New Lab Matters: The promise and challenge of newborn screening in 2019

New Lab Matters cover depicts a newborn baby

Newborn screening is a public health success story, ongoing for 56 years. On the one hand, new treatment and laboratory testing options open up the possibility of expanded screening panels. On the other hand, testing laboratories and follow-up providers are generally under-resourced and straining to keep pace with growing workloads. But as our feature article shows, scientists are working diligently to improve the accuracy and precision of existing tests and to bring on new disorders, even as they continue the high-stakes work of screening tens of thousands of infants a year.

Here are just a few of this issue’s highlights:

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Lab Culture Ep. 19: Dr. Mona Hanna-Attisha- Storytelling and the Flint Water Crisis

Michelle Forman interviewing Dr. Mona Hanna-Attisha.

Dr. Mona Hanna-Attisha, author of What the Eyes Don’t See: A Story of Crisis, Resistance, and Hope in an American City, joins us for an interview about the importance of storytelling in public health. Did Dr. Mona’s successful use of narratives allow Flint’s story to be as resilient as the people who lived it?

Listen here or wherever you get your podcasts.

Links

Is water in Flint safe to drink? It’s not just a question of chemistry. [Op-ed by Dr. Mona Hanna-Attisha]

What the Eyes Don’t See: A Story of Crisis, Resistance, and Hope in an American City

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2019 APHL Annual Meeting: Day 3

Dr. Mona Hanna-Attisha speaks at the APHL annual meeting

Today was day three of the annual meeting! We started the day with awards ceremony and concluded with the member assembly, listening to many great speakers in between. For many, the highlight was the Dr. Katherine Kelley Distinguished Lecture delivered by Dr. Mona Hanna-Attisha. Dr. Mona is a pediatrician, scientist, researcher, activist and author of What the Eyes Don’t See. Her research and the work of her team exposed the deliberate effort to cover up the Flint water crisis and the lead poisoning of Flint, Michigan’s children.

Listen here or wherever you get your podcasts:

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APHL honors public health leaders at 2019 annual meeting

Award winners

The Association of Public Health Laboratories (APHL) is pleased to announce the winners of its annual awards for outstanding achievements in laboratory science, creative approaches to solving today’s public health challenges and exemplary support of laboratories serving the public’s health. Awardees were honored during a ceremony at the 2019 APHL Annual Meeting in St. Louis, Missouri. Congratulations to all award winners!

The following awards were presented:

Healthiest Laboratory Award – This award is given to an APHL member laboratory that is committed to safety, environmental process, environmental policy and employee health and wellness.

Thomas E. Maxson Education, Training and Workforce Development Award – This award was established in August of 1998 in memory of Dr. Maxson, and honors an APHL member who is a public health or clinical laboratory practitioner, trainer or educator who has made significant contributions to public health laboratory practice by creating, delivering or developing continuing education opportunities, programs, policies or practices for the laboratory community. For the first time, the Maxson award was presented at the Public Health Laboratory Training Conference in April.

On the Front Line Award – This award honors an individual or organization outside of the association’s membership who makes significant contributions to APHL, its membership and mission.

Emerging Leader Award – This award honors an individual whose leadership has been instrumental in one or more advances in laboratory science, practice, management, policy or education within his or her first five to ten years in the profession.

Leadership in Biosafety and Biosecurity Award – This award honors a laboratory scientist with over 10 years of related service in the field of biosafety and biosecurity in a state and/or local public health laboratory.

Silver Award – This award honors a laboratory scientist with 10 to 15 years of service in a governmental public health laboratory that is recognized as a leader both within their home laboratory as well as external to their laboratory. This year we have two recipients of the Silver Award.

Gold Standard Award – This award recognizes an individual who makes or has made significant contributions to the technical advancement of public health laboratory science and/or practice.

Champion of the Public Health Laboratory Award – This award honors federal, state and local elected officials and executive branch employees who have recognized the importance of state and local governmental laboratories that perform testing of public health significance either through support of legislation or federal agency decisions.

Presidential Award – This award recipient is selected by APHL’s president and given to individuals who have made significant contributions to the Association’s work to promote policies that strengthen public health laboratories. This year there are two award winners.

Lifetime Achievement Award – This award recognizes an individual who has established a history of distinguished service to APHL, made significant contributions to the advancement of public health laboratory science or practice, exhibited leadership in the field of public health, and/or positively influenced public health policy on a national or global level.

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2019 APHL Annual Meeting: Day 2

Networking at the APHL annual meeting

It was another great day at the annual meeting in St. Louis! As the attendees interviewed on this episode will share, some of the highlights included Poster Speed Dating, learning about new technology from exhibitors and, of course, networking.

Follow #APHL on Twitter and Instagram for more updates!

Listen here or subscribe wherever you get your podcasts:

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2019 APHL Annual Meeting: Day 1

2019 Annual Meeting: Day 1 | www.APHLblog.org

We’re in St. Louis for the 2019 APHL Annual Meeting! This episode is a round-up of all the excitement of the first day. It was fascinating and exhausting, just as the annual meeting should be.

Follow #APHL on Twitter and Instagram for more updates!

Listen here or subscribe wherever you get your podcasts:

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Nigerian malaria researcher joined the Milwaukee laboratory for a cultural exchange beyond the bench

Nigerian malaria researcher joined the Milwaukee laboratory for a cultural exchange beyond the bench | www.APHLblog.org

Nearly two years ago, a malaria researcher named Dr. Abel Olusola “Sola” Idowu left Lagos, Nigeria and emerged into the frosty, winter air of Milwaukee, Wisconsin. Milwaukee, a quintessential Midwestern American city, may not be associated in many people’s minds with global health, but this Fulbright Scholar knew better: this journey was the opportunity of a lifetime.

Sola had pursued a Fulbright Visiting Researcher scholarship to continue his PhD research, which focused on how Plasmodium falciparum develop resistance to antimalarial drugs and the public health implications of such resistance. Not only would he be exposed to new ideas and techniques, but it was also “an opportunity for cultural exchange that would promote understanding among people of different nations,” Sola recalls. He chose Milwaukee for the opportunity to access the research facilities and learn from the staff at the University of Wisconsin-Milwaukee (UWM) and City of Milwaukee Health Department Laboratory (MHDL), which he knew would help expand his technical capabilities and enhance the quality of his research.

My research at MHDL enabled me to learn new skills, especially in molecular techniques, and to appreciate processes in a public health laboratory with the kind assistance of the wonderful staff of the laboratory,” Sola said. “The state-of-the-art facilities at MHDL and the UWM College of Health Sciences were an eye opener for me. Overall, it was a rewarding experience that enabled me to accomplish my doctoral research objectives.” It also helped him build a network with other researchers, as his research collaborations extended beyond Milwaukee to the Malaria Branch of the US Centers for Disease Control and Prevention (CDC) in Atlanta and the Wadsworth Center, the New York State Department of Health’s laboratory.

As he had foreseen, though, his research findings weren’t the only lessons he took away from his time in the US: Sola formed new relationships, both professional and personal, and experienced firsts such as surviving a Wisconsin winter, eating new American cuisine, volunteering at a local food pantry and Habitat for Humanity, and visiting historic sites in New York, Philadelphia, Milwaukee and Chicago.

I returned to my country with fond memories of my time in the US and look forward to (the) future opportunity to visit again,” Sola said.

Building a Culture That Grows More than Pathogens

Supporting research and experiences like Sola’s is part of MHDL’s larger, ongoing efforts to develop a strong laboratory workforce—both locally and globally—and cultivate a culture that encourages staff to work beyond the laboratory bench.

Over the last five years, MHDL has hosted internships and research rotations for over 60 local students, and, in addition to countless student tours, the laboratory’s leadership and staff routinely participate in career fairs, academic and community outreach events. MHDL has also hosted several international professional and student groups, including Nigerian public health professionals participating in the US State Department’s International Visitor Leadership Program, students from Kashiwa High School in Japan, and public health laboratory professionals from India and the Botswana Ministry of Health. The lab also hosted another University of Lagos PhD student, Dr. Nwamaka Igbokwe, who researched E. coli and antimicrobial susceptibility testing in drinking water at UW-Milwaukee and MHDL in 2012.

Laboratory Director Dr. Sanjib Bhattacharyya leads his staff by example through his involvement in global lab efforts, particularly around infectious diseases. Bhattacharyya, a current member of APHL’s Global Health Committee and the Milwaukee Global Health Consortium (MGHC) Advisory Committee, has served as CDC’s Influenza real-time PCR trainer, provided coaching and mentoring to public health laboratory professionals, Ministry of Health in Lesotho and Uganda, participated in APHL’s National Center for Public Health Lab Leadership coaching program. He has also represented APHL at the World Summit on Antivirals in Kunming, China, lectured on Influenza in India and gastrointestinal pathogen testing in Monaco. Closer to home, Bhattacharyya, an adjunct faculty at UWM, is engaged in dialogs with Zilber School of Public Health to develop public health laboratory leadership and management curriculum to integrate with school’s global health programs.

MHDL leadership and passionate laboratory staff work together to engage their local and global community to build strong public health laboratories and protect public health.

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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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Lab Culture Ep. 18: Alaska state virology lab — Freezing temps, wild animals, and extremely dedicated staff

Lab Culture Ep. 18: Alaska state virology lab -- Freezing temps, wild animals, and extremely dedicated staff | www.APHLblog.org

Every area of our country is unique in ways that make public health laboratory work vary from one state or locality to another. But just as Alaska is different from the lower-48 states in most ways, their public health lab’s work is too. Have you ever considered all the ways it might be different to work in the Alaska state lab in Fairbanks? This episode of Lab Culture reveals some of the many ways in which working in Alaska is unlike anywhere else.

Listen here, in iTunes or wherever you get your podcasts.


Jayme Parker
Manager, Virology Unit, Alaska State Public Health Laboratory (Fairbanks)

Nisha Fowler
Microbiologist, Alaska State Public Health Laboratory (Fairbanks)

Links:

Virology Unit of the Alaska State Public Health Laboratory

Alaska Department of Transportation and Public Facilities — FAQs

Alaska’s permafrost/ice lenses

 

 

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Congratulations to 2019 APHL newborn screening award winners

Congratulations to 2019 APHL newborn screening award winners | www.APHLblog.org

At the 2019 Newborn Screening and Genetic Testing Symposium in early April, APHL presented awards to leaders in the field of newborn screening. We commend the exceptional and innovative work of all those who were nominated.

The following awards were given:

George Cunningham Visionary Award in Newborn Screening – This year’s recipient was Ming Chan, PhD, retired director of the Florida Bureau of Public Health Laboratories (BPHL).

Dr. Chan has been influencing newborn screening and laboratory science in the state of Florida since 1972. In that time, under various capacities at the Florida BPHL, Dr. Chan has implemented and overseen numerous advances in environmental chemistry, clinical chemistry, newborn screening and genetic testing, and bacteriology, serology, and virology. Some of his accomplishments include:

  • adopting automation and a Laboratory Information Management System (LIMS) for the chemistry section that tracked specimen testing and interfaced analytical equipment for the electronic transfer of results;
  • development and implementation of newborn screening test procedures for the state’s Infant Screening Program in 1979; and
  • early adoption of SCID testing after its addition to the recommended uniform screening panel.

In 2008, he retired as the director of Florida’s BPHL but returned to newborn screening as a consultant to continue ensuring healthy outcomes for infants through early disease detection.

Harry Hannon Laboratory Improvement Award in Newborn Screening – This year’s recipient was Victor Skrinska, PhD, DABCC. Dr. Skrinska is the Head of Section for the metabolic laboratory and the National Newborn Screening Laboratory in Doha, Qatar since 2009.

Dr. Skrinska’s research and method development of homocystinuria screening by way of measuring total homocysteine in dried blood spots using LC-MS/MS increased the accuracy of screening, resulting in timely identification and reporting of cases. He has also spearheaded the expansion of conditions screened in Qatar to include alpha and beta thalassemias, as well as expansion to other newborn screening conditions through the use of second tier screening methods. He has championed quality improvement in the laboratory and has been able to make these achievements independent of any political crises and embargos on his country.

Judi Tuerck Follow Up and Education Award – APHL honored the efforts of two individuals this year: Barbara Ferreira, BSN, Area Service Center Director at Harbor-UCLA in California and Amy Gaviglio, MS, CGC, short-term follow-up supervisor for the Minnesota newborn screening program.

Ms. Ferreira has overseen the screening of more than 20 million babies during her 40 year tenure with the state of California. She has improved and influenced the quality of newborn screening follow-up both nationally and within her state. Her experience has advanced the quality of newborn screening at the national level through her active participation on the Education and Training workgroup of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) and the document development committee of the Clinical Laboratory Standards Institute (CLSI). Through participation in APHL’s Collaborative Improvement and Innovation Network and NewSTEPs 360 projects, she implemented measures to improve the timeliness of newborn screening in California.

Amy Gaviglio has been working in newborn screening follow-up in Minnesota for the past 12 years and has been the short-term follow-up supervisor for 10 of those years. She has been intimately involved in Minnesota’s implementation of new disorders, both for screening and for improving the communication of newborn screening results. Ms. Gaviglio has also been a leader in facilitating the initiation and maintenance of screening efforts for critical congenital heart disease in MN, and used this experience to facilitate screening in other states seeking to do the same. She has been instrumental in promoting training for implementation of DNA-based techniques in screening and her expertise has been widely acknowledged through her professional activities at the national level, which include her Vice Chair position for the CLSI Expert Panel on Newborn Screening, membership on the American College of Medical Genetics and Genomics ACT sheet workgroup, and membership on ACHDNC’s Education and Training workgroup, as well as numerous APHL committees and workgroups.

Everyday Life Saver Award – For the inaugural presentation of this award, APHL recognized the work and accomplishments of Krystal Baumert, follow-up coordinator for the Nebraska newborn screening program. Ms. Baumert has been working in newborn screening follow-up for over 25 years. Ms. Baumert was involved in the development of one of the first electronic match systems in the country to be able to accurately account for every newborn’s results, and she continues to work with PerkinElmer (Nebraska’s contracted newborn screening laboratory) to develop clear, effective daily reports for monitoring, tracking and follow-up so that none of the babies in Nebraska are lost to follow-up.

Congratulations to all award winners.

This program was supported by Cooperative Agreement # 5NU60OE000103 from 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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