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PIH
Establishing Laboratory
Facilities to Tackle the
Challenge of MDR & XDR TB
in the Kingdom of Lesotho
Dr. C.N. Paramasivan
Foundation for Innovative New
Diagnostics, Geneva
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PIH
Establishing NRL in Lesotho (1)
• Need to enhance and expand culture/DST capacity in response to M/XDR TB in southern Africa
• Lesotho identified as target country in fall 2006
• FIND/WHO assessment of NRL in Nov 2006– Shortage of qualified personnel
– Lack of technical know-how and training
– Shortage of equipment and funding
– Need for assistance to organize a quality-assured facility for culture and DST
– QAP for smear microscopy in need of support
• FIND/PIH/MoHSW 2-year collaboration
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PIH
Queen Elisabeth II Hospital, Maseru
TB Lab Entrance, Maseru
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PIH
Establishing NRL in Lesotho (2)
• FIND and PIH providing financial and technical assistance, including TB lab expert for 1 year to oversee laboratory renovations and provide training
• Laboratory renovated to meet basic requirements for AFB smear, media prep, biosafety for culture/DST, sterilization
• New equipment provided
• SOPs for culture/DST developed
• 4 new lab technicians hired/trained
• Guidelines/training for AFB QA in place
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PIH
Central TB Laboratory at QE II Hospital, Maseru
BEFORE Renovation AFTER Renovation
Office of
Microbiologist
Toilet
Microscopy,
centrifuge,
Incubator
Storage of
chemicals, stains
& inspissator
Staining areaB
S
C
Refrigerator
Culture room
28thMay to 22ndJuly
3m
MGIT 960, Fridge &
IncubatorBSC
A/CBSC
Cntfg
3
5
2.5
m
2m
Neg. Air Pressure
Specimen receipt
& Microscopy room
Sink
Sterilization room
Autoclave4
1
6
Sin
k
3.75m 3.25m
Culture room
7
Hand-wash
Toilet
InsspiMedia
room
BSC
2
Entry
National Reference lab facility is ready, now
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PIH
Before After
Safety cabinets Culture room
Anteroom
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PIH
Glass Partitioning &
Creation of Media
Room
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PIH
Microscopy room converted to
Sterilization room
with on-site Autoclave
Before
After After
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PIH
Negative air pressure facility
& monitoring
HEPA In-flow
HEPA Exhaust
Magne-helic gauge
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PIH
Media preparation, Culture processing
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PIH
YesDesirablePersonnel safety Monitoring Capacity
Yes, class II type BYesBiological safety cabinets (BSC) class I or II, ducted outside
NoDesirable-double-ended
NoDesirable-in laboratory room
YesYesAutoclave -on site
NoYes/NoEffluent treatment
YesDesirableAnteroom with hand-wash
NoNoAnteroom with shower
YesYesAccess through Anteroom
NoNoAirlock
YesYesDouble-door entry
YesYes-Monitors to check air pressure of containment room
YesYes-Existing building @ at least 6 APH HEPA exhaust
YesYes-HEPA-filtered air exhaust
YesYes-controlled ventilating system
YesYesVentilation -inward airflow
YesYesRoom sealable for decontamination
YesDesirableLaboratory at the blind-end of building
YesYesIsolation of laboratory
Central Lab, MaseruRequirement*Facility
* WHO requirements for liquid cultures, CDC & other agencies specifications for handling M. tb. culture
NRL Meets minimum bio-safety requirements for the TB culture laboratory
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PIH
Laboratory Culture & DST processing capacity
With the existing staff (2-Sr.LTs, 4-Jr.LTs & 1 Lab-in-charge, one
cleaning & washing person) and equipment/facility:
50 DSTs/week20 DSTs/weekDST for 1st line
drugs
80 smears/dayMicroscopy
(ZN staining)
40 specimens/day
(5 batches)#32 specimens/day
(4 batches)*
Primary culture
(Modified Petroffs)
Automated Liquid
system (MGIT 960)
Solid LJ mediumCapacity per Day
*Centrifuge has capacity of 8 tubes, per cycle#Capacity is > 700 specimens, but average turn-over time of 10-14 days
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PIH
Conclusions and Next Steps
• With adequate resources and political commitment it has been possible to establish the NRL in Lesotho
– Without compromising international standards
– With demonstrated proficiency in culture and DST on solid
medium
• Completion of EQA for DST (Oct)
• Establishment of MGIT culture and DST (Nov)
• DRS planned (Dec)
• Implementation of GenoType MDR TB (?Jan)