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DIR, ACCRED/REGULATORY AFFAIRS
Job Title: DIR, ACCRED/REGULATORY AFFAIRS
Job Code: 5667
FLSA: E
Job Level: I2
Revised Date: 06/01/2025
Supervisory Responsibility: Yes
General Description of the Job Class
The Director of Accreditation and Regulatory provides leadership, through leveraging extensive knowledge in regulations, standards and improvement methodologies, for the growth and development of an entity accreditation and regulatory program. The Director is responsible for collaborating with entity leadership, staff and medical staff to provide a proactive and unified perspective and understanding of accreditation, regulatory and disease specific certification requirements and activities. The Director plays a pivotal role at their entity organization in leading organizational level efforts to achieve the highest compliance with accreditation and certification standards and employ approaches to ensuring practices not only meet but exceed benchmarks for patient care excellence. The Director serves the entity organization as a resource, mentor, and educator for regulatory, accreditation and certification programs; works across the organization to assess, measure, and report ongoing compliance with standards, promote evidence-based best practices, standardize common survey processes and support survey readiness as part of day-to-day operations. The Director of Accreditation and Regulatory collaborates with operational, executive and medical staff leadership at their entity organization to operationalize an effective continuous readiness infrastructure that ensures the DUHS Accreditation and Regulatory Program goals of 1) Standard interpretation, 2) Standard compliance, 3) Education and communication, and 4) Survey operations are sustained.
Duties and Responsibilities of this Level
Lead continuous readiness efforts:
Proactively leads the ongoing evaluation, planning and support of a continuous compliance and readiness infrastructure and processes to ensure accreditation by deemed status organizations as well as other regulatory accreditation, certifications and applicable organizational licenses.
Leads accreditation and readiness efforts involving leaders and departments to assess policies, evaluate workflows, observe clinical care, assess environment of care with the goal of identifying gaps, consulting on priority of items needing correction, researching and advising on compliance with standards/strategies using evidence-based practice. Supports workflow needs and develop strengths of content experts and leadership to support workflows.
Conducts ongoing monitoring, measurement and analysis of survey data and trends, communicates aggregate results and analyses to appropriate entity departments, staff and leadership. Partners with leadership to implement risk reduction and continuous compliance activities.
Oversees project prioritization and timeline management of the Accreditation and Regulatory Program.
Co-leads, with operations, the resolution of initiatives for complex accreditation and regulatory compliance issues. Evaluates effectiveness of corrective actions for identified issues.
Develops and maintains a comprehensive accreditation project plan that covers continuous and ongoing monitoring of compliance with accreditation and regulatory standards.
Develops and manages the meetings and activities of the Accreditation Readiness Committee.
Develops and maintains continual readiness accreditation tools, education and reference materials. Monitors for changes in federal and state regulations and accreditation standards and communicates changes to leadership and staff.
Collaborates with Patient Safety, Quality, Professional Practice, Risk Management, Legal and other departments to ensure regulatory functions are assessed and in compliance with standards.
In partnership with entity leadership, identifies accreditation or regulatory risks or vulnerabilities and supports organizational leaders in the development, implementation and monitoring of regulatory improvement processes. Serves as an expert in identification of high risk and patient safety sensitive processes and ensures activities are in place for ongoing risk assessment.
In partnership with entity leadership, establishes processes to conduct ongoing proactive review of regulatory, accreditation and certification standards.
Co-ordinates and participates in entity internal surveys using process audit tools and techniques to assess and evaluate ongoing survey readiness.
Develops and implements initiatives to evaluate and monitor compliance with regulatory standards through ongoing organizational assessment (Intracycle monitoring, Focused Standards Assessment, Tracers, Mock Surveys and Measurement Data).
Supports, leads and participates in entity pre-survey, on-site survey and post-survey activities for accreditation, regulatory and certification programs.
Resource development and management: Tracks and maintains accreditation and certification budget plan.
Develops toolkits, education and reference materials and provides educational opportunities and presentations.
Ensures regulatory resources are up to date, such as Accreditation Manager Plus (AMP) software program, E-dition standards and links to the CMS Conditions of Participation Interpretive Guidelines and other applicable guidelines/resources.
Develops and implements a robust communication system that effectively informs all stakeholders about accreditation requirements, implications and changes. Disseminates information clarifying regulatory and accreditation standards and organizes departmental and interdepartmental survey preparation and responses.
Provides education and training related to regulatory, accreditation and disease specific certification requirements.
Collaborates with clinical and administrative departments to implement changes and improvements that enhance compliance with standards and excellence in patient outcomes.
Supports operational leaders to develop, review and update policies and procedures as needed to remain in compliance with accreditation, certification and regulatory requirements.
Serves as an educational resource and leader in accreditation, regulatory and certification:
Serves as contact and point person for applicable standards-related manuals, publications and newsletters and educational materials; ensures pertinent information is communicated to appropriate individuals.
Serves as an expert resource and leader in regards to deemed status accrediting organization and other regulatory or certification agencies.
Provides guidance on accrediting and certification standards interpretation and other regulatory requirements as they apply to care practices.
Serves as a resource to other content experts and executive sponsors in standards and CoP interpretation, insight on upcoming regulatory changes and new requirements. Collaborate in exploring with operational leaderships the options for operationalizing the requirements.
Enhances continuous improvement activities by acquiring, utilizing and teaching performance and process improvement concepts and methodologies such as Robust Process Improvement, LEAN, PDCA, DMAIC.
Remains current with regulatory, accreditation and certification changes through available resources such as conferences or internet-based learning, reviewing and researching specific program materials and/or reviewing professional journals.
Coordinate accreditation, regulatory or certification surveys:
Serve as a liaison between accreditation/regulatory bodies and the entity.
Develop, maintain and implement entity specific unannounced survey plan.
Co-manage with organizational leadership on-site accreditation, regulatory and certification surveys.
Manage communications, agendas and logistics for on-site survey activities.
Serve as the liaison between on-site surveyors and the entity being surveyed. Serves as first point of contact for surveyors.
In partnership with leadership, establishes a process to conduct a proactive review or regulatory, accreditation and certification to assess vulnerabilities to compliance with standards.
Collaborates and effectively communicates with a wide variety of disciplines within the entity and provides support and guidance to evaluate, improve and sustain regulatory and accreditation readiness. Fosters cooperation among departments and disciplines to achieve and sustain ongoing accreditation and regulatory compliance.
Co-manage with entity operations leadership ongoing application requirements and corrective action plans:
Collaborates with entity leadership to assign teams to develop corrective action in response to survey findings and facilitate development and implementation or a corrective action plan.
Ensures that applications, plans of correction and other required information under the scope of this position are submitted timely.
Provides expertise and support in the development and implementation of action plans including measurement support as needed for required follow-up from accrediting organizations, regulatory surveys and Intracycle monitoring.
Collaborate with content experts and executive sponsors to ensure corrective action plans are implemented, measures are in place and monitored to sustain accreditation or certification.
Submit corrective action plans/responses to regulatory agencies for survey and for cause and complaint investigations.
Ensures deemed status accrediting organization applications for accreditation are updated and submitted as required and as accurately as possible.
Facilitates resolution of survey non-compliance though monitoring the progress of corrective action plans on an ongoing basis. Conducts internal surveys with hospital survey teams to review and evaluate the implementation, effectiveness and sustainability of survey corrective action plans; provides reports from the surveys to hospital leadership on the status of survey findings corrective process and resolution.
Required Qualifications at this Level
Education
Bachelor's degree in Nursing, Business, Healthcare Administration. Master's degree preferred.
Experience
5 years of experience working with accreditation, certification, quality, risk management, patient safety. Must have knowledge of quality improvement methodologies, project management and regulatory standards; CMS, TJC or DNV, DOH.
Must be able to work on-site to ensure readiness for unannounced surveys.
Preferred qualifications: Management experience, especially with clinical operations in a clinical healthcare environment preferred. Experience with auditing/data analytics, staff training and creative problem-solving strategies preferred. Previous accreditation readiness experience, experience with project management systems/leadership experience strongly preferred.
Degrees, Licensure, and/or Certification
RN or other clinical professional with current licensure/certification preferred.
Preferred certifications:
CPHQ - Certified Professional Healthcare Quality or
Certified Quality Technician - ASQ, or
HACP - Healthcare Accreditation Program, or
CSHA - Certified Specialist in Healthcare Accreditation
Knowledge, Skills, and Abilities
Knowledge of deemed status accrediting organization standards and regulatory compliance issues.
Experience applying quality management/performance improvement and customer services approaches.
Management/project management skills.
Strong problem solving, analytical and negotiating skills paired with strong attention to detail. Ability to develop, prioritize and accomplish goals.
Positive interpersonal skills; establish relationships and interact and work effectively in a team environment. Ability to influence others who have no direct reporting relationship.
Strong analytical, facilitation, coaching, written and verbal skills.
Flexible with changes, processes and procedures to meet program/plan needs.
Ability to use discretion/use independent judgment when obtaining, compiling and distributing information and data required.
Leadership and management experience within an organization with complex relationships and multiple stakeholders that may have conflicting goals and priorities.
Demonstrated ability to manage conflict, build, support, mentor and monitor teams and the ability to recognize and address positive behaviors that contribute to successful achievement of plan goals.
Highly self-motivated, self-directed and independent thinker using independent judgment while being a strong resource and team player for the team.
Distinguishing Characteristics of this Level
N/A
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
