When considering the technical range of equipment needed for a new laboratory, a solid approach includes delineating operational silos and linking them to available test menus on specific analyzers. This should then be combined with a broad-based vision of how technical operations will coincide with leadership, personnel, and workflow operations. This process should be vetted through an implementation team (ie, the staff members directly involved in setting up instruments, analyzers, and workstations in the new lab) prior to ordering any new technology or automation.

Rightsizing a new laboratory space is typically a challenge regardless of the circumstances; new facilities are often reluctant to allocate a large work area for burgeoning laboratory operations, so details such as how many linear feet of bench space is needed for all necessary workstations (often, one analyzer or task), and how many cubic feet of storage is needed now and in the near future (by temperature/condition) can be of substantial benefit during the planning stage. Strongly advocating for appropriate workspaces enables a smoother operational ramp up and provides for safe and ergonomic accommodations for staff.

Start with the Basics

Midway through 2020, we were tasked with relaunching a recently closed small hospital in Fairmont, West Virginia. This new laboratory’s relationship to our central laboratory in Morgantown—part of the West Virginia University Health system—is a spoke in a hub-and-spoke style setup common in many hospital systems. As such, only critical equipment and testing options needed to serve the local providers within a distance of 1-2 hours was considered; all remaining, routine work would otherwise be routed to the hub laboratory at Morgantown.

Acquiring and accounting for new analyzers often can be the most straightforward part of a new laboratory endeavor, as each takes up a known amount of space and has specific system requirements. If a new chemistry system is “wet,” requiring a water system installation, the manufacturer should provide all necessary information for those parameters during the budget and prepurchase process. (Furthermore, the water system should meet the pure water needs for the tasks at hand.)

Among the more difficult elements for a new laboratory operation is accurately estimating the burden of the volume and complexity of forthcoming test requests. This requires gaining an understanding of metrics related to the reagents, calibrators, control materials, system solutions, and consumables needed to meet that burden. Further complicating this stage is the ongoing challenge of ensuring ideal storage conditions for all products. This is particularly true for automated platforms in core lab sections, such as chemistry/immunoassay, hematology, urinalysis, coagulation, and basic microbiology. Thus, considerable attention should be given to not only the size and working space of a given instrument, but its entire expected workload as well.

Technical Cornerstones

The basic configuration of the new laboratory build in Fairmont flows by stations, situated in the general order one would encounter while working through the laboratory space, from the front (ie, receiving) to the back. There is a computer at almost every bench (or one shared between adjacent benches) to allow quick and convenient access to the LIS/EMR, as almost every instrument is now connected to these IT systems. Computers also serve as access points for staff members to cycle through proper testing procedures or guidelines (if need be), internal laboratory and clinician call lists, paging systems, and other tasks, such as releasing exceptional results that fail autoverification. At the new Fairmont lab, the basic configuration is as follows:

• Receiving & processing: Placement and work areas for centrifuges, LIS/EMR computers, label printers, bar code readers, specimen racks, refrigerated and/or frozen storage, space for courier drops and pickups.
• Blood-gas testing: Two analyzers immediately adjacent to Receiving, which are relatively self-contained, requiring only the reagent cartridges and some gauze for dabbing the syringe apertures to accommodate the typical workflow.
• Blood bank: First, we began new lab operations performing manual type and cross before implementing a compact, automated analyzer shortly thereafter. Given our low staffing numbers allotted for the new lab, automation was key to an efficient workflow. The blood bank “bench” was deliberately placed near Receiving, given that is where we store a few RBC and plasma units on hand.
• Hematology: Started with a single small analyzer for basic automated CBC and differential and procured a second one after a couple months to balance the growing volume.
• Urinalysis: Implemented a small strip reader, typically used in point-of-care testing (POCT) applications, as well as a microscope for sediment evaluations.
• Coagulation: Began with one small platform that could perform basic coagulation testing (ie, PT, PTT, INR calculation, D-Dimer, Fibrinogen), and obtained a second instrument once volume began to rise.
• Molecular microbiology: Purchased a compact, CLIA-waived version of the PCR platform used at our main laboratory in Morgantown (the hub) so we could offer group A Streptococcus and flu/RSV testing. All other microbiology testing goes to the hub laboratory via courier (pickups 3 to 4 times per day).
• Chemistry: Obtained a chemistry/immunoassay workcell to enable metabolic panels, serum toxicology testing, urine drug screen panels, and basic cardiac, thyroid, and infectious serology screens. A second unit has been obtained and is in the implementation process.
• Point-of-Care Testing: The use of a glucometer in the ED requires stocking of the related strips and control over their allocation from the laboratory. We have a backup meter on-site in case of damage to or failure of the primary meter.

Address Non-technical Necessities

In addition to the obvious instrument, technology, and automation needs of a laboratory, there are ergonomic and other, less obvious aspects that should receive proper attention:

• Office Space: Incorporating a copier with scanner and fax capabilities was an important function for the new spoke laboratory, because its administrative leadership is based at the Morgantown hub laboratory. With this system, staff at the Fairmont lab can scan and send a document to the hub via email, which is much faster than sending via traditional interoffice mail. That said, the Fairmont lab’s technical specialist has a dedicated office space there, as she is on-site daily. It is important to forecast the administrative placements for a new laboratory, especially one working as a spoke or satellite to a hub laboratory. Having a clear overall layout that includes both operational and administrative locations with descriptive workflows can alleviate bottlenecks and inefficient movement patterns downstream.
• General laboratory supplies: As all laboratories have experienced issues securing various supply chains over the last 12 to 15 months, we had to scramble to set up inventories of gauze, transfer pipettors, fixed-volume micropipettors, sample cups and blank tubes for decanted specimens, wooden reamers, lipid skimmers (we could not justify an ultracentrifuge), office supplies, surface and equipment disinfectants, and PPE. Maintaining a proper inventory management system is obviously vital to any ongoing laboratory enterprise.
• Break room & personal space: Our recent lab startup was executed rather quickly and as the hospital it is serving did not have a full on-site cafeteria, we decided to incorporate a break room stocked with drinks and snacks in case on-site staff members were left without a meal for any reason. We also dedicated locker space for staff to store personal items. Maintaining ergonomic conditions for our staff is an ongoing satisfaction goal for our institution.
• Ancillary essential equipment: When running a well-established laboratory, it can be easy to set into the background certain ancillary, yet essential equipment necessary for a safe and regulatory compliant laboratory work environment. Thus, be sure to stock and train on the proper use of PPE and other safety gear, including coats and gloves, face and bench shields, a fire blanket, eyewash and shower stations, volatiles cabinet, and maps to pull-stations and for evacuation routes in case of emergency.
• Registrations & applications: New laboratories have to gain accreditation, of course, and completing this process can extend several months beyond the initial setup and launch of operations. For example, while investigators at the State level (eg, Office of Health Facility Licensure & Certification [OHFLAC]) had performed multiple inspections of the Fairmont facility prior to opening, The Joint Commission conducted its initial inspection within a few weeks of opening, and the College of American Pathologists (CAP) accreditation inspection is scheduled approximately 6 months after the laboratory has been operational. These differences exist so the respective agencies can review and assess compliance for various regulations. The delay in the initial CAP inspection is deliberate, intended to allow a laboratory to create, implement, and monitor a quality plan long enough for the agency to have true operational metrics to evaluate.

While some of these formalities may be semi-automated at an established lab, these requirements still need close attention, as do the attendant surveys and inspections. Therefore, operational checklists of daily, weekly, monthly, quarterly, semi-annual, and annual milestones can be highly beneficial to ramping up new lab operations. This includes broader concepts such as competency checklists, as well as details such as when to order linearity materials (and which), and other occasional activities that are easy to forget (eg, semi-annual comparison studies between analyzers).

Start with a Broad View

The main challenge that comes up in any type of wide-ranging project—such as jump-starting a new lab—is having the time to conceive a workable and efficient process based on limited initial data or information. If the new lab is part of an existing hospital or clinical operation, then processes need to be vetted with your new clinical partners so there is an understanding about processes that may need tweaking or outright change. Doing this in real time, in a clinical setting, with relatively limited human resources available, is a challenge that can lead to lost sleep.

This type of planning is not simply a matter of going from bench to bench creating “ideal” workflows; rather, it requires a global view of operations both internal to the lab and external to all the lab’s service areas. A significant part of a new lab operation should consider how lab services link to clinical practice, where service lines intersect (or collide), and how to mitigate potential conflicts immediately and in the future.

Choose Your Battles

As mentioned in the list above, likely there will be some processes that need to evolve from manual to automated (or perhaps not) during the course of the operational ramp up. This will depend in large part on forecasted-vs-realized testing volumes. As such, processes that can begin using manual methods during start-up (and which may need to persist until analyzers are justified by workflow and volumes) include basic blood type and cross, blood differentials, and urinalysis chemistry/dipstick and microscopy. This is a relatively limited list of activities, but starting with these will help stage equipment acquisitions over a longer period of time.

Never forget the value of your experience running an existing lab. Look to your recent history of instrument upgrading or process automation. Reviewing these experiences can provide insight as to which operations can function manually, and which will rely heavily on equipment or automation acquisition.

Another consideration is scalability and the utility of potential POCT alternatives both within and outside the laboratory setting. If a single test is needed for a section, and funds are too tight to justify analyzer purchase for a single test, a point-of-care option within the laboratory could provide a middle ground until justification is complete or utility is confirmed. Point-of-care devices could then be repurposed or stored as needed, as larger platforms are acquired and implemented.

Continue Building after Go-live

There is always room for continued improvement, even in the unlikely case of a flawless new lab go-live. That said, following the above checklist will serve as a solid foundation. Moving forward, we are now researching automated urinalysis (UA), not because the POC dipstick reader and manual microscopy are problematic or have produced questionable results, but because we are concerned about maintaining staff competency for manual spinal fluid cell counts. This testing activity could be easily added to a UA analyzer’s microscopic component.

This illustrated a lesson learned from our first 6 months in operation. Initially, we were asked to offer on-site spinal fluid Gram stains at go-live, and we were able to meet that goal. However, after 6 months, the lab had not received a single order for this service and felt the time spent on competency, proficiency testing, quality control, and inventory to support the test was not warranted. Furthermore, without clinical volume, relevant staff were not gaining experience from case work or sharing slides to review, and the potential for incorrect calls that could negatively impact patient care would only grow under this mandate. We discussed discontinuing the spinal fluid Gram stain test with ED leaders at the site and agreed to do so on the contingency that the service could be reactivated if deemed necessary in the future. As we are expanding the on-site services provided at this facility, spinal fluid Gram staining certainly could become more viable in the future, but this is an example of an adjustment made due to real-world experience.

When ED leadership inquired about performing spinal fluid cell counts, we reprised the question and dynamic of demand, competency, and clinical urgency, and this process helped us place a UA analyzer into consideration for capital budget when it comes available. We plan to not offer the spinal fluid cell counts on-site until we can utilize an automated solution, as we want to capture clinical examples and use them for ongoing competency.

Expect Unexpected Challenges

An additional valuable lesson involved planning for and expanding into a second analyzer and beyond. Leading into this project, we did not fully factor in the total (ie, non-laboratory-based) effort required to configure QC materials in the LIS. With a second analyzer in place, we need to distinguish data from each analyzer in order to monitor their agreement and individual behavior, simultaneously. This required crafting separate QC materials, each with associated tests run on the QC material, as well as expected mean and SD information. The bar codes used to transmit daily QC data to their associated LIS files has to be exact, as well as different. This “minor” detail in the lab’s estimation was actually a much larger request of IT resources than we anticipated. We assumed the infrastructure already existed and did not understand how the data are kept separate in the LIS. It can be easy to miss these aspects of a new lab build in the initial setup phase and then carry that missed consideration over when seeking to replicate a workflow to accommodate analyzer expansions.

As a hub and spoke operation in this case, there remains a balancing of human resources between long-standing and new operations at the hub, and new and growing operations at the spoke. This is why establishing a schedule of goals and expected outcomes by certain dates is key to success. A new operation cannot rely fully on resources from an existing operation in perpetuity. A detailed schedule not only helps keep leaders in the new space abreast of their responsibilities as they adapt, it also helps the hub laboratory properly allocate resources and time to assist with troubleshooting and avoid surprises.

Conclusion

A director may lead a laboratory for years and not be aware of all the details involved in building and maintaining that space, perhaps until the opportunity to create a new space from scratch is presented. This opportunity should be a blessing and not a curse. I would advise that new laboratory directors in established laboratories pay attention to so-called minor details and factor in mental exercises that consider alternative approaches, even for successful projects.

For new laboratory directors in a new space, capitalize on the education and training resources offered by accreditation agencies regarding regulatory requirements and best practices. Dedicate a significant amount of time to observing successful workflows and probing questions about processes with your staff. Something most seasoned laboratory directors know is this: A process can look simple and clean on paper but translate terribly into practice. As a leader, present strong ideas but remain flexible by listening to those with frontline experience when optimizing a workflow or developing new processes. Part of good leadership is seeking to strike a balance between the desire to fix something and move on, and ensuring the changes are executed properly and benefit all parties involved.

Danyel H. Tacker, PhD, DABCC, FAACC, is the medical director of clinical chemistry & mass spectrometry laboratories, and CLIA medical director of blood gas laboratories at WVU Hospital & JW Ruby Memorial Hospital in Morgantown, West Virginia. In addition, she is an associate clinical professor of pathology at West Virginia University School of Medicine. Danyel is also CLIA medical director at WVU Hospitals – Fairmont Medical Center. Beyond these roles, she assists with specimen processing, outreach, point-of-care, and send-out functions of the WVUH laboratories.