Towards a biomedical engineering quality system: Writing documentation to support clinical laboratory accreditation at MRC unit in the Gambia

摘要

This paper presents the planning and implementation process for a quality system being developed by the biomedical engineering programme at the Medical Research Council (MRC) Unit in the Gambia, West Africa. The biomedical engineering programme offers a fully in-house technology management programme for the Unit's 1,700 laboratory and clinical devices. In 2009, it began implementing a quality system based on the principles outlined in the UK Medical and Healthcare products Regulatory Agency (MHRA)'s `Managing Medical Devices: Guidance for healthcare and social services organisations' guideline. This was part of a larger Unit strategy being led by a newly recruited Quality Manager to improve quality Unit-wide and work towards Good Clinical Laboratory Practice (GCLP) accreditation for the Unit's clinical laboratories. Using the MHRA guideline and other good practice guidelines for medical equipment maintenance and management, the biomedical engineering team began formalising their work processes, writing documentation and focusing on quality improvement of their services, particularly for clinical laboratory devices. In early 2011, the MRC's clinical laboratories were the first site in West Africa to be accredited to the GCLP standard. The team has learned a lot during the process and continues to, recognising that quality improvement is an on-going process as opposed to a discrete project. The major lesson learned were a deeper understanding of the concept of quality standards, documentation and quality work processes, getting tuned into the practice of quality service delivery, and above all understanding the importance and crucial role Biomedical engineering plays in MRC the Gambia Unit's overall objective of maintaining and working towards GCLP and GCP standards.