Fig. 1
Organization Chart by Hierarchy. This chart considers hospital departments and academic hierarchy
The site had the investment and strategy to begin the project. The Institutional Review Board (IRB) received the project for ethical approval and regulatory affairs. The research site principal investigator and the project manager defined and recruited the medical staff and the stakeholders. The patient allocation started after IRB approval.
The first position was the principal investigator (PI), followed by the subinvestigator who would execute the project. Both knew how to do operations with basic and advanced skills. A project manager was responsible for planning the project details and leading the project team [12].
The research sector team was responsible for all ethical and regulatory documents, informed consent form (ICF), patients’ follow-up, random spreadsheets, monitoring, and inventory control of the investigational devices and data management [13].
Having one reference for everybody was the most important point for project success and information availability. All involved hospital departments were considered. Each department must work with its own personnel under the command of the project manager and the principal investigator to include regulatory documents, patient informed consent, data management, quality control, nurses, monitor, agenda, instruments control, contracts, and external audition or an involuntary specific situation that needs outside revision (Fig. 1).
Hospital Organogram | Research | Engineering | Information Technology | Nurse Staff | Material Arsenal |
For the surgical organization, we considered a scale as: specialists, theory, laboratory, patient, and results, as follows.
Surgical Staff
The tutor considers all the personnel involved. All departments were invited to the first meeting, regarding administration, structure, engineering, informatics, and support [14]. We had small meetings, peer to peer or distant professionals’ teleconferences for further punctual fine adjustments, as needed, including international invites. The OR was prepared to broadcast live locally, inside the university institutes and internationally considering the most updated communication technology available [15, 16]. Surgical procedures could be broadcast for distant supervision and tutoring [17].
The fluxogram begins with the principal investigator, who is responsible for the brainstorming and idea sum. The project design is in his head, from zero to complete, even with some imaginary results to be conquered. He is observing everything from a macro view, doing some adjustments and changing strategies, avoiding conflicts and obstacles.
The disease must be part of the executive plan, but the reference is always the patient [18]. Each group took care of its disease. General knowledge, basic concepts, anatomy, physiology, functional behavior, and patient lifestyle were important and respected. The principal investigator was concerned with how to prepare an adequate safety procedure. This was essential to develop a consistent pathway for a new technology and robotic academic facilities in this environment [19].
A step-by-step specialist training was initially done by virtual robotic computer basic concepts training [20, 21]. This was accomplished by merging a portfolio from the robot manufacturer and the university staff. It was a mechanical theory explanation about the robot itself regarding technical procedure details, including videos, sketch charts, technical explanations, safety rules of functioning, and mechanical details [22]. This was around 10 h in computer and by presence and could be updated as needed [23]. This comes from industry orientation and it has FDA approval. The training continued in the laboratory after that [24]. It was still sometimes virtual but it was done with the robot itself inside the OR for planning. The machine in the OR was used for “physical training.” The surgeon, engineering, scrub nurse, and informatics technician went to the OR as one surgical team before the surgery itself. Each person rehearsed his or her responsibilities inside the room as a preparation for the operating day. This should take 2 h training [25–27]. One important detail was always to have the tutor with this team (Photo 1).
Photo 1
Another training step was added to this beginning as a 4 h laboratory complement: 1 h in dry lab, with instruments management, repetitive movements, object/instruments training, and update procedures as the experience was brought to the lab. Three consecutive hours were offered to the staff with wet lab, animal side, for dissection, hemostasis, stapling, and suturing exercises after that. Every training was the same until this point, no matter the area of interest [7, 8, 28].
Because of the necessity to deal with complex cases in a reference institution we figured out the necessity to offer more straightforward laboratory training to a refinement completion [29, 30]. Eight more hours were followed to enhance confidence in the surgeon before the first patient robotic meeting. These hours were divided in 4 h of animal lab to a specific organ management, repetitive movements, object/instruments specific training, and updated training. This training was for the group who was interested in a specific organ, who sometimes does not need to make a dissection or movement done in another situation. The interest was stressed in its area alone and the skill was developed for that procedure. The further 4 h were used for team integration, working on time-saving exercises, patient side positioning, and staff fine tuning. Patient side simulation, difficult situations, and special needs could give confidence to the team before dealing with real patient contact. This was the opportunity for procedure simulation, precautions, and safety rules. We defined table positioning, equipment, and staff position in the room, as sign in and time out.
Theory Preparation
Surgeons, research nucleus, hospital logistics, nurses, and OR agenda had the same goal of making a high-quality automatic system with enough instruments and conditions for good practicing. A multidisciplinary meeting must be done before the first robotic surgery . The patient must be presented and the surgical team must know the case in advance as a team. The surgeon must be confident and he must show his team how advanced the procedure and their technical ability must be. These meetings, as a committee, were needed for identifying trending issues and improving surgery as to its time and quality. It was a continuous educational environment in an adequate institution. This organization was done for retaining developed skills to assist in mentoring new teammates. It was good for immediate answers, for knowledge, and development of new procedures.
From time to time reviewing training and lab attendance must be done, as needed. New technologies must be well discussed by the group.
Laboratory
The procedures permit development of criticism. Every time the principal investigator sees a problem one must go back to the lab and change for better results. The high-level technical leader needs to go back to her team for small changes. A peer-to-peer meeting analyzes reports in a fine-tuning spot trend. Broken instruments should be recognized and discussed in the group to clarify why they broke and how to avoid their breaking again. Repetitive exercises are important to change one evitable error. It is important to go back to the lab any time necessary.
Procedure
The program could change any time. All the risks must be observed, from the smallest to the most significant. The principal investigator could call the staff any time. The staff should be prepared for management changes. Patient postoperative interactions in the hospital must be evident to the group. Revisions should be done constantly. Continuous communication and permanent information in all areas are important as part of organization.
Mentoring and coaching are necessary to maintain the staff under constant development [33]. The hospital must provide this condition and could consider surgical time for performance evaluation [34].
Senior surgeons were chosen primarily to conduct the program. They were prepared to recognize and introduce new surgeons for training. The program must be opened for any novel conduct, transition, and/or changes.
The databank was the reference for all these changes. It was kept in the research department and updated on time. Alerts could be released for exceptional meetings, training plan changes, and calls for re-education and GCP. The department was reference for regulatory papers and topics. It was responsible for data, storage, and staff meetings regarding quality/monitor control. This departmental control was considered essential for developing our future leaders in the educational institution. It was responsible for information trade between the department professors and other university areas for other area studies development.