Analysis of Regulatory Compliance on Radiation Safety Parameters with Chain of Diagnostic Centers in Tamil Nadu, India

Abstract

Aims: To evaluate compliance against Atomic Energy Regulatory Body guidelines in India with chain of diagnostic centers, aimed at protecting the health of people while using human made ionizing radiation. To assess whether revenue, patient queue size and Quality System accreditation influence the Regulatory compliance. Study Design:  Descriptive Research Design was used to study the existing practices. Place and Duration of Study: 107 chain of diagnostic centers, which houses the diagnostic imaging equipments that emanates radiation, which needs regulatory compliance were studied. This study was conducted in 25 identified cities across Tamil Nadu, in India between April 2016 and June 2017. Methodology: We included 65 chains of diagnostic centers accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) and 42 Non-NABL diagnostic centers. The Radiologists and Technicians were the point of contacts for primary data collection through a structured questionnaire. The compliance to regulatory guidelines was assessed using a 7 point scale, based on the existing practices followed. There were 70 questions covering Regulatory, Layout Engineering, Technician Competency, Human Safety, Operations Know-How, Radiation Exposure Monitoring and Top Management Commitment included in this study. Non-Parametric statistics was used to perform the analysis. Results: The probability distribution was estimated using ”mode” as a measure of compliance. The compliance on 7 parameters studied has shown, Regulatory (3, Significant compliance), Layout Engineering (3, Significant compliance), Technician Competency (4, High Compliance), Human Safety (4, High Compliance), Operations Know-How (3, Significant Compliance), Monitoring Radiation Exposure (4, High Compliance) and Top Management Commitment (4, High Compliance). Wilcoxon Rank Sum test has shown a ‘P’ value of .083 @ 95 percent confidence interval established no difference in compliance between NABL and Non-NABL diagnostic centers. Spearman correlation co-efficient (Rho +0.12 and ‘P’ value, .43) has established a positive weak and insignificant relationship between Revenue and Compliance and negative weak and insignificant relationship (Rho -.093, ‘P’, 0.52) between patient queue size and compliance. Conclusion: The chain of diagnostic centers did not pose any risk of radiation leakage supported by significant and high compliance scores across all parameters studied. The NABL accreditation did not influence the compliance. Revenue and Patient queue size did not establish significant relationship on compliance. Similar studies can be initiated with Government Hospitals, Corporate Hospitals and Private Diagnostic centers in other states of India.