The Manager, Regulatory Affairs is responsible for the overall daily planning, developing, implementation, and coordinating the Hospital’s regulatory and accreditation compliance program. The Manager, Regulatory Affairs is responsible for the entire scope of the regulatory and accreditation compliance program throughout Stamford Hospital’s Health System. The Manager, Regulatory Affairs participates and collaborates with the investigations and will ensure completion and follow-up of Cause Analyses/Plans of Correction related to actual or potential sentinel events, adverse events, or regulatory findings. In order to succeed at our vision as the most trusted healthcare partner, we need to ensure regulatory compliance, defined as the minimal level of care and treatment to promote safe, high-quality care. A strong Regulatory Compliance program enhances the strategic goal core capability of patient safety and quality, growing programs and in addition supports the organizational goal of being the most trusted healthcare partner
MAJOR ACCOUNTABILITIES/CRITICAL RESPONSIBILITIES:
- REGULATORY FUNCTIONS:
- Directs and assumes responsibility as the contact person for Regulatory and Accrediting organizations for the hospital.
- Assumes overall daily responsibility and oversight for the organization’s regulatory compliance program pursuant to legislative, regulatory, and accrediting guidelines at all Hospital sites.
- Provides assistance to Stamford Health departments with preparation for regulatory surveys/inspections and site visits.
- Directs and coordinates all phases of preparation for surveys/inspections including but not limited to The Joint Commission, CT Department of Public Health (DPH), Center for Medicare and Medicaid Services (CMS), Department of Environmental Protection, Nuclear Regulation Committee, Drug Enforcement Agency, The Joint Commission Disease Specific Certification etc.
- Has direct responsibilities for oversight of key regulatory applications including Department of Health re-licensing and The Joint Commission surveys. Completes other regulatory applications as directed by Director, Regulatory Affairs or Executive Leadership Team.
- Directs, coordinates and participates as needed in meetings with regulatory and accrediting agencies.
- Coordinates efforts to provide assistance to regulatory agencies in response to inquiries or requests for information and/or medical records consistent with legislative, regulatory, accrediting, and Hospital policy.
- Assume responsibility, within Department and Hospital policy, for reporting to and interfacing with regulatory agencies on compliance issues.
- Responsible for supervision and management for Regulatory Associate(s), and other staffing resources including temporary and consulting resources.
- Will oversee all Performance Management, Competency Assessment and Retention Planning process.
- Responsible for all phases of department personnel management: recruitment, performance management and tale ensuring departmental and individual team goals are tracked and on target.
- Responsible for tracking and trending department goals and metrics and ensuring they are communicated to key stakeholders
- In collaboration with SH leadership, leads development, coordinating, and monitoring of plans of correction and alleged deficiencies for regulatory and accrediting agencies
- Responsible for reporting critical and sentinel events to regulatory and accrediting agencies.
- Responsible for creation of annual Regulatory Budget, monitoring monthly variances, and review of monthly variances with Director, Regulatory Affairs.
- Assist in investigation of malfunction and/or defective product devices.
- Coordinates and assists with investigation for diversions in clinical practice issues, i.e., drug diversion.
- Reports, supports, and educates executive staff on new regulatory statutes and standards.
- Co-chairs the Policy and Procedures Governance committee and policy and procedure process for organization including education of and monitoring of compliance of the hospital policy/procedure management system.
- Participates in Quality/Performance and Patient Safety Improvement Committees to ensure compliance with regulatory and accrediting agencies.
- Directs and supports employees in the performance of job function as well as the coordination of activities to assure regulatory compliance
- Participates as a key team member to support various committees in obtaining regulatory compliance.
- Supports hospital operations in meeting mandatory regulatory and accrediting requirements.
2.PERFORMANCE IMPROVEMENT FUNCTIONS:
- Ensures safe practice throughout the healthcare organization based on legal statutes and regulatory requirements.
- Collaborates with the Chief Quality Officer to ensure regulatory and policy compliance.
- Contributes and participates in the Performance Improvement and Quality Improvement activities of the assigned department.
- Participates in improvement/Continuous Quality Improvement (CQI) teams, consistent adherence to the specific rules and regulations of the Stamford Hospital (a) Safety and Security Policies, (b) Risk Management: Incident and Occurrence Reporting, (c) Infection Control Policies and Procedures and (d) Patient and Customer Service.
- Follow up for risk reduction strategies and corrective action in response to sentinel events or quality of care issues.
- Interface with other departments to address patient care issues or complaints promptly and effectively.
- Develop and maintain programs for tracking and trending significant and/or reportable occurrences and professional practice concerns
- Coordinate or participate in Performance Improvement committees and Patient Safety committees as necessary
- Coordinates with external regulatory consultants for onsite survey schedule and follow up.
- Participates as directed in committees during a public health emergency.
3. RISK MANAGEMENT COLLABORATION:
Collaborates with the Senior Vice President of Risk Management, Director (s) and Risk Associates as appropriate to:
- Analyze and evaluate occurrence reports generated by departments and individuals responsible for Medical, Nursing and Utilization review to determine regulatory reportability of events.
- Assist departments in determining appropriate corrective actions with reportable events involving risk and medical error reduction.
- Participate as the regulatory representative Root Cause Analysis and Sentinel Event Review Panel team meetings.
- Interface with medical records department as necessary to ensure efficient processing of inquiries from regulatory agencies and legal representatives of patients.
- GENERAL FUNCTIONS:
Performs other related duties as assigned or requested to maintain a high level of service.
Completes required continuous training and education, including department specific requirements.
Demonstrates professional work behavior by following Service Standards and Success factors.
Complies with departmental organizational policies and procedures and adheres to external agency requirements.
Establish and maintain positive relationships with patients, visitors, and other employees.
Interact professionally, courteously, and appropriately with patients, visitors, employees and external agencies.
Behave in a manner consistent with maintaining and furthering a positive public perception of the Stamford Hospital and its employees.
Maintains high ethical standards consistent with business, medical, and nursing principles to enhance hospital compliance and credibility with regulatory agencies and the general public
- EDUCATIONAL FUNCTIONS:
- Provide in-service training at the new employee and physician orientation sessions, and ongoing training activities regarding regulatory affairs issues and department functions.
- Provide ongoing organizational education to ensure regulatory compliance.
- Participate in and/or attend educational seminars and conferences.
- Collaborates and directs as necessary staff educational programs involving patient safety, medical injury prevention, documentation, regulatory reporting, Joint Commission reporting, reporting involving other regulatory agencies, policies and procedures, Health Care Proxy policies and procedures, and other programs as requested or as determined by the Director, Regulatory Affairs
Required Skills
- Bachelor’s Degree in nursing or healthcare is required
- Master’s Degree Preferred
- Valid CT RN or other health care license
- Ability to accurately complete and analyze regulatory data, produce accurate and detailed written reports
- 3 to 5 years of prior regulatory compliance experience in an acute care setting is required.
- 3-5 years’ prior leadership experience which may include supervisor or team lead roles.
- Excellent written, oral and communication skills are essential.
- Demonstrated organization skills are essential.
- Expertise in the utilization of quality improvement methods related to data management and analysis is required.
- Experience developing and conducting educational programs.
- Proficient in Excel, PowerPoint, Teams
- Able to work independently with attention to detail including:
*Collaborating with other leaders and staff to develop and approve regulatory plans of correction.
*Address daily challenges while escalating and requesting input from leaders when necessary.
*Proactively identify areas of concern.
*Delegating assignments as needed when appropriate
*Tracking metrics and goals and communicate concerns as needed.
Required Experience