Designing a Brand New Molecular Core Lab

Contributing Lab Leader: John Longshore, PhD, FACMG

Operational

Article highlights:

Lab leaders can learn from example in the successful design of Atrium's core lab.
Dr. Longshore used Lean principles to collaborate effectively with stakeholders at all levels, instilling an ethos of continuous process improvement.
By continually refining the design, Atrium built an efficient, time- and cost-saving core lab.

With the trend of consolidation heating up in the molecular lab industry, many lab leaders have begun to ask: If I were going to design a molecular core lab, how would I do it?

The brand new molecular core lab at Atrium Health—designed by Dr. John Longshore, director of molecular pathology at Atrium—provides valuable insight into how such an undertaking can be approached. Here, Dr. Longshore describes the process for building the lab—from lab design, to getting stakeholders on board and involved, to finding unifying objectives for success, as well as the challenges his team encountered and the eventual outcome of their efforts.

Big Principles

Dr. Longshore's goal was to consolidate what were once seven non-contiguous lab spaces into a 29,000 square foot core lab, which would process three-quarters of a million samples per year. This included moving cytogenics, immunology, flow cytometry, HLA testing, pathology, microbiology, chemistry, hematology, and toxicology under one roof. No easy task. The move came as a response to trends familiar to lab leaders: decreasing reimbursement and budgets, increased workloads, personnel shortages, and tremendous growth.

Dr. Longshore began this complex task by framing the process with simple overarching goals. His four big principles were: consolidating the work flow, cross-training staff, continuing to challenge their skills, and controlling utilization for testing services.

Moreover, Dr. Longshore applied a Lean methodology to the lab design, which involved ground-up collaboration with stakeholders at all levels, in both design and execution stages.

These big ideas have resulted in tangible results: Now finished, the highly automated core lab has seen dramatically improved workflows, process efficiencies, and supply chain operations. Moreover, the lab now has the benefit of a collaborative ethos, where continual process improvement is the norm. For lab leaders hoping to emulate this success, Dr. Longshore's design process is a case study.

Collaboration as the Key to Improvement and Buy-In

Dr. Longshore's design process, in many ways, was straightforward: He simply brought stakeholders together in groups to ask where and how the lab could improve. "We held a series of Three P [Lean principle] events for every area of the lab," he says. "We trained them on principles, brainstormed, created ideas, and then finally built the model lab out of cardboard and simulated the testing. After that, we would talk about what happened, what we liked, what we didn't like, and we would improve the lab design and try it all again."

By actually walking through the mock-up lab, stakeholders could continually refine the core lab design until it met performance expectations. This kind of continual process improvement is a hallmark of Lean methodology, and here it proved invaluable. For instance, the lab team took similar efforts to reduce costs and improve output by, for example, scrutinizing lab bills to help lower utilization for tests that provided no clinical utility, as well as finding opportunities to cross-train technical staff, so they could perform more efficiently in a core lab environment.

It's also worth noting that, where many labs have a top-down, medical-director-driven mentality, Dr. Longshore saw the value in hearing from stakeholders at all levels. For instance, in addition to technical staff, Dr Longshore invited security guards, nurses, pharmacists, environmental services, an architect, among others to weigh in on lab design. The result, apart from efficient design, was that stakeholders were highly involved throughout the process, making it easier to secure buy-in at all levels. "[This approach] really improved our collaborative environment and the team concept," he says.

On a Number of Improvements

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On Leveraging LEAN Design Principles

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John Longshore, PhD, FACMG

Director of Molecular Pathology

Carolinas Pathology Group, Atrium Health, Carolinas HealthCare System

Challenges Encountered

With such an ambitious undertaking, speed bumps were inevitable. The first, in this case, was the fact of major change. "It's been a challenge to have a large paradigm shift of moving from a traditional laboratory medicine structure into more of a Lean-type environment with continuous process improvement," says Dr. Longshore. He says that Lean, originally created for manufacturing environments, doesn't always lend itself to a medical laboratory—that things familiar to manufacturing, like standard work and standard processes, can be challenging to institute.

Personnel, meanwhile, remains an issue. Since Atrium's core lab runs 24/7, Dr. Longshore says that it can be difficult, with limited labor resources, to find individuals with aptitudes for high and ultra-high complexity testing, like next-generation sequencing. Still, this is an issue for almost every lab, regardless of circumstance.

On the whole, however, Dr. Longshore says that the transition has been a boon for the team, in spite of these challenges. "We have had a lot of improved communication, when lab directors and multiple areas of the lab are co-located under the same roof and the same facility," he says. In fact, it is this ethos of continuous process improvement that helps to minimize challenges as they arise.

Lessons Learned

For any lab leader, the design and build of a brand new molecular core lab is a daunting task. Yet, Atrium's core lab provides valuable lessons. For instance, lab leaders will be well served by inviting as much varied stakeholder support as possible—to both generate momentum for the project and to uncover any and all opportunities for

improvement. Moreover, it is helpful to frame the project with clear principles and objectives, using education (training and brainstorming events) to guide team members toward a common goal. Finally, lab leaders must develop a solutions-based mindset to handle inevitable challenges as a process.

Dr. Longshore observes, understatedly, that "it has been quite a journey," to design and build a brand new molecular core lab. But, as Atrium's success shows, the undertaking has been well worth the effort.