Joint Circular No. 13/2014/TTLT-BKHCN-BYT on ensuring radiation safety in healthcare

JOINT CIRCULAR

Regulations on Ensuring Radiation Safety in Healthcare

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Pursuant to the Atomic Energy Law on June 3, 2008;

Pursuant to Decree No. 07/2010/NĐ-CP dated January 25, 2010 of the Government detailing and guiding the implementation of certain provisions of the Atomic Energy Law;

Pursuant to Decree No. 20/2013/NĐ-CP dated February 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

The Minister of Science and Technology and the Minister of Health issue this Joint Circular to regulate ensuring radiation safety for radiation equipment, radioactive sources, radiopharmaceuticals, and nuclear medicine equipment used in healthcare; requirements for rooms housing radiation equipment, working with radioactive sources and radiopharmaceuticals, patient rooms for radiotherapy (oral radiopharmaceuticals or implanted radioactive sources), and storage facilities for radioactive sources or radioactive waste; installation and operation requirements for radiation equipment; occupational, public, and medical radiation control requirements; emergency response requirements for radiation incidents; and responsibilities of organizations and individuals involved in ensuring radiation safety in healthcare.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Joint Circular applies to healthcare facilities, scientific research institutions, training centers, preventive healthcare services, and pharmaceutical testing laboratories (hereinafter referred to collectively as healthcare facilities) that use radiation equipment, radioactive sources, radiopharmaceuticals, and nuclear medicine equipment.

2. This Joint Circular does not apply to the production of radiopharmaceuticals using cyclotrons.

Medical Radiation

Article 2. Interpretation of Terms

In this Circular, the following terms shall be understood as follows:

1. refers to the impact of ionizing radiation on the following objects: a) Patients during diagnosis or treatment;

b) Individuals undergoing health checks or examinations;

c) Volunteers participating in biomedical research;

d) Non-professional helpers or caregivers assisting patients when they are being diagnosed or treated with ionizing radiation.

Guideline Levels in Medical Radiation

2. refer to recommended values of dose, dose rate, or radioactivity used as references for controlling medical radiation and conducting practical work; if these values are exceeded or fall significantly below them, a reassessment must be conducted to achieve reasonable levels of medical radiation. Head of Healthcare Facility

3. means the owner or the legal representative of the owner, or the person authorized by the legal representative to manage the healthcare facility. Medical Radiation Workers

4. include physicians, nurses, technicians, engineers, pharmacists, pharmacy assistants, midwives at healthcare facilities who work directly with radiation equipment or sealed radioactive sources, unsealed radioactive sources, or care for patients treated with radionuclides, or work in areas with potential radiation exposure exceeding 1 mSv/year or in areas at risk of radioactive contamination. Radiation Equipment

5. as mentioned in this Joint Circular includes X-ray devices or devices containing radioactive sources used in healthcare for diagnosis and treatment, including medical diagnostic X-ray equipment, diagnostic equipment using radioactive sources, and radiotherapy equipment. Medical Diagnostic X-ray Equipment

6. refers to X-ray devices used for diagnostic imaging, including dental X-ray equipment (panoramic dental X-ray, skull X-ray, intraoral dental X-ray), mammography X-ray equipment, mobile X-ray equipment, bone density measurement X-ray equipment, general X-ray fluoroscopy and radiography equipment, computed tomography (CT) scanners, interventional and vascular X-ray equipment. Radiotherapy Equipment

7. refers to devices emitting ionizing radiation used in healthcare for cancer treatment, including X-ray radiotherapy equipment, linear accelerators, teletherapy equipment using radioactive sources, high-dose-rate brachytherapy equipment, and gamma knife equipment. Nuclear Medicine Equipment

8. includes gamma cameras, single-photon emission computed tomography (SPECT), SPECT/CT, positron emission tomography (PET), PET/CT, radiopharmaceutical dosimeters, whole-body radioactivity monitors (renal scintigraphy, radioactivity concentration monitors). are gamma cameras, SPECT, SPECT/CT, PET, PET/CT, radioactive drug dose calibrators, and body radiation activity measuring devices (renal scintigraphy, concentration radiation measurement devices).

Article 3. General principles for ensuring radiation safety in healthcare

1. Organizations and individuals conducting radiation work using radiation equipment, radioactive sources, and radiopharmaceuticals in healthcare facilities must ensure:

a) The prescription of diagnosis and treatment with ionizing radiation brings significant actual benefits to patients compared to the harm they have to endure;

b) The radiation dose caused by these activities for medical radiation workers and the public does not exceed the limit dose; ensure that the radiation dose for patients is at the recommended level;

c) Maintain the radiation dose for patients, medical radiation workers, the public, and the number of people exposed at the lowest level that can be reasonably achieved.

2. Only carry out diagnostic, treatment, scientific research, training, preventive healthcare, and pharmaceutical testing activities using radiation equipment, radioactive sources, and radiopharmaceuticals when authorized by the competent state management agency to conduct radiation work.

Chapter II

REQUIREMENTS FOR RADIATION SAFETY

Article 4. General requirements for ensuring safety for radiation equipment and equipment used in nuclear medicine

1. Radiation equipment used for diagnosis, treatment, and equipment used in nuclear medicine must have a quality certificate for the type or model of equipment indicating compliance with safety requirements according to the standards of the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), or equivalent national standards.

2. Equipment must come with documentation including technical specifications, operation and maintenance instructions, and safety guidelines. Operation and safety guidelines must be translated into Vietnamese.

3. Operation instructions or abbreviations and operational values on the control panel of radiation equipment must be in Vietnamese or in a language suitable for the operator's use.

4. Radiation equipment must have beam control mechanisms clearly and reliably indicating whether the beam is "off" or "on."

5. Radiation equipment must have a mechanism to confine the beam for the purpose of targeting the beam to the area of the patient's body requiring diagnosis or treatment.

6. The radiation field emitted in the area for diagnosis or treatment on the patient must be uniform, and the degree of non-uniformity of the radiation field must be specified by the supplier.

Article 5. Safety requirements for diagnostic X-ray equipment in healthcare

Diagnostic X-ray equipment in healthcare, in addition to complying with the requirements stipulated in Article 4 of this Circular, must also meet the following requirements:

1. The leakage radiation level from the X-ray tube head must not exceed 1 mGy/hour at a distance of 1 meter from the surface of the X-ray tube head, averaged over an area not exceeding 100 cm² for all operating modes recommended by the manufacturer.

2. The fixed filtration value of the X-ray tube housing system in millimeters of aluminum equivalent (mm Al) must be clearly marked on the tube housing box.

3. There must be a source light beam size checking system, except for dental X-ray equipment using film placed behind the tooth socket and mammography X-ray equipment.

4. The kilovoltage (kV), milliamperage (mA), exposure time (s), or milliampere-seconds (mAs) values must be displayed on the control console when setting the operating mode and during imaging.

5. For X-ray imaging equipment, the emission of radiation must cease after a preset time or upon reaching a preset mAs value or preset dose value.

6. For fluoroscopy X-ray equipment, there must be an automatic exposure control (AEC) system or a push-button switch control mechanism to ensure that the equipment emits radiation only when the switch is pressed and held, and stops emitting radiation when the switch is released.

7. Mobile X-ray equipment must have a sufficiently long cable to ensure a minimum distance of 2 meters between the operator and the X-ray tube. For other radiation equipment, this distance must be a minimum of 3 meters.

8. Interventional X-ray equipment must have lead rubber shielding panels installed on the patient table to shield radiation affecting staff and hanging shielding panels suspended from the ceiling for the purpose of protecting staff eyes and thyroid glands while monitoring the patient. Lead rubber shielding panels must ensure a shielding thickness of no less than 0.5 mm lead equivalent.

Article 6. Safety Requirements for Radiotherapy Equipment

In addition to complying with the requirements stipulated in Article 4 of this Joint Circular, radiotherapy equipment must also meet the following requirements:

1. Permitting radiation exposure to be stopped from the control panel, and restarting the exposure after stopping can only be done from the control panel; automatically returning the power source to the protective position when there is a power outage and maintaining it at that protective position until the equipment is restarted from the control panel.

2. Radiotherapy equipment using radioactive sources must have at least two (2) control mechanisms allowing automatic return to a safe position and cessation of radiation exposure in case of an incident.

3. Remote radiotherapy equipment using radioactive sources and high-dose-rate (HDR) brachytherapy equipment must be designed to allow manual operation to bring the source back to the protective position in emergency situations. Gamma knife devices must have a mechanism to manually close the shielding window in emergency situations.

4. The source container of remote radiotherapy equipment using radioactive sources and the radioactive source container of high-dose-rate (HDR) brachytherapy equipment must bear clear and durable radiation warning signs according to established standards.

Article 7. Safety Requirements for Encapsulated Radioactive Sources and Radiopharmaceuticals

1. Encapsulated radioactive sources used in remote radiotherapy or high-dose-rate (HDR) brachytherapy equipment must comply with the international standard ISO 2919:2012 Radiation Protection - Encapsulated Radioactive Sources - General Requirements and Classification or the national standard TCVN 6853:2001 - Radiation Safety - Encapsulated Radioactive Sources - General Requirements and Classification, and if continued use beyond the recommended usage period by the manufacturer, they must undergo leakage testing to confirm that the source remains intact as designed. TCVN 6853:2001 - Radiation safety - Sealed radioactive sources - General requirements and classification and if continued use beyond the recommended usage period by the manufacturer, leakage radiation testing must be conducted to confirm that the source remains intact as designed.

2. Radiopharmaceuticals used in nuclear medicine must be legally permitted for circulation in Vietnam according to drug laws, and can only be used for preventive, curative, and functional adjustment purposes, and must comply with internationally recognized standards for the following parameters:

a) Nuclear purity (the percentage of the activity of the labeled radionuclide in the radiopharmaceutical compared to the total activity of all radionuclides in the radiopharmaceutical);

b) Specific activity (the activity of a specific radionuclide per unit mass of the labeled compound, including both bound and unbound forms within the radiopharmaceutical);

c) Chemical purity of the radiolabeled compound (the percentage of the radionuclide in the desired chemical form of the labeled compound compared to the total radionuclide in the radiopharmaceutical, focusing on radionuclides separated from the labeled compound);

d) Chemical purity (the ratio of the main labeled compound form not considering the radioactivity within it to the entire radiopharmaceutical preparation. A radiopharmaceutical preparation is the quantity of radiopharmaceutical ready for patient use);

đ) pH level;

e) Other parameters required for drugs under drug laws.

3. All radiopharmaceutical preparations must be clearly labeled with the following information:

a) Radionuclide isotope; chemical form (drug name and chemical formula);

b) Total activity of the preparation;

c) Date of activity measurement;

d) Measurement results of chemical impurity purity;

đ) Name, address of the manufacturer and date of manufacture;

e) Expiry date;

g) Batch or production run number;

h) Volume of the radiopharmaceutical preparation (in cases where it is a solution);

i) Other information required for drug labeling under drug laws.

Article 8. Safety Requirements for Radiation Measurement Equipment, Protective Devices, and Tools

1. Medical facilities using teletherapy equipment and brachytherapy equipment must be equipped with radiation dose rate measurement devices. Medical facilities using radioactive drugs (nuclear medicine facilities) must be equipped with radiation dose rate measurement devices and surface contamination measurement devices with energy ranges suitable for the type of radiation emitted from radiation sources and radioactive materials used at the facility to continuously monitor environmental radiation levels, radioactive contamination, and control radiation exposure when entering areas with radioactive sources.

2. Nuclear medicine facilities must be equipped with the following radiation safety protective devices and tools:

a) A fume hood with appropriate volume and suction capacity for preparing and dispensing radioactive drug doses;

b) A preparation table for radioactive drug doses with lead shielding combined with L-shaped beta radiation shielding material and a lead glass observation screen;

c) Grabbers and clamps for remote handling of radioactive sources;

d) Containers for radioactive drugs with lead shielding and outer layers designed to prevent breakage;

đ) Specialized trays for preparing and dispensing liquid radioactive drug doses;

e) Lead-shielded syringes specially designed for use in nuclear medicine;

g) Single-use automatic pipettes;

h) Tools for handling spilled radioactive substances.

3. Medical facilities using radioactive sources in brachytherapy must be equipped with the following radiation safety protective devices and tools:

a) An operation table for radioactive sources with L-shaped lead shielding and a lead glass observation screen;

b) Long-handled grabbers and clamps for handling radioactive sources;

c) Storage cabinets with separate compartments for storing radioactive sources of different activities;

d) Containers for transporting radioactive sources.

Article 9. Calibration and Verification of Radiation Equipment and Radiation Measurement Equipment

1. Medical facilities must perform calibration on radiation equipment used at their facilities as follows:

a) Before initial use;

b) Annually for teletherapy equipment, CT scanners, fluoroscopy X-ray machines, and every two years for other diagnostic X-ray equipment from the date of installation;

c) After reinstallation or repair of the equipment;

d) Teletherapy equipment, in addition to the calibrations specified in Points a, b, and c of this Clause, must also undergo radiation dose verification according to the frequency recommended by the manufacturer.

2. If calibration results show that operational parameters related to the safety of radiation equipment deviate from permissible values, the equipment must be recalibrated before it can be allowed to continue use; testing and calibration must be carried out according to procedures provided by the manufacturer or corresponding national standards.

3. Radiation measurement equipment (radiation dose rate measurement devices, surface contamination measurement devices, radioactivity dose calibrators) must undergo initial calibration, calibration after repair, and annual periodic calibration.

4. Calibration and verification of radiation equipment and radiation measurement equipment must be performed by organizations or individuals registered by the Ministry of Science and Technology to provide calibration and verification services.

Article 10. Radiation equipment rooms, radiation source workrooms and radiopharmaceuticals, radioactive source storage rooms or radioactive waste storage rooms, and patient rooms for radiation therapy

1. Radiation equipment rooms, radiation source workrooms and radiopharmaceuticals, radioactive source storage rooms or radioactive waste storage rooms, and patient rooms for radiation therapy shall not be located adjacent to obstetrics and pediatrics departments.

2. Radiation equipment rooms must ensure dimensions as prescribed in Appendix I attached hereto.

3. The protective thickness of walls, floors, ceilings, entry doors of radiation equipment rooms, and observation doors of control rooms must be designed according to the provisions of Article 7 of Circular No. 19/2012/TT-BKHCN dated November 18, 2012 issued by the Minister of Science and Technology on controlling and ensuring safety in occupational and public radiation exposure, and must ensure the potential radiation dose level of the working environment in reality (excluding natural background radiation) as follows:

a) In the control room or where the control cabinet of the radiation treatment device is placed, it shall not exceed 20 mSv/year;

b) At all locations outside the radiation treatment device room where the public walks or patients wait, it shall not exceed 1 mSv/year;

c) In the control room or where the control cabinet of the medical X-ray diagnostic equipment is placed (except for mobile X-ray devices), it shall not exceed 10 µSv/hour;

d) At all locations outside the medical X-ray diagnostic equipment room where the public walks, patients wait, and nearby workrooms, it shall not exceed 0.5 µSv/hour. In cases where the medical X-ray diagnostic equipment room is located within residential areas, adjacent to housing or workplaces, the radiation dose at all measurement points outside the room must equal the natural background radiation level.

4. The design of remote radiation therapy rooms and high-dose contact radiation therapy rooms, in addition to requirements for shielding radiation, must have interlocking door systems for entry doors to ensure that the radiation therapy device can only be activated when the entry door is fully closed and automatically stops radiation when the door is unexpectedly opened; there must also be a radiation level monitoring system and at least one emergency radiation cessation system installed in the room.

5. The design of radiation therapy rooms must be reviewed and licensed by the Radiation and Nuclear Safety Administration before construction according to the provisions of Circular No. 08/2010/TT-BKHCN dated July 22, 2010 issued by the Minister of Science and Technology guiding the declaration, issuance of radiation work permits, and certification of radiation workers.

6. Nuclear medicine facilities must have radiopharmaceutical storage and workrooms (dosing), patient rooms for oral or intravenous administration of radiopharmaceuticals, radioactive waste storage rooms, separate bathrooms for patients who have received radiopharmaceuticals, gamma camera equipment rooms, patient rooms if hyperthyroidism or thyroid cancer patients are treated, and washing areas for staff after handling radiopharmaceuticals. These rooms and areas must be designed to protect against external exposure and radioactive contamination as follows:

a) They must be designed to shield radiation so that the radiation dose levels where the public walk, patients wait, and nearby workrooms do not exceed 0.5 µSv/hour;

b) Floors and walls of rooms at risk of radioactive contamination must be covered with smooth, waterproof, and easily washable materials;

c) Wash basins for staff after handling radiopharmaceuticals must be equipped with automatic faucets or faucets operated by foot or elbow;

d) All contaminated radioactive wastewater must be collected through a dedicated drainage system and directed to a liquid radioactive waste treatment tank.

7. Radiation equipment rooms, radiation source workrooms and radiopharmaceuticals, patient rooms for nuclear medicine radiopharmaceutical ingestion or contact radiation therapy, and control rooms for radiation treatment equipment must be classified as controlled areas and the following measures must be applied:

a) A radiation warning sign as prescribed in Appendix II attached hereto must be placed above the entrance to the controlled area;

b) Warning lights must be installed at the entrances of radiation equipment rooms, contact radiation therapy implantation rooms, radiopharmaceutical preparation rooms, and must remain lit throughout the duration of radiation work;

c) Safety regulations must be posted at the entrance to the controlled area;

d) For remote radiation therapy rooms, high-dose contact radiation therapy rooms, patient rooms for radiopharmaceutical ingestion or contact radiation therapy implants, additional access prevention measures such as barriers, locked doors, or direct supervision by staff must be used.

8. Radioactive source storage rooms or radioactive waste storage rooms must be designed and apply the following control measures:

a) Ensure that the radiation dose level at all positions on the outer surface of the warehouse wall does not exceed 0.5 µSv/hour;

b) Place radiation warning signs as prescribed in Appendix II attached hereto at the warehouse entrance and the outer wall adjacent to areas with pedestrian traffic;

c) Apply surveillance measures to prevent unauthorized personnel from entering the warehouse.

Article 11. Installation of Radiation Equipment

The installation of radiation equipment must meet the following requirements:

1. Each room may only be installed with one piece of radiation equipment, except for diagnostic X-ray equipment which allows two pieces to be arranged in one room but must ensure that only one piece is operated at any given time.

2. Installed radiation equipment must ensure that the beam does not direct towards the control panel, entrance door, window, or public areas when in use.

3. The control panel for radiation equipment must be placed outside and adjacent to the room where the equipment is located, and must have means to observe patients and communication between the operator and patient. In cases where diagnostic X-ray equipment operates at less than 150 kV, the control panel may be placed within the room containing the equipment but must have lead shielding to ensure radiation levels at the position where staff operate the equipment are below 10 µSv/hour.

Article 12. Radiation Safety Regulations and Safe Operation of Radiation Equipment

1. Medical facilities must establish procedures for working with radiation equipment and radioactive sources, and radiation safety regulations ensuring the following requirements:

a) Procedures must clearly outline the steps for operating radiation equipment, working with radioactive sources, working in areas with risk of exposure or contamination from radioactive materials, caring for patients who have ingested radioactive medication or implanted radioactive sources; operational procedures for each device, treatment protocols for each type of disease;

b) Radiation safety regulations must clearly specify the requirements for protecting medical radiation workers, other medical facility staff, patients, caregivers or supporters of patients, and the public from radiation hazards.

2. Staff operating radiation equipment must strictly follow the procedural steps:

a) Conduct safety checks on the equipment before starting and after completing work;

b) Keep the entrance door closed throughout the operation of the equipment;

c) Adhere to the equipment operation procedures;

d) Pay attention to any unusual signals from the radiation equipment and monitoring devices to promptly detect incidents and prevent accidents;

e) Do not remove faulty components from the equipment's protective system and bypass them to operate, for example, bypassing the interlocking system for the entrance door of the radiotherapy room.

Article 13. Employment of Workers for Radiological Work

1. Medical facilities are responsible for arranging for female medical radiation workers to perform non-radiation related tasks during their pregnancy or while nursing children under 12 months old.

2. Medical facilities shall not employ individuals under 18 years old or those with contraindications to radiation to operate radiation equipment, work with radioactive sources, care for patients treated with radioactive isotopes or must work in areas with a potential radiation dose greater than 1 mSv/year or in areas with a risk of radioactive contamination.

3. Medical facilities employing trainees, interns, or students operating radiation equipment, working with radioactive sources, caring for patients treated with radioactive sources or radioactive drugs, working in areas with a potential radiation dose greater than 1 mSv/year or in areas with a risk of radioactive contamination must ensure:

a) Organize training for these individuals on basic radiation safety requirements, radiation safety regulations and rules of the facility;

b) Arrange specialized staff to guide, monitor, and supervise during work;

c) Apply dose control measures to ensure that the radiation dose received by these individuals does not exceed the dose limit specified in Appendix I of Circular No. 19/2012/TT-BKHCN dated November 18, 2012 issued by the Minister of Science and Technology on radiation protection and safety assurance in occupational and public radiation exposure.

Article 14. Radiation Safety Training

Medical facilities shall be responsible for training radiation safety for medical radiation workers, specifically as follows:

1. Organize radiation safety training for newly hired medical radiation workers according to the basic radiation safety training program prescribed by the Ministry of Science and Technology.

2. Periodically organize refresher and supplementary training on advanced knowledge and new information about radiation safety for medical radiation workers at least once every three years.

3. Annually organize training for medical radiation workers on radiation safety regulations, facility-specific rules related to ensuring radiation safety, emergency response procedures for radiation incidents, or disseminate new regulations and information on ensuring radiation safety.

4. Ensure that radiation safety training as stipulated in Clause 1 and 2 of this Article is conducted by organizations or individuals registered to provide radiation safety training services by the Ministry of Science and Technology.

5. Establish, update, and retain records of radiation safety training and instruction.

Article 15. Radiation Monitoring of Work Areas

1. Medical facilities must conduct environmental radiation monitoring in accordance with the following provisions:

a) Measure environmental radiation levels and establish investigation levels when preparing application files for radiation work permits;

b) Annually check radiation levels at positions where medical radiation workers operate, environmental radiation levels at entry points and surrounding areas of rooms housing radiation equipment, and storage locations for radioactive sources and radioactive waste;

c) Monthly monitor radioactive contamination levels at workplaces and surrounding environments for nuclear medicine facilities using radiopharmaceuticals for diagnosis and treatment;

d) Compare measured environmental radiation levels with established investigation levels and determine causes, applying corrective measures if the measurement results exceed the investigation levels.

2. Medical facilities must establish and retain records of environmental radiation monitoring results and inform medical radiation workers of these results.

Article 16. Monitoring and Evaluating Individual Dose Exposure

1. Medical facilities must implement individual dose exposure monitoring and evaluation for medical radiation workers, specifically as follows:

a) Equip personal dosimeters for medical radiation workers and conduct individual dose exposure measurements for medical radiation workers at least once every three months at a facility registered by the Ministry of Science and Technology to provide individual dose exposure measurement services;

b) Evaluate total individual dose exposure for medical radiation workers who come into contact with open radioactive sources (radiopharmaceuticals, contaminated objects, radioactive waste) by summing external dose (based on personal dosimeter readings) and internal dose (measured directly or estimated based on workplace radiation background, air radioactivity concentration, workplace contamination levels, working time, and work procedures);

c) Facilities using interventional X-ray equipment must equip each person working directly in the room housing the equipment (equipment operators, doctors, technicians, nurses, attendants) with two personal dosimeters, one worn inside a lead apron at waist level and another worn outside the apron at neck level to accurately assess individual dose exposure for these personnel according to the formula: Effective Dose = 0.5 HW + 0.025 HN Where HW is the reading from the dosimeter worn inside the lead apron, and HN is the reading from the dosimeter worn outside the lead apron;

d) If the effective dose due to external exposure for X-ray diagnostic equipment operators and radiation therapy equipment operators, or the total effective dose (including both external and internal exposure) for medical radiation workers handling open radioactive sources exceeds the established investigation levels, re-evaluate work procedures, radiation protection measures, and take corrective actions;

e) Guide and inspect to ensure that medical radiation workers wear personal dosimeters and store them properly according to the service provider's instructions;

f) In case a medical radiation worker loses or damages their personal dosimeter, immediately replace it and evaluate the individual dose exposure during the period without wearing a dosimeter based on actual working hours or the usual dose expected during that period from previous measurements;

g) Inform medical radiation workers of their individual dose exposure measurement results;

h) Establish, retain, and manage individual dose exposure records for medical radiation workers in accordance with Article 17 of Circular No. 19/2012/TT-BKHCN dated November 8, 2012, issued by the Minister of Science and Technology on controlling and ensuring radiation safety in occupational and public radiation exposure.

2. In cases where medical radiation workers simultaneously work for multiple medical facilities, each facility must separately monitor and evaluate individual dose exposure for such workers in accordance with Clause 1 of this Article related to radiation work performed at that facility; Medical radiation workers must ensure that their total occupational dose exposure from all radiation work at different facilities does not exceed the occupational dose limit for radiation workers specified in Appendix I of Circular No. 19/2012/TT-BKHCN dated November 8, 2012, issued by the Minister of Science and Technology on controlling and ensuring radiation safety in occupational and public radiation exposure.

Article 17. Personal Protective Equipment

Medical facilities must provide sufficient personal protective equipment and protective devices for medical radiation workers, specifically:

1. Lead aprons for staff operating panoramic dental X-ray machines, skull X-ray machines, general X-ray machines, fluoroscopy machines, and CT scanners.

2. Lead aprons and thyroid shields for staff operating mobile X-ray machines.

3. Lead aprons, thyroid shields, lead glasses, and lead gloves for staff operating interventional X-ray machines, doctors, and personnel working in rooms with interventional X-ray and angiography equipment.

4. Radiation protection clothing, gloves, head covers, masks, and protective footwear or foot coverings for medical radiation workers who come into contact with open radioactive sources (radioactive drugs, contaminated objects, radioactive waste).

5. Lead barriers to shield staff when they come into contact with patients who have used radioactive drugs or implanted radioactive sources.

Article 18. Health Examination for Medical Radiation Workers

1. Annually, medical facilities must organize health examinations for medical radiation workers in accordance with Circular No. 19/2011/TT-BYT dated June 6, 2011, issued by the Minister of Health, guiding occupational health management, occupational diseases, employee health care, and occupational health check-ups.

2. Medical facilities are responsible for arranging for medical radiation workers who do not meet health requirements to perform other jobs that do not involve radiation exposure.

3. Medical facilities must establish, retain, and manage health examination records of medical radiation workers in accordance with Article 17 of Circular No. 19/2012/TT-BKHCN dated November 8, 2012, issued by the Minister of Science and Technology, regarding radiation safety control and assurance in occupational and public radiation exposure.

Article 19. Internal Inspection and Supervision

1. Medical facilities must develop plans and organize internal inspections and supervision of the implementation of regulations, radiation safety rules, and work procedures.

2. Medical facilities must ensure that any deficiencies in radiation safety management identified through inspections are reviewed and corrected.

3. Annually, medical facilities must review contents related to radiation safety management in accordance with Article 18 of Circular No. 19/2012/TT-BKHCN dated November 8, 2012, issued by the Minister of Science and Technology, regarding radiation safety control and assurance in occupational and public radiation exposure.

4. The results of internal inspections and supervision must be recorded in minutes and retained in the radiation safety file.

Article 20. Radiation Control in Medical Imaging

1. The treating physician is responsible for ensuring radiation safety for patients and has the responsibility to:

a) Prescribe diagnostic or therapeutic procedures using ionizing radiation only when it is certain that the benefits outweigh the risks to the patient;

b) When two methods yield similar results, do not prescribe the method involving ionizing radiation;

c) Special consideration must be given when prescribing diagnostic or therapeutic procedures using ionizing radiation for children, women of reproductive age, pregnant women, or women nursing infants under 12 months old, specifically:

- Ask the patient and conduct tests to confirm that they are not pregnant or nursing an infant under 12 months old (in cases where radioactive drugs are prescribed) before prescribing diagnostic or therapeutic procedures;

- Avoid prescribing diagnostic or therapeutic procedures using ionizing radiation for pregnant women, suspected pregnant women, or women nursing infants under 12 months old (when using radioactive drugs) unless clinically necessary. In such cases, inform medical staff and equipment operators to take appropriate protective measures for the patient;

- Only use radioactive drugs for children if clinically necessary and reduce the prescribed radioactivity dose.

d) Review previous medical records to avoid unnecessary additional tests;

e) Prescribe the lowest possible radiation dose or radioactive drug dosage sufficient to achieve the diagnostic or therapeutic goal based on the radiation levels specified in Appendix III attached to this Joint Circular.

2. Medical staff and radiation equipment operators have the responsibility to ensure radiation safety for patients during their duties as follows:

a) Ensure that all medical imaging procedures are performed only upon prescription by the treating physician and strictly follow the physician's instructions;

b) Ensure that the equipment used is appropriate.

3. Personnel operating diagnostic X-ray equipment, in addition to the general responsibilities for protecting patients as stipulated in Clause 2 of this Article, must implement measures to protect patients as follows:

a) Ensure that imaging procedures are conducted according to established equipment operation protocols;

b) Use collimation structures appropriately to minimize patient radiation dose while maintaining image quality suitable for diagnosis in X-ray imaging;

c) Avoid irradiating sensitive areas of the body such as reproductive organs, lenses of the eyes, breasts, and thyroid glands, and use appropriate shielding measures when avoidance is not possible;

d) Avoid irradiating the abdomen and pelvic regions of pregnant or suspected pregnant women except for clinical necessity and apply measures to minimize radiation exposure to the fetus;

e) Do not allow patients and non-staff members to wait in the X-ray room while another patient is being imaged.

4. Medical staff and radiation therapy equipment operators, in addition to the general responsibilities for protecting patients as stipulated in Clause 2 of this Article, must apply measures to keep radiation doses to healthy tissues as low as possible while achieving the therapeutic goals.

5. Medical staff and radiopharmaceutical dosing technicians in nuclear medicine must ensure that the dose of radioactive drugs is accurately administered according to the physician's prescription.

6. Healthcare facilities using radioactive drugs for treatment, if they have patients who have used radioactive drugs staying, must ensure that each room accommodates only one patient. In cases where multiple patients must be placed in the same room, mobile lead shields must be used to protect them from radiation exposure from other patients.

7. Healthcare facilities must establish a specific quality assurance program for medical radiation including the following contents:

a) Ensuring that radiation equipment and standard dosimeters for measuring radioactive drugs are calibrated and verified in accordance with Article 9 of this Joint Circular;

b) Establishing parameters and optimal conditions for using radiation equipment to serve as reference values for calibration and verification.

8. Healthcare facilities are responsible for ensuring radiation safety for caregivers assisting patients undergoing ionizing radiation diagnosis or treatment through the following measures:

a) Providing basic guidance on radiation safety procedures before allowing them to participate in such activities;

b) Supplying appropriate protective equipment to reduce radiation dose;

c) Monitoring to ensure that the radiation dose these individuals receive during the patient's diagnostic or treatment period does not exceed 5 mSv.

9. Healthcare facilities must conduct investigations, implement corrective measures, and document all cases of medical radiation incidents causing or potentially leading to radiation doses exceeding the expected levels for patients.

Article 21. Public Radiation Control

Healthcare facilities must comply with the following requirements to ensure public safety:

1. Implement control measures to allow only necessary radiation medical staff and designated helpers to remain in examination and treatment rooms during radiation exposure.

2. Implement measures to prevent unauthorized personnel from entering areas containing radiation equipment, radioactive materials, rooms housing patients treated with radioactive drugs, or implanted radioactive sources.

3. Only permit patients treated with radioactive drugs to be discharged home when their residual radioactivity level does not exceed 400 MBq.

4. Surrounding areas including workrooms, corridors, hallways, or restrooms, and other areas with frequent movement must apply the following protective measures:

a) Monitor radiation levels to ensure there are no changes during operations;

b) Use radiation warning signs (warning boards, warning lights, warning signals) and restrict access to these areas.

Article 22. Response to Radiation Incidents

1. Healthcare facilities using radioactive sources and radiation equipment must develop and approve a facility-level radiation incident response plan in accordance with Circular No. 24/2012/TT-BKHCN dated December 4, 2012, issued by the Minister of Science and Technology guiding the development and approval of facility-level and provincial-level radiation incident and nuclear accident response plans, and the specific requirements stipulated in Clauses 2, 3, and 4 of this Article.

2. Healthcare facilities using X-ray diagnostic imaging equipment must develop a radiation incident response plan with the following specific requirements:

a) Specify and monitor preventive measures to avoid the following incidents:

- Unauthorized personnel remaining in the room with the equipment while it is operational;

- Operators setting incorrect modes, performing incorrect imaging as per the physician's prescription, or imaging the wrong patient;

- Equipment malfunction resulting in unintended radiation exposure requiring repeat imaging.

b) Specify procedures for investigating and assessing radiation dose and monitoring health status for interventional X-ray patients exposed to significantly higher doses than prescribed; investigate and assess radiation dose and monitor health status for radiation medical staff exposed beyond the specified dose limits;

c) Specify reporting responsibilities for incidents mentioned in Point a and significant overexposure cases mentioned in Point b of this Clause;

d) Specify procedures for documenting and retaining records of incidents occurring.

3. Healthcare facilities using radioactive drugs for diagnosis and treatment must develop a radiation incident response plan with the following specific requirements:

a) Specify measures to prevent incidents and response procedures for the following situations:

- Loss of radioactive drugs;

- Spillage of radioactive drugs causing contamination;

- Unauthorized personnel remaining in the room where radioactive drug dosing is being performed;

- Incorrect dosage, type of radioactive drug, patient, or incorrect dosimetry;

- Fire or explosion in the storage room for radioactive drugs or radioactive waste;

- Breakage or leakage of liquid radioactive waste storage tanks.

b) Specify procedures for investigating and assessing absorbed dose and monitoring health status for patients mistakenly given or injected with radioactive drugs at significantly higher doses than prescribed; investigate and assess radiation dose and monitor health status for radiation medical staff exposed beyond the specified dose limits; investigate and assess the impact on the public and environment in incident scenarios;

c) Specify reporting responsibilities for incidents mentioned in Point a and significant overexposure cases mentioned in Point b of this Clause;

d) Specify procedures for documenting and retaining records of incidents occurring;

đ) Specify procedures for conducting emergency response drills.

4. Healthcare facilities using radiation therapy equipment and sealed radioactive sources for radiation therapy must develop a radiation incident response plan with the following specific requirements:

a) Specify measures to prevent incidents and response procedures for the following situations:

- Loss of radioactive sources;

- Sealed sources unable to return to a safe position due to equipment failure;

- Leakage or breakage of sealed sources causing contamination;

- Fire or explosion in the room housing radiation therapy equipment or storage room for radioactive sources.

- Persons without authorization being present in the radiation therapy room during patient radiation therapy; 

- Radiation incidents involving patients: irradiating the wrong patient, irradiating the wrong tissue, incorrect treatment planning, actual radiation dose exceeding the prescribed dose.

b) Provisions on the investigation and assessment of radiation doses, dose distribution in the patient's body, and monitoring the health status of the patient in cases of radiation incidents involving patients; investigation and assessment of radiation doses and monitoring the health status of medical radiation workers in situations where they are exposed to radiation levels exceeding the specified limits; investigation and assessment of the impact on the public and the environment in cases of incidents;

c) Provisions regarding the responsibility for reporting when incidents as stipulated in Point a occur and in cases of radiation incidents as stipulated in Point b of this Clause;

d) Specify procedures for documenting and retaining records of incidents occurring;

đ) Specify procedures for conducting emergency response drills.

Article 23. Management of radioactive waste and used sealed radioactive sources

1. Radioactive waste generated from activities using radioactive materials in healthcare facilities (including contaminated radioactive wastewater from preparation rooms, radioactive drug dosing rooms; water used to wash bottles and tools used with radioactive drugs; wastewater from toilets used by patients who have taken radioactive drugs; contaminated radioactive wipes, syringes, and needles used for radioactive drugs that are discarded; packaging and bottles containing discarded radioactive drugs; contaminated clothing and shoes from radioactive substances and other discarded radioactive-contaminated objects) must be collected, stored, treated, and disposed of according to regulations on radioactive waste management issued by the Ministry of Science and Technology.

2. Solid radioactive waste (including contaminated radioactive wipes; discarded syringes and needles used for radioactive drugs; packaging and bottles containing discarded radioactive drugs; contaminated clothing and shoes from radioactive substances and other discarded radioactive-contaminated objects) in addition to being managed safely as provided for in Clause 1 of this Article, must also be managed in accordance with Decision No. 43/2007/QD-BYT dated November 30, 2007 of the Minister of Health on the issuance of regulations on the management of medical waste.

3. Used sealed radioactive sources (including expired sealed radioactive sources from remote radiation therapy equipment, non-used sealed radioactive sources in close radiation therapy, and other sealed radioactive sources used for equipment calibration and research that are no longer in use) must be managed and stored according to regulations on the management of used sealed radioactive sources issued by the Ministry of Science and Technology.

Article 24. Radiation Safety Records

Healthcare facilities are responsible for establishing, retaining, and managing records related to radiation safety in accordance with Article 17 of Circular No. 19/2012/TT-BKHCN dated November 8, 2012 of the Minister of Science and Technology on the control and assurance of radiation safety in occupational and public radiation exposure.

Chapter III

RESPONSIBILITY FOR RADIATION SAFETY

Article 25. Responsibilities of Healthcare Facilities and Heads of Healthcare Facilities

1. Healthcare facilities using radiation equipment, radioactive sources, and radioactive drugs must comply with radiation safety requirements stipulated in this Joint Circular and other current regulatory legal documents relevant to radiation safety.

2. Healthcare facilities using radiation equipment, radioactive sources, and radioactive drugs may only conduct radiation medical activities after obtaining a permit from the competent authority to carry out radiation work.

3. The head of a healthcare facility must bear ultimate responsibility for ensuring radiation safety for medical radiation workers, other staff within the facility, the public, and the surrounding environment, with specific responsibilities as follows:

a) Being thoroughly familiar with and strictly implementing legal provisions on radiation safety and radiation safety requirements stipulated in this Joint Circular;

b) Announcing the facility's policy on radiation safety, affirming its commitment to safety measures, and providing priority conditions for the implementation of radiation safety measures;

c) Appointing a radiation safety officer; clearly defining the functions, duties, and authority of the radiation safety officer; providing sufficient time and financial resources for the radiation safety officer to fulfill their responsibilities;

d) Creating conditions for inspection teams and inspectors to perform their specialized radiation safety and nuclear inspection tasks; providing all necessary information upon request;

e) Assigning alternative work unrelated to radiation to pregnant female medical radiation workers upon receipt of a written notification from such workers.

Article 26. Responsibilities of the Radiation Safety Officer

1. The Radiation Safety Officer must be a person directly conducting radiation work, possessing specialized knowledge, thoroughly trained in regulations on ensuring radiation safety in healthcare, laws on ensuring radiation safety, and nuclear security, and holding a radiation worker certificate issued by the Radiation and Nuclear Safety Agency under the Ministry of Science and Technology or the Department of Science and Technology of provinces and centrally governed cities.

2. The Radiation Safety Officer shall have the responsibility to assist the head of the medical facility in implementing legal provisions and requirements stipulated in this Circular regarding ensuring radiation safety, including:

a) Implementing technical measures and administrative controls to ensure safe working conditions for employees and public safety appropriate to the ongoing radiation work at the facility;

b) Fulfilling requirements for declaration, issuance, and renewal of permits as prescribed by law;

c) Being accountable to the head of the facility and jointly bearing legal responsibility with the head of the facility when a radiation incident occurs or legal provisions are violated;

d) Advising the head of the medical facility to arrange alternative work suitable and unrelated to radiation for pregnant female radiation workers upon receiving a written notification.

3. The Radiation Safety Officer has the authority to halt ongoing radiation work if signs or risks of compromising safety are detected.

Article 27. Responsibilities of Medical Radiation Workers

1. Medical radiation workers must be trained and certified by authorized agencies with qualifications and vocational training certificates appropriate to their radiation work.

2. Medical radiation workers shall have the responsibility to:

a) Participate in radiation safety training as required by the Radiation Safety Officer;

b) Only participate in radiation work or perform tasks with radiation exposure risk after being trained and mastering legal requirements for ensuring radiation safety, radiation protection measures, and only operate radiation equipment and devices used in nuclear medicine if they hold a workplace safety card;

c) Strictly follow internal rules, work procedures, and radiation safety guidelines of the unit;

d) Use personal protective equipment, personal dose meters, radiation measuring devices, and tools for handling radioactive sources according to instructions;

e) Cooperate with the Radiation Safety Officer to strictly implement annual health check-ups and personal dose assessments as prescribed;

f) Report immediately to the Radiation Safety Officer or the head of the medical facility any unusual radiation safety incidents, loss of radioactive sources, and participate in remediation of radiation incidents when requested.

3. Pregnant female medical radiation workers must notify the Radiation Safety Officer and the head of the facility in writing to be assigned alternative work unrelated to radiation.

Article 28. Responsibilities of State Agencies with Competent Authority in Healthcare

1. The Department of Medical Examination and Treatment under the Ministry of Health shall coordinate with relevant units to direct and inspect radiation safety work at medical facilities nationwide.

2. Provincial and centrally governed city Health Departments shall be responsible for urging, inspecting, and monitoring compliance with radiation safety regulations by medical facilities within their jurisdiction. The Military Medical Service under the Ministry of National Defense shall be responsible for managing, inspecting, and monitoring compliance with radiation safety regulations by military medical facilities throughout the country.

Article 29. Responsibilities of the Radiation and Nuclear Safety Management Agency

1. The Radiation and Nuclear Safety Agency under the Ministry of Science and Technology shall be responsible for managing radiation safety at healthcare facilities nationwide, including:

a) Receiving declarations regarding diagnostic radiographic equipment, radiotherapy equipment, sealed radioactive sources, and radioactive drugs;

b) Reviewing safety, issuing permits for radiation work involving the use of diagnostic radiographic equipment; operating radiotherapy equipment; storing and using radioactive sources and radioactive drugs; processing and storing used sealed radioactive sources; constructing, changing the scale and scope of operation of radiotherapy facilities; ceasing operations of radiotherapy facilities; and issuing radiation worker certificates within its authority;

c) Inspecting compliance with legal regulations on ensuring radiation safety in healthcare and handling violations.

2. Provincial Departments of Science and Technology shall be responsible for managing radiation safety at healthcare facilities operating within their jurisdiction, including:

a) Receiving declarations regarding medical X-ray diagnostic equipment;

b) Reviewing safety, issuing permits for radiation work involving the use of medical X-ray diagnostic equipment, and issuing radiation worker certificates to the safety managers of healthcare facilities within their authority;

c) Inspecting compliance with legal regulations on ensuring radiation safety in healthcare for healthcare facilities operating within their jurisdiction and handling violations;

d) Cooperating with the Military Medical Department under the Ministry of National Defense in reviewing safety, issuing permits for radiation work, and inspecting and supervising the use of medical X-ray diagnostic equipment at military healthcare facilities within their jurisdiction.

Chapter IV

IMPLEMENTING PROVISIONS

Article 30. Application of Referenced Documents

In cases where legal regulatory documents, technical standards, or standards referenced in this Circular are amended, supplemented, or replaced, they shall be applied according to the amended, supplemented, or replacement documents.

Article 31. Effective Date

1. This Circular takes effect from July 25, 2014.

2. Circular Jointly Issued No. 2237/1999/TTLT-BKHCNMT-BYT dated December 28, 1999 of the Ministry of Science, Technology, and Environment and the Ministry of Health guiding the implementation of radiation safety in healthcare shall cease to be effective from the date this Circular takes effect.

During the implementation process, if there are any difficulties, it is requested that agencies, organizations, and individuals promptly report them to the Ministry of Science and Technology and the Ministry of Health for consideration and resolution./.