The COVID-19 outbreak has forced rapid adaptation across the entire health care industry, with life sciences companies around the world adjusting their own operational and business processes – and working with their partners to do the same – to quickly help address the pandemic. While makers of facemasks, respirators and other personal protection equipment (PPE) have ramped up production, other companies have also stepped in to help protect health care personnel in the time of COVID-19.
Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic.
Based in Salt Lake City, Utah, Nelson Labs is a MasterControl customer heavily involved in testing the efficacy of facemasks and respirators. With 13 global lab sites, the company performs more than 700 rigorous lab tests across the medical device, pharmaceutical and tissue industries.
Since the novel coronavirus outbreak, the company has seen a 1,200% increase in the number of tests and a 2,700% increase in the number of samples, with each test having a number of samples. The company had to act fast but deliberately.
“We quickly moved people to where the demand is: protective barriers,” Jeffrey R. Nelson, president of Nelson Labs, said in a recent interview with MasterControl.
By adapting processes and getting the training right to address the outbreak, the company was able to achieve 24/7 coverage while maintaining quality.
A harmonized quality management solution has been essential for Nelson Labs and its global customers, establishing consistent processes, procedures and metrics throughout operations and across locations.
“Every day we recognize the importance of consistent procedures that increase efficiency at each location and forms that ensure we are collecting the right information. MasterControl has been our go-to solution to encourage that,” Nelson (shown in photo above) said.
By helping manufacturers validate products and reprocess those products, Nelson Labs is helping ensure there are solutions to COVID-19 and other complex health care problems.
“I’m really so proud of our team for digging in and adjusting to help manufacturers validate the solutions to safeguard global health,” Nelson said.
Nelson Labs has faced numerous obstacles in recent months, and across all the challenges, adaptability and communication have been crucial.
As with many organizations, supply chain disruption caused by COVID-19 has demanded adaptability for Nelson Labs and its partners.
“Supply shortages have required our quality team to work with the production shortages and manage the changes properly,” according to Nelson. “For example, quality leaders and operational leaders have been working together and communicating often, putting in pre-approved deviations so we can adjust to supplies.”
Due to the company’s critical role in getting life sciences manufacturers’ products to market, and the lifesaving nature of supporting the health care supply flow, Nelson Labs has taken steps to ensure ongoing communication with customers, to keep them informed about changes and validating any new supply to maintain the volume of testing operations.
“We continue to coordinate closely with our suppliers to ensure we can maintain the continuity of our supply to sustain testing,” Nelson said. “The last thing we want is to have any of our tests affected by supply shortages or delays.”
Being firmly entrenched in several regulations, Nelson Labs has also faced regulatory challenges unique to the pandemic.
“Obviously, this has been a dynamic, fast-moving environment,” Nelson said before praising the U.S. Food and Drug Administration (FDA) for its responsiveness. “On the regulatory side, the FDA has adapted to the situation where we all have to move faster.”
Things tend to move slowly in the life sciences industry, but the FDA has been issuing Emergency Use Authorizations (EUAs) for COVID-19 diagnostic tests and devices, including all PPE such as masks and respirators, in an effort to reduce the red tape. The EUA program authorizes the temporary use of unapproved products, or unapproved uses of products, that fulfill urgent medical needs during public health emergencies, such as the COVID-19 pandemic.
The expectations of Nelson Labs’ customers are also changing daily, not just in the U.S., but also in China, Europe and elsewhere, according to Nelson.
“Everyone is trying to address the situation and establish new expectations in this new environment. We have to learn quickly and stay updated on the regulatory changes and expectations, including federal, state and local municipality expectations,” he said. “I’m really proud of our team’s ability to adapt in this dynamic environment.”
Social distancing and employee safety measures have put an additional level of pressure on life sciences organizations in recent months. Nelson Labs, a Sotera Health company, has about 1,000 global employees, including more than 450 scientists and more than 75 registered and specialist microbiologists. The company has taken definitive steps to ensure the necessary staff at its facilities can continue testing customers’ products in a safe work environment.
“To help keep our people safe while meeting the greater, more urgent demand, we were proactive [early on] to increase disinfection, social distancing and communication with employees,” Nelson said.
Each laboratory location has employed a rotating shift schedule with divided teams to minimize the risk of an infection disrupting an entire service line. Where possible, non-laboratory staff began working from home to increase social distancing and again reduce the potential for infection. Key onsite personnel remained onsite, with additional preventive steps to allow them to continue doing their important work for our front-line workers.
“We are fanatical about disinfecting, and about communicating preventative measures daily to our global team,” according to the company’s president.
Staying closely connected as a company through constant communication has been crucial. Daily updates with staff keep them abreast not only of changing regulatory expectations and how they affect customers, but also about preventive measures and overall health and safety practices during the pandemic.
“We treat onsite staff as essential and have actively engaged them without major infection or outbreak,” Nelson said. “A lot of credit goes to our safety and HR teams for how well we’ve communicated in this situation, which has allowed us to continue testing in a safe work environment.”
The COVID-19 pandemic has underscored the importance of adaptability and ongoing communication in the life sciences, especially during turbulent times, according to Nelson. Moving forward, he expects life sciences organizations to be thinking a lot about how manufacturing is done, about supply in health care and safety stock like PPE, and about how to ensure a robust domestic supply.
“We have to be ready to move fast, adapt quickly and do the things our team needs, our customers need and the world needs,” Nelson said. “I’m confident we will overcome this situation and am hopeful that the life sciences – the medical industry, in particular – will create the solutions we need to continue to safeguard global health.”
A version of this article was originally published on MasterControl Insider, a blog for MasterControl customers.
Enjoying this blog? Learn More.
What is the True Cost of Not Having an eQMS?Download Now