This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Jun 2016.
Drs. Pearl, Fellinger, Dunkin, Pauli, Trus, Marks, Fanelli, Meara, Stefanidis, and Richardson
Author Email Addresses:
Dr. Pearl: [email protected]
Dr. Fellinger: [email protected]
Dr. Dunkin: [email protected]
Dr. Pauli: [email protected]
Dr. Trus: [email protected]
Dr. Marks: [email protected]
Dr. Fanelli: [email protected]
Dr. Meara: [email protected]
Dr. Stefanidis: [email protected]
Dr. Richardson: [email protected]
Corresponding Author Information:
Dr. Jonathan Pearl- Assistant Professor of Surgery, University of Maryland Medical Center
Dr. Erika Fellinger- Professor of Surgery, Harvard Medical School
Dr. Brian Dunkin- Head of Surgery, Houston Methodist Hospital
Dr. Eric Pauli- General Surgery, Penn State Hershey Medical Center
Dr. Thadeus Trus- Associate Professor of Surgery, Dartmouth Medical School
Dr. Jeffrey Marks- Professor of Surgery, University Hospitals Case Medical Center
Dr. Robert Fanelli- Chief of Surgery, The Guthrie Clinic
Dr. Michael Meara- Assistant Professor of Surgery, Ohio State Univeristy
Dr. Dimitrios Stefanidis- Associate Professor of Surgery, Indiana University
Dr. William Richardson- Head of Surgery, Ochsner Health System
These guidelines are intended to assist and provide practical guidance to hospital, ambulatory facility or other credentialing committees in their task of granting privileges for flexible gastrointestinal endoscopy.
Privileging in flexible gastrointestinal endoscopy should be based on demonstration of competency in these techniques.
Privileges should be separately granted for each major category of endoscopy (i.e. upper endoscopy, enteroscopy, biliopancreatic endoscopy, sigmoidoscopy, colonoscopy, etc.) as the ability to perform one endoscopic procedure does not imply competency to perform others. Many operative procedures require intraoperative endoscopy and credentialing for these endoscopic procedures should be included in the credentialing for the index operation.
Initial credentialing should be followed by measurement and monitoring of quality metrics by the local credentialing organization and the renewal of privileges should be based on adherence to established quality metrics, practice recommendations, and clinical outcomes.
Guidelines are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations are based on existing data or a consensus of expert opinions when little or no data are available. These guidelines are applicable to all physicians who perform flexible gastrointestinal endoscopy without regard to medical specialty, training pathway, or practice interests. They are intended to indicate the preferred approach, but not necessarily the only acceptable one, due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care system, the local credentialing committee must always choose the course best suited to the variables in existence at the time of the credentialing decision.
Each guideline below has been systematically researched, reviewed and revised by the guidelines committee. The recommendations are therefore considered valid at the time of production based on the available data. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research, knowledge and practice.
Literature Review Methodology
A systematic literature search using PubMed, Medline, and Cochrane Databases was done between October 1992 and September 2015.
Search strategy was limited to adult human studies in English. The relevance of each study was assessed and those not relevant were dismissed.
|Keywords||Colonoscopy, gastrointestinal endoscopy, upper endoscopy, credentialing, competence, competency, surgeons, quality, training, privileges, privileging, surgical education, endoscopy training, intraoperative endoscopy, simulation.|
|Years included||1992 to 2015|
|Study types||Randomized trials, meta-analyses, systematic reviews, prospective, retrospective, editorials, existing and past guidelines|
|Dates of review||October 1992 to September 2015|
Reviewers manually searched bibliographies to identify any missed additional articles and then graded the level of evidence.
FES: Fundamentals of Endoscopic Surgery
FPPE: Focused Practice Professional Evaluation\
GAGES: Global Assessment of Gastrointestinal Endoscopic Skills
MCSAT: Mayo Colonoscopy Skills Assessment Tool
OPPE: Ongoing Practice Professional Evaluation
Uniformity of Standards
Uniform standards should be developed that apply to all physicians requesting privileges to perform endoscopy and to all practice environments in which endoscopy is performed. Evidenced-based criteria must be applied to all those requesting endoscopy privileges. The goal must be to grant endoscopy privileges to all physicians with proper training and experience, thereby ensuring the delivery of high- quality and safe patient care.
Responsibility for Privileging
The current credentialing structure in the US requires each health care facility and its credentialing body to manage the process. It should be the responsibility of an appropriate local leader (e.g. chief of surgery, chief of gastroenterology, or director of endoscopy) to recommend that an individual receive privileges in gastrointestinal endoscopy. These recommendations are then subject to evaluation for approval by the appropriate institutional credentialing body and held to evidence based national standards.
This document is intended to be used in conjunction with standard state or national criteria for granting hospital privileges and with requirements for delivering safe and high quality patient care.
Minimum Requirements for Granting Privileges
Guideline: Eligibility for credentialing in endoscopy requires completion of a program that includes formal training in gastrointestinal endoscopy.
The fields of surgery and gastroenterology are structured such that successful completion of a formal training program grants permission to enter into independent clinical practice. Therefore, completion of the training program implies basic competence in that field. Current requirements for completion of general surgery residency or gastroenterology fellowship include performance of a minimal number of endoscopic procedures, acquisition of core knowledge of gastrointestinal diseases encountered during endoscopy, and demonstration of competent endoscopy skills as determined by the program director.
Governing bodies have recently adjusted the requirements for residency programs. The Accreditation Council for Graduate Medical Education (ACGME) has mandated that programs in general surgery and gastroenterology provide experience to each resident or fellow in the performance of esophagogastroduodenoscopy and colonoscopy [1, 2]. Surgery residents are required to complete at least 50 colonoscopies and 35 upper endoscopy procedures. Beginning in 2018, the American Board of Surgery will require that graduating residents complete a dedicated flexible endoscopy curriculum which includes validated measures of knowledge and skill, both in a simulated environment and in clinical practice, prior to taking the ABS Qualifying Examination. The ABS Certifying Examination has also been modified to include more questions about the use of flexible endoscopy in the care of patients with gastrointestinal diseases.
Additional intense “mini-fellowship” immersion programs for practicing physicians are an alternative training avenue for individuals who have already completed a residency which did not include appropriate endoscopy training. These programs similarly include performance of a minimal number of endoscopic procedures, acquisition of core knowledge of gastrointestinal disease, and demonstration of competent endoscopy skills, as determined by the program director.
By completing a formal training program, the endoscopist will have acquired sufficient cognitive experience in anatomy, physiology, and disease processes to manage gastrointestinal diseases. Training programs that include endoscopy must ensure progressive development of visual and psychomotor skills necessary for safe and effective performance of procedures. Trainees should be required to maintain a log of cases documenting the type of procedure and their role in the procedure. Completion of a training program makes one eligible for credentialing in endoscopy.
Guideline: Efficiency in endoscopy increases with increasing experience, but quality measures and complication rates are not related to specialty, experience, or case volume.
Endoscopy procedure completion rates, complication rates, and other quality metrics are comparable among different specialties performing endoscopy (general surgery, gastroenterology, colorectal surgery).
Although improved efficiency is noted with increasing experience, there is no difference in safety, complication rates, or completion rates as more procedures are performed [4-7]. A recent study of over 10,000 colonoscopies done by surgeons and gastroenterologists showed equivalent adenoma detection rate, completion rates, and complications .
One study indicates that colonoscopy performed in a hospital by a non- gastroenterologist is a risk factor for interval development of colon cancer . In this same study, however, when the colonoscopy was performed in an outpatient setting, there was no difference in interval cancer rate among specialties.
A recent study of almost 60,000 colonoscopies showed no difference in quality outcomes according to specialty (gastroenterologist, surgery, other) or setting (hospital or office). There were minor variations noted, with hospital-based gastroenterologists having a higher flat polyp detection rate and lower carcinoma detection rate than office-based gastroenterologists and surgeons having a lower complication rate than others .
Training programs in general surgery, gastroenterology and colorectal surgery have differing requirements for minimal endoscopic case numbers. Given the comparable outcomes in endoscopy cases performed by these specialties, a variety of different training pathways can be expected to produce competent and safe endoscopists. As such, case volume alone is not a valid predictor of competence in flexible endoscopy. Differences in the minimum procedure requirements of training programs should therefore not be used to support or refute credentialing of an individual endoscopist.
Satisfactory completion of a training program’s minimum case requirements does not, in and of itself, ensure competency. Physicians learn at different rates and possess different psychomotor skill sets at baseline. Individual variation in ability and learning pattern should be considered in the training program. Successful completion of training requires objective assessment with a validated tool rather than relying on case numbers alone.[4, 11-14].
Guideline: Credentials for intraoperative endoscopy by surgeons should be included as part of the index surgical procedure.
Many operations require intraoperative endoscopy as an inherent part of the procedure. Surgeons with appropriate training are qualified to perform intraoperative endoscopic procedures as an integral part of operations (e.g., esophagomyotomy, bariatric procedures, fundoplication, and colectomy). These endoscopic procedures should be included as part of the operative procedure when granting privileges to perform specific operations, and surgeons should be asked to provide evidence of competency in the specific endoscopic procedures required as part of that operation. This includes providing evidence of safe performance of intraoperative endoscopic procedures, acquisition of core knowledge of endoscopic findings encountered during intraoperative endoscopy, and demonstration of competent endoscopy skills, as determined by the program director. In addition, training and proctoring for new procedures as well as ongoing assessment of skills and outcomes should be performed to ensure competency and promote patient safety.
Guideline: Endoscopic training may be gained outside of a formal residency program.
Candidates for endoscopy privileges who did not complete a formal training program that included endoscopy must receive training similar in scope to that obtained in a residency or fellowship that does include endoscopy. An intense training program dedicated to endoscopy, oftentimes termed “mini-fellowship”, can meet these requirements. Mini-fellowships should fulfill the requirements for minimal case volume, knowledge of gastrointestinal diseases, objective assessment of performance, and certification of proficiency by a qualified endoscopist.
It is not acceptable for physicians to gain endoscopic experience by performing procedures without appropriate proctoring or through endoscopy courses that do not provide supervised hands-on training with patients. Short courses (weekend courses, courses at conventions, etc.) provide exposure to endoscopic procedures but cannot be considered a substitute for formal, structured training programs with well-defined completion criteria. There is no defined minimum length of training.
Guideline: Proctoring may be used to assess competency when competency cannot be adequately verified by other means.
Proctoring and direct observation of applicants for privileging in gastrointestinal endoscopy by a qualified, unbiased endoscopist may be used as a method to assess competency. Proctoring and direct observation should be combined with a formal, validated, assessment tool of endoscopic skills, such as the Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) or Mayo Colonoscopy Skills Assessment Tool (MCSAT).
Proctors may be chosen from credentialed local endoscopy staff or solicited from endoscopic societies. The proctor should be responsible to the local credentialing committee, which has established the criteria needed to assess and define proficiency. Proctoring should be confidential, unbiased, and objective. Proctoring duration (time or procedure volume) should be established by the local credentialing body with the recognition that flexibility in the proctoring duration should be included to reduce the requirements for those who quickly meet proficiency requirements. The proctor should submit a written evaluation to the credentialing committee including the scores from any assessment tools and a summary of their recommendations.
Guideline: Acquisition and assessment of skill and determination of competency should be standardized across specialties and include a formal curriculum, simulation, and validated tools for assessment.
Curricula in surgery and gastroenterology provide the foundation of knowledge and technical skills necessary to perform endoscopy. While surgery and gastroenterology training programs differ in requirements for case numbers, the ultimate goal of both tracks is to produce safe and competent endoscopists and data shows that they do.
Regardless of the pathway to becoming an endoscopist, acquisition of and demonstration of cognitive and technical competence should be included in the pathway in order to be eligible for endoscopy privileges. Learners have varied aptitude for skills acquisition, and performance may plateau at lower volumes than previously thought. As such, assessment of skills is best done with validated tools rather than relying on case volume as a surrogate for competency. Completion of a standardized curriculum, which includes objective skills assessment, is a more reliable marker of endoscopic proficiency than case numbers alone. [8-10, 13].
Participation by residents in a formal training program including a curriculum that includes simulation and structured endoscopy time can produce trainees that meet standard quality benchmarks and objectively improve flexible endoscopy skills [15-18].
Guideline: Skills assessment using a validated tool should be one of the criteria to establish eligibility for credentialing.
Validated measures should be used to assess endoscopic competence rather than basing competence on procedure numbers or recommendations. Several studies have shown that endoscopy assessment tools reliably discern novice from experienced endoscopists and may contribute to the definition of endoscopic proficiency [12-14, 19-23]. Validated tools provide an objective and unbiased assessment of endoscopic skills and knowledge.
Currently available tools include the Global Assessment of Gastrointestinal Endoscopy Skills (GAGES), the Mayo Colonoscopy Skills Assessment Tool (MCSAT), and the Fundamentals of Endoscopic Surgery (FES) program. GAGES assesses performance of clinical upper and lower endoscopy and measures skills in five domains including esophageal intubation (upper endoscopy), strategies for scope advancement (colonoscopy), scope navigation, mucosal inspection, use of instrumentation, and overall performance. MCSAT also provides a tool for performance evaluation of clinical procedures and includes scores in eight motor skills and six cognitive domains. FES is a didactic and simulation-based program in upper and lower endoscopy. The hands-on skills test and knowledge component have been shown to correlate well with level of endoscopic experience and may contribute to the determination of competence.
Guideline: Completion of a comprehensive endoscopy curriculum, which includes use of validated assessment tools, may make one eligible for initial privileging for endoscopy. Early assessment of skills and outcomes after granting initial privileges should be intensive, individualized and ongoing.
Although an endoscopist may have met the requirements for initial credentialing, early assessment of skills and outcomes should be performed to ensure competency and promote patient safety. An initial Focused Professional Practice Evaluation (FPPE) should evaluate endoscopic skills, assess quality metrics, and follow patient outcomes. Periodic performance of an Ongoing Professional Practice Evaluation (OPPE) and continuous tracking of outcomes are recommended. The OPPE can include assessment of endoscopic skills with a validated method, as determined by the institution.
Colonoscopy quality parameters improve with increasing experience until the endoscopist reaches expert level . While competent to perform endoscopy, newly privileged endoscopists may not yet have reached expert level. It is critical to perform early initial assessments of endoscopy outcomes to ensure that the endoscopist is meeting the minimal quality benchmarks. Deficiencies can be corrected by the institution through proctoring, additional training, and education.Frequent assessments should be done until the endoscopist reaches expert level of skill and outcomes.
Guideline: Renewal and maintenance of privileges should include assessment of quality metrics and participation in quality improvement measures.
Quality metrics in colonoscopy are well defined and include cecal intubation rate, adenoma detection rate, polyp detection rate complication rate, and appropriateness of follow up recommendations. [25, 26]. Although there is expected variability among endoscopists, meeting minimum quality standards should be required for maintenance of unrestricted endoscopy privileges. Deficiencies identified during OPPE assessments require follow up with FPPE, additional proctoring, or limiting privileges until deficiencies are corrected.
Minimal quality metrics for colonoscopy include cecal intubation rate greater than 90%, screening colonoscopy adenoma detection rate greater than 25%, perforation rate less than 0.2%, and appropriate colonoscopy surveillance recommended in greater than 95% of patients.
There are no defined quality metrics for upper endoscopy. OPPE assessments for upper endoscopy could include direct case observation or retrospective case review. As in colonoscopy, deficiencies identified during OPPE for upper endoscopy require follow up with FPPE, additional proctoring, or limiting privileges until deficiencies are corrected.
Guideline: Simulation is a useful adjunct in endoscopy training. Simulation may be used as part of training curricula and skills assessment, but it cannot supplant clinical experience.
Simulation training improves early clinical endoscopic performance but does not affect the time to achieve competency. It has uses both in training and assessment but is not a substitute for clinical cases or assessment of skill during clinical procedures. [13, 16, 17, 27-32].
Performance on simulated endoscopic tasks correlates well with level experience of the operator. This suggests that endoscopy simulation can discern novices from experts and may be used as part of the determination of endoscopic competency.
Based on the above guidelines, the following provides a suggested checklist for institutions seeking guidance on credentialing physicians in gastrointestinal endoscopy.
Checklist for Initial Privileging in Gastrointestinal Endoscopy
- Evidence of adequate training
_______ Completion of ACGME accredited residency program in general surgery, fellowship in colorectal surgery, pediatric surgery, or gastroenterology.
_______Completion of training program with experience equivalent to one of the above.
_______ Completion of an intense immersion training program with a robust curriculum that achieves endoscopic competence equivalent to one of the above.
- Evidence of technical skill
_______ Acknowledgement and attestation of skill level by current or past department chief or supervising physicians.
_______ Successful performance scores on a validated assessment tool of endoscopic skill
- Participation in an ongoing Quality Assessment program
_______ Track the following metrics for colonoscopy
- Quality Assessment Cecal intubation rate
- Adenoma detection rate
- Complications (perforation, bleeding, sedation complications).
- Follow up recommendations
_______ Perform FPPE and OPPE per institution guidelines for both upper and lower endoscopy
_______ Participation in an Ongoing Quality Assessment Program
_______ Periodic OPPE
_______ FPPE for recognized deficiencies
Drs. Pearl, Fellinger, Dunkin, Pauli, Trus, Marks, Fanelli, Meara, Stefanidis, and Richardson
The authors of this guideline would like to thank the members of two committees whose members are listed below.
Flexible Endoscopy: Drs. Matthew Albert, Joel Anderson, Juliane Bingener-Casey, Curtis Bower, Robert Bowles, Racquel Bueno, Amy Cha, John Cosgrove, Giovanni Dapri, Brian Davis, Peter Denk, Brian Dunkin, Manoel Galvao Neto, Melanie Hafford, Robert Hawes, Jeffrey Hazey, Eric Hungness, Andrew Kastenmeier, Leena Khaitan, Michael Kochman, Edward Lin, Saniea Majid, John Marks, Jeffrey Marks, Jose Martinez, Daniel McKenna, Elisabeth McLemore, Ellen Morrow, Faris Murad, Ankit Patel, Eric Pauli, Kyle Perry, Melissa Phillips, Jeffrey Ponsky, Kinga Powers, Archana Ramaswamy, Michael Russo, Mario Salazar, Bryan Sandler, Wayne Schwesinger, Niazy Selim, Lee Smith, Nabil Tariq, Ezra Teitelbaum, Dana Telem, Thadeus Trus, Michael Ujiki, David Urbach, Vic Velanovich, Gary Vitale, Richard Whelan, Andrew Wright, Manabu Yamamoto, Bradley Zagol, and Kashif Zuberi.
Guidelines: Drs. Sajida Ahad, Edward Auyang, Ziad Awad, Dustin Bermudez, Giovanni Dapri, Steven DeMeester, Robert Fanelli, Liane Feldman, Erika Fellinger, Patrice Frederick, Teresa H. deBeche-Adams, Stephen Haggerty, Imran Hassan, Celeste Hollands, William Hope, Mustafa Hussain, Duke Jaspal, Jason Keune, Geoffrey Kohn, Daniel McKenna, Oliver Muensterer, Vimal Narula, David Overby, Jonathan Pearl, Raymond Price, Michael Pucci, Francisco Quinteros, Nathan Richards, William Richardson, Dimitrios Stefanidis, Nathaniel Stoikes, Mark Talamini, Akuezunkpa Ude, Pratibha Vemulapalli, Danielle Walsh, Joerg Zehetner, and Marc Zerey.
Dr. Pearl has nothing to disclose. Dr. Fellinger has nothing to disclose. Dr. Dunkin has nothing to disclose. Dr. Pauli has nothing to disclose. Dr. Trus has nothing to disclose. Dr. Marks reports personal fees from Boston Scientific, personal fees from Olympus, personal fees from US Endoscopy, personal fees from WL Gore, personal fees from GI Supply, personal fees from Apollo Endosurgery, outside the submitted work. Dr. Fanelli reports other from Allurion Technologies, Inc, other from Respiratory Motion, Inc, other from Mozaic Medical, Inc, other from Cook, Inc; he reports that he is a member of the Governing Board for SAGES, committee member for ASGE, and a Director for the American Board of Surgery. All reported activity is outside the submitted work. Dr. Meara has nothing to disclose. Dr. Stefanidis reports personal fees from WL Gore, personal fees from Davol, outside the submitted work. Dr. Richardson has nothing to disclose.
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This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Jun 2016.
For more information please contact:
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.
Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.