Field experience in implementing ISO 15189 in Kisumu, Kenya

Area of Science:

• Medical laboratory services
• Public health
• International standards

Background:

• Quality laboratory services are essential for healthcare, research, and public health, yet scarce in Africa.
• Sub-Saharan Africa faces a critical need for improved laboratory services due to its disease burden.
• International initiatives aim to strengthen laboratory infrastructure through accreditation, such as ISO 15189.

Purpose of the Study:

• To discuss the challenges and benefits of pursuing and maintaining ISO 15189 accreditation.
• To examine the specific case of the Kenya Medical Research Institute/Centre for Disease Control HIV-Research Laboratory in Kisumu, Kenya.
• To highlight factors affecting accreditation in resource-limited settings.

Main Methods:

• Case study analysis of ISO 15189 accreditation process.
• Discussion of common limiting factors: funding, government support, equipment, training, and procurement.
• Exploration of benefits derived from accreditation.

Main Results:

• Pursuing and sustaining ISO 15189 accreditation presents significant challenges in resource-limited settings.
• Common barriers include financial constraints, lack of government support, inadequate equipment, limited training, and poor procurement infrastructure.
• Successful accreditation offers substantial benefits for laboratory quality and services.

Conclusions:

• ISO 15189 accreditation is a crucial step towards enhancing medical laboratory quality in Africa.
• Addressing challenges related to funding, infrastructure, and training is essential for successful accreditation.
• Sustaining accreditation requires ongoing commitment and strategic planning.