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How Are Organ Procurement Organizations Regulated?

Organ, eye and tissue transplant is often the last hope for critically ill or injured people. This is why Organ Procurement Organizations (OPO’s), like LifeSource are so heavily monitored and regulated.

Regulatory and accreditation organizations create standards and regulations as well as monitor OPO’s to ensure their practices are legal, safe, and fair. This includes scrutinization of an OPO’s clinical processes, interactions with transplant centers and the public, and the OPO’s business operations and organizational structure.

Regulation in Organ Procurement

Regulations keep OPO’s operating safely and fairly. Because there is potential for disease transmission during the transplant process, it is incredibly important that the processes an OPO uses to recover and transport organs and tissue are safe and follow all quality assurance standards. For OPO’s, following these rules is not only mandatory, but a matter of pride. In fact, for LifeSource meeting or exceeding standards is one of the ways we show our respect for those who given the gift of life.

It might be surprising to learn that regulators also look at the business practices of OPO’s. OPTN for example, ensures that OPO practices are equitable and fair regarding allocation of organs. Additionally, regulators ensure that OPO’s are using good and current business practices, quality assurance standards, and safety standards. Even an OPO’s governance structure is looked at by regulators to make sure decisions within the organization are being made appropriately. All OPO’s must meet regulatory rules and guidelines to operate.

Accreditation in Organ Procurement

OPO accreditation is voluntary and OPO’s are not required to meet the accreditation standards of these organizations. However, many OPOs (including LifeSource) choose to seek accreditation through various organizations (such as the Association of Organ Procurement Organizations and the American Association of Tissue Banks) to hold themselves to higher standards and actively engage in a process of continuous improvement.

While each accrediting body has its own areas of focus, not all are unique. One common area of focus for our accrediting organizations are related to the integrity of our operations. The types of agreements an OPO has. An OPO should never provide incentive for accepting gifts (tissues and organs) they have recovered. They also look at the exchange of money for the services OPO’s provide and make sure fees are reasonable considering industry standards and the OPO’s geographic location.

Other Oversight

Multiple government agencies are involved in the oversight and regulation of OPO’s. Examples of this include The Center for Medicare and Medicaid Services (CMS) and The U.S. Food and Drug Administration (FDA). CMS certifies and decertifies OPOs. This certification is based on an OPO’s ability to meet multiple process standards and outcomes (metrics). The FDA ensures that Tissue and Eye banks are meeting safety standards. The FDA conducts unannounced on-site visits every couple of years to make sure standards are being met.

Certification at LifeSource

When it comes to current requirements in place for OPOs, LifeSource meets or exceeds industry standards. From our beginning in 1989, LifeSource has consistently served our area safely, fairly and with sound business practices. We are proud of our history of compliance with federal, state, and industry oversight bodies and are consistently asked to share best practices with other OPO’s.

While compliance with regulators is necessary, we consider the safe recovery and transport of donated organs and tissue to be the least we can do to honor the gifts of donors. We consider it a privilege to recover and transport life-saving gifts safely, so they can heal lives. We take the responsibility of allocating organs fairly (based on medical criteria identified by OPTN), seriously.

LifeSource will continue to work to exceed standards and maintain the level of excellence our donors, their families, recipients, and community deserve.