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Mayo Clinic Virology team works around the clock to develop, validate COVID-19 test

Laboratory Professionals Week

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA spotlights the fifteen members of the Mayo Clinic’s COVID-19 rapid response team who worked tirelessly behind the scenes to develop and validate their COVID-19 test.

Mayo Clinic Virology team works around the clock to develop, validate COVID-19 test

As the COVID-19 pandemic began to sweep across the United States, fifteen Mayo Clinic Laboratory staff members set out to develop, validate and offer molecular tests to those in their communities. Lab technicians and staff worked around the clock to make the diagnostic tests widely available, and in just three weeks, Mayo Clinic’s Minnesota-based COVID-19 rapid response team made available to order their COVID-19 polymerise chain reaction (PCR) test.

Thanks to their tireless efforts, Mayo Clinic has been sharing results with providers in less than 24 hours since the test’s launch in March, helping patients get the critical results they need. This group has helped ACLA members perform a collective total of 2.45 million tests to date.

 

The COVID-19 rapid response team that worked to develop and implement the laboratory-developed test. (Not pictured: Cassiey, Wennie, Brian, Tad.)

 

Dave King joins ACLA as Special Advisor

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WASHINGTON, D.C. — The American Clinical Laboratory Association (ACLA) today announced Dave King, former CEO of Laboratory Corporation of America Holdings (LabCorp), will join ACLA as a special advisor.

Building on his twenty years of service to the industry, including more than a decade serving on the ACLA board, King will support the association’s strategic and tactical responses to the COVID-19 pandemic. In this role, he will also work closely with ACLA members to share information about emerging supply needs and help support the sharing of best practices. He will also assist the association in communications with the White House Coronavirus Task Force and other governmental agencies.

“A fierce advocate for our industry, Dave’s depth of knowledge has been a great asset to our membership for over a decade,” said Julie Khani, President of ACLA. “As our nation confronts this unprecedented challenge, we are grateful to have his steady voice of reason and considerable expertise on our team.”

King stepped down from his role as CEO of LabCorp in October 2019, and until May 13, 2020 will continue to serve as Executive Chairman of the Board.

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

Meet Emliee & Chris, employees at ARUP’s Molecular Infectious Disease Lab

Laboratory Professionals Week, All News

This Laboratory Professionals Week, we’re taking a moment to thank laboratory researchers, technicians, administrative staff and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic. Today, ACLA is shining a light on two employees at ARUP’s Molecular Infectious Disease Lab: one who spent weeks training volunteers to assist with COVID-19 testing, and another who worked around the clock to bring ARUP’s COVID-19 test online in just five days.

Emilee, a New York-qualified medical laboratory scientist & teaching specialist in ARUP’s Molecular Infectious Disease Lab

At first, Emilee wanted to be a math or physics teacher. Then, one semester shy of earning a degree in microbiology, she learned about a medical laboratory science program. Fast forward 15 years, and she is now a medical laboratory scientist and a teaching specialist in ARUP’s Molecular Infectious Disease (MID) Lab. “I guess you could call it coming full circle,” she says. “I love helping people understand things.”

Emilee’s teaching skills were in high demand when thousands of COVID-19 specimens started pouring into the MID lab in mid-March.

“My workload exploded,” she said. Emilee started working 50 to 70 hours a week to train volunteers from other labs and departments at ARUP so they could assist with COVID-19 molecular testing. “I was hyper-focused on just getting people up and running so they could start performing the tests – the energy and excitement they brought with them into the lab was impressive.”

All the media coverage around COVID-19 testing has placed a spotlight on laboratory medicine as a profession. Now, when people ask Emilee if she works in a lab and does COVID-19 testing, she catches their attention.

“I’m kind of a big deal now,” she says, adding that a lot of her coworkers consider themselves to be introverts and never anticipated so much recognition. “But honestly, it feels good to be noticed and for people to know that what we are doing is good for society—it’s kind of a boost.”

Chris, certified technologist specialist in ARUP’s Molecular Infectious Disease Lab

Chris has learned to be responsive in his role as a certified technologist specialist in ARUP Laboratories’ Molecular Infectious Disease (MID) Lab. That ability was never more important than when he and his colleagues learned that they had five days to bring ARUP’s COVID-19 molecular diagnostic test online.

One of the two instruments used to run the test at the time was down.* “Our entire ability to run the COVID test was banking on getting this fixed,” Chris recalls. It was a Friday; the test would go live Monday. Chris, along with a Hologic technician, worked until midnight, then he worked through the weekend.

“I wasn’t alone. A whole bunch of us were here and sharing the load.” That weekend, his team received training on using the new reagents for the test. “These reagents were precious, like gold,” he says. “The shipping folks would look for the labels and immediately bring the packages directly to us.”

“My dad keeps saying, ‘You’re right at the epicenter of all this. You should take notes. You could write a book about this one day,’” Chris says with a shy smile. “It does feel good to be making a difference. The better we do, the better everyone is going to do.”

Thanks to Emilee and Chris’ hard work, and the work of their fellow lab professionals, commercial labs across the nation have conducted 2.45 million COVID-19 tests to date.

*ARUP currently has five instruments running COVID-19 tests and the capacity to perform more than 4,600 tests a day.

As Nation Recognizes Laboratory Professionals Week, ACLA Highlights Extraordinary Efforts of “The Laboratory People”

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Association announces plans to highlight members’ efforts during Laboratory Professionals Week (April 19 – 25)

WASHINGTON, D.C. — Today, the American Clinical Laboratory Association (ACLA) announced plans to highlight stories of laboratory researchers, technicians, administrative staff, and medical officers who are going above and beyond the call of duty to serve patients during the COVID-19 pandemic.

“Tens of thousands of laboratory staff are working around the clock to deliver accurate, reliable tests results to all who need it,” said Julie Khani, president of ACLA. “As we mark the start of Laboratory Professionals Week today, there’s never been a better time to honor their dedication and service,” Khani said.

Responding to unprecedented demand for testing, ACLA members, including ARUP, BioReference Laboratories, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, Sonic Healthcare, Exact Sciences and Biodesix have dramatically increased testing capacity over the past several weeks, performing more than 2.45 million tests to date.

As noted at Friday’s White House briefing, ACLA members can serve virtually every area of the United States. “The American Clinical Laboratory Association — this is America’s commercial industrial backbone,” said Admiral Brett Giroir. “They have no backlog of tests, they’ve ramped up their production, so their turnaround time is about 48 hours.”

For today’s behind-the-scenes look at the people working to bring vital testing capacity to the U.S, click here. You can also follow ACLA on LinkedIn and Twitter.

 

 

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

 

CMS Takes Decisive Action to Support Laboratories Responding to COVID-19 Pandemic

Featured News, ACLA Press Releases

WASHINGTON, D.C. – Following the decision announced today by Centers for Medicare & Medicaid Services (CMS) to raise the Medicare reimbursement rate for high throughput COVID-19 molecular tests from about $51 to $100 dollars, ACLA President Julie Khani issued the following statement:

“In an acknowledgement of the considerable strain that has been placed on clinical laboratories supporting our nation’s response to the COVID-19 pandemic, the Administration today took decisive action to expand the availability of testing for patients nationwide.

As we’ve said from the beginning, this crisis demands the full force of the clinical laboratory industry—private, public, academic and hospital laboratories are all in this together. We know that the lack of predictable reimbursement for tests performed has been a barrier to entry for some laboratories, and today’s decision will help encourage all laboratories with the appropriate expertise to come to the table and perform COVID-19 testing. We also hope that other payers will follow CMS’s strong example of leadership today.

Following FDA guidance on February 29 that allowed commercial laboratories to test for COVID-19, ACLA members have performed more than two million tests, working around the clock to expand capacity without clear reimbursement guidelines or designated resources. At the same time, labs have been asked to do more with less. The cost of supplies has increased, and laboratories are seeing a substantial decline in non-COVID-19 testing, as patient visits to physicians plummet and elective surgeries, screenings and routine care services are postponed.

After scaling up to meet an unprecedented demand for testing, ACLA members have now eliminated testing backlogs and have considerable capacity that is not in use. We stand ready to perform more testing and are in close communication with public health partners about ways we can support additional needs.”

ACLA President Julie Khani Outlines Key Challenges Facing Testing Capacity

Public Health Preparedness and Infrastructure, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – Today, ACLA President Julie Khani released the following statement:

“One month ago today, the FDA cleared the regulatory barriers preventing commercial labs from performing COVID-19 testing. Since then, ACLA member laboratories have steadily increased COVID-19 testing capacity each week. In total, ACLA members have performed approximately 650,000 COVID-19 tests to date, including 84,000 tests completed just yesterday. We currently have six ACLA members testing for COVID-19, and other members are working to bring additional tests online.

Although ACLA members are rapidly expanding testing capacity nationwide, demand for testing is also growing significantly each day. As labs continue to extend resources to expand capacity, the most immediate action we can all take is to prioritize who gets tested. ACLA greatly appreciates recent efforts by the federal government to reinforce clear guidelines to ensure that testing remains readily available for those who need it most. It is essential that doctors and hospitals order COVID-19 tests in accordance with the CDC recommendations and adhere to these guidelines when identifying samples to be prioritized.

This crisis demands the full force of the clinical laboratory industry. We’re in uncharted territory, and our ability to make headway against this pandemic hinges on the availability of testing. In order to continue to increase capacity, all laboratories must have predictable and consistent access to swabs, personal protective equipment, test kits, reagents and other supplies necessary for testing. We are also working closely with our manufacturing partners who produce the high-throughput platforms that are essential to further expand testing capacity. For laboratories processing thousands of specimens a day, having additional platforms available can help boost daily capacity, a shared goal for our industry and our public health partners.

We must remain proactive in response to these anticipated challenges. Any constriction or disruption in the supply chain could suddenly create a bottle neck, and we continue to work closely with the administration to address the obstacles we face.”

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

 

 

ACLA Statement on CARES Act

ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – Following the release the Coronavirus Aid, Relief, and Economic Security Act this evening, ACLA President Julie Khani released the following statement:

“For the third time, Congress has failed to provide the necessary funds to support ‘free testing’ for all Americans. Our members remain in an untenable situation, absorbing growing, uncompensated costs for testing specimens with no assurance that they will be appropriately or fairly reimbursed for all the tests they are performing.

This emergency requires the full force of laboratories nationwide, and Americans are counting on us to deliver. As labs continue to extend tremendous resources to rapidly expand testing capacity, the most immediate action we can all take is to prioritize who gets tested. ACLA greatly appreciates efforts this week by the federal government and several states to reinforce clear guidelines and provide new guidance to ensure that testing is performed where and for whom it is most needed. It is essential that doctors order COVID-19 tests in accordance with recommendations from the CDC, HHS and local health authorities, and that hospitals adhere to guidelines when identifying the samples to be prioritized.

In a moment when labs have been asked to make unprecedented investments to meet surge capacity, we were encouraged to see the inclusion of one particular provision in this bill. Over the past several years, labs have sustained significant year-over-year cuts to Medicare reimbursement for common lab tests, which will average about 30% when fully implemented. As part of this third stimulus package, most Medicare lab rates will freeze for one year—an important step for seniors and our most vulnerable patients who rely on vital, routine tests for their health.

Our ability to make headway against this pandemic hinges on the availability of testing. If Congress fails to designate essential emergency funding for clinical laboratories to support our efforts, labs will be soon be forced to make difficult decisions about whether they can keep building the capacity our nation needs.”

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.