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Coronavirus Updates

Due to the rapidly evolving nature of the COVID-19 world situation we will be posting all related updates on this page. We want to ensure all of our customers that especially in these trying times we are doing everything we can to continue to Safeguard Global Health® and our operations are continuing as normal.


PRESS RELEASES & UPDATES

 

Nelson Labs Does Perform Testing With Sars-CoV-2

10 November 2021

From the beginning of the COVID-19 pandemic, we have received many inquiries about Nelson Labs’ ability to perform laboratory testing using the Sars-CoV-2 virus. There are significant risks associated with using this relatively new and potentially harmful virus and its variants in laboratory testing; therefore, tests using Sars-CoV-2 should be handled only in BSL-3 facilities that are designed for lab tests with requisite levels of safety and control.

We are happy to announce that with the recent acquisition of BioScience Laboratories (Bozeman, MT), Nelson Labs is now able to perform laboratory testing using Sars-CoV-2 on select tests. BioScience Laboratories has a robust virology lab with BSL-3 capabilities—one of the few non-government BSL-3 labs testing Sars-CoV-2 in the United States—with over 15 years of experience performing time-kill studies, hard-surface disinfection studies, and customized virucidal-efficacy studies. Most of these studies focus on supporting manufacturer label claims for hand sanitizers, disinfectants, and related products.

BioScience Laboratories is an ISO 17025-accredited facility with the capability to perform tests following EN, ISO, or ASTM standards. It has an extensive library of viruses, including 9 different SARS-CoV-2 strains.

In addition to testing with Sars-CoV-2 in our BioScience Laboratories facility, we also provide test services with other laboratory-safe, research-grade virus surrogates. Our virologists can help you customize your study to meet your product, project, or label-claim needs.

Disinfectants and Antimicrobials – Virus challenges (Tests with Sars-CoV-2 and Infectious Viruses)

BioScience Laboratories is a leading test facility that provides support for virucidal label claims. Most hand sanitizers and antimicrobial soaps follow AOAC disinfectant or USP testing plans for efficacy testing against pathogenic and objectionable organisms, and the panel of organisms used is more resistant than most viruses, including Sars-CoV-2. To determine an appropriate surrogacy equivalence or challenge organism for your product, you can follow the guidance on virucidal claims from the US EPA for disinfectants or from the US FDA for medical devices. And, of course, you can reach out to our service center at 801-290-7500 to obtain guidance from one of our in-house consulting experts.

BioScience Laboratories can provide virus testing for a broad panel of infectious and non-infectious viruses. They are among the few facilities that can perform both the virucidal bench tests and human clinical studies for topical products (hand sanitizers, soaps, etc.). If you are interested in lab testing on sanitizers and disinfectants or have any questions about our capabilities, please contact our service center, and they can put you in touch with the most appropriate in-house expert. We will be happy to meet your testing needs.

Personal Protective Equipment – Virus challenges (Tests with Surrogate Viruses)

Nelson Labs’ protective-barrier testing for personal protective equipment (PPE) uses a virus that is a recognized surrogate for virus penetration properties, as published in several standards recognized by the US FDA and other notified bodies. PPE tests include face masks, surgical masks, respirators, surgical gowns, and drapes. By using surrogates for PPE-product tests, we create worst-case challenges that safely simulate the physical characteristics of the Sars-CoV-2 virus to determine how well the PPE will function against the actual virus. This is widely accepted by the US FDA, EU notified bodies, and other regulatory agencies around the world.


Nelson Labs Defined as an Essential Business

03 April 2020

Dear valued customers,

We have heard from many of you with concerns about whether Nelson Labs is an “Essential Business” due to the critical nature of the work we perform for you.  I can assure you that we are.

Essential Businesses are defined in the US Cybersecurity and Infrastructure Security Agency (CISA)  Guidance as updated on March 28, 2020.  The following are excerpts from the guidance that help to define essential Life Science industry operations like Nelson Labs:

  • Workers who perform critical clinical research, development, and testing needed for COVID-19 response.
  • Manufacturer workers for health manufacturing (including biotechnology companies), materials and parts suppliers, logistics and warehouse operators, distributors of medical equipment (including those who test and repair), personal protective equipment (PPE), isolation barriers, medical gases, pharmaceuticals (including materials used in radioactive drugs), dietary supplements, blood and blood products, vaccines, testing materials, laboratory supplies, cleaning, sanitizing, disinfecting or sterilization supplies, and tissue and paper towel products.
  • Workers necessary for the manufacturing of materials and products needed to manufacture medical equipment and personal protective equipment (PPE).

Nelson Labs clearly falls under the designation of an Essential Business meaning that operations may continue under shelter-in-place orders put into effect by various government agencies.  The fact our company is allowed to continue operating places an even greater responsibility on us to implement appropriate protective measures for our employees.

I want to stress once again that because of the importance of getting your products to market and the critical nature of supporting the healthcare supply flow, we will do all in our power to have the necessary staff at all of our facilities to continue testing your products.

If we can do anything to help you, please contact our service center at 801-290-7500.

 

Onward!

Jeffery R. Nelson, M.B.A. SM(NRCM)
President
Nelson Laboratories, LLC

DOWNLOAD A PDF OF THIS UPDATE HERE


Nelson Labs – Sustaining Operations and Change Control Notice (North America)

24 March 2020

Dear Clients,
There is an unprecedented shortage of personal protective equipment (PPE), gloves, masks and lab supplies used in global healthcare due to the COVID-19 event.  At Nelson Labs we are working to minimize our consumption of these critical supplies while sustaining our customer service and test capabilities to continue our mission of Safeguarding Global Health.

What This Means For Nelson Labs’ Customers

  • Ready To Test: We remain operational as an essential part of the healthcare supply chain
  • Supply Management: Some material substitutions or usage alterations will be implemented
  • Lab Network: Test services may be shifted within our accredited lab network to meet demand

Lab Supply and Material Change Control

To ensure business continuity we are taking the following actions related to lab supplies and materials effective immediately:

  • Issuing change control QE# 22001 for lab supplies and materials due to COVID-19 shortages
  • Performing a quality and science review of supply and material changes with each lab area
  • Sourcing and using substantially equivalent materials with documentation
  • Minimizing consumption by reducing supply use and implementing reuse, where possible
  • Documenting any change of lab supplies or materials to ensure traceability

While we have qualified many alternative supply types and sources it has become necessary to go further in our attempt to keep our labs open.  This requires us to keep our people safe while making some operational accommodations.

Nelson Labs is committed to sustaining lab operations to the highest standards of quality and science our customers have come to expect from us.  Thank you for your support and understanding.

 

John S. Bolinder
VP, Operations – North America
Nelson Laboratories, LLC

DOWNLOAD A PDF OF THIS UPDATE HERE


Nelson Labs Coronavirus Restrictions and Shelter-in-Place Orders—Update

23 March 2020

Dear valued customers.  I wanted to reach out to you at this important time to let you know that we will continue to be operational at all of our laboratory locations during the Coronavirus restrictions and shelter-in-place orders put into effect in many US states and international locations.  Given the critical nature of your products and the importance of supporting the critical needs of the healthcare supply flow, we will continue to have essential staff at all of our facilities to ensure your products are tested.

Your products help save lives and it is our mission and commitment to help you do that.

If you have any questions, or if we can do anything to help you, please contact our service center at 801-290-7500.

Be well,

Jeffery R. Nelson, M.B.A. SM(NRCM)
President
Nelson Laboratories, LLC

DOWNLOAD A PDF OF THIS UPDATE HERE


Nelson Labs Earthquake & COVID-19 Continuity Plan — Update

March 18, 2020

Earthquake in Salt Lake City, Utah

This morning, Salt Lake City, UT experienced a magnitude 5.7 earthquake as well as several smaller aftershocks. Although we felt it strongly, I am happy to report that our buildings operated as designed and weathered this event very well. We sustained only minor cosmetic damage (some drywall cracks and a broken pipe, which is now repaired). This unexpected event has not disrupted our operations and our testing continues with a focus on sustaining our mission of Safeguarding Global Health® at this very crucial time.

Nelson Labs Coronavirus Continuity Plan Update

In addition to weathering the earthquake this week, we have taken the following additional steps to secure our operations to continue to meet your testing needs:

• Each laboratory location is employing a rotating shift schedule with divided teams. This division of labor will minimize the risk of an infection disrupting an entire service line.
• Shifted all possible non-laboratory staff to work-at-home status to increase social distancing, and to minimize the risk of infection of our staff. We maintain key, on-site personnel to perform testing.
• We have closed our Salt Lake City location cafeteria to increase social distancing and to minimize infection risk in compliance with Utah State expectations
• We continue to coordinate closely with our suppliers to ensure consistent supply flow to sustain testing

As I mentioned in my last update, our continuity plan is constantly being re-evaluated by our team and we are taking whatever measures we can to minimize the risks associated with this outbreak—without negative impacts or disruptions for our customers.

Please know that we realize the products you produce are as important as the patients they represent. That is why we are committed to working through this challenge as seamlessly as possible.

Sincerely,

Jeffery R. Nelson, M.B.A. SM(NRCM)
President
Nelson Laboratories, LLC

 

DOWNLOAD A PDF OF THIS PRESS RELEASE HERE


COVID-19 Continuity Plan

March 4, 2020

Nelson Labs Coronavirus Continuity Plan

As a global leader in Safeguarding Global Health®, Nelson Labs’ top priority remains the health and wellbeing of our customers, their patients, and our employees worldwide.  On January 30, 2020, the World Health Organization declared COVID-19 a global emergency.  With that declaration, potential supply chain disruption in the medical industry became a risk that we all must manage.

Although no business continuity plan can provide assurance of the removal of all risk, at Nelson Labs we are committed to maintain strong processes and controls to minimize the risk of a significant disruption to business operations related to COVID-19.  Our continuity plan includes ensuring the safety and wellness of our staff, maintaining a consistent supply of essential testing components, and consistent communication with our customers.

Key Elements for Continuity

We have taken the following steps to ensure the safety and wellness of our staff, to ensure continuous service and availability for our customers:

  • Minimized outbound staff travel with restrictions on high-risk areas.
  • Off-site quarantine of individuals who are ill or test positive for infectious diseases.
  • Increased facility sanitization and employee handwashing to ensure cleanliness and minimize infection spread.
  • Screening of all visitors (for symptoms and recent travel) to minimize the risk of infection spread at our facilities.
  • Ongoing proactive communication with our staff and customers to ensure best practices and ongoing awareness.

We are implementing the following steps to ensure supply consistency to minimize the risk of testing disruptions or delays:

  • Maintain inventories of essential testing components to protect against disruptions.
  • Proactively communicate and collaborate with our suppliers to ensure essential test components are available and shortages are minimized.
  • Avoid single sourcing of vital supplies.
  • Work across our global network of facilities (12 laboratory locations worldwide) to distribute supplies based on our customers’ needs.
  • Utilize our global network of facilities to distribute testing to the laboratory location that can best meet our customers’ needs.

We will continue to take the following steps to ensure consistent, ongoing communication with our customers about their testing status:

  • Updates via email and our customer portal of any outages, delays, or disruptions at any of our 12 global laboratory locations worldwide.
  • We will work with customers to relocate work to the lab in our network that can best meet their testing and turnaround-time needs.
  • As always, we will provide consistent, reliable updates through our customer portal about the status of each test.
  • We will continue to contact customers individually about any problems, changes, or deviations to their testing.

 

With these measures in place, and constantly being re-evaluated by our team, we are confident that we will be able to minimize the risks associated with this outbreak without negative impacts or disruptions for our customers.

Please know we value our partnership with you and are committed to working through this challenge as seamlessly as possible.  It is our commitment to provide you with world-class service and support always.

 

Sincerely,

Jeffery R. Nelson, M.B.A. SM(NRCM)
President
Nelson Laboratories, LLC.

 

DOWNLOAD A PDF VERSION OF THIS PRESS RELEASE HERE


EDUCATION