Chest
Topics in Practice ManagementStarting a Lung Transplant Program
Section snippets
Study Population
Our source population consisted of the first 101 patients who underwent transplantation at the University of Iowa between May 2007 and July 2014. The Scientific Registry of Transplant Recipients (SRTR) database was used to benchmark University of Iowa recipient outcomes against national recipient outcomes.
Why Does Volume Matter?
A transplant program must maintain minimum yearly volumes for several reasons: (1) link between frequency and competency for both physicians and support staff in the care of patients with complex medical conditions,5, 6, 7 (2) Centers for Medicare and Medicaid Services (CMS) mandated volume requirements for program certification,8 (3) private insurers often have volume requirements, and (4) there must be a sufficient number of cases to financially support specialized personnel.
Programmatic
Recruitment
Institutional programs in interstitial lung disease, cystic fibrosis, COPD, and pulmonary hypertension are important to identify patients regionally who may benefit from transplantation. Additionally, collaborative relationships with referring physicians in the catchment area are necessary. Finally, institutional contracts with insurers are needed for patients to be evaluated and ultimately receive transplants.
Recipient Selection
ISHLT provides general guidance regarding suitability of recipient characteristic; however, centers vary broadly in their individual criteria for listing.10 Centers willing to list extended criteria recipients (obese, limited functional status, patient supported with mechanical ventilation or extracorporeal membrane oxygenation, high-risk pathogen infections like Burkholderia cepacia complex) will have a larger pool of recipients than centers that do not accept these patients. However, the
Allocation
Donor lung allocation is determined by three main parameters: geographic location, followed by blood group and lung allocation score (LAS) as outlined by Organ Procurement and Transplant Network (OPTN) policy.16, 17, 18, 19 Organs are initially offered to recipients within the local Organ Procurement Organization's (OPO) designated service area (DSA). OPOs are responsible for identifying donor organs within their assigned geographic area (DSA) and then allocating these organs based first on
Donor Criteria
The availability of suitable organs remains a significant issue in solid organ transplantation, particularly in lung transplant, where only 15% to 20% of potential lungs are used.21 Standard donor criteria identify ideal organs; however, most centers consider extended criteria donors routinely.22, 23, 24, 25 Willingness to accept extended donors (lung contusion, pneumonia, extensive smoking history), donor after cardiocirculatory death donors, Centers for Disease Control and Prevention
Local OPO Assessment
A strong local OPO is important. The more donor lungs available in the local OPO, the more transplants the local center can potentially perform. Lung-protective management protocols must be in place to maximize organ recovery.
Import Offers
Import offers represent organs from an outside OPO. These organs have either been turned down by the local program(s) or are from OPOs that do not have an active lung program. The importing center must have the infrastructure needed to fly its own surgical personnel to the donor hospital to procure these organs. The availability of these import offers is largely predicted by population density and characteristics of other active programs in the region.
Esprit de corps
By necessity, lung transplantation practices are driven largely by experience rather than evidenced-based medicine. Therefore, the Medical and Surgical Directors need to have a shared philosophy regarding donor and recipient selection and management.
The LAS system, adopted in 2005, provides an additional challenge for new programs. A new program that chooses to list very-high-acuity patients risks poor outcomes that can jeopardize insurance contracts and CMS certification.15 Conversely,
Multidisciplinary Team
Patient complexity as well as transplantation regulatory bodies (OPTN, UNOS, and CMS) dictate many of the members of the multidisciplinary team (Table 2).8, 26 The program, by CMS and UNOS rule, must be staffed to provide continuous coverage (365 days a year, 7 days a week, 24 h a day) by qualified personnel to allow for maximal organ use. Additional information regarding staffing estimates can be obtained from the UNOS-sponsored transplant program survey. This is a voluntary survey that
Institutional Administrative Support
Finally, institutional expertise in organ transplantation is needed for compliance, support of the Quality Assessment and Performance Improvement (QAPI) (mandated by CMS), and financial analysis of the program. SRTR data are used in multiple formats that are critical for programmatic success. Appropriately educated and prepared staff is necessary to routinely input SRTR data elements used to calculate programmatic characteristics, such as transplant rates, expected vs observed mortality, and
Programmatic Strategy
Our pre-programmatic viability analysis included an assessment of potential volumes and institutional expertise. We then selected four measures of programmatic success and devised strategies to develop and evaluate our progress in these areas: volume, outcomes, financial solvency, and academic research contributions.
(1) Potential Recipients
Local population and actuarial data were used to project annual number of lung transplant recipients (Table 2). This analysis estimated that annual resident recipient need in Iowa was approximately 15 patients.
Referrals
Timely evaluation was one of our goals for patient and provider satisfaction. We tracked three phases in the referral process on a quarterly basis: number of referrals, time from referral to records obtained, time to first office appointment, and time to transplant listing decision. This analysis allowed us to identify inefficiencies in our process and make changes. UNOS database was used to identify Iowa recipients receiving transplants elsewhere to pinpoint geographic areas in the state that
Recipient Selection
Our program in general follows the recommendations of the ISHLT position statement regarding patient listing criteria.10 We have a strictly enforced pulmonary rehabilitation policy for ambulatory patients requiring documented exercise 5 d/wk; in general this is 30 min on the treadmill, although occasionally for patients who cannot maintain saturation above 88% on facemask oxygen we will use NuStep. Our BMI maximum for listing is 30 kg/m2, and minimum is 18 kg/m2. We individually consider
(2) Donor Volumes
Historic analysis of donated organs in our OPO indicated that sufficient organs were available regionally.31 We then designed a program to maximize lung recovery from potential donors. A best practice protocol for optimal donor management was developed in collaboration with our OPO to provide optimal lung-protective management. All donor cases were reviewed in a quarterly meeting to assess protocol adherence and discuss potential ways to improve organ recovery. Physicians from lung transplant
Outcomes
Successful implementation of a new program requires both rapid growth and sustained excellent recipient outcomes (Fig 2). For the first 2 years, our 1-year recipient survival was 100% and has remained above the national average (Fig 2A). Similarly, 3-year recipient survivals are excellent (Fig 2B). Early on in the program, intense involvement of attending staff was required. For the first 2 years, the programmatic directors took almost continuous call. This was exhausting and unreimbursed, but
Financial Solvency
The revenue stream for a lung transplant program includes the pretransplant evaluation, the actual transplant episode, and posttransplant care. Often times, bundled contracts are such that reimbursement is not based on services provided but rather on a predetermined fee schedule. As the margin continues to tighten in delivering medical care, it is important to evaluate the usefulness of pretransplant and posttransplant testing and control costs where possible without sacrificing outcomes.
Academic Research Mission
The research mission stands equal in importance to the clinical mission of our program. We protect physician time for academic pursuits and evaluate productivity based on publications, clinical trial enrollment, and funding record. To build the research enterprise, our program has a unique leadership of physician scientists. The physicians on our team spend 50% time in research and 50% time on clinical service. This schedule allows our physicians substantial blocks of time for research and also
Other Considerations
Since inception, the lung transplant program has been housed within the Heart and Vascular Center at the University. Initially, administrative support was provided by the general hospital compliance office and a 0.5 FTE data manager. As CMS regulations and QAPI requirements have increased dramatically over the past 5 years, as an institution we have moved the administration of transplant QAPI into our solid organ transplant center.
Conclusions
Strategic analysis of lung transplant program viability should include an assessment of potential transplant volumes and institutional expertise to manage clinical, regulatory, and financial aspects unique to lung transplantation. Programmatic goals should be clearly identified, measured, and reported to team members at regular intervals to ensure quality and durability of the program. At our institution, we use volume, recipient outcomes, financial solvency, and academic research contributions
Acknowledgments
Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Role of sponsors: The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
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2017, Seminars in Fetal and Neonatal MedicineCitation Excerpt :This is why there are volume requirements for other highly technical surgical endeavors, such as heart or lung transplant centers. For transplant, Centers for Medicare and Medicaid Services, as well as many private insurers, mandate volume requirements for program certification [43]. The volume–outcome relationship, demonstrated for many medical and surgical treatments, creates a policy conundrum.
FUNDING/SUPPORT: This work was supported by the National Institutes of Health/National Heart, Lung, and Blood Institute [Grant K08 HL114725-01 to Dr Parekh], the American Heart Association [Grant 0675028N to Dr Klesney-Tait], the Institute for Clinical and Translational Science at the University of Iowa via the National Institutes of Health Clinical and Translational Science Award program [Grant 3UL1RR024979-03S3 to Dr Parekh and 2UL1TR000442-06 to Dr Eberlein]. United Network of Organ Sharing data in this work was supported in part by Health Resources and Services Administration [Contract 234-2005-37011C].
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