Who Assesses the Assessors? Qualification Gaps and Competence Deficits in Medical Laboratory Accreditation: A Multi-Centre Observational Study from India

Background The credibility of any accreditation system ultimately rests on the competence and integrity of its assessors. Despite the rapid expansion of laboratory accreditation in India through the National Accreditation Board for Testing and Calibration Laboratories (NABL), the qualifications and capabilities of individuals empowered to evaluate complex medical laboratories have received remarkably little scrutiny. Objectives To systematically evaluate the educational backgrounds, professional experience, and demonstrated competencies of assessors operating within the NABL framework, and to document instances where qualification gaps may compromise assessment quality. Methods This multi-centre observational study examined assessor profiles across 86 NABL-accredited medical laboratories over a 15-year period (2010–2025). We documented educational qualifications, clinical experience, and assessment performance for 63 assessors. Additionally, we conducted structured interviews with 47 pathologists and 19 laboratory managers to capture reported instances of assessor knowledge gaps. Results Sixty-three percent of assessors (40/63) held non-medical qualifications. Mean clinical laboratory experience was significantly lower among non-medical assessors (2.3 ± 2.8 years) compared to medical assessors (12.4 ± 6.8 years, p < 0.001). We documented 18 instances of fundamental misunderstanding of laboratory measurements, quality control principles, or clinical significance. The four-day training program qualifying assessors has no published validation studies demonstrating its effectiveness. Conclusions Significant qualification gaps exist among laboratory accreditation assessors, with the majority lacking medical training or substantial clinical experience. The current training and credentialing pathway appears inadequate for ensuring competent assessment of complex medical laboratory operations. We propose evidence-based reforms including mandatory medical qualifications for clinical laboratory assessors, extended competency-based training, and independent validation of assessor performance.