Lab design techniques to accelerate COVID-19 test processing
Testing is a crucial component of our global response to COVID-19 and producing enough tests processing the results quickly to the public is a challenge we currently face.
Testing is a crucial component of our global response to COVID-19. The more people we can test for the virus, the better we can understand the threat we’re up against. Producing enough tests and making them available to the public is just one half of this challenge. Processing the results quickly is the other.
Before this pandemic, for example, a testing lab might process close to 5,000 samples a day; now that lab could be called on to process nearly 100,000. To cope with this significant increase and the vital need for urgency, we need to think out of the box to increase lab throughput while utilizing the current facility square footage and the same number of employees.
Even with those constraints in place, there are plenty of variables that can be adjusted and strategies that can be implemented to get more capacity out of an existing lab. Automation, optimization, and flexibility are three approaches that can help labs process tests faster, while also operating more safely.
Three ways ways to increase existing lab processing throughput
Before we dive into the aspects inside the lab that impact processing speed, it’s important to acknowledge that there are factors outside the lab at play, too. First, during the testing process, providers typically handwrite the test subject’s name and the date on the vial. This system can create a backlog when the samples are received at the testing center. Once the samples arrive via overnight shipping, it takes time to unpackage, sort, and validate the samples before the information is entered into the computer or tracking system. And that manual entry process can be slow and tedious. Additionally, labs that were only receiving a few thousand samples at a time might be overwhelmed receiving and storing hundreds of thousands of samples. These challenges can also be addressed with automation, optimization, and flexibility.
For many years, the clinical and wellness sample testing world has been moving toward automation. Companies like Abbott are using a track system, which connects all the testing machines into a single unit. As a result, samples run down these automated lines, and tests are processed based on a bar code system as needed. We even see robots deliver samples at the beginning of the line and collect these same samples for automated cold storage after testing.
The molecular testing world has not moved toward automation as quickly. Molecular testing—like the real-time polymerase chain reaction (RT-PCR) test that detects COVID-19—requires specialized equipment to automate and process. This complicated equipment can take months to build in normal times, but possibly longer with a reduced workforce.
However, these obstacles do not rule out automation as a solution. In fact, introducing a small amount of automation can still make a big difference.
- Low level of robotic animation: There’s probably a low level of automation already in every lab. This might be a small piece of equipment that automates one part of the process, like a repetitive task, such as extracting DNA from samples. Implementing one low-level piece of automation in a lab can free up the scientists significantly, allowing them to more effectively use their time and increase productivity. Another place to consider adding low-level automation is the data entry process. Digitizing the system for recording patient and sample information would free up time and personnel, and it would ensure more accurate records.
- Medium level of robotic automation: A medium amount of automation typically puts a couple of processes into a contained box. So there are still manual functions in the lab, but a few repetitious tasks can be eliminated by bringing in an equipment system that addresses part of the process. This medium example takes our coffee machine turns it into a room that could be 11’x20’ in size (call it a Starbucks if you want). All the equipment associated with both pre and post PCR work can be placed on a racking system with a sliding collaborative robot arm.
- High level of robotic animation: While a high-level of automation or a fully automated process might not be the most expedient or feasible solution in the current situation, it’s worth mentioning for the future. In this instance, robotic automation would conduct the entirety of test processing, even moving samples in and out. While the equipment to make this happen could be hard to come by now, it may be worth the investment to better prepare your lab for future uncertainty and fluctuations. This can create a great opportunity to have a sustainable lab with a greater reduction in air change rates.
In the same way that automation eliminates certain tasks to free up the scientists, lab optimization is about finding opportunities to make little changes that unlock outsized potential. An optimization effort analyzes your lab operations, your layout and your equipment to determine where adjustments can be made to improve efficiency.
Working with a consultant here can be particularly helpful to get an outside perspective on your set up. Typically, the process looks like this:
- Define objectives/metrics – Define objectives and determine metrics based on the objectives. The objective is to increase the throughput of test processing so the metrics would be how long it takes to process one test; how many tests are processed in an hour, a day, etc.; and even how long each component of the process takes.
- Data collection – Collect data (surveys, interviews, observations) to support the metrics. Observe each part of the process, recording time, and observations about how the process is done.
- Data analysis – From the collected data the deep-dive analysis of the wants vs. needs of the users can be determined. Lab users need to do certain steps in a certain order, and they’re constrained by the space layout and equipment availability—how can the process go faster or be more efficient without negatively impacting the users?
- Improvement opportunity identification –Identify aspects for the lab design to meet the design objectives and improve operations. Maybe it’s a matter of moving some equipment to create a more logical flow path for your personnel, or maybe the solution is introducing low-level automation to eliminate unnecessary personnel movement.
- Prioritization and Opportunity Selection – Determine cost and schedule estimates to prioritize the opportunities based on operational impact vs. implementation. Compare the cost and time it will take to implement each solution against the benefit it provides to determine which solution(s) should be prioritized.
In the case of modifying your lab to increase COVID-19 test processing, it may be a matter of adjusting your personnel travel paths or bench utilization to make your lab more efficient.
The design of labs must be flexible under normal circumstances, but even more so now as testing efforts continue to ramp up and the future is unclear. For example, as we work to improve the testing process, we also need to look at the new antibody tests. Should a vaccine become available in the future, there may be other variations of testing that we will need to consider. You can make plans now to ensure your lab will continue to function optimally.
Typically, molecular testing equipment requires power, data, and compressed air. Distributing these utilities overhead with quick disconnects allows for the equipment to be reconfigured or even replaced in the future. Floor drains are usually required, and placement is critical to keep the labs safe by avoiding waste lines on the floor. The workflow should be logically organized to reduce the number of steps that employees take, as the task of processing such a large number of samples can be compounded by inefficient workflows. Lab optimization will help improve flexibility.
Regulations will be driven by Clinical Laboratory Improvement Amendments (CLIA) and BSL-2 (Biosafety Level) which is defined in the BMBL (Biosafety in Microbiological and Biomedical Laboratories 5th Edition). It is important to note that these facilities must follow the minimum BSL-2 requirements. Standard requirements include a handwashing sink, proper finishes for decontamination, doors with locks, an emergency eyewash station, and outside air supply without recirculation, to name a few.
There are a few other simple things that you can do to ensure lab efficiency. For example, make sure that all the materials used by the testing facility are available on site. If items such as masks and other personal protective equipment (PPE) for the employees are in short supply, it can slow down the testing process.
Unlike the office workplace, labs are pre-designed to adapt to the new norm with PPE and social distancing. Many labs use 6’-0” wide tables. Aisles may need to become one-way thoroughfares similar to those in a grocery store. We can learn in these times, and hopefully, we can improve our lab spaces to prepare for any future events we may encounter.
As we learn more about COVID-19, we need to be prepared to adapt our design techniques, including how we as people interact within the laboratory space. The laboratory design world is changing, and we should consider how automation and robotics can help us keep up with the pace. We can also make simple adjustments now to optimize lab operations, and we can plan in flexibility to respond to future unknowns.