Public Health Laboratory System Research Articles

Strengthening the US Public Health Lab System: Summary of Coronavirus Disease (COVID-19) After Action Review Workshop.

The COVID-19 pandemic highlighted the significance of public health laboratories across the United States, while also revealing weaknesses in the laboratory system. To identify actionable recommendations for building a more resilient public health laboratory system based on previously published lessons learned from COVID-19. In April 2023, the Association of Public Health Laboratories, in cooperation with RAND , convened a 1.5-day after action review workshop of approximately 30 public health laboratory stakeholders to reevaluate priorities, improve processes, and affect policies. Analysis of workshop discussions identified 5 priority areas and 19 recommendations related to clarifying laboratories' unique role and promoting workforce capacity/agility, technology, and collaboration with governmental and nongovernmental partners. Within the identified priority areas, workshop participants described how the recommendations would address challenges encountered during COVID-19 and contribute to strengthening the system. As the risk of novel infectious diseases persists and grows, the importance of maintaining laboratory response capabilities is likely to increase. Addressing the system's weaknesses will require active engagement of laboratories and the many stakeholders who depend on them, along with consistent, adequate funding to strengthen and sustain capabilities.

Seroprevalence and Genotype Diversity of Hepatitis C Virus in the Caribbean-A Review.

Hepatitis C (HCV) continues to present a global public health challenge, with no vaccine available for prevention. Despite the availability of direct-acting antivirals (DAAs) to cure HCV, it remains prevalent in many regions including the Caribbean. As efforts are made to eliminate HCV from the region, existing barriers, such as the high cost of DAAs and lack of an established database of HCV cases within the Caribbean, must be addressed. This review seeks to assess epidemiologic trends (seroprevalence and genotypic diversity) of HCV in the Caribbean and identify gaps in surveillance of the disease. The literature for the period 1 January 2005 to October 2022 was reviewed to gather country-specific data on HCV across the Caribbean. References were identified through indexed journals accessed through established databases using the following keywords: Caribbean, genotype distribution, and general epidemiologic characteristics. The usage pattern of HCV drugs was determined from information obtained from pharmacists across the Caribbean including Jamaica. The prevalence of HCV in the Caribbean was 1.5%; the region should therefore be considered an area of moderate HCV prevalence. The prevalence of HCV among intravenous drug users (21.9-58.8%), persons living with HIV/AIDS (0.8 to 58.5%), prisoners (32.8-64%), and men who have sex with men (MSM) (0.8-6.9%) was generally higher than in the general population (0.8-2.3%). Genotype 1 (83%) was most prevalent followed by genotypes 2 (7.2%) and 3 (2.1%), respectively. Less than 50% of countries in the Caribbean have reliable or well-curated surveillance data on HCV. Drugs currently being used for treatment of HCV infections across the Caribbean include Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir). Some of these drugs are only available in the private sector and are sourced externally whenever needed. While trends point to a potentially higher prevalence of HCV, it will require well-designed random surveys to obtain better estimates of the infection seroprevalence, supported by strong public health laboratory systems. DAAs that are pan-genotypic should translate into treatments that are affordable, accessible, and available to improve cure rates and reduce the HCV burden in the population.

Development and national scale implementation of an open-source electronic laboratory information system (OpenELIS) in Côte d’Ivoire: Sustainability lessons from the first 13 years

PurposeCôte d'Ivoire has a tiered public health laboratory system of 9 reference laboratories, 77 laboratories at regional and general hospitals, and 100 laboratories among 1,486 district health centers. Prior to 2009, nearly all of these laboratories used paper registers and reports to collect and report laboratory data to clinicians and national disease monitoring programs. ProjectSince 2009 the Ministry of Health (MOH) in Côte d'Ivoire has sought to implement a comprehensive set of activities aimed at strengthening the laboratory system. One of these activities is the sustainable development, expansion, and technical support of an open-source electronic laboratory information system (OpenELIS), with the long-term goal of Ivorian technical support and managerial sustainment of the system. This project has addressed the need for a comprehensive, customizable, low- to no-cost, open-source LIS to serve the public health systems with initial attention to HIV clients and later expansion to cover the general population. This descriptive case study presents the first published summary of original work which has been ongoing since 2009 in Côte d’Ivoire to transform the laboratory information management systems and processes nationally. ImpactOpenELIS is now in use at 106 laboratories across Côte d’Ivoire. This article describes the iterative planning, design, and implementation process of OpenELIS in Côte d'Ivoire, and the evolving leadership, ownership, and capacity of the Ivorian MOH in sustaining the system. This original work synthesizes lessons learned from this 13-year experience towards strengthening laboratory information systems in other low resource settings.

Establishment of the Namibian National Public Health Institute: laboratory systems strengthening

Abstract In 2020, the Namibian Ministry of Health and Social Services (MoHSS) and the Robert Koch Institute (RKI) started a twinning project with the long-term goal of establishing a Namibia Institute of Public Health (NIPH). A fundamental pillar of an NIPH is a fully operational Public Health laboratory system. Due to the COVID-19 pandemic, the need for strengthening the existing Namibian Laboratory system became eminent. Following the Intra-Action Review (IAR) of the COVID-19 response in Namibia in 2020, three regional diagnostic laboratories, at points of entry, were assessed. The major issues identified were long delays between sampling of both suspected cases and COVID-19 patients and receiving test results due to extended sample transport times to the central laboratory in Windhoek and the overload of the central capacities due to overwhelming numbers of samples during peak times. This led to the establishment of three SARS-CoV-2 PCR diagnostic laboratories through procurement and installation of equipment, provision of consumables/reagents, and on-site training of laboratory technicians with continued virtual technical support. Consequently, an important reduction of the diagnosis turnaround time was achieved. Of great value was the technical support given by the staff at the central laboratory during the trainings allowing for immediate validation of the newly established laboratories and to strengthen the communication between regional laboratories and the central laboratory. The Namibian molecular diagnostic capacities have increased in important regions in Namibia and will provide data to support the health policies of the future NIPH. New diagnostic protocols will be developed to foster the sustainability of the established laboratories and could support the implementation of genomic surveillance capacities. Finally, stronger relationships were built through these joint activities, which will support and the next steps of the establishment of the NIPH. Key messages • Supporting and Strengthening the Namibian Public Health Laboratory system. • Long-term goal of establishing a Namibia Institute of Public Health (NIPH).

Giants on Clay Feet-COVID-19, infection control and public health laboratory networks in England, the USA and (West-)Germany (1945-2020).

SummaryIn early 2020, COVID-19 exposed differences in public health laboratory systems’ testing abilities. Focusing on Germany, the USA and the UK between 1900 and 2020, this article argues that studying the distinct evolution of laboratory infrastructures is critical to understanding the history of infection control and the limits of template-based reforms in global health. While each analysed laboratory infrastructure was shaped by a unique national context, neoliberal visions of lean public services and declining resources led to significant reform pressure from the 1970s. The US Center of Disease Control’s model of epidemic intelligence provided an attractive template to integrate resources and focus planning on preparedness scenarios. It also helped justify cuts to local laboratory infrastructures. Effects were uneven: in the USA and the UK, improved integration failed to compensate for local laboratory cuts and loss of autonomy. By contrast, Germany’s subsidiary principle allowed for limited federal integration while leaving local services mostly intact.

Laboratory capacity strengthening in Zimbabwe as part of the COVID-19 response: what has worked? What still needs to be done?

The COVID-19 pandemic was declared a Public Health Emergency of International Concern on January 30, 2020. The government of Zimbabwe through the Ministry of Health and Child Care set up the COVID-19 national preparedness and response plan in which the laboratory was a key pillar. The implementation of PCR testing, genomic sequencing, and the establishment of quality management systems during the COVID-19 response strengthened the capacity of the public health laboratory system in responding to the pandemic. Here we present the different strategies taken by the government that strengthened laboratory capacity, the lessons learned during the COVID-19 response, and recommendations on how the capacity can be sustained and leveraged for outbreak response in the future.

Testing surge capacity—A Canadian COVID-19 experience, Ontario's surge capacity for the first wave

As of September 1st 2020, over 42 000 COVID-19 cases and 2 800 COVID-19-related deaths have been confirmed in Ontario, Canada. Testing enables quick identification of cases, which results in effective contact tracing and containment of virus spread. Faced with a lack of surge capacity in the public health laboratory system at the start, health officials implemented changes to testing and laboratory infrastructure to significantly expand testing capacity to include 1) the centralization of resources; and 2) the integration of private and independent labs into the COVID-19 testing program. With these changes, testing capacity has grown from approximately 4,000/day in March to 32,000/day by the end of August, 2020. Eligibility criteria for testing has expanded to increase sensitivity and include testing of asymptomatic individuals. Along with previous outbreaks, the COVID-19 pandemic has highlighted the need for integration of testing surge capacity in public health systems before outbreaks occur. This paper details the development and implementation of a COVID-19 testing program in Ontario from January 2020 to September 2020 during the first-wave of the pandemic. The goal of this analysis is to explore the historical precedence, present influences, and future implications of the program.

Who Gets Cured? COVID-19 and Developing a Critical Medical Sociology and Anthropology of Cure.

In this opinion piece, I argue that a sociology and anthropology of cure is accelerated by various features of the scientific and social responses to the COVID-19 pandemic. I illustrate how the pandemic has made the general public rethink popular notions of “cure,” foregrounded ethical dilemmas and inequalities in who has access to “cures” and also revealed deep uncertainties correlated to a future where there is no such thing as cure anymore. Such developments in the pandemic response illustrate the need for a critical interdisciplinary agenda to interrogate the social, ethical, cultural, economic, political and technological innovations of cures nationally and internationally. The race for a vaccine for the SARS-CoV-2 virus that causes COVID-19 illustrated the urgency to find a cure during a pandemic but also deep anxieties, as the general public realizes they have to leave behind absolutes of “cure” and deal with uncertainties of who now gets cured? In medical sociological and anthropological literature, absolutes of cure have long been criticized in research, amongst others, focusing on changing ideas of: inequalities in who becomes incurable or curable, for example, during the HIV/AIDS epidemic (Schoepf, 2001; Nguyen, 2010), inclusion in clinical trials (Petryna, 2009), or due to genomic advancements (Inhorn and Wentzell, 2012); environmental, lifestyle and embodied (epigenetic) risks which have reconceptualised understandings of nature and nurture (Kavanagh and Broom, 1998; Lock, 2013; Gale et al., 2016), as “situated biologies” mean rethinking notion of bounded bodies in favor of how biology is affected by environment (Niewohner and Lock, 2018); expectations and hopes of new biotechnologies and artificial intelligence that bring to the fore the way in which scientific advancements can politically shape subjectivities, temporality, emotions and care (Brown and Michael, 2003; Brown, 2005; van der Niet and Bleakley, 2020); “promissory futures” of biomedical and scientific innovations, such as in the field of regenerative medicine, become correlated to neoliberal policy-making and economic investments (Brown et al., 2006; Selin, 2008; Morrison, 2012); novelty, for instance in epigenetics, becomes socially constructed (Pickersgill, 2020); clinical forecasting is relationally imbedded and negotiated in clinical practices (Timmermans and Stivers, 2018); and dealing with uncertainty of conditions with no cure, where instead experiments become perilous options for patients (Fox, 2020). The above is just a sliver of the breadth and depth of knowledge built on a continuum of cures, but the very notion itself of “a cure” and how the concept is changing, is never explicitly questioned as such. Yet, as illustrated, just as comprehension of COVID-19 is marked by social understandings of inequalities in infection, environment, prevention and intervention (Lupton and Willis, 2020; Trout and Kleinman, 2020), knowledge of cure is socially and culturally informed too. Public health pandemic responses to COVID-19 have focused on scaling up disease prevention and control efforts, public health information, laboratory systems and development of private and public partnerships to develop diagnostics, therapies, antiretrovirals and vaccines. Furthermore, critical social commentaries have been noted in terms of ethics of access to: care; life-saving equipment like ventilators; therapies (e.g., remdesivir); vaccines; as well as debunking the idea of recovery and immunity. Presently, with hopeful vaccines on the horizon (Horton, 2020), a “critical bioethics of cure” is developing, informed by differing ethical norms and values in society, associated to who gets access to vaccines and how they will be allocated (see, Emanuel et al., 2020). For example, in the United Kingdom (UK), the disability community has warned of overt discrimination in lack of ethical inclusion in pandemic preparedness and response (Armitage and Nellums, 2020), “ableism” (Campbell, 2009) of foregrounding of able body in withholding, triage or rationing of care as cure, as well as warning of “social” deaths in our disablist language use, and real deaths in revoking of rights in health and social care policies (Abrams and Abbott, 2020; Tidball et al., 2020). Disability studies researchers, while long critical of the medical model and curative imperative (Clare, 2017), are pointing to an unethical “curation” or “social sorting” (Grover and Piggott, 2010) in how the able body now gets protection against an infection, access to critical care, therapies and vaccines (Scully, 2020), according to a new curative “imperative of health” (Lupton, 1995) or distributed “logic” of cure (Mol, 2008). The logic of cure describes how an “imperative of cure” becomes normalized in our social and cultural lives and is increasingly commodified but not distributed equally nor a choice. Neoliberalism and promises of late modernity have been incorporated in such a logic of cure, in terms of a “biopolitics of cure” in how patients, doctors, researchers, pharmaceutical companies and financial investors create momentum around specific infectious diseases, genetic disorders, chronic or neurological conditions and now in its acceleration for the general population during the COVID-19 pandemic.

Advancing the Public Health Laboratory System Through Partnerships.

Advancing the Public Health Laboratory System Through Partnerships.

International Public Health Laboratory Twinning: An Innovative Approach to Strengthen the National Health Laboratory System in Uganda, 2014-2017.

International initiatives to strengthen national health laboratory systems in resource-poor countries are often hampered by unfamiliarity with the country's health laboratory environment and turnover of international partners during the initiative. This study provides an overview of, and lessons learned from, the use of a laboratory long-term partnership approach (ie, "twinning") to strengthen the national public health laboratory system in an international setting. We focused on the partnering of the Uganda Ministry of Health Central Public Health Laboratory (CPHL) with the New Mexico State Public Health Laboratory to help the CPHL become Uganda's national public health reference laboratory (Uganda National Health Laboratory Services [UNHLS] Institute) and leader of its nascent Uganda National Health Laboratory Network (UNHLN). Via twinning, CPHL leadership received training on laboratory leadership and management, quality systems, facility management, and the One Health environmental strategy (ie, that the health of persons is connected to the health of animals and the environment), and drafted a National Health Laboratory Policy, UNHLS Institute business plan, and strategic and operating plans for the UNHLS Institute and UNHLN. The CPHL is now responsible for the UNHLS Institute and coordinates the UNHLN. Lessons learned include (1) twinning establishes stable long-term collaborations and (2) success requires commitment to a formal statement of activities and objectives, as well as clear and regular communication among partners.

Strengthening laboratory capacity for detection of respiratory viral pathogens through the Global Health Security Agenda (GHSA) framework.

BackgroundEndemic and emerging respiratory viruses are a threat to public health, and a robust public health laboratory system is essential to ensure global health security.ObjectiveThis program sought to expand molecular laboratory testing capacity to detect a broad range of respiratory pathogens in clinical respiratory specimens collected during disease surveillance and outbreak investigations.MethodsAs a part of the Global Health Security Agenda (GHSA), the United States Centers for Disease Control and Prevention utilised the equipment and training infrastructure already in place at the World Health Organization National Influenza Centers to expand testing capacity for respiratory viruses in laboratories in GHSA partner countries. This was done through the provision of quality assured reagents, including multiplex platforms and technical guidance for laboratory staff, as well as the assessment of laboratory testing accuracy.ConclusionEarly findings illustrated that GHSA laboratories have been able to expand testing capacity using specimens from routine surveillance, as well as from outbreak situations.

Global Health Security Implementation: Expanding the Evidence Base.

Global Health Security Implementation: Expanding the Evidence Base.

Combatting the Increasing Threat of Vector-Borne Disease in the United States with a National Vector-Borne Disease Prevention and Control System.

.Reported cases of vector-borne diseases in the United States have more than tripled since 2004, characterized by steadily increasing incidence of tick-borne diseases and sporadic outbreaks of domestic and invasive mosquito-borne diseases. An effective public health response to these trends relies on public health surveillance and laboratory systems, proven prevention and mitigation measures, scalable capacity to implement these measures, sensitive and specific diagnostics, and effective therapeutics. However, significant obstacles hinder successful implementation of these public health strategies. The recent emergence of Haemaphysalis longicornis, the first invasive tick to emerge in the United States in approximately 80 years, serves as the most recent example of the need for a coordinated public health response. Addressing the dual needs for innovation and discovery and for building state and local capacities may overcome current challenges in vector-borne disease prevention and control, but will require coordination across a national network of collaborators operating under a national strategy. Such an effort should reduce the impact of emerging vectors and could reverse the increasing trend of vector-borne disease incidence and associated morbidity and mortality.

Contributions of the US Centers for Disease Control and Prevention in Implementing the Global Health Security Agenda in 17 Partner Countries.

The Global Health Security Agenda (GHSA), a partnership of nations, international organizations, and civil society, was launched in 2014 with a mission to build countries’ capacities to respond to infectious disease threats and to foster global compliance with the International Health Regulations (IHR 2005). The US Centers for Disease Control and Prevention (CDC) assists partner nations to improve IHR 2005 capacities and achieve GHSA targets. To assess progress through these CDC-supported efforts, we analyzed country activity reports dating from April 2015 through March 2017. Our analysis shows that CDC helped 17 Phase I countries achieve 675 major GHSA accomplishments, particularly in the cross-cutting areas of public health surveillance, laboratory systems, workforce development, and emergency response management. CDC’s engagement has been critical to these accomplishments, but sustained support is needed until countries attain IHR 2005 capacities, thereby fostering national and regional health protection and ensuring a world safer and more secure from global health threats.

Building and Rebuilding: The National Public Health Laboratory Systems and Services Before and After the Earthquake and Cholera Epidemic, Haiti, 2009-2015.

.Before the 2010 devastating earthquake and cholera outbreak, Haiti’s public health laboratory systems were weak and services were limited. There was no national laboratory strategic plan and only minimal coordination across the laboratory network. Laboratory capacity was further weakened by the destruction of over 25 laboratories and testing sites at the departmental and peripheral levels and the loss of life among the laboratory health-care workers. However, since 2010, tremendous progress has been made in building stronger laboratory infrastructure and training a qualified public health laboratory workforce across the country, allowing for decentralization of access to quality-assured services. Major achievements include development and implementation of a national laboratory strategic plan with a formalized and strengthened laboratory network; introduction of automation of testing to ensure better quality of results and diversify the menu of tests to effectively respond to outbreaks; expansion of molecular testing for tuberculosis, human immunodeficiency virus, malaria, diarrheal and respiratory diseases; establishment of laboratory-based surveillance of epidemic-prone diseases; and improvement of the overall quality of testing. Nonetheless, the progress and gains made remain fragile and require the full ownership and continuous investment from the Haitian government to sustain these successes and achievements.

Integrating Advanced Molecular Technologies into Public Health.

Advances in laboratory and information technologies are transforming public health microbiology. High-throughput genome sequencing and bioinformatics are enhancing our ability to investigate and control outbreaks, detect emerging infectious diseases, develop vaccines, and combat antimicrobial resistance, all with increased accuracy, timeliness, and efficiency. The Advanced Molecular Detection (AMD) initiative has allowed the Centers for Disease Control and Prevention (CDC) to provide leadership and coordination in integrating new technologies into routine practice throughout the U.S. public health laboratory system. Collaboration and partnerships are the key to navigating this transition and to leveraging the next generation of methods and tools most effectively for public health.

Ebola 2014: Clarifying the Confusion—A Public Health and Laboratory Containment Perspective

The 2014 West African Ebola outbreak has spawned a chain of preparedness planning in the United States (U.S.). Although clinical and public health laboratories are hard at work preparing for the presentation of highly suspect patients, a number of issues have been identified that need to be addressed. Guidelines have been developed and distributed; procedures need to be revised and training needs to occur. It is imperative that public health laboratory systems support their clinical infrastructure. The purpose of this article is to share information the authors have gleaned from their research and involvement in the 2014 public health response.

An innovative educational approach to professional development of medical laboratory scientists in Botswana.

PurposeTo address the shortage of laboratory scientists in Botswana, an innovative, one-year academic bridging program was initiated at the University of Botswana, to advance diploma-holding laboratory technicians towards becoming laboratory scientists holding Bachelor’s degrees. An evaluation was conducted, which described the outcomes of the program and the lessons learned from this novel approach to meeting human resource needs.MethodsThis was a cross-sectional, mixed-methods evaluation. Qualitative interviews were conducted with graduates of the Bachelor of Science (BSc) Medical Laboratory Sciences (MLS) bridging program, along with the graduates’ current supervisors, and key informants who were involved in program development or implementation. The quantitative data collected included a written questionnaire, completed by program graduates, with a retrospective pre-test/post-test survey of graduates’ confidence, in terms of key laboratory competencies.ResultsThe BSc MLS bridging program produced thirty-three laboratory scientists over 3 years. There was a significant increase in confidence among graduates, for specified competencies, after the program (P<0.05). Graduates reported acquiring new skills and, often, accepting new responsibilities at their former workplace, particularly in relationship to leadership and management. Five graduates enrolled in advanced degree programs. Most graduates assumed increased responsibility. However, only two graduates were promoted after completing the training program. The lessons learned include: the importance of stakeholder involvement, the need for data to identify local needs, financial sustainability, catering for the needs of adult learners, and ensuring a technically challenging work environment, conducive to the application of skills learned during training.ConclusionA strong public health and clinical laboratory system is essential for the rapid detection and control of emerging health threats, and for patient care. However, there is a need to adequately prepare laboratory human resources, to ensure efficient and effective laboratory services. Advancement of laboratory technicians towards becoming laboratory scientists, through a bridging program, can provide the necessary skills within a short time.

Milwaukee Laboratory System Improvement Program (L-SIP)

The Laboratory System Improvement Program (L-SIP) of the Association of Public Health Laboratories aims to improve state public health laboratory (PHL) system performance through continuous quality improvement. We successfully applied this state assessment tool to a local PHL (LPHL) system by tailoring it to reflect local system needs and created an LPHL system definition explaining how a local system differs from, yet complements, a state system. On November 18, 2010, 75 stakeholders from 40 agencies assessed the Milwaukee, Wisconsin, PHL system, capturing themes, strengths and weaknesses of the system, and scores for each of the 10 Essential Public Health Services. A Laboratory Advisory Committee analyzed assessment results to identify a strategic focus of research and workforce development and define an action plan, which is now being carried out. Milwaukee's L-SIP process is effectively improving LPHL system research and workforce development while raising community awareness of the system.

Public Health Laboratory Systems: At the Crossroads

Public Health Laboratory Systems: At the Crossroads