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 direction of Executive Director of Quality provides day to day operational leadership for risk management, responsible for the development and coordination of risk management programs, patient safety programs, and accreditation compliance and readiness programs designed to enhance the culture of safety, reduce incidence and magnitude of damage claims made against the hospital and to maintain regulatory compliance. Works to enhance the effectiveness of the systems to monitor and manage risk and patient safety events. Develops structure and process to analyze risk management and patient safety event data. Leads facility wide projects, prepares claims files (med mal, auto, property and general liability insurance), works with claims and legal counsel in case management, assists in determining claims causation, provides education to the facility relating to risk, regulatory compliance, risk exposure and facilitates immediate process improvements to avoid repeat events in response to significant risk incidents. They also lead cause analysis meetings and supports compliance with applicable regulatory agencies and the Joint Commission.
The manager will work very closely with the hospital Manager(s) and Risk Specialist(s) ensuring risk management and patient safety functions are consistent, effective, and efficient while collectively ensuring High reliability organization (HRO) best practices are being used
On a rotating basis with other risk management designated individuals, provide 24x7 call coverage and other assigned areas which may include physically being present at the facility during off-hours, weekends, and/or holidays.
Development and maintenance of appropriate and necessary departmental policies, procedures, objectives, and activities relating to improving organization performance.
Directs the work of the risk specialist(s), patient safety, physician peer review, to ensure department needs and expectations are being met.
Provides investigative support for all activities regarding actual or alleged Medical Center liability (not including Workers' Compensation) relative to patients, employees, physicians, and visitors. Ensures Executive Director is kept apprised of status of discovery and investigations.
Ensures appropriate executive leadership, in conjunction with the Executive Director, are kept apprised of status of litigation, and, when needed, obtain authorization for payment of monies to settle claims.
May be required to attend legal proceedings as a representative on behalf of the organization in conjunction with legal counsel.
Act as a liaison, on behalf of the Executive Director, between respective PSJH enterprise risk management, integrity, compliance, privacy, and/or legal departments.
May act as a delegate of the Executive Director at internal and external meetings.
Coordinates insurance new/renewal activities and submits the required documentation.
Provides support for regulatory agency survey and reporting activities, including CDPH, DMH, DHS, CMS, FDA and The Joint Commission in collaboration with the regulatory program manager(s).
Coordinates mandatory and statutory reporting to licensing, accrediting, and other governmental bodies under the direction of the Executive Director. This may include, but not limited to, sentinel events, health & safety code reportable events, unusual occurrences, and workplace violence reporting, etc.
Maintains and disseminates knowledge of accreditation and licensing standards pertinent to improving organization performance and maintaining survey readiness. Oversees and coordinates continued survey readiness for all regulatory agencies. Provides education to medical staff and hospital departments on standards affecting their areas of responsibility. Ensures excellence in patient care consistent with TJC, title 22, CMS, CDPH, and other regulatory agencies through clearly defined performance standards and verifying the proficiency of staff.
Prepares and submits appropriate facility licensing documentation in collaboration with the regulatory program manager(s).
Provides investigative and other support for event analysis (Root Cause Analysis, Apparent Cause Analysis, Failure Mode & Effect Analysis).
Coordinates facility-wide communication of lessons learned and improvements from event analysis (RCA, ACA, and FMEA) in collaboration with regulatory and/or patient safety program manager(s).
Under the supervision of the Executive Director, acts as facility Super User of Unusual Occurrence Report system, assigning permission levels to managers/others, reviewing and analyzing UOR submissions, and prepares quarterly summaries of UOR data for Leadership and committee support.
Works to reduce facility risks and promotes patient safety.
Participates in hospital/medical staff committee meetings as required. Attends and serves on professional/civic service organizations as hospital representative.
Interacts with legal counsel and insurance claims representatives. Collaborates to determine event causation, claim worth, mediation, completion of discovery and interrogatories.
Manage the claims process for those actions that are not covered under the self-insured trust.
Oversees analyzing clinical processes, identify potential risks for patients and develop strategies to maximize safety, effectiveness and efficiency. Along with the Patient Safety Officer, the Risk Manager develops the education regarding patient safety, and works to influence leaders to achieve measurable improvements in patient safety that will support the sustainability of reductions in medical/healthcare errors and other factors that contribute to unintended adverse patient outcomes.
Oversees the Physician Peer Review process by case finding per Interdisciplinary/Departmental Specific, Medical Staff Indicators for peer review in collaboration with the quality department. Assigns peer review cases to appropriate Medical Staff reviewers and monitors progression of case through committees until completion. Maintains database of peer review records and develops and designs reports and queries to support committee needs. Prepares summaries of peer review data for the Executive Director, Clinical Risk Manager(s), Leadership, Medical Staff, Board, and other committees as necessary. Keeps Clinical Risk Manager(s), Executive Director, Chief Medical Officer and Medical Staff Officers apprised of status of peer review cases and any issues that may exist. Attends hospital and medical staff committee meetings as required.
Enhances professional growth and development through participation in educational programs, professional affiliations, current literature, in service meetings, and workshops.
Above all, we are looking for a servant leader whose personal and professional background demonstrates a genuine passion for the mission and core values of Providence Health & Services. You have a style that emphasizes openness, collaboration, visibility, and connectivity. A strong, confident, results-oriented, and decisive leader with the capacity to balance the big picture and strategic perspective with a focus on operations and the details of execution. You can articulate how your work improves healthcare delivery in the communities that we serve.
Required experience/education for this position include:
Bachelor's Degree in Science, Healthcare or Nursing/or equivalent education/experience
5 years of Patient Safety experience in an Acute Care background
Current California Registered Nurse License, or equivalent or higher level licensure preferred.
Needs to be an inspirational leader who can lead and mentor by example.
Have a background with emphasis on regulatory readiness.
Certified Professional in Healthcare Risk Management (CPHRM) strongly preferred.
Knowledge of national healthcare trends, multi-disciplinary professional practice models, information systems, quality management, and customer service needs.
Knowledge of the fundamentals of risk management, privacy, compliance, patient safety and/or performance improvement.
Work efficiently and effectively in a matrix structured environment.
Must possess strong presentation and interpersonal skills that display a presence of relevant knowledge in a wide range of settings.
Must possess skills and understanding of hospital clinical healthcare operations and quality data management.
Quality and Safety.
Efficiently problem solve, while dealing with a diverse set of systems and individuals.
Ability to interact effectively with physicians, patients and employees at all levels of the organizational hierarchy.
Maintaining good working relationships both inter- and intra-departmentally.
Ability to manage sensitive and confidential issues.
Success in responding to multiple duties simultaneously.
Ability to meet strict deadlines.
For information on our comprehensive range of benefits, visit:
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
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When applying online, please reference job number 261191.
Providence Health & Services is a not-for-profit health system committed to providing a comprehensive array of services to meet the needs of communities across five states, including Alaska, Washington, Montana, Oregon and California. Providence continues the legacy of the Sisters of Providence and the Sisters of the Little Company of Mary in the West spanning more than 150 years.