New Lab Matters: Making data fly

Cover of Fall 2019 issue of Lab Matters magazine illustrating high volume of data

In today’s technology-connected world, information moves quickly. But in the world of public health, pathogens often travel faster than the data needed to diagnose, treat and prevent illness. Reporting delays and incomplete or incompatible data delay insights into pressing public health problems. The solution? Investing in public health infrastructure and resources to rapidly deliver data to public health and clinical decision makers.

Here are a few of this issue’s highlights:

Read the full issue.

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APHL’s newborn screening program goes global

APHL's Jelili Ojodu receives the the Gerard Loeber Award for Contributions to Newborn Screening Expansion in Developing Countries

Outside of the US and other resource-rich nations, few countries have the capital, infrastructure and human resources required to sustain a newborn screening program. Despite these barriers, APHL staff and members have worked diligently to increase access to newborn screening worldwide. In recognition of these efforts, APHL Newborn Screening and Genetics Director Jelili Ojodu received the Gerard Loeber Award for Contributions to Newborn Screening Expansion in Developing Countries at the tenth in September. The award recognizes years of work by Ojodu and his team at APHL to make newborn screening the norm—not the exception—for babies around the world.

While much remains to be done to achieve this goal, as more countries consider the impact of non-communicable diseases on their populations, interest in newborn screening is growing. In the last year alone, APHL has received requests for technical assistance to develop or expand newborn screening programs from Brazil, Canada, Ghana, Jordan, India, Mexico, Nepal, Nigeria and Tanzania.

Such interest has led APHL to expand partnerships with nonprofits and governmental agencies to develop newborn screening guidance and resources. For example, APHL has collaborated with the Global Issues Working Group of the Sickle Cell Disease Coalition to develop a Global Resource Library with information on sickle cell disease activities worldwide and a public service announcement. In addition, the association worked with other sickle cell disease advocates to create tools to assess a nation’s needs and readiness to develop a sickle cell disease program. APHL is also currently collaborating with the US Centers for Disease Control and Prevention (CDC), the CDC Foundation, the Pediatric Endocrine Society and Vanderbilt University Medical Center to finalize a document detailing the capabilities required to launch a newborn screening program.

On the ground, APHL continues to extend its reach within Africa, South America, Europe and Southeast Asia. It supports development of implementation plans and strategies, offers related training and shares recent developments in US newborn screening. For example, APHL recently participated in the first Pan-African Workshop on Newborn Screening in Rabat, Morocco, where delegates reported on the status of newborn screening in their countries, and APHL discussed developing a newborn screening case registry to coordinate patient follow up, and infrastructure required for electronic data exchange of newborn screening results.

The association has also been collaborating with partners in India as that country gears up to implement universal newborn screening—a daunting undertaking in a country where 1.5 million babies are born each month. APHL recently teamed up with PerkinElmer to support newborn screening and genetics training for a fellow from Jaipur, whom APHL staff later visited to assess readiness for newborn screening new disorder implementation and technical assistance in that state. Currently, APHL is developing case studies about the benefits of newborn screening to educate physicians in Jaipur, and, with the International Neonatology Association (ISNS), is coordinating with local NBS leaders to explore opportunities to initiate an ISNS chapter in India.

Despite the challenges of strengthening newborn screening programs in countries where the service is now virtually unknown, Ojodu and his team foresee tremendous benefits to public health as well as national income and stability. Says Ojodu: “When we reduce or eliminate the symptoms of newborn screening disorders, kids are healthier, healthcare costs go down and mothers can take on income-generating work. This raises family income and, when multiplied by millions of families, also raises national income. We get a cascade of benefits from a single investment in public health.”

 

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APHL’s newborn screening program goes global

APHL's Jelili Ojodu receives the the Gerard Loeber Award for Contributions to Newborn Screening Expansion in Developing Countries

Outside of the US and other resource-rich nations, few countries have the capital, infrastructure and human resources required to sustain a newborn screening program. Despite these barriers, APHL staff and members have worked diligently to increase access to newborn screening worldwide. In recognition of these efforts, APHL

While much remains to be done to achieve this goal, as more countries consider the impact of non-communicable diseases on their populations, interest in newborn screening is growing. In the last year alone, APHL has received requests for technical assistance to develop or expand newborn screening programs from Brazil, Canada, Ghana, Jordan, India, Mexico, Nepal, Nigeria and Tanzania.

Such interest has led APHL to expand partnerships with nonprofits and governmental agencies to develop newborn screening guidance and resources. For example, APHL has collaborated with the Global Issues Working Group of the Sickle Cell Disease Coalition to develop a Global Resource Library with information on sickle cell disease activities worldwide and a public service announcement. In addition, the association worked with other sickle cell disease advocates to create tools to assess a nation’s needs and readiness to develop a sickle cell disease program. APHL is also currently collaborating with the US Centers for Disease Control and Prevention (CDC), the CDC Foundation, the Pediatric Endocrine Society and Vanderbilt University Medical Center to finalize a document detailing the capabilities required to launch a newborn screening program.

On the ground, APHL continues to extend its reach within Africa, South America, Europe and Southeast Asia. It supports development of implementation plans and strategies, offers related training and shares recent developments in US newborn screening. For example, APHL recently participated in the first Pan-African Workshop on Newborn Screening in Rabat, Morocco, where delegates reported on the status of newborn screening in their countries, and APHL discussed developing a newborn screening case registry to coordinate patient follow up, and infrastructure required for electronic data exchange of newborn screening results.

The association has also been collaborating with partners in India as that country gears up to implement universal newborn screening—a daunting undertaking in a country where 1.5 million babies are born each month. APHL recently teamed up with PerkinElmer to support newborn screening and genetics training for a fellow from Jaipur, whom APHL staff later visited to assess readiness for newborn screening new disorder implementation and technical assistance in that state. Currently, APHL is developing case studies about the benefits of newborn screening to educate physicians in Jaipur, and, with the International Neonatology Association (ISNS), is coordinating with local NBS leaders to explore opportunities to initiate an ISNS chapter in India.

Despite the challenges of strengthening newborn screening programs in countries where the service is now virtually unknown, Ojodu and his team foresee tremendous benefits to public health as well as national income and stability. Says Ojodu: “When we reduce or eliminate the symptoms of newborn screening disorders, kids are healthier, healthcare costs go down and mothers can take on income-generating work. This raises family income and, when multiplied by millions of families, also raises national income. We get a cascade of benefits from a single investment in public health.”

 

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In Puerto Rico, a new molecular bacteriology lab allows better control of foodborne outbreaks

Public health laboratory scientist performing tests

Sometimes a new facility is more than just four walls and a roof. In Puerto Rico, it was the springboard to improving foodborne outbreak response on the whole island.

In May 2019, Puerto Rico inaugurated a new molecular bacteriology laboratory at the Puerto Rico Department of Health’s laboratory (PRDOH) in San Juan. The original laboratory had been out of commission since Hurricane Maria devastated the island in 2017, and was rebuilt with APHL contracting support for repair and redesign. Today, the new laboratory boasts additional space for laboratory instruments, supplies and staff, as well as a reliable roof.

With the molecular bacteriology laboratory up and running, the PRDOH could take on a top goal: implementing whole genome sequencing (WGS) for foodborne outbreak response. WGS provides faster detection of pathogens than alternative methods, leading to rapid implementation of prevention and control measures and speedier investigation of foodborne outbreaks. Like other members of PulseNet, the US network for detection of foodborne outbreaks, the PRDOH needed to add WGS as another detection tool. Now, with a bit of assistance, it could.

APHL helped the PRDOH by procuring Illumina’s MiSeq Sequencing Platform and supporting installation and hands-on training for laboratory staff. The association also facilitated staff travel to CDC headquarters in Atlanta for a deeper dive into WGS methodology and procured BioNumerics software to upgrade the laboratory’s database so it could support WGS data. These efforts were all financed with crisis response funding from the US Centers for Disease Control and Prevention (CDC).

To date, the molecular bacteriology laboratory has made excellent progress toward implementing WGS methods for foodborne pathogens. The laboratory is now working toward validation of these methods; once validation is completed it will apply for certification under the Clinical Laboratory Improvement Amendments Program, which oversees standards and certification for human testing in the US. The laboratory also plans to introduce a new tool—matrix-assisted laser desorption/ionization – time of flight (MALDI-TOF) mass spectrometry—as a complement to WGS in the effort to detect foodborne outbreaks.

The post In Puerto Rico, a new molecular bacteriology lab allows better control of foodborne outbreaks appeared first on APHL Lab Blog.

In Puerto Rico, a new molecular bacteriology lab allows better control of foodborne outbreaks

Public health laboratory scientist performing tests

Sometimes a new facility is more than just four walls and a roof. In Puerto Rico, it was the springboard to improving foodborne outbreak response on the whole island.

In May 2019, Puerto Rico inaugurated a new molecular bacteriology laboratory at the Puerto Rico Department of Health’s laboratory (PRDOH) in San Juan. The original laboratory had been out of commission since Hurricane Maria devastated the island in 2017, and was rebuilt with APHL contracting support for repair and redesign. Today, the new laboratory boasts additional space for laboratory instruments, supplies and staff, as well as a reliable roof.

With the molecular bacteriology laboratory up and running, the PRDOH could take on a top goal: implementing whole genome sequencing (WGS) for foodborne outbreak response. WGS provides faster detection of pathogens than alternative methods, leading to rapid implementation of prevention and control measures and speedier investigation of foodborne outbreaks. Like other members of PulseNet, the US network for detection of foodborne outbreaks, the PRDOH needed to add WGS as another detection tool. Now, with a bit of assistance, it could.

APHL helped the PRDOH by procuring Illumina’s MiSeq Sequencing Platform and supporting installation and hands-on training for laboratory staff. The association also facilitated staff travel to CDC headquarters in Atlanta for a deeper dive into WGS methodology and procured BioNumerics software to upgrade the laboratory’s database so it could support WGS data.

To date, the molecular bacteriology laboratory has made excellent progress toward implementing WGS methods for foodborne pathogens. The laboratory is now working toward validation of these methods; once validation is completed it will apply for certification under the Clinical Laboratory Improvement Amendments Program, which oversees standards and certification for human testing in the US. The laboratory also plans to introduce a new tool—matrix-assisted laser desorption/ionization – time of flight (MALDI-TOF) mass spectrometry—as a complement to WGS in the effort to detect foodborne outbreaks.

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CDC findings mark a breakthrough in investigation of lung injury associated with vaping

Man vaping

Statement from Scott J. Becker, executive director, Association of Public Health Laboratories

Silver Spring, MD, November 8, 2019 — “Test results announced today by the Centers for Disease Control and Prevention mark a breakthrough in the ongoing investigation of lung injury associated with e-cigarette use or vaping.

“Laboratory scientists testing samples of lung fluid from 29 patients found vitamin E acetate present in all samples. These results provide direct evidence of this toxin at the primary site of injury within the lungs. They also complement tests conducted by the Food and Drug Administration and state public health laboratories that identified vitamin E acetate in e-cigarette or vaping products.

“While this is a big step in helping us understand what may be causing these injuries, these findings do not rule out the potential for other compounds or ingredients as contributing factors. There may be more than one cause of the outbreak.

“APHL applauds state public health laboratories, CDC, FDA and partners including the Council of State and Territorial Epidemiologists for their extraordinary collaboration and tireless and innovative work.

“This has been a complex investigation, and the work continues. But good science takes time, and public health laboratory work is critical to helping solve this important health challenge and stopping the outbreak.”

# # #

More APHL’s support of the EVALI response

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CDC findings mark a breakthrough in investigation of lung injury associated with vaping

Man vaping

Statement from Scott J. Becker, executive director, Association of Public Health Laboratories

Silver Spring, MD, November 8, 2019 — “Test results announced today by the Centers for Disease Control and Prevention mark a breakthrough in the ongoing investigation of lung injury associated with e-cigarette use or vaping.

“Laboratory scientists testing samples of lung fluid from 29 patients found vitamin E acetate present in all samples. These results provide direct evidence of this toxin at the primary site of injury within the lungs. They also complement tests conducted by the Food and Drug Administration and state public health laboratories that identified vitamin E acetate in e-cigarette or vaping products.

“While this is a big step in helping us understand what may be causing these injuries, these findings do not rule out the potential for other compounds or ingredients as contributing factors. There may be more than one cause of the outbreak.

“APHL applauds state public health laboratories, CDC, FDA and partners including the Council of State and Territorial Epidemiologists for their extraordinary collaboration and tireless and innovative work.

“This has been a complex investigation, and the work continues. But good science takes time, and public health laboratory work is critical to helping solve this important health challenge and stopping the outbreak.”

# # #

More APHL’s support of the EVALI response

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Humboldt County Public Health Lab was ready for ricin thanks to LRN

Humboldt County Public Health Laboratory team poses in the lab.

By Jody DeVoll, advisor, communications, APHL

Jeremy Corrigan, Humboldt County Public Health Laboratory manager, was having a quiet Tuesday morning when he received a call from a member of the local hazmat team. Workers processing mail at a nearby California state prison had found envelopes containing an unidentified white powder, and samples were being sent to the lab for testing. Meanwhile, 116 prison workers were under quarantine at the prison.

Fortunately, the Humboldt County laboratory was well prepared and equipped to handle this sort of request. As a member of the Laboratory Response Network for Biological Threats, the national laboratory system that protects Americans from serious biological threats, such as anthrax and plague, and from emerging infectious diseases, it is the only facility with these capabilities in this remote section of northern California.

Three Humboldt County Public Health Laboratory scientists dressed in protective gear take a selfie in the laboratory.Though the situation was urgent, Humboldt laboratory staff were careful to maintain chain of custody and preserve evidence and therefore did not immediately launch into testing when the samples arrived. Following protocol, they devoted two hours to documenting, photographing and opening the samples, handling them with the utmost care. Then they turned to testing with a time-resolved fluorescence immunoassay (TRF) followed by molecular testing.

The results were startling. Normally white powder samples come back negative for any select agent as so-called “white-powder incidents” are typically hoaxes, but these tested positive, specifically for ricin A chain. Ricin has two protein chains – ricin A chain and ricin B chain – and both must be present to have toxic effects. When ricin is used as a biothreat agent, the presence of A chain usually means testing will also reveal B chain.

Once Corrigan had the preliminary results, he called his Federal Bureau of Investigation (FBI) weapons of mass destruction contact, the US Centers for Disease Control and Prevention (CDC) and the prison incident commander. This was the beginning of an all-night phone marathon with the CDC, the FBI and local and state government officials. During a short break, Corrigan lay down for 30 minutes to rest his eyes.

Back at the laboratory early Wednesday morning, Corrigan’s next challenge was shipping. To be certain the samples were positive for ricin A chain and ricin B chain, they would have to go to a federal laboratory for confirmatory testing. However, the Humboldt laboratory did not have the materials required for shipping ricin and delivery would take up to two days. Seeing no other alternative, Corrigan placed the order for the shipping materials and waited.

Then came a call from an FBI agent traveling aboard a C-130 military transport aircraft announcing that he would be arriving within the hour to pick up the samples. Corrigan later learned that the California Governor’s Office and the FBI had prevailed upon federal authorities to make their resources available to expedite transport of the samples.

Once at the FBI laboratory, the samples tested positive for both ricin A chain and ricin B chain. The unidentified white powder from the prison mailroom was indeed ricin and the toxin was active. Using samples forwarded by the FBI, CDC laboratories reached the same conclusion. At this point, the acute phase of the incident ended for the laboratory as the focus shifted to the criminal investigation for the FBI and United States Postal Service. While not actively involved, Corrigan and his team at the Humboldt laboratory offered any additional testing support should the need arise.

Corrigan credits the Laboratory Response Network for his facility’s efficient response to the crisis. “The LRN backbone is what allowed us to respond so quickly. We had the protocols, the procedures, the partners, the proficiency and the relationships to handle the response.” He also commends the strong support he received from the county, the health department, the acting state public health officer and the Sonoma County Public Health Laboratory, which handled Humboldt’s overflow testing during the height of the crisis.

According to Corrigan, “The ricin event strengthened our existing relationships and allowed us to develop new ones.” To build upon this dynamic, he is planning a regional training that will bring together Humboldt laboratory staff, local hazmat teams, the sheriff’s department and the region’s civil support team.

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Lab Culture Ep. 20: 20 Years of the Laboratory Response Network

Stefan Saravia and Maureen Sullivan at the Minnesota Public Health Laboratory

This year marks 20 years since the inception of the Laboratory Response Network (LRN). Founded by APHL, CDC and the FBI, the LRN exists to protect the public from biological and chemical threats. How did the LRN get its start? And how has it evolved over the past 20 years? This episode of Lab Culture features an interview with two public health laboratory scientists and LRN experts.

Listen here or wherever you get your podcasts:

Maureen “Moe” Sullivan
Emergency Preparedness and Response Laboratory Supervisor
Public Health Laboratory, Minnesota Department of Health

Stefan Saravia
Biomonitoring and Emerging Contaminants Unit Supervisor
Public Health Laboratory, Minnesota Department of Health

Links:

Minnesota Laboratory Emergency Preparedness
About the Laboratory Response Network (APHL.org)
The Laboratory Response Network Partners in Preparedness (CDC.gov)
What is biomonitoring? (Video)
“Pine County man charged with government center threats, more” (StarTribune)

 

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APHL Newborn Screening Systems Quality Improvement Projects Award Recipients Announced

Newborn screening laboratory scientist at work

The Association of Public Health Laboratories (APHL) is pleased to announce the recipients of the Newborn Screening Systems Quality Improvement Projects awards. Funded through a cooperative agreement with Genetic Services Branch of the US Health and Human Services Health Resources and Services Administration (HRSA), these awards will provide funding to support continuous quality improvement (CQI) initiatives led by state newborn screening programs.

The Newborn Screening Systems Quality Improvement Projects build on the combined success of previous HRSA Maternal and Child Health Bureau funded cooperative agreements for NewSTEPs, NewSTEPs 360 and the NewSTEPs Timeliness Collaborative Improvement and Innovation Network (CoIIN). However, the Newborn Screening Systems Quality Improvement Projects are unique in that agencies are able to identify specific system challenges within their programs and request the funding necessary to work through their challenges using CQI methods. The ultimate goal is to improve their state or territorial newborn screening program thus improving health outcomes for newborns.

A total of 14 project proposals from 12 agencies were selected to participate in the QI projects, with focus areas including newborn screening timeliness, improvements to long- and short- term follow-up, patient and provider education, health information technology (HIT) and improvements to results reporting. These agencies include:

  • Alaska Department of Health and Social Services
  • Colorado Department of Public Health and Environment
  • Georgia Department of Public Health Laboratory
  • Georgia Department of Public Health Laboratory
  • Heluna Health in partnership with the California Department of Health
  • Iowa Department of Public Health
  • Louisiana Office of Public Health Laboratories
  • Minnesota Department of Health
  • New York State Department of Health
  • Puerto Rico Newborn Screening Program
  • Puerto Rico Newborn Screening Program
  • South Carolina Department of Health and Environmental Control
  • Tennessee Department of Health
  • Virginia Department of General Services/Division of Consolidated Services

In addition to funding support, awardees of the Newborn Screening Systems Quality Improvement Projects participate in a multidisciplinary collaborative network focused on improving newborn screening. They will receive customized coaching and technical assistance on designing and implementing their quality improvement project; support around data and reporting; and opportunities to disseminate their projects to other members of the newborn screening community.

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This program is 100% funded through Cooperative Agreement # UG8MC31893 from the Health Resources and Services Administration. All publications and presentations are solely the responsibility of the authors and do not necessarily represent the official views of HRSA.

The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the US and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats.

 

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