Clinical Referral Laboratories in Rwanda.

Area of Science:

• Medical Laboratory Science
• Public Health
• Healthcare Quality Management

Background:

• Referral laboratories are critical for healthcare delivery in Rwanda.
• Accreditation is a key benchmark for laboratory quality and performance.
• Previous assessments indicated a higher level of quality system performance.

Purpose of the Study:

• To assess the current quality system performance of Rwandan referral laboratories.
• To evaluate progress toward laboratory accreditation.
• To identify factors influencing quality system performance.

Main Methods:

• Audits were conducted in five Rwandan referral laboratories in 2017.
• The Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist was utilized.
• Laboratories were scored using the World Health Organization 0-5 star grading scale and compared to previous audits.

Main Results:

• Between 2012 and 2017, only one laboratory improved its score (from 4 to 5 stars).
• Four laboratories experienced a decline in performance, with scores decreasing to 0 or 1 star.
• Key quality system components like management reviews, document control, and nonconformity identification demonstrated low performance.

Conclusions:

• Four out of five Rwandan referral laboratories are regressing in their journey toward accreditation.
• Achieving accreditation remains feasible through enhanced stakeholder engagement and robust monitoring and evaluation.
• Leveraging past laboratory capabilities and supportive health policies can drive sustainable quality improvements.