#134321 Regulatory and Compliance Specialist-Transplant

DESCRIPTION

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

MINIMUM QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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.

SPECIAL CONDITIONS

• 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.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, the only Burn Center in the county, and and dozens of outpatient clinics. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20
For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

a. "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace