Fig. 1
Photograph of first kidney transplant. L–R. Miss Rhodes (Scrub Nurse), Dr. Daniel Pugh (Assistant Surgeon), Dr. Joseph E. Murray, Dr. John Rowbotham (Assistant Surgeon), Dr. Edward B. Gray (Assistant Surgeon), Miss Edith Comisky (Circulating Nurse), Dr. Leroy D. Vandam (Anesthetist) (From https://www.countway.harvard.edu/chm/archives/iotm/iotm_2004-11.html Accessed 1 Sept 2014)
As living donation grew mostly in kidney transplant programs and then in the late 1990s for liver transplantation, many programs realized that evaluation of the potential donors’ motivation was an important aspect for ethical and surgical success. The success of transplantation drove more patients suffering with end-stage organ failure to seek care, making the evaluation and management of candidates and potential donors, as well as the follow-up care of the growing numbers of survivors more complex. Consequently, psychological and social work evaluation increasingly became a routine part of assessment of donors and potential transplant candidates. Particularly because lots of liver disease is referable to behavioral issues, experts in assessing and treating addictions and personality disorders became critical collaborators for liver transplant programs. Moreover, because the patients and their care became much more complicated, nursing personnel became first skilled and, later, essential for the coordination of the care these patients received. These professionals became integral parts, as did the many other providers in pharmacies, blood bank, and laboratories and financial and administrative paramedical roles.
Recognizing that training and certification for transplant professionals was an important part for ensuring quality transplant care, professional societies developed programs to provide for these growing and increasingly complex programs. The American Society of Transplant Surgeons developed training program criteria for transplant. Soon afterward training program criteria for medical specialists in transplant nephrology, hepatology, cardiology, nursing anesthesia, and organ procurement were put into practice.
In 1972, an amendment to the US Social Security Act provided federal funding for the care of patients with end-stage renal disease including those who are candidates for, and/or receive renal transplants (CMS, Medicare.gov 2015). This introduced the beginning of governmental oversight of transplantation. As success mounted in the clinical arena and more and more patients sought the lifesaving treatment that was now possible with successful organ transplantation, the public and policymakers increasingly recognized the need for a national system that would provide policy for procuring and allocating organs and collecting data for the purpose of assessing the results of the allocation policies. As experience accumulated, it became clear that some standards defining characteristics of successful programs were necessary to ensure quality and coordinated care. This compelling need to be sure programs are delivering the highest quality care was propelled by the need to ensure that the precious donor organ resources are used wisely and with the utmost expertise. This has been the driving force for the evolution of the regulations around what the minimum standards should be for organ transplant programs in the current era. While these do not necessarily ensure success, they do set the standard across the USA. Most other countries where transplantation is well developed have created similar regulations that aim to define transplant center compositions. In 1984, the US Congress passed The National Organ Transplant Act (NOTA) in which the Organ Procurement and Transplantation Network (OPTN) was established. One of the many functions authorized by NOTA for the OPTN was to define minimum criteria for transplant programs. Centers were required to meet these in order to participate in the OPTN and thereby gain access to the deceased donor pool. In 1999, the Final Rule promulgated by the Centers for Medicaid and Medicare (CMS) also adopted regulations defining standards for transplant programs wanting to receive payment for transplant services delivered to Medicare beneficiaries. Subsequently, the CMS Conditions of Participation (CoP) clearly defined CMS expectations for transplant center structure (Federal Register 2007). A comparison of the UNOS and CMS program standards is provided in Table 1. (a link to the full table with references to OPTN and CMS survey methods can be found at http://optn.transplant.hrsa.gov/governance/compliance/crosswalk-guide/).
Table 1
A comparison of the UNOS and CMS program standards. Adapted from http://optn.transplant.hrsa.gov/governance/compliance/crosswalk-guide/
Requirement description | Applies to deceased donor component reviews? | Applies to living donor component reviews | Applicable organ programs | Oversight entity |
---|---|---|---|---|
Membership in the OPTN | Yes | Yes | All | CMS; OPTN |
Getting approval for a pediatric program if the majority of transplants performed at your program are for adults | Yes | Yes | Pediatric programs | CMS |
Getting approval for an adult program if the majority of transplants performed at your program are for pediatrics | Yes | Yes | Pediatric programs | CMS |
Data submission requirements (initial approval) | Yes | Yes | All | CMS; OPTN |
Living donor forms: data submission requirements | No | Yes | All (CMS); kidney (OPTN) | CMS; OPTN |
Organ procurement | Yes | No | All | CMS |
End-stage renal disease service requirements | Yes | Yes | Kidney | CMS |
Inpatient dialysis services | Yes | Yes | Kidney | CMS |
Participation in the ESRD network activities | Yes | Yes | Kidney | CMS |
Vessel storage | Yes | Yes | Liver | OPTN |
Patient and living donor selection/OPTN routine referrals and candidate selection procedures | Yes | Yes | All | CMS; OPTN |
Psychosocial evaluation for transplant candidate | Yes | Yes | All | CMS |
Living donor: medical and psychosocial evaluation | No | Yes | CMS: all; OPTN: kidney | CMS; OPTN |
Social services | Yes | Yes | All | CMS |
Nutritional services | Yes | Yes | All | CMS |
Human resources condition | Yes | Yes | All | CMS |
Director of a transplant center | Yes | Yes | All | CMS; OPTN |
Transplant center director responsibilities | Yes | Yes | All | CMS |
Director of a transplant center responsibilities coordinating care adequate training of nursing | Yes | Yes | All | CMS |
Director of organ procurement services | Yes | Yes | All | CMS; OPTN |
Director of transplantation tissue typing | Yes | Yes | All | CMS; OPTN |
Director ensuring transplant surgery is performed under the direct supervision of a qualified transplant surgeon | Yes | Yes | All | CMS |
OPTN designated transplant surgeon and physician | Yes | Yes | All | CMS |
Clinical transplant coordinator | Yes | Yes | All | CMS; OPTN |
Transplant coordinator is licensed RN or clinician | Yes | Yes | All | CMS |
Living donor advocate/team knowledge and understanding | No | Yes | CMS: all living donor programs; OPTN: kidney | CMS; OPTN |
Transplant team | Yes | Yes | All | CMS |
Director of anesthesia | Yes | Yes | Liver | OPTN |
Financial coordinator | Yes | Yes | All | OPTN |
Mental health and social support | Yes | Yes | All | OPTN |
OPTN program approval requirements – primary surgeon/physician, general facilities, and resources | Yes | Yes | All | OPTN |
Primary program administrator | Yes | Yes | All | OPTN |
Transplant pharmacist | Yes | Yes | All | OPTN |
QAPI program | Yes | Yes | All | CMS |
Current State of Liver Transplant Program Structure
Personnel
In this section, the various requirements outlined in Table 1 will be discussed and the rationale for why they should be part of a transplant program. The principles outlined here are also generally applicable to other solid organ transplant programs although there are procedure-specific and medical specialty-specific considerations for each organ type. Later, we will build on these to outline how they need to function together and discuss how this framework provides a model for the delivery of complex multidisciplinary care in the future.