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Establishing a TB specimen referral system

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					    PEPFAR-Becton Dickinson
Laboratory Strengthening Program
           in Uganda
Background
• PPP between OGAC & Becton Dickinson in 2007
• Scoping trip to Uganda by BD, CDC and FDA in early 2008
• Three potential projects identified;
   1.   Laboratory Quality Management using CD4+ counting as a model
        system - labs enrolled in UK EQA scheme (NEQAS) - adopted
   2.   National roll-out of CDC/WHO Workshop in a Box for TB smear
        microscopy
   3.   TB specimen referral network - adopted
• Globally, the partnership
   – utilizes BD associate assistance
   – supports 8 African countries through collaboration with in-country
     partners
   – committed to 5-year program valued at up to $18M - BD personnel
     time and contributions valued at $9M


                                                                          2
Strengthening CD4+ counting
• 36 sites enrolled in NEQAS - overall performance
  persistently unsatisfactory
• Local gap analysis conducted
• Training in lab quality management identified as an
  urgent need
• Course curriculum developed in collaboration with
  local partners
• Phase1: Build LQM capacity at the testing site
  • 119 lab techs at 92 CD4+ counting sites trained
  • Baseline site assessments conducted including lab
    environment
  • On-site coaching
  • Enrollment into UK NEQAS
  • Free supply of IQC materials

                                                        3
Strengthening CD4+ counting
• Phase 2: Build LQM capacity at regional level
  • Train the Trainer – 9 participants

  • Workshop-in-a-box

  • Practice workshop conducted by new trainers - 15
    new sites trained

  • Currently building basic flow cytometry
     curriculum in collaboration with BD-Kenya for
     FACSCount and FACSCaliber

  • Continuous onsite coaching by local training team



                                                        4
Strengthening CD4+ counting:
Impact
                               Percentage averages of laboratories with satisfactory performance for                                                          Enrollment of laboratories on the UK NEQAS EQA Program
                                                         absolute counts
                     100
                      90
Percentage average




                                                                                                                                                  100.00%
                      80
                                                                                                                                                  90.00%
                      70




                                                                                                                   % of Laboratories Subscribed
                      60                                                                                                                          80.00%
                      50                                                                    Satisfactory_CD4+Abs
                      40                         LQMTP period                               Satisfactory-CD3+Abs                                  70.00%

                      30
                                                                                            Satisfactory-CD8+Abs                                  60.00%
                      20
                      10                                                                                                                          50.00%
                       0
                                                                                                                                                  40.00%
                                 08




                                 09
                                  8




                                  9
                                  8
                                  8




                                  9
                                  8




                                 09
                                 08
                               r0




                               r0
                              v0
                              y0




                              y0
                           0




                                                                                                                                                  30.00%
                             Jul




                             Jul
                       Jan




                            Jan
                           Sep
                           Ma




                           Ma
                           No
                           Ma




                           Ma




                                                                                                                                                  20.00%

                                                    Trial date                                                                                    10.00%

                                                                                                                                                   0.00%
                                                                                                                                                            Jan 2008       July 2008          Jan 2009   Apr 2009

                                                                                                                                                                                       Date
Strengthening CD4+ counting
Pre-requisites

• Well-equipped sites with trained staff, suitable lab environment and
  instrument maintenance contract
• Proficiency testing scheme – international or local – opted for established
  international scheme – UK NEQAS
• In-country shipping mechanism to distribute PT panels and
  communications to verify receipt
• No stock-outs of CD4+ counting kits at sites
• Access to NEQAS internet site by participating facility and by coordination
  office to enter data and to monitor performance
• Process controls with known CD4+ count
• Capacity to follow-up on poorly-performing sites
• Funding to make all this happen



                                                                                6
Establishing a TB specimen
referral system
          • TB burden in Uganda

          • Ranked 16th among 22 high-burden
            countries
          • 41,000 TB cases detected per year but
            only 21,000 confirmed smear-positive
          • DOTS case-detection rate only 51% -
            many TB cases remain undetected
          • Only 1 government lab with capacity for
            TB drug susceptibility testing – Kampala
          • No MDR treatment facilities
                                                  7
    Establishing a TB specimen
    referral system
Implementation

   TB specimen referral system established Sept 2008 in conjunction with DST

   Target re-treatment cases, smear-positive patients on treatment for 2-3
    months and extra-pulmonary cases
   Prior to start of referral system in a zone:
      Sensitization visits to districts, health facilities and post offices

      One–day training for health facility focal persons (shippers), district TB
        supervisors, lab focal persons and post-office officials

      Participating health units mapped (GIS) for distribution, coverage and
        trends (hot spots)


                                                                                    8
Establishing a TB specimen
referral system
     Bio-Safety

     1. Sputum container – screw-capped and leak-proof




     2. Zip lock bag - leak-proof secondary packaging




     3. Safety shipping box - an outer packaging box



                                                         9
Establishing a TB specimen
referral system
Shipping system

   Kampala TB zone: Health facility focal persons call a toll-free Posta
    Uganda telephone number to collect the sample and deliver to NTRL

   Other TB zones: Health facility focal persons deliver samples to the
    local post office - NTRL refunds transport costs

   Samples shipped at room temperature

   Lab results sent back through post-office network

   Currently investigating the use of SMS printers to report results
                                                                            10
Establishing a TB specimen
referral system
Implementation progress

• September 2008 - system introduced in Kampala TB zone
• May 2010 - system operational in 8 of the 9 TB zones (89%
  coverage)
• Referral samples received in 2009 – 882
• Culture-positive – 425
• MDR positive – 54
• MDR negative – 286
• Others pending


                                                              11
Establishing a TB specimen
referral system
Pre-requisites

• Sensitization and training visits to districts, health facilities
  and post-offices
• GIS mapping of health units for distribution, coverage and
  trends and as a management tool
• Capacity at reference lab to handle MDR TB and for DST
• Shipping boxes meeting international safety standards
• Contract with POSTA-Uganda for shipping specimens and
  returning results
• Toll-free telephone at POSTA-Uganda
• Capacity to follow-up on poorly-performing sites
• Funding to make all this happen


                                                                      12
Comments on the PEPFAR-BD PPP
Strengths                            Weaknesses
• Access to highly experienced       • High cost of bringing BD
   staff at BD and elsewhere           associates to Uganda
• Local training teams               • Insufficient coordination with
   established for sustainability      other training partners,
• TB specimen referral system          particularly in lab
   can be used for any specimen        management
• Project gave a tremendous
   boost to GIS efforts in-country
• Networking opportunities with
   other organizations at the
   forefront of technological
   innovation



                                                                        13

				
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posted:4/12/2013
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