The Donor and Patient Safety Program Manager (DPSPM) is responsible for promoting a culture of safety and regulatory compliance across the organization, ensuring the highest standards of care for organ donors and transplant recipients. This role oversees donor safety initiatives, adverse event management, and patient safety risk reduction strategies while aligning practices with CMS, OPTN/UNOS, FDA, AATB and other applicable regulatory requirements and best practices. The DPSPM collaborates with clinical and quality teams to identify risks, implement corrective actions, and support continuous performance improvement within the organization.
ESSENTIAL JOB FUNCTIONS
Donor and Patient Safety Oversight
- Design and implement a comprehensive program to monitor and evaluate donor and patient safety events, including near misses, adverse outcomes, and deviations from established protocols to minimize risk to donors and potential transplant recipients.
- Serve as an internal resource and subject matter expert on patient safety practices, promoting a culture of safety, transparency, and continuous improvement.
- Ensure timely reporting of patient and donor safety events to appropriate regulatory bodies and partners (e.g. OPTN/UNOS, FDA, AATB, transplant centers, tissue and eye banks).
- Lead investigations of donor and recipient adverse events in collaboration with LifeCenter’s Medical Director and advisory staff, performing root cause analyses (RCA) and developing effective corrective and preventive action (CAPA) plans.
- Monitor CAPA plans for timely completion and effectiveness.
- Track and trend safety-related data to identify patterns, risks, and opportunities for proactive interventions.
- Lead collaborative efforts with external stakeholders (e.g., donor hospitals, transplant centers), and regulatory bodies to address and resolve patient safety concerns related to organ and tissue donation and transplantation.
- Provide regular patient safety reports to extended senior leadership.
Regulatory Compliance & Reporting
- Ensure compliance with CMS Conditions for Coverage, OPTN/UNOS bylaws and policies, FDA regulations, AATB standards and other applicable requirements relevant to donor and patient safety.
- Maintain complete and accurate documentation of all donor and patient safety investigations, reviews, and outcomes.
- In collaboration with the Quality team, participate in and perform internal audits and support regulatory inspections with a focus on donor and patient safety
- Serve as subject matter expert for patient safety–related policies and procedures within the organization.
Education & Training
- Develop and deliver safety-related education programs for LifeCenter staff, partner hospitals, and transplant centers.
- Promote a culture of safety by engaging staff in best practices, transparent communication, and share lessons learned from safety events.
- Provide onboarding and ongoing training to ensure staff awareness of best practice, organizational safety expectations, and regulatory requirements related to door and patient safety.
Quality Improvement
- Collaborate with the Quality Assurance & Performance Improvement (QAPI) Committee to integrate safety initiatives into standard practice and align with organizational priorities.
- Contribute to strategic safety goals, including reducing adverse events, enhancing donor evaluation and management practices, and improving recipient outcomes.
- Participate in the development of and review of policies, procedures, and protocols that could impact donor and recipient safety.
Supervision
- This position has no formal supervisory responsibility but serves as an advisor and consultant for the organization, and coach and mentor for other positions in the department.
Other Responsibilities
- Performs other related duties as required by the needs of the company and the leadership team.
- Participates in, and may lead, employee committees, and events.
- Complies with applicable laws, regulations, and LifeCenter policies and procedures.
KNOWLEDGE, SKILLS, ABILITIES
- Subject Matter Expert knowledge of patient safety principles and healthcare regulations.
- Proven ability to analyze safety event data and performance metrics to identify trends, drive improvement initiatives, and monitor outcomes using quality improvement methodologies.
- Strong background in interdisciplinary collaboration, with a track record of engaging clinical and operational leaders, compliance/legal teams, and front-line staff to advance safety culture and implement system-wide governance practices.
- Familiarity with legal and ethical risk considerations in patient safety, including event disclosure, patient rights, documentation practices, and coordination with legal or risk counsel as appropriate.
- Ability to design, implement, review, and maintain various programs.
- Exceptional analytical, problem-solving, and decision-making skills.
- Strong written and verbal communication abilities, with skill in engaging diverse stakeholders.
- Ability to manage sensitive information with discretion and professionalism.
- Competence in data collection, analysis, and presentation (Microsoft Excel, PowerPoint, or other quality improvement tools).
- Ability to be flexible to respond to continuously changing situations, issues and priorities.
- Must be able to work effectively with others, some in remote locations.
- The ability to prioritize and complete work despite competing objectives.
BEHAVIORAL REQUIREMENTS
The employee in this position must uphold the core values of LifeCenter; these include:
- Integrity: We are trustworthy, reliable, respectful, and accountable.
- Collaboration: We work in partnership with others, seeking to understand and be understood, and finding common ground and shared goals to build upon together.
- Courage: We take personal responsibility and face challenges head-on.
- Service: Through professionalism and dedication, we honor our commitment to serve others and our obligation to be good stewards of the gift of life.
Physical Activities/Requirements
- Travel out of the general work area may be required.
- Position functions while sitting and/or standing, use of keyboard, telephone, and specialized office equipment. The employee is required to be able to move up to 35 pounds with or without assistance.
- This position requires the ability to effectively operate phones, computers, and other office equipment.
- The individual must have the ability to communicate clearly using the English language to accurately convey information and be able to hear at normal speaking levels both in person and over the phone.
- Specific vision abilities required by this position include close vision and the ability to adjust focus.
- Generally, working conditions do not require exposure to hazardous materials or extremes in health and safety hazards. Work is normally performed in an office or hospital setting, as well as in other business environments.
Anticipated Weekly Time Commitment
This position may need to work outside of regular business hours, including evenings and weekends.
EDUCATION, EXPERIENCE & JOB REQUIREMENTS
- 5+ years of experience as a Patient Safety Manager or Specialist in healthcare required; experience in a critical care hospital setting preferred. Similar role/job responsibilities in healthcare quality or regulatory compliance will be considered.
- Bachelor’s degree in nursing, Healthcare Administration, Public Health, or related field required.
- Relevant work experience can be considered and substituted for academic requirements.
- Progressive experience with:
- Patient safety, quality, or risk management within a healthcare setting, demonstrating increasing responsibility in leading safety initiatives, conducting risk assessments, root cause analyses, and implementing Corrective And Preventative Action (CAPA) plans and improvement strategies aligned with national safety standards and regulations.
- Developing and managing patient safety programs or infrastructure, including policy development, staff education, committee facilitation, and escalation protocols that support a culture of safety.
- Proof of COVID-19 vaccination or applicable medical or religious exemption will be required as a condition of employment upon offer.
