You are part of a team visiting Country A to assess their biosurveillance system, consisting of all individuals, infrastructure, policy, and other components required to effectively and accurately detect, diagnose, report, and respond to outbreaks, particularly those involving pathogens of security concern. You will meet with national-level stakeholders across multiple ministries—including the Ministry of Agriculture, Ministry of Health, and Ministry of Emergency Situations—and provincial, district, and village stakeholders at various laboratories, centers of epidemiology, infectious disease hospitals, and veterinary centers.

Please draft 10-15 questions on epidemiology (including veterinary epidemiology) and 5-10 questions on other system components, including human/animal health and laboratory diagnostics that will help the team assess the current state of the national biosurveillance system. Questions should be addressed to a mix of the stakeholders listed above. Please use the background provided below and the attached reference documents for assistance with framing your questions for Country A.

Additionally, please draft a summary paragraph introducing your questions to the client and explaining its value to the program in conducting assessments with partner countries.

BACKGROUND

Caveat lector: All information provided below was gathered through open source research conducted primarily via the internet; Country A has been fairly insular in the past and the engagement by your government client represents one of the first overtures from Country A to the USG in recent decades. Country A has engaged, in a limited fashion, with international organizations and non-governmental organizations in the past and reports from these engagements were available online, forming a portion of this background document.

Country A is a Socialist Republic governed by a President and Prime Minister belonging to the communist party. It is a member state of both the World Health Organization (WHO) and World Organization for Animal Health (OIE).Country A has had an increase in reported outbreaks of a number of infectious diseases in the past decade, including multiple pathogens on the HHS/USDA Select Agents and Toxins list.

The country is divided into 65 provinces with 88 million inhabitants. It is a lower middle-income country with basic health indicators comparable to those of middle-income countries. The Ministry of Health, through its departments, plays a significant role in provision of healthcare, disease surveillance, and disease reporting with regards to human diseases. Of the fourteen departments within the MOH, the Department of Preventative Medicine is the lead agency for disease surveillance. The Ministries of Defense and Education/Training are involved in training of staff and support of health centers. The Ministry of Agriculture and Rural Development plays a role in border and animal health surveillance. The Ministry of Emergency Services is responsible for coordination of disaster response, including biological events.

The public health care network is organized into central, provincial, district, and village levels, with the MOH at the central level. There is a mix of public and private healthcare services in Country A with the public system playing the major role in policy, prevention, research, and training. However, the private sector, including hospitals, veterinary clinics, and laboratories, is playing an increasing role in the area of health and disease surveillance. Expenditures on health services tend to be greater in wealthier provinces in the river delta region, which is associated with major health disparities between the river delta region population and all those outside the region. The main point of delivery of care is the provincial health service, governed by Provincial People’s Committees, although MOH retains central control over technical direction and monitoring. District health centers under the direction of the Provincial Health Services implement district plans and provide preventative and curative services. At the local level, commune health centers, which fall under the direction of the district health center, and village health workers provide basic care and preventative services.

Within the Ministry of Agriculture and Rural Development, six departments are responsible for disease surveillance across livestock and animal products; the Department of Veterinary Medicine is the primary agency responsible for animal disease surveillance in production species. While there is a veterinary school in the capital, few fully-trained veterinarians work in the public sector. Many of the existing veterinarians are older and there are concerns about recruitment of new veterinarians, particularly for production animal practice. The bulk of animal health workers are semi-skilled paraprofessionals with highly variable training. Many are hired on an as-needed basis as part of annual campaigns.

Common livestock species in Country A include chickens, swine, and small ruminants. Chickens and swine are commercially farmed, with a few large operations in the river delta region while sheep and goats are farmed by smallholders and backyard farmers throughout the country. Small backyard chicken flocks of layer hens are also common in the provinces outside the river delta region. Poultry products are exported from the country to neighboring countries and poultry trade is a significant industry for the country.

The country has at least two government laboratories (human clinical and veterinary) in each of its 65 provinces. Samples run at these laboratories only cost the patient or farmer a nominal amount. Unfortunately, these laboratories are in varying states of disrepair and do not always have the tests required, resulting in the increased use of private laboratories. The country has four central laboratories, of which two are for human diseases and two are for animal diseases. Of the human laboratories, one is for tuberculosis and the other is for all other pathogens; of the animal laboratories, one is for influenza and the other is for all other pathogens. Samples are brought into provincial and central laboratories by a variety of means, including mail, delivery vehicle, and sometimes by patients or farmers themselves, bypassing hospitals.

REFERENCES

1)Department of Defense Strategic Policy Guidance for the Cooperative Biological Engagement Program, Aug 21 2013

CBEP policy objectives are to:

Enhance partner country/region’s capability to rapidly and accurately survey, detect, diagnose, and report biological terrorism and outbreaks of pathogens and diseases of security concern in accordance with international reporting requirements.

  • Establish a baseline of endemic disease and pathogens of security concern
  • Assess capabilities for clinical recognition, epidemiological investigation, laboratory diagnostics, and international reporting of disease of security concern
  • Improve accuracy and timeline of reporting to international organizations regarding outbreaks of diseases of security concern
  • Encourage the use of modern diagnostics and advanced scientific methods – commensurate with the technological capacity of the country/region – to identify pathogens of security concern and potential disease outbreaks and improve local, regional, and global biosurveillance capacity
  • Strengthen and deploy biosurveillance and information systems to rapidly identify, confirm, and report deliberate biological attacks, including differentiating endemic pathogens from those introduced by accident or nefarious intent and enhancing capacity for and linkages between disease surveillance and reporting systems to national, regional, and global outbreak response systems, including emergency operations centers
  • Promote compliance with international reporting standards and guidelines under the WHO and OIE, and other relevant requirements
  • Link disease surveillance and reporting systems to national, regional, and global outbreak response systems, including multi-sectoral engagement to enhance discussion and exercise the system across the health, foreign affairs, law enforcement, responder, and other relevant communities

Requirements and Constraints

Outbreak Response

It is necessary that biological threat reduction capabilities be fully integrated with other plans and capabilities to respond to deliberate or accidental releases of pathogens or naturally occurring outbreaks of diseases. Toward this end, CBEP may assist partner countries in linking disease surveillance and reporting systems established through CBEP collaboration to national, regional, and global outbreak response systems. However, CBEP is not a consequence or a crisis management program and its activities must focus on enhancing a partner country/region’s capabilities to respond to disease outbreaks of real or potential security concern for the purpose of identifying and reporting the cause of the outbreak.

Laboratory Engagement

CBEP implementing organizations should accelerate accurate disease detection, diagnosis, and reporting, promote diagnostic approaches that the partner country will sustain, and minimize the need for containment facilities and pathogen culturing.

Integration

CBEP should seek programmatic linkages and coordinate projects and implementation plans with appropriate USG departments and agencies, regional and international organizations (WHO and OIE), and other donors to integrate efforts, avoid duplication, and transition, if necessary, long-term sustainment of capabilities.

2)World Health Organization International Health Regulations (2005) Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties, February 2011

The Core Capacities

Core capacity 1: National legislation, policy and financing

The IHR (2005) provide obligations and rights for States Parties. States Parties have been required to comply with and implement the IHR starting with their entry into force in 2007. To do so, States Parties need to have an adequate legal framework to support and enable implementation of all of their obligations and rights. In some States Parties, implementation of the IHR may require that they adopt implementing or enabling legislation for some or all of these obligations and rights. New or modified legislation may also be needed by States to support the new technical capacities being developed in accordance with Annex 1. Even where new or revised legislation may not be specifically required under the State Party’s legal system for implementation of provisions in the IHR (2005), States may still choose to revise some legislation, regulations or other instruments in order to facilitate implementation in a more efficient, effective or beneficial manner. Implementing legislation could serve to institutionalize and strengthen the role of IHR (2005) and operations within the State Party. It can also facilitate coordination among the different entities involved in implementation. In addition, policies which identify national structures and responsibilities (and otherwise support implementation) as well as the allocation of adequate financial resources) are also important.

Core capacity 2: Coordination and NFP communications

The effective implementation of the IHR requires multisectoral/multidisciplinary approaches through national partnerships for effective alert and response systems. Coordination of nation-wide resources, including the designation of an IHR NFP, which is a national centre for IHR communications, is a key requisite for IHR implementation. The IHR NFP should be accessible at all times to communicate with the WHO IHR Contact Points and with all relevant sectors and other stakeholders in the country. The States Parties must provide WHO with annually updated contact details for the national IHR Focal Point.

Core capacity 3: Surveillance

The IHR require the rapid detection of public health risks, as well as the prompt risk assessment, notification, and response to these risks. To this end, a sensitive and flexible surveillance system is needed with an early warning function is necessary. The structure of the system and the roles and responsibilities of those involved in implementing the system need to be clear and preferably should be defined through public health policy and legislation. Chains of responsibility need to be clearly identified to ensure effective communications within the country, with WHO and with other countries as needed.

Core capacity 4: Response

Command, communications and control operations mechanisms are required to facilitate the coordination and management of outbreak operations and other public health events. Multidisciplinary/multisectoral Rapid Response Teams (RRT) should be established and be available 24 hours a day, 7 days a week. They should be able to rapidly respond to events that may constitute a public health emergency of national or international concern. Appropriate case management, infection control, and decontamination are all critical components of this capacity that need to be considered.

Core capacity 5: Preparedness

Preparedness includes the development of national, intermediate and community/primary response level public health emergency response plans for relevant biological, chemical, radiological and nuclear hazards. Other components of preparedness include mapping of potential hazards and hazard sites, the identification of available resources, the development of appropriate national stockpiles of resources and the capacity to support operations at the intermediate and community/primary response levels during a public health emergency.

Core capacity 6: Risk communication

Risk communications should be a multi-level and multi-faceted process which aims to help stakeholders define risks, identify hazards, assess vulnerabilities and promote community resilience, thereby promoting the capacity to cope with an unfolding public health emergency. An essential part of risk communication is the dissemination of information to the public about health risks and events, such as outbreaks of disease.

For any communication about risk caused by a specific event to be effective, it needs to take into account the social, religious, cultural, political and economic aspects associated with the event, as well as the voice of the affected population. Communications of this kind promote the establishment of appropriate prevention and control action through community-based interventions at individual, family and community levels. Disseminating the information through the appropriate channels is also important.

Communication partners and stakeholders in the country need to be identified, and functional coordination and communication mechanisms established. In addition, it is important to establish communication policies and procedures on the timely release of information with transparency in decision making that is essential for building trust between authorities, populations and partners. Emergency communications plans need to be developed, tested and updated as needed.

Core capacity 7: Human resources

Strengthening the skills and competencies of public health personnel is critical to the sustainment of public health surveillance and response at all levels of the health system and the effective implementation of the IHR.

Core capacity 8: Laboratory

Laboratory services are part of every phase of alert and response, including detection, investigation and response, with laboratory analysis of samples performed either domestically or through collaborating centres. States Parties need to establish mechanisms that assure the reliable and timely laboratory identification of infectious agents and other hazards likely to cause public health emergencies of national and international con concern, including shipment of specimens to the appropriate laboratories if necessary.

3)Global Health Security Agenda

Prevent Avoidable Epidemics: including naturally occurring outbreaks and intentional or accidental releases by:

  • Preventing the emergence and spread of antimicrobial drug resistant organisms and emerging zoonotic diseases and strengthening international regulatory frameworks governing food safety: Act to reduce the individual and institutional factors that enable antimicrobial resistance and the emergence of zoonotic disease threats; increase surveillance and early detection of antimicrobial resistant microorganisms and novel zoonotic diseases; measurably enhance antimicrobial stewardship; strengthen supply chains; promote safe practices in livestock production and the marketing of animals; and promote the appropriate and responsible use of antibiotics in all settings, including developing strategies to improve food safety;
  • Promoting national biosafety and biosecurity systems: Promote the development of specific multi-sectoral approaches in countries and regions for managing biological materials to support diagnostic, research and biosurveillance activities, including identifying, securing, safely monitoring and storing dangerous pathogens in a minimal number of facilities while advancing global biosurveillance, and frameworks to advance safe and responsible conduct; and
  • Reducing the number and magnitude of infectious disease outbreaks: Establish effective programs for vaccination against epidemic-prone diseases and nosocomial infection control.

Detect Threats Early: including detecting, characterizing, and transparently reporting emerging biological threats early through real-time biosurveillance, by:

  • Launching, strengthening and linking global networks for real-time biosurveillance: Promote the establishment of monitoring systems that can predict and identify infectious disease threats; interoperable, networked information-sharing platforms and bioinformatic systems; and networks that link to regional disease detection hubs;
  • Strengthening the global norm of rapid, transparent reporting and sample sharing in the event of health emergencies of international concern: Strengthen capabilities for accurate and transparent reporting to the WHO, OIE, and FAO during emergencies, with rapid sample and reagent sharing between countries and international organizations;
  • Developing and deploying novel diagnostics and strengthen laboratory systems: Strengthen country and regional capacity at the point-of-care and point-of-need to enable accurate, timely collection and analysis of information, and laboratory systems capable of safely and accurately detecting all major dangerous pathogens with minimal biorisk; and
  • Training and deploying an effective biosurveillance workforce: Build capacity for trained and functioning biosurveillance workforce, with trained disease detectives and laboratory scientists.

Respond Rapidly and Effectively to biological threats of international concern by:

  • Developing an interconnected global network of Emergency Operations Centers and multi-sectoral response to biological incidents: Promote establishment of Emergency Operations Centers; trained, functioning, multi-sectoral rapid response teams, with access to a real-time information system; and capacity to attribute the source of an outbreak; and
  • Improving global access to medical and non-medical countermeasures during health emergencies: Strengthen capacity to produce or procure personal protective equipment, medications, vaccines, and technical expertise, as well as the capacity to plan for and deploy non-medical countermeasures. Strengthen policies and operational frameworks to share public and animal health and medical personnel and countermeasures with partners.

4)OIE Tool for the Evaluation of Performance of Veterinary Services (PVS), sixth edition, 2013: Excerpt from Introduction.