Current Commentary

Surgical Proctoring for Gynecologic Surgery Michael Heit,

MD, PhD

Surgical proctoring allows a hospital’s credentialing committee to objectively monitor, regulate, or oversee surgical privileging for its medical staff to ensure the safety and quality of care for its patients. The surgical proctor does not participate directly in patient care and does not establish a patient–physician relationship before the procedure and therefore is under no obligation to intervene if an intraoperative complication occurs or substandard care is witnessed. Good Samaritan legislation enacted in every state should provide immunity for the proctoring physician if intervention is necessary. Teleproctoring may become the most cost-effective method for institutions that are unable to identify a local proctor for surgical privileging. (Obstet Gynecol 2014;123:349–52) DOI: 10.1097/AOG.0000000000000076

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n 2010, approximately 25% (75,000 procedures) of pelvic organ prolapse surgeries in the United States were performed transvaginally with mesh; the U.S. Food and Drug Administration warned patients about the procedure when a large number of attributable complications were reported.1 The American Urogynecologic Society published guidelines establishing the requisite surgical knowledge, experience,

From the Urogynecology Associates, Indianapolis, Indiana. This clinical commentary is not intended to provide guidance on the credentialing requirements for specific surgical procedures, competency requirements for the applicant surgeon, or preceptorships designed to teach a surgical procedure in anticipation of a privileging request. Guidance toward competency and credentialing requirements for some surgical procedures can be found in documents created by national and international professional societies responsible for the specialties activities. This document is focused on concurrent proctoring where the proctor actually observes and assesses the applicant’s technical and cognitive skills during a surgical procedure to satisfy privileging requirements. Guidance for prospective or retrospective proctoring of patient charts is not included in this document. Corresponding author: Michael Heit, MD, PhD, Urogynecology Associates, 1633 N Capital Avenue, Suite 436, Indianapolis, IN 46202; e-mail: mheitmd@ gmail.com. Financial Disclosure The author did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14

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and skills required for transvaginal mesh placement recommending surgical proctoring for physicians requesting privileges at their home institution.2,3 The American College of Obstetricians and Gynecologists acknowledges the need for proctors and proctoring guidelines for the assignment of initial practice privileges and reentry into clinical practice programs.4,5 Neither of these societies provides specific surgical proctoring guidance for the applicant surgeon or local credentialing committee. The purpose of this clinical commentary is to educate physicians about the surgical proctoring process and provide credentialing committees with guidance for establishing a proctoring program for privileging in gynecologic surgery. Surgical proctoring is a peer review process governed by institutional bylaws and administered through the credentialing committee to objectively monitor, regulate, or oversee surgical privileging for its medical staff. Its primary purpose is to ensure the safety and quality of care for patients undergoing surgical procedures at the institution. Indications for surgical proctoring should include 1) initial privileging, reprivileging, or periodic (maintenance) surgical privileging for new or established applicant medical staff at the institution; and 2) restoring surgical privileging for applicant medical staff whose privileges have been restricted or revoked. The need for and timing of reprivileging, periodic (maintenance), or restorative surgical privileging should be established by the credentialing committee at the local institution. Applicants who provide the credentialing committee with evidence of proctored privileging for a specified procedure at an outside institution may be accepted as an alternative to in-house proctoring if the process is consistent with the guidelines governed by the home institution’s bylaws. The role of the surgical proctor is to act as an independent and unbiased monitor responsible for the evaluation, not teaching (preceptor), of the cognitive and technical skills required by an applicant surgeon through direct observation of a surgical procedure. A surgical preceptor is an instructor or teacher who is responsible for the actions of their trainees as well as

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himself or herself. Surgical preceptorships are designed to provide the surgeon with the requisite knowledge and skills to perform a surgical procedure before proctored surgical privileging at their local institution. A surgical preceptorship is the ideal mechanism for acquiring the surgical skills to perform procedures “by feel” rather than direct visualization such as midurethral sling placement, sacrospinous ligament fixation, or transvaginal placement of surgical mesh for pelvic organ prolapse. It becomes the responsibility of the applicant surgeon thereafter to review the steps of the surgical procedure and provide their proctor with albeit obstructed views of the surgical dissection planes during the privileging process. The proctor should not participate directly in patient care and therefore does not establish a patient– physician relationship before or during the proctored procedure. The proctor should only represent the institution and its credentialing committee and is solely responsible to them during the proctoring process. It is recommended that consideration be given to compensation from the institution as their representative for time served.6 This minimizes conflicts of interest when proctors are sponsored by the medical device industry whose interest may include increasing demand for their products through surgical training. A surgical proctor should be a staff physician with surgical privileges for the procedure requiring evaluation at the institution. Suitable candidates may be recruited from outside institutions. It should be the responsibility of the home institution’s credentialing committee to identify such individuals and assure that the candidate possesses competencies and credentials consistent with the requirements for surgical privileging at the home institution. Alternatively, national, international, or both professional surgical societies acting as a central certification authority could take responsibility for the identification and authorization of designated experts capable of surgical proctoring at institutions in need of services based on peer review, submitted videos, and case logs.7 It is unclear if any professional medical societies provide this service despite this recommendation. Teleproctoring or the remote evaluation of an applicant surgeon’s technical and cognitive skills through direct observation of a procedure is possible given the speed, bandwidth, and security of today’s Internet connections. Teleproctoring may be the most cost-effective method for institutions that are unable to identify a local proctor for surgical privileging.8 The medicolegal aspects of surgical proctoring must be clearly understood by the applicant physician, surgical proctor, and patient before any surgical

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procedure can be performed as part of the peer review process for privileging at an institution. According to U.S. case law, the surgical proctor is under no obligation to intervene if an intraoperative complication occurs or substandard care is witnessed because no patient–physician relationship had been established before the procedure.9 In Clark v Hoek, 1985, the court “recognized proctoring as a valuable aspect of peer review that should be protected” and held that the “spirit of state laws extending confidentiality and immunity protection to good faith peer review would be violated if proctors were held to have duty to patients whose care was being proctored.”10 However, a policy of nonintervention conflicts with the ethics of beneficence, which states, “first do no harm (primum non nocere), prevent harm, and remove harm” and forms the basis for our Hippocratic Oath.11 In fact, the American Society for Gastrointestinal Endoscopy states that a proctor “has a duty to take remedial action” when substandard care is witnessed by contacting a superior, asking the applicant to stop the procedure, or intervening as a last resort.12,13 Good Samaritan legislation enacted in every state should provide immunity for the proctoring physician if intervention is necessary. Good Samaritan laws encourage physicians’ participation if 1) they are acting in good faith; 2) a medical emergency requiring care exists; and 3) no pre-existing duty to treat the patient has been established.9 Intraoperative complications or witnessed substandard care during a proctored surgical procedure likely fulfill these criteria. Minnesota and Vermont’s Good Samaritan statutes require a person to provide reasonable assistance to a person in need. In Vermont, individuals can be fined up to $100 for a petty misdemeanor in violation of their “duty to assist” clause. Proctoring consents should be signed by the patient before the procedure acknowledging that the applicant surgeon is being proctored, the proctor has no pre-existing patient–physician relationship, and that the institution’s policy toward intervention if intraoperative complications occur or substandard care is witnessed has been discussed.6,9 The institution governed by bylaws should indemnify the surgical proctor should intervention be necessary.7,14 The University of San Diego Medical Center’s medical staff policy and procedure for proctoring states that “proctors are subject to all immunities accorded medical staff peer review activities and applicable regulation statutes or legal decisions” (Policy no. MSP-019, revised February 18, 2010) but makes no mention of proctoring consent forms.15 It is unclear if any local institutions provide proctoring consent forms despite this recommendation.

OBSTETRICS & GYNECOLOGY

It is recommended that applicant surgeons should have laparotomy privileges before proctored conventional endoscopic or robotic surgeries so problems encountered during these procedures can be alternatively managed.7 The applicant’s surgical partner or a sponsoring physician with privileges for the proctored procedure should be available to assist and intervene if a complication occurs or substandard care is witnessed.6 The proctoring process should include the following steps after informed consent is obtained based on a review of existing proctoring literature. Applicant medical staff should only be granted provisional privileges by the institution’s credentialing committee before the proctored procedure. This eliminates the need to report restriction or revocation of full privileges to the National Practitioner’s Databank should this recommendation be made at the conclusion of the proctoring process.9 Only one candidate surgeon should be proctored at a time. The length of proctoring or the number of procedures to be proctored should be quantified by the credentialing committee governed by bylaws. These decisions should be based on recommendations from the chairman at departmentalized institutions, the medical executive committee, or national and international professional societies responsible for the specialties’ activities. The technical and cognitive skills to be evaluated during the proctoring process should be outlined in privileging guidelines for the specified procedure established by national and international professional surgical societies responsible for the specialties’ activities.2,3 Operating room staff should receive adequate notification of a proctored procedure including the institution’s policy regarding proctor intervention in the case of intraoperative complications or witnessed substandard care.16 A standardized, confidential proctor evaluation form should be available to describe the cases being proctored, the applicant’s performance, and recommendations for surgical privileging. These recommendations may include 1) granting of full, new, or maintenance privileges for the proctored procedure; 2) a request for extension of the proctoring period; or 3) restriction or revocation of privileges for the proctored procedure.14 Termination of existing full privileges must be reported to the National Practitioner Databank by the credentialing committee.9 The proctored report should contain a written explanation from the proctor why a final determination was recommended. The report should also include the circumstances and extent of proctor intervention should such action become necessary. The proctoring report should be

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only one component of the peer review process used by the institution’s credentialing committee for the determination of surgical privileging. This minimizes the possibility of bias and secondary gain when an applicant surgeon is proctored by a local competitor. Institutional bylaws should establish the confidentiality of the report, where and for how long the reports will be filed, who will have access, and the procedural process for an applicant’s appeal of the report’s findings. REFERENCES 1. U.S. Food and Drug Administration Urogynecologic Surgical Mesh. Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Available at: http://www. fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/ UCM262760.pdf. Retrieved October 23, 2013. 2. American Urogynecologic Society’s Guidelines Development Committee. Guidelines for providing privileges and credentials to physicians for transvaginal placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2012; 18:194–7. 3. American Urogynecologic Society’s Guidelines Development Committee. Guidelines for privileging and credentialing physicians for sacrocolpopexy for pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2013;19:62–5. 4. Re-entering the practice of obstetrics and gynecology. Committee Opinion No. 523. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;119:1066–9. 5. AAFP-ACOG joint statement of cooperative practice and hospital privileges. American Academy of Family Physicians. American College of Obstetricians and Gynecologists. Am Fam Physician 1998;58:277–8. 6. Satava RM. Proctors, preceptors, and laparoscopic surgery. The role of ’proctor’ in the surgical credentialing process. Surg Endosc 1993;7:283–4. 7. Zorn KC, Gautam G, Shalhav AL, Clayman RV, Ahlering TE, Albala DM, et al; Members of the Society of Urologic Robotic Surgeons. Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the Society of Urologic robotic surgeons. J Urol 2009;182:1126–32. 8. Rosser JC, Gabriel N, Herman BA, Murayama M. Telementoring and teleproctoring. World J Surg 2001;25:1438–48. 9. Livingston EH, Harwell JD. The medicolegal aspects of proctoring. Am J Surg 2002;184:26–30. 10. American College of Surgeons. Division of Advocacy and health policy. Can using emergent technology incur liability? Available at: http://www.facs.org/ahp/proliab/1198a.html. Retrieved October 22, 2013. 11. Rancich AM, Pérez ML, Morales C, Gelpi RJ. Beneficence, justice, and lifelong learning expressed in medical oaths. J Contin Educ Health Prof 2005;25:211–20. 12. ASGE guidelines for clinical application. Proctoring for hospital endoscopy privileges. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc 1999;50:901–5. 13. Standards of Practice Committee, Dominitz JA, Ikenberry SO, AndersonM A, Banerjee S, Baron TH, et al. Renewal of and proctoring for endoscopic privileges. Gastrointest Endosc 2008; 67:10–6. 14. American Academy of Family Practitioners. Clinical proctoring. Available at: http://www.aafp.org/online/en/home/

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policy/policies/c/clinicalproctor.html. Retrieved October 22, 2013. 15. University of California San Diego Medical Center. Medical staff policy and procedure (MSP-019). Proctoring. Available at: health.ucsd.edu/medinfo/medical-staff/Documents/Proctoring.doc. Retrieved October 24, 2013.

16. Pelletier SJ. Proctoring conundrums: how to credential an OR observer. Credentialing Resource Center connection. Available at: http://www.healthleadersmedia. com/content/HOM-75377/Proctoring-conundrums-Howto-credential-an-OR-observer.html. Retrieved October 21, 2013.

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OBSTETRICS & GYNECOLOGY

Surgical proctoring for gynecologic surgery.

Surgical proctoring allows a hospital's credentialing committee to objectively monitor, regulate, or oversee surgical privileging for its medical staf...
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