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CREDENTIALING CRITERIADelineation of Clinical Privileges

(GYN /Surgery/Urology)ROBOTIC (DA VINCI SYSTEM) ASSISTED SURGERY PRIVILEGES

To be eligible to request clinical privileges using the da Vinci System for robotic assisted surgery in the applicant’s specialty, an applicant must meet the following minimum threshold criteria:

GENERAL REQUIREMENTS SPECIFIC REQUIREMENTS Education: M.D. or D.O.

Minimal formal training: Completion of approved residency or fellowship program in surgery or surgical subspecialty in an ACGME/AOA accredited training program.

Certification or Board Eligible in the surgeon’s specialty by a board recognized by the ABMS.

Eligibility and active privileges to perform laparoscopic and open major procedures.

AND ONE OF THE FOLLOWING TWO ALTERNATIVES

Satisfactory completion of the Intuitive Surgical Clinical Pathway course, within 12 months prior to performing the first proctored case after being granted this privilege, in the da Vinci Surgical System from Intuitive Surgical, Inc. that included:

a. 10 hours of computer-based trainingb. 2 hours of live case observationc. 4 hours of hands-on training with the robot using

inanimate training aidsd. 8 hours in a live porcine laboratory case

OR

The following criteria must be met:

Previous practical experience via an accredited residency or fellowship program with documented clinical experience in a minimum of ten (10) procedures during training. The following is required: 1) letter from the surgeon’s training program director must be submitted directly to UMC detailing the extent of training and that the applicant is proficient in robotic assisted surgery.

Prior training during residency or fellowship or at a Joint Commission accredited institution meeting the minimal formal training parameters listed above.

If this alternative is selected, evidence of current (within the preceding 2 years) competence must include a letter provided directly to UMC from the surgeon’s training program director, for residency or fellowship, or from the Department or Robotic Committee Chairman with direct knowledge of the practitioner’s clinical performance in using the da Vinci System, detailing the extent of training and level of proficiency.

Minimal Current Privileges: Fully credentialied in Advanced Laparoscopy in their specialty with supportive documentation.

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Full privileges to perform the equivalent open procedure without robotic assistance for which robotic privileges are sought, and/or

Full privileges to perform the equivalent laparoscopic procedure without robotic assistance for which robotic privileges are sought.

*Preceptor is defined as a surgeon who has met the above outlined qualification for credentialing and has had practical experience in the successful use of da Vinci surgical system.

INITIAL PRIVILEGES: If the applicant is determined to have satisfied the training requirementsand is initially granted privileges to utilize the DaVinci Surgical Platform, such privileges will be considered provisional and shall be subject to the following proctoring, review, and monitoring :

Two (2) cases minimum, on two (2) different proctoring occasions (minimum 4 cases) no more than 2 weeks apart, proctored by a practitioner who is a Board Certified surgeon currently privileged to perform da Vinci System robotic surgery and who has performed a minimum of forty (40) successful robotic cases, must be successfully completed.

To successfully complete the training, 10 robotic cases must be performed within the ensuing 12 months. In some cases, as determined by the Da Vinci Robotics Credentialing Subcommittee, credentialing will involve the demonstration of proficiency and safety in executing theses cases, and will be reviewed by the Da Vinci Robotics Credentialing Subcommittee. Further, 5 of these cases will be reviewed by Quality Management as part of FPPE (Focused Professional Practice Evaluation) for initial robotic privileges.

If the surgeon is currently privileged at another Joint Commission Accredited facility and has successfully performed a minimum of ten (10) robotic cases within the preceding twelve (12) months and satisfactory evidence of this experience is provided, UMC proctoring may be waived at the discretion of the Credentials Committee.

After satisfactorily completing the foregoing four proctored cases or a waiver has been granted as provided in the preceding paragraph, the next five (5) cases must be reviewed by the Robotics Subcommittee. If a proctoring waiver is granted, the five cases referenced in this paragraph must be performed with the assistance of a robotic trained and UMC privileged assistant. If one or more of these first five cases was not performed fully satisfactorily, including documentation, an additional five (5) cases, for a total of ten (10) will be required. The assessment provided by the reviewer must be documented on the form provided by the hospital and must be individual case specific as to the surgeon’s judgment, knowledge and skill in using the system. An overall recommendation as to the granting of this privilege will also be required.

For the purposes hereof, the terms “proctored” and “proctoring” shall mean the physical presence of, and direct observation by, the proctor of the surgeon's performance of the procedure.

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Interim Provisional privileges to be granted to the applicant for a period of no longer than 12 months under the supervision of a proctor/preceptor with the cases brought back to the Credentials Committee and Executive Committee upon completion in order to finalize privileges.

Privilege Maintenance: This privilege is granted for a twenty four month period; however, in order to maintain full robotic privileges, the surgeon must perform (or assist with at least one hour console time in each counted case) a minimum of twenty (20) robotic procedures each twelve (12) month period following initial granting and subsequent renewal of this privilege. If less than 20 cases are performed in a 12 month period, the following structured re-training program must be used for privilege maintenance:

15 - 19 cases—Morristown Protocol (10 simulation skills with a minimum score of 90% to be completed within 30 days), the details of which will be given by the Robotics Subcommittee.

10 - 14 cases—Morristown Protocol and 1 expert proctored case by a Board Certified surgeon in the same specialty

<10 cases—privileges will be considered voluntarily withdrawn after review and notification by the Robotics Subcommittee.

The surgeon must continuously meet the minimal current privileges requirement. If these conditions are not met, the privilege will be considered to have been voluntarily withdrawn by the surgeon. Reinstatement of the privilege may be considerd upon satisfactorily completing the minimal formal training and current privilege requirements listed herein from the beginning.

If a surgeon performs less than this, that surgeon must have one proctored case and five reviewed cases satisfactorily completed before being eligible to request the reestablishing of full robotic privileges. Tubal ligation, salpingectomies, and diagnostic laparoscopy will not be counted towards privilege maintenance requirement.

The surgeon must actively participate in the UMC ongoing clinical performance improvement program associated with robotic surgery.

At least 2 hours of CME, robotic surgery education, simulation, or related courses within the realm of minimally invasive surgery (MIS) may meet this requirement upon review by the Robotics Subcommittee.

When a surgeon is up for review for privilege maintenance, his/her robotic cases, 4 hours of education in MIS, robotics profile and complications will be reviewed by the Robotics Subcommittee.

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Specialty Specific Additional Requirements:

The applicant must be fully credentialed in open and laparoscopic procedures that correspond to the da Vinci robotic approach as listed below:

The cases listed below are defined as either Basic or Advanced robotic procedures.

1. A new robotic surgeon will be expected to perform at least thirty (30) cases from the Basic Group before being eligible to request privileges for advanced robotic surgery. Recommendations regarding privileges will be made by the Da Vinci Robotics Credentialing SubCommittee .

2. Gynecologic Oncologists will be eligible to proceed to Tier II cases after satisfactorily completing their first four (4) proctored and five (5) reviewed cases and upon recommendation by the Da Vinci Robotics Credentialing Subcommittee .

3. If the Surgeon has completed advanced fellowship training or can submit a laparoscopic case list, the surgeon may be eligible to request privileges for advanced robotic surgery upon recommendation by the Robotic Section. In some cases, credentialing will involve the demonstration of proficiency and safety in executing these cases, and will be reviewed by the Da Vinci Robotic Credentialing Subcommittee.

TIER I – BASIC GYNECOLOGIC ROBOTIC SURGERY1. Adnexal surgeries including ovarian cystectomies, salpingo-oophorectomies and adhesiolysis. (Excludes tubal reanastomosis)

2. Laparoscopic supracervical hysterectomies for uteruses with an estimated uterine volume of < 350 cc3, with or without BSO.

3. Laparoscopic total hysterectomies for uteruses with an estimated uterine volume of < 350 cc3, with or without BSO

4. Laparoscopic assisted vaginal hysterectomies with or without BSO.

5. Laparoscopic myomectomies <7cm.

6. Resection/biopsy Stage 1-2 endometriosis.

7. Bladder repair

8. Biopsy of masses

TIER II – ADVANCED GYNECOLOGIC ROBOTIC SURGERY1. Pelvic lymphadenectomy.

2. Retroperitoneal procedures including presacral neurectomy, complete ureterolysis.

3. Sacrocolpopexy, Burch Procedures and other pelvic reconstruction operations

4. Resection stage 3-4 endometriosis surgery.

5. Bowel surgery including appendectomy (does not include bowel resection)

6. Tubal reanastomosis.

7. Myomectomies >7cm and hysterectomy for uteruses with an estimated uterine volume of > 350 cc3.

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8. Ureterolysis

9. Any other new, not previously described complex procedure.

Gynecologic Oncology Robotic Surgery1. Infracolic omentectomy

2. Radical Hysterectomy

3. Large & small bowel resections

4. Para aortic lymph nodes

5. Exenterations

6. Ureteral Reimplantation or Repair

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UROLOGY ROBOTICS CREDENTIALLING

Applicant must be fully credentialed in open and laparoscopic procedures that correspond to the da Vinci robotic approach.

The cases listed below are defined as either Basic or Advanced robotic procedures.

1. A new robotic surgeon will be expected to perform at least twenty (20) cases from the Basic Group being eligible to request privileges for advanced robotic surgery. Recommendations regarding privileges will be made by the Da Vinci Robotics Credentialing SubComittee.

2. If the surgeon has completed advanced fellowship training or can submit a laparoscopic case list, the surgeon may be eligible to request privileges for advanced robotic surgery upon recommendation by the Robotic Section. In some cases, credentialing will involve the demonstration of proficiency and safety in executing these cases, and will be reviewed by the Da Vinci Robotic Credentialing Subcommittee.

TIER I- BASIC UROLOGY ROBOTIC CASES1. Prostatectomy (with or without obturator lymph nodes)

2. Obturator lymph nodes (Separate procedure)

3. Pyeloplasty

4. Pyelotomy

5. Ureteral reimplant (with or without tailoring, intra- or extravesical approach)

6. Bladder repair or fistula excision

7. Nephrectomy (Radical or simple)

8. Adrenalectomy (Total or partial)

9. Partial nephrectomy

10. Ureterolysis

11. Cystectomy (Radical or simple, total or partial)

12. Sacrocolpopexy, Burch procedures, or other pelvic reconstruction procedures

TIER II – ADVANCED UROLOGY ROBOTIC CASES1. Pelvic lymph nodes (iliac and obturator)

2. Retroperitoneal lymph node dissection (total or modified)

3. Appendectomy or other bowel surgery

4. Any radical pelvic exenteration procedure

5. Any other new, not previously described complex procedure after committee approval

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GENERAL SURGERY ROBOTICS CREDENTIALLING

Applicant must be fully credentialed in open and laparoscopic procedures that correspond to the da Vinci robotic approach.

Robotic Privileging Recommendations for General Surgery

1. A new robotic surgeon will be expected to perform at least twenty (20) cases from the Basic Group before being eligible to request privileges for advanced robotic surgery. Recommendations regarding privileges will be made by the Da Vinci Robotics Credentialing Subcommittee.

2. If the surgeon has completed advanced fellowship training or can submit a laparoscopic case list, the surgeon may be eligible to request privileges for advanced robotic surgery upon recommendation by the Robotic Section. In some cases, credentialing will involve the demonstration of proficiency and safety in executing these cases, and will be reviewed by the Da Vinci Robotics Credentialing Subcommittee.

3. The following recommendations are made for case progression. The goal of all new robotic surgeons is to perform basic (easy) cases initially before being eligible to request to be proctored/assisted on more difficult and complex cases. This process will vary somewhat based on the sub-specialty:

TIER I- GENERAL SURGERY ROBOTIC CASES:1. Cholecystectomy

2. Gastric banding

3. Appendectomy

4. Simple hernia repairs

5. Right colectomy

6. Repair bowel lacerations

7. Splenectomy

TIER II – GENERAL SURGERY ROBOTIC CASES:1. Nissen Fundoplication

2. Rectal surgery (Low anterior resection)

3. Whipple procedure

4. Pancreatectomy

This list is not all inclusive. In general, a Basic Procedure is done on an essentially healthy normal weight (BMI < 35) patient that can be concluded in less than two (2) hours. Surgeries that require advanced skills with fourth arm manipulation, sewing and complex anatomy should be postponed until the surgeon has mastered basic cases first. In our institution, this is defined as thirty (30) cases. As with all other specialties, the first two (2) cases will require proctoring; the first five (5) cases will require a focused review.

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PHYSICIAN ASSISTANT (PA-C) and ADVANCED NURSE PRACTITIONER (ANP) ROBOTICS CREDENTIALLING:

1. Must be a licensed in the State of Texas, practicing Physician’s Assistant/Advanced Nurse Practitioner, employed by a physician who has surgical privileges at University Medical Center of El Paso.

2. Must successfully complete an Off-Site Training program in the role of Patient –Side Assisting using the DaVinci Robot Surgical System, through Intuitive Surgical must complete four (4) hours of hands-on robotic orientation and skill testing conducted by Intuitive DaVinci representative.

3. Must observe two (2) successfully completed robotic surgery cases including set-up, patient positioning, and orientation of equipment, surgeon preferences, the procedure and post-operative instruction.

4. Must scrub and assist on two (2) successfully completed proctored robotic procedures. The licensed assistant (PA, ANP or Physician) proctor must be available for instant hands-on instruction or performance as dictated by case need.

5. Each primary surgeon must be comfortable with the assistant’s role and ability, having the right to require longer observation periods as they deem necessary.

6. For a PA or ANP to serve as an assistant trainer for another PA or ANP, they must have completed at least twenty (20) robotic laparoscopic cases and feel comfortable in this role.

Physician Assistants/Advanced Nurse Practitioners may only assist surgeons who have successfully and satisfactorily completed the requirements currently in effect and have received Robot Section approval to utilize a PA/ANP as the primary assistant.

When assisting in a robotic procedure, a PA/ANP may perform those additional activities for which the PA/ANP is already credentialed.

Approved: 09/2013Revised: 07/2014, 10/2016

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