Abstract: | This interim final rule with comment sets forth changes to the conditions of coverage for organ procurement organizations (OPOs). It redefines an OPO service area, revises the qualifications for the Board of Directors, specifies the assistance to be provided by an OPO to hospitals in establishing and implementing protocols governing organ procurement activity, requires an OPO to establish criteria for allocating organs, and requires an OPO to ensure that tests are performed on prospective organ donors to prevent the acquisition of organs that are infected with the etiologic agent for Acquired Immune Deficiency Syndrome. These changes are required by the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) and the Transplant Amendments Act of 1990 (Public Law 101-616). We also clarify the distinction between certification and designation and amend the criteria with respect to compliance with performance standards, change of ownership, and termination procedures. |