Regulatory Inspection of Radiotherapy Facility.

Abstract

REGULATORY INSPECTION OF RADIOTHERAPY FACILITY Inspection has been defined as an examination, observation, measurement or test undertaken by the Regulatory Authority to assess structures, systems, components and materials, as well as operational activities, processes, procedures and personnel competence. The major objective of inspection is to satisfy the authority that the Licensee complies with the legislation, regulations and any imposed conditions as well as to ensure the competence of the operator or his employees while being on the lookout for deficiencies or deviations from standard practice and correcting them without undue delay. It is also pertinent to cite here that inspection and Authorization which are core duties of the NNRA are ingrained in legal documents establishing the authority especially in Section 34 of the Act. Other allied areas which fall under the inspector’s sphere of duties include authorization, equipment inventory and standards, design requirements, acceptance tests and commissioning, personnel, management commitment, quality assurance, classification of areas of regulations and making sure that the operator follows regulation as it pertains to other requirements and local rules. As a rule the inspector is to apply a methodology which should involve the procedures of General observations of work practices and facilities, Examination of records, Examination of written guidance on working procedures, Interview with management and workers, Independent measurements of radiation and contamination levels and Routine checks of safety control systems. Furthermore, special attention can be paid to other areas depending on the peculiarity of the equipment or principal area under inspection which must also be conducted following laid down regulations and guides. For example, in inspecting equipments which are ionizing radiation sources and determining the equipment standard; the inspector is to verify by sighting and obtaining relevant records to confirm compliance with Reg. 21 (2) of Radiotherapy Regulations which also requires that the equipment conform to applicable standards of the International Electro-technical Commission (IEC) and the ISO or equivalent national standards. On health surveillance the inspector would adopt a different approach by that the licensee has written health surveillance programme to assess the initial and continuing fitness of employees for their intended tasks, according to the dictates of Regulation 46 of Radiotherapy Regulations 2006 each of his employees is under adequate medical surveillance by an appointed doctor, which is in line with Regulation 54(2) of NiBiRR 2003. Finally, the goal of the inspector in the conduct of an inspection is to allow him or her draw conclusions about licensee’s performance with regard to the implementation of the requirements as laid down in the Act, Regulations and license conditions in a manner that meets moral and professional standards. Thus, it suffices to say that the burden of the inspector is one which requires a keen power of observation and sharp focus of intellect together with knowledge of the various regulations surrounding radiotherapy so as to ensure the continuous optimal and safe delivery of medical services, not just for the benefit of the teeming population in need of medical care but also to protect operators of radiotherapy facilities from running afoul of the law. Seminar presented by, Nasiru-Deen Bello