Regulatory and Compliance Specialist-Transplant - 134321

Under the supervision of the Transplant Quality Manager, the Transplant Regulatory Specialist role will be responsible for the regulatory compliance and patient safety aspects of the heart transplant, lung transplant, liver transplant, kidney transplant, living donor liver, living donor kidney and ventricular assistive device (VAD) Programs to foster the development of a high reliable organization.

Key role responsibilities include:

* Conducting monthly chart audits for all phases of transplantation, living donation and for the VAD program to monitor ongoing compliance with The Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) Bylaws and Policies, the Centers for Medicare and Medicaid Services (CMS) Conditions of Coverage and Participation for Organ Transplant Programs as well as The Joint Commission (TJC) requirements for Advanced Certification for Ventricular Assist Device.

* Identifying deficiencies and areas of noncompliance via chart audit, via direct observation or as disclosed by other staff. Working with the Medical and Surgical Directors and Program Managers to ensure that the corrective action plans are developed and executed to improve compliance with internal and external requirements; Consulting and collaborating with Patient Safety, Regulatory Affairs, Legal, Risk Management and operational leadership as needed.

* Monitoring proposed OPTN, CMS and TJC VAD regulatory changes as well as state and federal legislation pertinent to transplant and VAD program.

* Assessing the impact of approved regulatory changes work with the transplant multidisciplinary team on practice changes necessary to ensure compliance with OPTN, CMS and TJC VAD regulatory requirements.

* Developing and maintaining internal policies and procedures to ensure compliance with OPTN, CMS and TJC VAD regulatory requirements

* Leading the programs in setting patient care standards and defining best practices in the care of VAD, transplant patients and living donors to improve patient safety.

* Facilitating projects resulting from OPTN, CMS and TJC VAD regulatory changes, transplant specific events or identified areas of non-compliance.

* Developing and executing ongoing educational activities and materials pertinent to regulatory changes or practice changes resulting from regulatory changes, as well as for survey readiness for transplant and VAD program.

* Planning and facilitating mock OPTN/UNOS, CMS certification/re-certification and TJC VAD accreditation surveys with transplant leadership to promote survey readiness.

* Leading OPTN, CMS and TJC VAD survey readiness meetings in collaboration with Regulatory Affairs (as needed) to ensure standard requirements are met and areas of risk are identified pre-survey, develop a "day-of" plan and for follow-up on corrective actions post-survey.

* Analyzing patient safety metrics and events including Complaints, Grievances & iReports on a monthly and/or on an as needed basis and report key trends to internal stakeholders and committees including but not limited to the Transplant Quality Medical Directors, the organ specific Quality Assurance and Performance Improvement (QAPI) Committees, Inpatient Unit Based Practice Counsels, UCSDH Patient Safety and Regulatory Affairs and their associated committees to facilitate resolution.

* Assisting to the Transplant Quality Medical Directors in facilitating the investigation of transplant specific events; Collaborating with UCSDH Patient Safety, Regulatory Affairs, Legal and Risk Management (as applicable) to facilitate the investigation of transplant related events that meet the definition of a hospital event; and leading resulting initiatives to close the loop with key stakeholders across the institution on any actionable items or improvements identified during the investigation.

* Coordinating submission of regulatory documents and communications required by the OPTN/UNOS, CMS and TJC including program status changes (inactivation or voluntary relinquishment of program status, changes in key personnel) and patient safety events; Collaborating with the UCSDH Patient Safety, Regulatory Affairs, for submission of regulatory documents including patient safety events to the California Department of Public Health and other non-transplant specific regulatory agencies as required.

* Utilizing the Microsoft office applications for data collection, presentation and report outs.

* Collaborate with the programmatic leadership including the multidisciplinary team to implement interventions from survey findings to measure outcomes.

* Collaboration with UCSDH Quality, Patient Safety and Regulatory Affairs

• Bachelor's Degree in healthcare or health science or equivalent experience.

• Five (5) years of related experience.

• Three to five (3 - 5) years working knowledge in transplant regulatory compliance monitoring, patient safety and survey readiness.

• Minimum two (2) years' experience with chart audit and data collection.

• Experience and proven success in knowledge of the methods, tools, and practices involved with regulatory compliance.

• Experience in applying performance improvement methodology.

• Experience in utilizing Microsoft Office applications.

• Master's level education/degree in a relevant area.
• Registered Nurse (RN) license issued by the state of California.
• Previous Regulatory Affairs experience.
• Leadership or supervisory experience.

• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check and pre-employment physical.