Progress in Implementing Biosafety in Clinical and Research Laboratories in Vietnam; 2010-2017

Background Outbreaks of disease in humans and animals and their cross-species transmission pose a significant risk to the health of the population, poultry, fisheries and livestock, and could influence business, economy, tourism, and reputation of a country [1]. To prevent and protect population from bio-terror (from the act of bioterrorism) or bio-error (accidental or incidental release of pathogens) three Internationally mandated regulations including the International Health Regulations (IHR) 2005 (WHO 2005); ABSTRACT Background: Biosafety and biosecurity compliant laboratories play a crucial role in the successful implementation of the International Health Regulation (IHR) 2005 in a country. Biosafety implementation in laboratories require legislative framework (laws, guidelines, and standards), a roadmap for biosafety program implementation, biosafety training, monitoring and supervision

implemented globally [2]. Under IHR 2005, states are legally bound to improve the core capabilities "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade" [2,3].
IHR 2005 requires countries to strengthen eight-core capacities (national legislation, coordination and communication, surveillance, response, preparedness, risk communication, human resource capacity and laboratory), on four hazards (zoonotic events, chemical events, food safety, radiation emergencies), at the points of entry to a country. Strengthening laboratory core capabilities to comply with IHR 2005 would require i) availability of laws, regulations and guidelines, ii) designation of responsible entity for biosafety and biosecurity, iii) biorisk assessment, iv) availability and accessibility of biosafety guidelines, v) biosafety training, vi) national classification of microorganism by risk group, and vii) laboratory biosafety certification program [4,2].
Laboratories play a vital role in the successful implementation of IHR 2005 in all three key areas including "prevent", "detect" and "respond". This includes i) diagnosis of endemic or exotic infectious diseases in humans or animals, ii) detection of contamination of foods with infectious pathogens or toxins, and iii) disease surveillance with detection and reporting of infectious diseases of public health interest. Besides this, laboratories are involved in receiving, transport, analyze, storage or disposal of pathogens and biological samples. Therefore, biosafety and biosecurity measures in laboratories are crucial for containing the spread of diseases, to prevent Laboratory Acquired Infections (LAIs), the transmission of infections to the community, reduce contamination of the environment, prevent the risk of access/possession of pathogens by unauthorized individuals, and the threats of bioterrorism [5].
Biosafety and biosecurity implementation in public and private laboratories in the Asia Pacific region including Vietnam are not optimum [6]. Lack of appropriate legislations, policies, regulations, the absence of appropriate strategies, limitations of resources, lack of training opportunities, and limited international assistance are a few reasons to mention [7]. As a signatory of IHR 2005, Ministry of Health (MoH), Vietnam along with other relevant ministries have taken steps to enhance the biosafety and biosecurity in laboratories in Vietnam. Here, we present the initiatives, the key successes, and the major challenges in strengthening the biosafety and biosecurity in clinical and research laboratories in Vietnam.
Government/parliament issues laws and decrees and MoH, technical expert committee issues circulars and technical requirements. Experts from different disciplines form specialized committees and/or task forces to develop and review the decrees, decisions, and circulars.

Response to Emerging Disease Outbreak
To respond the emerging infectious disease outbreaks (e.g.

Global Health Security (GHS) Preparedness
To assess the national preparedness for a coordinated response to any infectious disease outbreak, MoH/DoH and GDPM conducts GHS drill exercises [8]. The exercise focused on establishing an emergency operations center (EOC) at the GDPM, assessing the nationwide laboratory system, diagnostic capacity for priority pathogens (i.e., H5N1, MARS CoVI), and communication and coordination during an epidemic outbreak. Similar EOC are established during outbreaks and epidemics.

National and International Collaboration
MoH, Vietnam facilitates bilateral and multilateral collaboration with different countries and international agencies for strengthening biosafety and biosecurity capacity. These collaborations result in infrastructure improvement, human resource capacity building, training capacity building and implementation of biosafety and biosecurity monitoring systems.

Management of Laboratories
There are 2,420 BSL1 and BSL2 clinical and research laboratories in Vietnam. Of these, 657 laboratories are located in the North, 500 in the Central, and 1263 in the South (Table 1)   NA: not applicable

Legislation on Laboratory Biosafety and Biosecurity
From 2010 to 2017, MoH/DoH issued 10 legislations (one law, two decree, and seven circulars) to enhance biosafety and biosecurity ( Table 2) practices. Table 2    • The management of waste generated from the burial and cremation, and radioactive waste generated from medical activities shall be not governed by this Circular. (The management of waste generated from the burial and cremation shall comply with regulations on hygiene in burial and cremation fields. The management of radioactive waste generated from medical activities shall comply with regulations on the management of radioactive waste and used radioactive sources and the assurance of radiation safety in medical field. )  Comprehensive waste management including segregation at the origin, color-coded waste collection containers (green for general waste, yellow for clinical and infectious waste and black for chemical waste) and waste autoclave procedure are implemented.
Evaluation of microbial contamination of wastewater, wastewater treatment before releasing to the environment is implemented.

Biosafety Curriculum and Training
To facilitate biosafety training, four national preventive medicine institutes were authorized to provide standardized biosafety training. These are the National Institute of Hygiene and  (Table 3). A generic biosafety manual "Program of biosafety in the laboratory" was developed and circulated to laboratory staff as a part of the training program in the south region.

Biosafety Certification Program
To ensure compliance to circular 29/2012/TT-BYT a laboratory biosafety certification program was established.

Preparedness for Outbreaks and Epidemics
To address the threat of potential emerging infectious diseases,

Global Health Security (GHS) Preparedness
In