Gastroenterology Delineation of Clinical Privileges and Procedures

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1 Gastroenterology Delineation of Clinical Privileges and Procedures Basic Education: MD or DO Training & Experience: Training: Successful completion of a residency in internal medicine, followed by fellowship training in gastroenterology accredited by the ACGME or approved by the AOA.1 Experience: Performance of the following procedures: -esophagogastroduodenoscopy (EGD), minimum 130 supervised studies; -esophageal dilation, minimum of 20 supervised studies; -flexible sigmoidoscopy, minimum 30 supervised studies; -colonoscopy w/polypectomy, minimum 140 supervised colonoscopies and 30 supervised studies; -percutaneous liver biopsy, minimum 20 supervised studies; -percutaneous endoscopic gastrostomy (PEG), minimum 15 supervised studies; -nonvariceal hemostasis (upper/lower), 25 supervised cases, including 10 active bleeders; -variceal hemostasis, 20 supervised cases including 5 active bleeders. This can be demonstrated in one of the following ways: An applicant who has just completed a residency or fellowship shall provide his/her residency or fellowship log. An applicant who is not applying directly out of residency or fellowship shall provide a quality profile from hospital(s) where he/she currently has privileges showing his or her clinical activity for the past 12 months, including numbers of procedures performed, morbidity, mortality, infection rates and other complications. If a quality profile is not available from the hospital(s) where the applicant currently has privileges, documentation of the applicant's hospital-based clinical activity for the past 12 months. Certification: Within five years of completion of an approved residency or fellowship in gastroenterology, certification in gastroenterology by the American Board of Internal Medicine or the American Osteopathic Board of Internal Medicine. Specialty Description: Evaluation and management of disease of the esophagus, acid peptic disorders of the gastrointestinal tract, motor disorders of the gastrointestinal tract, irritable bowel syndrome, disorders of nutrient assimilation, inflammatory bowel diseases, vascular disorders of the gastrointestinal tract, gastrointestinal infections, gastrointestinal diseases with an immune basis, gallstones and cholecystitis, alcoholic liver disease, cholestatic syndrome, chronic liver disease, acute and chronic hepatitis, cirrhosis and portal hypertension, and gastrointestinal bleeding. Proctoring: Direct observation of 5 cases of EGD, 5 cases of colonoscopy and/or 5 cases of ERCP, (if requested).

2 Core Management Acid peptic disorders of the gastrointestinal tract, evaluation and management of Acute and chronic hepatitis, evaluation and management of Alcoholic liver diseases, evaluation and management of Biliary and pancreatic diseases, evaluation and management of Cholestatic syndromes, evaluation and management of Chronic liver disease, evaluation and management of Cirrhosis and portal hypertension, evaluation and management of Computed tomography, interpretation of Contrast radiography, interpretation of Diseases of the esophagus, evaluation and management of Disorders of nutrient assimilation, evaluation and management of Drug-induced hepatic injury, evaluation and management of Enteral alimentation, management of ERCP, in all its diagnostic and therapeutic applications Gallstones and cholecystitis, evaluation and management of Gastric secretory tests, interpretation of Gastrointestinal bleeding, evaluation and management of Gastrointestinal diseases with an immune basis, evaluation and management of Gastrointestinal infections, including retroviral, mycotic, and parasitic diseases, evaluation and management of Gastrointestinal manifestations of HIV infections, evaluation and management of Gastrointestinal motility studies and 24-hour ph monitoring Gastrointestinal neoplastic disease, evaluation and management of Gastrointestinal ultrasound, interpretation of Genetic/inherited gastrointestinal disorders, evaluation and management of Geriatric gastroenterology, evaluation and management of GI emergencies in the acutely ill patient, management of Hepatobiliary neoplasms, evaluation and management of

3 History and physical examination (H&P) Inflammatory bowel diseases, evaluation and management of Irritable bowel syndrome, evaluation and management of Magnetic resonance imaging (MRI), interpretation of Motor disorders of the gastrointestinal tract, evaluation and management of Pancreatic secretory tests, interpretation of Parenteral alimentation, management of Patients under surgical care for gastrointestinal disorders, medical management of Percutaneous cholangiography, interpretation of Vascular disorders of the gastrointestinal tract, evaluation and management of Vascular radiography, interpretation of Women's health issues in digestive diseases, evaluation and management Core Procedures Esophagogastroduodenoscopy Colonoscopy w/polypectomy Push Enteroscopy Flexible Sigmoidoscopy Percutaneous Gastrostomy Tube Placement Percutaneous Liver Biopsy Proctoscopy Esophageal Tests, interpretation of: (Interpretation of physiologic studies i.e. Bravo & Catheter ph monitoring, Manometry and Impedance Technology) Included in the above procedures are: Tissue Acquisition (biopsy, polypectomy, etc.) Hemostatis Dilation Stent Placement

4 Advanced Procedures (requiring additional credentials) Endoscopic Ultrasound (EUS), performance with FNA cyst aspiration and drainage Celiac Plexus Block Capsule Endoscopy Enteroscopy with spirus overtube or double or single balloon Endoscopic Retrograde Cholangio-Pancreatography Endoscopic Ultrasonography Radiofrequency Esophageal Mucosa Ablation (and its application in the GI Tract)/Esophageal Mucosal Ablation (BARRX Halo Coagulation System) Endoscopic Fundoplication Lithotripsy (both by electro hydraulic or laser means) Choledochoscopy Endoscopic Suturing Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection/Per-Oral Endoscopic Myotomy (POEM) Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12

5 Criteria for Privileges in CAPSULE ENDOSCOPY (CE) (also known as: WIRELESS CAPSULE ENDOSCOPY) I. Definition: Diagnostic procedure performed using the M2A Given Diagnostic Imaging System, which consists of a disposable imaging capsule manufactured by Given Imaging, Ltd. in Norcross, GA. The small capsule, containing a digital camera, light-emitting diodes, 8-hour batteries, and a transmitter, is swallowed by the patient allowing thousands of images to be transmitted to a recording device worn around the patient s waist. After the exam, the patient returns to the doctor s office where the stored images can be downloaded onto a workstation allowing the doctor to view and process the images in order to evaluate abnormalities of the small bowel. The system received clearance from the FDA in August The capsule endoscope is designed to provide an examination of the small intestine (Table 1). Imaging of the esophagus, stomach, and colon is typically brief, incomplete, or hampered by anatomy and preparation, respectively. The most common indication for a capsule enteroscopy is obscure gastrointestinal bleeding. This is typically performed after routine upper endoscopy, colonoscopy, push enteroscopy, and small intestinal contrast studies have been performed. Attempts are usually made to time the examination as close as possible to any evidence of bleeding, especially in those patients who have obscure recurrent acute or overt bleeding. Other potential indications for capsule use that are under evaluation and, in some instances, being applied, are the evaluation of unexplained diarrhea, malabsorptive disorders such as celiac sprue, and inflammatory diseases such as Crohn s disease. Contraindications include known mechanical intestinal obstruction or a history of obstruction, known intestinal strictures (as in Crohn s disease), Zenker s diverticulum, intestinal pseudoobstruction, cardiac pacemakers and defibrillators, and other implanted electromedical devices. Relative contraindications include longstanding history of daily nonsteroidal anti-inflammatory drug (NSAID) use, pregnancy, and large or numerous diverticula. II. Eligibility: Core privileges in gastroenterology; Completion of a gastrointestinal endoscopy training program that included training in the recognition and management of small intestinal diseases (for small intestine capsule endoscopy); Competency and privileges to perform EGD, colonoscopy, and (for small intestine capsule endoscopy) enteroscopy; Familiarity with the hardware and software systems;

6 ONE OF THE FOLLOWING: Training in the performance of capsule endoscopy as part of a GI fellowship training program; Completion of a hands-on course with a minimum of 8 hours CME credit, endorsed by a national or international GI or surgical society and review of first 10 capsule studies by a credentialed capsule endoscopist. 1 Demonstrate current clinical competence by performance of 20 capsule endoscopies in the last 12 months; 2 III. Required Documentation: An evaluation from the director of the applicant's residency or fellowship training program that included capsule endoscopy (CE) from the director of another appropriate training program in capsule endoscopy (CE); An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform capsule endoscopy (CE) from another professional colleague who has direct knowledge of the applicant's competence to perform capsule endoscopy (CE); Note: If privileges in capsule endoscopy (CE) are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. FPPE: Review of first 5 capsule studies by a credentialed capsule endoscopist. IV. Reappointment: Demonstration of continuing competence by performance of at least 20 capsule endoscopy (CE) procedures in the past 24 months; 2 Evidence of continuing medical education related to capsule endoscopy (CE) procedures. OPPE: Performance of at least 20 capsule endoscopy (CE) procedures in the past 24 months. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12 1 These are the minimum requirements suggested by the American Society for Gastrointestinal Endoscopy, "Guidelines for Credentialing and Granting Privileges for Capsule Endoscopy These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by qualified, experienced physicians in capsule endoscopy.

7 If you are interested in receiving additional information, please contact the research department for the Universal Privileging System at December 13, 2008

8 Criteria for Privileges in ENDOSCOPIC FULL-THICKNESS PLICATION (Transoral Incisionless Fundoplication - TIF) I. Definition: The surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the gastroesophageal junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating a full thickness, serosa-to-serosa plication.1 II. Eligibility: Core privileges in gastroenterology which includes endoscopic surgery privileges; Completion of an approved site-specific surgical Full-Thickness Plicator TM Physician Training Program; 2 Demonstrate proficiency in all aspects of the plicator procedure with a minimum of 5 proctored endoscopic fullthickness plication procedures. 2, 3 III. Required Documentation: Certificate of completion of the surgical Full-Thickness Plicator TM Physician Training Program; An evaluation from the course instructor of the applicant's surgical Full-Thickness Plicator TM Physician Training Program; An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform endoscopic full-thickness plication procedures from another professional colleague who has direct knowledge of the applicant's competence to perform the endoscopic full-thickness plication procedures. Note: If privileges in endoscopic full-thickness plication procedures are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. FPPE: Review of 5 proctored endoscopic full-thickness plication procedures.

9 IV. Reappointment: Demonstration of continuing competence by performance of the endoscopic full-thickness plication procedures as reflected in the applicant s quality profile; Evidence of continuing medical education related to the endoscopic full-thickness plication procedures. OPPE: Performance of at least 10 endoscopic full-thickness plication procedures in the past 24 months. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: Approved by Board of Directors: 1 The NDO Surgical Full-Thickness Plicator TM is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy by the FDA. 2 The NDO Surgical Full-Thickness Plicator TM Physician Training Program. 3 These are the minimum volume requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by qualified, experienced physicians in endoscopic full-thickness plication. If you are interested in receiving additional information, please contact the research department for the Universal Privileging System at May 21, 2007

10 Criteria for Privileges in GASTROINTESTINAL ENDOSCOPY ADVANCED PROCEDURES I. Definition: Procedure allowing a direct view of the lining of the esophagus, stomach, and duodenum by means of an illuminating optical instrument that is gently guided through the esophagus, stomach, and into the duodenum. The procedure is performed diagnostically to discover abnormalities and remove biopsy lesions as appropriate and is performed therapeutically to manage bleeding, and to remove neoplasms, foreign bodies, obstructions, and gallstones. Advanced procedures include ERCP and all associated interventions, EUS, esophageal stent placement, laser therapy (see "Laser Surgery" threshold criteria), and endoscopic tumor ablation. 1 II. Eligibility: Core privileges in colon & rectal surgery, gastroenterology, pediatric gastroenterology, or general surgery. Training in the performance of advanced gastrointestinal endoscopy as part of a residency or fellowship training program; (NOTE: The learning of advanced procedures is founded on a thorough mastery of standard procedures and often requires an additional year of training beyond the standard three-year fellowship. 1 Successful completion of an appropriate training program in the performance of advanced gastrointestinal endoscopy; Demonstration of current clinical competency by performance of a minimum of the advanced privilege requested in the last 12 months; ERCP (includes 40 sphincterotomies and 10 stent placements) 40 EUS: Submucosal Abnormalities (for competence in imaging both mucosal and submucosal abnormalities, a minimum of 100 supervised cases is recommended) 75 Pancreaticobiliary (for comprehensive competence in all aspects of EUS, a minimum of 150 supervised cases, of which 75 should be pancreaticobiliary and 50 EUS-guided FNA is recommended) 25 Non-pancreatic EUS-guided FNA (intramural lesions or lynph nodes. Must be competent to perform mucosal EUS)

11 25 Pancreatic EUS-guided FNA (Must be competent to perform pancreaticobiliary EUS) 20 Tumor Ablation 25 Laparoscopy 10 Esophageal Stent Placement III. Required Documentation: An evaluation from the director of the applicant's residency training program that included advanced gastrointestinal endoscopy procedures from the director of another appropriate training program in advanced gastrointestinal endoscopy; An evaluation from the department chief at another hospital where the applicant is/was granted privileges to perform advanced gastrointestinal endoscopy procedures from another professional colleague who has direct knowledge of the applicant's competence to perform advanced gastrointestinal endoscopy procedures; Documentation of CMEs related to knowledge and technical skill in advanced gastrointestinal endoscopy procedures. Note: If privileges in advanced gastrointestinal endoscopy procedures are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies. IV. Reappointment: Demonstration of continuing competence in performance of the advanced gastrointestinal endoscopy privilege requested as reflected in the applicant's quality profile; Evidence of continuing medical education related to advanced gastrointestinal endoscopy procedures privileges. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12 1 American Society for Gastrointestinal Endoscopy, "ASGE: Principles of Training in Gastrointestinal Endoscopy" 2 These are the minimum volume requirements for a physician to establish proficiency in performing these procedures that were recommended by the American Society of Gastrointestinal Endoscopy, Methods for Granting Hospital Privileges to Perform Gastrointestinal Endoscopy If you are interested in receiving additional information, please contact the research department for the Universal Privileging System at July 9, 2008

12 Criteria for Privileges in CHOLEDOCHOSCOPY SPYGLASS DIRECT VISUALIZATION SYSTEM (ERCP) I. Definition: Conventional ERCP uses a two-dimensional fluoroscopic imaging system. To overcome some of the imaging limitations of non-direct visualization with fluoroscopy, the Choledochoscopy SpyGlass Direct Visualization System was developed to allow direct optical visualization intraductally. This single-use imaging catheter directs a 6,000 pixel fiber optic probe into a desired location under direct visualization. / /seo.serve Intended Use: The proposed Choledochoscopy SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. 1 II. Eligibility: Core privileges in gastroenterology or general surgery; Current privileges in Endoscopic retrograde cholangiopancreatography (ERCP); 2 Demonstrate previous experience with cholangioscopy using scopes from other vendors of a minimum of 10 procedures; 3 If no adequate cholangioscopy experience, a recommended 10 supervised cases a combination of 5 case observations performed by SpyGlass experts a minimum of 5 supervised cases. 3 III. Required Documentation: Documentation of successful completion of Choledochoscopy SpyGlass Direct Visualization System ERCP training under the supervision of approved supervising physicians. Note: If privileges to perform Choledochoscopy SpyGlass Direct Visualization System ERCP are granted, the initial exercise of the privileges shall be evaluated as outlined in the medical staff bylaws or other hospital policies.

13 FPPE: 5 supervised cases a combination of 5 case obsesrvations performed by SpyGlass TM experts a minimum of 5 supervised cases. IV. Reappointment: Demonstration of continuing competence in performance of Choledochoscopy SpyGlass Direct Visualization System ERCP procedures as reflected in the applicant s quality profile; Evidence of continuing medical education as related to current ERCP procedures. OPPE: Performance of at least 20 Choledochoscopy SpyGlass Direct Visualization System ERCP procedures. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12 1 FDA 510(k) Summary, SpyGlass Direct Visualization, Intended Use. 2 These are the minimum requirements suggested for a physician to establish proficiency in performing this procedure that were recommended by Boston Scientific. For further information please see or contact 3 These are the minimum requirements for a physician to establish proficiency in performing this procedure that were recommended by an experienced, qualified, physician in the SpyGlass Direct Visualization System procedure. If you have any questions or require further information, please contact the research department for the Universal Privileging System at November 12, 2008

14 Criteria for Privileges in LITHOTRIPSY OF COMMON BILE DUCT STONES PRIVILEGES I. Definition: Mechanical, electrohydraulic and laser lithotripsy involves technology which is applied to the bile or pancreatic duct to remove difficult stones. The major indications are for the removal of stones in the biliary pancreatic ducts. II. Eligibility: A practitioner must demonstrate competency and familiarity with the hardware/software systems involved with Endoscopic Retrograde Cholangio Pancreatography and choledochoscopy. Practitioner must have completed a gastrointestinal endoscopy training, program which involves recognition of management of biliary and pancreatic disease. III. Required Documentation: 1. Education: GI fellowship training 2. Minimum Required Experience: A. Successful completion of an accredited post-graduate training program in gastroenterology, and/or fellowship in advanced endoscopy training was undertaken and documented with numbers of cases, experience and competency by a fellowship program director or other person of authority. B. Privileges to perform lithotripsy at another institution with ability to demonstrate competency by a physician already known to have lithotripsy privileges Privileges to perform Choledochoscopy (EHL, Laser) 3. References: Documentation that includes a letter of reference from the Residency or Fellowship Program Director or Deparment Chairman where the candidate received training in Lithotripsy or an official letter from the facility from which prior experience could be demonstrated. If Lithotripsy skills were acquired after formal training, two letters or reference from independent practitioners who possess the knowledge of the applicant s skill. 4. Additional equipment and training of nurses is required. Nurses will attend a course or get certified to perform such procedure. For laser lithotripsy, nurses must be certified in laser operations. FPPE: Performance of 2 supervised cases of lithotripsy of common bile duct stones OPPE: Performance of at least 10 cases of lithotripsy of common bile duct stones over the past 24 months. Approved by GI Committee: 9/12

15 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12

16 Criteria for Privileges in DEEP ENTEROSCOPY PRIVILEGES I. Definition: Deep enteroscopy (spiral technology, single and double balloon enteroscopy) involves advancing an endoscope beyond ligament of Treitz and is designed primarily for evaluation of the small intestine. The major indications are for obscure bleeding or early diagnosis of infiltrative or inflammatory diseases of the small intestine. II. Eligibility: A practitioner must demonstrate competency and familiarity with the hardware systems involved with deep enteroscopy. A practitioner must have completed a gastrointestinal endoscopy training program which involves recognition of management of small bowel diseases. III. Required Documentation: 1. Education: GI fellowship training 2. Minimum Required Experience: A. Successful completion of an accredited post-graduate training program in gastroenterology and advanced enteroscopy, including fellowship in which deep enteroscopy training was undertaken and documented with numbers of cases, experience and competency by a fellowship program director or other person of authority. B. Privileges to perform deep enteroscopy at another institution with ability to demonstrate competency by a physician already known to have deep enteroscopy privileges. Certification by an approved training/instructional course of deep enteroscopy 3. References: Documentation that includes a letter of reference from the Residency or Fellowship Program Director or Department Chairman where the candidate received training in deep enteroscopy or an official letter from the facility from which prior experience could be demonstrated. If deep enteroscopy skills were acquired after formal training, two letters of reference from independent practitioners who possess the knowledge of the applicant s skill. 4. Additional equipment or training of nurses Scope configuration, balloon technology or spiral overtubes are required. The training of support staff is by observation. Most equipment currently available follows the usual design of equipment currently used. FPPE: Proctoring of first 2 cases and review of next 5 cases of deep enteroscopy (spiral technology or single and double balloon enteroscopy)

17 OPPE: Performance of at least 10 cases of deep enteroscopy (spiral technology, single and double balloon enteroscopy) over 24 months. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12 Approved by Board of Directors: 11/12

18 Criteria for Privileges in ENDOSCOPIC MUCOSAL RESSECTION (EMR) ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PER-AL ENDOSCOPIC MYOTOMY (POEM) I. Definition: Endoscopic Mucosal Ressection (EMR) and Submucosal Dissection (ESD) is the deep removal of lesions and is performed in the luminal GI track by separating out the tissue layers in the wall tunneling through those tissue layers and subsequently requisition of the lesion. The major indications for endoscopic mucosal/submucosal dissection are removal of lesions in the GI tract in patients who have localized lesions or are nonsurgical candidates or prefer not to have surgery to remove these lesions. The major indication of Per-Oral Endoscopic Myotomy (POEM) is achalasia or hypertension sphincters. II. Eligibility: A practitioner must demonstrate competency and familiarity with the hardware/software systems involved with ESD. Practitioners must have completed gastrointestinal endoscopy training program which involves recognition of management of submucosal lesions III. Requirements: 1. Education: a. GI fellowship training 2. Minimum Required Experience: A. Successful completion of an accredited post-graduate training program in gastroenterology, including fellowship in endoscopic submucosal dissection training was undertaken and documented with numbers of cases, experience and competency by a fellowship program director or other person of authority. B. Attendance at an approved training course and practice in the animal lab with certificate of completion. C. Privileges to perform endoscopic submucosal dissection or POEM at another institution with ability to demonstrate competency by a physician already known to have ESD privileges a case list. 3. References: Documentation that includes a letter of reference from the Residency or Fellowship Program Director or Department Chairman where the candidate received training in EMR or an official letter from the facility from which prior experience could be demonstrated. If EMR/ESD skills were acquired after formal training, two letters of reference from independent practitioners who

19 possess the knowledge of the applicant s skill or demonstration of attending and completing post-graduate education (as above). FPPE: Proctoring of first 2 cases and review of next 5 cases of EMR/ESD/POEM OPPE: Performance of at least 10 cases of EMR/ESD/POEM over 24 months. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: Approved by Board of Directors:

20 Criteria for Privileges in ENDOSCOPIC CLIPPING PRIVILEGES I. Definition: Endoscopic clipping involves disposable devices that apply metal or plastic material to close mucosal defects or for the hemeostasis in the luminal GI track. The major indications are for closure mucosal defects or hemeostasis. II. Eligibility: A practitioners must demonstrate competency and familiarity with the hardware systems involved with endoscopic clipping. Practitioner must have completed a gastrointestinal endoscopy training program which involves endoscopic clipping. III. Required Documentation: 1. Education: a. GI fellowship training 2. Minimum Required Experience: A. Successful completion of an accredited post-graduate training program in gastroenterology, including fellowship in which endoscopic clipping training was undertaken and documented with numbers of cases, experience and competency by a fellowship program director or other person of authority. B. Privileges to perform endoscopic clipping at another institution with ability to demonstrate competency by a physician already known to have endoscopic clipping privileges. C. Attendance at a training course and practice in the animal lab with certificate of completion 3. References: Documentation that includes a letter of reference from the Residency or Fellowship Program Director or Department Chairman where the candidate received training in endoscopic clipping or an official letter from the facility from which prior experience could be demonstrated. If endoscopic clipping skills were acquired after formal training, two letters of reference from independent practitioners who possess the knowledge of the applicant s skill. 4. Additional Equipment and Training for Nurses Device specific materials will need to be is acquired. Training of support staff is by observation. Assembly and application of devices is performed by the endoscopist. FPPE: Proctoring of first 2 cases and review of next 5 cases of endoscopic clipping OPPE: Performance of at least 10 cases of endoscopic clipping over 24 months. Approved by GI Committee: 9/12 Approved by Credentials Committee: 9/12 Approved by Medical Staff Executive Committee: 10/12

21 Approved by Board of Directors: 11/12 Approved by Board of Directors:

22 ST. JOHN S HOSPITAL MEDICAL STAFF EXTENSION OF CLINICAL PRIVILEGES PROFILE Credentialing Criteria for Endoscopic Radiofrequency Ablation for Barrett s Esophagus Procedure I. Qualifications of Initial Applicant 1. M.D. or D.O. 2. Board certified or board prepared in Internal Medicine and Gastroenterology or in Surgery 3. Currently maintains unrestricted privileges for endoscopic procedure 4. Evidence of attendance at a hands-on training practicum in the use of HALO equipment as required by the manufacturer which includes personal time on the system during the training practicum which will occur no longer than 60 days prior to the first proctored case (see Section II below). II. Initial Granting of Privileges Having been determined to meet the qualifications as indicated above, the applicant will be granted preliminary privileges subject to the following: 1. Must perform the procedure under the supervision of a qualified physician credentialed to perform this procedure. This proctor will complete a proctor evaluation form which must eventually indicate the satisfactory performance of two (2) cases before proctoring will be considered complete. 2. The results of proctoring will be reviewed by the applicable Department Chair who will make a recommendation to the Credentials Committee concerning the award of provisional privilege status for one (1) year. 3. All cases performed by a physician with provisional privilege utilizing the HALO equipment will be reviewed by the Department Chair to determine when to recommend the award of full privileges to the Credentials Committee. The provisional period will last no longer than two (2) years. The recommendation to move to full privilege will be based on, but not limited to, case volume and outcome data review. IV. Independent - Requested Maintenance: Demonstrated current competence with acceptable results within the past 24 months. Continued

23 Credentialing Criteria for Endoscopic Radiofrequency Ablation for Barrett s Esophagus Procedure Page 2 V. Reappointment Reappointment of privileges for utilization of the HALO equipment will be based on but not limited to the following: 1. Volume of cases over two (2) years. 2. Demonstrated satisfactory outcomes data. 3. Recommendation of the Department Chair. 4. Recommendation of the Credentials Committee. Approval: Credentials Committee 3/25/11 Medical Staff Executive Committee 4/2/11 Board of Directors 5/4/11

24 TO: Medical Staff Office Confidential File Dr. # Medical Record # Patient age: Procedure date: Procedure performed: Evaluation of patient care: Indication Excellent Standard Unacceptable Unable to evaluate Preoperative evaluation Diagnostic judgment Operative technique Quality of medical record documentation Outcome Operative time was: Reasonable Excessive Surgery was: Warranted Questionable Unnecessary Other aspects of surgery: 1. Was there unnecessary risk to patient? Yes No 2. Was there unplanned organ/tissue removal? Yes No In your opinion, does the surgeon need further proctoring? If yes, please explain. Name of proctor (please print) Date Signature of Proctor

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