Attention to preanalytics is essential as medical laboratories plan for a potential second wave of COVID-19 infections, according to lab expert.
When establishing a COVID-19 testing program, it is essential for clinical laboratories to give close attention to the preanalytic stage of the testing process, because most errors and issues that affect the quality and accuracy of a lab test occur before the specimen gets to the bench. This is particularly true of SARS-CoV-2 testing, since much remains unknown about this novel coronavirus.
To better understand what preanalytical issues have been unique to SARS-CoV-2 testing and how clinical laboratories are approaching these issues, the COVID-19 STAT Intelligence Briefings Service spoke with Nora Hess, MBA, MT(ASCP), Senior Consultant at Accumen Inc. Hess has 20 years of experience as a healthcare administrator, with particular expertise in strategic planning, process redesign, compliance, quality management, and cost reduction.
Hess defined the scope of what preanalytics involves. “The whole concept of preanalytics is everything before you actually test. This involves the strategy for testing, how you’re going to collect these specimens, and where you’re going to collect these specimens,” Hess explained.
For the COVID-19 STAT Intelligence Briefings Service, Nora Hess, MBA, MT(ASCP), Senior Consultant at Accumen Inc., explained preanalytic issues with SARS-CoV-2 (COVID-19) diagnostic testing. Hess, pictured at Lab Quality Confab 2019, is often a featured expert on issues such as clinical laboratory quality management and compliance. (Photo copyright: The Dark Intelligence Group)
From the start of the COVID-19 pandemic, the most significant preanalytic problem, according to Hess, is the availability of testing reagents and supplies, and how those issues shape testing strategies. “How does your lab make sure it has enough materials?” questioned Hess. “This has been one of the biggest issues. The shortfall of swabs, viral transport media, of tubes, PPE … availability of the supplies required for the preanalytical processes has been problematic.
Multiple Clinical Lab Testing Options Support Quality Management
One potential method of compensating for the shortages of testing supplies is to have multiple testing options available. “I have a client that has seven different methodologies for molecular COVID-19 testing,” Hess told COVID-19 STAT. “Daily, this lab evaluates the reagent supplies for each method so as to determine which instrument platform will be used to perform the testing. The tests may be performed on one piece of equipment today and on another one tomorrow.”
While the availability of reagents and supplies has been an important preanalytical factor, another important issue for clinical laboratories has been a lack of testing strategies, including who is to be tested and when.
“The strategy includes answering several questions,” noted Hess. “First, who will be tested? When, and under what circumstances? Secondly, how will the COVID-19 test be performed? Thirdly, what does the supply chain for SARS-CoV-2 testing need to be in order to meet those needs.
“We hear all the time that we’re battling this virus and there is a recognized concept, called the ‘fog of war’ which describes how—in the middle of a battle—combatants cannot see what’s going on,” continued Hess. “The early months of this pandemic were certainly foggy. I think the fog is starting to clear for most clinical laboratory professionals now. We are starting to see what our labs need to do in order to be better prepared for a potential second wave of COVID-19 infections in the fall.”
Preparing for a Second Wave of COVID-19
Hess explained to COVID-19 STAT that preparation for a second wave of SARS-CoV-2 infections needs to be a priority for forward-planning clinical laboratories and pathology groups. “It would be prudent for clinical labs to think about and prepare for a second wave,” advised Hess. “It is a respiratory virus—like influenza—and the odds are great that it could reappear sometime in the next year, until there is an effective vaccine.”
Discussing a potential second wave of COVID-19, Hess does not think supply chain issues for SARS-CoV-2 testing will feature as prominently. Supply chain experts anticipate that the reagent situation is going to resolve itself over the next few months as the in vitro diagnostics (IVD) manufacturers catch up, Hess said. “It is in the vendors’ best interest to have the reagents ready to go. So, we anticipate that by the fall most reagent supplies for COVID-19 testing will be available.”
To plan ahead, Hess told COVID-19 STAT: “We still see some clinical laboratories that don’t do the diagnostic testing themselves, but send their COVID-19 specimens to reference labs. While using another lab for testing is certainly a valid option, turnaround time requirements for results may be a reason to support patient testing that happens nearer to patient-care settings. The FDA continues to provide EUA (Emergency Use Authorization) to vendors which provide multiple options for local testing.”
Hess went on to explain that clinical laboratories, especially smaller facilities, may not be performing COVID-19 testing today. Their future plans can include in-house COVID-19 testing, supported by a backup plan should their locale experience a spike in cases of the novel coronavirus. “Having a backup plan is important,” noted Hess. “Knowing this plan—and speaking with the people at the facility that you plan to use as your backup so that they know that you’re planning to use them as your backup—is important. For a standalone hospital that is not part of a hospital system or network, it’s doubly important to have a backup plan should the demand for COVID-19 testing rapidly increase in the community.”
At the moment, most clinical laboratories in the United States would agree that the two biggest challenges in preanalytical issues specific to COVID-19 would be, first, the decision on how COVID-19 testing is to be done. The second big challenge is how to obtain the reagents and supplies necessary to perform SARS-CoV-2 testing using the methods and instruments chosen by the lab team. Next, it would be timely to plan now for a second wave and have backup plans for COVID-19, should demand for testing continue to increase.
—By Caleb Williams, Editor, COVID-19 STAT