LABORATORY

Our laboratory is also biometrics access controlled and fitted with a burglar door. The laboratory has a sample collection window. The laboratory personnel also wear Personal Protective Equipment (PPE), and the laboratory is always under the supervision of a laboratory technician. We also work with Pathcare (local private laboratory) which is our laboratory which conducts additional tests as per study protocol. Our internal laboratory runs point of care tests.

The site laboratory runs Internal Quality Control on all kits for HIV, Urinalysis, Urine Pregnancy and Covid etc weekly.

Our laboratory is equipped with calibrated ambient Centrifuge, 2-8 Degrees Fridge, Lock and Key Water and Fireproof Cupboards, labelled, and designated for each study consumables. Laboratory also has a serviced air-conditioning unit.

Inside the laboratory there is also a designated printer for laboratory results print outs that is only connected to the laboratory personnel laptops.

All fridges and freezers are monitored by Continuous Temperature Monitoring System (CTM) as well as the min/max manual temperature monitoring system. The CTM system records temperature in real-time and alert staff in case of temperature deviation. The laboratory is access controlled and has access to back up generator to ensure constant power supply in the event of power failure.

Our laboratory has a functional QA system to ensure processes and procedures are up to date and well controlled. The system ensures proper handling of clinical samples, issuing of results, sample storage and staff trainings. The system also controls equipment calibration and maintenance and standard operating procedures (SOPs) within the laboratory.

The QA system is overseen by the site QA and Regulatory Affair Officer. Site runs External Quality Assurance monthly. Daily temperature monitoring including a data logger (TESTO). The laboratory also has operational SOPs and keeps ISF Laboratory Binders which are under lock and key.