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 COREs 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 COREs 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 COREs 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.

Qualifications

Work Environment and Physical Requirements:

The position primarily performs professional, analytical, administrative, and collaborative work in an office or approved remote/hybrid work environment, depending on COREs established work arrangements. The role requires regular computer use, prolonged periods of sitting, participation in meetings, review of electronic records and data, preparation of reports, and communication with internal and external stakeholders.

The position requires interaction with clinical, operational, and hospital environments to observe processes, conduct investigations, evaluate hazards, facilitate process mapping, and support improvement initiatives. Occasional travel to CORE facilities, partner hospitals, or other relevant locations may be required, subject to organizational needs.

The position may require schedule flexibility to respond to significant patient safety events, urgent investigations, regulatory matters, or time-sensitive operational concerns, including occasional evening or weekend availability as necessary.

Required Education and Experience:

- Bachelors degree in Engineering, Quality Management, Human Factors, Healthcare Administration, Public Health or a related field.

- Five (5) years of progressively responsible experience in healthcare quality, patient safety, risk management, regulatory compliance, healthcare operations, performance improvement, or related healthcare functions.

- Demonstrated experience conducting structured investigations, analyzing contributing factors, developing corrective and preventive actions, and evaluating intervention effectiveness.

- Demonstrated knowledge of process improvement methodologies and tools, such as Root Cause Analysis, FMEA, process mapping, PDSA, Lean, Six Sigma, or comparable approaches.

- Ability to analyze performance data, establish measurable indicators, identify trends, and communicate findings and recommendations to operational and executive stakeholders.

- Knowledge of patient safety principles, systems thinking, human factors, root cause analysis methodologies, and performance improvement practices.

- Strong written and verbal communication, facilitation, organizational, and project management skills.

- Ability to manage sensitive information, exercise sound judgment, and collaborate effectively across multidisciplinary teams.

- Ability to evaluate complex processes, identify system-level risks, and develop practical recommendations that improve safety, reliability, and compliance.

Preferred Education and Experience:

- Masters degree in related field.

- Experience in an organ procurement organization (OPO), transplant center, hospital, or other highly regulated healthcare environment.

- Familiarity with applicable OPTN, HRSA, CMS, and other regulatory or accreditation requirements relevant to organ donation, transplantation, healthcare quality, and patient safety programs.

- Experience supporting regulatory surveys, compliance reviews, external inquiries, corrective-action plans, or organizational readiness activities.

- Professional certification such as CPPS, CPHQ, Lean Six Sigma, or equivalent.

- Experience developing patient safety dashboards, performance metrics, risk indicators, and executive-level reports.

- Experience applying a hierarchy of controls, human factors engineering, process reliability methods, and error-proofing to high-risk workflows.

- Experience facilitating multidisciplinary investigations, cross-functional improvement teams, and organizational learning initiatives.

- Knowledge of clinical information systems, workflow technology, data analytics, and technology-related safety risks.

Work Authorization/Security Clearance Requirements

Must be legally authorized to work in the United States. Employment is contingent upon successful completion of a background investigation conducted by CORE and satisfactory results in accordance with CORE requirements. Must meet any additional credentialing, screening, or access requirements applicable to the position and its responsibilities.

EEO Statement

CORE is proud to be an Equal Opportunity Employer (EEO), dedicated to building a work culture of integrity, compassion, and respect. As an EEO employer, we support an inclusive workplace where all can excel based on their merit, qualifications, experience, and job performance. We do not discriminate, tolerate harassment, or condone retaliation of any kind.

Supervisory Responsibilities:

Provides functional leadership for patient safety investigations, risk assessments, corrective-action coordination, and cross-functional improvement initiatives. Drives Patient Safety Centered culture throughout organization and instill in the leadership team.

Supervises Enterprise Performance Improvement Engineers and activities within the scope of Performance Improvement.