The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Under the general supervision of the Director-WSH Accreditation and Licensure, provides regional leadership and oversight for the accreditation and licensure activities at the other hospitals based in the assigned WellSpan Region. Provides direction and leadership by coordinating activities designed to achieve and maintain compliance with the PA Department of Health, hospital accreditation organizations, CMS Conditions of Participation and the Department of Human Services regulations (accreditation standards) directly for the Hospital and for all outpatient centers/practices that are licensed by the Hospital. Performs a variety of clinical audits, analysis of the data as well as ensures compliance with regulatory audits. Acts as Coordinator for on-site surveys and works in collaboration with others to facilitate system process and outcome improvements. Working with clinical teams and facilities staff, determines root cause for identified defects and deficiencies and prepares standard work and policy recommendations as appropriate. Spreads information through communication forums such as WellSpan’s Quality Leadership Team (QLT) and Accreditation Leadership Team (ALT).
Duties and Responsibilities
Ensures that all standards related to licensure and hospital accreditation standards are being met.
Works closely with leadership and appropriate staff to coordinate survey follow-up activities, including plans of action, monitoring systems, clarifications and challenges.
Keeps abreast of appropriate regulatory agency requirements related to accreditation and licensure.
Educates others in interpretation of standards and assists as needed in planning improvements/compliance.
Initiates mock tracers as well as analyzing the data, reporting results to the appropriate oversight committee(s), and plans intervention activities for improvement, as appropriate.
Facilitates the Survey Readiness Committee and related activities.
Compiles data for and prepares regularly scheduled or special reports, analyses and statements.
Develops and oversees the implementation of corrective action plans to address survey findings.
Keeps abreast of appropriate regulatory agency requirements related to accreditation.
Utilizes findings to initiate improvement. Utilizes Tracer activities as educational opportunity for staff.
Serves as local resource for clinical risk management activities and as liaison with WellSpan Health System Risk Management staff.
Provides ongoing reports and updates of existing and potential regulatory compliance issues to the DAL, Senior leadership, hospital Board(s) and other individuals and groups as directed. 13 Knowledgeable about Lean methodologies and uses Lean Daily Management System tools to implement effective process improvements.
Active participant in the Hospital Environmental Safety Committee, Emergency Management Committee, and Environment of Care Rounds. 15Coordinates and disseminates information to all hospital employees regarding accreditation and licensure, providing educational guidance as appropriate.
Develops, establishes and implements goals, objectives, and policies and procedures for department and hospital operations, which guide and support the provision of services.
Continuously assesses and improves the department, entity’s performance. Maintains appropriate quality control/assessment programs (if applicable).
Other combinations of formal education, training and experience may be considered.
Min Field of ExpertiseGovernment Regulations; Healthcare and Regulatory Affairs; clinical experience related to Patient Safety
Master’s Degree in a related field such as Healthcare Administration
istrationCurrent and active RN license in PA preferred; other clinical experience considered; HACP and CJCP are preferred
Skills of Lean methodologies preferred, Demonstrated leadership skills and ability to work independently; Demonstrated knowledge of health care and regulatory affairs; Must have a global view of the WellSpan Health vision and mission; Needs to be analytical, inquisitive, persistent and detail-minded; Must possess a work ethic that is fair, moral, objective and discreet; Project management and computer skills are required.
Internal Number: 66429
About Wellspan Health
Working as one to improve health through exceptional care for all, lifelong wellness and healthy communities.
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•Working as One
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