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GHP Helps Kenya Launch Ground-breaking Product Validation Program

CLSI’s Global Health Partnerships staff and Board of Directors President, Mary Lou Gantzer, PhD, FACB, are working with the Kenya Medical Technicians and Technologists Board to launch an ambitious program to validate laboratory equipment and reagents

“Laboratory equipment manufacturers frequently donate products or sell them at a reduced cost to developing countries,” said GHP Vice President, Karen McClure, PhD, MLS(ASCP), SBB. “While their assistance is greatly needed, they frequently give the developing health systems outdated equipment or poor-quality reagents.” Products that are faulty or outdated can cause laboratories to produce incorrect test results. Kenya’s legislature recognized the severity of this problem and passed a bill mandating that the government-appointed Kenya Medical Technicians and Technologists Board develop policies and procedures for validating laboratory products that are brought into the country. The scope of this validation project is unprecedented among the developing countries in the region.

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“Kenya is leading the way,” said McClure. “And CLSI will be guiding them through the process.”

With funding from the President’s Emergency Fund for AIDS Relief (PEPFAR), Dr. Ganzter, Dr. McClure, and GHP Director, Frances Ingersoll traveled to Kenya at the end of January for a meeting to discuss how they can accomplish the project. Gantzer remained in Kenya for the first week of February to review the board’s plans in more detail.

“Product validation will have to be conducted in laboratories that meet international accreditation standards that are aligned with ISO 15189,” said McClure. “This is so that manufacturers can feel confident about the validation results obtained by the testing laboratories. Kenya has several accredited laboratories and more that are close to achieving accreditation.”

The GHP staff will return to Kenya in April to conduct a validation workshop and provide technical assistance to the board as its members develop the program’s policies and procedures. They will travel to Kenya again in August to lead workshops for managers in laboratories that were selected as potential validation sites.

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“These efforts will greatly enhance the quality of laboratory testing in Kenya and, hopefully, act as an example for additional African countries,” McClure said.

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 lwiley@clsi.org.

 

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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GHP has helped 4 LABORATORIES achieve accreditation to international laboratory standards. An ADDITIONAL 5 LABORATORIES are anticipated to achieve accreditation by mid-2013.

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