Rapid Deployment of New Laboratory Operations

December 2020 - Vol.9 No. 11 - Page #2

Q&A with Danyel H. Tacker, PhD, D(ABCC), FAACC

Medical Director of Clinical Chemistry & Mass Spectrometry

CLIA Medical Director of Blood Gas Laboratories

WVU Hospitals

Medical Lab Management: In June of 2020, you were tasked with deploying a new satellite laboratory operation at a small hospital proximate to your larger facilities in Morgantown, West Virginia. Can you provide some background on the genesis of this project?

Danyel Tacker: Fairmont is a town approximately 20 miles from our main campus at West Virginia University Hospital in Morgantown. Their small hospital closed in February of this year and our administration knew that we needed to address this closure and support the local community. WVU Medicine announced that they were taking over preliminary operations at the facility in mid-May, and as the CLIA medical director of laboratory services, I was asked by the system director to spearhead the lab operation at this location. The initial configuration includes a 12-bed emergency department along with a small observation unit. (It was predetermined that any patients requiring specialty care would be sent to Morgantown or Clarksburg, where the next closest, large hospital is located.) The catch was that this operation was expected to be up and running in approximately 6 weeks.

To do so, we needed to recruit staff for a 24/7 laboratory operation, evaluate the existing laboratory and tag elements to retain, remove the remaining materials, clean and disinfect the lab space, and get it up to code, all while arranging for the requisite computer systems and instrumentation necessary to run the laboratory’s operations. Although this is not an overly sophisticated operation in terms of menu, we did need basic technology to run microbiology, hematology, chemistry, coagulation, basic blood type and screen, and so on. We ended up receiving the bulk of our instruments and systems approximately two weeks before the scheduled go-live date, and while we were in fact able to go-live by our tight deadline, challenges remain in rendering that laboratory as fully and autonomously operational.

MLM: Who were you able to recruit to begin staffing and organizing how the lab would be run?

Tacker: Although I serve as CLIA medical director at the new Fairmont laboratory as well, essential to the ongoing success of this project has been the manager of that laboratory, Ashley Schmidt, MLS(ASCP), who currently also serves as manager in our main laboratory at WVU Hospital. Ashley split her time between the main hospital and the new laboratory, overseeing deliveries, working with facilities staff on upgrading and rendering operable the physical laboratory space, coordinating with vendors, hiring staff, and generally enabling this project to work. We would not have made our deadline without her efforts.

As part of our staffing decisions for the new lab, a technical specialist was recruited from the WVU Hospital’s specimen processing area, and several other technical staff members transferred to the new laboratory from existing laboratory sections at WVU Hospital. While positive for the new operation, this effort created staffing gaps at the WVU Hospital laboratory that we are still trying to fill and stabilize. Even with the full support of WVU Medicine and the Morgantown Hospital leadership, human resources in laboratory medicine and other key clinical areas are hard to acquire; a problem facing many clinical laboratories across the country. That said, we are confident that the recovery will be 100%, but we know it will take time.

MLM: What technology and instruments did you deem as necessary for operations to begin?

Tacker: Moving through the laboratory space with an eye on the basic services we intended to offer, we focused on technology that would garner test results deemed most useful in the first hour of treatment. Thus, blood type and cross, blood gases, basic hematology and coagulation testing, urinalysis (dipstick and manual microscopic), and chemistry/immunoassay were among the methods we wanted on site at go-live. At the beginning, we were performing type and cross manually, but we have since obtained a small automated platform for this workflow.

In addition, due to our individualized quality control program (IQCP) needs for molecular testing, we obtained a small PCR analyzer for group A Strep testing. We are likewise working on making available flu and RSV testing as soon as possible. We will offer no on-site pathology services (eg, histology), since the facility has no operating rooms. Any tissue specimens could be routed to the main laboratory, along with other specimens and test requests not covered locally. Now that we are live, we are working on implementing redundancies, with full-sized backup hematology, coagulation, and chemistry/immunoassay analyzers.

MLM: What were some of the expected challenges embodied by this project?

Tacker: We knew right away that providing a working laboratory space with the proper personnel to manage it would be an expected challenge. With a 6-week working time frame, recruiting and hiring a technical specialist and eight additional laboratory staff members is a challenging task to begin with. Add to that the need to equip the entire space—from analyzers and IT infrastructure to transfer pipettes and office supplies—and we knew the undertaking was substantial, to say the least.

More specifically, one example of an interesting challenge was being told that the equipment for the chemistry analyzer would be delivered on site in one week, but the vendor’s technical application specialist (TAS) was not going to be available to configure the analyzer for another 3 weeks from delivery of the analyzer. Given our time and scheduling crunch, we asked what was needed in order to set up the chemistry instrumentation ourselves.

Commonly, a vendor’s TAS will come to the site to set up and configure the analyzer ahead of go live, but as they would not have one available in such a short time frame, we offered to perform the set up ourselves. This is obviously somewhat unorthodox, but we had the technical knowledge to establish the configuration and get the validation underway between installation and TAS arrival. That way, when the TAS did arrive, most of the up-front work would be done and the TAS could focus on completing the remaining linearity, imprecision, and correlation studies. Because we are using the same technology types in the Fairmont lab as one of our previously established labs (purposefully for this reason), I asked Morgantown lab leaders to print out all the configuration screens from our core chemistry/immunoassay analyzers in Morgantown and I was able to configure the analyzer myself. We then recruited one of our main laboratory’s technicians, who happened to live near the site, to come in and perform calibrations and linearities; this proved a big help to the TAS when she arrived shortly thereafter. This type of teamwork enabled us to get our feet under us relatively quickly and complete the proper studies on time.

I will say, it is not often you hear that laboratory directors are rolling up their sleeves and configuring a chemistry analyzer, but when the challenge calls, it is good practice to sharpen our skills. Among the many lessons learned during this project was a better perspective on just how well our management and delegation structure works. For instance, a section supervisor would not normally come to me and say, “I am validating a new lot of QC and here is the lot number and here is the validation process;” rather, that tech knows what to do and executes that task. I learned firsthand about an entire layer of processes that lie between what I do as laboratory director and what is happening at the bench level. This kind of interaction makes you appreciate each level of practitioner in the lab and understand the relative strengths and weaknesses of each staff member.

MLM: What unexpected challenges did you face?

Tacker: As if to test us, the very first patient that came into the new ED presented with critical blood gas and hematology results—things we do not necessarily see in our main lab, so this was an early stress test for our workflows, testing and resulting, and even the calling structures and the brand-new phone list. Fortunately (and as expected), most of the subsequent patient admits have been for non-life-threatening issues and non-COVID-related issues. As this facility is not outfitted with advanced pulmonary, cardiac, and psychiatric services, for example, we are intended to render the more basic imaging and lab testing services. If a patient needs more advanced services, we transfer that patient to a larger facility. We are mainly concerned with stabilizing patients and releasing them with medications or routing them to more appropriate care locations. The broader idea is that this operation is a prelude to services that will eventually extend once our health system is ready to add services, or perhaps even build a new hospital.

This process also revealed some more nuanced issues that we do not experience at our long-since established home facility. For example, we have a CLIA certificate that allows the Fairmont laboratory to be operational, but that lab likely will not receive a CAP inspection until early 2021, so as part of our initial operations, we needed to establish the laboratory’s operational plan and quality control plan and gather data before CAP will inspect for accreditation. This leaves us in something of a preliminary or provisional status in terms of accreditation, while we accumulate evidence of compliance and quality work until our initial inspection. Therefore, we are doing everything according to the best practices we have developed and established at the laboratory in Morgantown with the accreditation inspection to come.

As I had never thought about starting a lab from scratch, much of this process was unexpected, but it has proved enlightening. Fortunately, CAP offers excellent resources and representatives to work with us on making sure we are doing things appropriately. So far, most of the work has involved proficiency testing and further ramping up our operations. We benefitted from the well-vetted policies, procedures, and job aids for involved staffing and testing used at the main hospital.

MLM: Any lessons or advice you would give to other laboratory directors facing a similar new lab challenge?

Tacker: I do not think any laboratory director would choose to build up a lab operation from scratch in such a compressed time frame, but that process was made possible by excellent teamwork and the willingness of our staff to perform duties outside the norm. Furthermore, it is important to always keep an eye on continuous improvement. By way of example, as we were nearing our go-live date, I had a discussion with Ashley regarding three particular tests that did not appear on the initial chemistry test menu. These were fairly common tests (lactic acid, ammonia, and creatine kinase/CK) and the ED providers agreed that they were needed on site. While lactic acid was available on our blood-gas platform, ammonia is best tested rapidly and CK is useful in evaluating crush injury, so we were able to get these onto the test menu within a week of go-live after an aggressive and focused validation.

Ultimately, a team effort is necessary for a project with multiple variables to be successful. We are certainly pleased with our efforts in rendering the new lab safely and properly operational and look forward to further refining the services offered.

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.


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