Why Credentialing Is Vital To Robotic Surgery and How To Make It Work

Recently, training surgeons and surgical teams has been one of the focus areas in litigation for robotic surgery. Test cases have stated that the responsibility for training, credentialing, and privileging surgeons to use new technologies belongs to physicians and the hospitals where they work. (Taylor v. Intuitive Surgical, WA State 2015).

Dr. John Lenihan, Medical Director of Robotics & MIS, MultiCare Health Systems, Tacoma, WA, is also a trained Air Force pilot and flight surgeon. For a long time he has seen the similarities between flying and using a robotic surgical system. Both involve using systems that can have impact on human life, both have a learning curve that varies with the user, both require that the user makes sure their skills are being maintained before they use the system, and both can be validated on an annual basis.

As a Gynecologist, Dr. Lenihan also worries that given the national trend moving away from Hysterectomies toward other treatment modalities, that surgeons may not have as many opportunities as they had previously to keep their skill levels up. (Wright JD et al. Nationwide Trends in Inpat Hysterectomy in the US. Obstet Gynecol. Aug 2013 122(2), Part 1. 233-41).

A paper by Wallenstein MR, et al., titled “On Effects of Surgical Volume on Outcomes for Laparoscopic Hysterectomy for Benign Conditions,” highlighted this fact. It shows that the overall volume of laparoscopic hysterectomies has decreased by some 30% over the period 2000 to 2010, however, the percentage of cases being carried out by low volume surgeons (less than 6 laparoscopic hysterectomies a year) has increased.

Effects of Surgical Volume on Outcomes for Laparoscopic Hysterectomy for Benign Conditions

Wallenstein MR et. al. Effects of Surgical Volume on Outcomes for Laparoscopic Hysterectomy for Benign Conditions. April 2012 Obstet Gynecol.119(4); 710-16

As a member of the AAGL (formerly the American Association of Gynecologic Laparoscopists) Special Interest Group on robotics, Dr. Lenihan produced with his colleagues guidelines for privileging for robotic-assisted Gynecological Laparoscopy. These were approved by the AAGL Board as an official recommendation by the Society in February of 2014. (J Minim Invasiv Gynecol, 21(2), Mar-Apr 2014).

It follows the same model and parameters you would expect of a pilot and is divided into three groups:

• Initial Credentialing:

o Establish standards to comply with learning curves

o Basic cases first with qualified assistants

o Then progress to more complicated cases

• Maintenance “Currency”:

o Establish minimum guidelines for numbers of cases to maintain surgical skills o Encourage the use of simulators to maintain skills

o If minimums not met, require re-training and re-certification (proctoring)

• Competency Certification:

o Establish standards, utilize simulation, consider “check rides” and/or do case review

Dr. Lenihan is a firm believer in establishing proficiency through simulation. “The key to developing proficiency is practice, practice, practice,” Lenihan says, “you have to do each exercise until you have passed it at least five times with at least two consecutive passes.” All this within a structured approach with defined curriculum for basic and advanced users as well as specific curricula developed for annual credentialing.

Lenihan has taken this philosophy and applied to his own institution at MultiCare Tacoma. Between 2008 & 2009, competency was initially evaluated on outcomes. Surgeons were not expected to deviate more than 2 standard deviations away from hospital or national norms in key metrics such as operative times, blood loss, complications, etc. From 2009 to the present day, surgeons are expected to demonstrate proficiency annually using simulators. If there are poor outcomes, these are reviewed by the robotic committee and corrective actions, including simulation training, will be put in place.

More recently, Dr. Lenihan has been investigating the possibility of initiating a continuous improvement program through the use of the C-SATS platform to offer performance evaluation through crowd sourcing. Videos can be reviewed and technical weakness using a GEARS score can be calculated looking for such things as depth perception, bi-manual dexterity, efficiency, force sensitivity, and overall robotic control. When weaknesses are assessed then surgeon can be given specific curricula on their Mimic dV-Trainer that will allow them to improve and practice in those key areas. The improvement can be validate again via crowd sourcing before a surgeon operates again on a patient.

“The fundamentals are simple,” says Dr Lenihan, “you establish a credentialing and privileging system that relies in simulation. You use simulation to improve and maintain skills during period of inactivity. You can then use video review to help document proficiency and help low volume surgeons with tailored skill improvement curricula.”