R. Rajan, Paul Rajan Rajkumar
The demand for Diagnostic Centers in India is propelled by changes in culture, increase in population, rise in infectious disease, increase in healthcare expenditure and rising adoption of preventive health check-ups. The Private diagnostic market in India has limited number of organized players and the overall market is driven by unorganized laboratories. The Diagnostic Imaging equipments such as X-ray, CT (Computed Tomography) Scanner and BMD (Bone Mineral Densitometer) need to be handled with utmost care as they have human made ionizing radiation exposure risks. India is one of the largest consumers of refurbished diagnostic imaging equipments and the beneficiaries include Diagnostic Centers, Corporate Hospitals and Chain of Diagnostic Laboratories. The Atomic Energy Regulatory Body (AERB) in India regulates the usage of diagnostic imaging equipments by evolving policies and procedures to be strictly followed by Diagnostic Centers for containing excessive radiation. The changes in procurement policy made by AERB in September 2015 have restricted importing of used diagnostic imaging equipments up to a maximum of 7 years. This regulatory change has triggered a research question, Diagnostic Laboratories – Are these Radiation Safe? This research was conducted with the objective of assessing whether diagnostic centers follow the best practices mandated by AERB. The researcher has conducted a very structured assessment on AERB compliance using 7 different parameters namely, Regulatory, Layout Engineering, Technician Competency, Human Safety, Operations Knowhow, Radiation Exposure Monitoring and Top Management Commitment. This study was conducted in 192 diagnostic centers across multiple cities in Tamil Nadu, with a structured questionnaire contained 34 questions. Based on the responses received on the actual practices followed by diagnostic centers to contain Radiation risk, Radiological Compliance Index (RCI) was estimated. The analysis has revealed that Top Management Commitment was very low with a RCI score of 2.02 (Moderate Presence of AERB recommended best practices) and Operations “Know-Know” was high with a score of 4.40 (High Presence of AERB recommended best practices). The comparative analysis of RCI between National Accreditation Board for testing and Laboratories (NABL) accredited (RCI Score 3.19) and Non NABL (RCI Score 3.18) diagnostic centers has indicated that the accreditation did not significantly influence the compliance. The Pearson correlation co-efficient has established moderately positive correlation with Revenue (+ 0.321) & Patient Queue size (+0.293) on RCI. This study has concluded with sufficient evidence and analysis that Private Diagnostic Centers need to focus on appointing Radiation Safety Officer, monitoring radiation exposure dosage, periodical equipment service, continuous training of their staff and periodical QA tests for equipment fitness in order to achieve significant regulatory compliance maturity levels. This research has further recommended similar research in private diagnostic laboratories in other states in India and comparative analysis of compliance to AERB guide lines between Government Hospitals and Private Diagnostic Centers.
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