Tammy Roalsvig

• Led cross-functional teams to deliver IT projects on time and within scope.
• Project Lead for 3rd party vendors interfacing with the new Epic EMR for Kaleida, and its community partners such as ECMC and GPPC for a complete integration.
• Managed a successful go-live for Haemonetics SafeTraceTx (New - Blood Bank Lab LIS), Haemonetics BloodTrack (Upgrade and Interfaced -Emerge Blood Kiosk), CBORD/Illumia (New -Nutritional & Dietary Services Management) GE Viewpoint (Upgrade and Interfaced -Women's Ultrasound) and GE MUSE (New - ECG Management)
• Maintained project timelines, ensuring alignment with organizational goals and objectives.
• Managed cross-functional teams for successful implementation of large-scale technology upgrades.
• Implemented risk management strategies to identify, mitigate, and monitor potential project risks. Resolved issues promptly.
• Facilitated knowledge sharing among team members through mentoring, operation workgroups, and documentation sharing initiatives.
• Coordinated with vendors to ensure seamless implementation of third-party software applications within existing infrastructure.
• Employed tools and methods to track progress throughout lifecycle of projects or initiatives.
• Provided detailed project status updates to stakeholders and executive management.
• Proved successful working within tight deadlines and a fast-paced environment.
• Wrote, updated and maintained project documentation.

• In charge of all biopharma projects and operational functions as related to genomic (DNA/RNA) testing from oncology patients for clinical trial enrollment or pharmaceutical R&D investigative analysis of already enrolled patients.
• Grew the biopharma services projects and ultimately the scientific staff by managing 10-20 simultaneous projects with approximate annual revenue around $10M USD with overall total study timeline revenue of approximately $20M USD.
• Developed R&D team through a process improvement initiative to one with standardized written procedures while maintaining quality and regulatory initiatives in accordance with NYSDOH, CGP, CFR 21 and assuring the LDT adheres to ISO 13485 as a medical device.
• Managed R&D new test development projects.
• Mentored staff (direct and indirect reports) while providing coaching on performance improvements, communication, and relationship management. Provided training and learning opportunities for staff growth and development.
• Created all scope documents with detailed scientific workflow, billing processes and reviewed all agreements for all biopharma projects to be performed at OmniSeq.
• Reviewed all clinical trial and test development protocols and monitored sample tracking, testing and documentation are adhering to IRB approved protocol, per ICH and specific study CRO requirements.
• Forecasted baseline OmniSeq revenue for a rolling 3-year timeframe while providing quarterly updates on projection adjustments and justifications for any revenue target changes/misses.
• Created project closing documents which included expected budget vs actual revenue, data delivery timelines details, testing outcome/failure specifics, project challenges, and lessons learned.
• Defined IT and software improvement initiatives impacting biopharma services department and approved sprint implementation plans and timelines of IT or software development.
• Performed or approved user testing as functional department lead prior to software validation.
• Developed and managed weekly biopharma meetings with cross-functional global teams for alignment and planning to meet company and sponsor goals. Created or approved RACI charts.
• Initiated or approved internal quality events or CAPA investigations as related to biopharma or bioinformatics data outcomes.
• Represented Buffalo lab in enterprise-wide Kaizen workshop to reduce turn-around-times in clinical trial setup utilizing strategic problem-solving skills for a significant process improvement goal.
• Improved previous tracking of project details and developed standardized workflows for maintaining tracking through tools such as SharePoint, Teams, One Note, Excel, Planner and/or Confluence allowing greater visibility and communication internally and to external clients.

Analyzed business processes for both staff workflow and IT constraints and presented improvement initiatives to leadership as well as the board of directors.

• Streamlined and created new patient HIPPA and consent forms.
• Managed all IT projects within Windsong for all software implementations and specific workflow process improvements. Created RACI charts and real-time status tracking reports.
• Led demonstration review and analysis of new Picture Archiving and Communication System (PACS) and Radiology Information Systems (RIS) with presentations to the Board of Directors for approval.
• Initiated implementation of mammography workflow changes which included a hereditary cancer self-questionnaire (Ambry Genetics), triaging to genetic counseling, if needed, as well as processes to incorporate the breast surgeon’s office post imaging to improve patient experience and outcomes.
• Performed RIS system setup configurations and preliminary table builds of the new RIS (MedInformatics) and PACS (Clario scheduling and Intelerad imaging). Also, performed preliminary setup of new RIS (Fuji) when project changed direction,
• Accomplished a 6-month re-development of the Human Resources Information System (HRIS) Kronos modules: Recruitment, Onboarding and Leave of Absence after a previously failed initial implementation years prior leaving the team with manual tracking & processes. Also initiated new development of an electronic annual benefit selection within Kronos instead of paper request submission.
• Implemented the Windsong’s Customer Relationship Management (CRM) marketing tool (Abbadox) which improved tracking and monitoring of referring providers with respect to revenue and physician ordering trends. This process improvement removed redundancies, errors and significantly improved processes for the marketing team and reporting for senior leadership.
• Spearheaded the design and creation of the non for profit Windsong Cares Foundation. Investigated requirements, developed the proposal for board approval, coordinated with outside counsel on the completion of 501c3 application and supported the launch of the foundation.
• Developed mammography initiative to support local primary care physicians and BCBS for patient screening compliance per recommended quality metrics. Initiative successfully improved PCP quality scores.
• Evaluated the critical business needs and executed the project and implementation of telemedicine for the Interventional Radiology and the Genetics Department during the COVID-19 medical crisis. Built tables in Medent EMR to include new visit type per specific providers, notes to document length of call and discussion and appropriate CPT codes for billing. Tested system prior to provider testing.

• Performed Operational Qualifications (OQ) prior to locking of database tables for validation.
• Evaluated clients blood bank laboratory software, SafeTraceTx for readiness to FDA/AABB/CAP/TJC/local DOH compliance standards by performing pre-validation testing of software scripts which included step by step screen capture of inputs and outcomes.

• Evaluated the Project Delivery Office (PDO) documentation & reporting processes for all projects and project managers.
• Performed detailed project audits & reported on PDO documentation compliance with Fidelis procedures as well as SOX readiness of said documents stored within Confluence.
• Evaluated current processes and detailed recommendations for improvements and best practice initiatives.
• Performed crosswalk of current Portfolio Management tool PPM Pro (Innotas) to JIRA during the company’s transition from Waterfall to Agile methodologies and reported to leadership. Tracking of tasks utilizing the Jira Kanban board.

• Conducted multiple simultaneous software projects throughout the hospital including HIM coding upgrade (3M), Pharmacy 340B drug pricing implementation (Verity), Anesthesia EMR implementation from paper (Anesthesia Touch), Meditech EMR implementation (Transfusion Record Administration – TAR), and Enterprise IT Single-Sign-On MFA (Imprivata).
• Anesthesia EMR project involved significant process evaluation of current vs future state and the addition of an EMR to the department allowed for significant improvements for OR staff as well as patient care and tracking.
• Created Project Charters, including appropriate disaster recovery documentation on venders and assured implementations adhered to the agreed scope of work.
• Compiled documentation & submitted change requests detailing required change, test plan and back out plan to the Change Advisory Board.
• Coordinated & documented meetings between department work teams and venders to facilitate weekly traction.
• Followed-up on pending items/issues, while assuring tasks are assigned and completed and appropriate follow-up was being performed while escalating to leadership as needed. Assigned and documented training prior to launch.
• Created reports and project documentation via preferred methods of communication to all stakeholders via Smartsheet, Excel and/or PowerPoint.
• Adhered to the standardized PMO practices.

• Evaluated current detailed project timeline and unresolved/pending tasks from multi-year Haemonetics software project implementation of SafeTraceTx and ElDorado Donor. Evaluated risk readiness (multi-site hospital facility) for go live including review of validation activities, parallel testing, staff competency/training as well as developing all cover our activities and responsibilities.
• Improved documentation and SOP storage and tracking by utilizing SharePoint.
• Led cross-functional team meetings to identify gaps between previous and current software setup to standardize and improve workflow across campuses, streamlined to a standardized improvement processes which included any necessary movement of equipment or workstations.
• Logged all issues and change requests through Workfront. Performed updates as task progressed and closed all completed tasks.
• Assisted in creation of staff training materials (quizzes) and SOP’s related to LIS steps.
• Point person for escalation to senior leadership & project steering committee.
• Trained LIS staff on software functionality, database changes/builds and continued maintenance to eliminate vendor assistance.
• Implemented process improvements that enhanced operational efficiency across hospital sites.
• Mentored junior project managers and team members, fostering professional development and best practices.
• Analyzed project performance metrics to drive decision-making and continuous improvement efforts.

• Managed 5-10 simultaneous multi-year client projects and million-dollar budgets.
• Proficient in multiple clinical regulated healthcare software applications.
• Reviewed contract requirements and assisted with demos with sales team and worked to determine deliverables.
• Developed client project plans, using Microsoft Project, based on contractual scope, customized and performed each client’s education and training, developed software testing plans, and evaluated project risks during a phased implementation approach unique to the diverse scope and complexity of each project.
• On-site requirements gathering visits to assess current workflow and changes needed. Provided client solutions to enhance and streamline processes to improve workflow and operations for each client based on best practices.
• Quickly grasped client’s business and regulatory requirements and implementation challenges to facilitate strategic planning execution with client’s executive leadership.

• Reviewed/updated policies for blood component manufacturing in accordance with FDA regulations and GMP.
• Documented variances and change of protocols from standard operating procedures.
• Streamlined redundancy while maintaining consistency and adherence of quality standards through documentation review and audit plan development and Root Cause investigations.
• Trained staff and students in good manufacturing processes of blood products.
• One of few trained on the CellSearch system. Processed samples, performed test, and interpreted results for Circulating Tumor Cells with latest innovative technology at the time.

• Managed all daily operations for Transfusion Services Laboratory and Blood Component Manufacturing (processes & staff).
• Oversight of procedures & staff for off-shift Hematology, Chemistry & Microbiology labs.
• Significantly improved overall compliance with regulatory inspections by creating and revising policies. Assured staff compliance to written policies.
• Direct supervisory oversight of numerous staff that included performance evaluations, job related competencies, conflict management, and skill development.
• Improved nursing documentation and training by partnering with Risk Management and Nursing Education to improve Quality Assurance standards.
• Partnered with EHR project team to improve physician blood bank orders to streamline and improve electronic documentation standards in compliance with regulations to assure patient safety.
• Responsible for maintaining departmental multi-million-dollar operating budget as well as submission of capital requests. Managed monthly invoices and approved purchasing requests and payments.
• Assisted with submission/review of RFP’s including defining the SOW.
• Interim Supervisory oversight of Stem Cell Laboratory in compliance with cGMP and FACT regulations. Member of Institutes STEM cell committee.
• Created the architectural design of workspace utilizing lean processes during laboratory relocation within the hospital campus to improve process workflow.
• Intimately involved in New York State Department of Health, Federal Drug Administration, The Joint Commission, Centers for Medicare, and Medicaid Services inspections as well as the American Association of Blood Banks accreditation.
• Lead in internal audits, root-cause analysis, patient, and institute risk assessments for the department as well as new equipment validation and procedures in accordance with regulatory quality assurance requirements.
• IT Project team co-lead involved in the selection, build, validation, and training for a new Blood Bank laboratory software system (Haemonetics’ Safetrace and Safetrace Tx), as well as continuous maintenance of data table changes due to patient and department needs.
• Participated in leadership conferences and training from the American Society of Clinical Pathology, American Association of Blood Banks, and cGMP FDA driven conferences, as well as internal RPCI leadership training.