6th GLI Partners Meeting ROMANCENCO ELENA30 April – 2 May 2014

Title/CountryTitle/CountryTitle/CountryTitle/Country

PresenterPresenterPresenterPresenterTitle

• REPUBLIC of MOLDOVA.Country experience

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: 360.000–800.000

persons (to east and to west).

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).

TB Incidence and Mortality, R. Moldova, 1991-2013

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40

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Tb incidence - Rate/100000 TB Mortality - Rate/100000

MDR-TB among new and retreatment cases

0%

10%

20%

30%

40%

50%

60%

70%

13%

19% 18%

24%22%

25% 26%24% 23%

50% 51% 52%

59%

68%65% 64%

62% 61%

Ponderea MDR din caz nou, % Ponderea MDR din retratament

TB LABORATORY SERVICE IN MOLDOVA

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

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Implementation of rapid methods for TB diagnostic

and TB drug Resistance in Moldova

• MGIT 960 – 2005

• ProbeTec - 2008

• MTBDRplus – 2009

• MTBDRsl - 2011

• MTBDRplus ver.2 -2012

• MODS - 2011

• PyroMark - 2011

• Xpert - 2012

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 $.

TB Laboratory Service

Supported by EXPAND TB

• 1 NRL

•

• 2 RRL

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MDR TB detection

• Planned to detect

– 1400 cases per each year

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• Detected 2011 – 2013

– More than 2000 MDR-TB cases.

2008 2009 2010 2011 2012 2013

1069 1002 1060 1036 952 889

Additional contribution of EXPAND TB for laboratory TB service in

Moldova

EXPAND TB PROJECT contribute (together with all our partners) to:

Improve quality of TB diagnosis in country1. Microbiological confirmation of TB was increased

– In 2011 - 56%, in 2013 – 68%.

2. Time for laboratory confirmation of TB was decreased– Before 2011 – 3-5 weeks (LJ culture); after 2011 – 1-2 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.

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?

Together with EXPAND TB project we have become:

- more professional, - more “smart” in Laboratory management- more prepare to face some problems …

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 3,855.24 13,090.40 0.29Processing for culture 1,097.79 3,000.00 0.37Solid culture 180.21 3,000.00 0.06Liquid culture 9,426.04 2,000.00 4.71DST liquid culture 3,818.63 250.00 15.27LPA 24,041.89 1,040.00 23.12Xpert MTB/RIF 31,822.00 3,000.00 10.61

Sub-Total 70,386.56

* excluding repeats **including repeats

Biosafety & Cleaning Costs (USD)

Biosafety 7,352.55Cleaning 3,557.19

Sub-Total 10,909.74

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 InstrumentLaboratory, Miscellaneous

Safety gas burnerGasprofi 1 SCS, saftey gas burnner, with foot switch, IR sensor, with rest heat display

PROCESSING InstrumentLaboratory, Miscellaneous

Safety gas tubingSaftey gas tube 750mm long, with clamps inner diameter 9mm

PROCESSING InstrumentMixers, Shakers, Stirrers

Overhead stirrer + Universal adapter

Overhead stirrer and universal adaptor, with individual ajustment from 20-100 U/min, for 2 vessels, max weight 1 kg, universal adaptor for vessels from 50-160mm height

PROCESSING InstrumentMixers, Shakers, Stirrers

Compact Orbital shaker (for BSC)

Compact, universal small shaker suitable for shaking tasks with all small vessels and microtiter plates, ajustable speed of upto 3.000 rpmPlates for 0.2ml PCR Tubes or Cryo vial 1.5ml or 2ml

PROCESSING Tools CentrifugesTest tube rack 18/8 stainless steel 35 mn

Test tube rack stainless steel, 3x7 places, 35mm

PROCESSING Tools Meters Alarm ClockAlarm clock, wiht stopfunction, digital, programmable for mx. 99 min, memory function, with alarm function at 0, 17

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

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FIŞA Evidenţă Individuală Consumabile şi Reagenţi

Consumul lunar curent Sursa Unitate de măsură Cod Data expirării

Alcool CNAM l

Preț

unitate40,07 MDL Lot T °C de păstrare

Consumul lunar curent Mediu ultimele

3 lMaxim ultimele 3 l

Minimultimele 3 l

PRIMIT DISTRIBUIT RĂMAS

Nr. d/o Data Bon Cantitate Tehnician Data Cantitate Sector Tehnician Cantitate Tehnician

1 0

2 8/16/2013 40200 3 ANS 8/22/2013 0.25 BACTEC VAC 2.75 ANS

3 8/22/2013 40273 8 ANS 8/28/2013 1 PREP REAG CNV 9.75 ANS

4 8/28/2013 1.4 PREP TAMP MVI 8.35 ANS

5 9/2/2013 1 PCR GME 7.35 ANS

We learned how to monitor consumption and how to do inventory of stocks for

consumables and reagents

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).

Main challenges for project implementation

Some difficulties, 2011 – 2013 Solutions

NTP was not fully involved in the process. Project should be address through NTP, not directly to NRL.

Custom clearance. Solved by designate dedicated person, not from laboratories.

Transportation from borders, custom to laboratories

Solved by contract transport company.

Installation of new equipment (autoclave, BSC, BACTEC)

Solved by local staff (autoclave, incubator); solved with external engineer for BACTEC; in process of solving for BSC.

Include additional RRL (Bender for Transnistrian region)

Not solved

Training of physicians in correct requesting and understanding of new laboratory methods

We address continue efforts in this direction

Store space, inventory of reagents, equipments.

In process.

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But all something is start to finish.

And now we should start to prepare for the new period …

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.

• 9-12 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.

To find FUTURE PARTNERS to support laboratory activities:

And there are not many:

• Government, Ministry of Health, National Assurance Company:– Microscopy (2013-2014)

– I line drugs from (2013-2014) and 100 patients for II line treatment (2014).

• GF – Now we start planning for 2015-2017 program.

– Address needs for more costly method – Xpert, LPA, BACTEC.

• Research study.

• Clinical study.

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 15189 for at least NRL in country.

Future plans, 2014 - 2015

• To finalize National Strategic Plan for TB Laboratory Service.

• To make a proposal for new GF project (2015-2017).

• To start trainings in QMS for RRL.

• To find funds for accreditation of NRL in ISO 15189.

• 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.

Thank you!

• We want to express our acknowledge for

• All EXPAND TB team, but

Especially for

Knut Fieldman,

Maka Akalaia,

Alexei Corobitin.

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