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

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

PIH

Queen Elisabeth II Hospital, Maseru

TB Lab Entrance, Maseru

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

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

PIH

Before After

Safety cabinets Culture room

Anteroom

PIH

Glass Partitioning &

Creation of Media

Room

PIH

Microscopy room converted to

Sterilization room

with on-site Autoclave

Before

After After

PIH

Negative air pressure facility

& monitoring

HEPA In-flow

HEPA Exhaust

Magne-helic gauge

PIH

Media preparation, Culture processing

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

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

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)