The Quality Journey at MRCG started with the Clinical Trials Support Office (CTSO) in 2006 which lead to the establishment of the Quality Department in 2008.In 2006, the Clinical Trial Support Office started to work closer towards The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guideline following the implementation of the European Directive on clinical trials into national law in the UK in 2004. The CTSO continued to play a critical role by ensuring compliance with international standards in clinical trials conducted at MRCG to assure protection of safety of trial participants and providing credible and reliable clinical trial data. With this approach quality assurance became essential to the office. It started with writing standard operating procedures for the conduct of clinical trials and introducing monitoring according to GCP requirements. In close collaboration with the CTSO a Quality Management System (QMS) was also developed in the laboratories.
The Unit management, recognising that quality measures need to be applied to the other departments, established a Quality Department in 2008 to ensure quality assurance for the whole Unit. This department started by developing and maintaining a robust quality infrastructure that could be built upon as The Unit’s demands and objectives change over time.
The Quality Department had a strategy which emphasised on strengthening the routine diagnostic laboratories, specifically, the Clinical Laboratories (CLAs), which includes Biochemistry, Haematology and Microbiology laboratories. This included identifying the most suitable standard for these facilities based on The Unit’s priorities and the majority of work conducted within the laboratories. Although clinical trials make up less than 20% of The Unit’s overall research activities, the Quality Department strategically reinforced the QMS to include elements that would further give assurance that the processes involved ensure the safety of study participants as well as ensure reliable and credible results.
As a result, Good Clinical Laboratory Practice (GCLP) was implemented in 2010 to address the pre-analytical, analytical, and post-analytical phases of laboratory diagnostics. In addition, the strategy included support areas such as Clinical Services Department, Quality Department, Procurement & Stores, Transport Department, Archives, Unit’s Management, Biomedical Engineering, Biobank Department, Data and Facilities Department. Figure 1, below illustrates the relationship between the Clinical laboratories and the external areas providing direct support. Implementing GCLP in the Clinical Laboratories also encouraged the relevant support areas to also comply with the applicable requirements of the international standard.
Implementing GCLP required the development of many standard operating procedures, training of personnel in GCLP and implemented procedures, frequent periodic internal audits, and external audits as required. All of these resulted in a successful assessment in 2011 when the Clinical laboratories received certification to GCLP, which was valid for 2 years.
After getting certified, The Unit’s Leadership identified additional routine laboratories, namely Serology and Mycobacteriology (TB) Diagnostics laboratories, where the standard should be implemented. As a result, the Quality Department worked closely with the Clinical Laboratories to support the new labs added to the scope. The strategy illustrated in figure 1 was again employed, with the objective to be assessed for certification in 2013, the same time when the re-assessment of the Clinical Laboratories was conducted. Furthermore, the support areas also applied the GCLP requirements in non-GCLP related facilities, where applicable. This further strengthened The Unit’s already established Quality Management System (QMS).
The key prerequisite to successfully implementing and maintaining a robust QMS is to have it based on continuous improvement. As a result, the Quality department introduced ISO 15189:2012, which is an all-inclusive standard that fully meets the needs of our medical laboratories and the clinical care provided to research or non-research patients. Similarly to Figure 1 above, the technical requirements were implemented in the laboratories and some support departments, alongside the management requirements in the remaining support departments, see figure 2 below.
The Quality Department in The Gambia Unit is fully established. However, since our QMS is based on continuous improvement, the QMS will continue to be built upon to meet the present demands and objectives of The Unit.
The table below gives a listing of the major achievements of the Quality Department in MRCG.
Summary of Achievements since 2008