Let’s be honest. The emergency disaster relief policies that labs had in place at the start of 2020 were high level placeholders required by our accrediting agencies. Very few—if any—of us had plans for responding to a global pandemic that seriously disrupted supply chains worldwide. Instead of strategizing and planning, we found ourselves primarily responding, trying to maintain our operations and serve our customers.
Like most everyone, Loyola Medicine, a three-hospital system based in the Chicago suburb of Maywood, Illinois, struggled with these issues. We started in-house SARS-CoV-2 testing on March 19, 2020, and by the end of the year had performed 120,000 polymerase chain reaction (PCR) tests using six testing platforms. We performed another 6,300 antibody tests, including on 4,000 colleagues. We’ve learned many valuable lessons this past year and, in this article, describe some of our key takeaways.
Just-in-time inventory doesn’t work for pandemics, but stockpiling has its limitations beyond essential personal protective equipment (PPE). We’ve had to balance between these extremes to support patient care activities. We wanted at least 4 weeks’ inventory to offset vendor disruptions. A key aspect of this involved tracking daily fluctuations in our test volume. Armed with this data, we were more adept in establishing pandemic par levels for reagents, kits, and collection supplies.
Cutting personnel in response to low test volumes is short-sighted. Early in the pandemic, as it became evident that supply shortages were coming, our microbiology lab redeployed two technologists to assist in sourcing critical sample collection and PPE supplies. They identified and placed multiple small orders across several vendors to obtain materials, which we validated to maintain par inventory levels.
Keep training staff. Our lab couldn’t completely cease training and competency evaluations during the pandemic. Even in this uncertain time, we’ve had turnover and filled vacant positions. Additionally, several associates assumed roles they weren’t hired to perform, but having met the qualifications, were trained to perform and assessed for competency. For example, our point-of-care (POC) coordinators trained for and began performing POC SARS-CoV-2 testing.
Fear of modifying a method, thereby making it a laboratory developed test (LDT), shouldn’t automatically rule out this option. The commercial interleukin-6 (IL-6) assay we validated to support management of patients hospitalized with COVID-19 was previously available for research use only. This necessitated a more extensive clinical evaluation to establish the assay’s utility in these patients. We enlisted several pathology residents to undertake thorough chart reviews and follow the medical history of approximately 100 hospitalized patients who had serial IL-6 measurements. The lab completed a comprehensive method validation to satisfy LDT requirements. Although this assay received an emergency use authorization (EUA) within 3 months of our validation, initial lack of this regulatory approval didn’t dissuade us from validating and making this assay available as a valuable clinical tool.
Vendor loyalty might bring products into a lab, but when that company experiences supply disruptions, not having relationships with multiple vendors could prove problematic. Initially, SARS-CoV-2 antibody assays entered the market extensively and rapidly, unlike anything we’ve seen in our collective 50+ years’ experience. Options were plentiful, but EUAs were not, at least on automated immunoassay systems. Many laboratories with vendor loyalty found themselves without options amid rapidly escalating demand. Those with more than one system had options for the types of antibodies they could detect and type of results they could render (quantitative versus qualitative).
Build supplier redundancies. Having redundancy in essential and emergent testing not only provides an operational safety net, but also facilitates a competitive marketplace. Few of us have had the luxury of evaluating secondary and tertiary methods or products, but as we emerge from the pandemic, we all will do well to establish lists of evaluated products that meet our needs.
Recognize when it’s time to execute backup. Notifications from vendors about backorders or delayed deliveries signal the need to seek alternate sources and/or prepare to implement established backups. We recommend that labs work with their logistics specialists to find emergency suppliers. Establish these relationships now for future needs by occasionally ordering and evaluating new items and building a surplus inventory. Laboratories that already have backup procedures should build semiannual events into their quality calendars to perform comparison testing and document compliance.
Develop systems for outsourcing nonessential testing. SARS-CoV-2 testing often has been our lab’s highest priority. This at times means instrumentation that typically runs 5-7 different infectious diseases tests runs only SARS-CoV-2 tests. While our volumes dropped significantly for many tests, they didn’t zero-out. This meant relying on our reference labs, first by confirming that a lab was accepting specimens for each test in question. Next, we communicated to providers that a test was being outsourced, which in turn would affect turnaround times. Finally, we updated order test codes to reflect these changes in our electronic medical record and laboratory information system.&
Look hard at all primary and essential methods to determine if a sound, validated backup exists, and detail the logistics required to implement this solution. Our lab established redundancy for our COVID-19-related diagnostic testing, and we already had redundancy for key tests that supported COVID-19 patients’ care, like blood gases, electrolytes, and coagulation testing. As demand for these assays grew nationwide, we maintained a steady reagent and instrument part supply inventory for our primary and backup platforms.
Audit and revise labs’ pandemic response plans. We expect to revise our business continuity plan by updating required staffing levels and interactions and supply inventory management steps for critical PPE and routine, high-use consumables like plastic transfer pipettes and pipette tips. We’re still exploring how we’ll audit this revised plan.
As the pandemic wears on, laboratories continue to lean on each other for ideas, support, and solutions. In our lab, we’ve had successes while still learning and adapting. We long for the days when we could pull a disaster plan off the shelf to guide us in evaluating options and executing solutions. In reality, we’re actively writing our plan for the future as we experience this (hopefully) once in a lifetime event.
Jack A. Maggiore, PhD, MT(ASCP), is assistant professor of pathology and laboratory medicine and associate director of core laboratory operations and point-of-care testing at Loyola University Medical Center in Maywood, Illinois.+Email: [email protected]
Jonathan Bakst, MBA, MHS, PA(ASCP)CM, is regional administrative director of laboratory services for Loyola Medicine.+Email: [email protected]