Guidelines for hospital privileges in vascular surgery and endovascular interventions: Recommendations of the Society for Vascular Surgery.

The Hospital Privileges Practice Guideline Writing Group of the Society for Vascular Surgery is making the following five recommendations concerning guidelines for hospital privileges for vascular surgery and endovascular therapy. Advanced endovascular procedures are currently entrenched in the everyday practice of specialized vascular interventionalists, including vascular surgeons, but open vascular surgery remains uniquely essential to the specialty. First, we endorse the Residency Review Committee for Surgery recommendations regarding open and endovascular cases during vascular residency and fellowship training. Second, applicants for new hospital privileges wishing to perform vascular surgery should have completed an Accreditation Council for Graduate Medical Education-accredited vascular surgery residency or fellowship or American Osteopathic Association-accredited training program before 2020 and should obtain American Board of Surgery certification in vascular surgery or American Osteopathic Association certification within 7 years of completion of their training. Third, we recommend that applicants for renewal of hospital privileges in vascular surgery include physicians who are board certified in vascular surgery, general surgery, or cardiothoracic surgery. These physicians with an established practice in vascular surgery should participate in Maintenance of Certification programs as established by the American Board of Surgery and maintain their respective board certification. Fourth, we provide recommendations concerning guidelines for endovascular procedures for vascular surgeons and other vascular interventionalists who are applying for new or renewed hospital privileges. All physicians performing open or endovascular procedures should track outcomes using nationally validated registries, ideally by the Vascular Quality Initiative. Fifth, we endorse the Intersocietal Accreditation Commission recommendations for noninvasive vascular laboratory interpretations and examinations to become a Registered Physician in Vascular Interpretation, which is included in the requirements for board eligibility in vascular surgery, but recommend that only physicians with demonstrated clinical experience in the diagnosis and management of vascular disease be allowed to interpret these studies.

Explaining the absence of surgical procedure regulation.

Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery. Yet, notwithstanding the frequency of surgical procedures and their often critical importance to patient health, no state or federal agency either approves the use of new surgical procedures or directly regulates existing procedures. The absence of surgical procedure regulation differs from the regulation of new pharmaceutical products, which can be introduced into interstate commerce only after the Food and Drug Administration (FDA) has reviewed "adequate and well-controlled [clinical] investigations" and concluded the data from those studies sufficiently establish the drug's safety and efficacy. Surgical procedures, by contrast, are more often conveyed from professor to student, the result being that surgical approaches may vary considerably from one geographic region to another. Whether different techniques produce different outcomes is not always clear, in part because the absence of regulation means that evidence often has not been systematically generated or may be in a form not suitable for comparison. Commentators have noted the differing treatment that persists between surgery and pharmaceuticals and have offered a number of justifications. For example, they have suggested that the surgical profession should self-regulate, that excessive regulation could deter surgeries of unproven benefit even when the surgery may be in the best interest of the patient, and that surgical trials could disrupt the doctor-patient relationship, such as by emphasizing uncertainty in a context where patient trust is important. In the context of innovative (as opposed to established) surgical procedures, controlled trials might be disfavored due to concern that desperate patients might unwisely submit themselves to risky experimental treatments undertaken by overzealous researchers. When commentators advocate for increased surgical regulation, they generally limit their calls for reform to innovative surgical procedures. The absence of direct regulation, however, has implications for the quality of evidence available to support an optimal choice from among all of the alternatives in the surgeon's armamentarium, whether innovative or standard, and whether surgical or non-surgical. This Article first examines the current framework of indirect regulation surrounding surgical procedures and then offers potential explanations as to why surgical procedures themselves are not already subject to direct federal regulation. Finally, it considers possible contributions of increased surgical regulation, including the identification of evidence gaps, the generation or collection of evidence to fill those gaps, and the impact on surgeon decision-making and patient consent.

Robotically Assisted Thoracic Surgery: Proposed Guidelines for Privileging and Credentialing.

OBJECTIVE: Increased use of robotically assisted thoracic surgery (RATS) necessitates effective credentialing guidelines to ensure safe outcomes. We provide a stepwise algorithm for granting privileges and credentials in RATS. This algorithm reflects graduated responsibility and complexity of the surgical procedures performed. Furthermore, it takes into account volume, outcomes, surgeon's competency, and appropriateness of robot usage. METHODS: We performed a literature review for available strategies to grant privileges and credentials for implementing robotic surgery. The following terms were queried: robot, robotic, surgery, and credentialing. We provide this algorithm on the basis of review of the literature, our institutional experience, and the experience of other medical centers around the United States. RESULTS: Currently, two pathways for robotic training exist: residency and nonresidency-trained. In the United Sates, Joint Commission: Accreditation, Health Care, Certification requires hospitals to credential and privilege physicians on their medical staff. In the proposed algorithm, a credentialing designee oversees and reviews all requests. Residency-trained surgeons must fulfill 20 cases with program directors' attestation to obtain full privileges. Nonresidency-trained surgeons are required to fulfill simulation, didactics including online modules, wet laboratories (cadaver or animal), and observation of at least two cases before provisional privileges can be granted. A minimum number of cases (10 per year) are required to maintain privileges. All procedures are monitored via departmental QA/QI committee review. Investigational uses of the robot require institutional review board approval, and complex operations may require additional proctoring and QA/QI review. CONCLUSIONS: Safety concerns with the introduction of novel and complex technologies such as RATS must be paramount. Our algorithm takes into consideration appropriate use and serves as a basic guideline for institutions that wish to implement a RATS program.

Core Privileging and Credentialing: Hospitals' Approach to Gynecologic Surgery.

STUDY OBJECTIVE: Privileging and credentialing requirements are determined by medical staff leadership at the hospital level to ensure clinicians provide safe healthcare services. No standardized guidelines exist for gynecologic surgery. The objective of this study is to examine the variability of the criteria used to grant surgical privileges and credentials for gynecologic procedures at 5 high-volume academic and community-based US hospitals. DESIGN: We conducted a cross-sectional study (Canadian Task Force classification III). SETTING: Data was obtained from obtained from 5 geographically diverse hospital systems. INTERVENTION: We examined criteria for designating core gynecologic privileges, credentialing, and other training requirements as well as minimum and annual case numbers for initial granting and maintenance of surgical privileges. MEASUREMENTS AND MAIN RESULTS: Major inconsistencies in privileging were found across the 5 institutions. Hospitals varied widely in procedures designated as core versus those requiring advanced training. Institutions greatly contrasted in the case numbers and temporal factors used to define experience. Of particular concern was absent privileging criteria for 38.4% to 76.9% of minor procedures, 26.7% to 46.7% of endoscopic procedures, and 6.67% to 56.7% of major procedures. Initial and maintenance privileging requirements for special procedures (i.e., robotic-assisted surgery) were likewise discrepant, with minimum annual case numbers ranging from 3 to 48 across hospitals. CONCLUSION: Considerable variability exists in the criteria used by hospitals for granting and maintaining surgical privileges for gynecologic procedures. Standardization will likely require efforts at a national leadership level.

Committee Opinion No 674 Summary: Guiding Principles for Privileging Of Innovative Procedures in Gynecologic Surgery.

New or emerging surgical procedures and technologies continue to be developed at a rapid rate and must be implemented safely into clinical practice. Additional privileging may be required if substantively new technical or cognitive skills are required to implement an innovative procedure or technology. Guiding principles for privileging should include cognitive and technical assessment to ensure appropriate patient selection and performance of the new procedure. Implementation also should include pertinent institutional and staff support as needed. A dynamic process for assessment and maintenance of current competency will enhance the safety of implementation and continued application of emerging procedures and technologies. The number of cases needed to demonstrate cognitive and technical proficiency will vary depending on many factors, including the health care provider's baseline expertise and technical acumen.