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The Official Baldrige Blog

A Role-Model Government Center That Keeps Getting Better

 In 2009, a federal government organization that supports multicenter clinical trials for the benefit of American military veterans received the prestigious national Baldrige Award. The Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (Center) distinguished itself for high productivity and for maintaining strong customer (investigator) relationships. For example, the Center’s 2008 productivity level of $221,000 per full-time employee compared favorably to eight top competitors (i.e. the highest competitor’s performance was approximately $195,000).  

The Center has maintained 75 percent of its customers for greater than 10 years, generating repeat business that raised the organization’s extramural funding (the leveraged portion generated outside Congressional appropriations) to a level of $11 million in 2008 demonstrating true customer engagement. The Center continues to focus on delivering exceptional service to its customers (investigators). Its 100+ employees support clinical trials across multiple clinical study sites by providing pharmaceutical expertise, project management, safety monitoring, regulatory oversight, and manufacturing and distribution services.

The Center encompasses five coordinating centers, the pharmacy center, three epidemiology centers, and a genomics center. Initially, the Center utilized the Baldrige Excellence Framework and its Criteria for Performance Excellence, and the International Organization for Standardization (ISO) 9001 Quality Management System standards as the foundation of continuous improvement. In 2004 the Center became the first ISO 9001-registered VA facility.

“The interlinking of Baldrige and ISO began many years ago when we asked ourselves how best to provide quality services for investigators and veterans, but over time we pondered if our performance measures were telling us enough and whether something was missing in our ISO-defined management review,” said Julia E. Vertrees, the Center's associate director of quality assurance. “Today, using the concept of a Total Integrated Performance Excellence System (TIPES), the Center is working towards a deeper integration and interlinking of our quality tools with the Baldrige framework key to building a holistic management approach.”

Jan Hickey, chief of clinical manufacturing for the Center, noted that when the recession hit several years ago, decreased federal funding“slashed travel and training dollars.” Yet she called the organization’s use of the Baldrige performance-excellence principles and ISO a “lifeline for us.” Vertrees added, “The TIPES supports an organizational culture and processes that can achieve and sustain high performance levels in good times or bad.”

For more information, see the organization's profile on the Baldrige website.

About the author

Christine Schaefer

Christine Schaefer is a longtime staff member of the Baldrige Performance Excellence Program (BPEP). Her work has focused on producing BPEP publications and communications. She also has been highly involved in the Baldrige Award process, Baldrige examiner training, and other offerings of the program.

She is a Phi Beta Kappa graduate of the University of Virginia, where she was an Echols Scholar and a double major, receiving highest distinction for her thesis in the interdisciplinary Political & Social Thought Program. She also has a master's degree from Georgetown University, where her studies and thesis focused on social and public policy issues. 

When not working, she sits in traffic in one of the most congested regions of the country, receives consolation from her rescued beagles, writes poetry, practices hot yoga, and tries to cultivate a foundation for three kids to direct their own lifelong learning (and to PLEASE STOP YELLING at each other—after all, we'll never end wars if we can't even make peace at home!).

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Linking of the Baldrige framework and the ISO 9001 QMS Standards is indeed the most commendable philosophical undercurrent in this story - hats off to both the quality leaders and the team! The workers are the same, the processes, the customers, the environment - all are the same, so why cannot the two "frameworks" be linked - in fact, they have to be linked, otherwise the organization will embark on divergent paths simultaneously, and the teams confused. The lesser the additional burden that is put on the team in maintaining "records" required by different quality / statutory frameworks / standards the happier the teams will be and the more efficient. What a wonderful thought to link different frameworks!

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