Pre-Analytical non-conformities in the clinical biology laboratory of the university clinics of Kinshasa, Democratic Republic Of Congo: A cross-sectional assessment of compliance with quality standards.

Abstract

Background:

Laboratory test reliability depends on quality standards across the pre-analytical, analytical, and post-analytical phases. The pre-analytical phase is the most error-prone, covering procedures from test prescription and patient preparation to specimen collection, transport, and processing. This study evaluated pre-analytical non-conformities and compliance with laboratory quality requirements at the Clinical Biology Laboratory of the University Clinics of Kinshasa, Democratic Republic of the Congo.

Methodology:

A descriptive cross-sectional study was conducted from June to August 2025 at the Clinical Biology Laboratory of the University Clinics of Kinshasa. A total of 392 pre-analytical observations were assessed using a standardized form based on ISO 15189 requirements and World Health Organization recommendations. Compliance was evaluated across six domains: beneficiary information, prescriber identification, patient identification, specimen collection, specimen transportation, and biosafety. Data were analyzed using descriptive statistics, with proportions reported using 95% confidence intervals.

Results:

All beneficiary information requirements showed complete non-compliance, including patient information materials, laboratory operating procedures, and communication about laboratory services. High compliance was observed for prescriber qualification and date of request (95.4% each), patient sex documentation (97.4%), appropriate tube selection, and patient-specimen identification (100%). Major deficiencies were found in clinical information documentation (3.8%), patient preparation before collection (12.0%), specimen protection from light during transport (31.4%), and hand hygiene before and after glove use (0.8% and 15.6%, respectively). Appropriate transport equipment and temperature-controlled transportation were absent in all cases.

Conclusion:

The study identified substantial non-conformities throughout the pre-analytical phase, particularly in beneficiary information, documentation practices, specimen transportation, and biosafety procedures. These findings highlight the need for strengthened implementation of ISO 15189 quality management requirements, staff training, and continuous monitoring to improve laboratory performance and ensure the reliability of diagnostic results.