R E V I E W S & A N A LY S E S Robotic-Assisted Surgery: Focus on Training and Credentialing Deborah Dubeck, RN, MPH INTRODUCTION Patient Safety Analyst Pennsylvania Patient Safety Authority The use of robotic technology has escalated over the past four years, and the number of robotic-assisted surgeries (RASs) performed worldwide nearly tripled between 2007 and 2010, from 80,000 to 205,000.1 Originally developed by the US Department of ABSTRACT Defense for use in the battlefield in the 1990s, robotic surgical technology has rapidly Since 2005, healthcare facilities have changed the practice of minimally invasive surgery.2,3 In 2000, the US Food and Drug reported 722 safety events involving Administration (FDA) cleared the da Vinci® Surgical System by Intuitive Surgical, Inc. robotic-assisted surgery (RAS) to the for laparoscopic surgery, and as of this writing, it remains the only commercially avail- Pennsylvania Patient Safety Authority. able system. This system is currently FDA-cleared for many procedures, including Five hundred forty-five (75.5%) were general surgery, cardiac, colorectal, noncardiac thoracic, head and neck, urologic, and categorized as Incidents that did not gynecologic procedures.4,5 The benefits of robotic technology include three-dimensional result in patient harm. Of the 545 magnified vision, enhanced ergonomics and tremor filtration, motion scaling, and Incidents reported, 344 (63.1%) of the improved manual dexterity.3,6-8 Patient-centered potential advantages include reduced events were categorized as complica- length of hospital stay, improved postoperative recovery time, decreased postopera- tions of a procedure/treatment/test or tive pain, and decreased blood loss.9 The manufacturer reports the major benefits errors related to a procedure/treat- experienced by surgeons include greater surgical precision, increased range of motion, ment/test. One hundred seventy-seven improved dexterity, enhanced visualization, and improved access.7 (24.5%) were reported as Serious Events Limited valid data is currently available on complication rates or adverse events related that resulted in patient injury, including to robotic surgery. FDA’s Manufacturer and User Facility Device Experience (MAUDE) 10 events that resulted in patient fatality. database collects medical device adverse event data, but this system has its limitations and Complications of a procedure/treat- states that information collected cannot be used to evaluate adverse outcome rates.10,11 ment/test (n = 131) and errors related to a procedure/treatment/test (n = 44) The cost of implementing a robotic surgery program requires a substantial financial comprised 98.9% of the Serious Events. commitment from the hospital, as the cost of a robotic system runs in the range of Further review of these cases showed $1.5 million to $2 million, with additional costs for maintenance of the system and that the event type subcategories of purchase of limited-use instruments.12 The cost of training the surgeons and the entire unintended laceration/puncture, bleed- surgical team is estimated to be about $10,000 per surgeon.8 As the learning curve is ing/hemorrhage, other events related steep, the hospital will also need to account for the increased operative costs during to patient positioning complications, this period. The professional organizations have not reached a consensus on training or retained foreign body, and infection credentialing standards.7,12,13 This leaves the individual hospital responsible to develop made up 75.1% of the Serious Events. and implement training and credentialing processes that are medically sound, that pro- The rapid growth of RAS has presented mote patient safety, and that protect the organization from undue risk. new challenges as this technology has Implementing a robotic surgery program is challenging. The focus of this article is not emerged as an alternative treatment to debate the efficacy of one surgical approach versus another but rather to identify option to many laparoscopic and open organizational training and credentialing processes that may increase RAS safe patient procedures. Current literature sup- outcomes within an organization as well as reduce organizational risk. ports that a steep learning curve exists as surgeons develop skills to perform COMPLICATIONS AND ADVERSE EVENTS RELATED TO robotic procedures. As professional ROBOTIC SURGERY organizations discuss developing and defining standards for training and cre- Valid data on complication rates and adverse patient events is limited and can be dentialing, the responsibility falls on the conflicting. No studies exist to support that RAS conducted by experienced robotic individual hospital to develop programs surgeons has complication rates that differ from other techniques.8 Current sources of to ensure that both the physician and national adverse event data include FDA’s MAUDE database and procedure-specific the entire surgical team are proficient studies. In addition, the Pennsylvania Patient Safety Authority’s Pennsylvania Patient and competent to safely perform robotic Safety Reporting System (PA-PSRS) contains event reports that were reviewed following procedures and that patient outcomes a query of the reporting system database that included the terms “robot” or “da Vinci.” are monitored to ensure ongoing staff Additional like events may have been reported through PA-PSRS but not captured in competency. (Pa Patient Saf Advis 2014 this analysis if this terminology was not included in the event report. Sep;11[3]:93-101.) Vol. 11, No. 3—September 2014 Pennsylvania Patient Safety Advisory Page 93 ©2014 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S MAUDE and 11.7% with an instrument accessory. pulmonary emboli (n = 4), open conver- At the national level, manufacturers, Gupta et al. opined that the number of sion (n = 1), ileus (n = 5), infections (n = 4), importers, and device user facilities are adverse events was low, or about 0.1% myocardial infarction (n = 2), urine required to report to FDA certain device- over two years.17 leaks (n = 7), fascial dehiscence (n = 1), related adverse events involving serious Cooper et al. also studied the FDA extremity weakness (n = 3), abdominal patient injury and/or death as well as MAUDE database for device-related bleed secondary to anticoagulation for product problems.14 Reports made to robotic surgery complications, by spe- pulmonary embolus (n = 1), death due to MAUDE include information that may cialty and procedure type, reported from pulmonary embolus (n = 1), reoperation identify patterns or problems or a fail- January 1, 2000, to August 1, 2012. In for fascial dehiscence (n = 1), readmission ure mode with a particular device that addition, the authors searched LexisNexis for pelvic abscesses (n = 2), and bladder organizations can review as part of their and Public Access to Court Electronic neck contractures (n = 3). The most signifi- ongoing robotic patient safety program. Records (PACER) databases for any cant decrease in operative time was seen MAUDE’s system limitations are widely legal judgments to see if there was a cor- after the first 25 patients, and blood loss known, and FDA has indicated that the responding report in MAUDE. Cooper was noted to decrease after 50 patients. data is not intended to be used either to et al. found that 245 cases had been Their overall complication rate was 26%. evaluate rates of adverse events or to com- reported, which included 71 deaths and Improvement of surgical outcomes and pare adverse event occurrence rates across 174 nonfatal injuries. Eight cases were patient safety was present with ongoing devices, as many reports may be missing, found in LexisNexis and PACER in which surgical experience.18 duplicated, or incomplete.10 the FDA report was inaccurate, filed late, Smith et al. at the University of Dr. Martin Makary, Johns Hopkins or not filed. Of these eight, FDA did not North Carolina conducted a study of University, was noted to say that MAUDE receive a report on five, although several 250 robotic-assisted radical cystectomy is a “haphazard reporting system that were in litigation and had been reported cases. This study showed no defini- uses immature data and only the best via the media. Cooper et al. recom- tive proof that the robotic approach experiences make it into the data.”15 On mended that a standardized mechanism decreased complications or improved November 23, 2013, Intuitive Surgical, Inc. be put in place to monitor device and patient outcomes as compared with open posted an analysis of the MAUDE data- patient safety. The authors opine that procedures. The authors found that base by date of event from 2010 to 2013. there are several reasons for underreport- patient selection was key when a surgeon Its analysis showed a decrease in the over- ing of robotic surgical events, including was new to robotics and suggested that all adverse event rate. Included in its rate difficulty in separating poor surgical simple cases be done until the surgeon calculation explanation, Intuitive states, skill from device-related injuries, little was past his or her learning curve. The “Rate computed by dividing number of oversight regarding reporting, and little authors found that use of perioperative adverse events by number of surgical proce- incentive to improve reporting.14 care pathways, intraoperative techniques dures completed worldwide through learned from increasing experience, and 31 October 2013. Q4 2013 procedures Reviews in Literature careful instrument selection helped avoid are an estimate.”12 The actual denominator Tsao et al. at the University of Pittsburgh complications.19 of total robotic cases was not found to reviewed their first 100 patients having Davis et al. performed a study utilizing be reported in the literature reviewed, robotic-assisted laparoscopic prostatec- a large database to assess the learn- but the manufacturer approximated that tomy from October 2004 to August 2007 ing curve effect for robotic-assisted 1.5 million procedures have been per- performed by three attending surgeons. radical prostatectomies (RARPs) and to formed worldwide as of December 2013.7,16 The variables reviewed included estimated compare the outcomes of RARP with Gupta et al. performed a study of the blood loss, operative time (trocar place- open radical prostatectomy (ORP). The MAUDE database for the years 2009 and ment to skin closure), margin status, database consisted of 71,312 reports of 2010 for which 741 events were identified length of stay, postoperative prostate- radical prostatectomies performed at that involved robotic surgery. The authors specific antigen level, and continence. more than 300 hospitals by more than reported that of the cases reviewed, 27.3% The authors found that 99% of the sur- 3,739 surgeons utilizing an open or were urology, 32.6% gynecology, 10.8% geries were completed robotically and only robotic approach from 2004 to 2010. The other, and 29.2% not specified. This one converted to an open case. No intra- key variables reviewed were conversion study found that 43.4% of the cases were operative complications were reported, to open, surgical time, inpatient length associated with use of an energy instru- and 23% of the surgeries had positive mar- of stay, and complications. The RARP ment, 19.3% with the surgical system, gins. Postoperative complications included results by surgeon experience showed Page 94 Pennsylvania Patient Safety Advisory Vol. 11, No. 3—September 2014 ©2014 Pennsylvania Patient Safety Authority improvements in conversion rates (1.13% Figure 1. Robotic-Assisted Surgery Events by Calendar Year 2005 to 2014, as to 0.31%), surgery time (5.0 hours to 4.1 Reported to the Pennsylvania Patient Safety Authority (N = 722 reports through hours), hospital stay (2.4 days to 2.0 days), March 2014) and complication rates (11.75% to 8.93%) NO. OF EVENTS within the initial 100 cases performed by the surgeon. The study also noted that 200 182 there was continued improvement in 180 167 conversion rates, surgery time, and hos- 154 pital stay beyond the initial 100 cases. In 160 comparing the two surgical approaches, 140 the length of surgical time was greater for 115 RARP than for ORP, but the length of the 120 hospital stay and overall complication rate 100 was lower for the robotic approach.20 78 79 80 PA-PSRS Reports 60 43 A query of PA-PSRS reports using the 40 27 terms “robot” and “da Vinci” from June 19 MS14417 2004 through March 2014 found 913 20 5 events. Of these reports, 722 events 0 directly involved RAS. Figure 1 shows the 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014* distribution of reports by calendar year. YEAR It was noted that the Authority did not * The number of events for 2014 is a forecasted value. Forecast was calculated using receive any reports involving RAS occur- formula a+bx, where a = y-b¯ , b = ∑(x-¯)(y-¯ )/∑(x-¯)2 and where x and y are the ¯ x x y x ring in 2004. sample means of known calendar years and of known events reported for full calen- dar years, respectively. The forecast section of the stacked bar for 2014 represents the Analyzing the event date by event type forecast total less the known number of events through first quarter 2014 (n = 35). shows that complications of procedure/ treatment/test, errors related to proce- dure/treatment/test, and equipment/ involved perforation or laceration of a which 20.0% were related to positioning supplies/devices events comprised 90.2% vessel or bowel. complications. See Figure 3. of all RAS events (see Figure 2). Five Further review was performed on the Hospitals also provide information hundred forty-five reports (75.5%) were subcategories and narrative details of the describing contributing factors and categorized as Incidents that may or may Serious Events to gain a better under- remedies to reduce reoccurrences. It was not have reached the patient and did standing of the reports that resulted in noted that two of the Serious Events not result in patient harm. Of the 545 patient harm. It was noted that errors identified inexperienced staff or issues of Incidents reported, 131 (24.0%) were related to procedure/treatment/test and staff proficiency as a contributing factor. attributed to equipment/supplies/devices. complications of procedure/treatment/ Fourteen Serious Events documented that One hundred and seventy-seven (24.5%) test totaled 98.9% of all Serious Events further education and training of the staff of the PA-PSRS reports were reported as (see Figure 2). and referral of these events to medical Serious Events that resulted in patient In reviewing the reported complications leadership, administration, and quality/ injury, including 10 events that resulted and narrative details of the PA-PSRS risk management for further review were in a patient death. Ninety-nine percent RAS Serious Events, the most frequently recommended to prevent reoccurrence. of Serious Events were attributed to occurring complications were unin- The following are samples of events complications of procedure/treatment/ tended laceration/puncture (43.5%) reported to the Authority. test and errors related to procedure/treat- and bleeding/hemorrhage (17.5%). Unintended Laceration/Puncture ment/test, with only one event attributed Retained foreign body and infection each to equipment/supplies/devices. Five of accounted for 4.0% of complications. During robotic-assisted lobectomy, the 10 patient events resulting in death Other complications were reported in the patient’s pulmonary artery was 31.1% of the Serious Event reports, of nicked. The procedure was converted Vol. 11, No. 3—September 2014 Pennsylvania Patient Safety Advisory Page 95 ©2014 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S to an open thoracotomy, resuscitation Figure 2. Robotic-Assisted Surgery by Event Report Types, 2005 through was not successful, and the patient March 2014, as Reported to the Pennsylvania Patient Safety Authority (N = 722) died. Training and education of the staff was recommended as a remedial EVENT TYPE measure to prevent recurrence. Complication of procedure/ 181 Bleeding/Hemorrhage treatment/test 131 Patient underwent robotic-assisted laparoscopic partial left nephrectomy Error related to procedure/ 163 without incident. H/H [hemoglo- treatment/test 44 bin and hematocrit] dropped, and 131 increased bleeding around the JP Equipment/supplies/devices 1 [Jackson-Pratt] drain was noted. Patient was taken back to the OR 44 [operating room] for exploratory Skin integrity 1 laparoscopy; evacuation of hematoma Incidents and cauterization of various bleeding 25 Other/miscellaneous Serious events points was performed. Patient was 0 returned to unit stable; later, the 1 MS14418 patient was observed with increased Fall 0 blood in JP drain. The decision was made to take the patient back to the 0 50 100 150 200 OR for open exploration. Nephrec- tomy was performed and adrenal NO. OF EVENTS gland found to be actively bleeding and also removed. Patient returned to the wound was closed. The staff was postoperatively. [More than five unit in stable condition. informed that this patient presented hours later,] patient complained of After a robotic TATA [transanal flank pain on same side as positioned to another hospital for removal of a abdominal transanal proctosigmoid- in OR. Symptoms of compartment retained foreign body. Case referred ectomy with descending coloanal syndrome noted. Return to OR for to surgical and ENT [ear, nose, and anastomosis] and diverting loop fasciotomy. Return to ICU. Condi- throat] departments for further qual- ileostomy procedure, the patient devel- tion deteriorated. Renal failure, ity review. oped hypotension, tachycardia, and a comfort measures per family request/ Infection drop in hemoglobin. The patient was decision. Patient expired. Education returned to the OR for laparoscopic and training of staff along with Debris left on robotic instrument and washout of intra-abdominal hema- review/revision of policies and pro- was introduced into the patient’s toma and vascular control of the cedures and referral to medical and abdominal cavity upon insertion of inferior mesenteric artery. administrative leadership for further instrument through port. Area irri- quality review were recommended. gated and patient received antibiotics Positioning postoperatively. Lack of staff profi- A patient underwent an elective Retained Foreign Body ciency noted as a contributing factor nephrectomy via laparoscopic robotic A patient underwent a robotic trans- to the event. procedure. Noted small bowel axillary thyroid lobotomy. Midway perforation in two separate areas. through the robotic dissection, the KEY STRATEGIES FOR Severe adhesions noted from previous electrical power was lost [on] three IMPLEMENTING A ROBOTIC abdominal surgery. Surgery consulted. separate occasions [not exceeding SURGERY PROGRAM Repair performed. Proceeded with 30 seconds]. The case was converted Training and Education open nephrectomy. Time patient to open. During the robotic procedure, positioned on side in OR exceeded metallic clips were used and the As noted in several of the included event expected surgical time. Patient went instruments were entangled in a gauze narratives, training and education, to the ICU [intensive care unit] sponge. The counts were correct and credentialing, and continuous quality Page 96 Pennsylvania Patient Safety Advisory Vol. 11, No. 3—September 2014 ©2014 Pennsylvania Patient Safety Authority Figure 3. Robotic-Assisted Surgery Serious Events by Reported Complications, both the short and the long term. This 2005 through March 2014, as Reported to the Pennsylvania Patient Safety Authority program was funded by a grant, but UC (N = 177) Irvine estimates that the cost of providing Retained foreign body this type of training would be approxi- 7 (4.0%) mately $10,000 per surgeon. Bleeding/ Infection Other—positioning 7 (4.0%) Another example of an organization’s hemorrhage complications 31 (17.5%) 11 (6.2%) RAS training program (at Tacoma General Hospital in Tacoma, Washington) is discussed by Lenihan.2 The military and aviation industries have a long history of requiring flight simulation training Other and strict regulations on licensing and 55 (31.1%) maintenance of skills.25 Lenihan likens operating a robotic surgical system, such as the da Vinci, to flying an airplane and believes that aviation safety standards can be employed. As part of a hospital’s train- ing program, the hospital can develop a Unintended Other—nonpositioning system whereby the surgeons, like pilots, laceration/puncture complications train and test to become credentialed, 77 (43.5%) 44 (24.9%) MS14419 then must perform a certain number of procedures, get additional training, and Note: Sum of percentages does not equal 100 due to rounding. take annual examinations to prove contin- ued competency.2 Lenihan reports that Tacoma General reviews are necessary to ensure that a In general, RASs performed by inexpe- Hospital’s robotic surgical training and robotic surgery program functions safely rienced surgeons result in longer OR credentialing system is based on the and efficiently. Attention to the following times and increased complications. When aviation model, and other hospitals may issues will assist the hospital in ensuring the necessary training time, increased consider this program as a template for optimal patient outcomes while mitigat- procedure times, and increased risks are establishing a robotic surgery program. ing RAS risks and complications. taken into account, overall RAS results The program identified training candi- increased costs to the medical system dur- dates as those surgeons who perform Robotic surgical training provided by ing the learning curve period. frequent major surgery, are comfortable the manufacturer provides basic training with complex surgical procedures, and but does not ensure that the surgeon is The University of California, Irvine (UC have laparoscopic experience. Consistent competent to perform RAS. Larson et al. Irvine) developed a successful robotic training was given to all, including didac- reported that the learning curve for a training program utilizing a three-phase tic training, dry lab on a robotic platform physician starting robotic surgery is steep, approach to learning and the guidance or simulator, case observation, live animal and the credentialing plan must address of an experienced mentor.23 In 2003, model lab training, and proctored cases. the individual learning needs.21 Steinberg McDougall et al. presented a five-day com- More steps could be added for residency et al. devised a theoretical model to prehensive mini-residency program at UC or fellowship programs. Each surgeon had determine the operative costs during the Irvine to 21 urologists from four countries a minimum of two cases proctored and learning curve for robotic-assisted pros- that included dry lab, animal/cadaver mentoring by a skilled robotic surgeon tatectomy and compared the costs with lab, and live demonstration in the OR.8,24 when the surgeon started performing an actual series of robotic-assisted prosta- Within 14 months of the course, 95% of more complex cases or new procedures. tectomies. The most expensive learning the participants were safely performing A proctor was defined as a surgeon who curve involved 360 cases with operative RARP. All participants recommended this has performed 40 RASs internally or and anesthesia costs totaling $1.3 million, program to their colleagues. Follow-up externally, has done the procedure they and the least expensive learning curve studies showed that these participants are proctoring, and has a standardized involved 24 cases and totaled $95,000.8,22 were able to keep up safe practice in Vol. 11, No. 3—September 2014 Pennsylvania Patient Safety Advisory Page 97 ©2014 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S evaluation process to report back to a surgeon seeking privileges in robotics: proper placement of the instruments both the surgeon and executive team at 8 preoperative, 15 intraoperative, and and supplies needed for RAS, along the hospital.2 2 postoperative tasks.27 with other instruments if the case con- Tacoma General Hospital required that verts to an open procedure. Rehearsed 12 to 15 simple cases be done first before Team Training practice will allow the surgical team to attempting complex cases. For the sur- Proper training of the entire team is refine their practice and evaluate what geon’s first advanced case, a physician critical to maintain patient safety. Staff changes they will need to incorporate first assistant is utilized. If it is a new need experience with the robotic system, into their practice and communication case, the physician is proctored. After cadaver training, observation of an expe- patterns.33 A second time-out occurs three completing training, the surgeon starts rienced team, and simulation training. to four hours after the start of RAS. This doing cases right away and no later than Simulation training studies show that it additional time-out is designed to assess 60 days after completion of training. takes surgeons eight attempts to achieve patient safety and promote communica- Tacoma General Hospital’s Robotics Peer proficiency in each step of a RAS pro- tion between the surgical, anesthesia, and Review Committee does a focused review cess.28 The entire team needs to practice nursing staff while addressing specialty of the first five basic cases and first three together on the equipment prior to using concerns, such as proper patient position- advanced cases. The established minimum it on patients.29 The University of Iowa ing, that affect patients during robotic number of cases for a surgeon to maintain Hospitals and Clinics has developed staff surgery.34 In addition, use of a robotic skills and privileges is set at 20 to 24 cases competency forms and robotic suite setup surgical safety checklist may help reduce per year and at least one every eight weeks. diagrams for prostatectomy as good visual the risk of intraoperative complications.35 If a surgeon does not meet their currency teaching aides for the clinical staff.30 requirements, they can try to increase their Credentialing Team training includes drills for any type volume of surgical procedures or they can of failure that might occur during robotic The Society of Urologic Robotic Surgeons retrain in the dry lab using a simulator surgery—for example, drills addressing has published suggested recommenda- and then have the next three cases proc- equipment failure, conversion to an open tions for the safe implementation and tored by a fully qualified robotic surgeon procedure, and removal of equipment credentialing of RARP at an institution. and reviewed.2 from the surgical cavity.31 It stresses the need for a centralized certi- fication authority that would not be the Although professional organizations have Because robotic equipment, particularly robotic industry. This authority would be not reached consensus on a consistent the robotic arm, necessitates unobstructed responsible for identifying and promoting training program, nor have they come to movement, patient positioning is more expert robotic surgeons who would be agreement on the definition of compe- complex. And once the robot is docked, it permitted to function as proctors for other tency to perform the procedures, several is difficult to access positioning. Patients physicians learning robotic skills. Among have published recommendations.7,12,13 In can experience position-related complica- the other recommendations presented 2007, a consensus document prepared by tions such as peripheral nerve injury and was the need to ensure that the novice the Society of American Gastrointestinal rhabdomyolysis. The deep Trendelenburg urologist would have three to five cases and Endoscopic Surgeons along with the position, in which the patient is inclined proctored for review by the healthcare Minimally Invasive Robotic Association at 45 degrees with the pelvis higher than organization’s credentialing commit- presented guidelines for the level of train- the head, used in gynecologic and urologic tee. The credentialing committee would ing needed to perform robotic surgery surgeries, can increase intraocular pres- develop written guidelines to reduce and for granting privileges as part of the sure. If the patient’s position is changed liability exposure for the proctor as well credentialing process. The guidelines during the procedure, it may not be as address informed consent. This pro- include didactic training, live case obser- noticed, as the large robot obscures the cess would include notifying the patient vation of an experienced robotic surgical patient. Elevating the patient’s head or regarding the role of the proctor during team, and simulation training in prepara- arm to make room for the robotic arm may the surgery. The organization further rec- tion for a mentored clinical experience lead to hyperabduction of the elevated arm ommended that evaluation of the robotic at the hospital.26 The Fundamentals of and a potential neurologic injury.32 surgeon be an ongoing process and that Robotic Surgery consensus conference The team will need to adapt to the size failure to perform at a satisfactory level brought together over 19 professional of the robot in the operative suite and would require a recommendation for fur- organizations and developed a list of ensure that there is adequate space for ther education or preceptoring.8 25 outcome measures to be mastered by Page 98 Pennsylvania Patient Safety Advisory Vol. 11, No. 3—September 2014 ©2014 Pennsylvania Patient Safety Authority Lenihan describes competency-based cre- review by risk management or any mem- A PENNSYLVANIA HOSPITAL’S dentialing for robotic surgery at Tacoma ber of the surgical or clinical team, and all EXPERIENCE General Hospital. Outcome standards 20 cases of a surgeon in provisional status Francine Miranda, director of OB/GYN were developed that include review of seeking advancement to full privileges.37 quality and performance improvement total operative time, estimated blood Martino et al. at Lehigh Valley Health at Lehigh Valley Hospital (LVH) and loss, and major robotic complications Network studied 2,554 patients who Authority editorial board member, such as injury or conversion to an open underwent a hysterectomy between January shared in a telephone interview on case. If the surgeon’s performance does 2008 and December 2012. Women under- May 22, 2014, the highlights of her not meet the organization’s established going robotic-assisted hysterectomy to treat organization’s robotics program.40 LVH outcome standards, the Robotics Peer benign disease had fewer readmissions implemented a robotics program in 2008 Review Committee reviews the surgeon’s within 30 days, less estimated blood loss, and currently has three robotic surgical performance. Options to improve skills shorter lengths of stay, and a cost savings systems. LVH performs between 800 and can be offered, such as working with a related to those readmissions when com- 900 RASs per year and has performed proctor on each case, obtaining advanced pared with laparoscopic, abdominal, and over 3,000 procedures since 2008. training, practicing on the simulator, vaginal approaches. More prospective stud- continuing to do only basic cases, or refer- Miranda stated that LVH adheres to a ies are recommended for all the surgical team approach and that training is a key ring cases to a more experienced surgeon. modalities so that surgeons can evaluate Use of simulators can be factored into component of the program. All members the outcome of robotic surgery and the of the robotics team receive coordi- competency evaluation or annual review benefit, or lack thereof, to the patient.38 of skills to document proficiency. If a nated and intense training. The team case falls out due to a competency issue, recently attended the Fundamentals of Patient Disclosure Robotic Gynecologic Surgery Consensus the committee can recommend focused reviews, additional training, having an Specific informed consent considerations Committee meeting. She reported experienced robotic surgeon review all the will need to be addressed with an RAS that what is clear is that there is much cases, having a proctor in on every case, or program. Patients need to know more discussion among the various surgical limiting privileges.2 than just the general risks, benefits, and disciplines and that this group is working alternatives that are associated with the on coming to a consensus on generalized A robust credentialing process requires procedure. The risk of robot malfunction training and credentialing standards for that an ongoing quality outcomes pro- and the readiness to implement a contin- all organizations to follow. LVH currently cess be in place. Literature supports the gency plan, such as converting to an open utilizes RAS in general surgery, urology, need to study patient outcomes and procedure, can also be addressed in the benign gynecology, gynecologic oncology, the cost-effectiveness of using a robotic informed consent discussion. Surgeons urogynecology, thoracic, colorectal, and technique versus another modality. For will need to spend time with the patient surgical oncology procedures. Simulator radical prostatectomies, most of which explaining the pros and cons of selecting training at LVH is part of the curriculum. are done robotically, oncologic outcomes robotic surgery over other modalities.13,34 The team also performs drills for all and improved complication rates have not types of emergency situations, including been proved.36 Outcomes to be measured Plaintiff’s attorneys are alleging insuf- ficient training and credentialing against converting to an open procedure. LVH may include blood loss, complication utilized taped vignettes that show the rates, hospital lengths of stay, operating the hospitals in medical malpractice litigation. Surgeons may be charged with correct and incorrect ways to handle emer- times, postoperative pain, and time to gency situations. return to activities of daily living.30 failing to obtain proper informed con- sent even if they have disclosed surgical In regard to credentialing and privileging, Brown University Women and Infants’ risk but have not disclosed the surgeon’s every surgeon has to perform at least Hospital’s Robotics Surgery Peer Review robotic training and where they are on the 25 cases—of which at least three to five are Committee consists of robotic surgeons learning curve. The argument presented is proctored by an experienced robotic privi- and quality, risk management, and that had the patient known that the sur- leged surgeon—before advancing to full infection control professionals. This com- geon lacked experience in robotic surgery, privileges. Each physician has a scorecard mittee reviews the following cases: any the patient would not have elected to have that the quality/performance improve- conversion to open surgery, any patient the procedure or would have selected a ment department prepares. Indicators seen in the emergency department within more experienced surgeon.39 such as number of surgeries performed two weeks of surgery, any case referred for and complications are reviewed. In Vol. 11, No. 3—September 2014 Pennsylvania Patient Safety Advisory Page 99 ©2014 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S addition, 100% of benign gynecologic, related to robotic surgery, such as nerve with accurate data that surgeons can gynecologic oncology, and urogynecologic damage, lymphedema, facial swelling, and use to compare RAS with other surgical robotic cases are reviewed by Miranda’s ear problems (LVH’s gynecology oncol- modalities is necessary. quality/performance improvement staff. ogy hysterectomy/other procedures form Until clear, consistent standards have been She stated that not all organizations are is available in the online version of this established by the professional organiza- able to do this, but she feels that by doing article). In addition, LVH educates the tions, the responsibility rests with the this, her organization knows exactly what community on robotic surgery. Every year, hospital to develop training programs issues need to be changed in order to the organization sponsors the Robotic that adequately prepare the physician and improve practice. Miranda noted that the Olympics, at which time it takes its the entire surgical team to safely perform more proficient a surgeon becomes, the robotic simulator out into the community robotic procedures. A documented steep better outcomes he or she sees. and lets the general public get a chance to learning curve for surgeons as they master Miranda stated that the team also does an operate the robotic simulator. the use of robotic systems may challenge additional time-out at four hours, as they hospitals to ensure that training and cre- know that a prolonged operative time CONCLUSION dentialing are done in a fashion that is along with the position of the patient can RAS is rapidly being deployed in hospitals both medically sound and consistent. Staff lead to complications. During this second throughout the United States and abroad. may utilize various forms of training, which time-out, the surgeon, anesthesiologist, The growth of robotics programs has may include simulation training, so that and entire OR staff review patient safety outpaced the industry’s ability to develop they are prepared to handle any emergency issues, including patient positioning and and implement clear, consistent standards situation that may occur during a robotic the need for additional antibiotics. for training and credentialing. Research is procedure. In addition, the hospital can LVH has updated its gynecology/ needed that evaluates outcomes, patient ensure optimum outcomes for patients urogynecology and gynecology oncology benefits, the ergonomics for the surgeon, and that appropriate policies and proce- hysterectomy/other procedures consent and the costs related to RAS. The need dures are in place for training, privileging forms to address potential risks specifically for standardized training, consistent and credentialing, proctoring, informed patient education, and outcome registries consent, and equipment maintenance. NOTES 1. Barbash GI, Glied SA. New technology United States: process, patient safety, 11. Greenberg H. Counting the problems and health care costs--the case of robotic- learning curves, and the public. World J with robot-assisted surgery [online]. 2013 assisted surgery. N Engl J Med 2010 Aug 19; Urol 2013 Jun;31(3):455-61. Apr 18 [cited 2014 May 29]. http://www. 368(8):701-4. 7. Intuitive Surgical, Inc. da Vinci surgery cnbc.com/id/100653176 2. Lenihan JP. Navigating credentialing, [online]. [cited 2014 May 29]. http:// 12. Intuitive Surgical, Inc. 2010-2013 privileging, and learning curves in robot- davincisurgery.com MAUDE database analysis by date of ics with an evidence and experience-based 8. 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Miranda, Francine (Director of OB/GYN Surg Tech A 2013 Jun;23(6):516-20. complications of robotic thoracic surgery. Quality and Performance Improvement, Minerva Anesthesiol 2014 Jan;80(1):83-8. Lehigh Valley Hospital). Telephone inter- view with: Deborah Dubeck. 2014 May 22. Vol. 11, No. 3—September 2014 Pennsylvania Patient Safety Advisory Page 101 ©2014 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 11, No. 3—September 2014. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2014 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. 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