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GHP Leads Document Development Workshop to Aid With Creation of Kenya Validation Program

CLSI Board of Directors President Mary Lou Gantzer, PhD, FACB, and Global Health Partnerships Director Frances Ingersoll, MS, MLS (ASCP), recently led a five-day document development workshop in Kenya to help the country’s laboratory leaders launch an ambitious program to validate laboratory equipment and reagents as they enter the country.

CLSI’s Global Health Partnerships (GHP) program is working with the Kenya Medical Technicians and Technologists Board (KMLTTB) on the program, which was sparked by a need to ensure the quality of all in vitro diagnostic (IVD) products entering the country. CLSI’s consulting work is supported by funding from the President’s Emergency Plan for AIDS Relief (PEPFAR).

Funding for health care in general, and laboratory supplies in particular, is limited in developing countries such as Kenya. Spending money on poor quality products, or products that don’t “fit” into the laboratory environmental conditions in Kenya, only adds to the problem.

Kenya’s legislature recognized the severity of this issue and passed legislation mandating that the government-appointed KMLTTB develop policies and procedures for validating laboratory products brought into the country.

Product validation will be conducted in laboratories that meet international accreditation standards that are aligned with International Organization for Standardization document ISO 15189:2012, Medical laboratories – Requirements for quality and competence, so manufacturers can feel confident about the validation results obtained by the testing laboratories. Although the number of accredited clinical laboratories in Kenya is lower than desired, the number is increasing. Twenty-three laboratory leaders attended the GHP workshop, including managers from laboratories selected as potential validation sites. The managers were brought together to develop standard operating procedures for the verification testing.

The five-day workshop included presentations on CLSI documents such as EP17-A2—Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition; EP15-A2—User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition; and EP12-A2—User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition. The participants also worked in groups on developing standard operating procedures.

GHP staff plans to return in October 2013 to conduct a quality management systems workshop for KMLTTB staff and members.

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 Director, Development Lauren Wiley at 484-588-5935 or



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