States have historically used Certificate of Need (CON) regulations to regulate cost, quality, and access to healthcare services. Federally mandated in 1974, the regulation required the states to review requests for new healthcare construction and services. In theory, community-level planning backed by the state-level CON review and health planning process would prevent unnecessary duplication of services and the accompanying costs (Smith-Mellot, 2004). However, none of the published studies have examined the association of CON regulation on volume and outcomes of solid organ transplants. In 1984, the federal mandate ended, and each state was allowed to determine whether or not to maintain its CON programs; more than one-third of the states eliminated them (Altman & Ostby, 1991). Currently, 37 states including the District of Columbia have CON programs (American Health Planning, 2010). Of those states, 21 include organ transplant as a reviewable, regulated service. Although several studies have investigated whether CON regulation has affected healthcare cost, to date very little has been written about the impact of CON on volume and quality of care; the data that does exist is contradictory. In 1988, investigators studied the effects of CON regulation on mortality and observed that greater regulatory stringency was a positive and significant predictor of hospital mortality rates (Shortell & Hughes, 1988). In contrast, DiSesa et al (2006) found no significant difference in risk-adjusted mortality for cardiac surgery patients in states with and without CON regulations. The gap between evidence and decision-making and the large number of states that use CON to regulate healthcare services indicate a need for a study on the quality of healthcare services. Solid organ transplantation is a complex, high-cost treatment that was performed over 27,000 times in 2008. The purpose of this study is to assess the association of solid organ transplant CON regulations using clinically rich data available from the Scientific Registry of Transplant Recipients (SRTR). This study tests the hypotheses that states with solid organ transplant CON regulations have fewer transplant centers, higher volumes of heart and kidney transplants per center, lower graft failure rates and lower patient mortality rates per center. In addition, this study assesses these hypotheses using two different transplant procedures (heart and kidney). This study provides additional information for transplant centers to use in their strategic decision making. Moreover, with the presence of minimum volume standards for transplant procedures mandated by the Centers for Medicare and Medicaid (CMS) now, the policy implications of continuing or repealing CON regulations should be examined.