As clinical laboratories are pressed to increase testing capacity for SARS-CoV-2, one key question looms. How do we secure the equipment and supplies needed to meet testing demands during this global pandemic? Clinical laboratories have spent the past eight months on what seems like an incessant roller coaster ride in the fight against SARS-CoV-2, the virus that causes COVID-19. An inefficient and fragmented supply chain has made it impossible for many laboratories to successfully navigate the demand for testing, with turn-around times ranging from a few hours to weeks. Delays in testing weakens efforts to stop the spread of SARS-CoV-2 by hindering the ability to effectively and efficiently conduct contact tracing, while the inability to obtain needed supplies has exposed a general lack of guidance and funding from federal, state and local government.
Laboratories have become more strategic in the wake of SARS-CoV-2 as supply chain issues have forced some laboratories to make tough decisions and utilize lean or six-sigma processes.1 Unable to perform all testing in-house, some laboratories have been forced to prioritize testing to ensure providers and public health agencies receive prompt results for high-risk patients. Often times this means that outpatient and public SARS-CoV-2 testing is sent to reference laboratories with turnaround times that can exceed seven days due to the avalanche of tests being received.2 Laboratories making the decision to perform SARS-CoV-2 testing in-house may mean other non-SARS-CoV-2 testing be sent to reference laboratories, resulting in increased cost for the clinical laboratory and patients. Increased costs of reference laboratory testing, coupled with skyrocketing costs of equipment and instrumentation due to supply and demand, has placed a financial strain on institutions while forcing management to be more budget conscientious.2
The high demand for SARS-CoV-2 related testing supplies has made it impossible for many manufacturers to keep up with production needs. A survey of clinical laboratories in the United States (U.S.) revealed that nearly half of respondents were still struggling to secure vital supplies needed for SARS-CoV-2 testing.3 The survey further revealed that 58% of laboratories experienced problems obtaining test kits, 46% had difficulty obtaining reagents, while 38% of labs had problems securing nasal swabs.3 For laboratories struggling to secure viral transport medium, the Centers for Disease Control offers guidelines to aid laboratories in preparing their own transport medium.4 A manufacturing focus on production of SARS-CoV-2 related supplies has also left many laboratories experiencing shortages of supplies needed to perform non-SARS-CoV-2 testing.2 Blood agar, chromogenic agar plates, selective agar, and tryptic soy broth are now on the short supply list. Issues obtaining basic supplies has caused some labs to revive retired procedures to complete testing. This not only decreases efficiency, but also affects patient care and could pose a problem for the management of other infectious disease.2
The SARS-CoV-2 pandemic has created unique supply chain issues not only for clinical laboratories in the U.S., but throughout the world.1 In the spring of 2020, Medical Laboratory Observer (MLO) conducted a survey of clinical laboratories regarding the challenges created by the pandemic. Almost half of respondents, 49%, stated sourcing as the single biggest challenge.5 One of the biggest challenges to the supply chain comes from major In Vitro Diagnostic (IVD) manufacturers moving production overseas to low-cost nations. The consequences of this move left the U.S. with little to no manufacturing infrastructure and weakened U.S. manufacturer control and influence over increasing production. Additionally, many of these major IVD manufacturers have their own multi-national supply chains, sourcing parts from all over the world.6 With major IVD manufacturers having their own supply chain issues, many had to start allocating supplies to current and new customers. Current customers have been able to receive allocations based on the previous year’s volume, whereas new customers have not received allocations on a regular basis.6 Additional factors affecting supply chains are the fickleness of SARS-CoV-2, mismanagement of supply chain by federal, state, local governments, and the influx of new companies offering supplies and SARS-CoV-2 test kits. The latter has caused clinical laboratories and healthcare systems to be stuck with unusable testing supplies and/or testing kits.6
As we look to the future and examine our quest to provide quality and efficient testing to combat COVID-19, it is also important to note the opportunities brought about by this pandemic. As clinical laboratory professionals, we have learned many lessons from the pandemic. Foremost, we have learned that we must promote the clinical laboratory profession and demand a seat at the table with government to address issues including supply chain obstacles and the nationwide workforce shortage. The American Society for Clinical Laboratory Science recently partnered with other professional organizations to support the Allied Health Personnel Shortage Act, which would establish scholarships and loan repayment for those pursuing a degree allied health.7 By strengthening the clinical laboratory workforce and increasing public and government awareness regarding the complexity of laboratory testing processes and problems observed in the acquisition of equipment, reagents and supplies, we can work together to ensure equitable and quality patient care.
- Leytham, T. COVID-19 disruptions of supply chains are one more challenge for clinical laboratories to bring value to hospitals and healthcare networks. Dark Daily. May 1, 2020. Retrieved on October 13, 2020 from www.darkdaily.com.
- Hagen A. Laboratory supply shortages are impacting COVID-19 and non-COVID diagnostic testing. Oct 15, 2020. American Society for Microbiology. Retrieved on October 17, 2020 from https://asm.org/Articles/2020/September/Laboratory-Supply-Shortages-Are-Impacting-COVID-19
- American Association for Clinical Chemistry. AACC survey shows labs still face supply shortages for SARS-CoV-2 testing. Sept 1, 2020. Clinical Laboratory News. Retrieved on October 17, 2020 from https://www.aacc.org/cln/articles/2020/september/aacc-survey-shows-labs-still-face-supply-shortages-for-sars-cov-2-testing
- Centers for Disease Control. Frequently asked questions about Coronavirus (COVID-19) for laboratories. August 15, 2020. Retrieved on October 17, 2020 from https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html .
- Wilson, L. COVID-19 testing, despite supply chain issues. Medical Laboratory Observer. June 24, 2020. Retrieved October 13, 2020 from www.mlo-online.com/disease/infectious-disease/article/21142733/covid-19-testing-despite-supply-chain-issues.
- Mitchell, R. Government officials intensify broad chaos in clinical lab supply chain: Might ‘inept’ be apt description of FEMA’s supply decisions? Dark Intelligence Group. 2020;27(10). Retrieved October 13, 2020 from www.darkintelligencegroup.com
- Scott, K. Solving the clinical laboratory workforce shortage. July 6, 2020. Clinical Lab Manager. Retrieved on October 17, 2020 from https://www.clinicallabmanager.com/trends/laboratory-staffing/solving-the-clinical-laboratory-workforce-shortage-23189