UNOS DonateLife

August 13, 2004

UNOS Receives ISO Certification for Several Key Functions

Richmond, Va. -- The United Network for Organ Sharing (UNOS), which operates the national Organ Procurement and Transplantation Network (OPTN) under contract with the Health Resources and Services Administration of the U.S Department of Health and Human Services, has been certified as compliant with ISO 9001:2000 standards for quality management and quality improvement for its information technology, organ placement and transplant data management functions.

"This is a significant step for the OPTN and UNOS," said executive director Walter Graham. "It should assure transplant professionals and those personally touched by donation and transplantation that we are maintaining the highest possible quality standards."

The International Organization for Standardization developed ISO 9001 standards to help organizations ensure that their products and services satisfy the quality requirements of customers and comply with applicable regulations. The standards, most recently updated in the year 2000, also address processes for quality improvement.

To qualify for certification, UNOS undertook a rigorous process of analyzing and documenting how it maintains the national, computerized system for organ allocation and data collection and how it assists in organ placement. UNOS then developed protocols to identify potential quality concerns and implement system improvements. Once these steps were complete, an independent auditing firm visited the organization in July and verified that it met the standards for certification.

"We've learned a lot from the process, but we also found that a lot of what we were doing already in quality management was of high value,"said Berkeley Keck, RN, M.P.H., UNOS' assistant executive director for information technology. "We started last October seriously thinking about seeking certification and thought it would take about a year to complete. We were very pleased that it took about three months less than we thought. That is a credit to the expertise and hard work of our staff."

UNOS will continue to seek certification for additional functions in the future, including its policy compliance and membership departments. These functions ensure that transplant organizations have properly trained and experienced personnel and are following established OPTN policies, thus helping ensure equitable organ allocation and quality outcomes for transplant candidates and recipients as well as living donors.

In addition, UNOS encourages other transplant organizations to undergo the process. "Currently we know of two organ procurement organizations that have been certified," said Graham. "We highly recommend this for those who share our commitment to act in the public trust to save lives through organ donation and transplantation."

The Organ Procurement and Transplantation Network (OPTN) is operated under contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation by the United Network for Organ Sharing (UNOS). The OPTN brings together medical professionals, transplant recipients and donor families to develop organ transplantation policy.