Thông tư liên tịch 13/2014/TTLT-BKHCN-BYT

Joint circular No. 13/2014/TTLT-BKHCN-BYT dated June 09, 2014, on medical radiation safety

Nội dung toàn văn Joint circular No. 13/2014/TTLT-BKHCN-BYT on medical radiation safety


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

Hanoi, June 09, 2014

 

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

GENERAL PROVISIONS

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;

c) Volunteers for biomedical researches;

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

1. Organizations and individuals who do radiological works using radiological equipment, radiation sources, and radiopharmaceuticals in medical facility must ensure that:

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.

3. Instructions, abbreviations, and value of the control panel of radiological equipment must be written in Vietnamese or a language that can be understood by the operator.

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.

5. The beam emission must be stopped after a set period or after a set value of mAs or exposure is reached.

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.

Article 7. Safety requirements applied to sealed radiation sources and radiopharmaceuticals

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:

a) Radioactive isotopes; chemical forms (drug name and chemical formula);

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

1. Medical facilities using teletherapy and brachytherapy equipment and must have dose rate meters. Medical facilities using radiopharmaceuticals (nuclear medicine facilities) must have dose rate meters, surface contamination meters whose spectra are suitable for the radiation emitted from radiological equipment and radiation sources used at the facility in order to frequently check background radiation, radioactive contamination, and control the level of radiation when entering radiation source areas.

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.

3. Nuclear medicine facilities using radiation sources for brachytherapy must have the following radiation protection equipment and apparatus:

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;

d) Apart from regulations in Point a, b, and c of this Clause, radiotherapy equipment must undergo dose calibration as frequently as recommended by manufacturers.

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;

c) does not exceed 10 mSv/hour in the control room of the diagnostic x-ray system (except for mobile x-ray system);

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.

7. Rooms for placing radiological equipment, working with radiation sources and radiopharmaceuticals, rooms for patients administered with radiopharmaceuticals or radioactive implants, radiotherapy equipment control room must be classified as controlled areas and apply the following measures:

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

Radiological equipment must be installed in accordance with the following regulations:

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;

b) Close the door throughout the operation of the equipment;

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;

c) Take dose exposure measures to ensure that exposure incurred by them does not exceed the limits in Appendix I of Circular No. 19/2012/TT-BKHCN.

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:

a) Carry out radiation monitoring of the working environment and establish limits when making the application for permission to do radiological works;

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:

Effective dose = 0.5 HW + 0.025 HN

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

Medical facilities must provide sufficient personal protective equipment and protective equipment for radiological workers, including:

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.

Article 19. Internal inspection

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:

- Ask the patient and check to make sure he/she is not pregnant, not having a child under 12 months (in case of administration of radiopharmaceuticals) before deciding on a method of diagnosis or treatment;

- 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;

b) Use beam properly to create the minimum exposure with acceptable quality of images serving diagnosis;

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.

8. The medical facility must take the following measures to ensure radiation safety for the caretakers of the patients being diagnosed or treated with ionizing irradiation:

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.

4. The following protective measures must be applied in the areas around the controlled area, including working rooms, pathways, restrooms, and other public areas:

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.

b) Regulations about assessment of exposure and monitoring of health status of patients given interventional imaging in the event of overexposure; assessment of exposure and monitoring of health status of radiological worker in the event of overexposure.

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;

- Damage, leakage of the reservoir for liquid radioactive waste.

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;

- Fire or explosion in the radiotherapy equipment, radiation source storage;

- 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.

3. Spent sealed radiation sources (including expired radiation sources from teletherapy equipment using radiation sources, radiation sources no longer used for brachytherapy, and other sealed radiation sources used for calibration or research that are no longer used) must be managed and stored in accordance with regulations on management of spent sealed radiation sources issued by the Ministry of Science and Technology.

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;

b) Announce policies on radiation safety in the facility, make commitment to assure safety and facilitate implementation of radiation safety measures;

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;

d) Request the head of the medical facility to assign other tasks that do not involve working with radiation to pregnant female radiological workers when receiving their written notifications.

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;

e) Promptly inform the safety officer or head of the medical facility of unusual phenomena in terms of radiation safety or loss of radiation sources; participate in recovery of radiation accident on request.

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.

2. Services of Health of provinces have the responsibility for management of radiation safety of local medical facilities, including:

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

1. This Circular comes into force from July 25, 2014.

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

Type

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

Multipurpose x-ray room without patient’s bed

12

3.5

3

Room for comprehensive dental imaging, skull imaging

14

3.5

4

Multipurpose x-ray room with patient’s bed

14

3.5

5

Multipurpose x-ray room with electrical bed for patients

20

3.5

6

CT scanner room

28

4

7

X-ray room with radiocontrast dye injectors for cardiovascular imaging

36

5.5

II

Radiotherapy equipment

1

Teletherapy equipment

30

4

2

Gamma knife

30

4

3

HDR brachytherapy equipment

30

4

Note: Dimensions of rooms for radiological equipment not mentioned in this Appendix are not regulated.

 


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