Regulatory Specialist

Department Overview

OHSU is Oregon’s 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 Portland’s 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 OHSU Healthcare. Key functions of the position include coordination of regulatory readiness, survey process and follow up activities including corrective action plan oversight, and production and tracking of data/ reports related to regulatory compliance and survey outcomes. This position is responsible for the administration of the Internal Audit Program and is a back-up system administrator for Regulatory Affairs administered software – document management software and rounding software. This position also provides support, consultation, and coaching to healthcare leaders with respect to interpretation of regulatory standards and compliance needs. This position independently gathers, compiles, analyzes and prepares qualitative and quantitative information and statistical data; provides complex systems support and presents information in narrative and schematic form for use in corrective action and performance improvement planning and decision making.

Function/Duties of Position

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 prioritizing of 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 Healthcare’s 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

Required Qualifications

• Bachelor's 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 Knowledge, Skills 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.

Preferred Qualifications

• Bachelor’s 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 Oregon’s Administrative Rules.
• Proficiency with various OHSU internal products.

Additional Details

Routine hours between 8am and 5pm M - F with variability driven by regulatory survey activity and regulatory agency requirements. Primarily works remotely, but will be required to travel to all HC sites on a recurring 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)

All are welcome

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.