GUIDANCE FOR PREPARATION OF RADIATION PROTECTION PROGRAMME

FOR NUCLEAR MEDICINE FACILITY

(This is a Guidance for preparation of Radiation Protection Programme (RPP) for a Nuclear
Medicine (NM) Facility. The NM facility can use the information in this as guidance for
preparing the RPP. The typical information needs to be included under each section is also
provided. Institute can modify as per their own requirement. The information provided is
limited, the facility can include additional contents as and when required and the facility also
has to remove those contents which are not relevant to the facility)

1. Introduction

1.1 Name and address of the Institute:

Please provide the name and address as registered in eLORA

1.2 e-LORA Institute No.:

eg: MH-XXXX

1.3 Details of NM equipment/ sources:

Details of all equipment and sources should be provided under this heading
1.4 Procedures carried out:

Name of procedure Availability Radioisotopes Handled/Proposed:

(Yes/No)
In-vitro assay
In-vivo non-imaging
In-vivo imaging
Low Dose Therapy
High Dose Therapy
Any other procedures carried out,
please specify

1.5 Details of the Imaging and Non-imaging Equipment:

(Provide list and list should be updated whenever new facility is added)

2. Objective

The objective of this Radiation Protection Programme (RPP) is to describe the measures
that would be implemented in the nuclear medicine facility (name of the facility, M/s.
ABC) to ensure radiation safety and regulatory compliance by systematically
implementing radiation protection measures. This programme outlines radiation
protection strategies under both normal operational conditions and emergency
scenarios. Moreover, it includes provisions for radiation safety in the management of
radioactive waste, disused unsealed and sealed sources and during the decommissioning
of nuclear medicine facilities, in accordance with regulatory requirements and best
practices in radiation protection.
3 Management Structure and Policies

3.1 Description of Management Structure-Organisation Chart

(Management structure should provide organisation structure hierarchy and reporting

structure of NM Physician, NM Technologist and RSO to Employer/Licensee.)

(List of Nuclear Medicine professionals and Radiation workers should match with e-LORA.
Update the list in e-LORA prior to finalizing the RPP)

(Current Organisation Chart to be provided. Any changes should be updated and kept with
the Nuclear Medicine facility)

3.1.1 Organization Chart:

Details of NM Physicians, NM Technologists, Radiological Safety Officer and Radiation

workers are updated in e-LORA. Current organisation chart is prepared and will be
updated as and when there is any change in the organisational structure. {The organisation
chart should reflect the accessibility of RSO to Employer}
Typical organisation chart:

Employer/Licensee
(Designation)

Nuclear Medicine Nuclear Medician Nuclear Medician

RSO Physician 1 Physician 2

Nuclear Medicine Nuclear Medicine Nuclear Medicine

Technologist 1 Technologist 2 Technologist 3

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4 Assignment of responsibilities for radiation safety
(Institution should identify various activities pertaining to Nuclear Medicine procedures.
The various processes involved for each such activity should be listed with identified
responsible person for the same. In case of multiple RSOs, the responsibility of each RSO
should be clearly identified and communicated. Few such activities and processes are
provided below for reference and guidance)

The responsibilities with respect to radiation safety for various activities and identified
responsible persons are provided here. All radiation workers are required to discharge the
responsibilities as identified below. The responsibility is communicated to the concerned
person(s).

Responsible Person (provide

Sr. Activities/processes the role only (e.g.
No. Licensee/RSO/NM Physician/
Technologist) (in case of
multiple RSO’s, mention names)
1. Procurement of any additional NM equipment

2. Procurement of radioactive sources

3. Maintaining inventory for Activity procurement

and usage
4. Ensuring Security of sources

5. Storage of radioactive waste at designated place

6. Disposal of Radioactive Waste and maintaining

records
7. Management of decayed sealed sources and
maintaining records

8. Radiopharmaceutical Preparation

9. Radiopharmaceutical administration

10. Ensuring periodic quality assurance of nuclear

medicine equipment and maintaining records
11. Calibration and periodic functional performance
checking of dose calibrator, contamination
monitor, radiation survey meter, gamma zone
monitor and Pocket dosimeters & maintaining
records (Methodology for periodic check to be
established by approved RSO)
12. Conduct of Radiation Protection Survey and
maintaining records

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 13. Record keeping for Personnel doses, Calibration of
measuring and monitoring instruments
14. Records of Patient Information Data including
activity administered
15. SOPs for Nuclear medicine diagnostic and
therapeutic procedures with emphasis on
individual responsibilities (preparation &
implementation)
16. Constitution of Local Safety Committee (LSC)

17. Periodic Meeting of LSC and maintenance of the

MoM
18. Incident Reporting and Investigation

19. Periodic updation of RPP in case of any change in

facility design, personnel, procedure etc.
20. Review of adequacy of RPP periodically and in
case of any unusual incident. For example reported
case of Excessive Exposure etc.
21. Preparation of Emergency Preparedness and
Response Plan (Copy is maintained in the facility)
22. Familiarisation of Emergency Preparedness and
Response Plan with all concerned employee

5 Education and training programme on radiation safety

(Typical Information to be included is provided below)
The employer/licensee is overall responsible for ensuring that all personnel who work
with radioactive materials have received comprehensive training and education on
radiation protection, including the safe handling of radioactive materials, use of personal
protective equipment, and emergency procedures. The program includes regular
refresher courses to ensure that all personnel understand the hazards associated with
radiation and how to protect themselves and others.

The RSO will provide training to all the staff with respect to the radiation safety
requirements. The training will be conducted once in ____________ and during
recruitment of new personnel.

The training will cover the following topics:

5.1. For Nuclear Medicine Physician/ Nuclear Medicine Technologists:

i. Importance of radiation safety during work and Radiation Safety Principle.
ii. Regulatory requirements and responsibilities of nuclear medicine physician and
nuclear medicine technologists as per AERB safety code for nuclear medicine
facilities (AERB/RF-MED/SC-2 (Rev. 2), as applicable.

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iii. Information about safe work practices to be followed in Nuclear Medicine
procedures/nuclear medicine laboratory and associated hazards.
iv. Proper use & storage of TLD and pocket dosimeters.
v. Use of Radiation Survey meter/ contamination monitor.
vi. Dissemination of various radiation safety related information received from
Regulatory Body or any other source, and sharing of experience among NM
Physicians/NM technologists.
vii. Handling of routine, off-normal situations & relevant practical demonstrations.
viii. Knowledge of Dose Limits prescribed by regulatory Body.
ix. Any other topic as relevant__________________________

5.2 For Auxiliary Staff (Nursing staff, ward boys etc.):

i. Radiation Safety Principle
ii. Safe Procedures to be followed, if auxiliary staff engaged in Nuclear Medicine
facilities. For ex. nursing staff in a high dose therapy ward.

The records of the Training will be maintained in the following format:

i. Place where training conducted:
ii. Date of Training:
iii. Name of the RSO conducted training:

List of Participants Designation Signature of Participant

(Signature of RSO)

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6 Operational instructions for ensuring radiation safety:
Under this section, Nuclear Medicine Department should include the written operating
procedures/standard operating procedures (SOP) for the various activities of Nuclear
Medicine.

Separate SOPs has to be prepared for, diagnostic procedures handling isotopes like Tc-
99m, F-18, I-131 etc. , therapy procedures handling isotopes I-131, Lu-177, P-32, Sm-153
and Y-90 microspheres, etc.

Sample content: Please modify based on your institute details

General working instructions during operation of a Nuclear Medicine facility are listed
below:

1. Unauthorized people will not be allowed inside the Nuclear Medicine facility.
2. Tools which are used for handling radioactive substances will be cleaned after use and
kept separate from other tools and instruments.
3. Eating, drinking or smoking will be forbidden in the active areas of Nuclear Medicine
facility.
4. During work stages with a risk of contamination, working surfaces will be covered with
a smooth, non-porous material for preventing spread of the contamination.
5. When handling radioactive substances, radiation shielding (syringe shields, lead shields
or equivalent) will be used whenever possible.
6. The dose rate and contamination level will be monitored regularly.
7. All the active areas such as activity storage area, dose administration area, radio-
pharmacy rooms, and imaging room will be periodically monitored for any
contamination. Whenever there is a spillage of activity or any contamination
(surface/air) is suspected, all the areas will be monitored. The results of such
measurements will be documented.
8. Monitoring of HDT patients is carried out periodically and they are discharged when
the radiation level at 1 m from patient being discharged does not exceed 50 μSv/h.
9. Outlet of delay tanks of HDT isolation ward is connected to main sewerage and not
recycled in the facility.
10. The sampling and monitoring of effluents from therapy wards prior to their release to
public sewers is carried out.
11. Round the clock availability of nursing and supporting staff will be ensured for high
dose therapy patients.

12. In case of radionuclide therapy procedures which are conducted in cathlab (e.g.
131-I lipiodol therapy, Y-90 microspheres etc)

 Procedures will be carried out only in the AERB licensed cathlab of our
hospital.
 SOP includes, storage of the source till administration, Role of RSO-NM for
the procedure, activity required per patient and procedure time, Emergency
management procedures, Decontamination of cathlab for making the room
available for other patients, Radiological surveillance of the staff involved
and the area during dose administration, Management of waste generated in
cathlab ,and during its transport to waste storage room, Access control

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 mechanism during the transfer of the patient from cathlab to isolation ward, path
for movement of such patients should be through least crowded areas etc.,
 Personnel involved in the cathlab procedure will have basic radiation safety
knowledge associated with the NM sources and cathlab.

6.1. Safe Transport of Radioactive Material

 Approval from AERB will be obtained before shipment of radioactive sources

used in nuclear medicine. ( for procurement as well as disposal)
 Requirements for the safe transport of radioactive material are specified in the
AERB Safety Code on “Safe Transport of Radioactive Material” (AERB-
NRF-TS/SC Rev.1), 2016.
 The prime responsibility for safety and security of the transport consignment
is with the Consignor/Licensee.

6.2. Any other topic as relevant__________________________

These procedures have been communicated to all the Nuclear Medicine staff and are
readily available to them.

7 Designation of controlled and supervised areas

(The radiation protection programme should describe how controlled areas and supervised
areas are to be designated for the conduct of Nuclear Medicine procedures. Information to
be included in this section is provided below)

In a nuclear medicine department, controlled or supervised areas are designated to establish

safety boundaries and limit radiation exposure to radiation workers, patients and general
public. These areas are determined based on the level of radiation exposure expected in
each area, and are subject to regulatory requirements and guidelines. The designation of
controlled or supervised areas in a nuclear medicine department involves careful
consideration of the radiation sources and activities involved, as well as the potential for
exposure to personnel, patients, and the public. The areas are clearly identified with
appropriate signage, and access are controlled through a combination of physical barriers,
administrative controls, and monitoring.

Controlled Areas:

The Controlled Area is a location within a nuclear medicine facility where access is
restricted to only authorised personnel who have received appropriate radiation safety
training. These personnel must wear radiation monitoring devices and follow strict safety
protocols to minimize their exposure to radiation. This area typically includes locations
where radioactive materials are stored, handled, or processed. Controlled areas in a nuclear
medicine department may include areas where unsealed radioactive materials are handled,
administered, or administered patients are waiting or undergoing imaging etc. or where
sealed sources are handled or stored etc. E.g. Hot-lab, dose admin room, post admin waiting
room, imaging room, radioactive source storage room, radioactive waste storage room etc.

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Supervised Areas:

The area immediately adjacent to the controlled area will be designated as supervised area.
This designation will be made on the basis that, although the potential for exposures in
these areas will be minimal, this situation could change (e.g. in the event of changes in
working practices or degradation of the shielding, radiation emergencies etc.). Therefore it
is appropriate to keep the situation in these areas under review. Supervised areas in a
nuclear medicine department include control console, waiting rooms, medical examination
rooms, nursing stations etc.

(Attach the approved layout of your NM facility indicating the controlled areas and
supervised areas)

8 Arrangements for monitoring of workers and workplace

(This section should provide information about radiation monitoring of workers as well as
workplace monitoring, emergency accessories etc. The radiation protection programme
should describe the programme for the selection, calibration, maintenance and testing of
equipment to measure radiation doses. The information to be included in this section is
provided here. )
Sample content: Please modify based on your institute details
Radiation monitoring is an important component of radiation safety in a nuclear medicine
department, and involves the measurement of radiation exposure to personnel and the
workplace. Arrangements for monitoring workers and the workplace may include:

8.1 Arrangements for monitoring of workers:

i. Personal dosimeters to all radiation workers for the purpose of occupational exposure
assessment are provided and are being used appropriately.
ii. All the personnel entering into the Controlled Area will be monitored for their
radiation doses.
iii. Control TLD badge is kept at a radiation free Area.
iv. Personnel dosimeters will be sent periodically to recognized laboratories for analysis.
v. TLD Dose records will be maintained in the institute and workers will be informed
of their individual doses.
vi. Pocket dosimeter readings will be recorded after use and such records will be
maintained. (Include a list of situations which would require the usage of pocket
dosimeter)
vii. RSO reviews the dose records periodically to identify doses that may be higher than
usual and to review whether doses are as low as reasonably achievable.
viii. In case of excessive exposure, Licensee and RSO will investigate the matter and
report will be submitted to AERB and preventive measures will be implemented as
required, to avoid recurrence of such cases.
ix. Any likelihood of excessive exposure to the person (genuine) such as handling of
accident, any accidental entry in radiation area etc. will be reported to AERB
promptly. Similarly any likelihood of non-genuine exposure (exposure to TLD badge

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 only) such as keeping the TLD badge in radiation area, accidental fall of TLD badges
in radiation area etc. should be reported to AERB promptly. In these cases, TLD
badge will be sent to the TLD laboratories for reading.

8.2 Arrangements for monitoring the workplace:

i. Minimum one working radiation monitoring instrument/s (with valid calibration

certificate/s) will be made available to carry out radiation protection survey of the
facility.
ii. Radiation protection survey around the installation is performed by using intended
radioisotope.
iii. Radiation survey and contamination monitoring are carried out periodically and
records will be maintained.
iv. Fixed zone monitors are installed in HDT department with appropriate set limits.
v. Measurement of liquid radioactive waste prior to release from delay tanks (in terms
of activity concentration).

8.3 Dose Limits for Occupation Radiation Worker:

The dose limits for occupational radiation worker are as follows;

Category Annual Effective Dose Limit (mSv) Annual Equivalent

Limit(mSv)
Lens of Skin Extremities
Eye
A. Radiation An effective dose of 20 mSv/yr
Worker averaged over five consecutive 150 500 500
years
30 mSv in any single year
B. Apprentices
and Trainees 6 50 150 150
C. Member of
Public 1 15 50 -

Pregnant women (staff): limits given above apply to female workers also. However, once
pregnancy is declared the equivalent dose limit to embryo/foetus shall be 1 mSv for the
remainder of the pregnancy.

The investigation level of 10 mSv in any monitoring period is defined by AERB. If any
radiation worker exceeds the dose of 10 mSv, the investigation will be carried out by RSO
and the report will be submitted to AERB in timely manner. The radiation professional
personnel will be made available whenever required by AERB for further investigation.

Institute has set the internal investigation level at ____mSv. It will be ensured that radiation
professional will follow all radiation safety principles so that they get the dose as low as
possible.

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9 Radiation protection during pregnancy of a female patient
and for lactating mother
Sample content: Please modify based on your institute details

9.1 Pregnancy of a female patient: Radiation exposure can be potentially harmful to the
developing foetus during pregnancy. SOPs will include the following
considerations for radiation protection during pregnancy of female patient in nuclear
medicine:

i. Medical Justification: The diagnostic or therapeutic procedure will be carried out,

only if, it is deemed necessary for the health of the mother or the developing foetus.

ii. Optimization of Imaging Protocols: Imaging protocols will be optimized to

minimize radiation exposure to the foetus while still achieving diagnostic quality
images. The protocol will include reducing the administered activity, adjusting
imaging parameters, or using shielding to minimize the radiation exposure.

iii. Patient Education: Pregnant women will be informed about the potential risks of
radiation exposure to the developing foetus. They will be counselled on the risks
and benefits of the procedure and information about the measures that will be taken
to minimize foetal exposure will be provided.

9.2 For lactating mother: As many of the radiopharmaceuticals in mother’s body can be
transferred to a baby via breast milk, appropriate instructions will be provided to
female patients who are lactating regarding cessation of breastfeeding post nuclear
medicine procedures for a time period based on the radiopharmaceuticals used and
activity administered.

10 Health surveillance programme

(This section should describe the health surveillance programme to be followed by
radiation facility. As per Rule 25 of Atomic Energy (Radiation Protection) Rules, 2004)

Health surveillance of all the Nuclear medicine staff will be carried out as per the
requirement in AE (RPR), 2004 (i.e., at the time appointment) and records will be
maintained.

11 Constitution of Local Safety Committee to ensure

occupational and radiation safety
(The constitution of a Local Safety Committee is an important step in ensuring occupational
and radiation safety in a nuclear medicine department. The committee will be composed of
a representative group of individuals who have a direct interest in, and responsibility for,
safety in the workplace.)
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 Sample content: Please modify based on your institute details

The following key considerations are included for the constitution of a Local Safety
Committee:

i. Members: The local safety committee will be formed with RSO as a member secretary,
and consist the licensee, management representative and other relevant members related
to safe operation of the Nuclear Medicine facility.

ii. Roles and Responsibilities: The committee will be provided with clearly defined roles
and responsibilities, including the review and implementation of safety policies and
procedures, the identification of potential hazards, the monitoring of safety performance,
and the provision of safety training and education.

iii. Meeting Frequency: The committee will meet regularly, with a schedule of meetings
established in advance. The frequency of meetings may depend on the size and
complexity of the department, as well as the level of risk associated with the activities
being conducted.

iv. Decision Making: The committee will be provided with the authority to make decisions
regarding safety policies, procedures, and practices. The committee shall also have the
ability to escalate safety issues to higher levels of management, as needed.

v. Documentation and Reporting: The committee will maintain accurate and complete
records of its meetings, decisions, and actions. The committee will also report regularly
to management and other stakeholders on safety performance and issues. In case of any
radiation safety issue, unusual incidents happened, meetings will be conducted for
review and improvement in the RPP

vi. Constitution order of the LSC: The constitution order of the LSC will have terms and
conditions as per the following;
- Review of Radiation Safety related issue
- Review of Safety status of the facility
- Review of cases of dose exceeding internal investigation levels
- Review of audit report of RPP and recommend revision/improvements if any
- Review and Investigation of Unusual Occurrence if any.
- ………………………………………….
- ……………………………………………
(Constitution order should be attached as annexure to this RPP document)

12 Emergency preparedness and response plan

(Emergency Preparedness Plan need to be prepared as per the guidance provided in
the AERB Safety documents. The plan should be attached as annexure to this RPP
document. Information to be included in this section is provided below)

Sample content: Please modify based on your institute details

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 i. The Emergency Preparedness Plan will be prepared and maintained as per the
guidance provided in the AERB Safety Guide on Nuclear Medicine.
ii. Emergency response plan will be familiarised to the employee during periodic
training/ refresher.
iii. The copy of the same will be maintained in the Nuclear Medicine Department.
iv. The Emergency Contact numbers will be displayed Nuclear Medicine Department.

13 Methods for periodically reviewing and auditing the

performance of the radiation protection programme
(Management is required to review the radiation protection programme and its
implementation periodically. For this purpose, Institution should conduct audit. In this
section NM facility should explain the process to carry out periodic review like composition
of checklist frequency of periodic audit, review of audit report and process for
improvements in the effectiveness of the radiation protection programme. The typical
information is provided below)
Sample content: Please modify based on your institute details
The periodic audit will be conducted internally to verify if the RPP as defined here are
implemented.
- The Audit will be carried out at least once in a year.
- The audit team will consist of at least two members such as Expert in field of Radiation
Safety and Employer/Licensee Nominated Person.
- The checklist for conducting the audit will be prepared as per the various contents of RPP
and the same will be used for audit.
- The audit report will be reviewed in Local Safety Committee.
- Based on the finding of the audit report further improvement in RPP will be carried out.

14 Decommissioning of Nuclear Medicine Facility/ Equipment

and management of Radioactive Wastes.
Decommissioning activities should be controlled through the use of documented procedures
and in consultation with the supplier of the equipment. A Decommissioning plan needs to be
prepared in accordance with the Atomic Energy (Safe Disposal of Radioactive Wastes) Rules,
1987, and AERB Safety Guides: “Regulatory Control of Radioactive Discharges to the
Environment and Disposal of Solid Waste: AERB/NRF/SG/RW-10, 2021”, & “Classification
of Radioactive Wastes” No. AERB/NRF/SG/RW-1, 2012. The plan should be attached as
annexure-V. Information to be included in the decommissioning plan is provided below.

Sample content: Please modify based on your institute details

14.1. Decommissioning of Nuclear Medicine facility/Equipment

Decommissioning plan should include:

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  Prior Approval from AERB.
 Waste disposal strategies for small, medium and large waste volumes.
 Hot-spot management through Radiological surveys
 Final contamination survey & clearance.
 Submission of final report to AERB.

14.2. Management of disused unsealed sources and radioactive wastes

The SOP should include the following aspects;

 Waste management: Adherence to Atomic Energy Waste Disposal Rules and

relevant AERB Safety Guides.
 Disposal/Transfer: Adhering to authorized levels or transferring to authorized
facilities.
 Removing/defacing radioactivity symbols before release.

14.3. Management of disused sealed source (e.g., Ge-68, Na-22)

 Returned to manufacturer/Disposed of at authorized facility, with prior approval

from AERB.

(The following annexures should be prepared and enclosed with RPP)

Annexure I: Annexure-I: Organisation Chart

Annexure II: Approved layout of NM facility indicating controlled and supervised areas
Annexure III: Constitution order of Local Safety Committee
Annexure IV: Emergency preparedness Plan
Annexure V: Decommissioning plan

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