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Global Health Partnerships Guides Creation of a Laboratory Quality Manual in Nigeria

CLSI’s Global Health Partnerships (GHP) International Program Manager Leonard LaFazia, MS, MLS (ASCP), recently assisted the Medical Laboratory Science Council of Nigeria (MLSCN) with the development of a quality manual for the implementation of International Organization for Standardization (ISO) standards ISO 15189, ISO 17011, and ISO 17043.

Nigeria established the MLSCN in 2003 as a federal agency with the mission to strengthen health laboratory systems and professional practice for quality services through strategic regulations and accreditation. According to its website, the council aims to establish a quality laboratory network so that Nigerians can gain enough confidence in their country’s health care system to have medical procedures performed in the country rather than going abroad for health care services.

MLSCN regulates the production, importation, sales, and stocking of diagnostic laboratory reagents and chemicals. The council also sets standards for the training of medical laboratory scientists, technicians, and assistants, and provides accreditation to training institutions. In addition, MLSCN oversees the accreditation of public and private laboratories in Nigeria.
LaFazia spent the first two weeks of June in Abuja, Nigeria, meeting with the MLSCN’s six-member quality team. After the first team meeting, the group agreed that their initial draft of a quality manual needed to be rewritten to reflect the 12 quality system essentials (QSEs): Organization, Customer Focus, Facilities and Safety, Personnel, Purchasing and Inventory, Equipment, Process Management, Documents and Records, Information Management, Nonconforming Event Management, Assessments, and Continual Improvement. Working with LaFazia, the team developed a draft of the manual centered on the 12 QSEs, and then presented the document to the Centers for Disease Control and Prevention for review.

LaFazia expressed confidence that the MLSCN staff will succeed in their effort to raise laboratory standards in Nigeria, noting that the government will invest in a new facility for the council that will feature laboratories for product evaluation and training facilities.

“This is a very energetic team that has met the challenge to begin this process of [implementing a quality management system (QMS)] in Nigeria,” he said. “They have a strong knowledge base of QMS and the importance of its establishment to meet the national mandate to improve quality in laboratory services.”

CLSI is seeking corporate and foundation support for GHP’s laboratory quality improvement programs. If your company is interested in learning more about GHP sponsorships and grants, please contact GHP’s Director of Development, Lauren Wiley at 484.588.5935 or


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