University of Washington, School of Medicine, Clinical Trials Proposal Process Improvement Project
In the biomedical arena, clinical trials are critical to the University of Washington’s research mission. Work processes related to clinical trials are complex because they range across internal UW departments and extend beyond UW’s institutional boundaries into complex relationships with other organizations such as the Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Harborview Medical Center and Children’s Hospital and Regional Medical Center.
Although the UW attracted substantial research dollars, there was concern that an increasing number of industry-sponsored studies were closed either before negotiations with the sponsor were completed or very soon after the contract was signed and the study opened to enrollment. Additionally, the UW and its partners had difficulty in initiating some studies in a timely fashion which meant lost research opportunities, lost revenue, unreimbursed start-up costs and lost staff effort.
Three executive sponsors initiated a project focusing on the clinical research proposal portion of the research process with a goal to reduce the time between initial submission of a research proposal and final approval to enroll patients. The Walker Company was hired to provide the project approach, process improvement methodology, framework, best practices and to coach the organization through the year-long project.
Managing this improvement project required a project structure that included stakeholder involvement across that spectrum. The following groups/roles comprised a project structure that invited intensive cross-organizational, cross-institutional participation:
- Executive Sponsors
- Steering Committee
- Cross-organizational/Cross-Institutional Ad Hoc Workgroups
- Project Director
- Project Manager
- Project Consultant (The Walker Company)
Using this project structure and The Walker Company process improvement steps, project outcomes included achieved and recommended improvements. Examples of key achievements included:
- Ownership of the process was defined.
- The complete process was mapped, cross organizationally and institutionally.
- A web-based Clinical Research Handbook was conceptualized, designed, planned and developed. Version 1 will be available in the first quarter of 2010. The Handbook contains several key features that will aid the user in navigating the proposal process:
- Maps of the process are included.
- The handbook has multiple ways for users to find information.
- Decision trees help the user plot a proposal path and determine required documents and forms.
- Contacts are identified if the user requires further help.
- The University of Washington Medical Center and the Seattle Cancer Care Alliance agreed to streamline separate Radiation Safety reviews into one process with a common form. Just one of the reviews could take 30 days or more.
- The University of Washington Medical Center and the Harborview Medical Center agreed to streamline separate Implant and Investigational Device reviews into one process with a common form. Like Radiation Safety, a review could take 30 days or more.
- Status points for each part of the process that are currently collected in organizational unit data systems were identified as a first step in developing a system to measure across the process.
University of Washington, Northwest AIDS Education and Training Center (NW AETC) Strategic Planning
The NW AETC, located at the University of Washington, offers HIV treatment education, clinical consultation, capacity building, and technical assistance to health care professionals and agencies in Washington, Alaska, Montana, Idaho, and Oregon. Although the organization had successfully delivered services for 20 years, a rapidly changing environment motivated them to take a strategic look into the future in order to ensure their continued success. The Walker Company was engaged to provide a strategic planning framework and to lead the NW AETC through the year-long process of developing a vision, mission, values, goals and an essential work picture. This timeframe allowed for an iterative process that invited extensive participation from stakeholders in the five states listed above. The vision, mission, values, goals and essential work picture (a high-level view of the organization’s key business processes) were developed within the project timeframe. The NW AETC is now using this information to respond to grant applications and develop work plans.
University of Washington, UW Technology Rapid Process Improvement (RPI)
UW Technology provides information technology services (network connectivity, server hardware, data storage and backup, systems to support UW’ basic processes, distribution of licensed software, etc.). Executive Sponsors Kelli Trosvig, COO, UW Technology, Alisa Hata, Deputy Chief Operating Officer, UW Technology and Bill Ferris, CFO, UW Technology initiated a Rapid Process Improvement Program to provide standards and tools for undertaking process improvements that would allow UW Technology to quickly launch efforts to solve problems and consistently improve processes over time. The Walker Company was engaged to provide a framework for launching RPI projects and to define process improvement methodologies, tools and standards to be used by the RPI teams. Six RPI teams were established and produced deliverables in the following high priority areas: billing, new revenue opportunities, printing, CacTrack implementation (project time-keeping), equipment replacement and maintenance and digital well. Ms. Walker provided training, monitored progress, provided feedback, guidance and support and reviewed deliverables. All teams produced deliverables within 90 days and the organization gained a repeatable process for making future improvements.
University of Washington, "Top 5" Project
The Executive Vice Provost sponsored this project to create University-wide agreement on institutional answers to questions related to reporting student, faculty and financial data. Ms. Walker managed this complex, cross-university project that included vertical and horizontal stakeholder representation in multiple teams. She designed, facilitated and managed information from three task teams, a Deans’ Advisory Group and executive sponsor meetings. Additionally, she designed and facilitated many ad hoc meetings with Information Technology and business staff as they worked to produce reports that aligned data with the institutional definitions. In nine months, project deliverables included: 1) enterprise student, faculty and finance definitions; 2) reports in each of the three areas; 3) documented issues, recommendations and decisions in each area; and, 4) a website providing access to the information and reports.
University of Washington, Seamless Procure to Pay Project
The University buys several hundred million dollars worth of goods and services each year. There are complex regulations to comply with and the process has become inefficient over time. Finance and Facilities undertook a project to make it easier and more efficient for customers to acquire and pay for goods and services. Ms. Walker was engaged by the Office of Information Management, Strategic Projects and Portfolios to partner with an internal project manager, provide the process improvement methodology and co-lead the organization through the steps. She worked with seven ad hoc groups across the University to document various components of the procurement process. Then she led a management team through the process of assimilating the process flowcharts, documenting and prioritizing the improvement ideas and launching a work team to redesign a component of the process deemed the top priority. Currently the work team is designing the new process. Additionally, Ms. Walker and the project manager reported progress to a steering committee.
University of Washington, Direct Loan Process Mapping Project
Student Financial Services initiated this project to map the complex processes for originating, disbursing and accounting for loans issued from the University’s Direct Loan Program. The objectives were to create maps that could be used to: 1) generate process procedures at various levels of detail; 2) use the maps in developing staff training; and, 3) identify areas for improvement. Ms. Walker used her process mapping methodology to lead a team through the steps of building the process flowcharts and identifying issues and improvement ideas. Cross-organizational input was incorporated from the Office of Student Financial Aid and Information Technology. Three complex processes were documented in less than three months (8 meetings).
University of Washington, USER Project – HR Payroll Project
Ms. Walker partnered with an internal project manager to lead the University of Washington through a 2.5 year project to redesign cross-University (including medical centers) financial processes that impacted all classifications of university employees (approximately 30,000). She created a project approach/framework for business staff and technical staff to collaboratively plan, acquire, develop and implement cross-University financial applications on a new web-based platform. She built a multi-layer approach for user input and a communications plan to build cross-University buy-in as the project progressed. Additionally, she led a steering group of high level administrators from across the University and facilitated User Task Groups in developing specific products.
University of Washington, USER Project – Financial Desktop Project
Ms. Walker provided a strategy/framework to conduct lessons-learned at the end of Phase I of the Financial Desktop project. Over seven teams operated during the two year cross-University, complex project as well as participation by many stakeholders. Ms. Walker convened a Design team to help plan a cross-organizational work session where representatives of all the teams could come together and comfortably share what worked and didn’t over the time span of the project. Each of the teams met before the cross-organizational work session to generate what worked, what didn’t information. Ms. Walker provided a facilitator’s resource packet for those meetings then facilitated the cross-organizational work session that was attended by approximately 30 people.
University of Washington, Financial Management, Human Resources and Computing and Communications
Although Human Resources, Financial Management and Computing and Communications are three separate University departments, their work continues to become more and more interdependent. Because the leaders realized that future success depended upon the ability of the groups to collaborate closely, they chose to engage in a joint effort to think strategically about their future work together. To build a common knowledge base, The Walker Company conducted an assessment to get the best picture of how the four departments collaborated, what worked, what didn’t and how to build a common vision for the interdependent areas. This information was used to work with the leaders and staff to build and understand the tactical ramifications of the common strategies.