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CAP Accreditation Achieved at MRTC Laboratory in Mali

Since 2008, GHP has been working in Mali to help the Malarial Research Training Center (MRTC) laboratory in Bamako reach College of American Pathologists (CAP) accreditation. The MRTC Clinical Laboratory supports malarial vaccine studies and trials conducted in Mali by the Malarial Vaccine Development Branch of the National Institute of Allergy and Infectious Diseases. In June 2010, MRTC achieved CAP accreditation.

Throughout the partnership with MRTC, CLSI has assessed the status of the laboratory as it compares to that of an accredited laboratory; provided suggestions for improvement; educated on standards of practice; and assisted in conducting activities including quality assurance, quality control, continuous quality improvement, laboratory medicine, and management. By using consensus documents, companion products, and checklists, CLSI assisted with the design and implementation of changes and improvement plans.

Mary Belanus Nagel, MED, MLS(ASCP)CM, former CLSI International Program Manager, who was responsible for the project from July 2008–July 2009, explained that her role was to help the laboratory staff at MRTC establish a quality management system (QMS), assess what was needed to reach CAP accreditation, and help build a laboratory quality system that was sustainable for them. She says, “After I made my first trip to Bamako, I created a master work plan and mapped the CLSI documents to each specific area for the quality system essentials (QSEs). My role was to mentor the laboratory staff, provide technical training, and help with the processes and implementation of a QMS.”

The CLSI documents were important resources in the establishment of the QMS in Bamako. Nagel used more than 100 of the CLSI documents as references for the laboratory to understand what was required to meet regulatory and accreditation requirements. If questions came up in meetings at the laboratory, the answer would always be ‘what does  the CLSI standard or guideline recommend?’ notes Nagel.

“The biggest challenges for MRTC were space issues, safety, and control of the laboratory. Laboratory Design; Approved Guideline—Second Edition (GP18-A2) was a helpful document to reference as we redesigned the laboratory to improve quality.  Other focus areas for the laboratory involved technical writing, documentation, and establishing reference intervals for all of their data,” comments Nagel.

Fran Ingersoll, CLSI Director, Global Health Programs, and Lilly Mukoka, MT(ASCP), CLSI International Project Coordinator, visited the laboratory at the end of 2009, and returned April 19–23, 2010 to assist in final preparations of the site for the CAP accreditation visit later that week.

Ingersoll says, “The CAP inspection at MRTC was performed on April 22, 2010. After a thorough inspection, MRTC received three Phase II deficiencies. Two of the deficiencies were corrected on-site. The third deficiency, which pertains to developing a continuous quality improvement indicator tracking strategy, was addressed within 30 days. Full accreditation was achieved as of June 2010.”

Ruth D. Ellis, MD, MPH, National Institutes of Health (NIH)/NIAID, commented on CLSI GHP work, saying, “CLSI’s support has been essential to moving the clinical laboratory in Bamako toward being fully accredited and able to provide reliable results not only for US Food and Drug Administration (FDA)-regulated clinical trials, but also to serve as a resource laboratory for others conducting clinical research in Mali. As one of the poorest nations in the world, Mali is an extremely resource-limited environment, and strategies that are effective in other settings are less likely to succeed here. With their extensive international experience and ability to devote focused time toward building capacity in the laboratory, CLSI’s consultants were able to build relationships with the  local staff that translated into results.”

Nagel concludes, “With the CLSI documents and products, we had the tools and resources we needed to move the laboratory forward. The documents provided the basis for the training necessary to form a QMS at MRTC. We had a wonderful working relationship and partnership with the laboratory staff in Mali. Reaching accreditation truly was a collaborative effort and is a wonderful achievement.”

“CLSI will serve as a continuous resource for the MRTC laboratory and personnel as they keep their quality system in place and maintain the newly achieved accreditation status,” says Ingersoll.

CLSI GHP work for MRTC Clinical Laboratory in Bamako, Mali is funded by the NIH/NIAID.


GHP By the Numbers

number of resource-constrained countries we’re working in

number of partners we collaborate with worldwide

workshops that have allowed GHP Staff to reach over 4,000 laboratory professionals globally

Patrick Mateta Video

Patrick Mateta, Senior International Program Manager, CLSI, describes the life-changing experience of volunteering for the Global Health Partnerships program.

CLSI touched every element of laboratory operations. The laboratory staff appreciated the continuing education on quality control, safety, and documentation.”

– Medard Beyanga, Laboratory  Quality Officer, Bugando  Medical Center


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