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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Manager, Quality Assurance and Performance Improvement
Responsibilities include providing leadership, direction, and oversight for our Quality and Performance Improvement program and in collaboration with the leadership team, ensuring compliance with all regulatory and credentialing agencies as well as planning, implementing, and evaluating educational opportunities to ensure ongoing staff development.
- Develops, plans, implements and evaluates Blue Ridge Hospice’s Performance Improvement and performance improvement initiatives. - Reviews all Incident Reports, Adverse Event Reports, and Infectious Disease Reports and ensures appropriate follow up. - Reviews and revises the Infection Control Plan on an annual basis. - Communicates identified areas of concern/opportunities for improvement to the chief Clinical Officer and other leadership staff. - Chairs the Quality Committee and completes reports for the Board of Directors. - Ensures a timely response to all levels of Medicare request for medical record documentation related to Additional Development Requests (ADRs) and manages all levels of appeals including: Redeterminations, Reconsiderations and Administrative Law Judge. Writes or edits all letters and ensures a final version is delivered to the Business Office prior to the due date. - Coordinates and leads the organization’s accreditation process. - Collaborates with clinical leadership to ensure employee orientation, initial competency assessment, annual competency training and in-service educational programs. - Establishes and chairs the Nursing Education Committee. - Participates and assists with community and professional educational opportunities regarding end-of-life care and hospice services.
- Graduate of an accredited school of nursing; BSN required; and Master's Degree preferred - Three-five years of nursing experience, including three years of progressive nursing leadership experience - One year of current hospice experience preferred - Must have a comprehensive knowledge of nursing practice, applicable regulatory requirements and standards of care related to hospice - Must have strong organizational skills with proficiency in Microsoft Office, data collection and analysis, and the ability to work with staff from a variety of disciplines in multiple settings