Lee Health Transplant Program Executive Summary - July 2018 Lynsey Biondi, MD, FACS Program Director/Transplant Surgeon Lee Health Transplant Institute Summary: Following the 2025 patient death and subsequent regulatory scrutiny, the completely rebuilt Transplant Program has recently accomplished many goals, including removal from UNOS probation, praise atthe national transplant level for being a “model transplant center”, and completion of a CMS survey with no citations and praise to “keep up the good work.” The program has also transplanted more patients than expected (33) since opening 25 months ago with 100% patient and graft survival. These benchmarks have been achieved by implementing a UNOS directed, physician led model with a transparent focus on quality and safety, including integration with hospital safety programs such as Team STEPPS, ‘The program is now at a critical juncture and faces a serious safety concern regarding surgical coverage. Due to delays in hiring a competent 2” transplant surgeon, our patients lack appropriate surgical ‘coverage and the program faces temporary if not permanent closure. The transplant team made LPG leadership aware of competency issues with transplant surgeon, Dr. Guiteau, beginning in June 2017, and ‘the delays in hiring a replacement surgeon (see addendum) have put the center at risk for lack of coverage. The delay also has postponed our living donor program reopening as we must have 2 ‘competent surgeons to start living donation. Dr. Biondi’s impending maternity now places the delay in 2 more obvious light. ‘As transplant team, we have worked undet the assumption that one of our three qualified surgeon applicants would be hired. We are disappointed by this decision. In our opinion, the temporary inactivation plan proposed by LPG creates serious safety concerns for patients who will not have local ‘access toa competent transplant surgeon to care for inevitable and unpredictable transplant surgery complications. In the case of our previous inactivation, a capable surgeon (Or. Biondi) was always available. Inactivation also creates regulatory concerns as UNOS and CMS both mandate availability of a qualified transplant surgeon. Moreover, the temporary closure of this program will cause our referring providers, ‘our patients, and the community to doubt Lee Health's commitment to transplantation. Even temporary closure will create safety, financial, regulatory, and public relations concerns that will likely become detrimental or even terminal for the program. ‘As program director, | strongly urge reconsideration of the proposed inactivation through either the prompt hiring of one of the potential candidates, use of temporary locums, or delay/truncation of my maternity leave (Le, | would return to work within 24 after giving birth to avoid need to inactivate and then take appropriate full leave when a second surgeon is available). Inactivation, even for a few weeks, ‘The remainder of this document outlines: 1) the necessary steps for implementing LPG’s current plan of Program inactivation, 2) the timeline of discussions pertaining to surgical isues, and 3) excerpts of pertinent regulatory guidelines MOVING FORWARD WITH TEMPORARY INACTIVATION PLAN, {f inactivation occurs, the following outlines the steps to meet regulatory (UNOS and CMS) requirements, and band-aid the program's safety issues. © Regulatory Steps ‘©The transplant program must immediately declare that the program is a single surgeon ‘center in accordance with regulation due to the fact that Dr, Guiteau is not capable of covering surgical issues alone. In light of the fact that Lee Health is terminating his ‘employment for these reasons, he cannot be considered as a separate transplant surgeon. ‘= Asa single surgeon center, Dr. Biondi can be away on leave for up to 14 days ata time for a total of 28 days. ©The transplant program is required to notify, in writing, all patients, dialysis units and referring providers, per regulation of the intent to voluntarily inactive. This letter should Include reasons for inactivation as well as timelines for reopening, We have draft versions but need to discuss our stated reason for inactivation. "Legal to review letter prior to sending. ‘Certified letters must go out 30 days prior to a planned inactivation. ‘= UNOS to review patient letters ‘Patients in all stages of evaluation (referral, evaluation, active/inactive wai and post-transplant) must be offered the opportunity to transfer to another transplant center. Assistance must be provided to all patients in this transfer, including calling other centers and sending records. ‘= Ongoing documentation must be provided to UNOS at a minimum of every 2 weeks regarding the transfer status of al patients. Our program is responsible for continuing to contact the patients and assist in their transfer to another ‘center (as many as patient would like). © Patient Safety Steps © Transplant patients must be provided with ongoing safe care. Transplant surgical complications can be emergent, unpredictable and are multifactorial {including patient compliance). Failure to provide appropriate surgical coverage would be patient abandonment on the part of Dr. Blond ‘© Though he is sill employed by LPG, Or. Guiteau cannot be counted as the surgical ‘coverage as he is unable to operate independently and performs worse under situations of stress or complic(© Inthe absence of a qualified transplant surgeon available in the program, al post- transplant patients must be referred to a qualified source of care. We must inform the patients and regulatory bodies ofthis plan. ‘© We must create a referral relationship with another transplant center for all post- transplant patients. Our patients must have direct and immediate access to the partnering surgeon and their transplant center. Surgical discussion/hand-off between Dr. Biondi and other surgeon to discuss any concerns as well as access Nephrology discussion with covering surgeon for issues and how to immediately ‘access the surgeon for patient care Medical records relayed for the immediate post patients (within 1 year of transplant) ‘Opportunity for our patients to schedule appointments with partnering surgeon Documentation in chart that the care continuum is ongoing Handoff of any issues back to Dr. Biondi upon her return ‘© Obviously, this solution is not ideal but necessary as a minimum step for patient safety. It ‘may create barriers to access due to travel distances, delays in care and other issues. Patients or referring providers may lose trust in Lee Health's commitment to transplantation. ‘* Other Considerations © Messaging Inform all staff and hospital of the intent to inactivate and plans surrounding inactivation ‘Staff will be anxious regarding job security (one new nurse on boarding at end of August) . Media coverage and messaging to the community © Marketing. Ramp up marketing while inactivated to continue care Change projected timeline for ing donor program © Financial Offer to share staff from transplant when workloads are low AP's on day shift also will be available to outsource to other Lee Health sites Reconsider budget projections for future transplants Place hold on some contracts depending on projections