Director, Transplant Regulation Compliance & Quality

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Overview :

Be inspired. Be valued. Belong.

At Emory Healthcare we fuel your professional journey with better benefits, valuable resources, ongoing mentorship and leadership programs for all types of jobs, and a supportive environment that enables you to reach new heights in your career and be what you want to be. We provide :

• Comprehensive health benefits that start day 1
• Student Loan Repayment Assistance & Reimbursement Programs
• Family-focused benefits
• Wellness incentives

Ongoing mentorship, development, leadership programs...and more!

Description :

• Responsible for ensuring the Emory Transplant Center (ETC) and its programs remain compliant with Centers for Medicare and Medicaid Services (CMS), Organ Procurement and Transplantation Network (OPTN) / United Network for Organ Sharing (UNOS), the State of Georgia and The Joint Commission (TJC) regulations specific to organ transplant and organ donation.
• Develops processes to monitor metrics and audit reports to ensure data integrity, policy compliance, and patient safety reporting both internally and externally, to appropriate regulatory and oversight committees and their agencies.
• Oversees the monitoring and leads reporting to ensure ongoing compliance with OPTN / UNOS and CMS.
• Provides oversight to ensure thorough, accurate 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 realistic and appropriate plans of correction (PoC).
• Keeps abreast of regulatory changes and communicates any new requirement concerns to ETCs Executive Director(s) and Sr. Vice President.
• Collaborates with ETC and program leadership and quality staff on policy and procedure development or revisions.
• Works collaboratively with each program's administrative, medical, and surgical directors and ETC quality team 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 ETC along with the clinical program managers during surveys from CMS, UNOS, and TJC.
• Provides design and oversight for chart audits and documentation to identify regulatory gaps for performance improvement.
• Oversees CMS and OPTN / UNOS QAPI requirements.
• Manages all communication and requests from CMS and OPTN / UNOS.
• Oversees all UNOS reporting (e.g., key personnel change applications, organ allocation investigations, patient safety reporting, outcomes compliance reporting).
• Primary Patient Safety Contact to OPTN / UNOS membership for reporting and investigation of all potential donor disease transmissions.
• 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.
• Collaborates with clinical managers to oversee accuracy of outcomes data submitted by program staff to UNOS for SRTR.
• Analyzes SRTR data to track and identify changes in SRTR data for Center and program leadership.
• Oversees and collaborates with the Quality team to proactively track and identify changes in SRTR data to program leadership.
• Manages and works with the Quality team on adverse events, investigations, reporting and action plans.
• Develops and oversees the transplant program Quality Assessment and Performance Improvement (QAPI) plan and improvement activities as required by TJC, CMS and OPTN policy.
• Oversees and works collaboratively with the Operations Improvement manager for all transplant related quality and process improvement activities.
• Primary liaison and contact for UNOS and other external Organ Procurement Organizations for organ offer related regulatory compliance issues.
• Collaboratively with ETC program leadership in effective implementation of UNOS policy changes and updates.
• Takes the lead with program directors and clinical managers in development of 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.
• Works with the clinical programs to develop appropriate 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 baccalaureate degree in nursing, public health, healthcare administration, nursing or related field required.
• Masters degree is preferred.
• Current RN licensure in the state currently practicing.
• Five years of healthcare experience in clinical nursing, public health, and / or healthcare policy required.
• Transplant regulatory compliance and quality experience preferred.

Additional Details :

Supporting a diverse, equitable and inclusive culture. Emory Healthcare (EHC) is dedicated to providing equal opportunities and access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression and / or veteran's status.

EHC does not discriminate on the basis of any factor stated above or prohibited under applicable law. EHC respects, values, and celebrates the unique perspectives and backgrounds of all individuals.

EHC aspires to create an environment of collaboration and true belonging for all our patients and team members. Emory Healthcare (EHC) is committed to achieving a diverse workforce through equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

ACCOMMODATIONS : EHC will provide reasonable accommodation to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Office of Diversity, Equity, and Inclusion.

• PHYSICAL REQUIREMENTS : (Medium-Heavy) 36-75 lbs., 0-33% of the work day (occasionally); 20-35 lbs., 34-66% of the workday;
• frequently); 10-20 lbs., 67-100% of the workday (constantly); Lifting 75 lbs. max; Carrying of objects up to 35 lbs.; Occasional to frequent standing & walking;

Occasional sitting; Close eye work (computers, typing, reading, writing); Physical demands may vary depending on assigned work area and work tasks.

ENVIRONMENTAL FACTORS : Factors affecting environmental conditions may vary depending on the assigned work area and tasks.

• Environmental exposures include, but are not limited to : Blood-borne pathogen exposure; Bio-hazardous waste Chemicals / gases / fumes / vapors;
• Communicable diseases; Electrical shock; Floor Surfaces; Hot / Cold Temperatures; Indoor / Outdoor conditions; Latex; Lighting;
• Patient care / handling injuries; Radiation; Shift work; Travel may be required; Use of personal protective equipment, including respirators;

environmental conditions may vary depending on assigned work area and work tasks.

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