Over the course of a three-year period beginning in early 2012, Carolinas HealthCare System was provided the opportunity to repurpose an existing structure within the health system to create a core, centralized laboratory for all health-system testing functions. Previously, the system’s laboratory divisions were scattered in several different locations, hindering their ability to quickly and efficiently provide services to Carolinas HealthCare System—a comprehensive, not-for-profit system comprising over 900 care locations and more than 7,500 licensed beds in greater Charlotte and surrounding areas. This piecemeal lab structure also limited our ability to share technologies and products, created operational gaps, and presented a challenging staffing model, all governed by a decentralized management structure.
As the lab’s outreach program became more successful in boosting testing volume, the burden placed on a fractured lab structure became untenable; a situation that was clear to both lab and system administration. Since 2011, the lab has experienced a 50 percent growth in testing volume, and from the beginning, we knew significant change was necessary. The solution was to bring all primary lab functions into a single location.
The overarching goal of moving to a centralized, core lab structure was to create opportunities for shared technologies, staff, and infrastructure, thereby driving logistical efficiencies (eg, decreased turnaround times, economies of scale when ordering supplies), and positively impacting patient care and customer service. We decided to place heavy emphasis on pre-planning the project and to proceed utilizing Lean principles and practices in the design and layout of the laboratory. Moving to a centralized lab also allowed us to create a new, unified management structure employing Lean principles.
Establishing Project Scope
Having outgrown our capabilities by 2012, several lab divisions—including molecular testing, and chemistry and hematology outreach business—faced significant challenges in managing test volume.
The first step was to develop a Certificate of Need to be submitted to the North Carolina Department of Health and Human Services. This state law prohibits health care providers from acquiring, replacing, or adding to their facilities and equipment, except in specified circumstances, without the prior approval of the Department. Once the project was approved, system leadership determined that the project approach would be defined by the Lean principle of people, preparation, process, or 3P. This principle is used to define and develop a Lean equipment and supply chain logistics system prior to implementation. Given the struggles inherent to our previous multi-location lab structure, we focused on optimizing a centralized operation by seeking input from front-line practitioners in all lab divisions as to what would work best for their operations and workflow, and then creating a lab design to support those best practices.
In addition to incorporating ideal-state workflow considerations from all lab departments (see TABLE 1), we forecasted our continued growth capability in concert with physical plant and automation support. That said, this growth was conditional to Lean concepts as well, meaning efficiency, not size, was key. We did not want an overly large space and after conducting more than a dozen site research visits, we realized several newly designed labs had gone from too small to too large, creating new inefficiencies. The 3P events greatly influenced our assessment of a robust, yet efficient space design, and the end result has proven the value of such pre-planning.
Integral to our design process was creating an affinity diagram (see FIGURE 1) to visualize the interconnections of our lab divisions and figure out ways to share processes and resources. We first reviewed the operations of molecular cytogenetics and immunology, given the commonalities of equipment, processes, and specimens, in some cases. Many common functions were identified between the three laboratory areas and a design goal was to eliminate duplication in order to increase overall efficiency. For example, this process allowed us to combine the pre– and post-amplification spaces for molecular pathology and transplant immunology/HLA testing into a shared space, since both technical areas perform PCR based analysis.
Impact on Molecular Testing
The full service molecular pathology lab at Carolinas HealthCare System handles inherited and infectious disease testing, hematologic and solid tumor oncology, and molecular cytogenetic analysis for the 47-hospital system. This includes a volume of 350,000 to 400,000 annual molecular tests with techniques that range from traditional PCR testing to next-generation sequencing to allow multi-gene testing for oncology samples. In addition, this laboratory also frequently serves as a central pathology laboratory for FDA registrational projects with lab industry partners. Up until the implementation of the new lab space, patient specimens had to travel through as many as seven different rooms to perform all molecular testing processes. This included sample receiving, electronic ordering of the testing within the LIS, DNA extraction, PCR in a clean room, followed by transport to another room for gel electrophoresis or other needed post-PCR analysis, result analysis, and data entry, before ultimately ending up with the pathologist for sign-out into the EMR. In addition, some samples required specialized DNA/RNA isolation procedures inside a BSL hood, protection from ozone for microarray-based testing, and even processing within a radiation room.
In the new lab structure, the molecular analyzers—employing fully automated sample preparation and real-time PCR for amplification and detection—function as stand-alone for FDA approved testing and are not attached to an automated line. During the design process the decision was made to optimize the testing workflow on our existing platforms rather than to change testing technology and equipment as part of our move. This allowed us to focus on specimen flow and improving our existing testing platforms to eliminate waste.
Although some technological changes were made, one Lean principle that guided the project was to design and build a workspace that made the most of existing equipment and technology, while remaining flexible for further growth, including adding new technology. Prior to any 3P events, we reviewed current technology for each division, as well as the devices and automation we intended to acquire in the near future, to make sure they would fit with the new design. From the beginning, we wanted modularity and an open concept to drive the layout of the lab. For example, all power outlets and data communication lines and outlets are located in the floor, allowing us to place benches, analyzers, and other equipment into any number of configurations based on need. We tried to place walls only where necessary, such as for molecular pre-amplification, but even those walls are largely glass, so that the wide majority of lab processes are transparent to the rest of the lab.
Impact on Chemistry and Hematology
We also reviewed our chemistry and hematology divisions to look for shared opportunities. Given the high volume growth experienced by these divisions (due in large part to a robust outreach program), the 3P event we ran for those divisions to determine efficiencies lead to the collaborative creation of a fixed automation line.
The chemistry automation line tracks and transports specimens to testing instrumentation, then to refrigerated storage for retrieval in the event add-on testing is requested. We have both general chemistry and immunochemistry analyzers attached to the high-speed line, which is among the only fixed elements in the entire lab, as it requires both water and air pressure lines. Key to this process was working with our automation line vendor on the placement of devices along the line, which was a novel experience for all. As part of the 3P event with chemistry and hematology, we had those staff members designate where on the line to place the analyzers, and where refrigerated storage should be located to maximize efficiency. They also indicated where patient sample tube outlets should be placed for pending samples to kick off. Refrigerated storage in the high-volume area was designed to have outward-facing access so a technician could easily access the space and remove expired samples without having to circumnavigate the technical areas (see FIGURE 2).
Analyzers for chemistry, hematology, coagulation, electrophoresis, serology, and urinalysis were combined in one area to allow for integration and cross training of technical staff. Typically, automation lines have two general chemistry analyzers grouped together and two immunochemistry analyzers grouped together, whereas our team developed a design that created two cells, each comprising a single general chemistry analyzer and a single immunochemistry analyzer. Thus, during low-volume times, the single cell could be used for testing, leaving the other cell only for higher volume times.
The entire 3P events process spanned the first six months of 2013. At the end of the individual, division-based events, we held a master layout event wherein we placed all the divisions together according to a logical plan. A significant determining factor for placement was expected volume of incoming specimens. We located the department with the greatest number of incoming specimens—high volume chemistry and hematology—closest to the specimen intake area, with the remaining divisions, including molecular cytogenetics, cascading out from there (see FIGURE 2).
Conclusion
Our 24/7, central laboratory operation has been fully functional for approximately 15 months. As a system, we continuously seek opportunities for improvement, but given our thoughtful approach to the central lab design, we have had to make minimal adjustments to our processes while reaping significant gains (see TABLE 2).
Our system leadership was highly supportive and invested the time and resources necessary at the front end to make sure we had a high-functioning, staff-influenced, efficient lab design moving forward. Each 3P event required numerous staff to take time away from their normal duties to help diagram an ideal-state practice area, further evidence of system-wide buy in and effort toward making sure we created the best possible facility for our laboratory functions. This turned out to be an excellent investment.
Barbara McElhiney, MLS(ASCP)SBB, is the operations director of the Carolinas HealthCare System Core Lab based in Charlotte, North Carolina.
Heather Todd, MLS, MB(ASCP), is the group leader of molecular pathology, immunology, and cytogenetics for the Carolinas HealthCare System Core Lab.
John W. Longshore, PhD, FACMG, is the director of molecular pathology at the Carolinas Pathology Group and Carolinas HealthCare System.
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