Beyond COVID-19: How public health laboratories keep us safe every day

people in a group wearing masks

by Jody DeVoll, advisor, Communications, APHL

Public health laboratories have figured so prominently in media coverage of coronavirus (COVID-19) testing that one might assume that this was their sole function. In fact, they protect our health and safety through a multiplicity of programs and services that touch us at all stages of our lives. The examples below represent a mere fraction of public health laboratories’ wide-ranging activities on our behalf.

Infectious Diseases

In the spring of 2020, public health laboratories’ communicable disease divisions are operating at full steam. In addition to testing for the coronavirus, they are conducting testing and surveillance for diseases ranging from HIV, hepatitis and TB, to rabies and vaccine-preventable diseases such as measles and mumps. They also are monitoring influenza viruses to aid in selection of strains to be included in next year’s flu vaccine. As the weather warms, they will begin testing and surveillance for West Nile Virus and other mosquito-borne diseases.

Environmental Health

Environmental health divisions are balancing routine functions, such as oversight of drinking water quality, with readiness for emergencies. Any day could bring a chemical spill on the Interstate, PFAS contamination of a playground, flooding that leads to drinking water contamination or a toxic algae bloom.

A select group of laboratories, members of the National Biomonitoring Network, test human fluids for potentially harmful chemicals and their metabolites. This test data, when correlated with environmental studies, can help to pinpoint the location of health threats and assess the need for remedial action. In addition, many public health laboratories are involved in testing the quality of cannabis products, analyzing opioids common to their region and identifying the contents of locally available e-cigarette and vaping products.

Newborn Screening

Since babies continue to be born even during a pandemic, newborn screening divisions are screening newborns for heritable conditions not visible at birth. These conditions often require immediate treatment to prevent a lifetime of disabilities or death. Public health laboratories are responsible for screening of 97% of the more than four million newborns born in the US each year.

Food Safety

Food Safety teams continue to sleuth for pathogens causing outbreaks of foodborne disease. As members of PulseNet, the national laboratory network for foodborne disease surveillance, they identify the genetic signature of pathogens implicated in cases of foodborne disease. They compare these signatures with those from other cases and share the data with epidemiologists to identify and stop outbreaks before they spread. Food safety teams may also test foods suspected to have caused an outbreak and search for harmful contaminants and adulterants in human and animal food.

Public Health Preparedness and Response

Emergency Response teams are supporting the COVID-19 response while detecting and responding to other biological, chemical and radiological threats and natural disasters. Because public health laboratories form the backbone of the Laboratory Response Network (LRN), emergency response teams are veterans of the 2009 H1N1 Influenza outbreak, Severe Acute Respiratory Syndrome-related Coronavirus (SARS), Middle East Respiratory Syndrome (MERS), Ebola, Zika and other events. A team from the Texas Department of State Health Services Public Health Laboratory was the first to detect Ebola in the US.

Global Health

In addition, selected public health laboratory staff are assisting stakeholders from other countries to develop national laboratory systems, laboratory infrastructure and trained laboratory personnel. Their contributions include strategic planning, design of informatics systems, managerial and technical training, mentoring and other technical assistance.

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Maximizing next-generation sequencing in newborn screening through bioinformatics

A baby sleeps with his dad

by Samantha Marcellus, MPH, APHL-CDC Newborn Screening Bioinformatics Fellow

We live in the era of rapid access to near limitless information, over-the-counter DNA testing, and emerging gene therapies. As genetic testing, technology, and treatments advance, newborn screening must broadly utilize bioinformatics to keep up with the ever-changing rare disease arena and other areas of public health. Infectious diseases groups have widely adopted bioinformatics and next-generation sequencing over the last decade, and many laboratories have the capability to sequence and interpret the whole genome of a pathogen in hours or days. Through bioinformatics, cases can be linked via their specific strains and outbreaks can be declared more rapidly than ever before.

For the states that have harnessed the power of next-generation sequencing and bioinformatics for second- or third-tier screens, test times have been reduced and more detailed genetic information is presented to the providers. Continued and widespread implementation of bioinformatics in NBS is vital for programs to keep up with advances in technology and to offer providers and parents a more complete picture of the newborn’s risk profile.

Getting Started in Texas
In spring 2019, APHL and the Newborn Screening and Molecular Biology Branch at the US Centers for Disease Control and Prevention (CDC) selected the inaugural class of Newborn Screening Bioinformatics Fellows—myself and three others. We were matched with state public health laboratories to enhance or implement bioinformatics in their NBS programs.

At the Texas Department of State Health Services Laboratory we are building a bioinformatics program from the ground up. We are developing and refining a program to efficiently and accurately analyze and interpret severe combined immunodeficiency (SCID) next generation sequencing data. The public health bioinformatics community has already developed many great pipelines and analysis tools, so we plan to draw from those tools while adding some of our own programs to best fit the needs of Texas newborns. While all states utilize bioinformatics in different ways, we can still learn a great deal from our collective experiences.

In Texas, geneticists and consultants from around the state have shown interest in receiving sequencing information from the newborn screening program. The results from next-generation sequencing can be used to complement currently available newborn screening results and provide parents with a more complete picture of their child’s risk for a screened disease. As gene therapy is developed for an increasing number of disorders and those diseases are added to the Recommended Uniform Screening Panel (RUSP), the need for rapid DNA sequencing may increase in kind.

Looking Forward
With in-house bioinformaticians, laboratories will be able to process and analyze next-generation and Sanger sequencing data more rapidly and with programs that are designed to fit the state’s specific needs. These capabilities can allow for faster test times, higher accuracy and precision in results, and quicker result reporting. In the case of newborn screening, that could mean referring a baby to a specialist more quickly and with more complete information. Through programs such as the APHL/CDC Newborn Screening Bioinformatics Fellowship, state laboratories have the opportunity to develop staff and infrastructure to meet the evolving needs of newborn screening programs and public health in general.

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Lab Culture Ep. 21: 2019 Year in Review

Collage of photos depicting APHL's 2019 year in review

Are we already at the end of 2019?! While to many of us it felt like the year flew by, APHL staff, members and partners accomplished a LOT in an effort to protect the public’s health. In this episode, Scott Becker, APHL’s executive director, reviews some of the highlights of the year along with Gynene Sullivan, APHL’s manager of communications, who is finalizing our Annual Report.

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Links:

APHL: Lung Injury Response Associated with Vaping

CDC: Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products

APHL work on opioids

Data: Elemental to Health advocacy campaign

Supporting rapid exchange of public health data is urgent, crucial and laden with challenges

APHL AIMS Platform

Lab Matters (Fall 2019): Making Data Fly

NewSTEPs Data Repository

APHL Newborn Screening Systems Quality Improvement Projects Award Recipients Announced

APHL Public Health Laboratory Fellowships

APHL Emerging Leader Program

Lab Culture Ep. 9: What is the APHL Emerging Leader Program?

CDC: US Measles Cases and Outbreaks in 2019

“Launching Whole Genome Sequencing in the Public Health Realm” Lab Matters (Fall 2013)

Accreditation for Human and Animal Food Labs

APHL Conferences

Lab Culture Extra: Progress in Sierra Leone

APHL Global Health Program: Countries we serve

Global Laboratory Leadership Programme (GLLP)

Laboratory Response Network (LRN)

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

“Two Decades of Preparedness Excellence: The Laboratory Response Network” Lab Matters (Fall 2019)

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

Strengthening Lab Biosafety & Biosecurity

“Ensuring Readiness for Rabies in Puerto Rico” Lab Matters (Spring 2019)

“Public Health System Recovery in Full Swing: Hurricane Response in Puerto Rico and the US Virgin Islands” Lab Matters (Spring 2019)

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

APHL Publications

“US officials identify ‘strong culprit’ in vaping illnesses” Associated Press (video interview)

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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.

Subscribe and get Lab Matters delivered to your inbox, or read Lab Matters on your mobile device.

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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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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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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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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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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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