The Documentation Paradox: Quantifying Administrative Burden in Accredited Medical Laboratories—A Fifteen-Year Longitudinal Study from India

Abstract Background: Laboratory accreditation under ISO 15189 and national frameworks promises enhanced diagnostic reliability. However, the administrative consequences of accreditation implementation in resource-limited settings remain inadequately quantified. We sought to measure the true documentation burden imposed by accreditation systems on Indian medical laboratories. Methods: We conducted a fifteen-year longitudinal observational study (2010-2025) across 86 NABL/CAP-accredited laboratories in 15 Indian states. Data collection included documentary analysis, financial records, performance metrics, and structured interviews with 86 healthcare professionals. Primary outcomes were non-clinical staff growth, documentation volume, and pathologist time allocation. Results: Non-clinical administrative staff increased from 1.8 ± 0.6 FTE pre-accreditation to 9.7 ± 2.1 FTE after eight or more years (p