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Guidelines for Privileging and Credentialing Physicians in Gastrointestinal Endoscopy

SAGES Guidelines Committee [Insert Author Address information here] Admin Group Outline: Working draft Update from 2002 and 2007 Guideline

Preamble These guidelines for granting privileging in gastrointestinal endoscopy 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, , biliopancreatic endoscopy, , , 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 surgical procedure.

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.

Disclaimer 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 , 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 These guidelines are the product of a systematic review of published literature and recommendations are linked to the supporting evidence. The GRADE system was used to evaluate the strength and weakness of available evidence and expert opinion referred to only where evidence was lacking [1].

A systematic literature search using PubMed, Medline, and Cochrane Databases was done between October 2011 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, , quality, training, privileges, privileging, surgical education, endoscopy training, intraoperative endoscopy, simulation.

Years 1992 to 2015 included

Study Randomized trials, meta-analyses, systematic reviews, types prospective, retrospective, editorials, existing and past guidelines Dates of October 2011 to September 2015 review

Reviewers manually searched bibliographies to identify any missed additional articles and then graded the level of evidence.

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 credentialing structure and process is the responsibility of each health care facility and its credentialing body. It should be the responsibility of an appropriate local leader (e.g. chief of , chief of , 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. 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 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 has mandated that programs in general surgery and gastroenterology provide experience to each resident or fellow in the performance of esophagogastroduodenoscopy and colonoscopy [2, 3]. Surgery residents are required to complete at least 50 and 35 upper endoscopy procedures. The American Board of Surgery requires trainees to complete a dedicated flexible endoscopy curriculum and to successfully complete the Fundamentals of Endoscopic Surgery program prior to sitting for their Qualifying Examination.

By completing a formal training program, the endoscopist will have acquired sufficient cognitive experience in , 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. Completion of a training program makes one eligible for credentialing in endoscopy, although individual programs may impose additional requirements to grant unrestricted privileges 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 between different specialties performing endoscopy (general surgery, gastroenterology, ). 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 indicates that having accreditation and a volume of over 100 colonoscopies per year were the most important factors for achieving quality standards. Surgeons had a slightly higher adenoma detection rate (ADR) and physicians a slightly higher cecal rate (CIR) but these differences were not significant and detection rate and complications were equivalent [8]. One study indicates that colonoscopy performed in a hospital by a non- gastroenterologist is a risk factor for interval development of colon [9]. In this same study however, when the colonoscopy was performed in an outpatient setting, there was no difference in interval cancer rate between specialties of endoscopist. This may reflect the benefits of more extensive training in challenging colonoscopies. A large recent study of almost 60,000 colonoscopies showed no difference in quality outcomes according to specialty (internists, surgery, other) or setting (hospital or office). There were minor insignificant differences with hospital based internists having a higher flat polyp detection rate and lower carcinoma detection rate than office- based internists and surgeons having a lower complication rate than internists. They concluded that having a standard quality monitoring program was the biggest indicator of good outcomes [10].

Training programs in general surgery, gastroenterology and colorectal surgery have differing requirements for minimal endoscopic case numbers. Given the comparable outcomes in endoscopy cases, 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 particular operative procedures. 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 ). These endoscopic procedures should be included as part of the operative procedure when granting privileges to surgeons to perform specific operations. Surgeons may be asked to provide evidence of competency in the specific endoscopic procedures required as part of the operation.

Guideline: Endoscopic training may be gained outside of a formal residency program as long as the training program, at a minimum, conforms to the standards used by ACGME-accredited training programs. Candidates for endoscopy privileges who did not complete a formal training program that included endoscopy must receive training equivalent to that obtained in a residency or fellowship that does include endoscopy. This includes meeting 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, as long as the trainee conforms to ACGME standards and achieves proficiency.

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 standardized 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, simulation, and structured endoscopy time can produce trainees that meet standard quality benchmarks and objectively improve flexible endoscopy skills [15-18]. Some surgical training programs need to make the appropriate adjustments to provide this kind of training [19].

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, 20-24]. Validated tools provide an objective and unbiased assessment of endoscopic skills and knowledge.

Currently available tools include Global Assessment of Gastrointestinal Endoscopy Skills (GAGES), Mayo Colonoscopy Skills Assessment Tool (MCSAT), and the Fundamentals of Endoscopic Surgery (FES) program. GAGES assesses performance of clinical upper lower endoscopy and measures skills in five categories including scope navigation, mucosal inspection, use of instrumentation, and overall performance. MCSAT also provides a tool for performance evaluation of clinical examinations and includes scores in eight motor skills and six cognitive capabilities. FES is a didactic and simulation-based testingtraining 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 completion of a validated assessment tool, 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 [25]. 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 endoscopy practice are well defined and include cecal intubation rate, adenoma detection rate, polyp detection rate complication rate, interval carcinoma development and appropriateness of follow up recommendations. [26, 27]. Although there is expected variability between endoscopists, meeting the 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 are defined as cecal intubation rate greater than 90%, overall adenoma detection rate greater than 25%, perforation rate less than 0.1%, and appropriate colonoscopy surveillance recommended in greater than 95% of patients.

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, 28-33]. 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.

SUMMARY Based on the above guidelines, the following provides a suggested checklist for institutions seeking guidance on credentialing physicians in gastrointestinal endoscopy.

Initial privileging: 1. Evidence of adequate training a. Completion of ACGME accredited residency program in general surgery, fellowship in colorectal surgery, , or gastroenterology.

or b. Completion of training program with experience equivalent to one of the above.

2. Evidence of technical skill: a. Acknowledgement and attestation of skill level by current or past department chief or supervising physicians. and b. Successful passing of a validated assessment tool such as Global Assessment of Gastrointestinal Endoscopic Skills (GAGES), Fundamentals of Endoscopic Surgery (FES), or Mayo Colonoscopy Skills Assessment Tool (MCSAT).

3. Participation in an ongoing Quality Assessment program a. The following metrics might be tracked in the QA program i. Cecal intubation rate i. Adenoma detection rate ii. Complications (perforation, bleeding, sedation complications). iii. Bowel prep quality. iv. Follow up recommendations b. Institution should perform FPPE and OPPE per institution guidelines

Renewal and Maintenance of Privileges: a. Participation in an ongoing Quality Assessment program b. Periodic OPPE c. FPPE for recognized deficiencies.

Competing interests [Insert Competing interests here]

Authors' contributions

[Insert Authors Contributions here] Acknowledgements [Insert Acknowledgements here]

Bibliography

1. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schunemann HJ (2008) GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336:924-926

2. ACGME (2012) ACGME Residency Requirements.

3. Britt LD, Richardson JD (2007) Residency review committee for surgery: an update. Arch Surg 142:573-575

4. Marshall JB (1995) Technical proficiency of trainees performing colonoscopy: a learning curve. Gastrointest Endosc 42:287-291

5. Mehran A, Jaffe P, Efron J, Vernava A, Liberman MA (2003) Colonoscopy: why are general surgeons being excluded? Surg Endosc 17:1971-1973

6. Reed WP, Kilkenny JW, Dias CE, Wexner SD (2004) A prospective analysis of 3525 esophagogastroduodenoscopies performed by surgeons. Surg Endosc 18:11-21

7. Wexner SD, Garbus JE, Singh JJ (2001) A prospective analysis of 13,580 colonoscopies. Reevaluation of credentialing guidelines. Surg Endosc 15:251-261

8. Bhangu A, Bowley DM, Horner R, Baranowski E, Raman S, Karandikar S (2012) Volume and accreditation, but not specialty, affect quality standards in colonoscopy. Br J Surg 99:1436-1444

9. Rabeneck L, Paszat LF, Saskin R (2010) Endoscopist specialty is associated with incident colorectal cancer after a negative colonoscopy. Clin Gastroenterol Hepatol 8:275-279

10. Kozbial K, Reinhart K, Heinze G, Zwatz C, Bannert C, Salzl P, Waldmann E, Britto-Arias M, Ferlitsch A, Trauner M, Weiss W, Ferlitsch M (2015) High quality of screening colonoscopy in Austria is not dependent on endoscopist specialty or setting. Endoscopy 47:207-216

11. Spier BJ, Durkin ET, Walker AJ, Foley E, Gaumnitz EA, Pfau PR (2010) Surgical resident's training in colonoscopy: numbers, competency, and perceptions. Surg Endosc 24:2556-2561

12. Adler DG, Bakis G, Coyle WJ, DeGregorio B, Dua KS, Lee LS, McHenry L, Pais SA, Rajan E, Sedlack RE, Shami VM, Faulx AL (2012) Principles of training in GI endoscopy. Gastrointestinal Endoscopy 75:231-235

13. Dunkin BJ, Vargo JJ (2008) Measuring procedural competence in endoscopy: what do the numbers really tell us? Gastrointest Endosc 68:1063-1065

14. Cass OW (1999) Training to competence in gastrointestinal endoscopy: a plea for continuous measuring of objective end points. Endoscopy 31:751- 754

15. Williams MR, Crossett JR, Cleveland EM, Smoot CP, Aluka KJ, Coviello LC, Davis KG (2015) Equivalence in colonoscopy results between gastroenterologists and general surgery residents following an endoscopy simulation curriculum. J Surg Educ 72:654-657

16. Sickle KR, Buck L, Willis R, Mangram A, Truitt MS, Shabahang M, Thomas S, Trombetta L, Dunkin B, Scott D (2011) A multicenter, simulation-based skills training collaborative using shared GI mentor II systems: results from the Texas association of surgical skills laboratories (TASSL) flexible endoscopy curriculum. Surgical Endoscopy 25:2980- 2986

17. Ende A, Zopf Y, Konturek P, Naegel A, Hahn EG, Matthes K, Maiss J (2012) Strategies for training in diagnostic upper endoscopy: a prospective, randomized trial. Gastrointestinal Endoscopy 75:254-260

18. Ortolani JB, Zhong X, Tershak DR, Ferrara JJ, Paget CJ (2015) Quality Metrics in Surgery Resident Performance of Screening Colonoscopy. Am Surg 81:710-713

19. Subhas G, Gupta A, Mittal VK (2010) Necessity for improvement in endoscopy training during surgical residency. Am J Surg 199:331-334; discussion 334-335

20. Cohen J (2010) Objective longitudinal performance measurement using the Mayo Colonoscopy Skills Assessment Tool: a step in the right direction. Gastrointestinal Endoscopy 72:1134-1137

21. Sedlack RE (2010) The Mayo Colonoscopy Skills Assessment Tool: validation of a unique instrument to assess colonoscopy skills in trainees. Gastrointest Endosc 72:1125-1133, 1133 e1121-1123

22. Vassiliou MC, Kaneva PA, Poulose BK, Dunkin BJ, Marks JM, Sadik R, Sroka G, Anvari M, Thaler K, Adrales GL, Hazey JW, Lightdale JR, Velanovich V, Swanstrom LL, Mellinger JD, Fried GM (2010) Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy. Surg Endosc 24:1834-1841

23. Sedlack RE (2011) Defining Competency in Colonoscopy: 140 Is Not Nearly Enough. A Call for Standardization Between Specialties. gastrointest Endosc 74

24. Freeman ML (2001) Training and competence in gastrointestinal endoscopy. Rev Gastroenterol Disord 1:73-86

25. Lee S-H, Chung I-K, Kim S-J, Kim J-O, Ko B-M, Hwangbo Y, Kim WH, Park DH, Lee SK, Park CH, Baek I-H, Park DI, Park S-J, Ji J-S, Jang B-I, Jeen Y-T, Shin JE, Byeon J-S, Eun C-S, Han DS (2008) An adequate level of training for technical competence in screening and diagnostic colonoscopy: a prospective multicenter evaluation of the learning curve. Gastrointestinal Endoscopy 67:683-689

26. Cotton PB, Hawes RH, Barkun A, Ginsberg GG, Amman S, Cohen J, Ponsky J, Rex DK, Schembre D, Wilcox CM (2006) Excellence in endoscopy: toward practical metrics. Gastrointest Endosc 63:286-291

27. ASGE (2000) Quality and outcomes assessment in gastointestinal endoscopy. Gastrointest Endosc 52

28. Adamsen S, Funch-Jensen PM, Drewes AM, Rosenberg J, Grantcharov TP (2005) A comparative study of skills in virtual and endoscopy. Surg Endosc 19:229-234

29. Adamsen S (2005) The endoscopic training triangle: advancing from focus on skills to competence-based training. Endoscopy 37:854-856

30. Cohen J, Cohen SA, Vora KC, Xue X, Burdick JS, Bank S, Bini EJ, Bodenheimer H, Cerulli M, Gerdes H, Greenwald D, Gress F, Grosman I, Hawes R, Mullin G, Schnoll-Sussman F, Starpoli A, Stevens P, Tenner S, Villanueva G (2006) Multicenter, randomized, controlled trial of virtual- reality simulator training in acquisition of competency in colonoscopy. Gastrointest Endosc 64:361-368

31. Sachdeva (2011) A new paradigm for surgical training. Curr Prob Surg 48

32. Dunkin B, Adrales GL, Apelgren K, Mellinger JD (2006) Surgical simulation: a current review. Surgical Endoscopy 21:357-366

33. Haycock A, Koch AD, Familiari P, van Delft F, Dekker E, Petruzziello L, Haringsma J, Thomas-Gibson S (2010) Training and transfer of colonoscopy skills: a multinational, randomized, blinded, controlled trial of simulator versus bedside training. Gastrointestinal Endoscopy 71:298- 307