Mission n 1. Date de la mission : du 22/10/2012 au 3/11/2012

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1 COMPTE RENDU DE MIISSIION Mission n 1 Date de la mission : du 22/10/2012 au 3/11/2012 France - Cambodge Mission de diagnostic des besoins et de développement d un plan de formation Mission et rapport réalisés par Philippe F. DUBOIS/IQLS Soumis le 8/11/2012 Mission financée par l Initiative 5%. L Initiative 5% est financée par le Ministère des Affaires Etrangères et européennes (MAEE) en contribution indirecte au Fonds mondial de lutte contre le sida, la tuberculose et le paludisme (FM), et mise en œuvre par France Expertise Internationale (FEI). Le présent compte-rendu ne reflète pas nécessairement les points de vue et opinions du MAEE, du FM ou de FEI.

2 I. MISSION OBJECTIVES 1. General objectives In order to jointly draft with the CNM/IPC a plan of action and a training plan, a deep assessment will be performed, highlighting the biggest gaps and needs. At central and district levels and in health centers, the needs assessments will cover the following areas among over: Laboratory diagnosis / quality assurance (QA), laboratory networks Epidemiology Drug procurement and management Clinical diagnosis and case management The training plan will primarily target CNM experts and executives. 2. Specific objectives Objectives of the diagnostic mission: To perform an assessment of the training needs in biology/quality assurance and in epidemiology, management and planning, and in monitoring and evaluation. To develop a training plan / action plan. 3. Expected results Meeting with key stakeholders: CNM, IPC, WHO, USS and other partners supporting CNM Listing of all partners/projects working in the field of malaria in Cambodia, highlighting lab partners Previous malaria activities listing: training, assessment, guideline/job aid production (national level), documents available in Khmer/English Quality Assurance: workshops, agendas Address book of persons met (name/title/institution/ / phone) An action/training plan will be developed in agreement with CNM and FEI Budget of the training plan. 2/14

3 II. MISSION DESCRIPTION 1. Activities performed The consultant gathered information on the situation of Malaria in Cambodia by visiting some of the principal stakeholders participating to the support of Malaria Programmes in Cambodia: Inga Olesky, MSPH, US Embassy, Global Fund Liaison Officer Sok Bunna, MD,MSC, US Embassy, USAID Technical Team Leader for HIV/AIDS Steve Bjorge, WHO Cambodia Office, Malaria & vector borne diseases, Team leader Abdur Rashid, WHO Cambodia Office Malaria & vector borne diseases, med. officer. Vincent Deubel Institut Pasteur in Cambodia, Director Didier Menard, Institut Pasteur, head of Malaria Molecular Epidemiology Unit, Pascal Millet, Université des Sciences de la Santé du Cambodge, Conseiller du Recteur Thierry Fournier, French Embassy, Attaché de Coopération Elodie Nabeng, French Embassy, Chargée de Mission SCAC Consultant also gathered information from CNM upon internal organization and realizations in the surveillance and diagnostic of malaria during a first visit to Dr Tho Sochantha, vice Director, who officially nominated by Dr Muth Sinuon as the contact person for the present project University of Sciences of Health of Cambodia has also been visited, namely the Dean of Faculty of Pharmacy, in order to discuss how University could be actively participating to the program. During a second visit close to end of mission in Phnom Penh, needs were discussed between Dr Sinuon and the consultant. At this time, the training laboratory at CNM has been visited. Several propositions were made to CNM, now summarized in an informal document given to the Director for final approval of the main propositions. 3/14

4 III. RESULTS 1. Complete overview of the strategies for the control of malaria in Cambodia was obtained through visits and discussions to the different involved partners. The Public Health Infrastructure in Cambodia consists in 68 Referral Hospitals; 942 Health Centers with or without inpatient facility, and 23 Health Posts. Cambodia has engaged since 2009 a National Programme For Elimination Of Malaria In The Kingdom Of Cambodia. A successful strategy allowing a drastic reduction of clinical cases of malaria was set-up through the deployment of Village Malaria Workers (VMW, in almost all endemic remote areas of the country) and use of impregnated bednets. An important decrease in forest coverage also contributed to the reduction. The reduction of incidence is however associated now with the appearance of Plasmodium falciparum parasites with a decreased sensitivity to Artemisinin, and with an increased incidence of Plasmodium vivax infections. Cambodia Ministry of Health has set-up the body of Village Malaria Workers, who are in charge of collecting fingerpricks from all febrile patients, and perform Rapid Diagnostic Tests (RDTs) to check for malaria. Positive patients receive immediate treatment with appropriate medication, Artesunate Combined Therapy, or DHA Piperaquin. The sensitivity of RDTs is not very high, they can detect parasites only in symptomatic patients, and they do not precisely identify the plasmodium species infecting the patient. Furthermore, the sensitivity to treatment is not addressed in most of the cases. This strategy has however shown a high efficacy for the overall decrease of malaria endemicity, therefore it was expanded to other diseases recently with apparently a minimal impact on efficacy of data transmission on clinical malaria. Several studies are performed in endemic areas (mostly forest regions close to borders), to control sensitivity to anti malaria treatment: the blood parasites are counted before and during the treatment, following the kinetics of decrease of alive parasites in the blood. These studies are used as a basis for the CNM and MoH to give advertisement for changing medicine combination for elimination of parasites. Recently Artesunate and combined Treatment containing artesunate have shown failure (significant decrease in parasites elimination). Co-infections with Plasmodium vivax were also often observed when Malaria microscopy was performed during this kinetics analysis; therefore DHA-Piperaquin was introduced as alternative. Surveillance and diagnosis of malaria is then mostly relying in local Village Malaria Workers, who cannot address the new issues that CNM and MoH are facing: Presence of infection by Plasmodium vivax? Appearance of resistance or decreased sensitivity to treatment? The network of malaria laboratories is not strong and efficient enough to cope with the problem in its actual organization status. Many international players are providing assistance to diagnosis and surveillance of malaria; however this is not clearly organized, coordinated and controlled by national authorities. 4/14

5 Assistance is provided mainly during scientific projects such as the analysis of resistance in precise areas of the country for epidemiological studies; long term capacity building at laboratory level is often not the first objective of the project. Thus many local or independent initiatives (public, international or private) are developed in the country and interactions between players not really coordinated by the CNM and MoH. Independent laboratories are developed by private local companies (there are no legislation for opening diagnostic laboratories, no licensing process). Research and diagnostic laboratories are also developed by international bodies (Armed Forces Research Institute for Medical Sciences laboratory, NAMRU-2 laboratory, US National Institute oh Health, Pasteur Institute); Management of the health system is also subsidized by international bodies ( USAID, University Research Co., LLC (URC), Population Services International). The main bodies involved in sustaining strategies for malaria elimination are WHO, through the joined WPRO-SEARO Mekong Malaria Programme (Strategic Plan to Strengthen Malaria Control and Elimination in the Greater Mekong Subregion ), and the Global Fund, through the Malaria Consortium. 2. Visits to the CNM allowed consultant to gather information of organization and management of malaria programme at CNM. Dr Sinuon is the Chief Laboratory Director, and responsible for drug procurement at CNM. She described the main achievements at CNM concerning the National Plan on Malaria. The National Strategic Plan for Elimination of Malaria in Cambodia specifically addresses the following objectives: Objective 1.4 Aim for 100% microscopy diagnosis in public health facilities (including military and police forces) by 2020 (excluding VMWs). Objective 1.5 Strengthen and improve the quality of diagnostic services CNM already did set in place the Microscopy Quality Control programme, as well as the national External Competency Assessment in CNM. The Microscopy Quality Control programme is based on a Rechecking protocol: Health Centres, Hospital and District malaria laboratories send back to CNM slides they already read for evaluation. The External Competency Assessment is based on use of a National Slide Bank, prepared from patients fingerpricks, which reflects what situations malaria microscopists will encounter during real diagnosis requests for malaria; The plan is to check competency of microscopists every 2 to 3 years. Participants are graded according to different levels, up to expert level, allowing them to provide training in Malaria laboratories. The first ECA session was set-up in 2008 in Cambodia, and 12 malaria microscopists were evaluated. A second session was organized in 2011, directed to the same people. 5/14

6 A National Workshop on Quality Assurance of malaria diagnosis was recently organized (25-27 September 2012 in Naga World Hotel, Phnom Penh). A report is due by the end of October. Consultant had access to presentations given by participants; some issues being directly related to the objectives of the present mission were addressed in depth: Current situation of QA activities for malaria in Cambodia Dr Sinuon described the current status of QA scheme in Cambodia: A refreshing training on malaria microscopy and RDTs was performed in 2011 in selected health facilities in 20 provinces (Malaria s endemic areas), using CNM slide bank for training. Trainees came from Public Health Districts: 20 Operation Domains44 Health Centers: 548 Strengths identified: Development of the slide bank for teaching Development of the Malaria Quality Control Procedure Trained human resources are now available where quality control was undertaken A routine is established for the transfer of material and information flow The overall system is established and functioning in some (20) provinces Weaknesses identified Incomplete coverage of the system: in some provinces no evaluation from national level was performed Decreased compliance by Health Centers laboratories in sending slides for evaluation Movement of the technician staffs that have been trained Limitation of internal quality control Insufficient budget, Insufficient resources for direct supervision During the meeting Dr Sinuon described the way forward proposed by the CNM: Scaling up the Quality Programme to other provinces Encouraging the Laboratory staffs to work in remote areas Provide malaria laboratories with sufficient material and correct equipment Assure quality and maintenance of microscopes Assure quality by developing customized and relevant staffs training at central and provincial levels Strongly seeking support from relevant stakeholders (technical, financial support) During the meeting, a comprehensive document drafting Standard Operating Procedures (SOPs) for Giemsa Malaria Microscopy (GM-microscopy), and Quality Assurance scheme in Cambodia was presented by Dr John Storey, consultant at WPRO, and adopted by CNM. 6/14

7 3. Training propositions VMW and district hospitals mostly rely on RDTs to achieve laboratory diagnostic of clinical malaria, allowing a rapid treatment of the cases. The new program however asks now for a more specific and sensitive diagnosis activities from laboratories: 1. One needs to know exactly the species involved in the infection, as P. vivax does not require the same treatment for infected patients 2. One needs to check for possible reduced sensitivity to ACTs or DHA-Piperaquin when P. falciparum is identified. 3. Elimination of malaria requires identification of sub-clinical infected patients, in order to have an estimate of reservoir in the population, and to be able to declare some day Cambodia as malaria transmission free. In this case, one needs to have the detection of blood parasites in a range beyond the actual sensitivity of Rapid Diagnostic Tests. Table below provides the sensitivity of the different malaria diagnosis methods: Technique used Sensitivity Species identification (parasites/microliter) RDT 50 No Light microscopy (thin smear) 150 Yes Light microscopy (thick smear) 5 +/- Fluorescence microscopy <5 Yes Molecular biology 1-2 Yes Most hospital laboratories were equipped with microscopes a while ago, but clinical diagnosis relies at present time mostly on parasite detection with RDTs. The new requirements according to the National plan suggest that microscopic examination should be set again in all places, as it is the classic technology which allows detection of low parasitemias and identification of parasite species, without needs for the implementation of new techniques. On the long range however, detection of very low parasitemias and identification of the parasite will require the implementation of molecular biological techniques (currently performed at Cambodia Pasteur Institute). Indeed only the sensitivity and specificity of genome detection methods by PCR will allow the surveillance system to follow the final decrease of malaria incidence. It will help also analysis of the resistance to antimalarial drugs. 7/14

8 IV. LESSONS LEARNT All partners consulted were very helpful in the global understanding of successes and pitfall of the National Programme for Malaria elimination in Cambodia. However the mission was seriously hampered by external event, the death of the former King Norodom Sihanouk. For this occasion, several additional holidays were given to the public employees, adding three days out in the 10day mission in Cambodia. Therefore there was no time left for in depth visits of diagnositic laboratories at centre and district levels in Cambodia. However the consultant had access to former laboratory assessments made by international missions, in Kampong Cham, Battambang and Takeo Hospital laboratories in 2008, 2011 and 2012, respectively. The last assessment in Takeo was performed using the WHO Laboratory Assessment Tool very similar to the tool developed by IQLS for assessment. It showed a very low level of overall Quality Management in the Takeo hospital Laboratory. 8/14

9 V. RECOMMENDATIONS In order to help CNM to develop a strategy for improving the malaria microscopy at national level, and organize an efficient network of malaria laboratories, it is proposed, as presented in the initial proposal, to reinforce a body of Trainers, who will be able to explain to local malaria laboratories the need for improving diagnostic techniques. Training sessions will be organized as Training of Trainers Regarding the topics for training listed in the proposal, it appears that procurement management of anti-malarial drugs might not be on the priority list for the CNM. In order to reinforce links with University, and more precisely the Faculty of Pharmacy, 2 students in Master degree could also attend the trainings. In order to reinforce links with Pasteur Institute (in charge of molecular biology techniques transmission to CNM), 2 technicians from malaria molecular epidemiology could also attend Training sessions will be then organized at district or hospital level. Trainers will debrief to the local malaria diagnostic laboratories the training they received, in order to inform them on the needs for adopting more precise and specific diagnostic techniques. Local biologists, technicians and microscopists will then understand the rationale for ensuring better data communication with the national malaria surveillance system. In parallel, several technical activities will be implemented: Slide rechecking programmes optimization Laboratory network improvement Training on molecular biology Development of specific microscopy assessment tools, training package, supply bundles and kits, etc. The first activities to organize are listed below. The rest of the activities will be definitively set after the second mission (including the initial training described below) 1. Role of diagnostic laboratories in malaria surveillance: Initial training Basics on National Malaria Eradication Programme Basics on epidemiology of malaria, different models for disease surveillance Needs for establishing new disease surveys in malaria-free areas of country. Roles of laboratories in disease surveillance including malaria Differences in information provided by clinical diagnostic, laboratory Rapid Diagnostic Tests, malaria microscopy, and Molecular Biology of parasites: sensitivity and specificity, analysis of sensitivity to antimalaria drugs. Data to be transmitted by laboratories to the national surveillance system FEI expert Bob Taylor will also present his work on malaria sensitivity to drugs in Cambodia, as an example of reality check of the problem 2. Refresher course for microscopists: Slide preparation, staining, conservation Identification of different plasmodium species, including P vivax and P falciparum Identification of different parasite stages, from rings to gametocytes Accurate quantification of parasites using WHO recommended method 9/14

10 Quality control of stains, maintenance of reagents Maintenance of microscopes Optical adjustment and cleaning of microscopes Didier Menard from Pasteur Institute in Cambodia, will perform as a technical demonstration a comparison of sensitivity and specificity of the different diagnostic techniques RDTs, Giemsa staining, and PCR 3. Quality management in malaria diagnostic laboratories: General facts on quality Basics on Quality Management o Maintenance of equipments, maintenance schemes o Reagents management o Continuous education of personnel Organizing an following an External Competency Assessment in malaria Building of the Slide bank Biorisk management : basics on Biosafety (mainly for blood sampling) Waste management Training of Quality Officers in hospital laboratories An expert will present her work as a Quality management expert, as a reality check for Quality in malaria laboratory. Proposed Gantt chart for the activities The Gantt chart below summarizes the current status of activities forecasted 10/14

11 Next mission will occur next January, including some preparation late December The Gantt chart is also available as a separate MS Project file. It will be updated after each mission and after each agreement made between CNM, FEI and IQLS Session 1: Session 2: Session 3: training room 10 students/trainers, etc. Documents, video projector Visit of Pasteur Institute training room 10 students/trainers, video projector, etc. equipped with microscopes (one/trainee). Samples from slide bank, staining reagents Disposables for fingerpricks, blood samples to prepare fresh smears Visit of CNM laboratory. training room Visit to malaria laboratories, to practice Laboratory Assessment Tools 11/14

12 VI. Annexes 1. ToR of the assignment Beneficiary: National Centre of Parasitology, Entomology and Malaria Control (CNM) Service Provider: Integrated Quality Laboratory Services (IQLS) I. Background In order to jointly draft with the CNM/IPC a plan of action and a training plan, a deep assessment will be performed, highlighting the biggest gaps and needs. At central and district levels and in health centers, the needs assessments will cover the following areas among over: Laboratory diagnosis / quality assurance (QA) Epidemiology Drug procurement and management Clinical diagnosis and case management The training plan will primarily target CNM experts and executives. During this first mission, IQLS will also consider opportunities to organize some training sessions in partnership with the University of Health Sciences at the Centre for Education Development of Heath Professionals (CEDHP) and IPC. Objectives of the diagnostic mission: To perform an assessment of the training needs in biology/quality assurance and in epidemiology, management and planning, and in monitoring and evaluation. To develop a training plan / action plan. II. Description of the expertise mission General: Meeting with key stakeholders: CNM, IPC, WHO, USS and other partners supporting CNM etc. Listing of all partners/projects working in the field of malaria in Cambodia, highlighting lab partners Previous malaria activities listing: training, assessment, guideline/job aid production (national level), documents available in Khmer/English Quality Assurance: workshops, agendas Address book of persons met (name/title/institution/ / phone) Laboratory assessment/qa assessment: (Central laboratory/2 peripheral laboratories) For the central laboratory: Job aid (lab level), guidelines, QA manual, objectives, roles, mission, vision at 2-5 years For the network Regulatory documents (laws, decrees) for laboratory in Cambodia Training needs assessment (central/peripheral, technical/management) on: Quality assurance 12/14

13 Malaria diagnosis (microscopy & RDT) Malaria molecular biology Epidemiology Drug procurement and management Clinical diagnosis and case management ISO15189 accreditation Waste management Biosafety and risk assessment Laboratory management Tuberculosis slide rechecking: Assessment of the Malaria & TB (if time allows) slide rechecking programmes Assessment results: Gap analysis, prioritization Organization needs assessment Development of the action/training plan: An action/training plan will be developed in agreement with CNM and FEI Budget of the training plan. III. Place, duration and implementation details The mission will be implemented by Dr. Philippe DUBOIS On site: October 22 to November 2, 2012 (10 working days on site) In France: 3 working days The mission will start with a briefing on the objectives of the mission with representatives of the French Embassy and the CNM. IV. Deliverables Needs assessment analysis (including address book, ) Gap analysis development Action / training plan Training Calendar until September 2013 Mission report 13/14

14 2. Bibliography National and General Surveillance documents: National Strategic Plan for Elimination of Malaria in Cambodia Strategic Plan to Strengthen Malaria Control and Elimination in the Greater Mekong Subregion ( ) set-up by the WHO-Mekong Malaria Programme National Strategic Plan for Elimination of Malaria in the Kingdom of Cambodia Procedures and technical manuals: Malaria microscopy manual: CNM produced a khmer translation of the WHO manual Basic Manual M, PartI. Learner s Guide Microscopy WHO Bench Aids for the Diagnosis of malaria infections, available in English at CNM National treatment Guidelines for Malaria in the Kingdom of Cambodia Mai 2012 National Standard Operational Procedure for Malaria Microscopy Quality Assurance May 2012 Reports on follow-up visits: Kampong Cham Hospital Laboratory November Mission WHO(CSR)/US CDC/MoH/NIPH Takeo Hospital Laboratory November Mission WHO(CSR)/US CDC/MoH/NIPH Battambang Hospital Laboratory - 5th-7th April, Mission URC Cambodia/MoH Takeo Hospital Laboratory 18 April Mission Mérieux Fondation /MoH, (WHO/AFRO accreditation checklist Dec 2009) Scientific publications: Stefan Hoyer et al PLoS-one : October 2012 Volume 7 Issue 10 e45797: Focused Screening and Treatment (FSAT): A PCR-Based Strategy to Detect Malaria Parasite Carriers and Contain Drug Resistant P. falciparum, Pailin, Cambodia Yasuoka et al. Malaria Journal 2012, 11:4: Scale-up of community-based malaria control can be achieved without degrading community health workers service quality: the Village Malaria Worker project in Cambodia ( Malaria journal 2012, 11:352 Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific. ( Aung Pyae Phyo, et al, Lancet 2012; 379: : Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study ACTMalaria News, Vol 15 Issue 3 14/14