The question of whether to centralize operations is common in business — and there are compelling arguments on both sides of the issue. Hospitals wrestle with the same question when it comes to clinical labs. Several organizations are finding greater efficiencies and cost savings in centralizing their lab operations into a single core facility. They’re aided in this endeavor by new concepts in lab design and Lean principles.
Centralized or “core” labs can be tightly focused on routine tests such as chemistry, hematology and coagulation. Others might accommodate a much wider variety of specialty tests — including flow cytometry, special coagulation, molecular diagnostics, complex microbiology, virology, endocrinology, toxicology, cytogenetics, molecular genetics, cytology and anatomic pathology — as a way to offer one-stop shopping.
The end goal is to produce scientifically accurate results, provide efficient operations, reduce the cost per test and ensure that accurate results are returned to patients in hours rather than days. While core labs can significantly benefit health care providers and patients, planning such facilities can be complicated.
For example, advances in testing technology, particularly the enhanced speed and efficiency of automated equipment, can dramatically increase sample throughput. But the rise of automated testing systems and the expansion of these systems’ high-volume capabilities comes with a greater need to anticipate the flow of samples, equipment and employees.
Northwell Health, based in New Hyde Park, N.Y., considered an expanded core lab during a period of expansion, which included an increase in its physical footprint, the number of physicians it employs and the realization that it was sending many of its tests to commercial labs. The system decided to bring most of its tests in-house and was able to do so by building two core labs that service the entire system.
Moving a project forward
Before making a decision to centralize lab functions, a health care system needs to determine the number of tests it performs now as well as the number and types of tests it hopes to perform in the future.
It must then address questions of personnel and equipment to serve its anticipated test volume: How many people will the hospital need to staff its core lab — typically around the clock — to handle the hospital’s current and future volume? What training and skills will staff need? How much equipment will it take to handle the volume? What is the capacity of automated equipment? What infrastructure will be needed to support operations?
It sounds like a simple equation. The number and types of tests that will be performed determine the size of the staff and, therefore, the scale of the core lab. In practice, this can be difficult to solve when working with tight budgets.
Getting down to details
After determining the nature of the testing to be performed and the intended testing volume, administrators and planners can then draw a more detailed picture. It is not at all strange for the picture to take shape gradually.
Hospitals first must work out space considerations for the new lab. Labs require some flexibility and floor space, so many health systems will seek out existing, large, open-bay space. Ideally, the building is a simple, insulated shell: a well-built big-box store, for example. This is desirable in spite of many potential issues that can arise.
Northwell Health is replacing its existing core lab in Lake Success, N.Y., with two automated facilities, including a small facility in the borough of Queens that will be devoted to biological testing and function as the hospital system’s immediate connection to New York City, and a larger facility devoted to chemistry-related testing within Northwell’s Center for Advanced Medicine, six miles away.
Northwell’s anticipated testing growth was pegged at between 250 percent over capacity at the start and 400 percent in the future and, in time, a fully automated workflow and testing system was created by several different collaborating manufacturers in response to Northwell’s needs.
When it is fully implemented next year, Northwell will be home to an automated clinical testing platform in which two parallel, duplicate lines will run 120 linear feet and together will be able to process up to 20 million tests around the clock annually, utilizing the platform’s various analyzer modules.
Accommodating such a large platform and its accessories requires a large area of open space, so it is a design challenge to keep the layout logical and flows efficient, both now and in the future. Because the move from the loading dock to receiving to processing to accessioning is such an important arrangement of spaces leading to the automated platform, the automated platform and its inbound, pre-analytic workflow will sit relatively close to a perimeter wall.
Executive Corner: Planning the core lab
A variety of programmatic and design issues can influence the planning of a centralized clinical testing — or core — lab. While programmatic issues theoretically come before design, they are intertwined. The following categories of planning and design considerations, all of which are relevant to creating a successful facility solution, are therefore not sequential, even though the first two are likely the initial steps in the process.
• The operational concept: Programming the space begins with understanding the staffing model, which includes everything from hours of operation and the work-shift strategy to safety protocols and cleaning procedures. Then comes the development of a logistical plan for sample management along the entire chain of custody control, including receiving, sample login, distribution, testing, reporting, freezer or cold-room storage, waste removal and management of consumables. Equipment-related optimization issues like capacity modeling, throughput analysis and backup strategy round out this operational strategy.
• Organization of flows: Applying Lean principles, the team then tackles work cell development with sample flows and efficient use of equipment and space and evaluates layout opportunities as well as personnel, equipment, sample and waste flows. Flow analysis is used to confirm contamination control, sample integrity and protocols anticipated. The team looks for opportunities to prevent contamination, process overlaps and bottleneck conditions. It also evaluates furnishings and equipment arrangement (e.g., sample prep and instrument layout) to help optimize work patterns and shared equipment opportunities. The team considers lab, office and support space adjacencies, which are critical for connectivity and supervision, as well as interaction space for coordination between testing groups.
• Modular planning for flexibility: An open-lab concept allows the greatest flexibility of space for future change with functional separations only where required. Within this space, utility distribution is planned to allow for open floor plates and flexible connections. The team then establishes a planning grid that allows for adaptability in the technology platform, lab automation, and assay and equipment upgrades. Sample preparation, incubation, amplification/detection and recording stations — which are important to optimize movement between operations — are located within the grid. Additionally, serviceability of equipment and calibration requirements (utilization logs) are confirmed. Finally, structural loading and vibration criteria, essential for sensitive equipment and robotics, are reviewed.
• Development of a safety and containment strategy: The team determines the biosafety level or potency of compounds and provides safeguards for personnel (e.g., personal protective equipment) and product (e.g., containment device or room), gowning and degowning concepts and isolation requirements. It also conducts safety or hazard and operability reviews and confirms intended standard operating procedures.
• Cross-contamination control: This involves functional separation of special testing needs; space pressure cascade and relationships between adjacent areas; and special procedure/special design requirements, including those for cleanrooms designed to ISO standards, cleanable surfaces, particulate-free finishes, environmental monitoring and, potentially, high-efficiency particulate air filtration. An air-handling zoning and cleanliness strategy will need to be put in place, whether using directional air flows or special spatial monitoring, when required.
• Regulatory impacts: Besides typical building codes and standards, these may include Centers for Disease Control and Prevention and World Health Organization guides; Clinical and Laboratory Standards Institute regulations; American Society of Heating, Refrigerating and Air-Conditioning Engineers standards; and National Fire Protection Association standards for flammables and life safety, among others.
• Special systems and security considerations: This will involve controlled access, equipment monitoring and alarms, data storage and multiple electronic reporting systems (especially those governing uninterruptible power supply, validation, redundancy and protection of personal information) as well as a data backup strategy that is balanced against operational costs.
Other workflows — samples moving to and from manual testing areas or refrigerated storage and to disposal — can’t interfere with each other and thus loosely occupy the other quadrants of open space. There is space allocated in two directions, presumably farthest from the inbound workflow, to accommodate future expansion of automated systems. This places other functions, such as offices, conference rooms, restrooms, locker rooms and break rooms, along the periphery, possibly to be moved farther away later.
Aside from Northwell’s 40-some pathologists who inhabit a second, smaller floor in the core lab, the other roughly 1,000 employees share offices and open workstations across multiple shifts. These offices and workstations are arranged to allow for close proximity of lab supervisors to their associated labs.
Labs achieve adaptability through what are now standard design moves: utility services that can be accessed from cables that descend from the ceiling; floor drains provided in a grid pattern, that can be capped when not needed; and mobile furnishings or flexible lab furniture systems in which utilities are prewired and preplumbed.
New work models
Lab operators, too, have begun to reshape lab functions with an eye toward optimizing the testing process, often using Lean work cell concepts.
The Mayo Clinic in Rochester, Minn., for example, has adopted a strategy in which physicians, hospitals and clinics must all send samples that are already aliquoted so they can be more easily routed to different testing stations — something Northwell hopes to do in the future. Many labs are seeking similar ways to streamline operations, which could have an impact on the floor plan. Receiving samples in consistent form in a consistent electronic format and with a consistent means of tracking could mean fewer staff and less space devoted to accessioning and more to information technology, for example.
NYC Health + Hospitals Corp.’s agreement with Northwell to create its forthcoming core lab is being counted on to save costs through the efficiencies created with its centralized, modern, highly automated and ergonomic lab facilities. Such projects are sure to provide immeasurable benefits to physicians, lower costs and speed lab results to anxious patients. — Jim Gazvoda is a principal and Jeff Raasch is design principal at Flad Architects, headquartered in Madison, Wis.