BETHESDA, MD 15 January 2010—The pharmacist-directed Clinical Research Pharmacy Coordinating Center for the Department of Veterans Affairs (VA) has been selected to receive a Malcolm Baldrige National Quality Award—the highest honor given by the U.S. president for innovation and performance excellence.
Working out of a one-story building in Albuquerque, New Mexico, the 111 employees at the center manage drug- and device-related activities for multicenter clinical trials conducted by the VA and other federal organizations.
The award, announced December 7, 2009, caps what the center calls its 12-year quality journey.
During that journey, the center has achieved certification to the International Organization for Standardization’s (ISO’s) requirements for implementing a quality management system and following good manufacturing practice for pharmaceuticals’ primary packaging materials.
In 2004, the center received the VA secretary’s Robert W. Carey Performance Excellence Award, which is based on the Baldrige Award’s criteria. For three of the past four years, the center has been a VA Circle of Excellence awardee.
Congress established the Baldrige Award in memory of the Department of Commerce secretary who, in the 1980s, advocated quality management as a key to the nation’s prosperity and long-term strength. He died in a rodeo accident in 1987.
Two Health Systems Selected for Baldrige Award
AtlantiCare and Heartland Health have been named the 2009 recipients of the Malcolm Baldrige National Quality Award in the category of health care.
With regional medical centers in Atlantic City and Pomona and some 50 outpatient and other nonhospital locations in New Jersey, nonprofit AtlantiCare calls itself the largest provider of health care in the southeastern part of the state.
Nonprofit, community-based Heartland Health calls itself the leader in health care in a 21-county area covering northwest Missouri, northeast Kansas, and southeast Nebraska.
The award program began naming recipients in the health care category in 2002.
An emphasis on ethics. The award’s criteria fall into seven categories: leadership; strategic planning; customer and market focus; information and analysis; human resource focus; process management; and business results.
Since 2003, the criteria have stated that the senior leaders and governing body of an organization bear initial responsibility for its ethical and legal behavior.
Center Director Mike R. Sather said all employees had for several years been pledging to follow a list of internally developed ethical behaviors.
"Then we found out that Malcolm Baldrige was a cowboy," Sather said.
And Sather, a westerner, had been reading about the so-called code of the west for a number of years.
After James P. Owen published Cowboy Ethics: What Wall Street Can Learn from the Code of the West in 2004, "we sort of just took that and ran with it," Sather said.
The center’s senior leaders incorporated Owen’s 10 principles—"Live each day with courage" and "Remember that some things aren’t for sale" are two of them—into the behavioral expectations for all employees, Sather said.
"It’s all focused," he said, "on trying to get people to work together as a team. . . . If you work better as a team, obviously your organization is going to be much more productive."
Productivity in 2008, the center reported to the Baldrige National Quality Program, was $221,000 of revenue per employee—$26,000 per capita more than the most productive competitor.
Sather said occasionally a potential employee will say "Thanks, but no thanks" to the center’s behavioral expectations and thus employment.
"And that’s OK," he said, "because we’ve created a culture here. . . . Any new employee that comes into that culture has to really understand what’s expected of them."
Under way is an experiment in which employees anonymously evaluate senior leaders’ follow-through on the center’s behavioral expectations, Sather said.
Competitive for quality, safety. Deputy Director Stuart R. Warren said the center competes for business outside the VA, particularly studies conducted by the National Institutes of Health.
Whether the center wins depends, he said, on how its proposal and budget measure up to the others received by a study’s decision-makers.
In the nonprofit sector, said Julia Vertrees, an assistant director of pharmaceutical management and research, the center stands apart in its ability to provide an extensive set of services to support multicenter clinical studies.
Those services include designing and managing the study; manufacturing, packaging, labeling, and shipping drug supplies; monitoring participating patients’ safety; and complying with applicable federal regulations, such as those covering good manufacturing practice and investigational exemption for new drugs.
Many for-profit clinical research organizations, such as Quintiles Transnational Corporation, do what the VA’s center does, Vertrees said. It is those organizations that the center competes and benchmarks performance against.
Heather Campbell, the other assistant director of pharmaceutical management and research, said the center’s adherence to regulations and focus on offering high-quality products and services "ultimately guarantees patient safety."
Vertrees said the center has a "very rigorous program for corrective and preventative action, which is required by the FDA, it’s required by ISO, and it’s embedded in the whole philosophy of Baldrige."
Known by the acronym CAPA, a system of corrective and preventative action means that employees "find the problem and fix the problem and then improve the process," she explained.
"This organization really believes," Vertrees said, "that if [employees] find a problem they are empowered to report it, put it into our CAPA system, and fix it and that they’ll be part of the solution."
Not just pharmacists. Nonpharmacists at the Clinical Research Pharmacy Coordinating Center outnumber the pharmacists six to one.
In addition to the center’s 16 pharmacists, Warren said, there are 19 or 20 employees who perform manufacturing, packaging, and distributive duties commonly associated with the work of pharmacy technicians.
Chemists work in the quality control laboratory evaluating the uniformity of tablet and capsule blends, monitoring the stability of drugs, and analyzing raw materials, he said.
Also essential are the financial and information technology (IT) personnel.
Warren said the numerous IT personnel enable the center to provide websites for the investigators and nurses who see the patients and furnish the drugs at the various clinical sites.
Most of the center’s studies, he said, have a customized website that the investigators and nurses use to obtain and provide information that previously was transmitted via telephone and mail.
Commitment. Warren said the center has a low rate of employee turnover and "really good employee engagement scores."
The center, he said, annually uses Gallup Inc.’s 12-item Q12 survey to measure how employees perceive their role in the organization and how engaged they are in its operation. In areas where engagement is low, the senior leaders try to figure out how to improve and increase employees’ engagement, he said.
"If we have engaged employees," Sather said, "we’re going to have engaged customers . . . ‘human sigma.’"
In 2007, employee engagement at the center equaled the 75th percentile for all organizations using the Q12 survey. Among organizations providing professional, scientific, and technical services, the center outperformed the 75th percentile in 2006, 2007, and 2008.
