Patient Safety Officer

CENTER FOR ORGAN RECOVERY AND EDUCA•Pittsburgh, PA

About The Position

The Patient Safety Officer is a key member of CORE’s Performance Excellence & Strategy Department and leadership team, 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 position integrates patient safety activities into CORE’s Quality Assurance and Performance Improvement (QAPI) framework and supports compliance with applicable OPTN, HRSA, CMS, and other regulatory or oversight requirements governing organ donation and transplantation. Applying 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. The role serves as CORE’s lead resource for patient safety methodologies, event investigation, organizational learning, and systems-based risk reduction. Operational leaders retain accountability for the safety and performance of their processes; the Patient Safety Officer provides independent oversight, consultation, monitoring, and recommendations to support learning, compliance, and continuous improvement. The position primarily involves professional, analytical, administrative, and collaborative work in an office or approved remote or hybrid environment, depending on CORE’s established arrangements. It includes regular computer use, prolonged sitting, meetings, electronic record and data review, report preparation, and communication with internal and external stakeholders. The role also involves 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. Schedule flexibility may be needed for significant safety events, urgent investigations, regulatory matters, or time-sensitive operational concerns, including occasional evening or weekend availability. The role provides functional leadership for patient safety investigations, risk assessments, corrective-action coordination, and cross-functional improvement initiatives. It drives a patient-safety-centered culture throughout the organization and supervises Enterprise Performance Improvement Engineers and activities within the scope of Performance Improvement.

Requirements

Bachelor’s degree in Engineering, Quality Management, Human Factors, Healthcare Administration, Public Health, or a related field.
Five 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.
Must be legally authorized to work in the United States.
Employment is contingent on successful completion of a CORE background investigation and satisfactory results in accordance with CORE requirements; additional credentialing, screening, or access requirements may apply.
Ability to respond with schedule flexibility to significant patient safety events, urgent investigations, regulatory matters, or time-sensitive operational concerns, potentially including occasional evening or weekend availability.
Regular computer use and prolonged periods of sitting; participation in meetings, review of electronic records and data, report preparation, and communication with stakeholders.
Occasional travel to CORE facilities, partner hospitals, or other relevant locations may be required.

Nice To Haves

Master’s degree in a 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.

Responsibilities

Serve as CORE’s operational resource for applicable OPTN patient safety requirements and coordinate the identification, assessment, investigation, documentation, escalation, and timely reporting of applicable patient safety events.
Support CORE’s designated primary and secondary OPTN Patient Safety Contact functions; monitor OPTN policy changes, patient safety notices, and related communications and ensure appropriate evaluation, documentation, escalation, and follow-up.
Lead or facilitate structured investigations of adverse events, near misses, unsafe conditions, process deviations, complaints, safety concerns, and recurring or high-risk process failures using appropriate investigation methodologies.
Identify active failures and latent organizational weaknesses involving workflow design, communication, technology, staffing, environmental factors, training, policies, and organizational interfaces.
Apply 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.
Recommend and support engineered safeguards, including standardization, error-proofing, forcing functions, independent verification, automation, visual controls, technology enhancements, and improved communication and handoff processes; prioritize system and process design over education or individual intervention alone.
Conduct prospective risk assessments and FMEAs for high-risk, changing, or newly designed processes; partner with Information Technology and operational leaders to address technology-related safety risks and improve reliability.
Develop, coordinate, and monitor corrective and preventive action plans addressing underlying system risks; evaluate effectiveness and sustainability using objective data and measurable outcomes.
Provide patient safety and process reliability oversight for critical activities across the organ donation continuum, including referral and evaluation, donor management, ABO determination and verification, infectious disease testing and communication, recovery, identification and labeling, packaging and preservation, transportation and tracking, chain of custody, placement, DCD processes, donor-derived disease communication, and hospital/OPO/transplant-center handoffs, as applicable.
Work with process owners to establish measurable safety controls, detection methods, escalation pathways, response expectations, and reliability indicators for critical processes.
Integrate patient safety priorities into CORE’s data-driven QAPI program by evaluating events, near misses, complaints, audits, regulatory findings, OPTN requirements, risk assessments, and performance trends.
Lead or support Performance Improvement Projects using methodologies such as Lean, Six Sigma, PDSA, reliability engineering, and other evidence-informed approaches.
Establish baseline performance, targets, process and outcome measures; monitor progress, assess corrective-action effectiveness, and demonstrate sustained improvement.
Lead patient safety initiatives within Performance Excellence and partner with Data/Analytics to develop, maintain, and interpret patient safety and reliability dashboards.
Analyze safety data and communicate actionable findings covering what happened, contributing factors, corrective actions, intervention effectiveness, and remaining risk.
Provide 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.
Partner with Regulatory/Compliance and operational leaders to monitor OPTN compliance, support regulatory readiness, respond to OPTN inquiries and monitoring activities, and coordinate corrective actions related to findings.
Provide functional leadership for investigations, risk assessments, corrective-action coordination, and cross-functional improvement initiatives; drive a patient-safety-centered culture and supervise Enterprise Performance Improvement Engineers and activities within Performance Improvement.