Consenting Process for Radiation Facilities - Atomic Energy ...

AERB may inspect the facility before granting an Authorisation for
commissioning of nuclear medicine facility. The application format for
obtaining the Authorisation for operation of the nuclear medicine facility is
given in Annexure 34. The application format for procurement of
radioisotopes for nuclear medicine facilities is given in Annexure 33b.
The Consentee is required to submit to the AERB, periodic safety status
reports. Unusual occurrences should be promptly reported within 24 hours
and this should be followed by a detailed investigation report. The Consentee
shall report any misadministration 1 (wrong radionuclide, wrong patient, wrong
dose or wrong pathway). This should be investigated and reported to AERB.
The Consentee should promptly report to AERB about details of cadavers
with substantial activity in their body. AERB may conduct inspection of the
radiation facility as and when required.
The Consentee shall arrange to constitute a Local Safety Committee with the
Head of the institution as Chairman and the RSO as Members Secretary, to
review the safety status of all radiation facilities in the institution. The minutes
of the meetings and the action taken reports shall be available for inspection
by AERB.
3.10.1.5 Decommissioning/Disposal
The Consentee should obtain an Authorisation for disposal of radioactive
wastes, which include the routine discharge within authorised activity limits
in to sewerage, in the prescribed format. The application format for obtaining
the Authorisation for disposal of radioactive waste is given in Annexure 49.
When the nuclear medicine facility is no longer to be used, the Consentee
should arrange to check for any contamination in the facility and carry out
decontamination, if necessary. If no contamination is present, the facility
could be authorised for decommissioning and could be released for any other
purpose. The Consentee should submit to the AERB the decommissioning
1 Misadministration (nuclear medicine)
The administration of any one of the following:
(a)
(b)
(c)
(d)
(e)
a radiopharmaceutical other than the one intended;
a radiopharmaceutical to the wrong patient;
a radiopharmaceutical by a route of administration other than that intended by the prescribing
physician;
a diagnostic dose of a radiopharmaceutical differing from the prescribed dose by more than
50 percent;
a therapeutic dose of radiopharmaceutical differing from the prescribed dose by more than
10 percent.
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