REPUBLIC of MOLDOVA. Country experience. Title/Country. Presenter Title

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1 REPUBLIC of MOLDOVA. Country experience Title/Country Presenter Title 6 th GLI Partners Meeting ROMANCENCO ELENA 30 April 2 May 2014

2 REPUBLIC of MOLDOVA Independent from 1991 Ex-Soviet Union country, in continue transition period for ~ 20 years. Surface: 33.7 thousand sq. km. Population: 4,0 million. Migration: persons (to east and to west).

3 Despite multiple interventions in TB control in last period In TB treatment Universal access of treatment for I and II line. In TB diagnosis Implementation of a new, modern diagnostic tests (Xpert MTB/RIF, MGIT BACTEC, LPA). Universal access of all suspect new TB cases to these tests. In the medical community Training of GP. Financial assistance of GP by Medical Assurance Company for detection and treatment of TB patients. In general community Permanent, large information company for general population, risk groups. Support of TB patients (food, money, psychological support).

4 TB Incidence and Mortality, R. Moldova, Tb incidence - Rate/ TB Mortality - Rate/

5 MDR-TB among new and retreatment cases 70% 60% 50% 50% 51% 52% 59% 68% 65% 64% 62% 61% 40% 30% 20% 13% 19% 18% 24% 22% 25% 26% 24% 23% 10% 0% Ponderea MDR din caz nou, % Ponderea MDR din retratament

6 TB LABORATORY SERVICE IN MOLDOVA

7 TB Laboratory Service 1 NRL 3 RRL Micro; Xpert, LPA; LJ, MGIT (DST I, II line) 59 MC Micro; 16 of them has Xpert. Currier system work well for sputum transportation 7

8 Implementation of rapid methods for TB diagnostic and TB drug Resistance in Moldova MGIT ProbeTec MTBDRplus 2009 MTBDRsl MTBDRplus ver MODS PyroMark Xpert

9 EXPAND TB Project Came at the right time to consolidate and maintain laboratory activities for detection TB/MDR-TB/EXDR-TB cases. I Memorandum August 2010 First lot of reagents/consumables 2011 Support 3 RRL laboratories 80% of country. Funds around 1 mln $.

10 TB Laboratory Service Supported by EXPAND TB 1 NRL 2 RRL 10

11 MDR TB detection Planned to detect 1400 cases per each year Detected More than 2000 MDR-TB cases. 11

12 Additional contribution of EXPAND TB for laboratory TB service in Moldova

13 EXPAND TB PROJECT contribute (together with all our partners) to: Improve quality of TB diagnosis in country 1. Microbiological confirmation of TB was increased In %, in %. 2. Time for laboratory confirmation of TB was decreased Before weeks (LJ culture); after weeks. 3. Correct detection of TB according the susceptibility spectrum was improved. The time for initiation of correct treatment according DST results was decreased. Control infection measures was improved. due to increasing of the accessibility to rapid methods (MGIT, LPA) for all new suspect TB cases.

14 EXPAND TB PROJECT contribute to: Fortify laboratory capacity Implemented new methods in new RRL (LPA in Vorniceni); Procured new quality equipments (BACTEC, LPA equipments, BSC, autoclave, etc.); Procured new quality reagents, consumables; Flexible in planning - the plans were adjusted according the current situation and problem in country, strictly necessary at the moment. What else?

15 Together with EXPAND TB project we have become: - more professional, - more smart in Laboratory management - more prepare to face some problems

16 We learned how to forecast, to budget laboratory activities (EXPAND TB tool) Annual Budget Overview Area Reagents & consumables Costs (USD) total no. tests* costs / test** Microscopy 3, , Processing for culture 1, , Solid culture , Liquid culture 9, , DST liquid culture 3, LPA 24, , Xpert MTB/RIF 31, , Sub-Total 70, Biosafety & Cleaning Costs (USD) Biosafety 7, Cleaning 3, Sub-Total 10, * excluding repeats **including repeats

17 We learned how to prepare good specification of reagents, equipments on domestic acquisition (tender for MoH, GF, etc.) METHOD Family Sub Family ITEM NAME Supplier Specifications PROCESSING Instrument Laboratory, Miscellaneous Safety gas burner Gasprofi 1 SCS, saftey gas burnner, with foot switch, IR sensor, with rest heat display PROCESSING PROCESSING PROCESSING Instrument Instrument Instrument Laboratory, Miscellaneous Mixers, Shakers, Stirrers Mixers, Shakers, Stirrers PROCESSING Tools Centrifuges Safety gas tubing Overhead stirrer + Universal adapter Compact Orbital shaker (for BSC) Test tube rack 18/8 stainless steel 35 mn PROCESSING Tools Meters Alarm Clock Saftey gas tube 750mm long, with clamps inner diameter 9mm Overhead stirrer and universal adaptor, with individual ajustment from U/min, for 2 vessels, max weight 1 kg, universal adaptor for vessels from mm height Compact, universal small shaker suitable for shaking tasks with all small vessels and microtiter plates, ajustable speed of upto rpm Plates for 0.2ml PCR Tubes or Cryo vial 1.5ml or 2ml Test tube rack stainless steel, 3x7 places, 35mm Alarm clock, wiht stopfunction, digital, programmable for mx. 99 min, memory function, with alarm function at 0, 17

18 We learned how to check the functionality of BSC and other equipment (centrifuge, autoclave, etc.) 18

19 We learned how to monitor consumption and how to do inventory of stocks for consumables and reagents FIŞA Evidență Individuală Consumabile şi Reagenți Consumul lunar curent Sursa Unitate de măsură Cod Data expirării Alcool CNAM l Preț unitate Consumul lunar curent 40,07 MDL Lot T C de păstrare Mediu ultimele 3 l Maxim ultimele 3 l Minim ultimele 3 l PRIMIT DISTRIBUIT RĂMAS Nr. d/o Data Bon Cantitate Tehnician Data Cantitate Sector Tehnician Cantitate Tehnician /16/ ANS 8/22/ BACTEC VAC 2.75 ANS 3 8/22/ ANS 8/28/ PREP REAG CNV 9.75 ANS 4 8/28/ PREP TAMP MVI 8.35 ANS 5 9/2/ PCR GME 7.35 ANS 19

20 EXPAND TB PROJECT contribute to: Fortify staff capacity Laboratory staff (~25 persons) received training on working place on: Good Laboratory Practice; new implemented method (LPA for LRR Vorniceni); existing method (MGIT, LJ) as a refreshment for RRL, NRL; Interpretation of some doubt results (LPA).

21 Main challenges for project implementation

22 Some difficulties, NTP was not fully involved in the process. Custom clearance. Transportation from borders, custom to laboratories Installation of new equipment (autoclave, BSC, BACTEC) Include additional RRL (Bender for Transnistrian region) Training of physicians in correct requesting and understanding of new laboratory methods Store space, inventory of reagents, equipments. Solutions Project should be address through NTP, not directly to NRL. Solved by designate dedicated person, not from laboratories. Solved by contract transport company. Solved by local staff (autoclave, incubator); solved with external engineer for BACTEC; in process of solving for BSC. Not solved We address continue efforts in this direction In process. 22

23 But all something is start to finish. And now we should start to prepare for the new period

24 Due to support of EXPAND TB we start to develop Strategic Laboratory Plan To see the current situation and to plan real needs for future March 2014 I visit of FIND consultant Discussion of national policies in TB diagnosis Met with main partners and donors in TB control SWOT analysis with personal from NRL and RRL. April - first draft of the Strategic Laboratory Plan Next step Stakeholder meeting. Finalize plan and approve at national level.

25 To find FUTURE PARTNERS to support laboratory activities: And there are not many: Government, Ministry of Health, National Assurance Company: GF Microscopy ( ) I line drugs from ( ) and 100 patients for II line treatment (2014). Now we start planning for program. Address needs for more costly method Xpert, LPA, BACTEC. Research study. Clinical study.

26 Areas for future technical assistance of EXPAND TB or other partners To optimize TB diagnosis of patients through offer technical assistance to determine cost efficiency of new test, new algorithm (with less money to obtain better results); revising the current algorithm and improve/adapt to new conditions; offering the assistance for implementation of new methods in new territories (Xpert, sequencing method???, new methods); offering the consultancy in laboratory management (planning, budgeting of laboratories activities). To implement QMS in TB laboratories (MC, RRL, NRL) Train Responsible for QMS Train laboratory staff in basic QMS To help to achieve Accreditation in ISO for at least NRL in country.

27 Future plans, To finalize National Strategic Plan for TB Laboratory Service. To make a proposal for new GF project ( ). To start trainings in QMS for RRL. To find funds for accreditation of NRL in ISO To develop and implement an Integrated Laboratory Information System LIS (MGIT, Xpert, national system, laboratory local system) To participate in different operational, research project: In development of new methods (rapid, cheap, point of care test, new biomarkers). In development of new drugs. In implementation of new, individual more short scheme of treatment. But for all this activities we still need your support.

28 Thank you! We want to express our acknowledge for All EXPAND TB team, but Especially for Knut Fieldman, Maka Akalaia, Alexei Corobitin. 28

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