In Just 13 Days, Lab Buys, Validates & Uses Analyzer

Swift purchase was achieved despite demand by labs for COVID-19 analyzers, kits, and supplies

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CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But because of advance planning, working closely with its instrument vendor, and adjusting on the fly when needed, a 161-bed community hospital lab in Michigan cut that time to under two weeks!

IN THE MIDST OF THE SUPPLY CHAIN CHAOS  caused by the COVID-19 pandemic, one hospital lab and a major IVD company pulled off a true “mission impossible.” In just 13 days from signing a contract for a new molecular analyzer, the instrument was delivered, installed, validated, and put into service to perform SARS-CoV-2 tests.

What makes this a remarkable accomplishment is the fact that in vitro diagnostics (IVD) manufacturers and other lab vendors are overwhelmed with demand for their instruments, test kits, reagents, and collection supplies because of the soaring demand for more COVID-19 test capacity.

Thus, the story of how a community hospital lab contacted a new vendor and was able to get delivery of a new analyzer and bring it into service in just 13 days proves that it is still possible for labs to get instruments and kits from new vendors.

The lab at 161-bed Memorial Healthcare Hospital in Owosso, Mich., obtained funding for the new lab instrument on March 9. This story then commences on March 12, when the order was placed with Thermo Fisher Scientific for a QuantStudio 7. The instrument was installed on March 18, with validation and training completed by March 20. On March 23, the lab used the analyzer to run the first SARS-CoV-2 molecular tests.

Before the pandemic, these steps might take four weeks or more. “Once the instrument was delivered, it typically takes another month to get it installed and validated,” commented Nicholas Decker, MLS (ASCP), Lab Director at Memorial Healthcare, the only hospital serving rural Shiawassee County. “In an ideal environment, that’s about two months.”

Looking Ahead in Fall 2019

One factor that helped speed up acquisition of the new analyzer was Decker’s foresight in November 2019. Well before the novel coronavirus was identified in China, Decker discussed with Thermo Fisher’s sales staff the possibility of purchasing a molecular analyzer. But those conversations ended quickly.

“That discussion was a long-term game plan for the future,” recalled Holly Senter, the Genetic Analysis Solutions Representative in Thermo Fisher’s Life Sciences business. “By no means was a purchase authorized at this point.”

In the fall of 2019, Decker outlined the need for more molecular testing to hospital administrators. “Our lab normally runs 600,000 to 700,000 clinical lab tests each year, and we’ve had two molecular testing instruments—one from Cepheid and one from Abbott Laboratories,” he said. “But—in a normal year—if one or both of those machines runs short of supplies or goes down for any reason, the lab would need to send out its molecular tests.

That would increase the turnaround time and could affect patient care.”

Discussions Paid Dividends

These efforts to educate health system administrators about the need to expand their lab’s molecular testing capacity while adding redundancy paid big dividends sooner than anyone imagined.

In February, Memorial Healthcare and Thermo Fisher were still discussing molecular instruments, but not for the SARSCoV-2 coronavirus. “On February 28, we had our first in-person meeting at Memorial Healthcare to discuss bringing on non-COVID-19 molecular testing,” Senter reported. “Within a week of that meeting, we provided the first quote—for regular, non-COVID-19, molecular testing.”

On March 6, Decker presented the numbers to hospital administrators. That same week, coronavirus infections were spreading worldwide, and Decker was one of many clinical lab directors in Michigan considering whether to add SARS-CoV-2 molecular assays.

“We knew we were going to do a ton of lab work servicing nursing homes, group homes, and other high-risk groups that can be underserved during an emergency,” said Decker. “Our lab had to gain access to more molecular testing by any means necessary.”

That’s when Decker and hospital administrators shifted focus to molecular assays for COVID-19. For that testing, Memorial Healthcare considered the high-throughput QuantStudio 7 to run the company’s TaqPath COVID-19 Combo Kit for the qualitative detection of nucleic acid from SARS-CoV-2.

“For that instrument, we were asking the administration to step into uncharted waters to spend an initial amount of $60,000 to $70,000,” recalled Decker. “In addition to the analyzer itself, we needed equipment to do RNA extraction, which costs about $25,000. Altogether, we’ve invested about $100,000.

“At the beginning of the year, this amount wasn’t even budgeted,” he commented. “We had only discussed adding this instrument sometime in 2020. So, for our administration, that was a big ask. And they said, yes.”

On March 9, state health officials reported 373 coronavirus cases and Memorial Healthcare’s administrators approved funding to add more COVID-19 testing as soon as possible. Decker placed the order on March 12. The next day the FDA allowed the TaqPath COVID-19 Combo Kit under an emergency use authorization.

In the first two weeks of March, Thermo Fisher was flooded with orders and had no QuantStudio analyzers in stock. Therefore, its factory floor staff shifted production into high gear. “That’s when they started providing daily updates about all the steps in their process until the analyzer was physically here and installed,” recalled Decker.

Pieces Fit into Place

“At the same time, we also had to coordinate the ordering and shipment of testing supplies because we had to sprint through calibration and validation,” he commented. On Tuesday, March 17, Thermo Fisher (TF) confirmed the instrument would go out for overnight shipping. It arrived the next day. On Thursday morning, Thermo Fisher’s Field Service Engineer Don VanBuskirk was on site in Owosso to work with the lab team for the instrument’s shakedown runs.

On Friday, Thermo Fisher’s Field Applications Scientist Jessica Eichmiller, PhD, conducted training over an interactive web-connection, while Senter worked onsite with the lab staff. “There was no idle time,” Decker reported. “If you wrote an ideal project management script for the installation of this equipment, you’d see that it went just as you would want it go.”

Overcoming Hurdles

Set-up proceeded with few problems. However, the Memorial lab was missing a key piece of equipment—calibration plates—on Tuesday, March 24. To solve that problem, TF’s Senter drove to Sparrow Hospital in Lansing, borrowed the calibration plates, and drove back to Owosso. The lab ran the first patient test on Wednesday, March 25.

Even as the QuantStudio was running, the lab needed to further boost COVID-19 testing volume. “We’re capable of doing about 240 tests a day, but that’s mostly because of our staffing model,” he noted. “For each SARS-CoV-2 test, it takes time to extract the RNA. Currently, our lab can do only about 12 extractions every 30 minutes.

“In theory, we could do more than that,” he added. “But, as it stands now, we try to batch the samples so that we can get all the extractions done in the morning, and then report all of our PCR plates in the afternoon.”

Still, those 240 tests each day have made a significant difference for Memorial Healthcare’s physicians, because the QuantStudio fills the gap when supplies run short on the lab’s other molecular instruments. “Often, we wait days for a response from some vendors,” said Decker.

“It turned out that, as a vendor, Thermo Fisher really came through in the clutch,” Decker commented. “In addition, our administration was extremely supportive as well. I fully appreciate their confidence.”

Several Lessons Learned

For Decker, there were several lessons learned from this experience:

• First, look ahead to anticipate what testing capacity the hospital might need in the coming year or two.

• Second, engage lab team and the vendor’s support staff to identify resources required to meet increased demand for tests.

• Third, present to administration the plan to increase testing capabilities, how it improves patient care, capital requirements, and a return-on-investment (ROI) analysis.

13-Day Timeline to Buy, Install, Validate, & Test

AFTER NOVEMBER 2019, when Thermo Fisher Scientific (TF) began early discussions with Memorial Healthcare about a new molecular instrument, progress was slow for four months. But then in March, both sides began working in earnest.

• March 12: Memorial Healthcare placed the order for a QuantStudio 7.

• March 17: Instrument manufactured and shipped overnight to Owosso.

• March 19: Thermo Fisher’s Don VanBuskirk begins to install the instrument.

• March 20: Jessica Eichmiller, PhD, trains with lab staff via remote web connection.

• March 24: TF’s Holly Senter drives to Sparrow Hospital in Lansing to get calibration plates needed to prepare the instrument for COVID testing.

• March 25: Memorial Health’s lab staff runs its first live patient COVID-19 test on the QuantStudio.

Contact Nicholas Decker at ndecker@memorialhealthcare.org or 800-206-8706; Holly Senter at holly.senter@thermofisher.com or 248-345-4140.

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