UNOS DonateLife

August 10, 2005

Audit Recommends Continued ISO Certification

A recently concluded independent audit reported that the United Network for Organ Sharing (UNOS) continues to qualify for ISO 9001:2000 certification. UNOS 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.

"ISO certification is considered a 'gold standard' in many disciplines, and we are pleased to continue to meet these rigorous requirements," said UNOS Executive Director Walter Graham. "This translates into providing the best possible services to candidates awaiting a transplanted organ as well as the organizations who are OPTN members. We believe it also enhances trust in the transplant system, which can encourage more people to express their wish to save lives through organ donation."

The International Organization for Standardization developed ISO 9001 standards to help organizations ensure that their products, processes 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.

UNOS received ISO certification in 2004 for several key operations. To qualify for certification initially, UNOS undertook a rigorous process of analyzing and documenting how it maintains the national computerized system for organ allocation and data collection, how it assists in organ placement, and how it monitors member compliance with organ allocation policies and quality standards. UNOS then developed protocols to identify potential quality concerns and implement system improvements. To continue its certification, these functions must be audited every six months by an independent reviewer.

"Using the ISO principles of quality management, we successfully developed and implemented a major computer system revision to lung allocation policy in May," said Berkeley Keck, RN, M.P.H., UNOS' assistant executive director for information technology. "Despite its complexity, the system was implemented on schedule and without any operational errors. Our quality management and improvement processes continue to help us identify and address potential performance issues at an early stage."

UNOS also incorporates ISO procedures in evaluating OPTN members' outcomes and compliance with policy. "ISO requires us to document and adhere to our processes without exception," said Deanna Sampson, J.D., UNOS' director of evaluation and quality. "This ensures that every member receives the same level of scrutiny and is treated in a consistent way."

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.