Regulatory compliance in solid-organ transplantation: what you don't know can hurt your program.
The risk of noncompliance with rules and regulations in solid-organ transplantation is significant and may lead to probation, suspension, or program closure. Transplant program leadership is responsible for ensuring that programs and centers are in compliance with regulations and data reporting requirements. As the Centers for Medicare and Medicaid Services prepare to implement new rules and the Joint Commission on Accreditation of Healthcare Organizations positions itself to join the certification process for transplant programs, heightened awareness and vigilance by all members of the transplant community are warranted. This article aims to inform transplant team members, particularly transplant program leaders, of the various regulatory bodies that oversee solid-organ transplantation, as well as these bodies' responsibilities and current agendas. Information is also included to help leaders continuously prepare their programs for site visits and audits by these oversight bodies.
Benjey
Jane
J
Transplant Management Group, LLC, Livingston, TX, USA.
Cunanan
Mary
M
Thomson
Art
A
D026683:Advisory Committees; D001294:Attitude to Health; D014487:Centers for Medicare and Medicaid Services, U.S. / Q000458:organization & administration*; D002568:Certification / Q000458:organization & administration; D005161:Facility Regulation and Control / Q000458:organization & administration*; D019983:Guideline Adherence / Q000458:organization & administration; D017408:Guidelines as Topic; D006270:Health Facility Administrators / Q000458:organization & administration; D006801:Humans; D007591:Joint Commission on Accreditation of Healthcare Organizations / Q000458:organization & administration*; D007857:Leadership; D017146:Models, Organizational; D016377:Organ Transplantation / Q000592:standards*; D024382:Professional Role; D011639:Public Opinion; D012042:Registries; D009927:Tissue and Organ Procurement / Q000458:organization & administration*; D014481:United States; D014483:United States Dept. of Health and Human Services / Q000458:organization & administration