Rising to the Challenge: Shortages in Laboratory Medicine

Abstract

At the beginning of the SARS-CoV-2 pandemic, one immediate impact on everyone’s day-to-day lives was the sudden shortage of essential consumable goods, such as soap, hand sanitizer, toilet paper, and shelf-stable foods. As regions implemented lockdowns, workplaces reduced staff density to maintain social distancing, countries employed travel restrictions, and the production and shipping of goods decreased. This caused mass shortages in the workforce, which were further compounded by existing staff becoming sick and the older workforce choosing to retire early. Healthcare, where ubiquitous disposable items provide safety and consistency to nearly every task, was not immune to this phenomenon. Healthcare providers suffered shortages of critical items such as gloves, masks, collection kits/containers, pipette tips, reagent packs, and disinfectants at variable time intervals as successive waves of the pandemic rolled across the globe. In our globalized economy, the pandemic cast a spotlight on the highly interdependent networks that had previously provided a steady stream of products calibrated to meet customer demand. Previous aggressive supply-chain optimization had yielded substantial savings. The downside, however, was a brittle supply chain that was unable to accommodate such disruptions. As laboratory staff faced the risks of working in-person to provide essential test results, their value in medicine was acutely appreciated. Nonetheless, the pandemic brought major labor shortages across all sectors. Even before the pandemic, medical technologists were in high demand, which has only intensified in the intervening years. Small clinics, large healthcare systems, distributors, and manufacturers alike were impacted by shortages, and all have tested various mitigation strategies. Addressing these challenges has required extensive collaboration, cooperation, and coordination among administrators, supply-chain professionals, distributors, manufacturers, laboratory staff, and directors. The ripple effects of these shortages continue to be felt by the healthcare industry and have necessitated changes in how business is conducted. Our approach to these challenges as individuals and as a community will undoubtedly impact the success of laboratory medicine for years to come. Here, several invited experts from around the world and across various industries share their experiences with labor and supply shortages to shed light on how the field can move forward in this new reality. Paul J. Jannetto: My primary clinical responsibilities are serving as the codirector of the Clinical Mass Spectrometry Laboratory, Clinical and Forensic Toxicology Laboratory, and the Metals Laboratory at the Mayo Clinic. On January 1, 2020, I started as the vice chair of Supply Chain Management for the Department of Laboratory Medicine and Pathology. I work with an elite purchasing and supply-chain management group that is highly engaged and committed to securing supplies so that Mayo Clinic can provide uninterrupted laboratory testing for our patients. From a supply-chain standpoint, the initial challenge at the beginning of the pandemic was the limited number of COVID-19 diagnostic tests that Mayo Clinic was able to perform due to the reagent allocations from all the vendors. Timely molecular testing, identification, and isolation of patients with SARS-CoV-2 were key to minimizing the spread of the pandemic. As a result, Mayo Clinic validated 10 different molecular SARS-CoV-2 assays including a laboratory-developed test/Emergency Use Authorization for implementation across the enterprise since manufacturers could not meet the worldwide demand and provide us with the necessary quantity of reagents equivalent to instrument capacity and patient need. The supply chain issues spread into COVID-19 collection supplies (nasopharyngeal swabs and viral transport media) until universal transport media/phosphate buffered saline options offered some relief. Other critical supply shortages included plastic commodities such as pipette tips, microcentrifuge tubes, 96-well sample plates, transport tubes, and caps. Even today, blood-collection tubes remain an ongoing concern. Laboratory staffing, specifically for the large volume of SARS-CoV-2 molecular testing, was also a concern. Fortunately, the laboratory and most healthcare initially experienced a large decrease in overall patient testing volumes due to cancelled medical/surgical procedures and wellness visits. As a result, we were able to initially float technologists and laboratory assistants from other areas to support the increased molecular microbiology testing. However, once pre-COVID-19 testing volumes resumed along with increased exposed staff who needed to quarantine, we had to identify other strategies and sources to fill our labor shortages and maintain clinical testing and appropriate turn-around times. Joe M. El-Khoury: I am an associate professor of laboratory medicine at Yale School of Medicine and a director of the Clinical Chemistry Laboratory at Yale-New Haven Hospital. I oversee the automated chemistry and specialized chemistry laboratories where we have approximately 35 medical laboratory scientists running over 9 million tests per year on over 160 assays. In the beginning of 2020 and the early days of the pandemic, our total testing volume dropped markedly because people were afraid to show up for their check-ups or go to the hospital. However, that changed in 3 notable ways as cases in Connecticut shot up: (a) inpatient volume substantially increased as COVID patient numbers increased, (b) staffing became a major issue when our scientists became sick and quarantined at home, and (c) reagent shortages became a problem because of unusually high demand and the workforce shortages experienced by our industry partners that affected their ability to produce. This reduced the availability of certain pipette tips, assay reagents, blood-collection devices, and remains a threat today. We also noticed an increase in sample hemolysis rates, so these blood-collection device shortages were impacting sample collection quality. Staffing became a bigger issue as the pandemic raged on because clinical laboratories could not compete with the work-from-home model adopted by other industries to cope with COVID. So, we became a less attractive employer and, in less than 3 months, I almost lost my entire leadership team when the manager, 2 assistant managers, and 2 coordinators took other jobs with work-from-home flexibilities. Barnali Das: I am the lead consultant, heading the Biochemistry, Immunology and Toxicology sections of Laboratory Medicine in Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute in Mumbai, India. I am also a Quality Improvement Champion for laboratory and hospital accreditations and a member of the Institutional Ethics Committee. In addition to serving on several national and international professional committees, I worked as a member of the Integrated Global Healthcare Mission COVID task force. India is one of the most populous countries and dealt with mass casualties due to the COVID pandemic in a unique and holistic way. During the pandemic, we faced disruptions in the supply chain and felt the brunt of the broken system. Every time, a new set of challenges surfaced in different waves and varied in different sectors. India is diverse in terms of ethnicity, habits, cultures, practices, location, healthcare needs, resource availability, and budget allocation. We faced unrealistic demands for low-end items and price hikes for commodities like gowns, masks, and gloves. For high-end laboratory items, we faced reagent shortages, interrupted services, and supply reductions. During the lockdowns of the first and second waves, the workforce shortages became a major issue. We faced several roadblocks in supply-chain management. The 4 main pain areas were: (a) cost rationalization (price capping) without accounting for cost burden, (b) simplification, (c) service levels, and (d) working capital optimization. Workflow simplification in supply chain was a challenge. During the pandemic, with demand uncertainty, many matrices like fill rate, service level, turnaround time, and safety stock were compromised, and we needed to deal with these factors. William E. Winter: I serve as a staff clinical chemist for the University of Florida Health (UFH) Shands Teaching Hospital. In this role, I interpret hemoglobin, serum, and urine protein electrophoreses. I also lead special projects. Additionally, I am the medical director for phlebotomy and point-of-care testing. Our first challenge in early 2020 (even before the pandemic) was the unexpected removal from the market of point-of-care test cartridges that provide arterial blood gas measurements. In response, we began to consider the purchase of other platforms. Once the pandemic arrived and up to 25% of our hospital beds were filled with COVID-19 patients, the urgency of replacing point-of-care arose. Our blood gas instruments were overridden by other concerns. By the summer of 2020, labor shortages in our core laboratory became acute and serum and urine protein electrophoresis could no longer be supported. Subsequently, these tests were sent out to a reference laboratory. We retained hemoglobin electrophoresis in-house since this was acutely needed to diagnose and manage hemoglobinopathies and related conditions. Labor shortages negatively impacted my research laboratory. In the spring of 2020, our UFH Pathology Laboratory became the core laboratory for 3 major NIH grants, and this required the purchase and setup of 2 new analyzers to be in operation by the summer of 2020. We also began providing more testing for islet autoantibodies while triaging samples to our UFH Core Laboratory, the UFH Shands laboratory, and a reference laboratory. To the credit of our laboratory/IT manager, David L. Pittman, and our staff, we did begin research operations on schedule. However, this required long hours without vacations or days off. The staff performed extremely well; however, sustaining such levels of activity was difficult. Felicitas Lacbawan: I am the vice president, Medical Affairs for BD Integrated Diagnostic Solutions, Specimen Management. Like every business across every industry around the world, healthcare organizations continue to feel pressure from supply-chain disruptions, resulting in limited availability of and access to raw materials, shipping and transportation delays, and labor shortages. Compounding supply-chain disruptions, we have seen an increased demand worldwide for our specimen-collection products. Specifically, the demand for blood-collection tubes has increased, driven by multiple variables, including tubes supporting COVID-19 patient testing and clinical trials for vaccines and the inability of other specimen-collection device manufacturers to supply the amount of product they have in the past. The reality is this is not a short-term problem. We will continue to feel the effects of the pandemic-related supply challenges. But blood-collection tube waste and inefficiencies have been a major pain for laboratories long before the COVID-19 pandemic. Patient-centered care initiatives over the last decade have highlighted the need for fewer sticks, lower volume samples, fewer recollections, and less tube wastage. Paul J. Jannetto: Like all healthcare organizations, Mayo Clinic is dependent on reagents and other supplies from industry partners to conduct patient testing. Our supply chain teams work with our suppliers and laboratories daily to understand inventories so we can adapt to changing inventory levels and forecast future shortages. Fortunately, we have had tremendous responses from our industry partners, and everyone throughout the supply chain is committed to making testing available. In the end, I think there are several key strategies to Mayo Clinic’s successful supply-chain management team. It begins with having a well-defined existing supply-chain structure with clearly identified roles. It incorporates the ability to activate an enterprise supply-chain management command center populated with key leadership and resources who can provide the necessary support, coordination, escalation, and communication of any ongoing issues. Equally important is the establishment of long-term relationships with your trusted vendors. They can work with you to better understand your needs and alert you to products that have high demand and/or limited availability. Open bidirectional communication is required for success. Laboratories have previously identified equivalent items for or unique supply-chain items so they have one Laboratories work with the to the and of of certain items are all in the or in one of laboratories can into when are a pandemic. As a result, there a need to identify products that are by other manufacturers in different to and successful supply-chain around product In the of COVID-19 testing, one of the shortages was for swabs required for the molecular diagnostic we at our supply Mayo Clinic’s swabs had started in clinical and had equivalent or better than Mayo Clinic’s Laboratory was supply chain by and to to shortages. of their to and and a which was validated by on and Mayo Clinic could approximately with to the labor shortages, one that was included the ability to We were able to fill some labor needs and perform on limited or testing. In some these were on as to by Joe M. El-Khoury: To our staffing shortages, our hospital leadership that we needed to changes to our structure to the more attractive and So, we our in the laboratory and new for assay and to the on existing clinical staff in these We also provided across the and how was Additionally, we that many testing who could on or were afraid of out and or for the to the hospital Our leadership to for in the to our However, these changes took time to out and so to fill our immediate needs we with an to medical laboratory scientists who worked for of time to support This is not a because these individuals are and can out the existing staff with for people who not But they fill the in the For supply in addition to to supplies from other sources or we were successful in overall demand for testing by the number of or blood a could on an inpatient to one per up to 3 days to every hours for For sample and is important to that the effects of hemolysis are from sample collection and sample So, we on we could and to the effects of hemolysis that could be For certain we implemented the of serum tubes, which we were to hemolysis caused by the tube Barnali Das: During this pandemic, laboratories and other key have to the challenge with initiatives to and inventory resource total cost of and implementation of to supply-chain to maintain the healthcare The 3 key strategies of and in the supply on demand and management to the impact of supply-chain shortages. us many of the supply chain and to the of our patients. price and demands the of pandemic us to on more than one of supply and to We became dependent on for low-end and high-end items of on and international We and supply and our management practices, such as early of inventory implementation of and of for laboratory staff, were of more in can better supply availability and shortages can be better in the to the challenges of shortages the first and second waves, the had to the of rationalization of availability, and of tests like the test for COVID in the The a of supply-chain and implemented a for value cost rationalization to the burden, the cost per test for a tests in the laboratory was more than the most healthcare providers faced the cost for some tests while and turnaround we have seen laboratories in where resources and staffing were challenges. The organizations that need a special are of Medical Research and for and of laboratories all over India were to for SARS-CoV-2 testing total of and This set a in in India. In to and of and availability of medical and laboratory William E. Winter: By the of tube shortages became so for the first time, all UFH Shands staff were to or laboratory testing. My and I were so shortages we a clinical to appropriate specifically strategies for tube while appropriate clinical In the research laboratory, some supplies had to be from or international UFH Shands purchasing worked the to supplies from at than to our of this work was out without the of the clinical were more to however, can be that shortages have been long before the pandemic. Our purchasing group worked with suppliers and UFH Shands a to manage our The was to maintain 4 of all only days of supplies were was less than days of supplies were were out to for supplies and as as For we that be for blood from of a tube to a Felicitas Lacbawan: We continue to with the and other to the impact of raw shortages, and raw with raw suppliers to BD and the industry are and working with transportation providers and to move product to shipping and transportation We took to the impact of shortages by and raw the production of lower volume products where were running existing production and new production Paul J. Jannetto: In pandemic is key to remain and to options and not and one needs laboratory, and support to with supply chain to identify a beginning a new is important to the resources required and of to the since there are more than time and people to be to the and of supplies from or been before for samples to the product to purchasing supporting and and products not meet the of the laboratory or the Joe M. El-Khoury: is not an to in a large medical communication from our clinical was important to the out was and the changes we were I not for only on communication to are to or changes to the hospital that their options is we all need to be Barnali Das: The of changes for and test cost by the was a in my to the faced some challenges of cost In my there be a where and have before William E. Winter: Clinical staff that supplies were This to tubes, and I am not a molecular I am that our molecular laboratory began to samples for COVID-19 testing when with lower of COVID-19 were was of a to of tube supply patient care be negatively In we have than This our performed However, we are can increase there is no of we in future staff new staff will remain a problem. Paul J. Jannetto: Supply Chain and the Department of Laboratory Medicine and Pathology continue to to future supply and labor shortages, including (a) of and supply to and (b) and in the and (c) new and of who have been in other testing Joe M. El-Khoury: We new for individuals who a of not have from an laboratory for Clinical This by in Connecticut is not required for testing It was hospital so we changed that because we could not people with that However, that that we needed to have a more in because these individuals need more time and to to the we need before they can begin testing patients. I am in We have had more success these individuals in our mass laboratory because is an that is more for a with fewer tests to work with and less We are also options for for some of our with other like to fill in in our and Barnali Das: The strategies for better and with suppliers in and of supply chain for inventory management across all impact clinical command center or for supply chain the resource for the patient for the and William E. Winter: we are from the pandemic. a medical at my years and I was by the laboratory that we need staff To we need to be that we can During the of the pandemic, more than one medical our to work for to laboratories at than our organizations such as the for Clinical Chemistry set as a the of that high and into laboratory testing. We need staff, from to laboratory medical and Felicitas Lacbawan: BD has more than million in the 4 with in capacity to meet the needs of We are to increase capacity for our most specimen-collection products by our and providing options for tube We feel that our in and new and will us to serve patients better in the Paul J. Jannetto: In the the field of laboratory medicine is by the for and the Clinical Laboratory Improvement which all clinical laboratories a key was the ability to Use Authorization testing and laboratory-developed these and laboratories could not have the testing of patients in the and the of for various laboratory which who is to perform various of laboratory testing. can be to have an and for key laboratory to provide a limited of Joe M. El-Khoury: the unexpected demand for labor and supplies that the pandemic has we better manage the resources we have and Our industry partners can be better to by how many supplies they provide to a and consistency with with a is for toilet paper, medical supplies have so a laboratory up resources that need. Even for the there be a to you have to you that will your with your existing who will out who can supply with the products they need to To labor shortages, a be needed to the for certain for certain in some this was not a problem for us in in some that a laboratory could not we We have and that we are required to perform for every testing so in of we need to other to us to and more Barnali Das: The of of the be a The this national with care with and management were for of resources in I and However, a of care was not in and faced across the are in demand and and inventory management. To deal with future shortages, we better for future supply-chain and of the The and the healthcare and diagnostic industry have and to production and To major disruptions of the in diagnostic industry supply the healthcare supply chain and The of the supply chain us to and large and laboratories adopted like management systems, of and and in They have their supply for better and William E. Winter: We that changes in tubes or have been Our staff with us and as patient care of any other worked the I am by their and a for a the is not over will be with us for the they have to the of this and have the 4 (a) to the and of or and of (b) or the for (c) of the and (d) to be for all of the that related to the or of any of the are and all the and/or of Clinical Chemistry and of on the of for The of in the and from NIH to the University of support for and/or travel from support for

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