Opinion
VIEWPOINT
Jason C. Pradarelli, BS Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor; and University of Michigan Medical School, Ann Arbor. Darrell A. Campbell Jr, MD Michigan Surgical Quality Collaborative, University of Michigan, Ann Arbor; and Department of Surgery, University of Michigan, Ann Arbor. Justin B. Dimick, MD, MPH Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor; and Department of Surgery, University of Michigan, Ann Arbor.
Author Audio Interview at jama.com
Corresponding Author: Jason Pradarelli, BS, Center for Healthcare Outcomes and Policy, University of Michigan Medical School, 2800 Plymouth Rd, Bldg 16, Office 100N-07, Ann Arbor, MI 48109 ([email protected] .edu). jama.com
Hospital Credentialing and Privileging of Surgeons A Potential Safety Blind Spot Innovative procedures and technologies are regularly introduced into clinical practice. Although the US Food and Drug Administration (FDA) exercises strict regulatory control over new drugs, it exerts minimal oversight for new devices and no oversight for new surgical techniques. When technology such as the da Vinci robot enters the field of surgery, it is less clear who is responsible for ensuring its safe introduction. When implementing new technologies, physicians are guided by their sense of professionalism and the potential liability for medical malpractice; hospitals jointly share the medicolegal risks by confirming the qualifications of licensed physicians (credentialing) and by authorizing those physicians for specific patient care services (privileging). In recent years, controversy has arisen when manufacturers go beyond their traditional role (ie, to reasonably design and manufacture a device) and participate in training and credentialing physicians to use their company’s product. This Viewpoint reviews an important legal ruling on robotic surgery that highlights potential safety concerns regarding the regulation of novel procedures and technologies as they enter clinical practice. In 2000, the da Vinci Surgical System (Intuitive Surgical) was initially approved by the FDA for use in general laparoscopic surgical procedures. Despite little evidence, robotic surgery was touted to have many benefits. Dissemination of this technology was rapid in its first decade as the FDA expanded its list of approved indications across general surgery, urology, gynecology, cardiothoracic surgery, pediatric surgery, and otolaryngology disciplines. The widespread adoption of robotic surgery has been partially attributed to aggressive marketing tactics, which increased demand for the technology from patients and invoked fascination among patients, surgeons, and hospitals. A recent legal ruling on the lawsuits against Intuitive Surgical sheds light on where the responsibility may lie for ensuring the safe introduction of new procedures. In 2013, Taylor v Intuitive, the first of at least 26 lawsuits against Intuitive, went to trial alleging injuries or death tied to the da Vinci Surgical System. This is the only case to date that has reached trial.1 The patient underwent a robotic-assisted radical prostatectomy that was complicated by a markedly prolonged operating time and conversion to the open procedure. He experienced a collection of complications, including a rectal laceration leading to reoperation and colostomy, sepsis, acute renal and respiratory failure, stroke, and incontinence.2,3 The lawsuit was filed because of severe limitations in the patient’s postoperative functional quality of life; the plaintiffs argued that this debility accelerated his cardiovascular disease and led to his death 4 years later at age 71 years.
The surgeon who performed this operation was a board-certified urologist who had performed more than 100 open prostatectomies with good outcomes during a decade in practice.2,3 A novice in robotic surgery prior to this operation, the surgeon underwent preparatory training designed by Intuitive, involving 1 day of hands-on training at company headquarters and proctoring on 2 robotic cases by a more experienced surgeon.2,3 The hospital had little experience with robotic surgery; case documents report that the hospital’s newly created robotics committee—which included Intuitive consultants—based its credentialing requirements solely on Intuitive’s training program.2,3 The operation involving the patient in this case was the surgeon’s third operation using the da Vinci technology and was his first without supervision as the attending surgeon.2 His choice to perform an operation on a morbidly obese patient would have presented a challenge for nearly all inexperienced operators. Acknowledging their responsibility for ensuring patient safety, the attending surgeon, his private practice, and the hospital all settled individual malpractice lawsuits for undisclosed amounts without proceeding to trial. In the 2013 trial of Taylor v Intuitive, the plaintiffs’ attorneys argued that Intuitive failed to provide the attending surgeon with sufficient training and oversight to properly perform the operation using the da Vinci robot.1 The plaintiffs also alleged that the company failed to adequately warn the surgeon about risks, contraindications,anddecisionmakinginvolvedwithusingthedevice.1 However, a Washington State jury ruled in favor of the defense.1 In this exemplar case, negligence was not attributed to Intuitive, the manufacturer of an innovative device that—when improperly used—led to debilitating injuries and the eventual death of a patient. The plaintiffs have since filed an appeal challenging the rulings during the legal proceedings of this case and the verdict2,3; the appellate court heard oral arguments on January 6, 2015, and the matter awaits decision.2,3 In the remaining lawsuits, other courts might rule differently based on Intuitive’s level of involvement in the hospital’s credentialing process. What lessons can physicians and hospitals learn from this trial court ruling? By concluding that Intuitive was not negligent, this decision implies that the medicolegal responsibility for training, credentialing, and privileging surgeons to use new technologies belongs to physicians and the hospitals (or other institutions) where they work. Hospitals cannot rely on manufacturers to fulfill this role. Concordantly, the Joint Commission’s hospital standards state that, to provide safe, high-quality care, the hospital’s medical staff organization is responsible for credentialing and privileging all licensed inde(Reprinted) JAMA April 7, 2015 Volume 313, Number 13
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/14/2015
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Opinion Viewpoint
pendent practitioners.4 At least 25 states currently recognize negligent credentialing as a valid malpractice claim against hospitals.5 Therefore, hospitals continue to bear joint responsibility for medical malpractice resulting from poorly credentialed and privileged physicians. While maintaining the onus of procedural credentialing and privileging on individual hospitals, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Minimally Invasive Robotic Association created guidelines for designing these processes for robotic surgery.6 For surgeons who have never had formal training in robotic surgery through residency or fellowship, the consensus group recommended that hospitals require a structured training curriculum for the particular technology. Varying forms of real-life case experience using the new technology may fulfill the suggested privileging requirements (eg, proctoring by an expert or experience performing another equally complex procedure).6 Although these recommendations offer general guidance, the current system of surgical care delivery lacks the means, other than malpractice liability, of enforcing these safety measures when new procedures and technologies are introduced. For surgeons to have the confidence, experience, and expertise needed to request privileges at an individual hospital, effective educational interventions must be available to train surgeons with the new technology. Even though today’s residencies and fellowships in general surgery, urology, and gynecology, for example, support the learning of knowledge and skills using present-day laparoscopic and robotic technologies, many practicing surgeons have not experienced this formal training with newer minimally invasive techniques. Ensuring adequate training beyond surgical residency or fellowship is a major challenge for hospitals that want to grant privileges for new procedural skills. Recognizing that additional training requires time and is costly, professional specialty organizations might serve as vehicles for this continuing procedural education. As an attempt to ARTICLE INFORMATION Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Dimick is a cofounder of ArborMetrix, a company that makes software for profiling hospital quality and efficiency. Dr Campbell is the program director for the Michigan Surgical Quality Collaborative and was formerly the Chief Medical Officer at the University of Michigan Health System. No other disclosures were reported. Funding/Support: Dr Dimick receives grant funding from the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality, and the BlueCross BlueShield of Michigan Foundation. Mr Pradarelli is supported by an NIH grant (2UL1TR000433) through the Master of Science in Clinical Research program at the University of Michigan. Role of the Funder/Sponsor: The funding sources had no role in the preparation, review, or approval of the manuscript. REFERENCES 1. Estate of Fred Taylor et al v Intuitive Surgical, Inc, No. 09-2-03136-5 (Wash Super Ct, Kitsap County, March 25, 2013).
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ensure sufficient training in laparoscopy, the Fundamentals of Laparoscopic Surgery (FLS) program became a requirement for surgeons to become board-certified in general surgery in 2009.7 However, this web-based education module, endorsed by SAGES and the American College of Surgeons and designed for surgical residents, fellows, and practicing surgeons, teaches only a basic minimum level of laparoscopic surgical knowledge and skills. The effect of FLS on patient outcomes has yet to be determined. Robotic surgery does not yet have a standardized certification process, although organizations are attempting to create a parallel track with laparoscopic surgery and FLS.7 However, such certifications only ensure proficiency with basic tasks and are therefore unlikely to meet hospitals’ needs in credentialing surgeons for complex new procedures. Traditionally, board certification and sufficient experience, measured by surgeons’ procedure volumes, indicated procedural competency and justified surgeons’ credentials.8 Rigorous investigations are needed to find approaches to strengthen hospitals’ credentialing of competent surgeons using effective and novel methods.9,10 Once these methods are validated with evidence on a broad set of procedures, hospital safety committees could feasibly adapt these approaches for peer review to better assess competency in new procedures and to reinforce the credentialing process. This discussion of the events surrounding the case of Taylor v Intuitive highlights the importance of hospitals’ credentialing and privileging mechanisms for maintaining the quality and safety of surgical care, especially regarding new technologies for which practicing surgeons may not have formal training. Accordingly, hospitals bear legal liability for medical malpractice resulting from insufficiently credentialed and privileged physicians. As surgical innovations continue to emerge, and as pressures from patients and hospital administrators to be on the cutting edge of technology continue to increase, strengthening hospitals’ credentialing and privileging for new procedures should be a high-yield target for improving patient safety.
2. Taylor et al v Intuitive Surgical, Inc, No. 45052-6-II (Wash Ct App, Division II, 2015).
/publications/guidelines/consensus-document -robotic-surgery/. Accessed October 21, 2014.
3. Appellate court case summary. Taylor et al v Intuitive Surgical, Inc, No. 450526-II (Wash Ct App, Division II). http://dw.courts.wa.gov/index.cfm ?fa=home.casesummary&crt_itl_nu=A02 &casenumber=450526&searchtype=aName&token =19C4009DC6BDCBCFDECA0E09A4FEFF54 &dt=22486DAAC77DD74FF4AA2786C2CA04D9 &courtClassCode=A&casekey=166496546 &courtname=COA,%20Division%20II. Accessed February 13, 2015.
7. Smith R, Patel V, Satava R. Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot. 2014;10(3):379-384.
4. The Medical Staff Handbook: A Guide to Joint Commission Standards, Third Edition. Joint Commission Resources. http://www.jcrinc.com /the-medical-staff-handbook-a-guide-to-joint -commission-standards-third-edition/. Accessed March 6, 2015. 5. Sorrel AL. Hospital can be sued for credentialing doctor with questionable qualification, Minnesota high court rules. amednews.com. http://www .amednews.com/article/20071015/profession /310159964/4/. Accessed January 17, 2015.
8. Harrysson IJ, Cook J, Sirimanna P, Feldman LS, Darzi A, Aggarwal R. Systematic review of learning curves for minimally invasive abdominal surgery: a review of the methodology of data collection, depiction of outcomes, and statistical analysis. Ann Surg. 2014;260(1):37-45. 9. Birkmeyer JD, Finks JF, O’Reilly A, et al; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013;369(15):1434-1442. 10. Hu YY, Peyre SE, Arriaga AF, et al. Postgame analysis: using video-based coaching for continuous professional development. J Am Coll Surg. 2012;214 (1):115-124.
6. Herron D, Marohn M; SAGES-MIRA Robotic Surgery Consensus Group. A consensus document on robotic surgery. http://www.sages.org
JAMA April 7, 2015 Volume 313, Number 13 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/14/2015
jama.com
VIEWPOINT
Jason C. Pradarelli, BS Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor; and University of Michigan Medical School, Ann Arbor. Darrell A. Campbell Jr, MD Michigan Surgical Quality Collaborative, University of Michigan, Ann Arbor; and Department of Surgery, University of Michigan, Ann Arbor. Justin B. Dimick, MD, MPH Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor; and Department of Surgery, University of Michigan, Ann Arbor.
Author Audio Interview at jama.com
Corresponding Author: Jason Pradarelli, BS, Center for Healthcare Outcomes and Policy, University of Michigan Medical School, 2800 Plymouth Rd, Bldg 16, Office 100N-07, Ann Arbor, MI 48109 ([email protected] .edu). jama.com
Hospital Credentialing and Privileging of Surgeons A Potential Safety Blind Spot Innovative procedures and technologies are regularly introduced into clinical practice. Although the US Food and Drug Administration (FDA) exercises strict regulatory control over new drugs, it exerts minimal oversight for new devices and no oversight for new surgical techniques. When technology such as the da Vinci robot enters the field of surgery, it is less clear who is responsible for ensuring its safe introduction. When implementing new technologies, physicians are guided by their sense of professionalism and the potential liability for medical malpractice; hospitals jointly share the medicolegal risks by confirming the qualifications of licensed physicians (credentialing) and by authorizing those physicians for specific patient care services (privileging). In recent years, controversy has arisen when manufacturers go beyond their traditional role (ie, to reasonably design and manufacture a device) and participate in training and credentialing physicians to use their company’s product. This Viewpoint reviews an important legal ruling on robotic surgery that highlights potential safety concerns regarding the regulation of novel procedures and technologies as they enter clinical practice. In 2000, the da Vinci Surgical System (Intuitive Surgical) was initially approved by the FDA for use in general laparoscopic surgical procedures. Despite little evidence, robotic surgery was touted to have many benefits. Dissemination of this technology was rapid in its first decade as the FDA expanded its list of approved indications across general surgery, urology, gynecology, cardiothoracic surgery, pediatric surgery, and otolaryngology disciplines. The widespread adoption of robotic surgery has been partially attributed to aggressive marketing tactics, which increased demand for the technology from patients and invoked fascination among patients, surgeons, and hospitals. A recent legal ruling on the lawsuits against Intuitive Surgical sheds light on where the responsibility may lie for ensuring the safe introduction of new procedures. In 2013, Taylor v Intuitive, the first of at least 26 lawsuits against Intuitive, went to trial alleging injuries or death tied to the da Vinci Surgical System. This is the only case to date that has reached trial.1 The patient underwent a robotic-assisted radical prostatectomy that was complicated by a markedly prolonged operating time and conversion to the open procedure. He experienced a collection of complications, including a rectal laceration leading to reoperation and colostomy, sepsis, acute renal and respiratory failure, stroke, and incontinence.2,3 The lawsuit was filed because of severe limitations in the patient’s postoperative functional quality of life; the plaintiffs argued that this debility accelerated his cardiovascular disease and led to his death 4 years later at age 71 years.
The surgeon who performed this operation was a board-certified urologist who had performed more than 100 open prostatectomies with good outcomes during a decade in practice.2,3 A novice in robotic surgery prior to this operation, the surgeon underwent preparatory training designed by Intuitive, involving 1 day of hands-on training at company headquarters and proctoring on 2 robotic cases by a more experienced surgeon.2,3 The hospital had little experience with robotic surgery; case documents report that the hospital’s newly created robotics committee—which included Intuitive consultants—based its credentialing requirements solely on Intuitive’s training program.2,3 The operation involving the patient in this case was the surgeon’s third operation using the da Vinci technology and was his first without supervision as the attending surgeon.2 His choice to perform an operation on a morbidly obese patient would have presented a challenge for nearly all inexperienced operators. Acknowledging their responsibility for ensuring patient safety, the attending surgeon, his private practice, and the hospital all settled individual malpractice lawsuits for undisclosed amounts without proceeding to trial. In the 2013 trial of Taylor v Intuitive, the plaintiffs’ attorneys argued that Intuitive failed to provide the attending surgeon with sufficient training and oversight to properly perform the operation using the da Vinci robot.1 The plaintiffs also alleged that the company failed to adequately warn the surgeon about risks, contraindications,anddecisionmakinginvolvedwithusingthedevice.1 However, a Washington State jury ruled in favor of the defense.1 In this exemplar case, negligence was not attributed to Intuitive, the manufacturer of an innovative device that—when improperly used—led to debilitating injuries and the eventual death of a patient. The plaintiffs have since filed an appeal challenging the rulings during the legal proceedings of this case and the verdict2,3; the appellate court heard oral arguments on January 6, 2015, and the matter awaits decision.2,3 In the remaining lawsuits, other courts might rule differently based on Intuitive’s level of involvement in the hospital’s credentialing process. What lessons can physicians and hospitals learn from this trial court ruling? By concluding that Intuitive was not negligent, this decision implies that the medicolegal responsibility for training, credentialing, and privileging surgeons to use new technologies belongs to physicians and the hospitals (or other institutions) where they work. Hospitals cannot rely on manufacturers to fulfill this role. Concordantly, the Joint Commission’s hospital standards state that, to provide safe, high-quality care, the hospital’s medical staff organization is responsible for credentialing and privileging all licensed inde(Reprinted) JAMA April 7, 2015 Volume 313, Number 13
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/14/2015
1313
Opinion Viewpoint
pendent practitioners.4 At least 25 states currently recognize negligent credentialing as a valid malpractice claim against hospitals.5 Therefore, hospitals continue to bear joint responsibility for medical malpractice resulting from poorly credentialed and privileged physicians. While maintaining the onus of procedural credentialing and privileging on individual hospitals, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the Minimally Invasive Robotic Association created guidelines for designing these processes for robotic surgery.6 For surgeons who have never had formal training in robotic surgery through residency or fellowship, the consensus group recommended that hospitals require a structured training curriculum for the particular technology. Varying forms of real-life case experience using the new technology may fulfill the suggested privileging requirements (eg, proctoring by an expert or experience performing another equally complex procedure).6 Although these recommendations offer general guidance, the current system of surgical care delivery lacks the means, other than malpractice liability, of enforcing these safety measures when new procedures and technologies are introduced. For surgeons to have the confidence, experience, and expertise needed to request privileges at an individual hospital, effective educational interventions must be available to train surgeons with the new technology. Even though today’s residencies and fellowships in general surgery, urology, and gynecology, for example, support the learning of knowledge and skills using present-day laparoscopic and robotic technologies, many practicing surgeons have not experienced this formal training with newer minimally invasive techniques. Ensuring adequate training beyond surgical residency or fellowship is a major challenge for hospitals that want to grant privileges for new procedural skills. Recognizing that additional training requires time and is costly, professional specialty organizations might serve as vehicles for this continuing procedural education. As an attempt to ARTICLE INFORMATION Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Dimick is a cofounder of ArborMetrix, a company that makes software for profiling hospital quality and efficiency. Dr Campbell is the program director for the Michigan Surgical Quality Collaborative and was formerly the Chief Medical Officer at the University of Michigan Health System. No other disclosures were reported. Funding/Support: Dr Dimick receives grant funding from the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality, and the BlueCross BlueShield of Michigan Foundation. Mr Pradarelli is supported by an NIH grant (2UL1TR000433) through the Master of Science in Clinical Research program at the University of Michigan. Role of the Funder/Sponsor: The funding sources had no role in the preparation, review, or approval of the manuscript. REFERENCES 1. Estate of Fred Taylor et al v Intuitive Surgical, Inc, No. 09-2-03136-5 (Wash Super Ct, Kitsap County, March 25, 2013).
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ensure sufficient training in laparoscopy, the Fundamentals of Laparoscopic Surgery (FLS) program became a requirement for surgeons to become board-certified in general surgery in 2009.7 However, this web-based education module, endorsed by SAGES and the American College of Surgeons and designed for surgical residents, fellows, and practicing surgeons, teaches only a basic minimum level of laparoscopic surgical knowledge and skills. The effect of FLS on patient outcomes has yet to be determined. Robotic surgery does not yet have a standardized certification process, although organizations are attempting to create a parallel track with laparoscopic surgery and FLS.7 However, such certifications only ensure proficiency with basic tasks and are therefore unlikely to meet hospitals’ needs in credentialing surgeons for complex new procedures. Traditionally, board certification and sufficient experience, measured by surgeons’ procedure volumes, indicated procedural competency and justified surgeons’ credentials.8 Rigorous investigations are needed to find approaches to strengthen hospitals’ credentialing of competent surgeons using effective and novel methods.9,10 Once these methods are validated with evidence on a broad set of procedures, hospital safety committees could feasibly adapt these approaches for peer review to better assess competency in new procedures and to reinforce the credentialing process. This discussion of the events surrounding the case of Taylor v Intuitive highlights the importance of hospitals’ credentialing and privileging mechanisms for maintaining the quality and safety of surgical care, especially regarding new technologies for which practicing surgeons may not have formal training. Accordingly, hospitals bear legal liability for medical malpractice resulting from insufficiently credentialed and privileged physicians. As surgical innovations continue to emerge, and as pressures from patients and hospital administrators to be on the cutting edge of technology continue to increase, strengthening hospitals’ credentialing and privileging for new procedures should be a high-yield target for improving patient safety.
2. Taylor et al v Intuitive Surgical, Inc, No. 45052-6-II (Wash Ct App, Division II, 2015).
/publications/guidelines/consensus-document -robotic-surgery/. Accessed October 21, 2014.
3. Appellate court case summary. Taylor et al v Intuitive Surgical, Inc, No. 450526-II (Wash Ct App, Division II). http://dw.courts.wa.gov/index.cfm ?fa=home.casesummary&crt_itl_nu=A02 &casenumber=450526&searchtype=aName&token =19C4009DC6BDCBCFDECA0E09A4FEFF54 &dt=22486DAAC77DD74FF4AA2786C2CA04D9 &courtClassCode=A&casekey=166496546 &courtname=COA,%20Division%20II. Accessed February 13, 2015.
7. Smith R, Patel V, Satava R. Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot. 2014;10(3):379-384.
4. The Medical Staff Handbook: A Guide to Joint Commission Standards, Third Edition. Joint Commission Resources. http://www.jcrinc.com /the-medical-staff-handbook-a-guide-to-joint -commission-standards-third-edition/. Accessed March 6, 2015. 5. Sorrel AL. Hospital can be sued for credentialing doctor with questionable qualification, Minnesota high court rules. amednews.com. http://www .amednews.com/article/20071015/profession /310159964/4/. Accessed January 17, 2015.
8. Harrysson IJ, Cook J, Sirimanna P, Feldman LS, Darzi A, Aggarwal R. Systematic review of learning curves for minimally invasive abdominal surgery: a review of the methodology of data collection, depiction of outcomes, and statistical analysis. Ann Surg. 2014;260(1):37-45. 9. Birkmeyer JD, Finks JF, O’Reilly A, et al; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013;369(15):1434-1442. 10. Hu YY, Peyre SE, Arriaga AF, et al. Postgame analysis: using video-based coaching for continuous professional development. J Am Coll Surg. 2012;214 (1):115-124.
6. Herron D, Marohn M; SAGES-MIRA Robotic Surgery Consensus Group. A consensus document on robotic surgery. http://www.sages.org
JAMA April 7, 2015 Volume 313, Number 13 (Reprinted)
Copyright 2015 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/14/2015
jama.com
