In October 2017, MRCG at LSHTM Laboratories in Fajara operating according to GCLP were re-assessed by an independent certification body, Qualogy. The laboratories included in this assessment were Haematology, Clinical Chemistry, Microbiology, Serology and Mycobacteriology (TB) Laboratories. The objective of the assessment was to examine the laboratory facilities, processes, systems and procedures that have been implemented at the laboratories and to assess these for continued compliance with Good
Clinical Laboratory Practice (GCLP). In addition to the laboratories based at Fajara, for the first time, the laboratories at Basse and Keneba field stations were assessed for inclusion into the GCLP certification. It was recommended by Qualogy that continued and full accreditation to GCLP be granted to the laboratories in Fajara for another two years. Basse and Keneba laboratories were granted a conditional GCLP accreditation to last for one year. The next surveillance assessment for these two laboratories will get conducted in October 2018.
In March 2018, the Kenya Accreditation Service (KENAS) returned to the unit to conduct a re-accreditation assessment against ISO 15189 because accreditation from the first cycle is due to expire in July 2018. Yet again, the assessment was a success, and the unit is now re-accredited to ISO 15189 for another 3 years.
Laboratory accreditation to high quality standards is important for all laboratories in ensuring that reliable and accurate data and results are produced. Laboratories supporting clinical trials are required to meet the principles and objectives of the International Conference on Harmonization Good Clinical Practice (GCP); which are: ensuring that data generated by the laboratories are of high quality; that they are accurate and reliable for evidence-based decision for clinical management of patients; that there are appropriate systems for the management of investigational products, if applicable; and that the rights, safety and wellbeing of clinical trial participants are protected. It is therefore a major accomplishment for the unit to have the flexibility to carry out GCP-related work.
Re-accreditation of the laboratories to ISO 15189 provides confirmation that the unit’s Quality Management System is robust, and that the unit has maintained the technical competence to perform the accredited tests. During both assessments, all support systems and facilities required for GCLP and ISO 15189 compliance were added in the scope. These areas are Quality Management, Procurement, Logistics, Biomedical Engineering, Biobank, Human Resources, Archives, Clinical Trial Support Office, Research Laboratories Services, Clinical Services, Health Safety & Environment, Communications, Research Governance, and our Research Support Office were also assessed.