Director, Clinical Regulatory Compliance

Accreditation, Regulatory and Licensure

• Maintains current records of licensure, accreditation and regulatory compliance as required.
• Ensures establishment and operation of an Institute-wide program to ensure compliance in a highly matrixed, distributed model.
• Provides logistical support to all regulatory compliance surveys across the organization. Supports the efforts of other Dana-Farber accreditations by providing input, guidance, and logistical support, as needed.
• Leads interpretation and communication of all regulatory and licensing requirements of the Institute and our collaborative partnerships. Facilitates risk assessment, identification, and mitigation, leveraging appropriate consultative resources and internal stakeholders.
• Leads interpretation and communication of all regulatory guidance regarding plans for all Dana-Farber’s future growth and collaborations.
• Ensures leadership is aware of changes to regulatory requirements and routinely communicates changes and mitigation strategies to leadership on behalf of stakeholders. Oversees plans and communicates progress towards adherence of changes to regulatory requirements.
• Chairs the Continuous Readiness Leadership Committee.
• Reports regularly to the Quality Improvement Committee and the Board of Trustees regarding changes in the regulatory landscape, continual readiness efforts, risks, and mitigations.
• Leads the integration of standards and regulations with clinical programs, operations, and quality improvement, including Patient Care Services, Patient Safety, Risk Management, Infection Control, Environmental Safety, Human Resources, and Occupational Health Services.
• Serves as a trusted advisor to interpret regulations and to how they may apply to operations and clinical care.
• Provides project leadership and support to stakeholders to implement changes in support of clinical regulatory requirements.

Ongoing Standards Compliance

• Stays current with all evolving regulatory standards and interpretations. Communicates new and revised standards and interpretations to the Continuous Readiness Committee, appropriate departments, sites, or programs, and Institute leadership.
• Manages the assignment and implementation of standards and regulations in collaboration with leadership.
• Develops and oversees plans to audit and track compliance; presents findings with stakeholder collaboration at relevant meetings or via reports.

Survey Readiness

• Leads all aspects of survey readiness, including but not limited to organizational assessment and identification of risk, intracycle monitoring, assessment and data submission, development of remedial action plans, survey application, scheduling readiness surveys, mock surveys, tracer program, staff education, requests for revision, corrective action plans, and public reports.
• Provides education and training to Institute staff and leaders regarding the requirements of accreditation and regulatory organizations, both formal and informal venues, e.g. presentations, publications, email, Web-based methods, etc. Facilitates educational and staff support activities for readiness teams.
• Provides recommendations in DPH licensure activities with the relevant departments related to construction, renovation, and addition of services or clinics/beds.
• Provides guidance and support to stakeholders for purposes of implementation of DPH regulations and CMS Conditions of Participation.

Education and Consultation

• Provides regulatory expertise and guidance throughout the planning process, construction, and opening of Dana-Farber’s proposed Future Cancer Hospital, as well as the future collaboration and hospital within a hospital relationship with Beth Israel Deaconess Medical Center.
• Directs formal education to a variety of constituencies across the Institute, regarding compliance expectations, feedback on readiness efforts, strategies for success, etc.
• Provides direct consultation and advice to assist managers and their departments in improving performance.
• Directs development of tools, policies, and procedures, and learning aids to promote compliance with standards.

Team Management

• Manage a team supporting Dana-Farber’s regulatory readiness and the organization’s overall Quality Assurance and Performance Improvement (QAPI) programs.
• Mentor the team and encourage professional development among direct reports.
• Collaborate with the Senior Director, Quality Assurance and Regulatory Compliance, and other members of the leadership team in Quality and Patient Safety to identify both short- and long-term staffing needs to ensure all regulatory expectations can be met.

Other Duties and Responsibilities

• Acts as the liaison with all partner hospitals to ensure all regulatory and licensure requirements are met.
• Develops plans in conjunction with stakeholders to collect, collate, and implement mitigation plans for routinely audited data, Quality Assurance and Performance Improvement data, and service level agreements.
• Raises issues and concerns related to regulatory gaps.
• Collaborates with the policy team to ensure clear processes are in place to update policies based on new regulatory requirements.
• Performs other duties as required.

SUPERVISORY RESPONSIBILITIES:

• Regulatory Compliance and Quality Assurance staff.

• Bachelor’s degree in a healthcare related field required; Master’s degree preferred.
• 10 years of experience in healthcare quality, compliance, or a related field required.
• Experience in an inpatient hospital setting (preferably in Massachusetts) required; experience within a facility providing oncology services preferred.
• Direct experience related to interpreting regulatory requirements and managing survey processes of TJC, CMS, DPH, or other regulatory bodies required.
• 5 years of supervisory/management experience required.
• Knowledge of clinical terminology required.
• Project management, data management and/or information systems experience required.
• Applicable quality and safety professional certification required – i.e., Certified Professional in Healthcare Quality (CPHQ), Certified Joint Commission Professional (CJCP), Certified Professional in Patient Safety (CPPS), etc.
• Lean Six Sigma Green Belt or higher certification preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Extensive knowledge pertaining to state and federal reporting requirements and the associated rulemaking processes.
• Strong knowledge of quality measurements, health care policy, clinical regulatory compliance, and patient safety
• Strong knowledge of performance improvement methodologies
• Familiarity with Massachusetts hospital regulations, as well as requirements related to hospital colocation.
• Knowledge of incident reporting systems, clinical databases, electronic health records (preferably Epic and Cerner), business intelligence products (preferably Tableau), and a multitude of reporting and management systems (QualityNet, CDC/NHSN portal, National Cancer Database, MassHealth Quality Exchange Portal, and others)
• Oncology knowledge, preferably related to PPS-exempt cancer hospitals or similar organizations.
• Demonstrated strong personnel management skills.
• Demonstrated project management skills.
• Excellent verbal and written communication and interpersonal skills.
• Strong organizational skills to manage, coordinate, and communicate regulatory compliance to a wide audience.
• Public speaking and facilitation skills, with all levels of staff.
• Strong computer skills.
• Ability to use sound judgment and professional maturity.
• Ability to develop effective relationships with staff across Dana-Farber, as well as with staff at outside organizations.
• Ability to work with confidential and sensitive information.
• Ability to create engagement of key stakeholders for ensuring regulatory compliance.
• Ability to openly share concerns, risks, and mitigation plans.
• Ability to create a sense of comfort for staff in engaging with regulatory agencies to speak and share how Dana-Farber applies and meets regulatory requirements.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.  As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

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