Regulatory Specialist

OHSU is Oregons only public academic health center. We are a system of hospitals and clinics across Oregon and southwest Washington. We are an institution of higher learning with schools of medicine nursing pharmacy dentistry and public health and with a network of campuses and partners throughout Oregon. We are a national research hub with thousands of scientists developing lifesaving therapies and deeper understanding. We are a statewide economic engine and Portlands largest employer. And as a public organization we provide services for the most vulnerable Oregonians and outreach to improve health in communities across the state.

This position is a key contributor on the Regulatory Affairs team supporting the mission goals and objectives of OHSUHealthcare. Key functions of the position include coordination of regulatory readiness survey process and follow upactivities including corrective action plan oversight and production and tracking of data/ reports related to regulatorycompliance and survey outcomes. This position is responsible for the administration of the Internal Audit Program andis a back-up system administrator for Regulatory Affairs administered software document management software androunding software. This position also provides support consultation and coaching to healthcare leaders with respectto interpretation of regulatory standards and compliance needs. This position independently gathers compilesanalyzes and prepares qualitative and quantitative information and statistical data; provides complex systems supportand presents information in narrative and schematic form for use in corrective action and performance improvementplanning and decision making.

Administration of Internal Audit Program

• Serves as the primary administrator for the Internal Audit Program.
  • Develops and maintains internal audit program documents including but not limited to the internal audit policy standard work and forms
  • Compiles trends from various quality management system (QMS/OMS) inputs for evaluation and prioritizingof internal audit topics and creates a pathway for internal audit topics to be requested/proposed by other escalation processes (e.g. huddle structure admin team OMG)
  • Schedules and coordinates internal audits
  • Performs internal audits
  • Reviews and tracks completion of internal audit documentation and corrective actions including but not limited to internal audit summaries reports deficiencies and corrective actions
  • Escalates off track internal audit corrective actions as needed
  • Compiles executive summaries of internal audits
  • Schedules coordinates and facilitates the internal audit committee meetings
  • Develops internal auditor training materials coordinates and leads training

Management of Regulatory Affairs Systems and Software

• Serves as a back-up System Administrator for the two systems/software managed by Regulatory Affairs.
  • The electronic healthcare policy management system for policies procedures forms standard work department Scope of Service documents or Nurse Staffing Plans and any other applicable documents.
    • Manages policy management system organization structure approval groups categories and other critical system components.
    • Creates and implements standard work and training (for new staff and continuing education) for document control MCN navigation and document/folder/manual owners.
    • Responsible for system user management/permissions.
    • Manages ongoing OHSU Healthcare compliance with policy review/revision at least every three years.
    • Provides data and metrics related to current status of regulatory compliance related to policy oversight/management including communicating compliance status to OHSU leadership via a dashboard or other regularly updated and easily accessible/shareable source.
    • Identifies required regulatory policies through continuous research and study of regulatory standards and requirements including DNV NIAHO standards CMS Conditions of Participation and the Oregon Administrative Rules.
      • Manages a master Regulatory Required document list or system within electronic healthcare policy management system to identify/report against regulatory required documents.
    • Manages the communication of policy updates to all OHSU Healthcare workforce members.

Management of Regulatory Accreditation Certification Survey Processes and Survey Response/Follow-Up

• Key member of RA team responsible for OHSU Healthcares ongoing applications for accreditation and certification to regulatory bodies. Manages ongoing updates to the application with regular communication with the OHSU Healthcare leadership.
• Manages the survey process from regulatory agencies including but not limited to: planning and coordinating known surveys oversight of unscheduled surveys related to health care accreditation and certification as well as responses to regulatory agencies for any subsequent corrective action plans and related objective evidence summaries.
• Works with designated stakeholders ensures that appropriate timelines are followed for survey completion corrective action plan submission and objective evidence data reporting.
• Develops reports and provides data/updates related to regulatory findings and corrective action plan oversight/management/completion including communicating said information to OHSU leadership via a dashboard or other regularly updated and easily accessible/shareable source.
• Maintains a current Regulatory Calendar of all regulatory surveys reviews and activities as appropriate and prepares for posting / distribution.
• Manages the maintenance of licenses accreditations certifications and CLIA licenses from regulatory bodies.
• Manages the payment of invoices following regulatory accreditation certification reviews annual fees intra-cycle reviews and on-site visits.
• Manages / supports the Regulatory Affairs dept.-owned committees. Provides agendas schedules and coordinates meetings maintains minutes facilitates annual charter review and updates and provides relevant data.

Provision of Knowledge in Regulatory Compliance Standards and Regulation related to OHSU Healthcare

• Provides consultative services and compliance data to all levels of the organization regarding accreditation and regulatory issues. This includes interpreting standards and communicating regulatory changes as appropriate.
• Participates in and may support key committees involved in regulatory readiness and compliance with regulatory agencies.
• Performs studies tracers internal audits intended to assess hospital accreditation regulatory readiness and develops related reports and recommendations for actions based on findings.
• Manages highly confidential responses to requests from regulatory agencies including DNV Healthcare the Centers for Medicare and Medicaid Services and the Oregon Health Authority.
• Conducts continuous research using standards from DNV Healthcare CMS Conditions of Participation and the Oregon Administrative Rules maintaining an appropriate depth of knowledge related to key standards and regulations affecting healthcare accreditation certification and licensing.
• Key member of RA team responsible for submission of quarterly psychiatric hold data to Oregon Health Authority. This may include review of confidential medical records.
• Establishes effective partnerships with multiple departments from front line staff through Executive Leadership.

Other Duties as Asigned

• Bachelors Degree in a science or health related field or equivalent education and experience
• 2 years in a position requiring quality control quality assurance or regulatory compliance

Job Related KnowledgeSkills and Abilities(Competencies):

• Excellent communication skills to effectively interact with outside regulatory agencies and internal leaders.
• Proficiency in office automation computer software including the Microsoft Office Suite of products and other various OHSU internal products.
• Knowledge of healthcare regulatory agencies and standards.
• Ability to understand laws interpret laws and interpret standards for OHSU.
• Ability to work independently problem solve and decision making capabilities.
• Sensitivity tact and discretion in dealing with highly confidential information and communication.
• Ability to faciliate meetings and provide education as needed.

• Bachelors degree plus five years experience of below described experience.
• Project Management certification
• 7 to 10 years of experience administering or managing parts or subsets of a project or program within healthcare.
• Interpreting program policies and other control documentation writing and updating policy and other key documents and making recommendations for change.
• 3 years of experience managing electronic database and other information reporting computer systems.
• Working knowledge of website strategies.
• 3 years of experience with healthcare accreditation and/or certification regulatory standards surveys or program administration.
• At least 3 years of experience with responsibility for program or project monitoring and coordination. The experience must have included program evaluation responsibility.
• Clinical experience.
• Deep knowledge of NIAHO standards CMS Conditions of Participation and Oregons Administrative Rules.
• Proficiency with various OHSU internal products.

Routine hours between 8am and 5pm M - F with variability driven by regulatory survey activity andregulatory agency requirements. Primarily works remotely but will be required to travel to all HC sites on arecurring basis sometimes with very short notice (unannounced arrival of regulators onsite).

Benefits:

• Healthcare Options - Covered 100% for full-time employees and 88% for dependents and $25K of term life insurance provided at no cost to the employee
  
• Two separate above market pension plans to choose from
  
• Vacation- up to 200 hours per year depending on length of service
  
• Sick Leave- up to 96 hours per year
  
• 8 paid holidays per year
  
• Substantial Tri-met and C-Tran discounts
  
• Additional Programs including: Tuition Reimbursement and Employee Assistance Program (EAP)