Director of Patient Safety

Fresenius Medical Care • Waltham, MA

22h

About The Position

PURPOSE AND SCOPE: Subject Matter Expert supporting the implementation and coordination of the Clinical Services Resource line, Patient Grievance Line and works closely with the Compliance Department on Compliance Action Line (CAL) investigations. Leads day to day operations for all adverse event investigations and partners closely with the Legal, Department, Medical Office, Clinical Staff, Biomedical Engineering Department and others as needed in providing field support and communication. Maintains critical, collaborative relationship with Regulatory Affairs, Medical Office, Clinical Services, Clinical Operations, and Clinical Education and Quality. Works closely with Patient Safety and Clinical Services Leadership in support of the Patient Safety program. Provides informal leadership in developing a culture of safety, as well as in identifying opportunities and initiatives to enhance patient safety. Supports strategic and operational plans that build upon the present Patient Safety Program. PRINCIPAL DUTIES AND RESPONSIBILITIES: Provides SME and participates in the day to day Patient Safety Department Operations to ensure the operations effective achievement of goals within the assigned business unit. Coordinates activities with the appropriate interdisciplinary teams in corporate, field staff, or operations related to serious events, medical device complaints/problems, human resource and interdivisional and interdepartmental problems that affect clinical operations and outcomes. Provide direction to facilities regarding completion of required reports collaborating with Corporate Law Department and Risk Management as necessary. Reviews health records as necessary to assess and evaluate the appropriateness of care and treatment. Assists clinical management and staff with understanding and maintaining compliance with ESRD regulatory requirements including Subpart U-conditions of coverage, Federal and State regulations. Assists facilities in the implementation of annual Safety and Clinical Services Department initiatives such as, Influenza Vaccine Program, 5 Diamond Program, Hand Hygiene and Hepatitis initiatives. Acts as a resource for patients to address concerns and questions. Acts as a clinical resource to facilities, area and regional management, and corporate staff and physicians collaborating with the pertinent Regulatory Affairs staff, Education staff, Technical Services, Renal Therapies Group and other company groups to ensure the appropriate interpretation and adherence to company compliance and other department policies, to assist in identifying potential areas of non-compliance and to communicate identified problems and compliance initiatives to the field. Assists in resolving legal and litigation issues with the goal of diminishing expenses to the Company. Assists in the development of business integrity related policies and procedures. Develops educational materials and audit tools for Clinical and Corporate staff. Develops quality improvement plans when expected clinical outcomes are not met. Guides clinical practice via program development utilizing training manuals and other educational materials, consultation, review of current literature etc. Develops clinical policies and procedures related to machine technology used in facilities. Identifies data elements for use in future clinical quality programs, initiatives, policies and procedures. Assists the Medical Record Management Department to develop policy and training programs related to Clinical Quality. Contributes to ensuring quality of care for all home patients by providing input to Home Therapy policies and procedures. Addresses product issues and selection and to develop procedures for FDA approval for new products and product changes. Provides guidance, interpretation and subject matter expertise to the organization regarding inquiries about clinical policies and procedures, clinical standards, as well as professional practice.

Requirements

• Current unrestricted license as an RN-Registered Nurse.
• Bachelor's degree in Nursing, healthcare preferred.
• 8 - 12 years' related patient care experience in a clinical dialysis setting; or a Master's degree with 6 years' experience; or equivalent directly related work experience.
• Exemplary Customer Service, interpersonal, collaboration and relationship skills.
• Proficient computer skills essential; web-based collaboration and document management platform, Microsoft Office and Visio.
• Excellent communication skills-verbal and written.
• Ability to prioritize and manage multi-dimensional health care related activities.

Nice To Haves

• Advanced degree desirable.
• Certification in Nephrology Nursing preferred.
• 2+ years' experience as a Clinical Manager preferred.
• Certification in Patient Safety desired.

Responsibilities

• Provides SME and participates in the day to day Patient Safety Department Operations to ensure the operations effective achievement of goals within the assigned business unit.
• Coordinates activities with the appropriate interdisciplinary teams in corporate, field staff, or operations related to serious events, medical device complaints/problems, human resource and interdivisional and interdepartmental problems that affect clinical operations and outcomes.
• Provide direction to facilities regarding completion of required reports collaborating with Corporate Law Department and Risk Management as necessary.
• Reviews health records as necessary to assess and evaluate the appropriateness of care and treatment.
• Assists clinical management and staff with understanding and maintaining compliance with ESRD regulatory requirements including Subpart U-conditions of coverage, Federal and State regulations.
• Assists facilities in the implementation of annual Safety and Clinical Services Department initiatives such as, Influenza Vaccine Program, 5 Diamond Program, Hand Hygiene and Hepatitis initiatives.
• Acts as a resource for patients to address concerns and questions.
• Acts as a clinical resource to facilities, area and regional management, and corporate staff and physicians collaborating with the pertinent Regulatory Affairs staff, Education staff, Technical Services, Renal Therapies Group and other company groups to ensure the appropriate interpretation and adherence to company compliance and other department policies, to assist in identifying potential areas of non-compliance and to communicate identified problems and compliance initiatives to the field.
• Assists in resolving legal and litigation issues with the goal of diminishing expenses to the Company.
• Assists in the development of business integrity related policies and procedures.
• Develops educational materials and audit tools for Clinical and Corporate staff.
• Develops quality improvement plans when expected clinical outcomes are not met.
• Guides clinical practice via program development utilizing training manuals and other educational materials, consultation, review of current literature etc.
• Develops clinical policies and procedures related to machine technology used in facilities.
• Identifies data elements for use in future clinical quality programs, initiatives, policies and procedures.
• Assists the Medical Record Management Department to develop policy and training programs related to Clinical Quality.
• Contributes to ensuring quality of care for all home patients by providing input to Home Therapy policies and procedures.
• Addresses product issues and selection and to develop procedures for FDA approval for new products and product changes.
• Provides guidance, interpretation and subject matter expertise to the organization regarding inquiries about clinical policies and procedures, clinical standards, as well as professional practice.
• Maintains key relationships with Value Based Services Support Departments and Leads, Medical Department, Education Department, Technical Services Department, Legal and compliance Departments, Operations Leadership.
• Provides assistance to staff with complex tasks that require considerable judgment and initiative.
• Escalates difficult/complex issues to supervisor/manager for resolution, as deemed necessary.
• Performs other related duties as assigned.

Benefits

• This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees