Table 1.

Checklist for proctor, host physician, host institution, industry

Checklist for Proctor ✓Contract with industry sponsor adequately delineates the expectations, responsibilities, and reimbursement to proctor ✓Discussion with host physician, industry, and host facility to review the expectations and ensure all agree ✓ Facility is prepared ○ Reviewed equipment needed to safely perform procedure and rescue complications ○ Ensure that external services needed are available (vascular surgery, CT surgery) ○ Ensure site has or will acquire in time the necessary equipment ✓ Host physician appears adequately prepared ○ Review experience and training of host physician and comfort level. ✓ Cases are properly selected ○ Reviewed the proposed cases in advance with host physician for appropriateness overall and for the level of training ✓ If you are expected to scrub in and participate in the procedure ○ Medical license to practice in state ○ Temporary medical staff privileges from facility ○ Malpractice coverage (occurrence based) has been provided by industry or facility, OR letter of indemnification provided by facility ✓ Provide post-procedure feedback ○ Answer questions ○ Offer constructive critique ○ Review potential post-procedure complications with team ✓Provide written report of adequacy of procedure performance to host physician, host facility, and industry. Any deficiencies should include recommendations for remediation. Checklist for Host Physician ✓Have personally completed required training to perform procedure (either preceptorships or industry training) ✓Have established what type of proctoring is indicated (advice from observer outside room vs. hands-on support) ✓ Informed host institution of planned new procedure ○ Institutional approval of new services planned ○ Institutional support with resources needed for new service (additional staffing, anesthesia, room) ○ Institutional support of proctor’s presence ⁃ Temporary medical privileges ⁃ Malpractice coverage or letter of indemnification ✓ Patient selection and preparation ○ Select a first case that is medically appropriate, straightforward, uncontroversial, lower risk ○ Schedule 1-3 cases depending on cath lab capabilities, type of procedure, and assumption that first cases will take longer ○ Documented discussion with patients and family that they will have their procedure performed by someone newer to the procedure in a facility but with the support and advice of a proctor and industry representative, including alternative of being referred elsewhere. Reinforced documented discussion on day of procedure. ○ Signed consent should indicate consent to proctored procedure including release of medical records to nontreating physician proctor. ○ Review of proposed cases with proctor ✓ Clearance of personal and cath lab schedules ○ Cancel other elective procedures ○ Cancel clinics during proctoring day ○ Arrange for coverage of emergencies by other physician ✓ Cath lab preparation ○ Equipment checklist completed and reviewed with proctor ○ Selection of cath lab staff for proctoring day ○ Communication with cath lab management and staff regarding needs on cath lab day, role of proctor ✓ Host pre-procedure timeout meeting with proctoring physician, cath lab staff, and industry representative ○ Introductions including roles, responsibilities, and limitations ○ Clarification that host is the treating physician and is ultimately responsibility for orders ⁃“Ground rules” for communication including chain of command, circling back, code words for safety ○ Final review of equipment, backup plans, and post-op procedures necessary ○ Review of patient history and step-by-step procedure plan ○ Minimize unnecessary observers and distractions in the control room, and potentially minimize number of operating personnel ✓ Host a closing timeout/debrief with proctor, industry, staff ○ Review post-procedure care, potential complications, and follow-up ○ Review with potential shortfalls during procedure, especially equipment and staff preparation ○ Communicate with receiving physician/team/nurses post-procedure care and complications to watch for. ○ Secure resources (industry or proctor) for advice in post-procedure procedure in case of complication Checklist for Host Institution ✓Have a full understanding in advance of nature of procedure and facility/staff/equipment needs of procedure (typically obtained from host physician and industry) ✓Ensure that the host physician and performing team are adequately supported with equipment, supplies, and coverage to not be needed for other procedures ✓Provide written communication to proctor, host physician, and industry the expected roles and responsibilities of the proctor. ✓Provide temporary medical staff privileges AND malpractice coverage/indemnification of proctor if indicated ✓Provide temporary identification and review of required documents of proctor (at minimum TB test) Checklist for Industry Representative: ✓ Industry representative(s) themselves must have the experience to assist ○ Should have extensive experience with procedure ○ Should have experience with newer physicians and sites ✓ Proposed operator is adequately prepared ○ Operator has completed required training off-site (didactic, hands-on, and preceptorship training) ✓ Proposed site is suitable for this procedure ○ They have the facilities, staff, and equipment to safely proceed ○ They have or are anticipated to have adequate volume to develop and maintain minimum volume requirements for procedure ○ Staff have received an “in-service” on the procedure in advance ✓ Proctor is prepared for role ○ Proposed proctor has adequate experience and expertise ○ Proctor knows what the role involves (direct patient care or not) ○ Proctor contract adequately spells out proctor role and provides malpractice coverage if facility does not ○ Proctor is regularly evaluated/re-evaluated for role ○ Proctor has provided documents required for temporary medical privileges ✓ Work with host institution to facilitate ○ Aids in arranging for malpractice coverage or indemnification if needed ○ Aids in obtaining medical staff privileges for proctor ○ Liaison for communication between host physician and proctor in advance and following procedure ✓Work with host physician to review potential cases and ensure that required equipment and supplies are available ✓ Arrange for adequate time for the proctor/sponsor to have pre-procedure meeting/timeout and post-procedure debrief ○ Ideally this should be arrival afternoon/evening before procedure day, with flights out hours after last procedure is planned to be completed ○ Provide for travel/housing of proctor ✓Debrief proctor in-person for any deficiencies that were not directly communicated to host physician