Radiotherapy

Radiotherapy

NNRA REQUIREMENTS FOR OPERATION LICENCE OF RADIOTHERAPY FACILITIES IN NIGERIA

These  requirements  should  be  applied  in additions to the:

  1. Nigerian Basic Ionizing Radiation Regulations 2003
  2. Nigerian Radiation Safety in Radiotherapy Regulations 2006

Note that these requirements are not exhaustive and do not in any way preclude other decisions by the NNRA.

Administrative Requirements

  • Submission  of a  duly completed NNRA Authorization application form for operation licence for Radiotherapy facility;
  • Enlisting the services of an NNRA accredited Radiation Safety Adviser (RSA) to assist in attaining the requirements;
  • Payment of Three Hundred Thousand Naira only (N300,000:00) being requisite authorization fees in accordance with Section 47 (1c) of Nuclear Safety and Radiation Protection Act 19 of 1995.

Personnel/Training

  • Evidence of having all the necessary personnel such as Oncologist, Clinically Qualified Medical Physicists, Radiotherapy Radiographer, Oncology Nurses and Biomedical Engineer with evidence of training on specific radiotherapy equipment to be installed in the facility;
  • Evidence of designation of a Radiation Safety Officer (RSO) indicating his job description and authority to stop unsafe practice;
  • Copies of CVs, academic professional qualifications of all radiation workers and letters of their appointements.
Equipment
  • Evidence of having adequate and functional dosimetry and geometry equipment
  • Evidence of having equipment for conducting routine quality control (QC) test;
  • Submission of reports of repair and maintenance;
  • Evidence of having operation manual with details of overall safety systems including design features, defense in depth and prevention of unauthorized access to equipment when activated.
 
Facility
  • Records of survey carried out after installation of the equipment. In case of LINAC record of the neutron survey of the LINAC bunkers for energies above 10MV carried out during commissioning test;
  • Submission of Workplace Monitoring records
  • Evidence of posting radiation warning signs at strategic location within the facility and also installation of radiation warning lights on top of the door leading to all the rooms where the machines are installed;
  • Evidence of having functional safety control systems in place;
  • Evidence of installation of the machine interlock system and demonstration of their functionality
Technical document

  • A Safety Analysis Report (SAR) incorporating the following:

    1. Report of acceptance test, commissioning test and quality assurance (QA) shall be  prepared by the applicant and must be submitted to the Authority;
    2. A comprehensive Radiation protection program as outlined in the guide for filling NNRA application for authorization form;
    3. Report of quality control test carried out on the equipment
  • Submission of developed system of reporting an incident and accidents;
  • Submission of contractual service agreement with its appointed NNRA accredited Dosimetry Service Provider (DSP).
Inspection
Furthermore, upon receipt of your completed application form, applicable fees and documents reflecting the requirements listed above, a date shall be fixed for inspection of the facility. The authorization shall be issued upon a satisfactory report of the inspection exercise.

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