ENIVD CODE OF CONDUCT for Outbreak Assistance Laboratories CHECKLIST of major issues to address before departure and during the mission This document has been designed for ECDC and ENIVD-CLRN network members to allow more accurate interventions during outbreak assistance missions, as data from health laboratories, at the time of disease outbreaks or other public health events, are at the very heart of the public health investigation and response mechanisms. It is intended to remind laboratory experts of all the different aspects which should be looked at in preparation and during laboratory intervention in the field, to ensure proper handling of scientific, organisational, social and ethical issues when interacting with local partners, as well as participating network partners. It is based on conclusions drawn during the Expert meeting on ECDC outbreak assistance laboratories held in Stockholm, 28 29 June 2007, which was intended to set the bases of the modes of collaboration between ECDC and Outbreak Assistance laboratories. including procedures, need for funding arrangements and other practical implications for collaboration. This document has been divided in 3 main sections: The first section addresses the generic Code of Conduct for Intervention in the field as defined by ENIVD based on WHO GOARN recommendations. This Code should be read and signed by all members of the team. The second section gathers information on all elements to consider before departure. The third section gathers information on essential elements to consider within the Outbreak Intervention Team during intervention in the field. Acronyms: ENIVD: European Network for Diagnostics of Imported Viral Diseases ENIVD-CLRN: ENIVD Collaborative Laboratory Response Network ECDC: European Center for Disease Control GOARN: Global Outbreak and Alert Response Network MoH: Ministry of Health PPE: Personnel protective equipment SOPs: Standard Operating Procedures TL: Team Leader WHO: World Health Organization ENIVD - Collaborative Laboratory Response Network - Code of Conduct 1
Adherence to generic Code of Conduct for Intervention in the field as proposed in the original Technical Proposal for creation of ENIVD CLRN A member of an ECDC outbreak assistance team should: 1. Abide by the Terms of Reference agreed upon between ECDC and the country health authorities or partner institution (e.g. when supporting WHO) and provided to the members upon joining the team. 2. Strive to achieve the goals and objectives of his/her mission in co-operation with all others involved in the ECDC OAT. 3. Accept and respect the roles of other Team Members and the roles and authority of the Team Leader and national and local authorities. 4. Have a fair and equitable process for the participation of the different actors in the project. 5. Work in complete transparency. 6. Always try to integrate and coordinate activities to support national efforts and existing public health infrastructures. 7. Commit to national and regional capacity building as a follow up to international outbreak responses to improve preparedness and reduce future vulnerability to epidemic prone diseases. 8. Supervise and check the work performed is of quality. 9. Proceed with full respect for ethical standards, human rights, national and local laws, cultural sensitivities and traditions. 10. Only interact with the press/media after agreement of the Team Leader and/or the Ministry of Health. 11. Respect the established reporting, communications and decision-making processes, procedures and protocols. 12. Only undertake field epidemiological investigations after agreement of the Team Leader and/or Ministry of Health, and this in accordance with international ethical and professional standards. 13. Only remove any original data from the country after agreement of the Team Leader and/or the Ministry of Health, and ensure copies of all data are left with national authorities/institutions. 14. Only collect and distribute laboratory samples from the field after agreement of the Team Leader and/or the Ministry of Health. 15. Only undertake field research activities after agreement of the Team Leader and/or Ministry of Health, and this in accordance with international ethical and professional standards. 16. Only take samples from the local population for research goals after appropriate procedures for the use of human research subjects have been implemented, and this in accordance with the appropriate international and national ethical standards. 17. Consult the Team Leader when conflicts (might) arise between team members, or others involved in an OAT, including the local authorities and population. 18. Debrief in a timely, accurate manner with the relevant persons and partners (Team Leader, MoH etc.) in order to assure continuity of his activities, team operations and the OAT in general. 19. Contribute to the final report as agreed with the Team Leader. 20. Only publish (scientific) papers, articles, publications or abstracts after agreement and clearance through established mechanisms. Signature Date ENIVD - Collaborative Laboratory Response Network - Code of Conduct 2
Elements to consider before departure for organizing the Outbreak Intervention Team and its mission 1. Terms of reference agreed upon ECDC, National Authorities and other Partners (CLRN, WHO, GOARN Members) Outbreak Intervention missions are often organized at the last minute, with limited information on the local situation and stakeholders. Have you been informed on clear and well-defined conditions for interactions with local actors, and on clear and limited objectives of the mission? 1.1. Contacts have been taken between laboratories and institutions engaged in the international response to the event, and comprehensive Terms of Reference have been established for the Intervention 1.2. All members of the Outbreak Intervention Team have a precise knowledge of the objectives and goals of the mission, a formal adherence and approval of ToRs has been obtained from each of them 2. Team building As for interaction with local actors, clear and well-defined conditions for interactions within the team must be defined. Are you clearly identified as member of the team, or as the team leader? 2.1. Designation of members of the team has been performed before the start of the mission, and their identity is known and approved by all team members 2.2. Designation of Team Leader (TL) has been performed before the start of the mission, and TL identity is known and approved by all team members. ²If necessary, contracts were signed with TL and/or team members 3. Communication Communication must be established between all members and organizations or institutions involved. Have the ToRs been communicated to all, are you aware of what is expected from you as a team and have you all the contact details available and distributed to allow future communications? 3.1. TL and team members' names, function and contacts, and agreed ToRs are adressed to all entities involved 3.2. Meeting and debriefing of the TL and members by the international entity in charge 3.3. TL contacts all local entities involved. ENIVD - Collaborative Laboratory Response Network - Code of Conduct 3
4. Preparation of the mission Remark Before setting off, and in order not to lose time, one will need to make sure that the different persons in charge locally of helping the set up of the mission are available. Some activities might also need some preparation before departure. For example, some training activities can be prepared in advance and specific materials might be needed as for extra reagents. Some specific reagents and/or equipment might also be needed in the case of specific outbreaks. This can also concern PPE. Has everything been planned and prepared for the future mission so that you can rapidly set down to work on arrival in the best possible way? 4.1. All contact details are functioning and listed, the team members were briefed on cultural sensitivities and traditions, as well as eventual specific national local law(s) 4.2. First meeting(s) is(are) planned with the host entity(ies) 4.3. If necessary, preparation of certain activities and/or organization of shipment of specific material and/or reagents ENIVD - Collaborative Laboratory Response Network - Code of Conduct 4
Elements to consider within the Outbreak Intervention Team during intervention in the field 5. Communication Regular communication across the network is needed. Regular meetings with different entities, institutions, organizations and authorities must be scheduled to allow complete and correct communication. 5.1. Interactions with other members of intervention Team Remark Take into account different members available in the host team, as this is part of the fair and equitable process for participation. Have you taken all measures necessary for a good communication and agreement on the decision making among the team? 5.1.1. Meetings were organized between the expatriate team and host team, after names and contact details of persons in charge of the laboratory 24 hours/7 days were identified 5.1.2. Establishment of procedures for conflict resolution within the team,including local partners 5.2. Communication of Results Have the results been well adapted to be easily used, understood, communicated and stored? 5.2.1. Share of results and archives with other members of the intervention team is organized, including standardization of results to a communication format 5.2.2. Presentation of results has been adapted to ways of local communication and understanding 5.2.3. The team has organized the archiving and database production of results 5.3. Communication with host laboratory(ies) and within the laboratory network Are there regular meetings with the different laboratories to ensure that local laboratories are not isolated, or excluded from internal communication within the team?? 5.3.1. Meetings and information sharing with Laboratory director(s) and local laboratorians 5.3.2. Ensure that all laboratories are invited in meetings and conference calls of the laboratory network ENIVD - Collaborative Laboratory Response Network - Code of Conduct 5
5.4. Communication with Health Services Are there regular communications with the health services to allow combining and analysing of the data? 5.4.1. Meetings and information sharing with local surveillance system are organized 5.4.2. Contacts with local practitioners, clinicians and surveillance officers are effective, allowing the collection of clinical information, integration with laboratory data for statistical analysis of data. 5.5. Communication with local and national authorities Are there regular standard communications with the hospital and health authorities to keep them informed and involved in data analyses? 5.5.1. See if established reporting, communication and decision making processes, procedures or/and protocols exist. If so, use, adapt to new situation and improve, if not create. 5.5.2. Meetings are organized, ensuring information sharing with Hospital and Health authorities. 5.6. Communication with local scientific community Are there regular communications with the local scientific community to share and gain knowledge from the results of any research being carried out and obtain their eventual publications? 5.6.1. Meetings and information sharing with local and national scientists and scientific community. 5.6.2. Publish scientific publication after agreement and clearance through established mechanisms with the local scientific community. 5.7. Communication with media Are all members of the network aware of the contents and agreed on a communication to the local media? 5.7.1. Agreement with national, local and laboratory authorities and TL before any communication to media or press release 5.7.2. Communication with national public relations or press services in accordance with international ethical and professional standards ENIVD - Collaborative Laboratory Response Network - Code of Conduct 6
6. Assessment of the laboratories situation Remark Laboratory services are functional only if a combination of the following elements is adequate and in place: national policy, national regulation human resources and infrastructures reagents and equipment procurement and supplying systems networking, information management and appropriate financing system quality assurance system, addressing also biosafety and biosecurity issues The assessment can: provide information in a standardized way provide information on the health laboratory s administrative organization and environment provide a snapshot of a representative sample of laboratories at various levels identify strengths and weaknesses of health laboratories Raise awareness on the laboratories performance at country level Provide objective data to decision makers for planning and implementing laboratory capacity strengthening activities. The Laboratory Assessment Tool (LAT from WHO, Lyon) could be a solution for a rapid standardized laboratory assessment (see annex 1). Have you the knowledge of how the host laboratory functions, and if all elements allowing its functioning in the long term are present? 6.1. Rapid assessment of the existing structure(s) has been or will be performed 6.2. If needed, seek if the country has the capacity to deal with highly dangerous pathogens. 7. Training Remark Be ready to organize seminars and training sessions, if requested by local community and if you see an evident need. It could be wise to have already saved some extra time within the mission schedule. Have the different personnel been trained to ensure proper functioning of the path of workflow in the laboratory? 7.1. Training of local staff to sample collection and transport of laboratory specimens, including laboratory staff and drivers. 7.2. Training of local laboratory staff to relevant techniques used by the Outbreak Assistance Team, including issues of biosafety and quality management 7.3. Training of local laboratory staff to appropriate data use, feed and manage results database ENIVD - Collaborative Laboratory Response Network - Code of Conduct 7
8. Biosafety Are biosafety conditions in place locally to ensure safe work and environment? 8.1. You have taken knowledge of existing national legislation addressing minimal biosafety level, measures or requirements to be operated in the country 8.2. Identify emergency responders in local laboratories and match with the level of PPE required to perform their functions, check for training needed for the proper use, inspection and proper maintenance of PPE 8.3. Describe where the PPE equipment are stored and how the responders will access to them 9. Specimen collection Remark All samples received are recorded, proper labelling and registering is in place, including the time of collection and the time of reception of the sample in the laboratory. All rejection will be documented. Are all procedures in place to ensure proper sample collection? 9.1. SOPs for specimen collection was developed, and agreed on with the central laboratory. Agreement for adaptation or improvement was obtained to cope with the conditions of the outbreak, and validated with local institutions. 9.2. Ensure that consistent processes are developed by laboratories that address labelling and specimen registration 9.3. Emergency laboratory toolkits (personal protective equipment, sample collection material, transport media) are available for an immediate utilization 10. Specimen transport Are all procedures in place to ensure safe and proper transport of samples? 10.1 Are they national regulations for transport of samples, in agreement with international regulations, and do the local laboratories address transport conditions in consistent processes? 10.2 Use existing specimen transport network if already existing. If not existing, see if local carriers can ensure the transport of infectious samples, and assist laboratories in the region with developing backup plans for specimen transport to and from a secondary laboratory. 10.3 Take knowledge of existing restrictions for export/import of infectious substances and availability of couriers for international transport. Seek if local suppliers of triple packages are available, or if these can be imported or if the country will need external assistance. If necessary, take knowledge of laboratory staff trained according to ICAO requirements for the international air transport of infectious substances. ENIVD - Collaborative Laboratory Response Network - Code of Conduct 8
11. Data collection Are all the data needed being collected in a correct and timely manner? 11.1 The patient and sample identification are correct and that clinical information are given. 12. Process of Analysis Are procedures and quality controls in place to ensure proper analysis performance? 12.1 Collect relevant SOPs and adapt to local conditions if needed, to be able to perform the analysis with local equipment and reagents. 12.2 Be ready to provide assistance for development of Quality management strategy in local laboratory 13. Supervision How can you evaluate the overall quality and confidence of results and data generated during the project,? 13.1 Did the team establish quality indicators to be monitored and evaluated throughout the project?. 14. Local regulations on human rights and person protection Are human rights and person protection respected in the different activities concerned by the project? 14.1 Acquire knowledge of local/national regulations on person protection 14.2 Set-up forms and procedures to collect agreement and informed consent with patient and/or people involved in study 15. Local and international agreements or regulations on intellectual property Were the issues on intellectual property officially addressed, such as scientific publications and patent protection for exploitation of results, and are the collective decisions respected? ENIVD - Collaborative Laboratory Response Network - Code of Conduct 9
15.1 All members of the team, including local laboratories have knowledge of local, national and international regulations on intellectual property 15.2 A contractual agreement was signed with local scientists and laboratory authorities on future publications and on possibilities of patents 16. Timeline for future collaborations At the end of outbreak investigation, can one leave without ensuring proper continuation of activities for ongoing or /and eventual future collaborations? 16.1 Did the team address preparation for departure, organization of possible follow-up activities, such as the organization of immediate scientific collaboration, the share of research projects, the development of future collaborative projects, or the design and elaboration of funding proposals 16.2 Early on in the mission, or before departure, the gift of equipment and reagents, was addressed in the ToRs, including organization of maintenance and appropriate trainings. 16.3 Seek agreement from TL and /or MoH before removal of any original data or collection and distribution of laboratory samples from the country. If any removal of original data or collection and distribution of laboratory samples is agreed, ensure copies of all data or samples are left with national authorities/institution ENIVD - Collaborative Laboratory Response Network - Code of Conduct 10