American Urological Association - Robotic Surgery (Urologic) Standard Operating Procedure (SOP)

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Home Guidelines Policy Statements Robotic Surgery (Urologic) SOP

Robotic Surgery (Urologic) Standard Operating Procedure (SOP)

1. Purpose

Computer assisted surgery using remote tele-presence manipulators is widely referred to as robot assisted or robotic surgery. Since the term is used extensively in the press as well as medical journals, the term “robotic surgery” will be used in this document. The purpose of this document is to formulate standard operating practices for institutions to use during the process of credentialing of urologists for privileges to perform robotic surgery. The robotic approach involves the application of robotic technologies used primarily during laparoscopic surgery.

Since robotic technology is used mostly as a tool during laparoscopic surgery, surgeons performing robotic surgery must also be credentialed for privileges to perform laparoscopic surgery. The American Urological Association, Inc.® (AUA) recommends that privileges to perform laparoscopic urological procedures be granted by hospitals only to individuals who meet specific criteria. The surgeon must be proficient with the operative steps of the procedure that is being performed laparoscopically and must be proficient in the management of complications that may occur in association with performing the laparoscopic procedure. Surgeons privileged to perform laparoscopic urologic procedures must also have experience in laparoscopy that is acquired through previous clinical experience or through previous instruction. Lastly, surgeons privileged to perform laparoscopic urologic procedures should have completed an experience in supervised performance of laparoscopic urologic procedures. With laparoscopic urologic procedures performed with or without robotic technologies, institution’s must continue to evaluate evidence of the urologist’s competence for individual surgical procedures.

The standard operating practices were initially developed in 2009 and revised in April 2013, October 2014, and December 2016.

2. Responsibility

Credentialing of physicians and granting privileges to perform surgeries is the responsibility of the individual institution. The chief of medical staff/medical staff offices/committees/operating room committee or other qualified individual or committee may formulate requirements for credentialing for robotic surgery. Credentialing for individual urologic procedures should involve the chief of the urology service or the clinical supervisor of the urologist.

3. Definitions

Standard Operating Practices: A related set of generalizations derived from past experience arranged in a coherent structure to facilitate appropriate responses to specific situations. This set of standard operating practices has a broad base of acceptance among experts in the field.

  1. Competency- The state or quality of being adequately or well qualified to perform up to defined expectations.
  2. Must/shall- mandatory recommendation
  3. Should: highly desirable recommendation
  4. May/could: optional recommendation
  5. Credentials: Documented evidence of licensure, education, training, experience or other qualifications

4. Minimum Requirements for Granting Urologic Robotic Privileges

Part 4 A and Part B or C mandatory.

  1. Training in Urology
    1. Completion of an Accreditation Council for Graduate Medical Education (ACGME) accredited urology residency program and American Board of Urology eligibility or certification.
    2. Training in urology that is recognized as equivalent to item i, by the institution may be adequate.
  2. Robotic Surgical Training in Residency and/or Fellowship Programs
    1. Robotic surgery is now included in the American Urological Association’s (AUA) Core Curriculum for urology residencies. The majority of residencies in urology have adequate training in robotic surgery. The program director must provide credentials to document satisfactory training and confirm competence of the urologist to independently perform robotic surgery. A urologist completing a residency and/or fellowship training program should complete a minimum of 20 cases; these can be pediatric and/or adult robotic surgical cases, but the trainee must have console time for a key portion of the procedure with at least 10 cases.
    2. "A curriculum involving exercises using virtual reality simulators is recommended."
  3. No Residency or Fellowship Training in Urologic Robotic Surgery
    Several practicing urologists have had no formal training in robotic surgery as described in Part 4B. These physicians should complete a structured training program before being granted privileges. The curriculum/requirement may include the following:
    1. Completion of the AUA’s Fundamentals of Urologic Robotic Surgery module and completion of the post-test for that module with a score of at least 80% correct
    2. Recommend completion of at least one of the Basic Procedures modules of the AUA’s Urologic Robotic Surgery Online Course for the robotic procedure that will be the primary focus of the urologist’s clinical practice. The post-test for the selected Basic Procedure module should be completed with a score of at least 80% correct.
    3. Recommend completion of Intuitive Surgical’s Online System Training Module at http://www.davincisurgerycommunity.com, review of the Patient Preparation & Operating Room Setup for Laparoscopic and Robotic Surgery Chapter in the AUA’s “Urologic Robotic Surgery Curriculum”, and review of material specific to the robot type the urologist will be using in clinical practice; e.g. Standard, S robot, Si robot, or Xi robot.
    4. Have granted privileges for the surgery via an open approach and/or laparoscopic approach
    5. Observation of robotic surgeries performed by an experienced robotic surgeon sufficient for familiarity of the differences between robotic and open approaches with written confirmation that the procedure was performed safely.
    6. Hands-on experience using the surgical robotic system with instruction by an instructor. This may include:
      1. System set-up and docking
      2. Skills training using inanimate models and/or training with virtual reality simulators.
      3. Animal lab experience when available
      4. Familiarity of robotic setup and technique for either or both upper urinary tract and lower urinary tract procedures depending on which the surgeon performs.
      5. Training with electrosurgical devices and other instrumentation that is used during the performance of robotic surgery
    7. Passive proctoring and written confirmation by the proctor that the surgeon is competent to utilize the robotic platform independently of a proctor (appendix 1). In regards to proctoring, the American Urological Association has developed standard operating practices for proctors during the performance of robotic urologic procedure.  The standard operating practices include the following:
      1. Proctors should have completed at least 50 robotic surgical cases overall with at least 20 cases similar to the one that is being proctored.
      2. Informed consent should be obtained from the patient, about the presence and responsibility of the proctor.
      3. Granting temporary privileges to the proctor to assist during surgery, should that be required, may be considered.
      4. The role and responsibility of the proctor should be clearly defined including his/her responsibility in the event of a complication.
      5. The proctor should be present in the operating room for the entire surgery.
      6. Legal liability of the proctor should be minimized after consulting with the local legal counsel and the institution must indemnify the proctor against possible legal action.
        Acknowledgement: Adapted from the Recommendations of the Society of Urologic Robotic Surgeons (SURS). Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons. Zorn KC, Gautam G, Shalhav AL, et al, J Urol. 2009 Sep;182(3):1126-32.Assistance by another urologist until the urologist is comfortable operating independently.
    8. Presence of appropriate biomedical support until the urologist and the OR team are comfortable working with the robotic platform.
    9. Review of surgical outcomes after the surgeon’s initial experience by an unbiased group of peers at the same institution.
    10. For pediatric robotic novice surgeons, the above apply, but should be primarily in the pediatric robotic surgical patient domain.

5. Maintenance of Privileges

  1. Provisional Privileges: Provisional privileges may be appropriate for a surgeon’s initial robotic surgical experience. The period of time and number of cases before unrestricted privileges may be granted may be determined by the medical staff committee, chief of service or appropriate committee of the credentialing hospital.
  2. Once unrestricted privileges for robotic surgery have been granted the physician may perform surgeries different from the initial type of robotic surgery for which he/she was granted privileges provided the urologist has privileges to perform the same surgery using alternative approaches (e.g. open or laparoscopic surgery)
  3. Monitoring of privileges: After the initial privileges are granted, the surgeon’s clinical performance, surgical volume and complications may be monitored by an appropriate peer review to ensure adequate surgical outcome and volume in robotic surgery.
  4. Continuing Medical Education: Adequate evidence of CME activity in urological robotic surgery may be beneficial.
  5. Denial of privileges: Institutions that deny, restrict, suspend or modify privileges granted to a physician should have written regulations to apply the rules of the institution and should have

6. Institutional Support

Successful establishment of a urologic robotic program requires a commitment from the institution for resources including dedicated operating rooms, nursing team, a robotic surgical coordinator, regular maintenance, disposable instruments and training material.

Acknowledgements: Definitions and format adapted from “A consensus Document on Robotic Surgery” by the SAGES-MIRA Robotic Surgery Consensus Group.

Appendix 1: Sample Proctoring Form [pdf]

Board of Directors, 2017

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