When staff asked, “What do you want me to do, this quality stuff or my job?” The answer was always, “We want you to do both, but we want you to change the way you do your job.”
Such discussions came out of the VA Cooperative Studies Program’s “quality journey,” which has lasted for more than 20 years and resulted in higher employee engagement, higher customer engagement, better ability to develop new and to renew partnerships and collaborations, increased capability to provide new products and services, and increased capability and capacity to support more ongoing multicenter clinical trials (increased from 26 to 38 over 8 years)—all with little increase in staffing.
But how did they do it?
The Federal VA Cooperative Studies Program (CSP) Clinical Research Pharmacy Coordinating Center (the Center) set out “to systematically improve all areas of operations” with the implementation of a Total Integrated Performance Excellence System (TIPES). The system combines frameworks including the Baldrige Excellence Framework, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management). The Criteria within the Baldrige framework were used as the foundation; write the authors of a recent paper about TIPES, “Because Baldrige is more comprehensive and less prescriptive than ISO or OPM3, the Center uses the Baldrige Criteria as its foundational standard into which the other quality management systems are assimilated.”
According to a recent paper entitled “Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center," the implementation of TIPES has resulted in “the ultimate transformation at the employee level that enabled the Center to make progress and excel.” The paper was published in Contemporary Clinical Trials Communications on ScienceDirect.com.
The authors write that new capabilities have expanded the Center's offerings and provided the foundation for future growth. Quality journey results include the following:
- a re-organization of the Center's process and procedures structure, as well as the organizational structure, to support a culture of excellence
- fewer inadequate supplies in the field
- reduced shipping errors
- a steady trend of high employee engagement
- a steady trend of high customer engagement
- engaged repeat customers, even from outside of the VA (over 80% of the Center's non-VA collaborations are from repeat customers)
- improved web-based software systems for site inventory control, drug distribution, and patient randomization and treatment assignments
- establishment of a biorepository for bio-specimen storage and a method for direct-to-patient dispensing
“As the Baldrige Criteria continue to evolve with best practices found in industry, the Center is challenged to also evolve, to be responsive to new approaches, and to innovate," write the paper's authors. "Baldrige's requirement that organizations identify and use their strategic advantages has propelled the Center, as a government entity, to closely examine its unique position and to develop strategies capitalizing on its advantages and opportunities while addressing challenges. This in turn has created opportunities for innovation and intelligent risk taking in its pursuit of strategic objectives.”
The Center won the Baldrige Award in the nonprofit category in 2009, and as part of applying for the award, it received a detailed feedback report from Baldrige examiners. The TIPES paper notes that “Baldrige examiners as well as VA visitors have frequently noted that the Center does not operate like a government bureaucracy, but more closely resembles the private sector in its entrepreneurial approaches.”
The paper’s authors also write that winning the Baldrige Award, which was made possible by the Center’s quality journey, meant a huge sense of accomplishment for employees. “The journey contributed to job satisfaction, engagement and security, and a sense of accomplishment and personal and professional growth. Comments from employees made it clear that their ability to contribute to the well-being and spirit of the organization, to its important mission, and to the accomplishment of a lofty goal through the achievement of Presidential recognition . . . imparted a feeling of ‘importance’ and meaning.” In a recent survey, the Center found that 97.5% of its staff members understood how their jobs help the organization achieve success and 96.25% are proud to work for the organization.
The authors write, “It is our sincere hope that this paper will inspire other local, state, and Federal government entities, no matter how small or large, to pursue a performance excellence journey for the sake of customers, employees, stakeholders and the country. Government organizations can start and progress along the ‘road to excellence’ despite the many challenges inherent in government. Leadership must have the will and fortitude to begin and stay the course.”
A Systems Approach to Improving Your Organization’s Performance
Baldrige Excellence Framework
The Baldrige Excellence Framework has empowered organizations to accomplish their missions, improve results, and become more competitive. It includes the Criteria for Performance Excellence, core values and concepts, and guidelines for evaluating your processes and results.