A Contextualized Layered Risk Management Framework for Indian Medical Laboratories

Introduction: Medical laboratories are indispensable to modern health care; yet their operations inherently involve risks that can undermine quality and safety if not effectively managed.While established risk management frameworks exist, their direct applicability to the diverse and resource-variable landscape of Indian laboratories is questionable.A significant gap exists in comprehensive studies dedicated to developing a context-specific risk management framework tailored to the unique challenges of Indian laboratories, encompassing small private setups to large public health institutions.This study introduces a novel, layered approach to risk management designed to address this gap.Objective: This study aimed to develop a customized, layered risk management framework meticulously tailored to the specific characteristics and diverse requirements of medical laboratories operating across India.The framework is designed to be adaptable to different contexts and levels of health care within the Indian system.Materials and methods: The interventional study was conducted within the Central Clinical Biochemistry Laboratory under Department of Biochemistry at Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, from January to