Exploring the impact of national laboratory accreditation on quality and practices: a qualitative study from a government medical college in western India.

BACKGROUND

Medical laboratories play a crucial role in diagnostics and therapeutic decisions, with accreditation by bodies like the National Accreditation Board for Testing and Calibration Laboratories (NABL) ensuring technical competence. This study examines the impact of NABL accreditation on laboratory practices, highlighting benefits, challenges, and areas for improvement.

METHODS

This qualitative study used six focus group discussions (FGDs) and five in-depth interviews (IDIs) to explore experiences of laboratory professionals at NABL-accredited laboratories in Government Medical College, Bhavnagar, Gujarat. Participants were purposively selected to ensure diverse perspectives. Thematic analysis, employing an inductive approach, was validated through member checking.

RESULTS

The 29 participants reported NABL accreditation positively influenced quality control, standard adherence, and accuracy of laboratory reports. Maintenance of quality registers, equipment calibration, adherence to standard operating procedures (SOPs), and participation in External Quality Assessment Schemes (EQAS) promoted continuous improvement. However, significant challenges included excessive documentation, subjective assessments, workflow disruptions, and financial constraints. Participants recognized accreditation's educational value, skill enhancement opportunities, and improved market credibility. Recommended improvements included digital documentation systems, reduced administrative burdens, clearer assessment criteria, and increased clinician involvement.

CONCLUSIONS

NABL accreditation significantly elevates laboratory standards, improving patient care and clinical decision-making. However, challenges such as excessive paperwork, subjective assessments, financial constraints, and data integrity issues must be addressed. Digital documentation systems, unannounced inspections, clearer assessor guidelines, and greater clinician engagement could mitigate these barriers. Accreditation also enhances educational outcomes and market perception. Policymakers and accreditation bodies should incorporate these findings to refine accreditation processes and sustainably improve laboratory quality and healthcare outcomes.