Public health laboratory response capability advanced through – and in spite of – the Zika outbreak

Public health laboratory response capability advanced through – and in spite of – the Zika outbreak | www.APHLblog.org

When a health threat like the Zika virus disappears from the headlines, public health systems may appear to have halted their work. In fact, their efforts continue behind the scenes as lessons and enhancements from the last response are incorporated into public health systems and processes to enhance ongoing surveillance and inform future responses.

The US response to the 2016 Zika virus pandemic followed this pattern of event, insights and enhancements to public health response systems. It built upon past developments, such as the creation of the Laboratory Response Network (LRN) in 1999 and introduction of expedited approval of diagnostic tests in 2009, to drive improvements that will make future responses more rapid, robust and flexible.

Below are examples of how public health laboratory response capability advanced through – and in spite of – the Zika outbreak.

Zika Tests Deployed via EUA

During the 2009 H1N1 influenza outbreak, the public health community took advantage of a tool that had not been utilized previously: the Emergency Use Authorization or EUA. Under an EUA, the Food and Drug Administration (FDA) takes steps to speed up the typically long, laborious approval process for new drugs, devices and diagnostic tests, and authorizes emergency use of the product even if it has not yet gone through normal channels of approval.

On February 26, 2016, the secretary of the Department of Health and Human Services declared Zika to be a Public Health Emergency activating the EUA mechanism for expedited Zika diagnostic testing approval. By mid-March, the FDA granted EUAs for two key Zika tests. The first, the Trioplex Real-time RT-PCR, was a polymerase chain reaction (PCR) designed to detect the virus in a patient’s blood or urine. The second, the Zika MAC-ELIA, was an immunoglobulin M (IgM) test used to locate antibodies in the blood. Because of the expedited approval process under the EUA, these tests were approved in a matter of weeks instead of months or years.

Labs Roll Out Zika Tests in Record Time

By the time the FDA issued these EUAs, the tests had already been validated or shown to be effective in detecting the Zika virus in many laboratories. This required testing large numbers of samples—not an easy task in a high-pressure situation.  But the Centers for Disease Control and Prevention (CDC) found a way. Drawing on labs with the most testing expertise, the agency redirected its teams to focus on Zika. CDC’s Dengue Branch in Puerto Rico and its office in Fort Collins worked on the rollout of the tests and provided technical support to state laboratories participating in the emergency effort.

In the meantime, state and local public health labs weren’t waiting around. They were also validating PCR and IgM tests, and training on the required methods and technology.  “This proved to be crucial,” explained Kelly Wroblewski, director of infectious diseases at APHL. “Many scientists working in public health labs were not familiar with the serologic testing methods being used. Public health laboratories had largely moved to kit-based tests and the expertise required to implement this more complex method had been lost. On top of that, many labs didn’t have the proper equipment to perform the more manual tests. Due to funding cuts over the past 15 years, the labs had lost much of the capacity they had had during the West Nile outbreak that occurred about 15 years ago.”

CDC tried to fill this gap by offering more training once it began distributing the newly validated tests to qualified labs in the LRN. It provided technical assistance to labs conducting the test to ensure that they were ready for an expected surge of samples. By January 2017, LRN labs had conducted 25,439 RT-PCR tests and 35,349 Zika MAC-ELISA tests.

Inspections Postponed to Prepare for Zika Testing

In the midst of training and testing, the Centers for Medicare and Medicaid Services (CMS), which is charged with oversight of all laboratory-developed tests (LDTs), notified LRN laboratories that inspectors would be arriving to review Zika testing procedures and documentation to ensure the accuracy of test results. Though this was CMS’ prerogative under the Clinical Laboratory Improvement Amendments (CLIA), the timing could not have been worse.

“Our members began alerting us that they were anxious about the CLIA inspectors showing up at their labs,” recalls Eric Blank, chief program officer at APHL. “They were especially concerned about preparing all the necessary documentation for the inspectors.” As it had done during the H1N1 outbreak in 2009, APHL negotiated with CMS to delay inspections until the acute crisis had passed.

Task Force Launched to Coordinate Response to Future Crises

During a public health emergency, APHL works diligently to connect public health laboratories to APHL’s federal agency partners, CDC, FDA and CMS. “The federal partners along with APHL recognized the need for an improved, collective emergency response to public health emergencies,” explains Peter Kyriacopoulos, senior director of public policy at APHL. “CDC, FDA and CMS established a new entity, the Tri-Agency Task Force for Emergency Diagnostics. When the next disease comes along, this task force will enable the nation to respond much more effectively than before.”

Wroblewski adds that the task force makes communication more routine. “Having communication channels already open will make it easier to get the response going as quickly and efficiently as possible,” she says.

Since 2016, the threat of Zika has subsided. In 2017 and 2018, there wasn’t another outbreak, but Zika will likely come back. But this time, the public health community will be ready.

“With the Tri-Agency Task Force in place, we’re much better off than we were in 2016,” says Kyriacopoulos. “Other improvements, like more efficient ways to send data electronically, are still needed. But the systems we had and the new ones we’ve introduced have strengthened communication and coordination.”

For more information about public health laboratory response to the Zika crisis, check out APHL’s book, A Complex Virus, A Coordinated Response: Public Health Labs Battle Zika.

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Enhancing detection of newborn screening conditions via data analytics

Enhancing detection of newborn screening conditions via data analytics | www.APHLblog.org

For over 50 years, newborn screening programs across the United States have implemented laboratory screening and follow-up programs to detect and report infants at high risk for rare diseases. As we look towards the future, current testing challenges will likely become more pronounced with the anticipated addition of new conditions to the Recommended Uniform Screening Panel (RUSP), increasing sophistication of testing platforms and methodologies, and greater complexity of biomarker profiles.

Building the data analytic capacity of newborn screening programs will help support the analysis and interpretation of patient data, providing tools and resources to create efficiencies in time-intensive program activities.

APHL and the Newborn Screening and Molecular Biology Branch of the Centers for Disease Control and Prevention (CDC) are exploring solutions aimed at improving the interpretation of laboratory tests by expanding data analytic capacity in the following ways:

  • Increasing state newborn screening programs’ capacity to evaluate and interpret laboratory test data by providing Newborn Screening Bioinformatics Fellows
  • Creating a Newborn Screening Data Analytic Workgroup focused on sharing and harmonizing best practices and solutions
  • Enhancing data-driven decision making in the newborn screening community by designing and developing data science resources to address newborn screening-specific data challenges

In March 2019, APHL and CDC hosted a national meeting in Atlanta, GA to broaden their efforts, engage state newborn screening programs in a collective data analytics initiative, and discuss progress toward enhanced disease detection utilizing improved data analytics resources and technologies specific to newborn screening.

The meeting provided a forum for participants to discuss the needs around biochemical and molecular screening methodologies and their related data analytics requirements, as well as the value of data to improving health outcomes.

This national dialogue will help guide CDC development of an in-house data analytics resource that will improve the interpretation of biochemical and molecular test results.

This activity was supported by Cooperative Agreement #NU60OE000103-04 funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the Department of Health and Human Services.

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Are antibiotics making printers great…again?

Are antibiotics making printers great...again? | www.APHLblog.org

By Eric Ransom, APHL-CDC Antimicrobial Resistance Fellow

Let’s be honest: printers have never been that great. These frustrating devices turn what should be a simple office task into a game of chance. Is there paper? Did it jam? Can I get by without replacing the toner cartridge… again? Ugh! I personally cannot wait until this archaic technology sails off into the sunset. Goodbye frustration and hello forestation.

You can imagine my surprise when I heard a PRINTER could help fight one of the most significant public health threats of our time: antibiotic resistance. That’s right. The end of the antibiotic era looms, but hope lies with a printer!

To be fair, this is not your ordinary printer that puts ink to paper. This is a bioprinter that “prints” antibiotics! The technology ultimately helps clinicians decide which antibiotic is most likely to be effective in treating an infection. Prescribing the proper antibiotic is key to saving lives today and preserving antibiotics for tomorrow.

More specifically, the bioprinter makes antibiotic panels for broth microdilution susceptibility testing, a gold-standard method in clinical and public health microbiology. To make an antibiotic panel, the bioprinter dispenses minuscule amounts of antibiotics into a 96-well plate containing liquid that supports microbial growth. Microbiologists can then add a patient’s microbe to the plate and observe which antibiotic (or combination of antibiotics) inhibits growth. If an antibiotic inhibits growth on the plate, chances are good that it will also inhibit growth in the person. Results are shared with clinicians so they can prescribe the best antibiotic(s) to treat the infection. What makes the bioprinter unique is that it can easily make antibiotic plates with complex antibiotic combinations and new-to-market antibiotics. The latter is especially exciting given it can take years before new-to-market antibiotics are included on commercially available plates and systems found in most hospital laboratories.

In 2018, the Centers for Disease Control and Prevention announced a pilot program to implement the bioprinter technology in the Antibiotic Resistance Laboratory Network, a consortium of 56 public health laboratories that aims to rapidly detect and respond to antibiotic resistance. The pilot program already uses the bioprinter to offer expanded antibiotic susceptibility testing for hard-to-treat infections in four public health laboratories: Wisconsin State Laboratory of Hygiene, Minnesota Department of Health Public Health Laboratory, Wadsworth Center Laboratories and Tennessee State Public Health Laboratory. This susceptibility testing is free, compliant with patient testing regulations, and available for all qualifying isolates from any hospital laboratory. The testing is also performed within three working days to quickly assist clinicians with therapeutic management.

The pilot program has already begun susceptibility testing with a new drug combination (aztreonam-avibactam) against Enterobacteriaceae producing a metallo-β-lactamase (MβL). These are some of the most resistant microbes, and there are very few effective treatment options. To qualify for this particular testing, isolates must be non-susceptible to all current β-lactam antibiotics (including either ceftazidime-avibactam or meropenem-vaborbactam). Moving forward, the pilot program will expand testing to include other highly resistant microbes and new-to-market antibiotics.

So how exactly does the bioprinter pilot program work in practice? Let’s say a hospital patient has symptoms of a serious infection. Samples from the patient are tested in the hospital’s laboratory to identify the responsible microbe and to determine possible treatment options. If the microbe is found to be highly resistant and clinicians are in need of additional treatment options, the microbe is sent to one of the four public health laboratories piloting the bioprinter program. Microbiologists there can use the bioprinter to print plates for testing the newest antibiotics to see what, if any, are effective in treating the patient’s infection. Results are then returned to clinicians where the patient is being treated.

Implementation of the bioprinter in the AR Lab Network has the potential to be truly impactful. First, clinicians are given a resource to find new, effective treatment options for their patients’ most resistant infections. Second, compiled data from this pilot program can be used to improve antibiotic prescribing, capture national antibiotic efficacy, help establish antibiotic breakpoints and even inform infection control and prevention practices.

The bioprinter pilot program is a remarkable step forward in the fight against antibiotic resistance. It is important to realize though that this crisis still requires comprehensive long-term intervention including discovery of new antibiotics, development of new diagnostics, and an unequivocal commitment to antibiotic stewardship in healthcare and beyond. In the short term, though, a printer might just be exactly what the doctor ordered.

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The LRN’s job is to prepare, detect and respond. But what exactly does that mean?

The LRN’s job is to prepare, detect and respond. But what exactly does that mean? | www.APHLblog.org

As one of the nation’s emergency response systems, the Laboratory Response Network (LRN) is known for detecting and responding to all types of health threats. Its mission is to maintain an integrated network of laboratories that can respond to bioterrorism, emerging infectious diseases, chemical terrorism and other public health emergencies. During an emergency, one of the LRN’s most critical functions is ensuring that US laboratories have the right test at the right time.

When a public health threat emerges, one of the first tasks of public health systems is to make sure that laboratories are able to test for the causative agent, whether biological, chemical or radiological. However, the Centers for Disease Control and Prevention (CDC) quickly works with these laboratories and other partners to get the tests in place using equipment found in LRN reference laboratories. For instance in 2014, CDC partnered with the Department of Defense (DoD) and the LRN deployed a test for Ebola. The network  rolled out training and other programs to ensure quality testing and reporting. This approach ensured laboratories such as the Texas Department of State Health Services Laboratory was ready to test for Ebola before it struck. Similarly, CDC quickly worked with the Food and Drug Administration (FDA) to secure an Emergency Use Authorization (EUA) assay for Zika and again deployed the test via the LRN to laboratories across the country. Where training was needed, CDC partnered with APHL to deliver these skills to public health laboratory scientists. Whatever the testing needs may be, the LRN jumps into action to ensure testing capabilities are in place for an effective response.

So what exactly does the LRN do to support and expedite development and deployment of such tests? The LRN:

  • Collaborates with the specialized laboratory developing the test. This may be a laboratory at a government agency, such as CDC or DoD, or a private entity.
  • Optimizes the test to ensure it provides reliable results, operates on instrumentation available nationwide and integrates with systems for reporting of test results.
  • Prepares and submits a request to the FDA for use of the test on an emergency basis. This Emergency Use Authorization (EUA) details test detection limitations, reagents, instruments, authorized users and other technical information.
  • Issues proficiency tests to assure laboratory scientists across the network are capable of properly performing the tests and generating accurate results.
  • Quickly deploys the test to LRN laboratories with the capability to test for the agent.
  • Provides a mechanism for standardized electronic data exchange of test results.
  • Facilitates communications across partners such as APHL, DoD, FBI and other stakeholder.

Here are examples of public health emergences where the LRN made sure the proper test was at the proper laboratory just in time to initiate the response:

As a founding partner, APHL recognizes the value of the LRN and celebrates its accomplishments across the last 20 years. The LRN, via funding from CDC’s Public Health Emergency Preparedness Cooperative Agreement, provides a warm base for public health laboratories, positioning them to respond to all threats including the 2009 pandemic influenza and the recent opioid epidemic. Though many Americans have never heard of the LRN, the Network is nonetheless there, keeping us safe from threats known and unknown.

For more information about the Laboratory Response Network, visit CDC’s “The Laboratory Response Network Partners in Preparedness” webpage.

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5 most unexpected and unique partnerships forged through the Zika response

Top 5 most unexpected and unique partnerships forged through the Zika response | www.APHLblog.org

By Kelly Wroblewski, director, infectious disease, APHL

While the US public health system has been through a number of infectious disease responses in the last decade, the Zika response was unique in both its duration and complexity. For more than 20 months (January 22, 2016 – September 29, 2017), CDC’s Emergency Operations Center was activated to respond to the US’s largest Zika virus outbreak. State and local public health departments began their responses as early as November 2015 and continue to respond today. Through the uncertainty, public health built relationships with new partners and found opportunities for unique collaborations with old partners.

APHL explores the journey in detail in our new book, A Complex Virus, A Coordinated Response: Public Health Laboratories Battle Zika. For APHL and public health laboratories, five unique and unexpected partnerships forged during the Zika response proved critical to progress on this journey. Learn about them below:

1. Vector Control

Vector control is, of course, a time-honored, if underappreciated, public health partner; after all, CDC was established in the 1940s in response to malaria. The Zika response reinvigorated those relationships as public health laboratories and vector control programs worked together on the best methods and approaches for vector surveillance (i.e., testing vectors to see if the pathogen is present) and insecticide resistance testing (testing insects to determine which sprays will be most effective). Once local transmission occurred in Florida and Texas, vector control relied on public health laboratory test results to focus mosquito control efforts on the areas where transmission was most likely to occur.

2. Maternal and Child Health and OB/GYNs

While public health laboratories may connect with maternal and child health departments for other types of testing like newborn screening, it is unusual for these groups of public health professionals to work together in response to an emerging infectious disease. Many OB/GYNs treating patients concerned about their risk of Zika infection and exposure were used to working with clinical and commercial laboratories for prenatal testing, but had never ordered a test at a public health lab. Public health labs across the country worked with their maternal and child health counterparts to ensure they had the most up-to -date information on accessing testing, knew how to correctly complete test request forms and could interpret test results to pass along to appropriate healthcare providers.

3. Commercial Laboratories

At public health laboratories, Zika testing represented a massive increase in workload. Beyond demand from patients worried about their exposure, there were multiple new tests to validate, different tests required for different patient populations and often a single specimen from which multiple laboratories needed to conduct multiple tests. In April 2016, commercial laboratories began performing Zika testing, thus distributing some of the specimen volume, taking some of the load off public health labs and offering OB/GYNs access to testing from laboratories with whom they had established relationships.

4. The Zika Coalition (So. Many. Partners.)

This group, led by the March of Dimes, was comprised of more than 70 member organizations committed to the health and wellbeing of US children and families. It was established in response to Congress’ delay in approving the Obama Administration’s emergency request for funding to respond to the Zika crisis in the US. The request was made in in February of 2016 and was not approved by Congress until that September. The Zika Coalition visited congressional offices, wrote letters and testified before the Senate Appropriations Committee advocating for and applying pressure to ensure public health got the funding necessary to respond.

5. CDC, FDA and CMS – Tri-agency Taskforce for Emergency Diagnostics

Although partnerships with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are neither unique nor unexpected during an infectious disease emergency response, the Zika response did change their nature with the establishment of the Tri-agency Taskforce for Emergency Diagnostics. Throughout the 20 month response, as we learned more about how the Zika virus behaved, APHL worked with these agencies to ensure that laboratories had access to the best possible tests through the emergency use authorization (EUA) process (FDA’s role), guidance on how to use those tests (CDC’s role) and assurance that the tests were being implemented in compliance with quality testing standards (CMS’s role). This taskforce remains intact for future responses.

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Lab Culture Ep. 10: Public health labs do that?!

Lab Culture Ep. 10: Public health labs do that?! | www.APHLblog.org

Public health laboratories do a great deal of work that impacts the daily lives of everyone in America. Do you know exactly how much they’re doing? The first episode produced by members of the Emerging Leader Program cohort 10 looks at some of the work performed by public health lab scientists.

You can listen to our show via the player embedded below or on iTunes, Stitcher or wherever you get your podcasts. Please be sure to subscribe to Lab Culture so you never miss an episode.

Links

(*indicates ELP cohort 10 member)

Water Quality Testing

Interviewer: *Amanda Hughes, program manager of ambient air quality monitoring, State Hygienic Lab at the University of Iowa

Experts:
Michael Schueller, assistant director of operations, State Hygienic Lab at the University of Iowa
Nancy Hall, program manager, Environmental Microbiology, State Hygienic Lab at the University of Iowa

Water quality testing at the State Hygienic Lab at the University of Iowa

Alcohol Testing

Interviewer: *Gitika Panicker, microbiologist, Centers for Disease Control and Prevention

Expert: Laura Bailey, director, Office of Alcohol Testing, Arkansas State Public Health Laboratory

Alcohol testing at the Arkansas State Public Health Laboratory

 

Influenza Testing

Interviewer: *Shondra Johnson, laboratory information management system administrator, Missouri State Public Health Laboratory

Expert: Jessica Bauer, molecular unit manager, Missouri State Public Health Laboratory

Seasonal influenza testing at the Missouri State Public Health Laboratory

 

Bioterrorism

Interviewer: Avi Singh, food lab lead microbiologist, Washington State Public Health Laboratory

Expert: *Denny Russell, bioterrorism coordinator, Washington State Public Health Laboratory

 

Foodborne Outbreak Linked to Flour

Interviewer: *Rebecca Lindsey, Whole Genome Sequence Project lead, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC)

Experts:

Heather A. Carleton, bioinformatics team lead, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC)
Samuel J. Crowe, National Outbreak Reporting System team lead, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC)

E. coli outbreak linked to flour (CDC)

Shiga Toxin–Producing E. coli Infections Associated with Flour

 

 

 

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Lab Culture Ep. 8: Leaders for a TB free world

Every year on March 24, APHL recognizes World TB Day, a day to focus on the valuable work of our members and partners. While tuberculosis is often considered a disease of the past, it is resurging and presenting significant new public health challenges including drug resistance. This World TB Day, we are sharing an insightful conversation between two TB laboratory leaders: Dr. Marie-Claire Rowlinson, assistant laboratory director, Bureau of Public Health Laboratories, Florida Department of Health and Dr. Beverly Metchock, team lead, TB Reference Laboratory, CDC Division of Tuberculosis Elimination.

You can listen to our show via the player embedded below or on iTunes, Stitcher or wherever you get your podcasts. Please be sure to subscribe to Lab Culture so you never miss an episode.

Below you will find a complete transcript of this conversation as well as links to more information on TB.

Recorded March 16, 2018

Marie-Claire Rowlinson: Hi, Bev. Good to talk to you today.

Beverly “Bev” Metchock: Hi, how are you?

Marie-Claire: I’m good. So looking forward to having a conversation today. Couple of questions about TB and how you ended up being interested in TB. So maybe I can start and ask you: As a kid, how did you find yourself interested in science? Were you curious about the world around you? Did you always know that you wanted to work in a science related career?

World TB DayBev: Well, that’s an interesting question, and really not that I can remember. I was a good student overall, and I did enjoy biology and chemistry in high school. I certainly didn’t enjoy physics! And when it came time to choose a college major I was very pragmatic. I chose medical technology because I knew I could get a job. So I kind of went into the field very uninformed as to what it would be. But then when I took my first medical micro course as a junior in college, I just fell in love with clinical micro and I knew that’s where I wanted to go. And I was fortunate in my med tech rotation in a tertiary care medical center, micro was the first lab that I rotated through before chemistry and hematology and blood bank. And so I was able to start working in the micro lab on evenings and weekends, and I was offered a position – a full time position – when I graduated so I was very fortunate to find what I wanted to do, to sort of just fall into it. How about you?

Marie-Claire: Kind of similar. I mean, I think I was as a kid was always interested in biology and space and medicine and those kinds of things. But actually it wasn’t until high school that my biology teacher, when I was looking at degree courses to take, told me that she thought I would be a great microbiologist. And I don’t know if she knows what a profound impact that she’d go on to have in my life. I think it also happened to coincide with the film, Outbreak. I don’t know if you remember that. I think I really wanted to be a disease detective, but, sort of like you say, I don’t think I really knew exactly what I was doing when I got into medical microbiology. But I think I always dreamt of having a career in science, and I still have some parts of that dream yet to realize. I think it’s an exciting field to be in.

Marie-Claire: Can you think of a person or an event that inspired or encouraged you to get involved with public health laboratories or TB testing specifically?

Bev: Well, when I was working in the hospital as a medical technologist in the micro laboratory, I actually became interested in hospital acquired infections and antibiotic resistance. Personally what happened is my father had a hospital acquired – post-surgical infection – at the actual hospital where I worked. And then I was fortunate to be able to work – at a different situation – but work with the infection control practitioners and be the microbiologist that was involved in an outbreak of aminoglycoside-resistant Enterobacteriaceae in the neonatal intensive care unit. So I got very interested in hospital acquired infections, hospital epidemiology and antibiotic resistance. And, to be quite honest, I was one of the people who thought people don’t get TB anymore in the United States. So my original career path when I finally did go back to continue my education was in a school of public health because I wanted to get a background in epidemiology and statistics, and I thought that was the path I was going to go. But then when I got my job at Grady Memorial Hospital in Atlanta I had to become an “expert in TB” out of necessity because there was a lot of TB in Atlanta and since then there’s been no going back. I’ve been in and been involved in TB diagnostics since. How about you?

Marie-Claire: Well, I think that’s so fascinating that you say that because I, sort of in a way, have a similar story. So my Ph.D. is in parasitology, so not related to TB at all, but I did do quite a lot of international work when I was doing my Ph.D. I guess I was kind of always interested in tropical medicine or at least diseases that disproportionately affected disadvantaged populations and people who maybe didn’t have access to adequate healthcare including lab testing. But similarly like you, growing up in the UK, TB felt like a disease of the past or from another country. As you said, I think we all know that that’s not the case. And, in fact, in the UK there’s been a real resurgence of the disease in recent years. And when I was thinking about this podcast, doing some research, I saw that there were 10.5 cases per 100,000 population in 2015 (this is in the UK), but this was down from 15.6 per 100,000 in 2011 compared to three cases per 100,000 in the US in 2015. So, I mean, at that time when I was in the UK, I didn’t really think about TB, but now that I know so much about it and realize that it really is a great challenge in clinical diagnostics and in public health.

Bev: Similarly when I was at Grady that was a time when TB was “resurging” in the United States. And so there was a lot of pressure in the micro laboratory to do quicker diagnosis, to implement the newer technology that was available. And I remember in a matter of a few years when we went from just doing culture on solid media to transitioning to the radiometric broth method to incorporation of DNA probes for identification and then nucleic acid amplification for direct specimen testing. And I recall the days when… I remember one particular situation where a physician called and said, “This can’t this can’t be right.” And I said, “What do you mean?” He said, “We only sent the cultures down three days ago and you’re telling us it’s TB.” So the transition from taking weeks to months to just a few days – to be so very involved in that transitioning in such a short period of time and thinking about how long we have been doing things the same way and then all of a sudden there’s like this revolution. It’s a very exciting field to be in.

Marie-Claire: Absolutely. Can you think of any people or mentors who particularly inspired you? I have a couple to mention, for sure.

Bev: Well, like I said, at Grady the medical director of the micro lab, Dr. John McGowan, and then the supervisors in the laboratory, Portia Williams and David Lonsway, they taught me a lot and we’re all very involved together with working out how we were going to handle the situation in the medical center and working with the folks in the Georgia Public Health Laboratory to coordinate testing. Obviously, it was before I was at CDC, but working with the people here at CDC to coordinate testing that was being done here at CDC so we can get results as rapidly as possible. There’s a lot of people that were involved, and one I particularly remember as well was a hospital epidemiologist at the time, Hank Blumberg, who was a very young enthusiastic person who we worked really closely with his team in infection control and hospital epidemiology. How about your folks?

Marie-Claire: Well, I was quite lucky. When I came to the US to do my post-doctoral fellowship at UCLA, I sort of knew that I wanted to go into public health and actually Dr. Ed Desmond really encouraged me whilst I was doing my postdoc to go into public health and mentored me at the California state lab for two weeks. He arranged for me to go for a visit there for two weeks and spend that time with him. And I’m sure as the listeners out there know, Ed Desmond is a pretty renowned TB lab expert, so I was lucky to have him as one of my first mentors and he’s still a mentor to me and we still get to work together quite often. So that’s exciting. And then I suppose… I actually worked at APHL after I did my postdoc and I was in the global health program. So I was doing quite…although it was mostly focused on HIV there was still a big TB component so that was also a big driver for me in terms of public health labs and TB. But when I left APHL and joined Florida Department of Health, I was actually hired by Dr. Max Salfinger, who, again, people may be very familiar with his name, he’s a pretty renowned TB expert as well and has been an incredible mentor to me. And even though he actually moved to National Jewish Health shortly after I joined the Florida Department of Health we still – so this is six years later – we still have bi-weekly TB calls. So that’s made a big impression on me and been a big reason why TB has been a big part of my work. I think I would lastly mention also that the lab here in Florida really is a state of the art lab, always pushing the envelope, being involved in studies, and I think having such a strong lab in Florida and also having such a great collaborative relationship with our TB control program has been instrumental in my work in TB and my interest in TB. And I particularly I love working with Dr. David Ashkin, he’s our TB medical director for the Florida Department of Health, and he’s really inspiring and really dedicated. And actually, he does an amazing job of engaging the lab in the work that the TB control program does. So we really get to hear about the clinical side of TB care and the importance that the lab results have on patient care because sometimes we’re in the lab and we never actually hear about patients, but he really involved us in that and all the other facets of TB control and I find that really fascinating.

Bev: Yeah, I think that’s one of the most enjoyable parts of my job – is interacting with our public health laboratory partners, but state and local TB control practitioners, the TB clinicians… And TB laboratory work, I mean we are so important in the whole team of taking care of a patient and I think in some respects that’s unique in the clinical micro world that we are involved so much in laboratory results. And I think that the clinicians that we deal with understand that and treat us as part of the diagnostic team. So that’s the part I really enjoy of my position here. Being part of a team.

Marie-Claire: Yeah. And that’s the same feeling we have here and even the bench – I know the bench techs really feel a part of that team as well like everybody is involved in that process. So it’s really good.

Marie-Claire: Do you remember what first drew you into TB? Or was it really just being at Grady and being in Atlanta and seeing the resurgence of TB and TB cases?

Bev: I was drawn in out of necessity – to be able to do what needed to be done. But it was an interesting time because technology was changing, we were dealing with a lot of cases and trying to implement new testing, new technology in the laboratory. Like I said earlier, I would have never thought I would end up working with TB, but once I started it was really something I really enjoyed and being involved in that.

Marie-Claire: Yeah, I think once you start working on TB you realize how interesting it is. I think I love it because it’s so interesting for so many reasons. I mean, you think about it being such an ancient disease that you think about history, music, art, literature, I mean it’s steeped in TB references. So I can go back to books that I read when I was younger and be like, “Oh, there was a TB reference in there!” or  “That composer died of TB” or “He was writing this piece of music or painting this painting when he was afflicted with the disease.” So I think for me that’s really interesting. And then from another standpoint the fact that people can be exposed to TB but never develop symptoms or maybe only become symptomatic under certain situations later on. That makes it difficult to diagnose. And now with multidrug resistant TB and extensively drug resistant TB and things like coinfection with HIV, it’s driving more disease and driving morbidity with disease making, I think, accurate and timely diagnosis even more important. So I think all of those challenges for me make it really interesting, and so with this goal of TB Elimination I feel that we’ve got our work cut out for us.

Bev: Yes we do.

Marie-Claire: And I suppose I have to say again, for me being drawn into TB and why I’ve stayed interested in this field as well is that working in that team with these really dedicated people every day – the TB nurses and so forth in all the counties – are just so dedicated.

Bev: Yeah and that’s the thing. You know, if you don’t get outside the lab, you don’t realize that. But the dedication of all the folks who work with patients who have TB. And I think that’s why I enjoy when we have the National TB Controllers conference in the National Laboratory meeting that all those folks get together. It’s such a strong… it’s such a good feeling and a good meeting, and you meet your peers and people you talk to on the phone you meet them in person and everybody’s working on the same team. It is a really rewarding opportunity that I have here to have this job.

Marie-Claire: Absolutely. Can you… Thinking of that kind of thing, can you think of a specific case or situation where you really felt the impact of your work? Or your lab, the impact for you or your lab… the impact that your lab had on a community or a patient. I guess being at CDC even more broadly you have a national impact on TB lab diagnostics.

Bev: Yeah, I don’t want to really mention any specific cases. There are certain cases I can recall from my days at Grady and in certain cases that we’ve been involved with here with laboratory testing at CDC. But I think… we feel that the group here in the reference laboratory, I think we feel the impact all the time. We get phone calls from physicians, phone calls from TB control programs, obviously from the laboratory asking about testing. And once we implemented our molecular detection of drug resistance testing service I think we demonstrated that referral of specimens or isolates worked within the United States and we can get results out in relatively good real time that really impact decision making around particular patients. So whether it’s… somebody is a caregiver in a nursery and we can say fairly reliably it’s not drug resistant TB within a day or two versus letting them know “yes, indeed you have a case that’s drug resistant TB” and we know it’s going to be resistant to these other drugs, that the physicians can make good decisions about how they’re going to treat that patient. And I think how we impacted that kind of decision making. When we started the testing service – when before we started and we were talking to experts about “this is what we’re going to do,” one of the questions I was asked was, “Well, how many specimens do you think you’re going to get?” And I honestly didn’t know. I didn’t know if folks were going to use the service, if they’re going to trust the results or are still going to do the rapid molecular testing and still wait for the traditional growth based drug susceptibility testing. And that has – I think it’s a little bit changed over time – but I think now that’s one of the first things that folks go to and I know for you in Florida, you do the Hain tests and it’s the same. It’s the same type of thing that they get immediate information that either I would think either makes them feel relieved or knowing that now I can make a decision about what I’m going to do next with this patient based on the rapid tests that the laboratories can do.

Marie-Claire: Yeah. Even if it’s just to hold medications while waiting for something right. I think that for turnaround time makes a huge difference. I know you know, but we use the MDDR service a lot and it’s really amazing. And our physicians and providers that are big users of the MDDR really rely heavily on the information that comes from that. It’s a really wonderful service.

Bev: I appreciate that.

Marie-Claire: Yeah, I mean, for us, I feel that being in a state, we sometimes have these cases in situations where we can really feel the impact of our work. And as I’ve said before really being involved as a team with our TB control program. If I think at a community level… the Jacksonville Bureau of Public Health Labs is in the county, Duval County, and we actually had quite a serious TB outbreak. I don’t know if you remember back in 2012.

Bev: Right.

Marie-Claire: It infected the homeless population in Duval County, and so over the last six years the county has really made great strides in this patient population. And one of the ways that the lab has been involved in this effort is, in fact the last two years, our lab has been doing IGRA testing for their shelter card program. The shelter card program is the system to routinely perform testing and assessment for symptoms of TB for Duval County’s homeless clients that are seeking admittance to area shelters. So this has had an important impact on preventing transmission of TB amongst the homeless population, and so for the lab to be a part of that effort has been has been really interesting and really great, and having the opportunity to implement IGRA at our lab and see it have an impact has been really interesting. And then if I think about specific cases, as you said, there are several cases that come along every year that are really interesting, but I always have one that comes to mind because we had a really complicated patient a few years ago that – despite having no risk factors – he had disseminated TB. In the lab we were able to confirm diagnosis. We were able to confirm that it was disseminated TB by confirmation of TB from several body sites including CNS involvement and it actually turned out that strain had an rpoB mutation which was associated with low level resistance to rifampin. And so the TB control program actually ended up treating this case as MDR TB and I think over the course of time the lab received 20-plus specimens on this patient. And so, about a year and a half after that, it was actually amazing, we got to meet that person.

Bev: Oh, wow!

Marie-Claire: Yeah, and hear his survivor’s story. You know, sometimes we actually do get to meet the patients. And that was that was really inspiring for me. And he was successfully treated.

Bev: Well that’s great. So that’s an advantage of you being at the state… that you are closer to the patients than… we’re another step removed from them. So yes, I’ve not had that opportunity. But yeah that sounds like a…

Marie-Claire: Even hearing the survivor stories at the NTCA conferences, I think as you said, makes the job really rewarding because you see that all of the efforts of the lab, of the program, treating physicians and clinicians, everybody that’s a part of that team and helping these patients. So when you actually get to hear the survivors on the stage it’s pretty amazing it’s pretty powerful.

Bev: I absolutely agree. To hear the stories and what they have to go through with taking drugs that have side effects or the stigma of having TB and all those things. It really is. If you didn’t understand. You know, sometimes we have folks in the lab who are doing research or visitors and they don’t really understand the full effects, and that when they hear those stories they really understand it, and it’s inspiring what these patients who have TB go through and it’s great that they’re willing to share their stories.

Marie-Claire: I agree. Well thank you, Bev, it was really great talking to you today!

Bev: Well, thank you, Marie-Claire! I really appreciate the chance to have this conversation.

Marie-Claire: We’ll keep working towards a TB free world.

Bev: We can only hope.

 

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APHL: President Trump’s FY 2019 budget request is “disheartening and disappointing”

APHL: President Trump’s FY 2019 budget request is “disheartening and disappointing” | www.APHLblog.org

APHL: President Trump’s FY 2019 budget request is “disheartening and disappointing” | www.APHLblog.org

The Association of Public Health Laboratories (APHL) is very concerned about the decline in federal funding for public health functions such as detection, surveillance and response in the administration’s budget for fiscal year 2019. “It is extremely disheartening and disappointing to see such severe cuts to public health programs at CDC, HRSA, USAID and the Department of State at a time when the services they support are most in need,” said Scott Becker, executive director of APHL. “What is more, these cuts to public health funding come after a historic bipartisan agreement between Congress and the White House to increase federal spending overall for the next two years.”

CDC cuts include:

HRSA cuts include:

Global Health Programs:

  • $1.26 billion cut to Department of State Global Health Programs which includes funding provided to CDC for PEPFAR; and
  • $1.11 billion cut to USAID Global Health Programs.

While the majority of the president’s budget proposal is grim for public health, there were a few areas that are not as dark. APHL was pleased to see that the budget request designates $175 million to CDC to address the growing opioid crisis. Additionally, funding for the Global Disease Detection Program would increase by $51 million and funding for the Public Health Emergency Preparedness program would increase by $4.5 million.

As Scott Becker explained, “The director of the president’s Office of Management and Budget said, ‘the budget is a messaging document.’ In that case, the message to the American people seems to be, ‘Good luck if there is an outbreak or other public health emergency because federal early warning and response programs won’t be there to help you through.’”

APHL will continue work with Congress to assure that funding levels continue at the much-higher amounts provided in previous years. Adequate levels of federal support for state and local laboratory contributions are critical to the nation’s public health security.

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APHL responds to “banned words,” remains focused on CDC’s budget

APHL responds to “banned words,” remains focused on CDC’s budget | www.APHLblog.org

By Scott J. Becker, executive director, APHL

Recent news concerning limits on language permissible in CDC budgetary communications has drawn considerable attention in the media. As a longstanding partner of CDC, APHL shares its commitment to science-based work to protect the public’s health and improve its health status. We are heartened by CDC Director Fitzgerald’s statement that CDC remains committed to evidence-based work described using all appropriate language, and we are confident that CDC will continue to serve all communities, including those most vulnerable and diverse.

Our primary focus is on ensuring that CDC receives funding that will enable APHL members – local, state and territorial public health laboratories – to do the vital work necessary to detect and respond to public health threats. We feel strongly that, while the words CDC uses in their budget submission are extremely important, the funding levels are at least equally deserving of our attention.

We look forward to working with the Administration and Congress to ensure the best scientific evidence is used in all public health decision making and that all public health professionals are able to use language that appropriately conveys the public health policies and programs that allow for improvement for the health of our nation.

You can also read Scott Becker’s letter to the editor of The Washington Post on this matter.

 

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What you need to know about harmful algal blooms

What you need to know about harmful algal blooms | www.APHLblog.org

By Julianne Murphy, intern, Environmental Health

Warm weather brings nature walks, picnics and sunny days by the shore, but it can also bring unwanted changes to your favorite beach. As the temperature rises, lake and ocean waters can turn from blue to mossy green as algae proliferates in unsightly and potentially harmful algal blooms.

What are harmful algal blooms?

Algae are plant-like organisms of one or more cells that use sunlight to make food. Together they can form colonies called algal blooms in both marine and freshwater systems. Some of these algal blooms are hazardous to health, but not all algal blooms are harmful.

Harmful algal blooms may release toxins at concentrations unsafe to humans and animals and may drastically reduce oxygen available to aquatic life. In fresh water bodies, cyanobacteria, aka “blue-green algae,” can produce dangerous cyanotoxins; in saltwater or brackish water, acid-generating plankton – dinoflagellates and diatoms – can pose a health threat.

Should I be concerned about algal blooms?

Algal blooms can pose a risk for human and animal health. People and animals can become ill through eating, drinking, breathing or having direct skin contact with harmful algal blooms and their toxins. Illnesses vary based on the exposure, toxins and toxin levels. Public health and environmental laboratories test samples from harmful algal blooms to confirm the presence and level of toxicity. Remember, not all algal blooms are harmful.

How are public health officials responding to the increase in algal bloom events?

As climate change events amplify conditions favorable to algal blooms, public health scientists are studying when and where associated illnesses are occurring and how to mitigate the effects of exposure. Their efforts have led to increased laboratory testing and electronic surveillance measures at the state and federal level.

For example, public health and environmental officials in Alaska have been tracking and testing harmful algal blooms. The Alaska Harmful Algal Bloom Network, a collaboration of the Alaska Department of Health and Social Services (DHSS) and regional monitoring programs, analyzes fish kills, unusual animal behaviors and other related phenomenon to provide early warning of developing coastal marine blooms. DHSS scientists analyze human specimens for illnesses associated with harmful algal blooms, such as paralytic shellfish poisoning (PSP) caused by saxitoxins. PSP is a potentially fatal poisoning with no treatment except supportive care. Samples from symptomatic patients are forwarded to the Centers for Disease Control and Prevention (CDC) for confirmatory testing as needed. Testing of asymptomatic individuals may be included in future studies.

In addition, Alaska Department of Environmental Conservation (DEC) laboratories test marine shellfish meat samples protect public health and safety as well as for regulatory purposes, illness investigations and non-commercial shellfish upon request. This monitoring literally saves lives.

David Verbrugge, chief chemist at the DHSS Division of Public Health, explains the value of Alaska’s testing of harmful algal blooms, “[Laboratory analysis] helps us to understand the nature of PSP exposures: frequency of occurrence, confirmation when lacking meals to test, and the presence or absence of toxins in asymptomatic co-exposed groups. It also allows us to let people know what they are eating before they eat it.”

Is the CDC involved in testing and surveillance for harmful algal blooms?

Yes, only for freshwater. In 2016, CDC created the One Health Harmful Algal Bloom System to provide a voluntary, electronic reporting system for states, federal agencies and their partners. Using the system, which integrates human, animal and environmental health data using a One Health approach, public health departments and their environmental and animal health partners can report bloom events, and human and animal cases of associated illness. Members of the public may report a bloom event or a case of human or animal illness to the One Health system by contacting their local or state health department.

What is the outlook for future testing and surveillance of harmful algal blooms?

As climatic conditions become more favorable to development of harmful algal blooms, state and local health departments will have to ramp up surveillance and testing to protect public health and to preserve local revenue from beaches. These actions will come with a price tag, requiring action at all levels of government. Resources can be leveraged through collaboration to research and expand clinical testing capacity for these persistent health threats.

Learn More:

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