Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lessons that were learned. He also discusses how labs have dealt with the recent monkeypox outbreak and what significant changes may be in store for the Clinical Laboratory Improvement Amendments of 1988.

EDITOR’S NOTE: Reynolds Salerno, PhD, had a front row view into the federal government’s response, both to the SARS-CoV-2 pan­demic and the recent monkeypox outbreak. As Director of the Division of Laboratory Systems (DLS) at the U.S. Centers for Disease Control and Prevention (CDC), Salerno played an instrumental role in how diagnostic testing was provided during recent public health emergencies.

Salerno explains why the clinical labo­ratory and public health worlds will come together and how that relationship has been strained in the past. He also dis­cusses possible revisions to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), previewing Clinical Laboratory Improvement Advisory Committee (CLIAC) recommendations that he considers could be significant reforms to CLIA.

EDITOR: Can you explain the current structure of the Division of Laboratory Systems (DLS) within the CDC?

SALERNO: The DLS reports to the CDC’s Center for Surveillance Epidemiology and Laboratory Services. And that center’s director reports up to CDC Director, Dr. Rochelle Walensky.

EDITOR: What role does DLS have within CMS as it relates to CLIA?

SALERNO: Implementation of the CLIA program involves three fed­eral agencies, which I often call the tri-agency. It includes the Food and Drug Administration [FDA], the Centers for Medicare and Medicaid Services [CMS], and the CDC. The FDA and CMS have regulatory oversight responsibilities for CLIA. For example, FDA authorizes diag­nostic tests for use on people and catego­rizes tests based on their complexity. CMS inspects and enforces regulatory compli­ance that can result in laboratories being shut down for not operating according to the CLIA rules and regulations.

EDITOR: How do the CDC and DLS fit into the CLIA program?

Reynolds Salerno, PhD, Director of CDC's Division of Laboratory Systems
Reynolds Salerno, PhD

SALERNO: The CDC and our division do not have the same type of regulatory oversight role in CLIA as the FDA and CMS. We at CDC cannot enforce the CLIA regulations by penalizing labo­ratories. However, our role is unique. I like to describe it as we sit between the regulators [FDA and CMS] on one side and the regulated community [clinical laboratories] on the other side. We are responsible for outreach, communica­tion, and engagement with the clinical laboratory community. Our responsibil­ity is to explain the rules, regulations, and standards as best we can to that community. We also have the important role of understanding the challenges that the laboratory community has with the CLIA regulations and communicating that back to the regulators to say, “We need to address this or that part of the regulations.”

EDITOR: Despite DLS not having the power to enforce the CLIA regulations, you do have influence over regulatory development, correct?

SALERNO: Yes. We are part of the CLIA regulatory development process. The CLIA technical regulations and stan­dards are jointly developed by CDC and CMS, and jointly signed by the CDC director and the CMS administrator.

EDITOR: What is your role in relation to the Clinical Laboratory Improvement Advisory Committee (CLIAC) and labo­ratory training?

SALERNO: The CDC manages CLIAC, which is the federal advisory committee for CLIA. On behalf of the tri-agency, we also develop and distribute technical guidance and information. DLS does a tremendous amount of training course development. We develop tools and information guides that we make freely available to the com­munity to help them maintain compliance with CLIA. We also monitor CLIA’s profi­ciency testing program.

EDITOR: Let’s switch gears and talk about the COVID-19 pandemic. Over the past two-and-a-half years, how did DLS respond to the pandemic? And as you look back on it now, what success stories will guide you in the future with other public health emergencies?

SALERNO: I’d like to first look back at the Zika outbreak of 2016 to provide some context. Our division—even though we had the same role in CLIA that I just described to you—had basically no role in the response to the Zika outbreak. And one thing that happened during the Zika outbreak was that some of the Southern states that were most affected by Zika were overwhelmed by the demand for testing. The public health laboratories could not keep up with the demand. The CDC struggled because we did not have formal relationships with commercial laboratory companies that could help us do what we now call surge testing. We struggled to get immediate testing support from the private sector during the Zika response because we lacked those relationships.

EDITOR: How did this experience change things within the CDC and DLS?

SALERNO: After Zika, DLS recog­nized that it would be a benefit if the CDC and DLS could leverage their broad relationship with the clinical laboratory community to strengthen future public health responses. One of the first things we did was establish a memorandum of understanding [MOU] with the American Clinical Laboratory Association [ALCA], as well as the Association of Public Health Laboratories and the Council for State and Territory Epidemiologists. The mem­orandum signed in 2018, discussed how all parties could better prepare for surge laboratory testing when diagnostic testing, during a response, cannot be handled solely by the public health laboratories.

EDITOR: What improvements resulted from this memorandum?

SALERNO: First of all, the MOU helped us to formalize important relationships with the ACLA and the major commer­cial laboratories. Second, in 2019, the par­ties came together for a day-long tabletop exercise. By no means were all the kinks worked out for surge testing, but because of the relationships that we established, our division was able to engage with those organizations early in January 2020 when COVID-19 started surfacing. All we could do at that point was provide them with information. But just having those rela­tionships put us in a position to begin con­ducting weekly and even daily calls with ACLA members very early in the national response. We are confident that outreach and communication from the CDC helped that community feel as if they were more engaged in the public health response than they’d ever been before.

EDITOR: What results did clinical lab­oratories see from that new engagement?

SALERNO: There were many examples. One in particular proved very effective for engaging with the laboratory community. DLS began distributing messages through what we call the Laboratory Outreach and Communication System, or LOCS. Those messages initially went to about 500 clinical laboratories that we had email addresses for, but that LOCS system grew during the pandemic to a distribution list of over 110,000 clinical laboratories across the country. LOCS became an important tool that we used—and we continue to  use—to communicate information about various preparedness and response topics to the clinical laboratory community.

“That LOCS system grew during the pandemic to a distribution list of over 110,000 clinical laboratories across the country.”

—Reynolds Salerno, PhD

EDITOR: Were there other successes?

SALERNO: DLS also started holding what were originally called Clinical Lab COVID-19 Response Calls. They’re now called LOCS Calls. Initially they were every week, then every other week, and now they are held on the third Monday of each month at 3 p.m. EST. For those calls, we feature experts from CDC, FDA, and CMS, along with many other experts.

EDITOR: What were the topics of LOCS Calls initially?

SALERNO: It was an opportunity to bring the laboratory community together to discuss the latest guidance, to talk about the latest research, and to explain what we knew and what we didn’t know. The calls were well attended. At some points, we had 3,000 participants every single week. Even today, when there’s less urgency around public health response, between 700 and 1,000 people continue participating in each of these LOCS Calls.

EDITOR: Much CDC guidance also came out during the pandemic. Was the DLS involved with that?

SALERNO: Yes, DLS took responsi­bility for the majority of testing guid­ance that the CDC posted on its website. We developed the technical content and ensured it was approved by the subject matter experts at the CDC who may have been outside our division. We advocated that the CDC issue timely guidance, in as clear language as possible, to make this information available to the clinical labo­ratory and testing community.

EDITOR: How did DLS provide addi­tional services to clinical labs?

SALERNO: One thing we were happy about was that the first guidance page that we launched in March 2020 focused on biosafety for those clinical laboratories that would be receiving testing specimens for SARS-CoV-2.

EDITOR: Was this a first for the CDC and DLS?

SALERNO: Yes. This type of biosafety guidance was not previously available. That was a problem in previous responses, espe­cially during the Ebola outbreak in 2014. The laboratory community has criticized CDC for not providing guidance to clin­ical laboratories during the Ebola crisis. Many clinical laboratories were appre­hensive about the risks of handling these specimens. By comparison, we received a lot of positive feedback from the commu­nity about our biosafety guidance during COVID-19, especially that it was released as early as it was. Even though it went through numerous iterations and revisions as we learned more about COVID-19, the guidance helped the clinical laboratory community prepare for handling the spec­imens and performing the SARS-CoV-2 testing that they were asked to do.

EDITOR: What was one useful lesson that you learned from the COVID-19 response?

SALERNO: We believe DLS made many positive contributions during the pandemic. Further, it’s clear that the U.S. government and even the CDC has learned valuable lessons. We need to develop new systems and approaches to do better the next time a novel infectious agent appears.

EDITOR: You are upbeat about the learning curve at DLS and how it contrib­uted during the pandemic.

SALERNO: One thing I value about my background in clinical laboratory quality is that the name of the game is “continual improvement.” I think that’s where we as an agency are as well. Given that this was a completely unprecedented historical event, DLS did many things well. Of course, there are things that didn’t go as well as they should have. In terms of what our division can do better, we learned that—although we had this relationship with the ACLA and some of the largest commercial labo­ratories—we didn’t have as deep a relation­ship with the broader clinical laboratory community as we should have.

EDITOR: Can you explain that further?

SALERNO: If we look at the academic medical centers and the major hospital laboratories—which provided incredible service to patients during COVID-19— DLS was able to develop relationships with some of those laboratories during the pandemic, but we didn’t have those at the outset of the pandemic. Initially, we thought we were in good shape because we had relationships with Labcorp and Quest Diagnostics. But that wasn’t nearly enough. The deeper we went into the pan­demic, both the CDC and DLS recognized the need for more extensive relationships with the broader clinical laboratory com­munity that could be leveraged during public health responses. This is different thinking than we had in late 2019.

EDITOR: During the swine flu outbreak in 2009, the advances in PCR testing were such that numerous clinical laboratories were able to bring up laboratory-developed tests (LDT) quickly that were effective. But over the next 10 years or so, the regulatory public health establishment put in barriers that made it difficult for a qualified lab to bring up an in-house test for a novel infec­tious agent. That became an issue at the start of the SARS-CoV-2 pandemic when there were COVID-19 assays developed by clinical labs that were ready to go in early 2020. Do you want to comment on how the regulatory establishment has made it more difficult for a qualified lab to bring up an LDT quickly in response to an outbreak?

SALERNO: What I can say is that our public health system needs to have ways of engaging highly qualified technical experts in clinical laboratories and instru­ment manufacturers, especially to support new test development, at the onset of a potential outbreak. We need to under­stand how the regulatory system can best support and adapt to that demand.

EDITOR: How would you see the path forward?

“We need to envision a laboratory system that crosses public health and private sector boundaries and learns how to collaborate with one another.”
—Reynolds Salerno, PhD

SALERNO: Again, it comes back to my earlier point, which is that the clini­cal laboratory community now needs to think of itself as part of the public health community. And vice versa, the public health community needs to see the clinical laboratory community as a valuable con­tributor to public health and public health responses. It’s fair to say that three years ago, these were two silos that largely didn’t interact with one another. That caused chal­lenges for us as a nation at the onset of the pandemic. These communities need to continue to work together more seamlessly. We need to envision a laboratory system that crosses public health and private sector boundaries and learns how to collaborate with one another.

EDITOR: How should the public and private laboratory sectors view each other?

SALERNO: The public health commu­nity needs to see the clinical laboratory community as an asset, and the clinical laboratory community needs to see public health as part of their mission. Our division is really at the center of that from the CDC perspective. And that is one of the main objectives that we continue to pursue: How do we build those relationships and that capacity, and how do we provide more information to the clinical and commer­cial laboratory community, including the hospital community, to make them all feel genuinely part of public health? And then how do we address the challenging regula­tory issues that can bring the private sector to bear more quickly during responses?

EDITOR: What are your thoughts about the monkeypox outbreak response in the spring and summer?

SALERNO: Overall, I think the response has gone well, but, of course, opportunities still exist to improve. Again, this year’s monkeypox outbreak presented us with a slightly different scenario. We had a CDC test for monkeypox, but the clearance from the FDA limited the test to the Laboratory Response Network, which includes our public laboratories. When we realized that we needed access to testing more quickly, and we needed to distribute that test more widely than the Laboratory Response Network, it took some time. However, we were able to get our tests distributed to five large commercial labo­ratories within a month, and we increased our test capacity from 6,000 tests a week in the Laboratory Response Network to over 80,000 tests per week once we added those five commercial laboratories.

EDITOR: What factors made this distri­bution difficult?

SALERNO: It was difficult because we weren’t able to offer the test to everybody. The CDC has limited test kit manufactur­ing capacity, and CDC is not well suited to provide testing reagents to all testing labo­ratories. This is a good example of where we need help from the private sector, and where we still need to implement better sys­tems and processes to access that help more quickly during public health responses.

EDITOR: Were clinical laboratories responsive to this need?

SALERNO: Yes. The laboratory com­munity was very receptive to CDC early in the monkeypox response, asking if they could help. That was a huge benefit. With the monkeypox response, even though it wasn’t fast enough, my opinion is that the rapid expansion of access to monkeypox testing helped to quickly identify new cases and reduce the amount of transmis­sion. Overall, I feel good about how the clinical laboratory community contrib­uted to the nation’s monkeypox response.

EDITOR: What will unfold in 2023 for CLIA regulation updates and CLIAC activ­ities that CLIA-licensed laboratories would be interested to know about ahead of time?

SALERNO: The important thing to talk about is that three CLIAC work groups are currently operational. The first is the CLIAC Regulatory Assessment Work Group. It is examining three reports that were presented at CLIAC in April 2019. One report was on CLIA personnel regulations, one was on non-traditional workflow models, and the third was on next-generation sequencing.

EDITOR: Is there progress with these CLIAC initiatives?

SALERNO: The CLIA Regulatory Assessment Work Group is now integrat­ing those three earlier reports and saying, “There’s a number of elements within the CLIA regulatory framework that are out of date.” CLIAC asked that work group to look at those three prior reports and con­sider how the CLIA regulations should be updated. In my opinion, this is the most assertive CLIAC has been in convening work groups and assigning them man­dates regarding the need for revision of the CLIA regulations.

EDITOR: Does this work group have a timetable?

SALERNO: This work group will pres­ent a report at the November CLIAC meeting. That will be interesting. I antici­pate that CLIAC will begin to pressure the federal government to make more sub­stantive changes to the CLIA regulations.

EDITOR: What are the other two CLIAC work groups doing?

SALERNO: One is focused on CLIA certificate of waiver and provider-per­formed microscopy laboratories. That work group will also present to CLIAC in November. There is also a next-gener­ation sequencing [NGS] work group, sort of a second-generation work group on NGS. And it will present in April 2023. I believe these three work groups will enable CLIAC to make recommendations to the federal government for the most substantive CLIA reforms, perhaps in the history of CLIA.

EDITOR: What do you think lab lead­ers should know about the Department of Laboratory System’s offerings as they head into the next year?

SALERNO: The Division of Laboratory Systems’ website is one of the best web­sites at the CDC. All of our work is pre­sented on that website in a user-friendly format. For a several years now, we’ve had a next-generation sequencing quality initiative underway. That section of our website has over 90 free products to help clinical laboratories implement quality systems if they’re using NGS tests. This has been a challenge for CLIA because NGS did not exist in the early 1990s when the first CLIA regulations were written and published. So, we’ve worked hard over the last few years to convene experts from across the community to develop NGS products and tools that we can make freely available to everybody.

EDITOR: Does the DLS website have other information of interest to clinical laboratories?

SALERNO: Another program we started in 2020 is the OneLab Network. The idea was to connect clinical and public health laboratory professionals to build an ongoing learning commu­nity. We develop training, webinars, and job aids, as well as some of our virtual reality work. OneLab Network now has over 2,500 members. They meet virtually every month, and we solicit feedback from members. I think it’s a fabulous concept, and it’s growing very quickly.

EDITOR: Are there any new develop­ments in 2022 with OneLab?

SALERNO: Yes. This summer, we started OneLab Rapid Education and Capacity-Building Hub, or REACH. It’s a free, CDC-created laboratory training plat­form customized to the needs of the clinical laboratory community. This is the first time this sort of learning management system has ever existed at a federal level. It’s a great resource for the entire clinical laboratory community. It gives small clinical labora­tories that don’t have their own learning management system the opportunity to use this pre-existing CDC system on their own. Laboratories can put all their own people into it and have confidence that the training courses from OneLab REACH have been vetted extensively by subject matter experts. For laboratories that do have their own learning management system and want more robust tracking of their staff’s train­ing scores and progress, we also offer free syndication of our eLearning courses.

EDITOR: Thank you for sharing all this information about activities at the Division of Laboratory Systems. This will help our clients and regular readers under­stand how they can better collaborate with your division and tap the information that you make available on your website.

SALERNO: We appreciate the opportu­nity to share our lessons learned in recent years, along with all the services we offer to clinical laboratories.

 

Key Online CDC Resources for Labs

At the Centers for Disease Control and Prevention’s Division of Laboratory Services (DLS), there is a Q&A that men­tions several free resources that clinical lab directors may want to review:

    • DLS Laboratory Trainings: This page offers more than 40 training courses for clinical laboratories. www.cdc.gov/labtraining/
    • Laboratory Outreach and Communication System (LOCS): LOCS provides frequent alerts and advisories to the clinical laboratory community. www.cdc.gov/locs/
    • LOCS Calls: These calls take place every third Monday of the month at 3 p.m. Eastern and feature experts from federal health agencies and else­where. www.cdc.gov/locs/calls/
    • OneLab Network: OneLab offers training (including virtually), webi­nars, and job aids for registered members. www.cdc.gov/labtraining/onelab/network.html
    • OneLab Rapid Education and Capacity-Building Hub (REACH): OneLab REACH provides a lab-based learning management system vetted by experts. reach.cdc.gov/home

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