The
requirements and guidelines listed below includes procurement of any of the
Radiation Sources to be used in Radiation Therapy i.e. Source for Linac
Accelerator,
Clearance of the unit by AERB
1.Verify from the supplier that the unit is
approved by Atomic Energy Regulatory Board (AERB) or a NOC is issued
by AERB to the local supplier of the unit.
Approval of Room Layout Plan of Radiation Therapy Installation
2. Prepare room layout drawings and the
site layout drawing in consultation with Medical Physicists, Radiation
Oncologists, Architects and the supplier of the unit and submit two copies of
the drawings along with the application AERB/RSD/RT/PLAN to the Head, Radiological
Safety Division (RSD), AERB, Niyamak Bhavan, Anushaktinagar, Mumbai – 400 094
for approval from radiation safety stand point.
The location of the
teletherapy installation should be so chosen that it is away from unconnected facilities and is close to the
associated facilities. The associated facilities include Simulator room,
Minor Operation Theatre (for Brachytherapy), Mould room, Treatment Planning
System room, Physicist(s) room, Radiation Oncologist(s) room, Patient waiting
area etc.
3. Construct teletherapy/brachytherapy
facility as per the plan the approved by AERB at the location shown in the
approved plan. In case any modification is required to be carried out in the
approved layout plan, concurrence must be obtained from RSD, AERB prior to
modification.
Appointment of Radiation Therapy Staff
4. Appoint adequate number (must
also be considered for additional facility in existing setup) of full time
Radiation Oncologists, Medical Physicists and Radiation Therapy Technologists
as per the qualification and experience stipulated in AERB Safety Code SC/MED-
1 and 3. In case of appointment of Medical Physicists, it is to be ensured that
at least one of them is eligible to work as Radiological Safety Officer (RSO). (Those
who have passed Diploma in Radiological Physics from University of Mumbai are
eligible to work as level-III RSO in Medical, Industrial and Research Centres.
However, those who have passed M.Sc.(Medical Physics) or equivalent from other
universities are eligible to work as level-III RSO in Medical Institutions only
if they possess a certificate of successfully passing the RSO examination from
BARC.)
Nomination and Approval of
Radiological Safety Officer
5.
Nominate the Medical Physicist (if eligible), to work as Radiological Safety
Officer (RSO) in your institution by sending the filled in form
AERB/441/RSOM-II/III-FORM
Procurement of Personnel Monitors
6.
Procure Personnel Monitoring Badges from the agency recognised by AERB for all
the radiation workers so that they are available during installation of the
unit. Pocket dosimeters for the radiation workers may also be procured, which
are meant for measuring radiation dose received by the radiation worker on the
spot.
Measuring and Monitoring Instruments
7.
Procure appropriate measuring instruments for measurement of output and other
dosimetric parameters (Thimble Ionisation Chamber, Parallel Plate Ionisation
Chamber, Well type Ionization Chamber, Electrometer, Radiation Field Analyser
etc.) and appropriate monitoring instruments for area monitoring (Survey
Meters, Contamination Monitors, Gamma Zone Monitors etc.). It may be noted
that Gamma Zone Monitor for Telecobalt unit and Remote after loading
Brachytherapy unit should be of auto-reset type, whereas, that for manual
Brachytherapy must have manual-reset button.
Other Associated equipment/Accessories
8.
One of the major associated equipment for Radiotherapy includes Simulator /
CT-Simulator for simulating the patient prior to Radiation Therapy. The layout
plan of Simulator Installation also requires approval from this Division as
mentioned above and need authorisation prior to its procurement.
9.
The other associated equipments/accessories includes Treatment Planning System
(TPS), beam modifiers, patient immobilisation devices such as moulds, quality
assurance test tools etc.
Authorisation to procure Radiation
Sources
10.
Obtain authorisation from RSD, AERB by sending the filled in form
AERB/RSD/RT/ATH along with all the necessary documents mentioned therein for procurment
of sources to be used in Radiotherapy (which includes sealed radioactive
sources, depleted uranium and radiation generating equipments such as Medical
Accelerator and Simulator). The form must be filled in properly to avoid
undue delay.
11.
Procure radioactive sources, radiation generating equipment (Accelerator or
Simulator) as per the specifications mentioned in the authorisation letter.
Road Transport Approval
12.
Obtain road transport permission from RSD, AERB for transporting the
radioactive source from the airport/port to the institution (not required in
case of Accelerator and Simulator)
Receipt of Sources
13.
Intimate regarding the receipt of the source (includes Accelerator and
Simulator) to RSD, AERB by filling in the form AERB/RSD/RT/SRI within 15 days
of its receipt
Installation of the Unit
14.
Install the teletherapy/brachytherapy unit as per the approved plan and
carryout the mechanical and electrical tests thoroughly prior to source loading
or switching on the Radiation beam incase of Radiation Generating Equipment.
Loading of the source/Switching on
Radiation in case of Radiation Generating Equipment
15.
Incase of Telecobalt source, the source shall be loaded by the certified
service engineer under supervision of the Medical Physicist/RSO, who has been
authroised by AERB for the supervising the source transfer operation. To obtain
the authorisation for supervising the source loading operation the Medical
Physicist/RSO should submit the duly filled in form AERB/RSD/RT/SSA prior to 15
days of actual date of source transfer. Incase the Medical Physicist is not
having prior experience in source transfer operation of Telecobalt unit, the
institution may seek assistance of Medical Physicist from any other
Radiotherapy Centre under intimation to his/her employer. In such a case a
consent letter from the Medical Physicist with endorsement from his/her
employer must be attached along with the filled in form AERB/RSD/RT/SSA. The
telecobalt source shall not be loaded if the authorised Medical Physicist(s)
are not present. After loading the telecobalt source, the source transfer
report is to be submitted by the Medical Physicist/RSO in the prescribed format
AERB/RSD/RT/ST-REPORT.
16.
Before Loading of the source/Switching on Radiation in case of Radiation
Generating Equipment ensure that all the persons involved in the source
loading, operation and testing of the unit have personnel monitoring badges.
17.
After loading the source or switching the beam on, it is the responsibility of
the RSO and the service engineer to carryout radiation protection survey of the
installation prior to any other radiation tests. Incase the radiation levels
around the installation are not within the limit, all other tests must be
suspended and AERB shall be intimated promptly with the recorded survey data.
Quality Assurance/Acceptance test
18.
Perform thorough Quality Assurance/Acceptance test of the
teletherapy/brachytherapy unit and the report of the same must be kept in the
hospital records, which are to be produced while inspection of Radiotherapy
Department of your institution by AERB personnel.
Commissioning Approval for Patient
Treatment
19.
Obtain commissioning approval for using the unit for patient treatment from
RSD, AERB (i) submit undertaking regarding the performance of the unit in the
prescribed format AERB/RSD/RT/UT-COM and (ii) intimate regarding the
availability personnel, associated equipments
etc. by sending the filled in form AERB/RSD/RT/COM. Commissioning permission
shall not be granted unless adequate number of full-time staff in Radiotherapy
Department as mentioned in clause 4, personnel monitoring badges for all the
radiation workers and all the required associated instruments/accessories are
available. Please note that no patient treatment should be started without
obtaining the commissioning approval from RSD, AERB
Periodic Performance/ Quality
Assurance test
20.
Carryout performance tests of the unit, integrity check of the sources in case
of barchytherapy and survey of the radiation installation periodically and
maintain all the records, which are to be produced while inspection of
Radiotherapy Department of your institution by AERB personnel.
Annual Status Report
21.
Send Annual Report on Status of Radiation Safety in Radiotherapy Department in
the prescribed format AERB/RSD/RT/ASR/2K1 to RSD, AERB so that it reaches by
the end of each calendar year. Please note that it is a mandatory
requirement to submit the report every year.
Credit :Sivakumar Murugesan.Healthcare Project and Accreditation Consultant,Medpoint Healthcare
All
regulatory forms are available at our website www.aerb.gov.in
For Radiotherapy forms the link is as given below
Link: www.aerb.gov.in/t/forms/regforms/radiotherapy/Radiotherapy_forms.html