Device Events is a web-based tool that searches medical device post-market surveillance data and recalls in a way that has not been done before. The system launched in June 2016 and licenses are available on an annual subscription basis. This data has been featured in the British Medical Journal, RAPS, CNN.com, StarTribune, Reuters, NBC, Fox News, CNBC Power Lunch, QMED, ABC and CBS.

As a former FDA manager who led the charge to increase the value of UDI through its use in EHRs, claims payment systems, and in adverse event reporting, I have a special interest in seeing the UDI become fully integrated across the continuum of care. Ms. Tomes improved medical device knowledge through the use of state-of-the-art business intelligence and post-market surveillance, allowing Avalere to provide FDA insight and business intelligence to device companies, researchers, health payers and providers.

Center for Devices and Radiological Health (CDRH)Office of Surveillance and Biometrics (OSB)Division of Post-market Surveillance (DPS)FAERS Manager and Subject Matter ExpertUDI External Program ManagerUnique Device Identification (UDI): a global UDI system for medical devices will provide for early detection of defective devices and will facilitate device recalls to ultimately enhance patient safety and reduce medical errors.FDA's Adverse Events Reporting System (FAERS): a new FAERS will provide for enhanced adverse event reporting analytics to improve patient safetyMs. Tomes led the UDI External Program to further the outreach of UDI in several spaces:1. Clinical and hospital settings2. Patient and consumer setting3. Regulatory spaces including communication to agencies and entities who will help further the reach of UDI (via HIPAA, Meaningful Use, etc) Goal 1 of UDI: Promote understanding of how including UDI in Claims and Payments Systems will improve patient safety and further UDI adoption• Organized meeting of Medicare and Medicaid claims experts to discuss the implications of including UDI on claim forms• Met with CMS to understand their processes, systems and approval process for potential inclusion of UDI in future regulations • Met with medical device manufacturers, healthplan executives, and EHR vendors to decompose the various costs and benefits of UDI implementation in their environmentsGoal 2 of UDI: Analyze mechanisms for adoption of UDI in Meaningful Use standards to speed the use of UDI in EHRs from both the technical and clinical perspectives with stakeholders including:• Office of the National Coordinator• Centers for Medicare & Medicaid Services• The Joint Commission / JCAHO• Veteran’s Administration• Brookings InstituteLed meetings with the UK’s Medicines and Healthcare Devices Regulatory Agency (MHRA) --Discussed the technical and regulatory implications of sharing UDID data on a global basis

Client: FDA/Center for Drug Evaluation and Research (CDER)Ms. Tomes was the adverse events reporting subject matter expert (as a subcontractor) and lead the performance metrics development efforts for FAERS (FDA’s Adverse Events Reporting System) with CDER and the Office of Information Management (OIM). She was brought in to turn-around an ailing project several months prior to go-live, and brought the testing and development teams together through creation and standardization of use cases and performance metrics for CDER’s Oracle AERS implementation. Client: HHSMs. Tomes worked (as a subcontractor) with the HHS PSC (Program Support Center) as a subject matter expert on process improvement to deploy the onboarding process and most-utilized service areas in an Amazon cloud application. She led the creation of processes to reduce the steps for government employees to obtain security clearance and obtain travel authorization.

Project Manager for the FDA's Unique Device Identifier (UDI) project. It is a Congressionally mandated initiative to barcode medical devices to improve patient safety, supply chain tracking, and reduce fraud and abuse across the healthcare industry.-Managed requirements gathering for the Food and Drug Administration’s (FDA) adverse events database for medical device surveillance (MAUDE). -Worked on-site with FDA subject matter experts to re-define the business and technical needs of the Center for Devices and Radiological Health (CDRH) to improve patient safety and work toward the HHS’s Office of Inspector General’s (OIG) cross-agency IT exchange goals. -Managed the coordination of strategic milestones with the project officer across the Drugs, Devices and Biologics centers to ensure that CDRH’s system goals were communicated with the FDA’s Adverse Events Reporting System’s (FAERS) project team members and Oracle AERS contractors. -Provided subject matter expertise on briefs to the Centers for Medicare & Medicaid Services (CMS) Program Integrity Group around Part C (Managed Care) and D (Prescription Drug) program vulnerabilities.These briefings focused on the Fraud Waste and Abuse (FWA) detection methodology used by the Medicare Integrity Contractors (MEDICs) to determine whether audit targets were selected based on justifiable metrics. -Provided subject matter expertise in the area of Durable Medical Equipment Prosthetics and Orthotics Suppliers (DMEPOS)—the highest source area of fraudulent claims (approximately $30-40 billion per year) across all U.S. health programs.-CMS subject matter expert to the Booz Allen teams based at the NIH, the Navy, and SSA on topics ranging from optimization of the SSA’s Death Master File across multiple agencies (Department of Commerce, VA, MHS and DoD) to providing teaming opportunities to the Supply Chain and Logistics division around durable medical equipment fraud.

Managed combined teams in separate locations comprised of technical and functional analysts for a $29 million fraud identification project at HHS via the Centers for Medicare & Medicaid Services (CMS). This project is one of the cornerstones of current government healthcare funding initiatives to streamline processes and improve efficiencies through the use of healthcare informatics and standardization of institutional capabilities.-Responsible for project planning, LOE estimation for all SDLC phases; performance and deliverable quality control; project health reporting, risk identification and mitigation, Earned Value Management (EVM) and client relationship management. Ms. Tomes was active in hiring, training, staff development, and performance management. -Project Lead for the Unified Provider Enrollment Process (UPEP) project (combining Medicaid provider enrollment with PECOS--the Medicare provider enrollment system).-Created the Project Management Plan, Stakeholder Management Plan, Configuration Management Plan, Risk Management Plan and Training Plan in compliance with CMMI Level 3 and CMMI Level 4, and ISO 9001 for the Medicaid Integrity Group’s Division of Fraud and Research Detection at CMS.-Team Lead for the PECOS Durable Medical Equipment (DMEPOS) sub-project, aimed at reducing fraud by up to $10 billion per year through the use of data matching technologies, information assurance and standardization of institutional capabilities within a custom J2EE software application.-Led the development of an internal training program to hire and train 40 new staff members on the VB-based legacy enrollment system while transitioning to a web-based J2EE platform.-Subject Matter Expert on state Medicaid business environments, documenting target state requirements and identifying transformation projects to analyze the gap between Medicare contractors, State Medicaid Agency (SMA) business processes, 508 Compliance and MMIS provider enrollment systems.

Proven record in establishing portfolio approach and direction, providing thought leadership during project feasibility analysis, and supporting client relationship management and business development activities.Full SDLC projects included an Optical point of sale system, Medicare Risk Assessment Tracking System, Employee Health and Infection Control, MIDAS+, Provider Credentialing and Population Care Management; regulatory project releases including HEDIS, NCQA, Clinical Quality Scorecard, and Disease Registries to improve the information in HealthConnect -- Kaiser Permanente's EHR (Electronic Health Record).LeadershipIdentified six major business processes requiring substantial re-engineering; presented solutions to regional senior leadership, board of directors, and the corporate Enterprise Operations group. Challenges included initiating the restructuring of an approval and ordering process for PDAs with carriers Sprint and Verizon, as well as creating an Online Service Request to stream-line the on-boarding and departure of employees to ensure Sarbanes-Oxley compliance and alignment with SOA principles. Worked as a Subject Matter Expert facilitating creation of web portals, determining security protocols, trouble-shooting issues for the Availability Program Office, and developing performance metrics.Enterprise Strategy PlanningLed effort for Kaiser's Mid-Atlantic Region to develop a tool for multi-year strategy planning, resource management, LOE estimation and budget allocation for over 100 regional and national IT initiatives.Identified gaps in multi-million dollar processes that enabled $300K+ revenue return and cost savings. Provided on-going feedback on the success of the database and consulted with C-level executives at Kaiser's corporate office on ways to improve communication between the business (administration and care providers) and IT.

Management and Program Development-Initiated and administered business process improvement programs enhancing membership service for the for-profit subsidiary of a non-profit association. -Enhanced an already strong understanding of liability issues and insurance risk management, and gained knowledge about reinsurance and captive insurance programs.-Managed the division while providing leadership, financial management, marketing oversight, and supervision of direct daily operations of membership insurance and benefit programs.-Trained association staff to understand the for-profit side of the business and communicated about data security and procedures. -Advocate for social workers in professional liability cases.-Led communications management to 300,000+ stakeholders when Principal Financial Group demutualized.-Established Institutional Review Board process for a non-profit organization, creating programs and risk management policies for social workers using human subjects in behavioral research studies.-Initiated study to analyze non-profit foundations created by pharmaceutical companies for alignment with association goals and objectives. This was used to develop the corporate partnership strategy for NASW.-Developed marketing strategies (including pricing and online vehicles) to launch a bundled advertising campaign.-Negotiated contracts with design firms and printing companies and led print advertising campaigns for multiple lines of insurance. -Facilitated work across organization to meet creative and revenue goals within a strict time-frame.

Crisis Communications and Account ManagementClients and Broadcast News Stories: Firestone (tire recall), Wyeth (drug recall), IBM Websphere (product launch), Electric Power Supply Association, Cisco (partnership with Visa), Energy Star (public service announcement campaign), AOL, U.S. Army, U.S. Census Bureau, NASCAR, and the U.S. Department of Education.Developed a strategic plan to meet the requirements of the U.S. Census Bureau to release its figures state-by-state. Successfully achieved release of results for 23 targeted states within two weeks.Initiated business with Booz Allen Hamilton to produce the U.S. Army Industry Day Webcast, which was viewed by 18,000 people, received recognition from the Secretary of the Army and Booz Allen Hamilton, and earned $50,000 for Medialink for the one-day event. This event; the online education initiative provided by universities nationwide to U.S. Army personnel globally.

Kaplan Educational Centers (a Washington Post Company)Marketing and Program Management:Increased revenue by 71 percent in one year through use of innovative marketing techniques and development of new sponsorship programs as the Center Manager for Kaplan. Initiated long-term relationships with universities and corporate partners, giving the Baltimore and Washington D.C. centers a sustainable competitive advantage.Received in-person recognition from the CEO of Kaplan for increasing revenue by 28 percent, earning Kaplan's Mid-Atlantic Region the Number One position in the country.

Statistics and College Algebra