NNRA REQUIREMENTS FOR ESTABLISHING A NUCLEAR MEDICINE FACILITY IN NIGERIA

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Administrative Requirements

• Completion and submission of NNRA Authorization application form. The form and the guide for filling can be downloaded from the NNRA website
• Provision of a certified copies of Memorandum and Article of Association, certificate of incorporation from Corporate Affairs Commission (CAC) and particulars of your first Directors (form C02 & C05).
• Engage the services of NNRA accredited Radiation Safety Adviser (RSA) to assist you in attaining the requirements.
• Contractual agreement with the NNRA accredited Dosimetry Service Provider (DSP) for personnel monitoring;
• Payment of applicable authorization fees in accordance with Section 47 (1c) of Nuclear Safety and Radiation Protection Act 19 of 1995.
• The requirements above are compulsory for Premises Registration Certificate, Licence to import radiopharmaceuticals and Licence to use radionuclides for Nuclear Medicine.

Personnel/TrainingEvidence of having all necessary personnel indicated below

• Nuclear Medicine Physician
• Radio chemist or Radio pharmacist
• Medical Physicist
• Trained Radiation Safety Officer (RSO)
• Technologist
• Other auxiliary staff (e.g. Oncology Nurses, etc.)and
• Copies of CVs, academic and professional qualifications and letter of designation

Equipment

• Equipment Specifications: Name of equipment, serial and model numbers, name of manufacturer, year of manufacture, country of manufacture, etc.
• Standards to which the SPECT/CT or PET/CT scanner comply.
• Calibration Radioactive (sealed) Sources: Type of radionuclide, manufacturer, Activity, and serial number.
• Radio chemist or Radio pharmacist
• Source serial number
• Evidence of having adequate and function radiation survey meters with valid calibration certificates
• Evidence of having equipment and all instruments necessary for the installation and conduction of acceptance tests
• 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
• Evidence of Quality control Test conducted on all ionizing radiation generating equipment

Facility

• Name, Addresses and locations of facilities in Nigeria
• Provision of a detailed diagram of the layout of the
  1. SPECT/CT or PET/CT scanner Imaging room
  2. Patient uptake room/ward
  3. Dedicated patient toilets
  4. Radioactive waste storage facility
  5. Radionuclide (sealed and unsealed) storage facility.
• Submission of shielding assessment of the facility and demarcation of the control and supervised areas.

Radiation Protection Programme

• Adequate programs for radiation protection, safety and security equipment
• Evidence of engagement an NNRA accredited Dosimetry Service Provider (DSP) who shall be responsible for monitoring staff that will be involved in operations of the x-ray machines
• Emergency contact numbers including that of NNRA contact numbers to be included emergency programme
• Description of policies for assigning monitoring badges to workers, review of individual doses including reference levels and actions to be taken when values are exceeded
• Establishment of local rules in written form

Fee

• As prescribed in the authorization fee schedule.