Project START

1

• Project START
• LABORATORY PLANS
• Ayesha BM Kharsany

2

• LABORATORY PLANS
• GOAL
• Provide Project START
• accurate diagnostic and research testing
• high quality service (QA/QC)

3

• Clinical site (CDC / KEH) administration
• Training
• Laboratory personnel
• Study nurses
• GCP (SA) and GLP
• Chain of custody
• Recording and reporting
• On site testing procedures
• Proper transportation of specimens

4

• Regulatory compliance
• Certification (SANAS)
• Proficiency testing programs
• Shipping of dangerous goods protocols (IATA)
• IATA training of lab personnel
• Biohazard containment
• Occupational Health and Safety Committee
• (Institutional Biosafety Committee) (UN)

5

• Management of laboratory specimens (SOPS)
• Collection
• Labeling
• Shipping procedures
• Processing
• Storage
• SOPs (onsite lab), (QA/QC)

6

• Management of laboratory data
• Reporting of results
• on line (Meditech)
• lab reports (source documents)
• LDMS
• storage of serum / plasma
• shipping of specimens

7
Specimen collection protocol for scheduled visits
I intervention X both C
control / sequential / deferred
8
Specimen forwarding procedure
9
Standard operating procedures Specimen
collection, transportation and processing of
clinical specimens
Received by clinic site Lab personnel-Kit
receiving log
CDC initial
Lancet Lab
Shipping to clinics - Kit / test departing log

Specimen bottle labelling (SN)
Specimen collection instruction (SN)
Distributed to specimen collection section
Prep specimen collection kits
Received by clinic site Lab personnel-Kit
receiving log
KEH Follow-up Post TB Rx / control
On site test kits
On site- lab receiving log
Specimen collection (Patient, SN, clinician)
Spec collection log (SN)
Lancet Laboratory
On site routine testing
MED Micro KEH
Results
Africa Centre
shipping Spec collection log
Speci-men shipping
Online (Mx)
Lab reports S D
CAPRISA Lab / storage
NICD
UCT
Lab personnel Report abnormal results to site
clinicians
Lab personnel Verify results Flag abnormal
Results Clinician For Patient MX
Lab personnel reconcile online / source document
results