In September 2005, CLSI was awarded a cooperative agreement with funding to participate in efforts to develop clinical laboratory capacity in collaboration with the Centers for Disease Control and Prevention in support of the President's Emergency Plan for AIDS Relief (PEPFAR) initiatives. This partnership will advance CLSI's vision of global growth and fulfill its mission to place its products where they will be of the most benefit to the most people, thereby improving health care worldwide.

CLSI representatives met with key stakeholders in Tanzania at the 8^th Biennial Association of Pathologists of East, Central, and Southern Africa (APECSA) Congress 28-30 August 2006.

In late 2005 and again in the fall of 2006, CLSI representatives made trips to Tanzania, visiting district, regional, and local laboratories and meeting with in-country key stakeholders with the purpose of:

• providing introductions to the in-country partner organizations and their people;
• better understanding the spectrum of laboratories in Tanzania by seeing them in operation;
• beginning initial work with the partners;
• planning for quality systems and standard operating procedures implementation; and
• developing further the CLSI action plan.

Guiding philosophies of CLSI’s activities include:

• implementing International Standards for credibility;
• establishing local control for sustainability; and
• ensuring clinical and laboratory improvements through enhanced quality management.

For its second-year activities, CLSI will continue its work in Tanzania to build laboratory capacity through team-created interpretive guides; facilitate implementation of a quality management system within the clinical laboratory; and collaborate with the Ministry of Health and Social Welfare (MOH) to rebuild a full-cycle External Quality Assessment program. Additionally, CLSI will begin initial work in the region of Central Asia and the countries of Namibia, Nigeria, and Zimbabwe.

CLSI has named Dr. Michael Noble from the University of British Columbia as its Senior Technical Director and Senior Laboratory Advisor. Dr. Noble has provided strong leadership and expertise for this initiative. In addition, CLSI received an overwhelming response to requests for participation in project development. These individuals are uniquely qualified to travel and otherwise assist in the development of standard operating procedures and quality systems documents for the CDC partnership agreement. CLSI is extremely grateful to the appointed teams of volunteer experts, including:

• Yashwant Chudasama, Technical Specialist, St. Joseph Medical Center, Reading, Pennsylvania;
• Anne Daley, Senior Managing Consultant, Healthcare Solutions, Roche Diagnostics Corporation, Indianapolis, Indiana;
• Dr. Haynes Sheppard, Research Scientist and Section Chief, California Department of Health Services, Richmond, California;
• Susan Shuptar, Manager, Microbiology Laboratory, Memorial Sloan-Kettering Cancer Center, Sloan-Kettering Memorial Hospital, New York, New York; and
• Barbara Jean Van Der Pol, Research Associate, Indiana University School of Medicine, Indianapolis, Indiana.

Through CLSI’s work in Tanzania, and in anticipation of work in other PEPFAR countries, CLSI has appointed a writing group for the cooperative agreement who are charged with developing a suitable quality systems approach to meet laboratory quality systems requirements in collaboration with the Ministries of Health and CDC. This assignment includes support for the development of the National Quality Assurance Framework, the review of country-developed Standard Operating Procedures (SOPs), and the development of Job Aids.

CLSI Cooperative Agreement Writing Group participants include:

• Judy Arbique, Arbique-Rendell Onsite Training & Consulting, Halifax, Nova Scotia;
• Giselle Guevara, Manager, Laboratory Accreditation Division, Trinidad and Tobago Bureau of Standards
• Karen McClure, Director, CLS Program, University of TX M.D. Anderson Cancer Center, Houston, Texas;
• Robert Moran, Assistant Professor of Chemistry and Physics, Wentworth Institute of Technology, Cambridge, Massachusetts, and President, mvi Scientific, Methuen, Massachusetts;
• Sharon Pendergrass, Quality Assurance Officer, Minnesota Department of Health, St. Paul, Minnesota;
• Anne Rendell, Laboratory Technologist, Molecular Biology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia; and
• Shelia Woodcock, Principal Consultant, QSE Consulting, Rose Bay, Nova Scotia.

CLSI, along with the CDC Laboratory Coalition Partners—CDC Atlanta, APHL, ASCP, and ASM—are pleased with the progress made on the cooperative agreement. CLSI is committed to the successful completion of future outlined initiatives and will continue to focus on building and strengthening partnerships that advance its mission to facilitate the development and availability of useful and appropriate global best practices.    [ return to top ]