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CONTINUING EDUCATION :: AUTOMATIONThe benefits of lab automationfacilitate testing for SARS-CoV-2By Jamie Gramz, BSE, MBAFear, anxiety, uncertainty, and worldwide economic disasterhave all been factors stemming from the COVID-19 pandemic. Disruption is the new normal to daily life with veryfew areas of our personal or professional lives not impacted insome way. Although measures to “flatten the curve” and reducethe number of new COVID-19 cases from one day to the nexthave helped to prevent healthcare systems from becoming overwhelmed, the pandemic has exacerbated many of the existingchallenges laboratories commonly face and also has introduceda number of new ones to overcome.Test menu expansion, fluctuations in testing volumes, consistent supply of consumables, access to personal protectiveequipment and ongoing changes in management to a new way ofworking were all new challenges to which laboratories have hadto adapt throughout the pandemic. Automation and leveragingtechnology and innovation within the lab can play a key rolein helping laboratories minimize disruption and overcome thechallenges of testing for COVID-19.Testing for a new pandemicAs of early October, the number of confirmed COVID-19 infections surpassed more than 35 million confirmed cases andaccounted for more than 1 million deaths worldwide.1 Withinthe United States, there have been more than 7,679,908 cases,and 215,039 deaths since the first domestic case of COVID-19was reported on January 21, 2020. Diagnostic testing was quicklyidentified as a critical component to battle the pandemic andmultiple initiatives were put in place to help increase the availability of testing. Some of these included accelerating technologyavailability through emergency use authorization (EUA) fromthe U.S. Food and Drug Administration (FDA), expanded testing capacities and enabling federally funded surge testing inpartnership with communities experiencing outbreaks.2The need for laboratories to expand testing services to supportviral testing for SARS-CoV-2 diagnosis was one of the earliestEarning CEUsSee test on page xx or online at www.mlo-online.comunder the CE Tests tab. Passing scores of 70 percent orhigher are eligible for 1 contact hour of P.A.C.E. credit.LEARNING OBJECTIVESUpon completion of this article, the reader will be able to:1. Describe the challenges in the lab that have been exacerbated by COVID-192. Describe the role of serology testing during the COVID-19pandemic3. Describe the challenges that automation in the lab addresses4. Discuss the key capabilities lab automation provides duringthe pre-analytical, post-analytical and data managementphases of lab testing4DECEMBER 2020 MLO-ONLINE.COMnew challenges introduced. Labs were forced to either expandtheir menu of testing services or identify an alternative processto outsource viral testing to other laboratories. Diagnostic testingwas quickly made possible and testing rates increased drastically, growing from 20,000 tests per day in April to more than1,100,000 tests per day in early October.3Testing capabilities were then further expanded with serology-based antibody testing. These tests detect the presence ofantibodies in the blood based on the body’s immune responseto the COVID-19 infection. Laboratories prepared for antibodytesting to ramp up in mass numbers, anticipating demand asresults would provide greater detail and data to help safelyreopen communities. Meanwhile, antibody testing evolved insophistication from simple qualitative positive/negative resultsto semi-quantitative numerical measurements gauging thespecific level of IgG antibodies within a patient’s blood sample.4The expansive rollout of such tests, however, was not immediately realized. The pandemic was still in its infancy and, asa result, confirmatory diagnostic tests remained in greaterdemand. While antibody testing is not deemed suitable fordiagnosis of COVID-19, studies to help determine the appropriate use of serology testing for SARS-CoV-2 are underway.Potential benefits may include helping healthcare professionalsidentify individuals with an immune response to SARS-CoV-2,as well as blood donor candidates to enable convalescent plasmatherapy for patients seriously ill from COVID-19.5Other key benefits could include enabling clinicians to assessa patient’s natural immunity acquired through viral infection,as well as helping to determine the potential effectiveness ofvaccines. To help make this possible, IVD vendors and publichealth institutions– like the Centers for Disease Control andPrevention (CDC) within the United States and the JRC (JointResearch Centre) of the European Commission – are workingtogether to establish a standardized process related to SARSCoV-2 assays that will enable clinicians to track their patients’antibody concentrations, regardless of the test method ormanufacturer used.6New crisis, same key issuesA recent health-crisis readiness survey conducted by consulting and lab optimization firm Accumen assessed the level ofpreparedness hospitals and health systems had with respectto the COVID-19 pandemic. The survey included responsesfrom 242 health system leaders with representation rangingfrom small hospitals to large integrated systems and from ruralareas to large cities across the United States.When asked to identify the key challenges hospital labs arefacing, staffing (26 percent) and turnaround time (23 percent)were identified as the top priorities, with information technology/laboratory information system resources (17 percent) andsupply chain (17 percent) also receiving high response ratesas priorities.7Staffing challenges, including employee turnover and theinability to hire qualified staff, remain long-term chronic

CONTINUING EDUCATION :: AUTOMATIONFigure 1. Lab automation for SARS-CoV-2problems facing the laboratory. The Bureau of Labor Statistics (BLS) projects a nationwide increase in the demand formedical and clinical laboratory technologists of 13 percentbetween 2016 and 2026. The Human Resources and ServiceAdministration (HSRA), within the Department of Health andHuman Services (HHS), projects a growth in demand of nearlydouble that amount, or 22 percent, between 2012 and 2025.In addition, vacancy rates remain high, averaging 7.2 percentacross the nation.8 Interject the COVID-19 situation, with thepotential to reduce availability of lab staff due to personal orhealth reasons, together with the need to expand services forSARS-CoV-2 testing, and the age-old problem of the lab needingto do more with less is compounded.Automation plays a key role in helping to address staff shortages while enabling precious resources to focus on high value,clinical tasks, and this is particularly true during the COVID-19pandemic.Turnaround time (TAT) may be king of laboratory metricswhen it comes to monitoring key performance indicators, withsome medical professionals seeing TAT as something almost asimportant as the quality of test results themselves.9 Establishingthe logistics needed to enable new testing services for COVID-19– coupled with the lead time to collect and process samples – andthe extreme surge in testing volumes has led to much attentionand consternation on the amount of time it takes for patients toreceive results from testing for COVID-19. Turnaround timesfor COVID-19 testing can vary significantly, depending on thetype of test being performed, the analyzer or device being used,and the logistics involved in ordering the tests. The processesfor collecting and receiving the sample, performing the test andreporting the results also impact turnaround times.TAT for the actual processing of tests for COVID-19 variesgreatly depending upon the type of testing being performed,and can range from as little as 10 minutes for industry-leadingserology-based antibody tests, 15 to 30 minutes for antigen-basedPOC testing, 15 to 45 minutes for POC-based molecular testingand up to 7 hours for reverse transcriptase (RT) polymerasechain reaction (PCR) testing.10 For serology-based testing, fullyautomated laboratories are better positioned to optimize TAT byeliminating the need for human intervention between phasesand leveraging the added benefits of full transparency andcontrol over where the samples are throughout the process.For many labs where information technology or LIS resourcesalready pose a challenge, the incremental impact of COVID-19adds fuel to the fire. With many labs quickly expanding menusto include additional testing for both viral- and serology-basedantibody testing, the demand for what their existing lab IT solutions can offer and the service and support needed to make ithappen come into play. The challenges can vary with some labspositioned to simply add new tests to existing testing platforms,while other labs face the need to procure, implement, interfaceand commission new analyzers and support data workflows. Andthen beyond these common scenarios, comes the incrementalchallenge for all COVID-19 diagnostic and screening test sitesto report results to the appropriate state or local public healthdepartment daily and within 24 hours of test completion.11Leveraging automation in the wake of COVID-19Adoption of laboratory automation has advanced significantlysince the first total laboratory automation solution was implemented in North America back in 1996.12 Overcoming challengeswith staffing, fluctuations in testing volumes, improving TAT,and reducing errors and costs are all proven benefits that havefueled adoption of laboratory automation. Today, even labs processing smaller volumes of samples – ranging from 1 million to3 million tests per year or as low as 500 samples per day – oftenleverage the benefits of lab automation to help address theirchallenges. (See figure 1)The good news for many labs already equipped with automation technology and innovation is the built-in capabilities andscalability they may have available to help overcome manyof the COVID-19-related challenges. This includes physicallaboratory automation systems used to automate and reducethe number of process steps and manual touchpoints and thento expedite the physical handling, sorting and distribution ofsamples. It also includes software-based lab IT solutions toautomate and optimize workflows associated with generatingpatient and Quality Control (QC) results and the visualizationMLO-ONLINE.COMDECEMBER 20205

CONTINUING EDUCATION :: AUTOMATIONand management of all the information they need. Those laboratories already leveraging the benefits of total lab automationto perform multidisciplinary testing have been well equippedto not only accommodate the need for serology-based antibodytesting but also the incremental volume of coagulation, hematology and immunochemistry testing necessary for patientsimpacted by COVID-19.When expanding lab services to include serology testing forCOVID-19, there are several key workflow considerations thatneed to be evaluated for the lab to establish an ideal workflow.Which instrument(s) will work best for antibody testing? Whatis the expected testing volume and how will it fluctuate overtime? Will other tests need to be processed on the same sampleand which ones should be processed first? Should I integratetesting onto my automation system or manage it directly on astand-alone instrument? Will testing be performed on demandor will COVID-19 samples be batch tested? Is there any specialpost-processing sorting or storage criteria?All of these questions require careful evaluation to establishthe right strategy and implement the right workflow. Ensuringthat the solution provider has the expertise, consulting capabilities and tools needed to help you design, implement andoperate the right automation solution for your laboratory is key.Figure 2. ?6DECEMBER 2020 MLO-ONLINE.COMOptimizing the pre-analytical phaseThe pre-analytical phase of testing can be resource-intensive andhighly prone to error. A study done to evaluate the frequencyand types of errors that occur in laboratory medicine providedevidence that most errors occur during the pre-analytical phaseof testing and can include anywhere from 31 percent up to 75percent of total laboratory errors.13 Some of the most commontypes of pre-analytical errors include hemolyzed samples, insufficient sample volumes, incorrect or mislabeled samples andclotted samples. For COVID-19 patients at risk of complications,and whose treatment is often dependent upon sometimes minordifferentiations across comparative test results, erroneous errorcan gravely impact timely treatment.Lab automation can lead to dramatic improvements in staffing, TAT, and error reduction. It can even reduce the risk ofstaff exposure to biohazardous materials. (See figure 2) Someof the key capabilities that lab automation provides to supportpre-analytical activities include: Flexible sample loading options, which can accommodatedifferent scenarios, with multiple entry points and for different volumes of samples, including individual sample loading,rack loading and automated bulk loading for large volumes ofsamples. The benefits include centralized loading for multiple

CONTINUING EDUCATION :: AUTOMATIONtube sizes, multiple sample types, capped and uncapped tubes,spun and unspun samples, STAT and routine samples. Thisreduces effort for laboratory staff by eliminating the need topresort and standardize samples. Priority routing, presorting and batch-testing management,which enable labs to manage how and in what sequence samplesare processed for COVID-19. Options include the ability tospecify and automate which instruments are used and whichtests get processed first, as well as the ability to presort samplesand automate batch-testing processes. Sample inspection modules, which can be used to quickly andautomatically evaluate sample integrity and identify potentialerrors due to incorrectly capped or uncapped tubes, mislabeledor unreadable samples, incorrect sample types or tube types,hemolyzed samples and samples with insufficient volume. Online centrifugation, which saves time, reduces the needfor manual handling and can reduce the risk of exposure to biohazardous materials through offline centrifugation. Additionalbenefits include automated load balancing to accommodatemultiple sample types, configurable wait times, spin cycle timesand rotation speeds, temperature setting and STAT samplepriority unloading. Decapper modules, which increase productivity and safetyof lab staff while decreasing risk of sample contamination forbetter quality results. Aliquoting and recapping, which automates sample handlingfor send-outs and special storage scenarios (long-term andfrozen) while reducing exposure to biohazardous materials.Streamlining the post-analytical phaseThe same study showed that errors occurring during the postanalytical phase of testing also have a significant impact andcontributed to anywhere from 9 percent up to 30.8 percent oftotal laboratory errors.13 Similar to the pre-analytical phase,lab automation offers a number of specific capabilities thatcan help address challenges within the post-analytical phaseof testing including: Post-processing sorting and output modules, which enablequick operator access to “problem” samples and sorted tubes andprovides temporary storage leading to fast, automated sampleretrieval and analyzer delivery for reflex testing, repeat testing,add-on tests, and other custom scenarios that may require sending samples to output racks or sorting lanes. These capabilitiesmay be especially beneficial for labs processing multiple testson SARS-CoV-2 samples where add-on and reflex testing maybe necessary. Refrigerated storage and de-sealing, which enables all of thebenefits of automated sample retrieval and routing for reflexand repeat testing for temperature-controlled samples stored forlonger periods of time. In addition, automated sample disposalbased on test-life viability enables samples to be automaticallydiscarded while reducing the risk of exposure to biohazardousmaterials.The need for diagnostic softwareThe ability to visualize key information and understand howthe lab is performing is critical. Identifying where attention isneeded and enabling lab staff to quickly take the appropriateaction to resolve issues is key for any laboratory. To accommodate this need, many labs leverage middleware to complementand supplement the capabilities of their laboratory information system. These often include solutions for advanced datamanagement, process management, inventory managementand analytics that include tight integration with the analyzersand lab automation systems and play a key role in simplifyingoperations and accommodating the specific workflow needsof the lab. Specific functions include: Advanced data management, which enables the lab to standardize operations for patient and QC result management whilemaximizing staff efficiency, reducing errors, improving TATand simplifying the management of daily QC. It includes keycapabilities like dashboard visualization of testing status withalerting capabilities to create awareness and drive action. Itenables the efficient review of patient results through reviewby exception, ensuring lab staff focus on the results that needattention and skip the ones that do not. It enables the efficient, real-time monitoring of quality control with the abilityto quickly identify, troubleshoot and resolve problems. And itoften includes clinical decision support capabilities central tothe needs of the laboratory like panic value monitoring andalgorithms to support specific testing protocols. Process management, which provides centralized oversightand control of the analyzers and automation systems used withinthe lab and across multiple sites. It enables real-time monitoring and alerting of system issues and on-board consumableinventory status, enabling labs to maximize system uptime andminimize unplanned downtime. It also enables remote viewand control of the analyzers and helps avoid the need for staffto walk around the laboratory to physically inspect each system. Analytics, which play a crucial role in empowering laboratories to assess performance, identify inefficiencies and determinethe root cause of problems. It enables the lab to quickly andeasily benchmark performance and drive continuous improvement with the ability to monitor common KPIs through use ofreports for TAT, TAT exceptions, throughput, reagent efficiency,automation utilization, auto-validation rates, hemolysis, problemsamples and other key metrics important to the laboratory. Inventory management, which helps labs reduce cost andimprove efficiency by automating many of the manual stepsinvolved with ordering, receiving, utilization and reordering ofconsumable materials needed to operate their lab.On the IT side, there are additional needs from an information management perspective when expanding lab services toinclude serology testing for COVID-19. Labs need to be able toquickly identify how many and which samples are ready forSARS-CoV-2 testing. Which samples resulted for SARS-CoV-2need review? How many and which samples were tested forSARS-CoV-2? How many and which samples were positive forSARS-CoV-2? All of these can be efficiently managed throughthe advanced capabilities of diagnostic software.ConclusionThe impact of the COVID-19 pandemic exacerbated many of theexisting challenges labs face with staffing shortages, improvingTAT and reducing diagnostic testing errors. The need to onceagain do more with less within the laboratory is felt worldwideand the trend will continue based on the future availability oflab resources, the need to reduce costs, the aging populationand the increasing need for laboratory testing. Automationplays a key role in helping laboratories maximize efficiency,simplify operations and establish a scalable and sustainableapproach to minimize disruption to the services they provideand patients they serve.The demand for serology-based