Parikh Khushali D, Rupani Mihir P
Department of Pathology, Government Medical College Bhavnagar (Maharaja Krishnakumarsinhji Bhavnagar University), Jail Road, Bhavnagar, Gujarat, 364001, India.
Department of Pathology, Gujarat Cancer Society (GCS) Medical College, Opposite DRM Office, Near Chamunda Bridge, Ahmedabad, Gujarat, 380025, India.
BMC Health Serv Res. 2025 Jul 31;25(1):1005. doi: 10.1186/s12913-025-13195-6.
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.
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.
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.
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.
医学实验室在诊断和治疗决策中发挥着关键作用，由诸如国家测试和校准实验室认可委员会（NABL）等机构进行的认可确保了技术能力。本研究考察了NABL认可对实验室实践的影响，突出了其益处、挑战及改进领域。
这项定性研究采用了六次焦点小组讨论（FGD）和五次深入访谈（IDI），以探究古吉拉特邦巴夫那加尔政府医学院获得NABL认可的实验室中实验室专业人员的经历。参与者经过有目的的挑选以确保观点的多样性。采用归纳法的主题分析通过成员核对得到了验证。
29名参与者报告称，NABL认可对质量控制、标准遵守情况和实验室报告的准确性产生了积极影响。维护质量记录、设备校准、遵守标准操作程序（SOP）以及参与外部质量评估计划（EQAS）促进了持续改进。然而，重大挑战包括文件过多、主观评估、工作流程中断和资金限制。参与者认识到认可的教育价值、技能提升机会以及市场信誉的提高。建议的改进措施包括数字文档系统、减轻行政负担、更清晰的评估标准以及增加临床医生的参与。
NABL认可显著提高了实验室标准，改善了患者护理和临床决策。然而，诸如文书工作过多、主观评估、资金限制和数据完整性问题等挑战必须得到解决。数字文档系统、突击检查、更清晰的评估指南以及临床医生更多的参与可以减轻这些障碍。认可还提升了教育成果和市场认知。政策制定者和认可机构应纳入这些研究结果，以完善认可流程，并可持续地提高实验室质量和医疗保健成果。
