A consensus document on robotic surgery

Appendices

Appendix 1: Guidelines for Institutions Granting Privileges in Therapeutic Robotic Procedures

Preamble

The International Consensus Group of 2006 of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Minimally Invasive Robotic Association (MIRA) recommend the following guidelines for privileging qualified surgeons in the performance of surgical procedures using therapeutic robotic surgical devices alone or in a hybrid fashion. The basic premise is that the surgeon must have the judgment and training for safe completion of the procedure as intended, as well as the capability of immediately proceeding to an alternative therapy when circumstances so indicate.

I. Principles of Privileging

A. Purpose

The purpose of this statement is to outline principles and provide practical suggestions to assist healthcare institutions when granting privileges for the performance of procedures using these technologies. In conjunction with the guidelines of other organizations for granting hospital privileges, implementation of these methods should help hospital staffs ensure that surgery is performed in a manner that ensures high-quality patient care and proper procedure utilization.

B. Uniformity of Standards

Uniform standards should be developed that apply to all medical staff requesting privileges to perform procedures using these technologies. Criteria must be established that are medically sound but not unreasonably stringent, and that are universally applicable to all those wishing to obtain privileges. The goal must be the delivery of high-quality patient care. Surgical proficiency should be assessed for every surgeon, and privileges should not be granted or denied solely based on the number of procedures performed. Ongoing review of results and comparison with published data and/or recognized benchmarks are encouraged.

C. Responsibility for Privileging

The privileging structure and process remain the responsibility of the institution at which privileges are being sought. It should be the responsibility of the specialty department, through its chief, to recommend privileges for individual surgeons to perform procedures. These recommendations should then be approved by the appropriate institutional committee, board, or governing body.

D. Definitions

Must/shall: Mandatory recommendation

Should: Highly desirable recommendation

May/could: Optional recommendation; alternatives may be appropriate

Documented training and experience:

• 1. Case list specifying the applicant’s role (primary surgeon, co-surgeon, first assistant, chief resident, junior resident, or observer). Complications, outcomes, and conversion to traditional techniques should be included if known. The applicant must specify if these details are not known.

• 2. Summary letter from preceptor and/or program director and/or chief of service (should state whether applicant can independently and competently perform the procedure in question).

Privileging: The process whereby a specific scope and content of patient care services (i.e., clinical privileges) are authorized for a health care practitioner by a health care organization based on evaluation of the individual’s credentials and performance.

Competence or competency: A determination of an individual’s capability to perform up to defined expectations.

Credentials: Documented evidence of licensure, education, training, experience, or other qualifications.

Complete procedural performance: Competency of the applicant and/or institution regarding patient selection, periprocedural care, performance of the operation, technical skill and equipment necessary for safe completion of a procedure, and the ability to proceed immediately with the traditional open procedure.

Formal course: A formal course alone is not appropriate training for beginning to perform a procedure independently. The course should be taught by instructors with appropriate clinical experience, and should have a curriculum that includes didactic instruction as well as hands-on experience using inanimate and/or animate models. The course director and/or instructor should provide a written assessment of the participant’s mastery of course objectives. Documentation for certain courses comprising only didactic instruction may consist of verification of attendance.

Therapeutic robotic procedures: The spectrum of procedures using a human-controlled computer-assisted electromechanical system that converts information to targeted therapeutic action.

II. Minimum Requirements for Granting Privileges

Part IIA is mandatory, and must be accompanied by either part I B or IIC and at least one component of IID.

A. Formal Specialty Training

Prerequisite training must include satisfactory completion of an accredited surgical residency program, with subsequent certification by the applicable specialty board or an equivalent as required by the institution.

B. Formal Training in Residency and/or Fellowship Programs

This training is for surgeons who have successfully completed a residency and/or fellowship program that incorporated a structured curriculum in minimal access procedures and therapeutic robotic devices and their use. This should also include the science and the techniques of access to the body cavity and area of surgery. This includes adequate clinical experience. The applicant’s program director and, if desired, other faculty members should supply the appropriate documentation of training and clinical experience.

C. No Formal Residency Training in Therapeutic Robotic Surgery

For those surgeons without residency and/or fellowship training that included structured experience in therapeutic robotic procedures, or without documented prior experience in these areas, a structured training curriculum is required. The curriculum should be defined by the institution, and should include a structured program. The curriculum should include didactic education on the specific technology and an educational program for the specialty-specific approach to the organ systems. If the access involves an intracavitary procedure, then that experience and education should be a prerequisite to the training. Hands-on training, which includes experience with the device in a dry lab environment as well as a specialty-specific model that may include animate, cadaveric, and/or virtual reality and simulation modeling, is necessary. Observation of live case(s) should be considered mandatory as well. Other teaching aids may include video review and interactive computer programs.

D. Practical Experience

• 1. Applicant’s Experience: Documented experience must include an appropriate volume of cases with satisfactory outcomes, equivalent to the procedure in question in terms of complexity. The chief of service should determine the appropriateness of this experience.

• 2. Initial clinical experience with the specific procedure must be undertaken under the review of an expert and may include assisting. An adequate number of cases to allow proficient completion of the procedure should be performed with this expert review.

• 3. Preceptor or Proctor: The specific role and qualifications of the expert must be determined by the institution. Criteria of competency for each procedure should be established in advance and should include evaluation of familiarity with instrumentation and equipment, competence in their use, appropriateness of patient selection, clarity of dissection, safety, and successful completion of the procedure. The criteria should be established by the chief of service in conjunction with the specific-specialty chief where appropriate. It is essential that mentoring be provided in an unbiased, confidential, and objective manner.

E. Formal Assessment of Competency

When available, validated measures of competency should be used for further documentation of the applicant’s abilities. These may include knowledge, medical decision making, and/or technical skill assessments. This step may include certificates of completion of training or validated assessment tools for competency or proficiency in a specific procedure or set of similar procedures.

III. Institutional Support

It is necessary that the staff and technical support team undergo a similar formal technical training with the device before its use in a clinical scenario. Therapeutic robotic surgery requires technical support and must be approached with a team concept.

IV. Maintenance of Privileges

A. Provisional Privileges

Once competence has been determined, a period of provisional privileges may be appropriate. The time frame and/or number of cases during this period should be determined by the chief of service and/or the appropriate institutional committee, board, or governing body.

B. Monitoring of Performance

Once privileges have been granted, performance should be monitored through existing quality assurance mechanisms at the institution. These mechanisms may be modified as appropriate, and should evaluate outcomes as well as competency in the complete patient care process.

C. Continuing Medical Education

Continuing medical education related to the field should be required as part of the periodic renewal of privileges. Attendance at appropriate local, national, or international meetings and courses is encouraged.

D. Renewal

An appropriate level of continuing clinical activity should be required. This should include review of quality assurance data, as well as appropriate continuing medical education activity, in addition to existing mechanisms at the institution designed for this purpose.

E. Denial of Privileges

Institutions denying, withdrawing, or restricting privileges should have an appropriate mechanism for appeal in place. The procedural details of this mechanism should be developed by the institution, and must satisfy the institution’s bylaws and institutional recommendations.

Appendix 2. Guidelines for Training in Therapeutic Robotic Procedures

Purpose

To define guidelines for practical education in therapeutic robotics and its application to surgical specialties. A defined course should provide the necessary information, skill training, and familiarization with the technology for the initiation of a mentored clinical experience. The completion of a course should be considered only as preparation for the performance of a mentored clinical experience as determined by individual institutions

Expert Instructor

Instructors must have substantial practical experience with the specific advanced technology and must have used this technology in clinical applications with reported results and review. The individuals should have specialty-specific experience and expertise in the advanced technology.

Didactics

The length of this portion of the educational experience should reflect the complexity of the technology and the specialty-specific procedure, the underlying experience of the students, and the incremental increase in the procedure and technology. This should allow a complete understanding of the technology, device function, altered functional status, basic troubleshooting, other technical issues, and device parameters and limitations. Technology and team interactions should be addressed as well.

Procedure-specific information should include indications, workup patient selection, instrumentation, preoperative preparation, patient and system positioning, port placement, procedural steps, complications, and management. Learning curve–related issues should be presented. Reported outcomes and the expected perioperative course should be included.

Live Case Observation

The observation of a complete procedure is an important part of a total preclinical training program. The experience should include procedure preparation, system setup, patient positioning, review of case selection, and intraoperative technical aspects.

Hands-on Experience

Hands-on experience should include nonclinical simulation encompassing system setup, connections, operation, and troubleshooting. Initial skill training should include basic and advanced techniques required to develop adequate proficiency necessary for completion of the intended procedure. Clinical simulation should include procedure-specific modeling with successful completion of the key components using an appropriate model for the expected procedures. It is recommended that advanced simulation tools be used when available. The complexity of the procedure may dictate the length of the time necessary to complete the tasks.

Residency Programs

It is recommended that specialty training programs include exposure to therapeutic robotic interventions as part of their curriculum. A structured curriculum on therapeutic robotic procedures should be included in programs providing clinical experience for their trainees.