The Impact of Supply Chain Disruptions in the Laboratory Industry

By Marion Karl, MS

November 05, 2021

This is the first article in a two-part series on Supply Chain issues in healthcare. To see all StaffReady blog posts, click here.

In response to a global health crisis, clinical laboratories are feeling the crunch in more ways than one. An ever-increasing demand for COVID-19 testing along with products to support the management of COVID-19 patients has forced many laboratories to shift priorities. And supply chain disruptions have created the challenge of getting critical lab materials into the hands of qualified staff.

The high demand for COVID-19 testing and related research, along with a severe supply shortage, requires reevaluating current methods and adjusting lab management practices. While the global pandemic response has created an unanticipated strain on important clinical resources, lessons can be learned for better future preparedness.

What Is the Role of Laboratory Testing in the Pandemic Response?

The primary pandemic response adopted across the globe takes a three-pronged approach: social distancing, wearing masks, and testing for COVID-19. Even with the availability of approved vaccines, routine testing remains a critical strategy in stopping the spread of COVID-19.

However, excessive testing has depleted the inventory of certain lab supplies while putting increased demand on global manufacturing. In addition, transportation and distribution of supplies have been severely compromised due to the pandemic. The result has left many a lab with an unprecedented shortage of needed supplies—not just for COVID-19 testing but for other diseases as well.

For example, collection and transport of consumables (like swabs, pipettes, pipette tips, and test tubes) are increasingly difficult to come by—not to mention these are also used routinely for a number of non-testing laboratory procedures and patient care. Labs are also experiencing a shortage of culture mediums for producing reagents needed in assays used to identify different COVID-19 strains and bacterial infections, antibodies, and other disease markers.¹

How Have Supply Shortages Upended the Laboratory Industry?

As laboratories have an important role in the pandemic response, supply chain disruptions slow down the COVID-19 response overall, which is particularly evident in countries that rely on importing most of their lab materials.² The bottleneck of critical laboratory supplies furthermore affects lab costs and contributes to operational chaos as alternative supplies and testing methods are frantically sought.

During a recent meeting of the College of American Pathologists, presenters discussed how the high volume of COVID-19 testing had placed an enormous burden not only on supply chains and laboratory stockpiles but also on the medical technologists and laboratory scientists responsible for performing the tests.³ Supply shortages can take a significant toll on employee morale as they reassess supply strategies and sources.

Even items that remain available on the global market may be left sitting on a shelf as distribution and transportation systems face their own pandemic-created shortages. Lack of shipping containers, COVID-related shutdowns, shortages of delivery trucks and drivers, and uncertain stay-at-home orders all mean that rebuilding laboratory stockpiles during a pandemic is an unpredictable venture.

As for the supplies that make it onto a shipment, shut-down ports are causing the rerouting of ships and longer passages. This poses a particular challenge for certain supplies like temperature-sensitive reagents and enzymes: if they arrive spoiled and are unusable, that cost gets passed down to laboratories while the supply shortage remains unsolved.² If anything, this highlights the need for more home-grown supply and distribution efforts.

How Can Clinical Labs Adapt to Manage Supply Chain Disruptions?

Although many clinical laboratories effectively shifted their focus in response to the new global health emergency while maintaining operations, at the beginning of the COVID-19 pandemic, laboratories had very few moments in which to plan and strategize a thoughtful pandemic response. With the growing demand to produce COVID-19 tests, the strain on both laboratory supplies and staff intensified.

More than a year into the pandemic, several strategies may help labs prepare for a shortage of supplies, aid in reducing operational chaos, and improve employee morale.

Establish Pandemic Par Inventory Levels

One thing is clear, a “just-in-time” approach to supply management does not work amidst a global pandemic. What labs should do right now is start keeping track of the items that have been used in unanticipated abundance during the COVID-19 pandemic in order to begin building a better stockpile.² Tracking daily fluctuations in test volume provides the data to establish pandemic par levels for items like reagents, testing kits, and collection supplies; some labs have found success by maintaining four weeks’ worth of supplies to compensate for supply chain disruptions.⁴

Diversify Vendor Relationships and Establish Redundancy

Akin to stockpiling, lab managers need to start diversifying their established vendors. In fact, clinical labs should consider training staff to assist in sourcing critical supplies by placing small orders across several vendors and validating the products as they come in.⁴ This will offset future vendor disruptions and help build important supplier redundancies—this provides multiple options for different types of testing and facilitates a competitive marketplace.⁴

Work with a Logistics Specialist

A logistics specialist can help laboratory staff recognize alternate suppliers and emergency backup sources. Perhaps this means bartering with nearby institutions or approaching local manufacturers who have expanded their stock during the pandemic or added capacity to scale-up production of certain products.² A logistics specialist can also introduce lab management procedures such as semiannual quality events to perform comparison testing of critical lab supplies and document compliance.⁴

Modify Established Research Methods for Testing Purposes

Certain clinical methods used in research can be adapted as a laboratory-developed test (LDT). For example, a commercial interleukin-6 (IL-6) assay typically used for research on inflammatory conditions was modified and validated as an LDT to detect the viral cytokine storm associated with COVID-19.⁵ This effort requires clinical evaluation to establish a method’s utility, and a lab can enlist pathology residents to undertake a chart review of patients who have been tested using the method of interest.⁴

Outsource Nonessential Testing

When clinical laboratories started prioritizing COVID-19 testing in the wake of the global pandemic, they often pulled back on testing other infectious diseases. A laboratory that wishes to maintain pre-pandemic services may consider outsourcing nonessential tests. To do this, lab managers should first confirm that available reference labs are still accepting specimens for testing and should update test codes to reflect changes in the lab information system and patient’s health records.⁴ These changes should be communicated to providers along with an expectation of longer turnaround times.

Why Do Clinical Labs Need to Have Pandemic Response Plans?

Considering the role of clinical laboratories in responding to the COVID-19 pandemic, it is now more important than ever that these labs prepare a plan for supply emergencies in future health threats.

This includes considering staffing levels and interactions in preparedness planning and allowing for scheduling flexibility as well as additional training and competency assessment. In addition, planning should secure logistical details when it comes time to implement the backup solution, including the maintenance of reagent and consumable supply inventories for both primary and backup platforms.

Emergency preparedness requires continuous auditing and revision, but the primary goal of a pandemic response plan for clinical laboratories should ultimately allow for continuity and validation of the existence of backup methods.

References

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Marion Karl, MS

Marion Karl is a medical illustrator, writer, and content designer for the biomedical and health industries. Marion and her husband own a boutique animation studio, Lure Animations, specializing in the production of medical content. Marion received an MS in Biomedical Visualization from the University of Illinois at Chicago and an MFA in Fiber and Material Studies from the School of the Art Institute of Chicago. She completed her undergraduate education at Cornell University.

Marion was recently published as a contributor and associated editor on the Wiley project A Guide to the Scientific Career: Virtues, Communications, Research, and Academic Writing.