Regulatory Specialist

Overview

To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values – integrity, patient-centered, respect, accountability, and compassion – must guide what we do, as individuals and professionals, every day.

The position has responsibility and accountability for working to assess, plan, and organize overall regulatory compliance and readiness (e.g. CMS, DPH/DOH, TJC) at the assigned Yale New Haven Health delivery network(s), as well as to participate in the improvement of key processes, policies and procedures as they relate to regulatory compliance.

Works as an internal consultant with medical staff, nursing, support services, and other departments to plan, organize, facilitate, implement and measure delivery network efforts to improve process efficiencies, assess regulatory compliance and improve overall patient safety and clinical quality.

The Regulatory Specialist provides project management experience necessary to support significant breakthroughs. Responsible for independent action in project oversight, systems design and implementation, quality improvement and a variety of special projects.

In conjunction with Departments and Committees; e.g. Legal Office, Laboratory Medicine and Quality and Safety colleagues, works to assess the impact of quality projects on clinical operations as well as gauge readiness and compliance for internal and external surveys, and adverse event and complaint investigations by CMS, DPH/DOH, TJC, and others as needed.

The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report‑out to management of major regulatory changes and issues of mock or real survey results. The Regulatory Specialist supports activities associated with site visits.

The incumbent will support and coordinate clinical safety and quality activities throughout the health system delivery network(s) and ensure that all safety and quality compliance issues are addressed and resolved in a timely manner.

The incumbent will design and provide educational tools and curricula and evaluation of such for standards and issues related to regulatory compliance.

EEO/AA/Disability/Veteran

• As necessary, acts as a key member of projects to improve clinical and non‑clinical areas. Partners with internal and external departmental leadership in meeting goals and objectives. Interacts with Managers, Staff, Department Heads, Clinical Service Coordinators, Vice Presidents, and Chiefs of respective departments in relation to projects.
• Acts as an active participant in departmental process improvement to enhance clinical quality and patient safety.
• Provides key regulatory safety and quality data highlighting business and operational issues requiring management attention and resources.
• Participates in task forces, charters and committees to provide operational input and regulatory consultation. Participates in the coordination and completion of multidisciplinary efforts in regard to regulatory preparedness and completion of applications (e.g. Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH/DOH or CMS corrective action plans, and clinical charter teams).
• Creates, develops, and delivers educational and training programs and tools relating to compliance issues, safety and quality issues, and continuous regulatory readiness.
• Provides consultation to clinical and non‑clinical departments and serves on multiple committees to continually assess aspects of DPH/DOH readiness and compliance.
• In conjunction with other JC/Regulatory Committee members, coordinates tracer rounds (mock surveys) to assess compliance with regulatory requirements and helps prioritize and remediate to improve performance.
• Facilitates and provides coordination of adverse/sentinel event and complaint investigations, root cause analysis, and ensures related improvement plans are met for safety issues recognized by JC, DPH/DOH, and CMS in…