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ACLA Statement on the Paycheck Protection Program and Health Care Enhancement Act

WASHINGTON, D.C. — Following Senate passage of the Paycheck Protection Program and Health Care Enhancement Act, ACLA President Julie Khani released the following statement:

ACLA commends Congress for recognizing the need to substantially increase funding and support for testing in the most recent COVID-19 legislative package. This is an important step to provide states, federal agencies and the clinical laboratory community with the resources to further scale testing in response to the unprecedented need presented by the COVID-19 public health emergency.

Federal and state public health officials and business leaders across industries all agree that wide-scale molecular and serologic testing is vital to reopening the country and protecting the health of Americans. ACLA urges HHS to quickly provide clarity on how the funding will be allocated to support hotspots and high-risk populations, as well as broader efforts to increase high throughput testing nationwide. Continued support and funding for high throughput testing from commercial, hospital and academic laboratories is essential to achieve both of these goals.

ACLA is committed to working with Congress, the Administration and Governors to ensure that we can adequately expand America’s testing capacity, protect public health and support the reopening of our economy.

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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.

LabCorp Employees Work Behind-the-Scenes to Develop Critical COVID-19 Tests

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 members of the LabCorp team who are essential to developing and deploying critical COVID-19 tests. 

 

Ayla, Research Scientist II at LabCorp

Ayla is a Research Scientist II in the molecular microbiology research and development group at LabCorp’s Center for Esoteric Testing in Burlington, N.C. Ayla has spent the last three months developing, testing and deploying the LabCorp COVID-19 RT-PCR Test, which received FDA Emergency Use Authorization on March 16, 2020, making LabCorp the first commercial diagnostics laboratory to receive such authorization. Through tireless hard work and dedication, Ayla has played an integral role in allowing LabCorp to lead in COVID-19 testing and provide invaluable information to patients and health care providers in the battle against COVID-19.

 

 

Julia, Lab Supervisor at LabCorp

Julia has led the molecular diagnostics department at LabCorp’s Raritan, N.J., lab over the last several weeks with technical expertise and a calm disposition during a tense and trying time. Her admirable leadership and dedication to patient care enabled LabCorp to validate the company’s COVID-19 assay on three instruments in an extremely short period of time, while also supervising and training molecular employees and many additional volunteers.

 

 

 

Thanks to Ayla and Julia’s dedication, and the hard work of their fellow lab professionals, commercial labs across the nation have performed more than 2.5 million COVID-19 tests to date, and continue to scale up capacity.

 

Clinical Labs Support Congressional Funding To Ensure Robust Testing Infrastructure

Federal Funding Is Needed To Ensure Laboratories Can Scale High Throughput Testing For COVID-19

Washington, D.C. – The American Clinical Laboratory Association is encouraged by reports from Congressional leaders and the Administration regarding $25 billion in funding for COVID-19 testing. Moving forward, it is critical that any funding includes robust support for commercial laboratories performing and expanding COVID-19 testing, including high throughput tests that are required to achieve national scale. To expedite funding for expansion as quickly as possible, it’s recommended that federal funding route through HHS as opposed to individual states.

Improving testing capacity is one of the most critical steps that Congress and the Administration can take to protect Americans and restart the U.S. economy. Nearly every public health expert and economist agrees that a national testing infrastructure that supports high throughput testing must be in place to mitigate the spread of COVID-19. Yet, to date, no dedicated funding for laboratories has been made available to provide and increase nationwide COVID-19 testing that would assist in decisions to reopen the economy and allow Americans to return to work.

As policymakers work to provide funding for COVID-19 testing, it’s critically important that there is robust financial support for:

  • Expanded access to high throughput, accurate and reliable testing and supplies, including swabs, personal protective equipment, reagents, testing kits, etc.;
  • Equipment acquisition, including IT software, hardware and cybersecurity protection, to support nationwide testing capacity;
    Increased employee training and staffing;
  • Full cost associated with serology testing as well as uncompensated and undercompensated care; and
  • Robust coordination with state health agencies and federal authorities.

We appreciate the continued work of Congressional leaders in both the Senate and House who have released detailed plans in support of an expanded testing infrastructure. Congress must take immediate action to designate the funding necessary to ensure that all Americans have access to the high throughput, accurate and reliable testing that is needed.

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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.

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

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

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

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”

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

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.”