfort:
physical and psychological; and attitude and demeanor: physician and
endoscopy unit staff. Endoscopist expertise, procedural safety and
physical amenities were also important. Many patients expressed little
concern about quality indicators (106-108), reporting that they
trusted the accuracy and safety of the test on the presumption that
tests were closely monitored and regulated to ensure adherence to
standards.
Preprocedural educational interventions, such as provision of addi-
tional information, as an educational video (16,109), booklet (110),
face-to-face discussion (111) or behavioural intervention (112) can
support patients’ need to understand the procedure and improve their
satisfaction and appointment keeping. Interventions may have a lim-
ited effect, due to high preprocedural satisfaction levels (113), but they
can, nonetheless, improve patients’ knowledge about the procedure.
In theory, patients should be more likely to comply with follow-up
examinations if they experienced high levels of satisfaction with their
previous endoscopic procedure; to date however, this hypothesis
remains unproven.
Statement 23. Endoscopy facilities should systematically and at
least annually solicit patient feedback, report the results to the
service and to the institution’s quality committee, and implement
effective measures to address patients’ concerns.
Evidence grade: Very low
Strength of recommendation: Do it, 94%; possibly do it, 6%
Level of agreement with recommendation: Agree, 100% (agree
strongly, 82%; agree moderately, 15%; agree slightly, 3%)
Discussion
The increasing and appropriate emphasis on patient-centred care
requires that patients provide feedback on their experience to inform
endoscopy facilities’ decisions on balancing cost and volumes, access
and wait times, discomfort and completion rates, and resources and
procedural times. Patient feedback should be sought, at least annually
(10), using one or more methods including satisfaction surveys, focus
groups and invited comments. Patient feedback is essential for assess-
ing many aspects of endoscopy service delivery, such as the quality of
the informed consent process (114), and offers measurable improve-
ments in patient experience (115). Regular, structured measurement
of patient satisfaction ensures that patients’ perspectives are evaluated
alongside more traditional indicators such as appropriateness, accuracy
and safety.
CONCLUSIONS
Gastrointestinal endoscopy is a complex diagnostic and therapeutic
undertaking that demands a high level of skill and knowledge on the
part of the operator (2,5). However, high-quality endoscopy requires

Armstrong et al
Can J Gastroenterol Vol 26 No 1 January 201228
more than a skilled operator – the delivery of high-quality endoscopy
services, in a cost-effective manner consistent with the broader needs
of a health care system, requires a formal quality improvement frame-
work that addresses all aspects of endoscopy service delivery from the
patient’s initial contact with a health care provider (eg, the identifica-
tion of family history of colon cancer in an asymptomatic individual)
through to documentation of long-term outcomes (eg, freedom from
colon cancer over decades). Recognition of the patient as the focus of
the endoscopy process provides a structure for integrating the efforts of
the many diverse disciplines whose contribution is needed to ensure a
high-quality service.
The fundamental principle underlying high-quality health care is
the need for an iterative feedback loop centred on the patient’s needs.
The feedback loop requires identification of the patient’s needs, meas-
urement of the extent to which these needs are met, intervention to
ensure that unmet needs are addressed and reassessment of the
patient’s needs after intervention. The GRS (10) is a quality improve-
ment tool that enables the adoption of iterative quality improvement
processes in endoscopy, supported by the identification of quality and
safety indicators relevant to specific aspects of service delivery.
Whenever possible, health care recommendations are based on the
highest quality evidence available. Outcomes of this consensus confer-
ence confirm that there is a paucity of high-grade evidence relevant to
endoscopy service delivery. However, among a large multidisciplinary
group of health care professionals, there was a high level of agreement
on key features that should be addressed to improve endoscopy quality.
The fact that the supporting evidence was generally graded as ‘low’ or
‘very low’ does not indicate that the recommendations, themselves,
are weak; it indicates, rather, the need for concerted, widespread
efforts to document the short- and long-term effects of adopting new
quality improvement processes in endoscopy.
The consensus process, presented in the current report, provides
the framework for a quality improvement structure in endoscopy based
on explicit recommendations that will support systematic monitoring,
assessment and modifications in endoscopy service delivery; this
framework is intended to yield benefits for all patients whose care may
be affected by the practice of gastrointestinal endoscopy.
ACKNOWLEDGEMENTS:
The authors thank Sandra Daniels, Palma
Colacino and Paul Sinclair from the CAG for organizing the meeting, Dr
Catherine Hill and Dr Anja Becher from Oxford PharmaGenesis Ltd™ for
writing assistance, and Dr Khurram Khan for his work in grading the evi-
dence.
APPENDIX
List of attendees
Voting chair: David Armstrong, Hamilton, Ontario.
Nonvoting moderator: Jon Meddings, Calgary, Alberta.
Voting steering committee: Alan Barkun, Montreal, Quebec; Ron
Bridges, Calgary; Rose Carter, Edmonton, Alberta; Chris de Gara,
Edmonton; Catherine Dubé, Calgary; Robert Enns, Vancouver, British
Columbia; Roger Hollingworth, Mississauga, Ontario; Don MacIntosh,
Halifax, Nova Scotia.
Voting participants: Doug Bair, Oakville, Ontario; Simon Bergman,
Montreal; Mark Borgaonkar, St John’s, Newfoundland and Labrador;
Peter Cotton, Charleston, South Carolina, USA; Sylviane Forget,
Montreal; Alan Forster, Ottawa, Ontario; George Ghattas, Montreal;
Michael Gould, Etobicoke, Ontario; Pierre Hallé, Quebec City, Quebec;
Robert Hilsden, Calgary; Lawrence Hookey, Kingston, Ontario; Betty
Kennah, Hamilton; Ernst Kuipers, Rotterdam, The Netherlands; Eoin
Lalor, Edmonton; Tammy MacDonald, Halifax; Gary May, Toronto,
Ontario; Tony Nestel, Bridgewater, Nova Scotia; Neely Panton,
Vancouver; Victor Plourde, Montreal; Craig Render, Kelowna, British
Columbia; Dan Sadowski, Edmonton; Harminder Singh, Winnipeg,
Manitoba; Jennifer Telford, Vancouver; Jill Tinmouth, Toronto; Frances
Tse, Hamilton; Roland Valori, London, United Kingdom.
Advisors: Bret Peterson, Rochester, Minnesota, USA; Linda
Rabeneck, Toronto, Ontario.
Nonvoting observers: Bernard Badley, Colorectal Cancer Prevention
Program, Cancer Care Nova Scotia, Nova Scotia; Judy Budgell,
Department of Health and Community Services, Government of
Newfoundland and Labrador, Newfoundland and Labrador; Ford
Bursey, Memorial University, St John’s, Newfoundland and Labrador;
Tanya Chawla, Colonoscopy Program at the Joint Department of
Medical Imaging, Mount Sinai Hospital, Toronto; Surinder Dhaliwal,
McMaster University Medical Centre, Hamilton; Dan Faulkner, The
College of Physicians and Surgeons of Ontario, Toronto; Susan Fekete,
Canadian Partnership Against Cancer, Ontario; Wade Hillier, The
College of Physicians and Surgeons of Ontario, Toronto; Nasir Jaffer,
Department of Medical Imaging, Mount Sinai Hospital, Toronto;
Margaret Keresteci, Canadian Partnership Against Cancer, Ontario;
Jeff Kolbasnik, Ontario Association of General Surgeons, Ontario;
Grigorios Leontiadis, McMaster University Medical Centre, Hamilton;
Marnie MacKinnon, Cancer Care Ontario, Toronto; Diane Major,
Institut National de Santé Publique du Québec, Quebec; Robin Reece,
The College of Physicians and Surgeons of Ontario, Toronto; Janice
Sanger, Department of Health and Community Services, Government
of Newfoundland and Labrador, Newfoundland and Labrador; Giles
Stevenson, McMaster University, Hamilton; Ross Stimpson, Manitoba
CRC Screening Program Cancer Care, Manitoba.
Working groups
Quality indicators: Robert Enns (Lead), Craig Render, Harminder
Singh, Jennifer Telford.
Safety indicators: Mark Borgaonkar (Lead), Roger Hollingworth,
Lawrence Hookey, Ernst Kuipers.
Endoscopic reporting: Alan Barkun (Lead), Pierre Hallé, Jill
Tinmouth.
Ethics: Sylviane Forget (Lead), David Armstrong, Rose Carter, Nanda
Gopinath, Cliff Ottaway.
Training and credentials/privileges: Ron Bridges (Lead), Chris de
Gara, Gary May, Frances Tse, Peter Cotton (expert resource).
Monitoring and quality assurance: Ron Bridges (Lead), Rose Carter,
Neely Panton, Dan Sadowski, Roland Valori (expert resource).
GRS: Don MacIntosh (Lead), Catherine Dubé, Roger Hollingworth,
Georges Ghattas, Sander van Zanten, Roland Valori (expert
resource).
The patient’s perspective: Catherine Dubé (Lead), David Armstrong,
Alan Barkun, Surinder Dhaliwal, Robert Hilsden, Maida Sewitch.
CONFLICT OF INTEREST/STUDY SUPPORT
Guarantor of the article: David Armstrong.
Specific author contributions: All authors played a role in providing
the content for the manuscript (see ‘working groups’, above). All auth-
ors approved the final draft of the manuscript.
Financial support: The meeting was supported by Canadian
Partnership Against Cancer/Partenariat Canadien Contre le Cancer
and Canadian Institutes of Health Research/Instituts de Recherche en
Santé du Canada: Institute of Nutrition, Metabolism, and Diabetes.
Honoraria for participation were provided to the international experts
and for participants who were not members of the CAG. Travel and
accommodation was provided for all participants.
POTENTIAL COMPETING INTERESTS:
No industry or govern-
ment relationships to report: D Armstrong, M Borgaonkar, R Bridges,
R Carter, P Cotton, C de Gara, A Forster, P Hallé, R Hilsden,
R Hollingworth, B Kennah, E Kuipers, E Lalor, D MacIntosh, J Meddings,
T MacDonald, T Nestel, B Petersen, V Ploude, L Rabeneck, C Render,
D Sadowski, H Singh, J Telford, J Tinmouth, R Valori. Advisory board:
Olympus (R Enns), Merck (S Forget). Consultation fees: Ethicon
Endosurgical (N Panton), Johnson & Johnson (M Gould), Takeda
(A Barkun), Oakville Endoscopy Centre – partner and active clinical
practice/OHIP billings (D Bair).

CAG endoscopy consensus guidelines
Can J Gastroenterol Vol 26 No 1 January 2012 29
RESEARCH GRANTS/CLINICAL TRIAL FUNDING: Boston
Scientific (A Barkun), Olympus (C Dubé), UCB – Data Safety Monitoring
Board (S Forget). Speakers’ bureau: Abbott (S Forget, M Gould),
AstraZeneca (A Barkun), Nestlé (S Forget), Olympus (A Barkun).
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