Sr Manager, Regulatory Compliance, Transplant Center

Emory Healthcare   •  

Atlanta, GA

Industry: Healthcare


5 - 7 years

Posted 166 days ago

This job is no longer available.


JOB DESCRIPTION: Responsible for ensuring the Emory Transplant Center (ETC) and its programs¿ are compliant with CMS, UNOS, State of Georgia and TJC regulations specific to organ transplant. Develops processes, monitoring metrics and auditreports to ensure data integrity, policy compliance, and patient safety reporting both internally and externally, to appropriate regulatory and oversight committees/agencies. Oversees the monitoring and reporting to ensure ongoing compliance with UNOS and CMS. Responsible for preparation and submission of all regulatory agency Requests for Information (RFI) for clinical approvals of the programs including but not limited to: UNOS key personnel change applications, OPTN/UNOS MPSC inquiries, OPTN/UNOS and CMS survey findings with development and submission of plans of corrections. Keeps abreast of regulatory changes and communicates new requirements and concerns to ETC¿s Director and Quality Director. Collaborates with ETC and program leadership and staff on policy and procedure development or revisions. Works collaboratively with each program¿s administrative, medical, and surgical directors and ETC Quality leadership to ensure survey readiness. Primary liaison and contact for OPTN/UNOS and CMS. Responsible for regulatory compliance with CMS, UNOS, State of Georgia, and other bodies that regulate and grant certification for our center to perform solid organ transplants. Represents the Emory Transplant Center along with the clinical program managers during surveys from CMS, UNOS, and The Joint Commission. Oversees the chart audits and documentation to identify regulatory gaps for performance improvement. Oversees and manages CMS and OPTN/UNOS QAPI requirements. Manages all communication and requests from CMS, UNOS, and OPTN. Oversees all UNOS reporting (e.g., key personnel change applications, organ allocationinvestigations, patient safety reporting, outcomes compliance reporting). Primary liaison to hospital leadership for transplant regulatory compliance and policy management. Collaborates with transplant program leadership on policy and procedure development or revision. Maintains currency in CMS, UNOS, and State of Georgia transplant requirements and collaborates with key personnel to implement necessary operational changes. Works directly with faculty and staff to implement policies and procedures to ensure compliance with regulations. Oversees accuracy of outcomes data submitted to UNOS for SRTR. Collaborates with Quality/Regulatory Specialist to proactively track and identify changes in SRTR data to program leadership. Works with the Quality team on adverse events, investigations, reporting and action plans. Prepares materials for surveys and all follow-up requirements after surveys including corrective actions plans, policy and procedure edits, and any other necessary required actions. Guides Transplant Program Leadership, Nursing, Medical and Surgical Directors regarding strategies to ensure good standing with regulatory agencies. Educates staff about compliance with new and revised guidelines and regulations, or findings from internal audits. Provides regulatory compliance orientation education for all new hires. Manages staff and employee performance. Plans, assigns and directs work. Provides ongoing performance feedback, addresses problems, orients and trains new employees and resolves human resource related issues.

MINIMUM QUALIFICATIONS: A bachelor's degree in nursing, public health, healthcare administration, nursing or related field. Current RN licensure in the state currently practicing. Masters preferred. Five years of healthcare experience in clinical nursing, public health, and/or healthcare policy. Transplant experiencepreferred.