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MINISTRY OF
SCIENCE AND TECHNOLOGY AND MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
13/2014/TTLT-BKHCN-BYT
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Hanoi, June
09, 2014
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JOINT CIRCULAR
ON MEDICAL RADIATION SAFETY
Pursuant to the Law on Atomic Energy dated
June 03, 2008;
Pursuant to the Government's Decree No.
07/2010/NĐ-CP dated January 25, 2010 on guidelines for the Law on Atomic
Energy;
Pursuant to the Government's Decree No.
20/2013/NĐ-CP dated February 26 2013 defining the functions, tasks,
entitlements and organizational structure of the Ministry of Science and
Technology;
Pursuant to the Government's Decree No.
63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
The Minister of Science and Technology and
the Minister of Health promulgate a Joint Circular on medical radiation safety.
Chapter I
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Article 1. Scope and regulated entities
1. This Circular provides for radiation safety
requirements applied to radiological equipment, radiation sources,
radiopharmaceuticals used for healthcare, and equipment used for nuclear
medicine; requirements applied to radiological equipment rooms, rooms for
working with radiation sources and radiopharmaceuticals; rooms for patients
treated with radiation (using radiopharmaceuticals or radioactive implants),
and storage of radiation sources or radioactive waste; requirements applied to
installation and operation of radiological equipment; control of occupational
exposure, public exposure, and medical exposure; requirements for radiation
emergency response, responsibility of relevant entities for assurance of
radiation safety in healthcare.
2. This Circular is applied to medical
examination and treatment facilities, research institutions, training
institutions, defensive medicine facilities, and medicine testing facilities
(hereinafter referred to as medical facilities) that use radiological
equipment, radiation sources, radiopharmaceuticals, and nuclear medicine
equipment.
3. This Circular does not apply to manufacture
of radiopharmaceuticals with cyclotron.
Article 2. Interpretation of terms
In this
Circular, the terms below are construed as follows:
1.
Medical exposure means the impact of ionizing irradiation on:
a) Patients
during diagnosis or treatment;
b) Persons
undergoing health assessment;
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d)
Volunteers who help, take care of patients (which means this is not their
profession) who are diagnosed or treated with ionizing irradiation.
2. Recommended
medical exposure limits mean the recommended values of dose, dose rate, or
activity used as reference for controlling medical exposure and while doing
actual works. If these values are significantly higher or lower than the
recommended value, reassessment is necessary to achieve a reasonable level of
medical exposure.
3. Head
of medical facility means the owner or owner’s legal representative or the
owner’s authorized representative who manages the medical facility.
4. Radiological
workers are doctors, nurses, pharmacists, engineers, technicians, midwives
at the medical facility who directly works with radiological equipment of
closed, open radiation sources, or take care of patients treated with radioactive
isotopes, or work in areas with potential exposure with a dose rate exceeding 1
mSv per year, or work areas susceptible to radioactive contamination.
5. Radiological
equipment includes equipment that emits x-ray or contains radiation sources
used for medical diagnosis and treatment, including: diagnostic x-ray devices,
diagnostic imaging devices using radiation sources, radiotherapy equipment.
6. Diagnostic
x-ray equipment means equipment that emits x-ray used for diagnostic
imaging, including x-ray equipment for dental imaging (including full-mouth
dental imaging equipment, skull imaging equipment, and intraoral dental imaging
equipment), mammography equipment,
mobile x-ray equipment; x-ray equipment for measurement of bone density,
multipurpose x-ray imaging equipment, fluoroscopic TV x-ray system, CT scanner, vein imaging and vascular and
interventional radiology system.
7. Radiotherapy
equipment means equipment that emits ionizing irradiation used for cancer
treatment, including radiotherapy x-ray equipment, linear particle accelerator,
teletherapy (external beam radiotherapy) equipment using radiation sources,
contact high dose rate (HDR) brachytherapy equipment, gamma knife.
8. Nuclear
medicine equipment includes gamma camera, SPECT, SPECT/CT, PET, PET/CT,
radiopharmaceutical dose meter, bodily activity recorder (kidney radioactivity
meters, radiation density gauge).
Article 3. General rules for assurance of medical radiation safety
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a) The
diagnosis or treatment using ionizing irradiation has considerably great
benefits for patients than the harms they suffer;
b) Exposure
incurred by radiological workers and the public must not exceed the limits;
Exposure incurred by patients must not exceed prescribed levels;
c) Exposure incurred
by patients, radiological workers, and the public, and the number of exposed
persons must be kept as low as reasonably possible.
2. Only
conduct medical examination, treatment, scientific research, training,
defensive medicine works, and drug testing using radiological equipment,
radiation sources, or radiopharmaceuticals after a competent authority issues a
license to do radiological works.
Chapter II
MEDICAL RADIATION SAFETY
REQUIREMENTS
Article 4. General safety requirements applied to radiological equipment
and nuclear medicine equipment
1. Radiological equipment used for diagnosis,
treatment, and nuclear medicine equipment must have quality certificates for
types or models which certifies their conformance with safety requirements of
International Electrotechnical Commission (IEC), International Standardization
Organization (ISO), or equivalent Vietnam’s Standards.
2. There are documents attached to the
equipment, including specifications, operation, maintenance, and safety manual.
The manual must be translated into Vietnamese.
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4. The radiological equipment must have a mechanism
to control the radiation beam, clearly and reliably indicate that whether the
beam is off or on.
5. Radiological equipment must have a mechanism
to contain the beam in order to ensure that the beam is aimed at only the
patients that need diagnosis or treatment.
6. The radiation field emitted to serve
diagnosis or treatment must be even in the region. The unevenness of the
radiation field must be specified by the manufacturer.
Article 5. Safety requirements applied to diagnostic x-ray equipment
Apart from regulations in Article 4 of this
Circular, diagnostic x-ray equipment must satisfy the following requirements:
1. The level of leaked radiation of the x-ray
tube must not exceed 1 mGy/hour at the distance of 1 m from the x-ray tube
cover over an area not exceeding 100 cm2 in all working modes of the
equipment as recommended by the manufacturer.
2. The fixed filtration value of x-ray tube must
be written on the box (expressed as mm Al).
3. There is a system for checking beam dimension
using light sources, except for intraoral
dental imaging and mammography equipment.
4. Values of voltage (kV), tube current (mA),
duration (s), or generating constant (mAs) must be displayed on the control
panel when switching to working mode and while during the imaging process.
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6. X-ray scanning equipment must have the
automatic exposure control unit or beam control button that only allows beam
emission if the button is pressed and held tightly.
7. Mobile x-ray equipment must have a cable long
enough that the distance between the equipment and the x-ray tube is at least
02 m. For other radiological equipment, the minimum distance is 3 m.
8.
Interventional radiology equipment must have rubber lead covers at the
patient’s table to prevent radiations from affecting the operator. There must
be a ceiling-hanged cover system used for protecting the operator’s eyes and
thyroid gland while monitoring the patient. The minimum thickness of rubber
lead covers is 0.5 mm of equivalent lead.
Article 6. Safety requirements applied to radiotherapy equipment
Apart from the requirements in Article 4 of this
Circular, radiotherapy equipment must satisfy the following requirements:
1. Irradiation may be stopped from the control
panel and can only be resumed at the control panel; Protection mode is
automatically activated upon blackout until the equipment is turned on from the
control panel.
2. Radiotherapy equipment using radiation
sources must have at least 02 control mechanisms that automatically activates
protection mode and stops irradiation upon accident.
3. Teletherapy equipment using radiation sources
and HDR brachytherapy equipment must
allow the operator to manually activate protection mode in an emergency. Gamma
knives must allow the operator to manually close the window to block the source
in an emergency.
4. The box radiation sources of teletherapy
equipment using radiation sources and containers of radiation sources of HDR brachytherapy equipment must have clear
radiation warning symbol.
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1. Sealed radiation sources used for teletherapy
or HDR brachytherapy equipment must comply
with ISO 2919:2012 Radiation protection - Sealed radioactive sources - General
requirements and classification or Vietnam’s Standards 6853:2001. If they are
still used after the expiration of useful life recommended by the manufacturer,
radiation leak must be checked to assure that the sources are still as
designed.
2. Radiopharmaceuticals used in nuclear medicine
must be permitted for free sale as prescribed by regulations of law on
pharmacy, may only be used for prevention, treatment of diseases, regulation of
bodily functions, and the following factors must comply with recognized
international standards:
a) Purity of radionuclides (ratio of
radioactivity of tracer radionuclides in radiopharmaceuticals to total activity
of radionuclides therein);
b) Specific activity (activity of a unit of mass
of tracer of a specific radionuclide, whether inside the tracer of such
radionuclide or not);
c) Radiochemical purity (proportion of
radionuclides in the desired form of chemical connection of the tracer to the
total amount of radionuclides in the radiopharmaceutical, which means
radionuclides separated from the tracer);
d) Chemical purity (ratio of main tracer,
regardless of its activity, to the radiopharmaceutical; Radiopharmaceutical
means a prepared amount that is ready to be used for the patient);
dd) pH;
e) Other parameters of drugs prescribed by
regulations of law on pharmacy.
3. All radiopharmaceuticals must have labels
that contain the following information:
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b) Total radioactivity of the preparation;
c) Activity measuring date;
d) Result of radiochemical impurity measurement;
dd) Manufacturer’s name, address, and
manufacturing date;
e) Expiration date;
g) Batch number;
h) Volume of radiopharmaceuticals (those in
solutions);
i) Other information on drug labels prescribed
by regulations of law on pharmacy.
Article 8. Safety requirements applied to radiation measuring equipment,
radiation protection equipment and apparatus
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2. Nuclear medicine facilities must have the
following radiation protection equipment and apparatus:
a) Fume hood with volume and flow rate suitable
for preparation, division of radiopharmaceuticals;
b) Tables for preparation, division of
radiopharmaceuticals with lead sheets combined with L-shape radiation shielding
materials and lead glass window;
c) Clamps for working with radiation sources
from a distance;
d) Radiopharmaceutical containers with lead
covers and protective outer shells;
dd) Trays specially designed for preparing,
dividing liquid radiopharmaceuticals;
e) Cylinders with lead covers specially designed
for used in nuclear medicine;
g) Disposable automatic pipette;
h) Tools for handling spilled radioactive
substances.
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a) Tables with L-shape lead shields and lead
glass windows for working with radiation sources;
b) Clamps with long handles;
c) Source cabinet with separate compartments to
store sources with different activity;
d) Source bottle for transport.
Article 9. Inspection, calibration of radiological equipment and
radiation meters
1. Medical facilities must inspect radiological
equipment used in within their facilities:
a) before the equipment is used for the first
time;
b) every year (for radiotherapy equipment, CT
scanners, fluoroscopic TV x-ray system) and every two year (for other
diagnostic x-ray devices) from the day on which they are put into operation;
c) after the equipment is reinstalled or
repaired;
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2. If the inspection result shows that safety
parameters of radiological equipment deviate from permissible values, the
equipment must be calibrated before being permitted for use. Inspection and
calibration must be carried out according to the procedures provided by
manufacturers or an equivalent Vietnam’s Standard.
3. Radiation meters (dose rate meter, surface
contamination meters, radiopharmaceutical dosimeter) must be inspected before
being put into operation, after repair, and annually.
4. Radiological equipment and radiation meters
must be inspected and calibrated by entities licensed by the Ministry of
Science and Technology to provide inspection and/or calibration services.
Article
10. Rooms for placing radiological equipment, working with radiation sources
and radiopharmaceuticals; storage of radiation sources or radioactive waste,
rooms for patients treated with radiation
1. Rooms for
placing radiological equipment, working with radiation sources and radiopharmaceuticals;
storage of radiation sources or radioactive waste, rooms for patients treated
with radiation must not be positioned next to the obstetrics ward or pediatrics
ward.
2. The dimensions of rooms for placing
radiological equipment must comply with Appendix I enclosed herewith.
3. The thickness of the walls, ceiling, floor,
doors of the radiological equipment room, monitoring windows of the control
room must be designed in accordance with Article 7 of Circular No.
19/2012/TT-BKHCN and ensure that potential dose of the working environment (not
including natural background radiation):
a) does not exceed 20 mSv/year in the control
room or where the control panel of the radiotherapy equipment is place;
a) does not exceed 1 mSv/year at any position
outside the radiotherapy equipment room where the public and patients are
present;
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d) does not exceed 0.5 mSv/hour at any position
outside the diagnostic x-ray system room where the people and patients are
present.
Any diagnostic x-ray room located within a
residential area, adjacent to residential houses or workplaces must ensure that
radiation dose at any position outside the room is equal to natural background
radiation.
4. Apart from radiation shielding requirements,
the design of teletherapy and HDR brachytherapy rooms must have interlocking
system which only allows radiotherapy equipment to start up after the door is
closed and automatically terminates radiation if the door is suddenly opened;
There must be a radiation warning system and at least an emergency radiation
termination system in the room.
5. The design of a radiotherapy room must be
assessed and licensed by the Department of radiation and nuclear safety before
its construction as prescribed in Circular No. 08/2010/TT-BKHCN dated July 22,
2010 of the Minister of Science and Technology.
6. Every nuclear medicine facility must have
rooms for preserving for storing and working with radiopharmaceuticals (dose
packaging), rooms where radiopharmaceuticals are administered (taken orally or
injected), rooms for storage of radioactive waste, bathrooms reserved for
patients using radiopharmaceuticals, gamma camera rooms, rooms for
hyperthyroidism or thyroid gland cancer patients; bathrooms for workers after
working with radiopharmaceuticals. These rooms and areas must be protected from
external radiation and radioactive contamination as follows:
a) Radiation shielding must be so designed that
dose rate where the people, patients are present an in adjacent rooms does not
exceed 0.5 µSv per hour;
b) The floor and walls of rooms at risk of
radioactive contamination must be covered with smooth, watertight, and
cleanable materials;
c) Wash-basins for workers who work with radiopharmaceuticals
must have automatic faucets or faucets with foot-operated or elbow-operated
handles;
d) All contaminated water must be collected by
separate drainage system and discharged into a reservoir where liquid
radioactive wastes are treated.
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a) A radiation warning sign is place above the
door to the controlled area according to Appendix II enclosed herewith.
b) There are signal lights at doors of the
radiological equipment room, brachytherapy room, radiopharmaceutical
preparation room, which are on throughout the process of radiation works;
c) Rules and regulations are placed at the door
to the controlled area;
d) In the teletherapy room, HDR brachytherapy
room, room for patients treated with radiopharmaceuticals or radioactive
implants, additional contact prevention measures must be taken such as
installing fences, locking doors, or assigning supervisors.
8. Design of warehouse of radiation sources or
radioactive waste must comply with the following regulations:
a) Dose rate at any position on the outer side
of the wall does not exceed 0.5 µSv/hour;
b) Radiation warning signs (in Appendix II
enclosed herewith) are put up at the door to the warehouse and on the walls
adjacent to public area;
c) Measures must be taken to prevent
unauthorized persons from entering the warehouse.
Article 11. Installation of
radiological equipment
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1. Only one
piece of radiological equipment may be installed in a room. 02 diagnostic x-ray
systems may be installed in one room. However, only one of them may be operated
at a time.
2.
Radiological equipment must be so installed that the beam is not aimed towards
the control panel, door, windows, or public areas.
3. The
control panel of the radiological equipment must be placed outside and adjacent
to the equipment room. There must be a patient monitoring system and means of
communications between the operator and the patient. In case of diagnostic x-ray
system working at a voltage smaller than 150 kV, the control panel may be
placed in the same room as the system, provided there are lead shields to
ensure that the dose rate at the operator’s position is smaller than 10
µSv/hour.
Article 12. Internal regulation
on radiation safety and safe operation of radiological equipment
1. Every medical facility must establish
procedures for working with radiological equipment, radiation sources,
radiation safety regulations which satisfy the following requirements:
a) The procedures must specify the steps for
operating radiological equipment, working with radiation sources, working in
areas likely to be irradiated or contaminated, taking care of patients treated
with radiopharmaceuticals or radioactive implants; operating procedures for
each device, and treatment regimen of each disease;
b) Radiation safety regulations must point out
radiation protection for radiological workers and other employees of the
medical facility, patients, caretakers, and the public.
2. Radiological
equipment operators must follow the steps blow:
a) Check the
equipment safety before and after work;
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c) Adhere to
operation procedures;
d) Pay
attention to unusual signs of the radiological equipment and inspecting devices
in order to promptly discover problems and prevent accidents;
dd) Do not
remove broken parts of the protection system or short-circuit to operate the
equipment i.e. short-circuiting the interlocking system of radiotherapy room.
Article 13. Employment of
radiological workers
1. Medical
facility must assign other tasks to female radiological workers during their
pregnancy or while they are raising children under 12.
2. Medical
facilities must not employ people under 18, people having radiation sickness to
operate radiological equipment, work with radiation sources, take care of
patients treated with radioactive isotopes, work in areas at risk of
irradiation at over 1 mSv/year or in areas at risk of radioactive
contamination.
3. Medical facilities having apprentices,
learners, students who practice operating radiological equipment, working with
radiation sources, taking care of patients treated with radiation sources or radiopharmaceuticals,
work in areas at risk of irradiation at over 1 mSv/year or in areas at risk of
radioactive contamination have the responsibility to:
a) Provide
training in basic radiation safety, radiation safety regulations for them;
b) Assign specialists to instructs them and
monitor their works;
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Article 14. Radiation
safety training
Medical facilities are responsible for providing
radiation safety training for their radiological worker, particularly:
1. Provide radiation safety training for new
radiological worker according to the basic radiation safety training program
prescribed by the Ministry of Science and Technology.
2. Provide periodic retraining, refresher
courses, new information about radiation safety for radiological worker at
least every 03 years.
3. Provide training for radiological worker on
radiation safety regulations, radiation emergency response procedures, or new
regulations, information about radiation safety.
4. Ensure that radiation safety training
mentioned in Clause 1 and Clause 2 of this Article is provided entities
licensed to provide radiation safety training by the Ministry of Science and
Technology.
5. Make, update, and retain radiation safety
training documents.
Article 15. Radiation
monitoring at workplaces
1. Medical facility must carry out environmental
radiation monitoring as follows:
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b) Carry out annual inspection of radiation
level at radiological workers’ positions, environmental radiation level at
doors and surrounding areas of radiological equipment rooms, radiation sources
and radioactive waste storage;
c) Carry out monthly inspection of radioactive
contamination at the workplace and surroundings if the nuclear medicine
facility uses radiopharmaceuticals for diagnosis and treatment of diseases;
d) Compare results of workplace radiation
monitoring with established limits; determine causes and take remedial measures
if the results exceeds the limits.
2. The medical facility must make and keep
documents about workplace radiation monitoring and inform radiological worker
of the radiation monitoring results.
Article 16. Monitoring and
assessment of exposure
1. Medical facilities must monitor and assess
individual exposure incurred their radiological worker, particularly:
a) Provide personal dosimeters for radiological
worker and measure exposure incurred by radiological worker at least every 03
months at facilities licensed to provide exposure measurement services by the
Ministry of Science and Technology;
b) Assessment of total individual exposure
incurred by radiological workers directly working with open radiation sources
(radiopharmaceuticals, contaminated objects, radioactive waste), which equals
(=) to external exposure (according to personal dosimeters) and internal exposure
(by direct measurement or assessment of workplace background radiation,
workplace air activity concentration, level of workplace radioactive
contamination, working time, and working procedures);
c) Facilities using interventional radiology equipment must provide each person who
works in the equipment room (operators, doctors, technicians, nurses) 02
personal dosimeters, one to be worn inside the lead rubber apron at
abdomen-height, and one outside the apron at neck-height in order to accurately
assess individual exposure they incur using the following formula:
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Where HW is the value given by the
dosimeter inside the apron.
HN is the value given by the
dosimeter outside the apron.
d) If the value effective dose caused by external
exposure incurred by operators of diagnostic x-ray equipment and radiotherapy
equipment or value to total effective dose (including both external and
internal exposure) incurred by radiological workers directly working with open
radiation sources (radiopharmaceuticals, contaminated objects, radioactive
waste) exceeds the set limits, it is required to reconsider the working
procedures, radiation protection measures, and remedial measures;
dd) Provide instructions and carry out
inspections to ensure that radiological workers wear personal dosimeters while
working and protect them properly as instructed by the provider of individual
exposure measurement services;
e) If a radiological worker loses his/her
personal dosimeter or a personal dosimeter is broken, it must be immediately
replaced by a new one and assess exposure incurred by that worker throughout
the period of working without a dosimeter according to the practical working
time or usual exposure incurred in the previous times;
g) Inform radiological worker of their
individual exposure;
h) Make, retain, and manage documents about
individual exposure incurred by radiological workers according to Article 17 of
Circular No. 19/2012/TT-BKHCN.
2. In case a radiological worker simultaneously
works for multiple medical facilities, each of them must separately monitor and
assess individual exposure incurred by such person as prescribed in Clause 1 of
this Article. The person must ensure that total occupational exposure he/she
incurs at all facilities they work for does not exceed the limits in Appendix I
of Circular No. 19/2012/TT-BKHCN.
Article 17. Personal
protective equipment
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1. Lead rubber aprons for operator of full-mouth dental imaging systems, skull
imaging systems, multipurpose x-ray systems, fluoroscopic TV x-ray system, CT
scanners.
2. lead rubber apron, rubber cover for thyroid
gland for operators of mobile x-ray systems.
3. Lead rubber aprons, rubber cover for thyroid
gland, lead glass, lead rubber gloves for operators of interventional radiology systems, doctors, workers in vascular and interventional radiology room.
4. Protective clothing, gloves, goods,
facemasks, protective boots or foot covers for radiological workers who work
with open radiation sources (radiopharmaceuticals, contaminated objects,
radioactive waste).
5. Protective lead shields for workers who work
with patients that are treated with radiopharmaceuticals or radioactive
implants.
Article 18. Health
check-ups for radiological workers
1. Every year, the medical facility must provide
health check-ups for radiological worker in accordance with Circular No.
19/2011/TT-BYT dated June 06, 2011.
2. The medical facility must give other jobs
that do not involve radiation to radiological workers who have health issues.
3. The medical facility must make, retain, and
manage health profiles of radiological workers in accordance with Article 17 of
Circular No. 19/2012/TT-BKHCN dated November 08, 2012.
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1. The medical facility must plan and carry out
internal inspection of adherence to radiation safety regulations and working
procedures.
2. All shortcomings in the process of radiation
safety management must be found during the inspection and dealt with.
3. Every year, the medical facility must review
the radiation safety management process as prescribed in Article 18 of Circular
No. 19/2012/TT-BKHCN dated November 08, 2012.
4. The internal inspection result must be
recorded in writing and filed away in radiation safety documents.
Article 20. Medical
exposure control
1. The
treating physician is the person responsible for radiation safety of his/her
patients and is obliged to:
a) Only
resort to ionizing irradiation for diagnosis or treatment it is certain that
benefits for patients considerably outweigh the harms they incur.
b) Do not
use ionizing irradiation if there is another diagnosis or treatment method that
has the same result;
c) It is necessary to exercise caution when
using ionizing irradiation for children, women of child-bearing age, pregnant
women, or women with children under 12 months. To be specific:
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- Avoid using ionizing irradiation on pregnant
women or c) It is necessary to exercise caution when using ionizing irradiation
for children, women of child-bearing age, pregnant women, women showing signs
of pregnancy, or women with children younger than 12-month old. To be specific:
Responsible health workers and equipment operators must be notified to provide
the patient with proper protection;
- Only use radiopharmaceuticals for children if
compulsory and the activity must be reduced.
d) Refer to information about previous
examinations to avoid unnecessary examination;
dd) Decide the level of irradiation
radiopharmaceuticals as low as possible but still effective according to
instructions in Appendix III enclosed herewith.
2. Health workers,
operators of radiological equipment must provide radiation protection for
patients while doing their tasks as follows:
a) Ensure that medical irradiation is only used
when it is ordered by the treating physician, and used in accordance with the
order;
b) Ensure that the equipment used is suitable.
3. Apart from responsibility for patients’
safety prescribed in Clause 2 of this Article, operators of diagnostic x-ray
equipment must take the following measure to protect patients:
a) Ensure that the imaging complies with the
established operating procedures;
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c) Do not irradiate radiation-sensitive parts of
the patient’s body such as the gonads, crystalline lens, breasts, thyroid
gland; use proper shielding if this is unavoidable;
d) Avoid radiographing the abdomen area and
pelvic area of pregnant women or women showing signs of pregnancy unless is
mandatory because of clinical reasons. In this case, the exposure incurred by
the fetus must be minimized;
dd) Do not
allow patients and unauthorized persons stand inside the x-ray room while
another patient is being radiographed.
4. Apart
from responsibility for patients’ safety prescribed in Clause 2 of this
Article, Health workers, and operators of radiotherapy equipment must take
measures to that the level of exposure incurred by healthy tissues is minimized
but still effective.
5. Health
workers, technicians who package radiopharmaceuticals must ensure accurate
quantity of radiopharmaceuticals as ordered by physicians.
6. If a
medical facility retains patients that use radiopharmaceuticals, only one
patient is permitted in a room. If a room must contain multiple patients,
movable lead shields must be used to ensure that one patient is not affected by
irradiation of the other.
7. Each
medical facility must establish a separate medical exposure quality assurance
which the following contents:
a)
Radiological equipment, radiopharmaceutical dosimeters are inspected and
calibrated in accordance with Article 9 of this Circular;
b)
Parameters and optimal conditions of radiological equipment are used as
reference value for inspection and calibration.
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a) Instruct
basic measures for ensuring radiation safety and safety procedures before allow
them to participate in these tasks;
b) Provide
proper protective equipment to reduce exposure;
c) Ensure
that the exposure they incur over the period of diagnosis or treatment of the
patient does not exceed 5 mSv.
9. The
medical facility must carry out investigations, take remedial measures, and
record the cases of accidental medical exposure that leads to or threatens to
lead to higher exposure incurred by patients than expected.
Article 21. Control of
public exposure
The medical
facility must take the following measures to ensure safety for the public:
1. Only allow responsible for radiological
workers and persons appointed to help the patients to stay in the examination
or treatment room during the irradiation period.
2. Measures must be taken to prevent
unauthorized persons from entering the radiological equipment control room,
radioactive substance areas, rooms for patient treated with
radiopharmaceuticals or radioactive implants.
3. Only discharge a patient treated with
radiopharmaceuticals after the activity of radiation that remains in his/her
body does not exceed 400 MBq.
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a) Control the radiation level to ensure there
is no change during the operation;
b) Place radiation warning signs, lights,
signals, and take measures to restrict people from entering these areas.
Article 22. Radiation
emergency response
1. Every
medical facility that uses radiation sources and radiological equipment must make
and approve internal radiation emergency response plan as prescribed in
Circular No. 24/2012/TT-BKHCN dated December 04, 2012 of the Minister of
Science and Technology and regulations in Clauses 2, 3, and 4 of this Article.
2. Every medical facility using diagnostic x-ray
equipment must establish a radiation emergency response plan which contains:
a)
Regulations about implementation of measures to:
- Prevent
unauthorized persons from staying in the equipment room while the equipment is
irradiating;
- Prevent
operators from setting wrong imaging modes or operating the equipment against
the doctor’s order or mistaking patients;
- Prevent
malfunctioned equipment from working which leads to repeated irradiation.
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c)
Regulations on responsibility to report in the events mentioned in Point a and
in the cases of overexposure mentioned in Point b of this Clause;
d)
Regulations on making and retaining documents in the event of emergency.
3. Every
medical facility using radiopharmaceuticals for diagnostic and/or treatment
must establish a radiation emergency response plan which contains:
a) Measures
for prevention of accidents and response procedures in the event of the
following emergencies:
- Loss of
radiopharmaceuticals;
- Spilled
radiopharmaceuticals that cause contamination;
-
Unauthorized persons staying in radiopharmaceutical packing room during the
working process;
- Use of
incorrect dose, type of radiopharmaceuticals, on incorrect patients, or
incorrect dose calibration of radiopharmaceuticals;
- Fire in
the storage of radiopharmaceuticals or radioactive waste;
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b)
Regulations on assessment of absorbed dose and monitoring of health status of
patients who take or are given radiopharmaceuticals incorrectly and at risk of
overexposure; assessment of exposure and health status of radiological worker
in the event of overexposure; assessment of impact on the public and the
environment in case of emergencies;
c)
Regulations on responsibility to report in the events mentioned in Point a and
in the cases of overexposure mentioned in Point b of this Clause;
d)
Regulations on making and retaining documents in the event of emergency;
dd)
Regulations on emergency response drills.
4. Every
medical facility using radiotherapy equipment and/or sealed radiation sources
must establish a radiation emergency response plan which contains:
a) Measures
for prevention of accidents and response procedures in the event of the
following emergencies:
- Loss of
radiation sources;
- Radiation
sources are stuck and cannot be taken to the protection position; other
accidents related to equipment breakdown;
- Leaking or
broken sources that cause contamination;
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-
Unauthorized persons staying in the radiotherapy room during radiotherapy
process;
-
irradiation accidents: wrong patients, wrong tissues, wrong treatment plan,
overexposure.
b) Regulations
on assessment of dose and distribution of dose in the patient’s body,
monitoring of patients’ health status in case of irradiation accident;
assessment of exposure and monitoring of radiological workers’ health status in
case of overexposure; investigation and assessment of impact to the public and
the environment in case of emergencies;
c)
Regulations on responsibility to report in the event of emergencies mentioned
in Point a and in the event of irradiation accidents mentioned in Point b of this
Clause;
d)
Regulations on making and retaining documents in the event of emergency;
dd)
Regulations on emergency response drills.
Article 23. Management of
spent sealed radiation sources and radioactive waste
1.
Radioactive wastes produced from the use of radioactive substances in the
medical facility (including contaminated wastewater from the preparation room,
water for rinsing bottles and tools for working with radiopharmaceuticals;
wastewater from restrooms for patients using radiopharmaceuticals; contaminated
papers, towels; discarded tubular needles of radiopharmaceuticals; discarded
packages, bottles of radiopharmaceuticals; contaminated clothing, footwear, and
other items that are discarded) must be collected, stored, treated, and
discarded in accordance with regulations on radioactive waste management
promulgated by the Ministry of Science and Technology.
2. Apart
from the tasks in Clause 1 of this Article, solid radioactive waste
(contaminated papers, towels; discarded tubular needles of radiopharmaceuticals;
discarded packages, bottles of radiopharmaceuticals; contaminated clothing,
footwear, and other items that are discarded) must be managed in accordance
with Decision No. 43/2007/QĐ-BYT dated November 30, 2007 on management of
medical waste.
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Article 24. Radiation
safety documents
Medical
facilities are responsible for making, retaining, and managing documents about
radiation safety as prescribed in Article 17 of Circular No. 19/2012/TT-BKHCN
dated November 08, 2012 of the Minister of Science and Technology.
Chapter III
RESPONSIBILITY FOR
ASSURANCE OF RADIATION SAFETY
Article 25. Responsibility
of medical facilities and heads of medical facilities
1. Medical
facilities using radiological equipment, radiation sources, and/or
radiopharmaceuticals must comply with regulations on radiation safety in this
Circular and relevant legislative documents.
2. Medical
facilities using radiological equipment, radiation sources, and/or
radiopharmaceuticals may only do radiological works after being granted
licenses for radiological works by a competent agency.
3. The head
of the medical facility has to take the highest responsibility for assurance of
radiation safety for radiological workers, other employees of the medical
facility, the public, and the surrounding. To be specific:
a) Grasp and
comply with regulations of law on radiation safety and radiation safety
requirements in this Circular;
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b) Appoint
safety officers, specify their tasks, duties, and power; enable them to fulfill
their duties in terms of time and finance;
d) Enable
inspectorates and inspector to carry out inspection of nuclear and radiation
safety; provide sufficient information on request;
e) Assign
other tasks that do not involve working with radiation to pregnant female
radiological workers when receiving their written notifications.
Article 26. Responsibility of safety officers
1. A safety
officer must be a person who directly does the radiological works, has
professional knowledge, and grasp regulations on medical radiation safety,
regulations of law on radiation safety, radiation source security, and are
issued with a certificate of radiological worker by Vietnam Agency for
Radiation and Nuclear Safety or the Department of Science and Technology of the
province.
2. The
safety officer has the responsibility to assist the head of the medical
facility in implementation of regulations of law and requirements of this
Circular in terms of radiation safety, including:
a)
Application of technical and financial measures to ensure safe working
condition for employees and the public, which suit the radiological works
carried out at the facility;
b) Comply
with request for information provision, license issuance, and license renewal
as prescribed by law;
c) Take
responsibility to the head of the facility and take joint responsibility with
the head when a radiation emergency or violation occurs;
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3. The safety officer is entitled to suspend any
radiological works when finding a sigh or risk of danger.
Article 27. Responsibility of radiological workers
1.
Radiological worker must be trained and have radiology certificates issued by
competent authorities which are suitable for their radiological works.
2. Responsibility of radiological workers:
a) Participate in training courses on radiation
safety at the request of the safety officer;
b) Only do radiological works or works that that
involve exposure after having been trained in and grasped regulations of law on
radiation safety, radiation protection measures, and only operate radiological
equipment, nuclear medicine equipment if having occupational safety cards;
c) Comply with working regulations and
procedures as well as radiation safety instructions of the facility;
d) Use personal safety equipment, personal
dosimeters, radiation testers, and equipment for working with radiation sources
as instructed;
dd) Cooperate with the safety officer to comply
with regulations on annual health checkups and personal dose measurement;
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3. Female
radiological workers who are pregnant must inform the safety officer or head of
the medical facility in writing in order to be given other tasks that do not
involve radiation.
Article 28. Responsibility of health authorities
1. Medical examination and Treatment
Administration –Ministry of Health shall cooperate with relevant units in
instructing radiation safety works in medical facilities nationwide.
2. Services of Health of provinces are
responsible for supervising, monitoring implementation of regulations on
radiation safety in local medical facilities. Army Medical Department -
Ministry of National Defense are responsible for supervising, monitoring
implementation of regulations on radiation safety in army medical facilities.
Article 29. Responsibility of nuclear and radiation safety authorities
1. Vietnam Agency for Radiation and Nuclear
Safety –Ministry of Science and Technology has the responsibility for
management of radiation safety in medical facilities nationwide, including:
a) Receive information about containers of
radiation sources for diagnostic imaging, radiotherapy equipment, sealed
radiation sources, and radiopharmaceuticals;
b) Carry out safety inspection, issue licenses
to do radiological works with regard to use of containers of radiation sources
for diagnostic imaging, operation of radiotherapy equipment; retention, use of
radiation sources and radiopharmaceuticals; treatment, retention of used sealed
radiation sources, change of scale and scope of radiotherapy facilities,
shutdown of radiotherapy facilities; and issuance of radiological worker
certificates;
c) Carry out inspection of adherence to
regulations of law on medical radiation safety; take actions against
violations.
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a) Receive information about diagnostic x-ray
systems;
b) Carry out safety inspection, issue licenses
to do radiological works with regard to use of diagnostic x-ray systems and
issuance of radiological worker certificates for safety officers of medical
facilities;
c) Carry out inspection of adherence to regulations
of law on medical radiation safety in local medical facilities; take actions
against violations;
d) Cooperate with Army Medical Department –
Ministry of National Defense Carry out safety inspection, issue licenses to do
radiological works with regard to use of diagnostic x-ray systems in local army
medical facilities.
Chapter IV
IMPLEMENTATION
Article 30. Application of reference
If any of
the legislative documents, technical regulations, or standards referred to in
this Circular is amended, supplemented, or replaced, the newer one shall apply.
Article 31. Effect
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2. Joint
Circular No. 2237/1999/TTLT-BKHCNMT-BYT dated December 28, 1999 of the Ministry
of Science and Technology and the Ministry of Health on medical radiation
safety is annulled from the effective date of this Circular.
Difficulties
that arise during the implementation of this Circular should be reported to the
Ministry of Science and Technology and the Ministry of Health for
consideration./.
PP MINISTER OF THE MINISTRY OF HEALTH
DEPUTY MINISTER
Le Quang Cuong
PP MINISTER OF THE MINISTRY OF SCIENCE AND
TECHNOLOGY
DEPUTY MINISTER
Tran Quoc Khanh
APPENDIX I
DIMENSIONS OF
RADIOLOGICAL EQUIPMENT ROOMS
No
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Minimum
usable area (m2)
Minimum
dimension of a side (m)
I
PHÒNG ĐẶT THIẾT BỊ X - QUANG CHẨN ĐOÁN
TRONG Y TẾ
1
Mammography room
12
3.5
2
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12
3.5
3
Room for comprehensive dental imaging, skull
imaging
14
3.5
4
Multipurpose x-ray room with patient’s bed
14
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5
Multipurpose x-ray room with electrical bed
for patients
20
3.5
6
CT scanner room
28
4
7
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36
5.5
II
Radiotherapy equipment
1
Teletherapy
equipment
30
4
2
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30
4
3
HDR brachytherapy
equipment
30
4
Note: Dimensions of rooms for radiological equipment
not mentioned in this Appendix are not regulated.