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article · Risk Management and Healthcare Policy

Navigating Quality Assessment Hurdles in Clinical Laboratory Services: A Comprehensive Review in Resource-Limited Settings

202415 citationsOpen accessGondar University

In plain language

External quality assessment programmes evaluate laboratory performance and professional competence, serving as mandatory requirements for laboratory accreditation and standardisation. In resource-limited countries, establishing these quality programmes faces substantial obstacles. A literature review of relevant digital databases identified the primary barriers affecting implementation. Major challenges include the high cost of control materials, difficulties in assigning target values, and the noncommutability of control samples. Laboratories also struggle with equipment breakdowns, lack of maintenance, and knowledge gaps among staff. Furthermore, low participation rates in external quality assessment and failures to enact corrective actions undermine operational success. Overcoming these barriers requires coordinated attention from both programme suppliers and participating laboratories to implement corrective actions, secure accreditation, and improve clinical services for patient care.

Key takeaways

  • External quality assessment is essential for laboratory accreditation and standardising clinical services, but implementation is difficult in resource-limited settings.
  • Key material challenges include the high cost of control samples, problems assigning target values, and issues with sample noncommutability.
  • Operational hurdles include equipment failure, missing maintenance services, and knowledge gaps among laboratory professionals.
  • A widespread failure to participate in assessment programmes and an inability to take corrective action severely hinder laboratory performance.

Why it matters

Accurate clinical laboratory tests are vital for correct medical diagnoses and patient care. When laboratories in resource-constrained regions cannot access or maintain external quality standards, diagnostic errors become more likely. Understanding the operational, technical, and financial barriers enables healthcare systems and suppliers to target support, maintain equipment, and ensure dependable testing.

Commercialisation angle

The findings point to opportunities for diagnostic suppliers and quality control developers to design lower-cost, commutable control materials and robust, low-maintenance laboratory equipment suited for resource-limited regions. Training providers could also address documented professional knowledge gaps. However, the abstract does not indicate a direct commercial application pathway or specific technology readiness level.

AI-generated from the published abstract. Always read the original work before citing.

Abstract

External quality assessment is the process of evaluating the performance of a laboratory and the competence of professionals. Participation in EQA and standardizing the quality of laboratory services are a mandatory requirements for accreditation. This review is aimed at identifying and discussing challenges that hinder the effective implementation of an EQA program in countries with resource limited setting. To obtain abundant information, articles were identified by searching the literature publishedin English using the National Library of Medicine, PubMed, Science Direct and AMC digital library databases. The articles identified in the references were manually searched and included. After the article was identified, it was imported to Endnote version 8.1 and exported to Microsoft Word for citation. Based on this review, the major identified challenges that hinder the implementation of an EQA program include the high cost of control materials, malfunction and lack of maintenance for equipment failure and breakdown, a knowledge gap among laboratory professionals, noncommutability of control samples, and difficulty in assigning target values. In addition, failing to participate in EQA and failing to take corrective action are the major challenges identified. As a result, applying to an EQA program in resource-limited counties was highly challenging. To attain high performance in the laboratory and to provide quality laboratory service for patient care, the EQA supplier and the user laboratory must pay attention to these issues and take appropriate corrective actions for ongoing quality improvement and accreditation.

Research topics

  • Clinical Laboratory Practices and Quality Control
  • Health and Medical Research Impacts
  • Meta-analysis and systematic reviews

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DOI: 10.2147/rmhp.s453020

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