Improving Organ Procurement and Oversight

Background

The organ procurement process is a complex series of events that involves medical professionals at all levels in all areas of the donation and transplant community. The National Organ Transplant Act of 1984 (NOTA) established the framework for a national organ recovery and allocation system in the private sector. The goal of this system is to help ensure the organ allocation process is carried out in a fair and efficient way, leading to an equitable distribution of donated organs based on medical criteria.

NOTA provides the primary authority for the national organ procurement organization (OPO) system and the Organ Procurement and Transplantation Network (OPTN), both of which are under the purview of the Secretary of HHS. It also broadly outlines the structure, functions, responsibilities and funding model of each system.

The United Network for Organ Sharing (UNOS) is the not-for-profit organization that serves as the OPTN by contract with the federal government. Federal regulation requires that every OPO be a member of and participate in the OPTN – which assists OPOs in placing organs locally, regionally, and nationally.

The OPTN Final Rule is federal regulation that addresses the scope and authority of the OPTN. However, as provided in the Final Rule, no OPTN requirements are enforceable by the OPTN until approved by the Secretary. At present, only OPTN data submission requirements are enforceable.

The system is working: Record increases in organ donation continue

The U.S. system for organ donation and recovery is among the best in the world. As a result of innovation and continuous improvement, the nation’s 56 OPOs have increased deceased organ donation for thirteen consecutive years.

The increases are significant given that less than one percent of people die in a way that allows for organ donation.

What is needed for further improvement and enhanced oversight?

The Centers for Medicare and Medicaid Services (CMS) is currently considering a revision of its regulations governing oversight of OPOs. CMS is seeking to improve OPO performance metrics, in part through the use of independently reported and verified data.

The OPTN recommends the requirement that ventilated in-patient death data be transmitted directly from hospital electronic medical records to a third party (either CMS or UNOS as the OPTN). This approach would provide the best possible data both for OPO evaluation and improvement purposes, including sufficient clinical detail to assess whether a death has occurred under conditions consistent with organ donation.

This kind of data set would assist with two different goals:

1. Identification of OPOs that fail to perform at a minimum level of performance, necessitating improvement and/or regulatory action; and
2. Identification of where, during the donor referral and recovery process, specific hospitals and OPOS could improve practices to recover more organs.

OPO Oversight

CMS and UNOS have complementary roles concerning OPO oversight. Through HRSA, the Secretary is represented in both the OPTN and CMS compliance monitoring and regulatory oversight processes.

UNOS

To ensure the quality and safety of donors and recipients, UNOS, as the OPTN, requires OPOs to follow its policies and report key data to the OPTN and to the transplant hospitals receiving organ offers.

UNOS’ focus in working with all of its members, including OPOs, is help them comply with OPTN policies, including those that govern deceased donor procurement, organ allocation, the organ offer and acceptance process, donor-transmissible disease testing, organ packaging/labeling/shipping, and data submission.

As the OPTN, UNOS uses a peer review process outlined in OPTN policies and bylaws. UNOS offers data reports, tools and coaching to help members improve the quality of service they provide and achieve our joint goal of placing donated organs equitably and efficiently.

When members fail to meet OPTN performance standards, the OPTN has processes in place to help them improve and come into compliance.

The OPTN does not have the authority to:

• Decertify OPOs. Only CMS has this authority.
• Remove members from OPTN membership. However, if CMS were to decertify an OPO, the OPO would also no longer be a member of the OPTN.
• Review OPO finances. CMS has this authority. In addition, because OPOs are required by federal law to be 501c3 non-profit organizations, the IRS and State Attorney Generals have this authority – the publicly available IRS form 990 provides significant financial transparency.
• Bar participation in Medicare. CMS has this authority.

CMS

Under federal law, CMS conducts on-site, unannounced recertification inspections of OPOs for compliance with requirements and performance standards every four years as a condition of Medicare and Medicaid participation and payment. The CMS Conditions of Coverage include both outcome and extensive process measures (similar to hospitals), such as board requirements, clinical staffing, donor authorization, donor medical screening, documented policies and procedures, and donor chart documentation. OPOs must correct any problems cited in surveys in order to be recertified as an OPO and continue receiving payment for services from Medicare and Medicaid. OPOs submit detailed annual cost reports to CMS about their kidney-related costs.

An OPO must abide by not only CMS regulations but also any state law applicable in the OPO’s

Designated Service Area (set by CMS) and FDA regulations if the OPO is also a tissue recovery agency. OPOs are accredited by the Association of Organ Procurement Organizations (AOPO) and the American Association of Tissue Banks (AATB), each of which require OPOs to meet a full set of accreditation criteria.