HLD & Regulatory Compliance Manager

at  University of Michigan

SUMMARY

The High-Level Disinfection (HLD) and Regulatory Compliance Manager oversees fiscal and operational planning and implementation, regulatory compliance, employee engagement and continuous improvement for the Central Endoscope Reprocessing Department (CERD). Responsible for the oversight of disinfection and sterilization standards and practices for reusable instrumentation, flexible and rigid scopes and other medical devices across the clinical enterprise. Works in collaboration with CERD and Central Sterile Processing Department (CSPD) leaders to ensure compliance with regulatory standards and manufacturer instructions for use (IFUs). Serves as a content expert for High Level Disinfection standards and regulations. Supervises education activities for CERD and CSPD across the clinical enterprise including new employee training and ongoing competency programs to ensure standardization and practice adherence across sites. Interfaces with Infection Prevention, Accreditation, Safety Management, Acute Care, Ambulatory Care, Health System Administration, Facilities, and Value Analysis to ensure adherence to regulatory requirements, standards and best practices.

REQUIRED QUALIFICATIONS*

• Bachelor’s degree in healthcare administration, business administration or applicable field, or equivalent combination of related education and experience is required.
• Minimum three years of professional and relevant work experience, including some progressive supervisory/management positions in the leadership of sterile reprocessing departments, preferably in a large academic and/or complex medical facility.
• Flexible Endoscope Reprocessor (CFER) certification issued by the Certification Board for Sterile Processing and Distribution (CBSPD) required or obtained within one year of hire/transfer date.
• Subject matter expertise of high-level disinfection.
• Extensive knowledge of medical instruments, scopes and procedural area reprocessing procedures
• Demonstrated ability to build effective working relationships, interact effectively and negotiate professionally with influential entities.
• Demonstrated ability to motivate and influence others as well as to maintain an environment of collaboration and trust.
• Maintains expert knowledge of regulatory requirements and guidelines as they relate to HLD.
• Maintains active membership/affiliation with applicable professional organizations.
• Ability to pursue goals, analyze complex issues, facilitate change in response to a dynamic environment, and communicate effectively at all levels of the organization.
• Demonstrated expertise in human resources management; ability to lead and manage staff with diverse skills and expertise.
• Demonstrated managerial, analytical, organizational skills and financial acumen.
• Experience in developing and implementing process improvement strategies and quality initiatives (Lean Manufacturing, Six Sigma etc.)
• The flexibility to orient to and oversee multiple Michigan Medicine locations.
• Demonstrated strong computer skills and be proficient with various applications including Access, Excel and PowerPoint.

• Collaborates with Surgical Operations, Nursing and Hospital or ACU leadership, to oversee fiscal and operational planning, operational execution, regulatory compliance, employee engagement and continuous improvement for the Central Sterile Processing Departments within designated areas.
• Advises leadership on respective segment planning strategies, industry standards for all aspects of instrument processing and sterilization/HLD, and all regulatory standards.
• Design, manage and monitor staffing models, quality performance & operational productivity. Makes adaptations as predicated by changes in work environment, demand and regulatory requirements, etc.
• Develop / implement facilities standards (operational production, quality indicators, performance indicators, equipment performance indicators).
• The position provides and monitors compliance with policies and regulatory agency standards including, but not limited to The Joint Commission, CDC, OSHA, CMS, FDA, AORN and AAMI. Ensures continual accreditation readiness with sterilization and high level of disinfection.
• Operational Support - Ensures appropriate management of day-to-day operations at designated sites of service:
• Supervision of local management within Central Sterile Processing Departments
• Provides operational support and guidance to local CSPD leadership.
• Develops and provides educational opportunities for staff and leadership in partnership with CSPD educators.
• Partners with Human Resources, Labor Relations, AFSCME Bargaining Union Representatives and others in establishing, reviewing, modifying, and maintaining fundamental department infrastructure, policies, procedures, etc. (job descriptions, pay structure, policies, competencies, etc.).
• Ensures enterprise service coverage:
• Collaborates with local customers, Nursing, and Infection Prevention & Epidemiology to redirect reprocessing work to appropriate CSPD locations.
• Establishes Service Level Agreements with customers.
• Partners with Facilities, Maintenance and Planning in the development and building design of new/renovated CSPD departments.
• Creates and manages plans for service interruption at one or more CSPD site.
• Supports local leaders during regulatory visits.