Compliance and Safety Investigator

Position Description

The Investigator's primary role is to investigate potential noncompliance with OPTN (Organ Procurement and Transplantation Network) Obligations, including OPTN policies and bylaws, and applicable provisions of the OPTN Final Rule, and other matters that may pose a potential risk to patient health or public safety or the integrity of the OPTN.

Key Responsibilities

• The Investigator: Ensures that investigations follow established processes, are objectively and thoroughly conducted, and are appropriately documented
  
  
  
  • Works with members to implement appropriate risk mitigation strategies as needed
  • Prepares clear, concise and factual reports
  • Effectively communicates findings to the OPTN's peer review body, the Membership and Professional Standards Committee, and other key staff and stakeholders as appropriate
  • Recommends proactive measures that will reduce the risk of similar future incidents
  • Helps identify and develop educational resources for the OPTN community on matters pertaining to patient health, public safety, and noncompliance with OPTN Obligations
  
  
  
  
• Conduct and Document Investigations: Triage and appropriately classify patient safety reports submitted to the OPTN.
  
  
  
  • Independently develop and execute appropriate investigation strategy for assigned investigations.
  • Escalate findings to leadership as needed and based on documented processes.
  • Examine records/data, gather evidence, classify, and differentiate investigative elements.
  • Inquire with OPTN members and members of the general public and other organizations as needed to evaluate reports. Conduct interviews in an
  • Work with members to implement containment plans and other risk mitigation strategies in a timely manner when a potentially urgent or severe risk is identified
  • Review and analyze transplant-related medical records and documents
  • Collaborate with appropriate partners (including General Counsel, Policy and Research Departments and IT) during reviews and presentations of investigation findings as needed.
  • Act as subject matter expert for OPTN Obligations; assess investigative findings to determine whether a potential noncompliance occurred.
  • Extensively document activities in appropriate systems
  • Prepare comprehensive, concise and objective reports of investigative findings.
  • Routinely present updates on investigative activities in an effective and succinct manner to internal multi-disciplinary team, UNOS and MPSC leadership, and U.S. Department of Health and Human Services representatives
  
  
  
  
• Data Analysis and Education: Routinely analyze data to identify potential trends or areas of concern regarding compliance with OPTN Obligations and potential patient safety issues.
  
  
  
  • Based on data analysis results, identify and help develop potential educational opportunities for OPTN members or modifications to OPTN Obligations.
  • Educate OPTN members and the general public on the patient safety investigation process as needed.
  • Provide routine and ad hoc reports on investigative activities to stakeholders, including UNOS, MPSC and OPTN leadership, and the U.S. Department of Health and Human Services representatives.
  
  
  
  
• Special Projects: Routinely update templates and systems associated with principal duties and responsibilities
  
  
  
  • Conduct special investigations as directed by senior OPTN leadership
  • Lead or participate in special department projects as requested
  
  
  
  

Minimum Requirements

• 2 years professional experience required. Minimum three years investigative experience preferred.

Critical Skills

• Working knowledge of auditing principles and technical methodologies
• Case management and/or incident management experience
• Ability to review and analyze transplant-related medical records and other documents
• MS Office proficiency, including Word, Outlook, and Excel.
• Strong interpersonal and presentation skills - ability to communicate succinctly and effectively across all levels of the organization.
• Project management skills and the ability to act independently and responsibly in a fast-moving environment.

Additional Skills & Qualifications

• Experience in clinical/patient safety incident investigations, case management, or utilization review and quality assurance preferred.
• Problem solving; the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully
• Quality management; the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
• Judgment; the individual displays willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
• Planning/organizing; the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.

Education

• Four year degree or equivalent work experience required. Advanced degree in public health, healthcare administration, nursing or social work highly desirable.

Physical Requirements

• Participation in on-call rotation schedule, one week at a time, on average one week per month. (Monday-Friday approximately 5pm-10pm, Sat-Sun 8am-10pm; review incoming reports within 2 hours and follow up as needed)
• Some overnight travel may be required (approximately once per year)
• General office demands
  
  
  
  • Prolonged periods of sitting at a desk and working on a computer.
  • Frequent reaching, handling, and fine manipulation for using office equipment, filing, and managing paperwork.
  • Manual dexterity sufficient to operate a keyboard, mouse, and other office tools.
  • Occasional standing, walking, and bending.
  • Ability to lift up to 10-20 pounds occasionally.
  • Vision abilities required include close vision for computer work and reading documents.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.