OPTN Evaluation Plan - Organ Procurement and Transplantation ...

OPTN Member Evaluation PlanUpdated January 1, 2015Bylaws Appendix C.6.D: Regulatory Adverse ActionsEffective Date: 2/1/2014How the OPTN contractor will evaluate member compliance with this bylaw:The OPTN contractor will investigate and refer a member to the MPSC for review when:⦁ The OPTN contractor learns of a final adverse action taken by a regulatory agency against ahistocompatibility laboratory, and the histocompatibility laboratory did not report this action to the OPTNcontractor as defined in the bylawsHistocompatibility Laboratories must:Notify the OPTN contractor when any regulatory agency takes action against the laboratory. Notificationmust:⦁ Be in writing⦁ Be submitted within 10 business days after the histocompatibility laboratory receives notification of the finaladverse action⦁ Provide all documents relating to the final adverse action to the OPTN contractorDefinitions:Final adverse actions by an agency:Include, but are not limited to any of the following:• Decertification by the Center for Medicare and Medicaid Services (CMS)• !ny action by a state licensing authority that affects the organization's ability to function• !ny action by the state health department that affects the organization's ability to function• Loss of accreditation by the !ssociation of Organ Procurement Organizations (!OPO), !merican !ssociation ofTissue Banks (AATB), or Joint Commission on Accreditation of Healthcare OrganizationsWhere to send notification:⦁ By Mail: UNOS Member Quality700 N 4th StreetRichmond, VA 23219⦁ By Facsimile: (804) 782-4896⦁ By E-mail: to Senior Membership Standards Advisor49