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At Henry Ford, 36 lab sites now under ISO umbrella

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Anne Ford

November 2013—When Richard J. Zarbo, MD, reflects on the strategy that helped his Detroit-based Henry Ford Health System achieve CAP accreditation to the ISO 15189 standard this summer, he likes to quote the system’s famously methodical founder: “Nothing is particularly hard if you divide it into small jobs.”

Indeed, it’s clear that HFHS—the largest entity to receive the prestigious laboratory accreditation, which focuses on operational systems improvement, risk mitigation, and quality management—would never have succeeded in this regard without that one-piece-at-a-time, divide-and-conquer approach (just as Ford himself couldn’t have manufactured 15 million Model Ts without a little method called the moving assembly line).

But in light of HFHS’ history of continuous quality improvement, another Henry Ford saying applies as well: “There is safety in small beginnings.” That is, rather than jump directly into its 15189 journey, HFHS prepared for it gradually over a period of years, beginning by implementing Lean principles and establishing a Lean culture that would eventually serve as a robust framework for the ISO standard.

A celebration of 15189 accreditation at HFHS in August.  Above from left, Aaron Lupovitch, MD, director of regulatory quality initiatives; Rita D’Angelo; David Wolfe, CAP 15189 lead assessor; Dr. Richard Zarbo; and Michael Grilliot, manager of CAP 15189 and CAP Biorepository Accreditation.

A celebration of 15189 accreditation at HFHS in August. Above from left, Aaron Lupovitch, MD, director of regulatory quality initiatives; Rita D’Angelo; David Wolfe, CAP 15189 lead assessor; Dr. Richard Zarbo; and Michael Grilliot, manager of CAP 15189 and CAP Biorepository Accreditation.

“By taking this long-term approach, we were able to close this—that is, achieve ISO 15189 accreditation—with very little in the way of setback, if any at all, over a period of four years,” says Dr. Zarbo, senior vice president and chair of pathology and laboratory medicine for HFHS. By his reckoning, HFHS is not only the largest entity to become 15189-accredited; it’s the “only integrated delivery system, where all laboratories are standardized under one source of leadership,” to gain this accreditation. “There are other systems that have multiple sites, but they’re not integrated under one system laboratory leadership responsible for all pathology and laboratory medicine operations up and down the waterfront,” he says.

To be clear, Lean is not a requirement for ISO 15189 accreditation; only some of the 32 laboratories that have achieved this accreditation since the College introduced it in 2008 use Lean methods. But for an institution as large as HFHS to bring all 36 laboratory sites and 800 laboratory employees under the ISO 15189 umbrella, a previous grounding in Lean principles was necessary for success, the system’s leaders say.

Take employee buy-in. Every quality-initiative leader wants it but knows it is notoriously difficult to achieve. When HFHS began training its hundreds of laboratory workers in Lean eight years ago, it did so in groups of 40 to 50, says Rita D’Angelo, MS, ASQ CQE, SSBB, who was then the manager of quality systems for pathology. That incremental, small-scale approach, she says, made it easier for employees to understand the importance of Lean, rather than see it as just another corporate initiative imposed on them from above.

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