Patient Safety Officer

The Patient Safety Officer is a key member of CORE's Performance Excellence & Strategy Department and leadership team and is responsible for providing leadership, oversight, and subject matter expertise for CORE's patient safety program. The role advances patient safety, risk reduction, event investigation, process reliability, and continuous improvement across the organ donation continuum while promoting a culture of safety, accountability, and learning.

The Patient Safety Officer integrates patient safety activities into CORE's Quality Assurance and Performance Improvement (QAPI) framework and supports compliance with applicable Organ Procurement and Transplantation Network (OPTN), Health Resources and Services Administration (HRSA), Centers for Medicare & Medicaid Services (CMS), and other regulatory or oversight requirements governing organ donation and transplantation.

Through the application of patient safety science, systems thinking, human factors principles, risk management, and performance improvement methodologies, the Patient Safety Officer partners with operational leaders and cross-functional teams to identify risks, investigate events, evaluate contributing factors, implement sustainable corrective actions, and strengthen process reliability.

This position serves as CORE's lead resource for patient safety methodologies, event investigation, organizational learning, and systems-based risk reduction. While operational leaders maintain accountability for the safety and performance of their respective processes, the Patient Safety Officer provides independent oversight, consultation, monitoring, and recommendations to support organizational learning, regulatory compliance, and continuous improvement.

Essential Job Functions:

Patient Safety, Investigation, & Risk Reduction:

• Serves as CORE’s operational resource for applicable OPTN patient safety requirements and coordinates the identification, assessment, investigation, documentation, escalation, and timely reporting of applicable patient safety events.
• Supports CORE’s designated primary and secondary OPTN Patient Safety Contact functions and monitors OPTN policy changes, patient safety notices, and related communications to ensure appropriate evaluation, documentation, escalation, and follow-up.
• Leads or facilitates structured investigations of adverse events, near misses, unsafe conditions, process deviations, complaints, safety concerns, and recurring or high-risk process failures using appropriate methodologies, including Root Cause Analysis (RCA), Apparent Cause Analysis, Failure Mode and Effects Analysis (FMEA), process mapping, barrier analysis, and human factors assessment.
• Identifies active failures and latent organizational weaknesses contributing to risk, including workflow design, communication, technology, staffing, environmental factors, training, policies, and organizational interfaces.
• Applies systems engineering, human factors, and reliability engineering principles to evaluate high-risk workflows, identify hazards and failure modes, assess safety barriers, and recommend safer process designs.
• Recommends and supports implementation of engineered safeguards, including standardization, error-proofing, forcing functions, independent verification, automation, visual controls, technology enhancements, and improved communication and handoff processes. Prioritizes system and process design over education or individual intervention alone.
• Conducts prospective risk assessments and FMEAs for high-risk, changing, or newly designed processes. Partners with Information Technology and operational leaders to address technology-related safety risks and improve process reliability.
• Develops, coordinates, and monitors corrective and preventive action plans that address underlying system risks. Evaluates the effectiveness and sustainability of implemented actions using objective data and measurable outcomes.

Organ Donation Process Safety:

• Provides patient safety and process reliability oversight for critical activities across the organ donation continuum, as applicable, including donor referral and evaluation, donor management, ABO determination and verification, infectious disease testing and communication, organ recovery, identification and labeling, packaging and preservation, transportation and tracking, chain of custody, organ placement, donation after circulatory death (DCD) processes, donor-derived disease communication, and hospital/OPO/transplant-center handoffs.
• Works with process owners to establish measurable safety controls, detection methods, escalation pathways, response expectations, and reliability indicators for critical processes.

Quality Assessment, Performance Improvement, & Reliability:

• Integrates patient safety priorities into CORE’s comprehensive, data-driven QAPI program by evaluating events, near misses, complaints, audits, regulatory findings, OPTN requirements, risk assessments, and performance trends.
• Leads or supports Performance Improvement Projects using appropriate methodologies, including Lean, Six Sigma, Plan-Do-Study-Act (PDSA), reliability engineering, and other evidence-informed improvement approaches.
• Establishes baseline performance, targets, process measures, and outcome measures; monitors progress; evaluates corrective-action effectiveness; and demonstrates sustained improvement.

Data, Reporting, & Regulatory Readiness:

• Leads patient safety initiatives within Performance Excellence and partners with Data/Analytics to develop, maintain, and interpret patient safety and reliability dashboards, including measures of event reporting, recurring events, reportable events, control failures, high-risk process performance, corrective-action effectiveness, and improvement outcomes.
• Analyzes safety data and communicates findings through clear, actionable reporting that identifies what happened, contributing factors, corrective actions, effectiveness of interventions, and remaining risk.
• Provides regular patient safety reporting, risk assessments, investigation findings, trend analyses, corrective-action updates, and recommendations to QAPI governance, executive leadership, and the governing body, as appropriate.
• Partners with Regulatory/Compliance and operational leaders to monitor compliance with applicable OPTN requirements, support regulatory readiness, respond to OPTN inquiries and monitoring activities, and coordinate corrective-action activities related to identified findings.