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Folder In Catalog Marked As Requirements.

Regulatory Oversight and Requirements


  • The National Organ Transplantation Act (NOTA, 1984) created the Organ Procurement Transplantation Network (OPTN) with private contractors: the United Network for Organ Sharing (UNOS) and the Scientific Registry for Transplant Recipients (SRTR).
  • CMS approved transplant centers beginning in 1986, but provided no regulatory oversight until 2006.
  • CMS drafted and issued formal Conditions of Participation for Transplant Programs in 2006, which were designed with the intent to improve transplant patient outcomes.
  • All transplant programs were required to submit a letter to CMS agreeing to abide by the COPs. • Interpretive Guidelines were released by CMS in 2008. • Transplant programs then needed to implement policies to address the separate and distinct requirements of both CMS and UNOS.


  • Each state’s Department of Health began surveying transplant programs every three years, and initial findings revealed that not every program was following the CMS COPs as intended.
  • When programs were deemed non-compliant with the CMS COPs, CMS imposed very costly Systems Improvement Agreements (SIAs) on the transplant program, which required the program to demonstrate changes to policies, procedures and oversight.
  • Over the course of 10 years:
    • 145 programs cited by CMS
    • 83 improved within the 210-day period
    • 45 received an SIA
    • 17 programs terminated participation with CMS
  • UNOS also began conducting site surveys based on policies and by laws in 2000 every three years on transplant and living donor programs.


  • UNOS began collecting data in 1987 and implemented an electronic database, UNet SM, to facilitate submissions, in 1999.
  • Per UNOS guidelines, data is required to be submitted in UNetSM within 90 days of due date.
  • Initially the data collected was analyzed by UNOS but this is now managed by an external group: SRTR.
  • SRTR began reporting outcomes to the public in 1999 per regulatory requirements.
  • CMS and private insurers began close surveillance of outcomes released by SRTR.


  • CMS COPs state that transplant programs must have a Quality Program
    • Most transplant programs have a dedicated Quality Manager/Director/ Analyst/Coordinator
      • Data integrity is a key element to ensure accuracy of outcomes
  • COP 482.96 states transplant programs must have a written, comprehensive data-driven QAPI program that outlines and demonstrates:
    • Collaboration with hospital QAPI
    • Bidirectional flow of information between hospital and transplant QAPI
    • Collaboration with hospital Risk
  • Adverse events policy:
    • Identification on thorough analysis of events.
    • Programs have a separate Transplant Adverse Events Policy.


  • To help facilitate transplant program success, Hospital C-Suites should:
    • Obtain updates on transplant programs’ quality and outcomes (QAPI reports).
    • Provide adequate staffing and resources for the multidisciplinary team.
    • Ensure readiness with regulatory survey protocol.

We wish to thank Linda Ohler, Associate Director of Quality, Regulatory and Education at New York University Langone Medical Center for this special webisode presentation on Transplant Regulatory Oversight

A Special Thanks to This Series’ Contributors

DD6A2041 JD Edited
About the Editor |
Corey Bryant

Corey Bryant leads The Alliance’s communications, marketing and strategic efforts for unique national events, programming, partnerships and business development. With extensive corporate and non-profit experience, Corey has served in communications and public relations roles for Disney Parks and Resorts, Disney Cruise Line and TransLife (now OurLegacy), the OPO serving East Central Florida. He has also been an active board member of Donate Life Florida, having served as state team leader for Driver License Outreach. Corey is a proud alum of The University of Alabama and serves on the board of directors for Come Out With Pride Orlando as well as Five Horizons Health Services, a not-for-profit organization providing access to progressive HIV testing, prevention and LGBT+ focused healthcare throughout West Alabama and East Mississippi.

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