Table 1. Distinct quality measure recommendations listed by level of scientific evidence.
High-quality evidence | Type | Patient-centric | Quantifiable |
Exams should be performed only after adequate bowel preparation i. e. without any residual stool or liquid in the lumen that could mask any suspicious area | Process | Yes | Yes |
Exams should be complete to the caecum and there should be slow, careful inspection of the colonic mucosa during withdrawal of the scope | Process | Yes | Yes |
Where coeliac disease is suspected, a minimum of four biopsies should be taken, including representative specimens from the second part of the duodenum and at least one from the duodenal bulb | Process | No | Yes |
Attention should be focused on preventing transmission of highly resistant organisms by duodenoscopes, in particular, on ensuring cleaning and HLD of the elevator mechanism and elevator wire channel | Process | No | No |
General infection control principles should be complied with in the endoscopy unit | Structural | No | No |
Use of standard precautions reduces the transmission of infection from patients to endoscopy personnel | Process | Yes | Yes |
Adenoma detection rate | Outcome | Yes | Yes |
Adenoma detection rate after positive FOBT | Outcome | No | Yes |
Appropriate interval between colonoscopies | Process | Yes | Yes |
Mean number of adenomas excised per colonoscopy procedure | Structural | No | Yes |
Moderate-quality evidence | |||
Endoscopy facilities should ensure that the services they provide are patient-centered | Structural | No | No |
Patients can be divided into low, intermediate and high-risk groups with respect to their risk of developing advanced adenomas and cancer based on findings at baseline colonoscopy. The surveillance strategy can vary accordingly | Process | Yes | Yes |
A readjustment of the strategy can be made based on findings at the first and subsequent surveillance examinations | Structural | Yes | No |
Low risk. Patients with only one or two small (< 10 mm) adenomas are at low risk, and should be returned to the screening program | Process | No | No |
Intermediate risk. Patients with three or four small adenomas or at least one adenoma of size ≥ 10 mm and < 20 mm are at intermediate risk | Process | Yes | Yes |
Intermediate risk. Patients with three or four small adenomas or at least one adenoma of size ≥ 10 mm and < 20 mm are at intermediate risk and should be offered surveillance at 3-yearly intervals | Process | Yes | Yes |
High risk. If either of the following is detected at any single examination (at baseline or follow-up): 5 or more adenomas, or an adenoma ≥ 20 mm, the patient is at high risk and an extra examination should be undertaken within 12 months, to check for missed synchronous lesions, before initiating 3-yearly surveillance. In the absence of evidence on the safety of stopping surveillance in the high-risk group, surveillance should continue | Process | Yes | Yes |
High risk. If either of the following is detected at any single examination (at baseline or follow-up): 5 or more adenomas, or an adenoma ≥ 20 mm, after two consecutive normal exams, the interval can be extended to 5-yearly | Process | Yes | Yes |
The risk stratification is based on accurate detection and complete removal of adenomas otherwise risk status will be underestimated | Process | No | No |
Recommendations should not differ for patients with a family history who are found to have adenomas, unless it is suspected that they have one of the dominantly inherited conditions | Structural | No | No |
New symptoms should be assessed on the basis that a recent clearance colonoscopy reduces the chance of advanced adenomas and cancers but does not eliminate the risk altogether | Process | No | No |
By their nature locally removed pT1 cancers are high-risk lesions and therefore should undergo a surveillance strategy similar to the high-risk adenoma group | Structural | No | No |
There is no evidence that patients in whom only small, distally located hyperplastic polyps are detected are at increased risk for colorectal cancer; therefore, they should be offered routine screening | Structural | No | No |
A safety checklist should be completed before starting an esophagogastroduodenoscopy (EGD) | Process | No | Yes |
Intravenous sedation and local anesthetic throat spray can be used in conjunction if required. Caution should be exercised in those at risk of aspiration | Process | No | No |
Adequate mucosal visualization should be achieved by a combination of adequate air insufflation, aspiration and the use of mucosal cleansing techniques | Process | No | No |
When no lesions are detected within a Barrett’s segment, biopsies should be taken in accordance with the Seattle protocol | Process | No | Yes |
If squamous neoplasia is suspected, full assessment with enhanced imaging and/or Lugol’s chromo-endoscopy is required | Process | No | Yes |
Biopsies from two different regions in the esophagus should be taken to rule out eosinophilic esophagitis in those presenting with dysphagia/food bolus obstruction, where an alternate cause is not found | Process | No | Yes |
Where gastric or duodenal ulcers are identified, H. pylori should be tested and eradicated if positive | Process | No | Yes |
The presence of gastric polyps should be recorded, with the number, size, location and morphology described, and representative biopsies taken | Process | No | Yes |
In the event of reprocessing failure, the patient, the institution’s designated infection control personnel, local and/or state public health agencies, the FDA, the CDC, and the manufacturers of the involved equipment should be notified immediately | Structural | No | No |
Frequency with which endoscopy is performed for an indication that is included in a published standard list of appropriate indications, and the indication is documented (priority indicator) | Process | No | Yes |
Colonoscopy withdrawal time | Process | No | Yes |
Cecal intubation rate | Process | No | Yes |
Decontamination indicators | Structural | No | No |
We recommend endoscopy services have policies and processes in place to assess the appropriateness of procedures against guidelines and take action when endoscopic procedures have been performed inappropriately | Structural | No | No |
We recommend endoscopy services have procedures in place to assess the comfort of patients before, during, and after procedures | Structural | No | No |
We recommend that endoscopy services provide an environment and have processes in place that ensure the privacy and dignity of patients is respected and maintained | Structural | No | No |
Endoscopes should undergo HLD as recommended by governmental agencies and all pertinent professional organizations for the reprocessing of gastrointestinal endoscopes | Structural | No | Yes |
The efficacy of manual cleaning and HLD is operator dependent, thus assignment of personnel responsible for endoscope reprocessing, extensive training of reprocessing personnel, process validation, and quality assurance is vital, and staff competency should be assessed at the very least on an annual basis | Structural | No | Yes |
Low-quality evidence | |||
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 | Process | No | No |
Endoscopy facilities should meet or exceed defined operating standards, in all domains, consistent with accreditation under the appropriate national or regional standards | Structural | No | Yes |
Endoscopic procedures are performed for an appropriate, clearly documented indication, consistent with current, evidence-based guidelines | Process | No | Yes |
Endoscopy facilities should have the technical and personnel resources required by national and/or regional standards to complete all planned procedures safely and effectively | Structural | No | Yes |
Endoscopy facilities should implement and monitor the effect of pre-procedure policies that ensure best practice | Structural | No | No |
Endoscopy facilities should implement and monitor the effect of intraprocedural policies that ensure best practice | Structural | No | No |
The endoscopy facility should implement and monitor the effects of policies for the discharge of patients that ensure best practice | Structural | Yes | Yes |
Endoscopy facilities should ensure that there is a policy in place to notify patients of the need, and appropriate interval, for follow-up | Structural | Yes | No |
All patients, on discharge, are given written information regarding the procedural findings, plans for treatment and follow-up, worrisome symptoms to watch for, and steps to be taken | Process | Yes | Yes |
Endoscopy facilities should maintain a comprehensive quality improvement program incorporating formal, regular, scheduled review of performance reports | Structural | No | No |
Endoscopy facilities should appoint a review committee to monitor and report back to management on adherence to and implementation of quality standards | Structural | No | No |
Endoscopy facilities should systematically and regularly review current indicators of quality for all endoscopic procedures and implement appropriate responses | Structural | No | No |
Endoscopy facilities should systematically and regularly review current indicators of safety for all endoscopic procedures and implement appropriate responses | Structural | No | No |
Endoscopy facilities should provide high-quality education programs or opportunities for all staff | Structural | No | No |
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 | Process | No | Yes |
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 | Structural | No | Yes |
Endoscopists should regularly review their endoscopic practice and outcome data with the aim of continuous professional development | Structural | No | No |
Endoscopists should be granted privileges to perform specified procedures based on a formal evaluation of their competence consistent with appropriate current standards | Process | No | No |
Endoscopists’ privileges should be subject to formal, regular, scheduled review to ensure that renewal is based on documented competence to perform specified procedures consistent with appropriate current standards | Process | No | No |
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 | Structural | No | No |
Endoscopy facilities should implement policies to monitor and ensure the timeliness and completeness of procedure reporting | Structural | No | No |
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 | Structural | Yes | No |
Intermediate risk. Patients with three or four small adenomas or at least one adenoma of size ≥ 10 mm and < 20 mm, after one negative exam, the interval for surveillance can be extended to 5 years. After two consecutive normal exams, the patient can return to routine screening | Process | Yes | Yes |
High risk. If either of the following is detected at any single examination (at baseline or follow-up): 5 or more adenomas, or an adenoma ≥ 20 mm, in the absence of evidence on the safety of stopping surveillance in the high-risk group, surveillance should continue | Process | No | Yes |
Patients with a failed colonoscopy should, if possible, undergo repeat colonoscopy or an alternative complete colonic examination, particularly if they are in the high-risk group | Process | Yes | No |
The site of large sessile lesions removed piecemeal should be re-examined at 2 to 3 months. Small areas of residual tissue can then be treated endoscopically, with a further check for complete eradication within 3 months. India ink tattooing aids recognition of the site of excision at follow-up. If extensive residual lesion is seen, surgical resection must be considered, or alternatively, referral to a colonoscopist with special expertise in advanced endoscopic excision | Process | Yes | No |
The decision to undertake each colonoscopic surveillance examination should depend not only on adenoma characteristics, but also on the patient's age and wishes, and the presence of significant comorbidity. The patient status should be established prior to attendance for each examination | Structural | No | No |
The cut-off age for stopping surveillance is usually 75 years, but this should also depend upon patient wishes and comorbidity | Structural | No | No |
Following cessation of surveillance, individuals should be returned to the population screening program | Structural | No | No |
The potential benefit of supplementing colonoscopy exams with fecal occult blood testing is presumed to be too small to warrant double testing; therefore, it is recommended to stop fecal occult blood testing in individuals who are undergoing surveillance | Structural | No | No |
For surveillance purposes, serrated adenomas (traditional serrated adenomas and mixed polyps with at least one adenomatous component) should be dealt with like any other adenoma; there are no data to suggest that different surveillance intervals are required | Structural | No | No |
One or more large ( ≥ 10 mm) hyperplastic polyps or other non-neoplastic serrated lesions anywhere in the colon or multiple smaller lesions of these types in the proximal colon may confer an increased risk, but there are no data available to indicate appropriate surveillance intervals | Process | No | No |
Every screening program should have a policy on surveillance. The policy may limit surveillance to the high-risk group if sufficient resources are not available to include people with lower risk | Structural | No | No |
The responsibility of program management to assure the quality of screening services includes quality assurance of surveillance. For surveillance, the same principles, methods and standards of quality assurance apply that are elucidated elsewhere in the first edition of the European Guidelines | Structural | No | No |
Adherence to the guidelines should be monitored | Structural | No | No |
Surveillance histories should be documented and the results should be available for quality assurance | Structural | No | Yes |
The occurrence of colorectal cancer in any individual in whom adenomas or pT1 cancers have been detected at a previous exam should be captured as an auditable outcome for any surveillance program | Structural | No | No |
Patients should be assessed for fitness to undergo a diagnostic EGD | Process | No | Yes |
Patients should receive appropriate information about the procedure before undergoing an EGD | Process | No | No |
An appropriate time slot should be allocated dependent on procedure indications and patient characteristics | Structural | No | No |
A checklist should be undertaken after completing an EGD, before the patient leaves the room | Process | No | Yes |
Only an endoscopist with appropriate training and the relevant competencies should independently perform EGD | Structural | No | No |
We suggest that endoscopists should aim to perform a minimum of 100 EGDs a year, to maintain a high-quality examination standard | Structural | No | Yes |
UGI endoscopy should be performed with high-definition video endoscopy systems, with the ability to capture images and take biopsies | Structural | No | No |
A complete EGD should assess all relevant anatomical landmarks and high-risk stations | Process | No | Yes |
Photo documentation should be made of relevant anatomical landmarks and any detected lesions | Process | No | Yes |
The quality of mucosal visualization should be reported | Process | No | Yes |
It is suggested that the inspection time during a diagnostic EGD should be recorded for surveillance procedures, such as Barrett’s esophagus and gastric atrophy/intestinal metaplasia surveillance | Structural | No | Yes |
Where a lesion is identified, this should be described using the Paris classification and targeted biopsies taken | Process | No | Yes |
Endoscopy units should adhere to safe sedation practice | Structural | No | No |
The length of a Barrett’s segment should be classified according to the Prague classification | Process | No | Yes |
Where a lesion is identified within a Barrett’s segment, this should be described using the Paris classification and targeted biopsies taken | Process | No | Yes |
Esophageal ulcers and esophagitis that is grade D or atypical in appearance, should be biopsied, with further evaluation in 6 weeks after PPI therapy | Process | Yes | Yes |
The presence of an inlet patch should be photo-documented | Structural | No | Yes |
The presence of a hiatus hernia should be documented and measured | Structural | No | Yes |
Varices should be described according to a standardized classification | Process | No | Yes |
Strictures should be biopsied to exclude malignancy before dilatation | Process | No | Yes |
Gastric ulcers should be biopsied and re-evaluated after appropriate treatment, including H. pylori eradication where indicated, within 6–8 weeks | Process | No | Yes |
Where there are endoscopic features of gastric atrophy or IM separate biopsies from the gastric antrum and body should be taken | Process | No | Yes |
Where iron deficiency anemia is being investigated, separate biopsies from the gastric antrum and body should be taken, as well as duodenal specimens if coeliac serology is positive or has not been previously measured | Process | No | No |
A malignant looking lesion should be described, photo-documented and a minimum of six biopsies taken | Process | Yes | Yes |
After OGD readmission, mortality and complications should be audited | Structural | No | Yes |
A report summarizing the endoscopy findings and recommendations should be produced and the key information provided to the patient before discharge | Process | No | Yes |
A method for ensuring histological results are processed must be in place | Structural | No | No |
Endoscopy units should audit rates of failing to diagnose cancer at endoscopy up to 3 years before an esophago-gastric cancer is diagnosed | Structural | Yes | Yes |
Endoscopy units must have a qualified individual who directs their infection prevention plans | Structural | No | No |
Frequency with which pre-procedure history and directed physical examination are performed and documented | Process | No | Yes |
Frequency with which risk for adverse events is assessed and documented before sedation is started | Process | No | Yes |
Frequency with which prophylactic antibiotics are administered only for selected settings in which they are indicated (priority indicator) | Process | No | Yes |
Frequency with which a sedation plan is documented | Process | No | Yes |
Frequency with which management of antithrombotic therapy is formulated and documented before the procedure (priority indicator) | Process | No | Yes |
Frequency with which a team pause is conducted and documented | Process | No | Yes |
Frequency with which photo documentation is performed | Process | No | Yes |
Frequency with which patient monitoring among patients receiving sedation is performed and documented | Process | No | Yes |
Frequency with which the doses and routes of administration of all medications used during the procedure are documented | Process | No | Yes |
Frequency with which use of reversal agents is documented | Process | No | Yes |
Frequency with which procedure interruption and premature termination because of oversedation or airway management issues is documented | Process | No | Yes |
Frequency with which discharge from the endoscopy unit according to predetermined discharge criteria is documented | Process | No | Yes |
Frequency with which patient instructions are provided | Process | No | Yes |
Frequency with which the plan for pathology follow-up is specified and documented | Process | No | Yes |
Frequency with which a complete procedure report is created | Process | No | Yes |
Frequency with which immediate adverse events requiring interventions are documented | Process | No | Yes |
Frequency with which immediate adverse events requiring interventions including hospitalization occur | Process | No | Yes |
Frequency with which delayed adverse events leading to hospitalization or additional procedures or medical interventions occur within 14 days | Process | No | Yes |
Frequency with which patient satisfaction data are obtained | Process | No | Yes |
Frequency with which communication with referring providers is documented | Process | No | Yes |
Endoscopy unit has a defined leadership structure | Structural | No | No |
Process is in place to track each specific endoscope from storage, use, reprocessing, and back to storage | Structural | No | No |
1) Does the colonoscopy report include: a) depth of insertion, b) bowel preparation quality, c) patient tolerance of the procedure, d) description of polyps and whether they were removed or biopsied, e) pathology results for any biopsies, clear recommendations for Follow-up and/or surveillance (whether or not the exam was complete) | Process | Yes | Yes |
Does the endoscopist have a high enough cecal intubation rate? | Process | No | Yes |
Does the endoscopist have a high enough adenoma detection rate? | Process | Yes | Yes |
Is the colonoscopy performed in a safe setting? | Structural | No | No |
Endoscopist experience | Structural | No | No |
Waiting time from positive FOBT to colonoscopy | Structural | No | Yes |
Appropriate bowel cleansing | Process | Yes | Yes |
Colon perforation rate | Outcome | Yes | Yes |
Post-polypectomy bleeding rate | Outcome | Yes | Yes |
Independent screening colonoscopy program | Structural | No | No |
Record of complications | Structural | No | Yes |
Endoscopic resection of pedunculated polyps and sessile/flat polyps | Outcome | Yes | Yes |
Retrieval rate of resected polyps | Outcome | Yes | Yes |
Colonoscopy complications due to lack of previous assessment | Outcome | No | Yes |
Time slot allotted for colonoscopy | Structural | No | Yes |
Polyp detection rate (PDR) | Outcome | Yes | Yes |
Appropriate polypectomy technique | Process | No | No |
Advanced imaging assessment | Process | No | No |
Complication rate | Outcome | No | Yes |
Patient experience | Outcome | Yes | Yes |
Appropriate post-polypectomy surveillance recommendations | Process | Yes | Yes |
We recommend endoscopy services be organized to acquire the necessary resources to deliver the service and to maximize utilization of these resources while maintaining high patient satisfaction, quality, and safety | Structural | No | No |
We recommend that the endoscopy service carry out an assessment of the facilities and equipment required to deliver the service at least annually | Structural | No | No |
We recommend that the endoscopy service has a planned program of inspection, calibration, and maintenance of its clinical equipment according to the manufacturers’ advice and relevant national regulations | Structural | No | Yes |
We recommend that the endoscopy service has a plan to address shortfalls, plus replacement and purchase of facilities and equipment | Structural | No | No |
We recommend that decontamination facilities, equipment, and processes meet national and/or European standards | Structural | No | No |
We recommend key performance indicators are fed back to and discussed with endoscopists on a regular basis, and that corrective action for improvement, when indicated, with objectives are agreed with the individuals | Structural | No | No |
We recommend that the endoscopy service ensures that, if corrective actions for improvement have been ineffective, new actions are agreed and implemented, and/or that the host organization quality and risk committee is informed of the continued underperformance | Structural | No | No |
We recommend that it is made clear which diagnostic and therapeutic procedures endoscopists are competent in and allowed to perform in the service | Structural | No | No |
We recommend endoscopy services identify potential risks to patients and staff and implement policies and procedures to mitigate them | Process | No | No |
We recommend endoscopy services perform a root cause analysis of major events, such as missed cancers, unplanned admissions, and unexpected deaths following endoscopic procedures, and use the learning from the analysis to improve the service | Structural | No | No |
We recommend endoscopy services have available, in written and electronic form, referral guidelines for all endoscopic procedures performed within the service that are based on regional and/or national guidelines | Structural | No | No |
We recommend endoscopy services provide patients, prior to leaving the service, with the results of the procedure, the timing and mode of communication of pathology results, a plan of the next steps, and an explanation of what delayed complications can occur and what to do about them | Structural | No | No |
We recommend information on comfort is reviewed and fed back to endoscopists and staff and, where appropriate, action is taken to improve patient comfort levels | Structural | No | No |
We recommend that the endoscopy service undertakes regular reviews of staffing in relation to activity to identify gaps, and to improve the match between the skills of staff and the work undertaken | Process | No | No |
We recommend that all new staff (including new endoscopists) undertake an induction and orientation program before working in the service | Process | No | No |
We recommend the endoscopy service has methods in place to motivate staff to improve the service | Structural | No | No |
We recommend there is a process for confidential reporting, with action being taken for abuse of endoscopy staff by patients or other staff, including endoscopists, in line with institutional policies | Process | No | No |
We recommend the endoscopy service gathers patient feedback at least annually | Process | No | No |
We recommend there is a process for reviewing patient complaints and suggestions | Process | No | No |
We recommend that the service acts on both formal and informal feedback from patients to improve the service and to demonstrate it has addressed concerns when these are raised | Process | No | No |
Complete colonoscopy | Process | Yes | Yes |
Excision of all polyps smaller than 20 mm | Outcome | Yes | Yes |
All polyps smaller than 20 mm excised in one fragment | Process | Yes | Yes |
Biopsy sample collection in patients with chronic diarrhea | Process | No | Yes |
Number and distribution of biopsies in patients with inflammatory bowel disease (IBD) | Process | No | Yes |
Incidence of interval cancer after colonoscopy | Outcome | Yes | Yes |
Barrett’s inspection time | Process | No | Yes |
Neoplasia detection rate (NDR) – Barrett's | Process | No | Yes |
Adequate number of biopsies | Process | No | Yes |
Rates of H pylori testing and eradication | Process | No | Yes |
Number of biopsies taken for suspected celiac disease | Process | No | Yes |
Proximal and distal esophageal biopsies to evaluate for eosinophilic esophagitis | Process | No | Yes |
HLD, hypersensitivity lung disease; FOBT, fecal occult blood test; EGD, esophagogastroduodenoscopy; FDA, Food and Drug Administration; CDC, Centers for Disease Control and Prevention; UGI, upper gastrointestinal; PPI, proton pump inhibitor; PDR, poly detection rate; IBD, inflammatory bowel disease; NDR, neoplasia detection rate.