R. Rajan and Paul Rajan Rajkumar
Diagnostic Imaging Equipments, Atomic Energy Regulatory Body (AERB), Total Quality Management (TQM), Radiation Control Measures, Top Management Commitment, Radiation Compliance Index
|PUBLISHED DATE||April 2017|
|PUBLISHER||The Author(s) 2017. This article is published with open access at www.chitkara.edu.in/ Publications|
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.
The healthcare market in India is expected to grow from 6,70,000 Crores (INR) in 2015 to 18,76,000 Crores (INR) in 2022 (Shown in Fig1. Market Size of Private Hospitals). The healthcare expenditure is forecasted to expand at a CAGR (Compound Annual Growth Rate) of 17 percent over 2011 to 2020. The traditional health problem is replaced by lifestyle related disease and 50 percent of spend is on in-patient beds. There is a substantial demand for specialized high quality healthcare in Tier II and Tier III cities. The diagnostic market is set to grow at a CAGR of 20.4 percent to uSd 32 billion from uSd 5 billion over 2012-2022 (shown in Fig 2. Market Size of diagnostic Market). The diagnostic market is split between imaging and pathology with thirty percent and seventy percent share respectively. The doctor-to-patient ratio for rural India, as per Health Ministry statistics stands at 1:30,000, which is well below World Health Organization recommendation (WHO) of 1:1000 (Source: WHO, IMH, deloitte, EBH, Tech SCI Research, Jan 2016). This establishes very high potential for diagnostic Centers to grow across smaller towns in India.
|ISSN||Print : 2393-8536, Online : 2393-8544|
It was quite evident from this research study that private diagnostic centers housing diagnostic imaging equipments in Tamil Nadu have adequately protected the x-ray emanating equipments from any plausible excessive radiation through a robust layout engineering, operations know-how and radiation monitoring controls. The regulator (AERB) has orchestrated the dissemination of equipment layout requirements very meticulously through the Manufacturer submitting the layout for a formal review and approval by AERB while commissioning of the equipment. This is an important control for ensuring that no excessive radiation leakage is permitted to the human as well as to the surrounding external environment. However, the process practices followed by the diagnostic centers towards holistic deployment of all aspects of AERB guidelines are not adequate and extensive Top Management involvement in this change program is not visibly seen. On a top priority, diagnostic Centers need to put in place some of the key controls such as appointment of Radiation Safety Officer, encouraging the maximum use of AERB portal (elORA), continuous training of their staff and technicians, monitoring the radiation exposure dosage and corrective measures and uncompromised equipment service contracts, in order to achieve the overall objective set forth by the regulator. Hence further research on comparative study of practices followed by the institutions such as Corporate Hospitals, Government Hospitals, Chain of diagnostic Centers and Private diagnostic Centers can be a greatest socio-economic contribution which can instill high confidence to the public that they are radiation safe when undergoing for a scan. A research on “diagnostic Imaging Equipments Regulatory Framework for Evaluation of Business Practices” can help the implementers towards shifting their focus for achieving highly matured business practices.