Laws of Vietnam

d) When calculating and designing the walls with proper thickness, the floor, ceiling and door of the room where radiation equipment is installed, attention shall be paid to the parameters of the equipment (electric voltage, electric current or radiant intensity of the source), the equipment usage coefficient, the special occupation coefficient of each area outside the radiation equipment room in order to ensure that the annual limited dose for population outside the room is kept at 1mSv.

e) The equipment is shielded off in order to ensure that the annual limited dose for personnel operating the machine shall not exceed 20mSv.

1. Radiation equipment arrangement:

a) Each room is furnished with one radiation equipment. Where a room is furnished with two X-ray machines, such two machines must not operate simultaneously at a time. The radiation equipment must be installed in a way that when it operates, the radiation rays are not directed at the control cabinet, doors, windows or crowded places.

b) The control cabinet must be placed outside, close to the radiation equipment room, and must be equipped with device to monitor patients and device for communication between the operators and patients. Particularly for X-ray equipment operating at a voltage lower than 150kV, the control cabinet may be placed inside the equipment room but must be shielded off with lead screen.

2. The radiotherapy equipment room must be furnished with automatic control device to alarm the unusual status when using the equipment.

3. The passage to the place where the radio-teletherapy equipment is installed must be designed in zigzag.

4. The door of the radio-teletherapy room must be equipped with combined automatic lock in order to ensure that:

a) The radiotherapy equipment can start only when the door is completely closed.

b) The radiation shall automatically terminate when the door is suddenly opened.

5. Warning signals:

a) Placed above the door of the radiation equipment room is a red lamp which illuminates when the radiation equipment starts operating.

b) Placed above the door of the radiation equipment room is a radiation warning signboard (Appendix 5).

VI. GENERAL REQUIREMENTS TO ENSURE RADIATION SAFETY FOR NUCLEAR MEDICINE DEPARTMENTS

1. The nuclear medicine department must be separated from other departments so that people entering other departments must not pass through the former.

On the passage leading to this department, there must be a radiation warning signboard (Appendix 5).

2. The department’s rooms shall be arranged according to the principle of lower and lower radiation dose from inside to outside or from lower to upper storey if the department occupies many storeys (radioactive pharmaceutical substance storehouse and the radioactive pharmaceutical preparations room are arranged innermost). Rooms with open radioactive sources are arranged successively in order to avoid large-scale radioactive contamination.

3. Requirements on rooms with open radioactive sources:

a) Being well ventilated.

b) Their wall thickness, floor, ceiling, door must be calculated and made like those of radiation equipment rooms to shield off radiation with a view to keeping the annual limited dose for population outside the room at 1mSv. The wall shall not be rough and must be coated with an water-proof layer easy for radiation erasing.

c) The room’s floor should be coated with an water-proof layer, with water drainage conduit to radioactive waste water ditch.

d) The surface of radioactive source desk must be made of smooth materials non-absorbing of radioactive substance, non-cracked and easy for radiation erasing.

e) The cleaning basin shall be furnished with tap(s) which can be operated with foot or elbow or automatically.

f) Being furnished with dust-cleaning cabinet of the type used exclusively for work involving radioactive substances emitting vital force.

g) Shielded pincers or syringes must be used to reduce doses on hand.

4. Being equipped with at least the following measuring instruments:

- The radioactive pharmaceuticals dosemeter.

- The dose-ration meter with appropriate precision.

- The surface contamination detector, with enough sensitivity to emitting radiation.

5. The open radioactive sources must be preserved in separate storehouses with locks. Places for preserving open radioactive sources such as niches, wardrobes should be designed with may drawers so that when putting in or taking out of such drawers radioactive substances, personnel shall not be subject to radiation from other drawers. Each drawer is made with a separate door with label inscribing clearly the name and intensity of each radioactive isotope therein. The radioactive isotopes must be kept in solid packages (glass containers, plastic containers, metal containers). The taking out and putting in of radioactive isotopes must be recorded in diary for monitoring.

6. There must be rooms for confinement of patients who have used radioactive drugs. Such rooms must be shielded off to keep the outside dose within the annual dose limit for population (1mSv/year). Each room shall confine one patient. In cases where many patients are confined in a room, there must be mobile lead screens to shield off radiation from one patient to another.

Also there must be mobile lead screens to shield personnel when contacting patients.

Patients shall be discharged from hospitals only when the intensity of radioactive substance in their bodies reduces to below the prescribed limits (Appendix 6).

7. Radioactive contamination, when it occurs, must be done away with.

Areas contaminated with radioactive dusts must be cleansed from the outside inward in order to minimize the spread of contamination.

The persons in charge of radiation safety must be present when the radioactive decontamination is carried out.

VII. MANAGEMENT OF RADIOACTIVE WASTES

1. Radioactive wastes in gaseous, liquid or solid form shall be discharged into the environment only after they are inspected and reach the permitted limits prescribed by the Ministry of Science, Technology and Environment.

2. The closed sources used in radiotherapy, after becoming radioactive wastes at the end of its utility, must be preserved at separate storehouses shielded to keep off radiation and protect against stealing.

3. Radioactive wastes with short-term deactivation cycle (under 30 days) and with the general intensity or separate intensity being higher than the immunity level must be kept at establishments within a period of time necessary for their self-deactivation to the permitted levels before they are discharged into the environment. More concretely:

a) For liquid wastes: The liquid waste (including excreta of patients having used radioactive pharmaceuticals shall be led into either of 2 underground tanks which are unconnected to each other, tight-close enough to prevent liquids from penetrating outside and to shield off radiation, and large enough to hold the liquid wastes within necessary period of time (10 semi-deactivation cycles of the longest alive isotope among the discharged isotopes). One tank takes in liquid radioactive wastes discharged daily while the other tank is used for storing liquid radioactive wastes awaiting to be discharged into the environment or the liquid wastes are gathered then diluted with ordinary waste water in the mixing tank according to the regulations of the Ministry of Science, Technology and Environment.

b) For solid wastes: Solid materials radioactively contaminated: injection ampoules, broken glass… shall be gathered into plastic bags placed into metal barrels which is closed and opened by foot. Daily, these bags are brought into either of the two separate tanks like for liquid wastes. These tanks are built in separate areas, shielded off and protected till the radioactive substances disintegrate to below the prescribed level, then the bags are discharged into environment like ordinary garbage.

4. The management of small animal bodies containing radioactive elements in laboratories shall comply with the separate regulations.

VIII. QUALITY CONTROL AND RECTIFICATION OF RADIATION EQUIPMENT, MEASUREMENT OF CLINICAL DOSES, ASSURANCE OF MEDICAL RADIATION QUALITY

1. Radioactive sources and radiation equipment used in the medical service must be quality-controlled and rectified once a year. After they are installed or repaired, they must be rectified before being put into use. The establishments conducting the quality control and rectification of radiation equipment shall be appointed by the Ministry of Science, Technology and Environment, (which must satisfy the conditions on personnel qualified for radiation safety operation and equipment...).

2. The typical values of the parameters of clinical doses of patients must be determined and kept in dossiers.

3. The radiation sections, apart from observing the regulations on ensuring the quality of radiation safety management, shall have to work out a program on ensuring the specific quality for medical radiation, which involves specialists with appropriate qualifications in relevant fields such as radioactive physiotherapy, radioactive pharmaceuticals, and shall have to comply with the principles set by the Ministry of Health and World Health Organization (WHO).

4. The medical radiation ensuring programs must include:

a) The annual measurement of physio-parameters of radiation equipment from the beginning and during their subsequent use.

b) Examination of physio-clinical elements in diagnosis and treatment of patients.

c) Archiving of records on relevant processes and results.

d) Examination of rectification, conditions for operation and dose-measuring and radioactive inspection devices.

e) Reevaluation of results of independent and regular inspection of quality of the program on ensuring the quality of radiotherapy processes.

IX. REQUIREMENTS WHEN CONDUCTING MEDICAL RADIATION

1. General provisions.

a) Every medical radiation must be considered on the basis of comparing it with other methods in term of the profits and losses it results in or brought about by the doctors’ prescriptions. When two therapeutic methods result in the same effect, the radioactive therapy method shall not be used.

b) Only one patient and, if necessary, several persons assisting him/her, are allowed to stay in the radiation room.

2. Radioscopy and photography for medical examination and treatment

a) Doctors or technicians conducting radioscopy and photography shall have to:

- Ensure that the equipment are suitable.

- Select working parameters so that the entire combined work only creates a minimum radiation dose for the patient but the image quality still meets the requirement of diagnosis; special attention should be paid to this when radioscopy and/or photography are performed on children.

- Refer to information from previous examinations in order to avoid repeated radioscopy or photography if not necessary.

b) Portable or mobile radioscopy and photography equipment shall be used only when patients can not be transferred to fixed establishments due to their conditions or other practical conditions and only after safety measures are taken for the use of equipment.

c) To avoid radiation on the belly area and basin area of women who are pregnant or suspected to be pregnant, except where it must be done so due to clinical reasons; for such case, necessary measures should be applied in order to create the minimum dose for the fetus.

d) Patients’ organs which are sensitive to radiation (such as gonad, crystalline lens, nipple, thyroid gland) must be properly shielded off.

3. Medical examination and treatment in nuclear medicine.

a) Doctors prescribing the medical examination and/or treatment with radioactive substances shall have to:

- Ensure that the dose for the patient is minimum but strong enough to achieve the diagnostic and therapeutic objectives.

- Refer to information from the previous examinations so as to avoid unnecessary additional examination.

- Refer to the radioactive intensity prescribed for medical radiation by domestic and foreign agencies such as IAEA, WHO…

b) To avoid using radioactive substances to give medical examination to women who are pregnant or suspected of being pregnant, except where it must be done so due to clinical prescription.

c) For nursing women, the breast-feeding of their children should be temporarily ceased until the radioactive drugs no longer affect the children.

d) Radioactive pharmaceuticals shall be used for examination of babies only when it must be so due to the clinical prescription and the prescribed radioactive intensity must be reduced according to stipulations.

e) Patients must be notified of possible risks which may entail when radioactive substances are used.

4. Assistance to patients, subjected to radiation.

a) No one is allowed to stay in the examination or therapy rooms during the radiation period, except for necessary radiation personnel and persons permitted to assist the patients when they are given medical examination and/or treatment.

b) Pregnant women and persons aged under 18 are not allowed to assist patients when the latter are given radiation.

c) Persons who assist the patients being exposed to radiation must put on appropriate protection devices (rubber-lead napkins, rubber-lead gloves, protection overalls, lead screens). Even when they are equipped with protection devices, not any part of their bodies shall be on the way of the streams of useful rays.

d) Persons tending or assisting patients who are subject to radiation or use radioactive drugs must be dose-controlled.

X. SAFETY IN TRANSPORTATION OF RADIATION EQUIPMENT

1. Radiation sections must elaborate and promulgate the rules on the use of machinery rooms, processes for operation of each equipment, therapy diagram for each kind of illness in order to ensure safety for radiation personnel and patients.

2. Radiation personnel shall have to:

- Check the source safety before operating the equipment and after the completion of work.

- Close the doors throughout the process of operating the machines.

- Abide by the processes of operating the machines.

- Pay attention to unusual signals or assorted equipment so as to timely detect incidents and ward off accidents.

- Not to disassemble out-of-order parts in the in-depth protection system for manual operation.

- Archive data on operation.

- Immediately notify the manager of the radiation section or the person in charge of radiation safety of the loss of radiation source, if detected, the possible occurrence of radiation incidents. Within the scope of their responsibility, to participate in overcoming the radiation incidents.

- Use radiation safety means suitable to work.

3. Equipment of radiation safety means.

- Each radiation section should be equipped with radiation control devices suitable to its radiation equipment.

- Persons working directly on radiation sources must be equipped with necessary protection means such as lead screens, rubber-lead napkins, rubber-lead gloves, protection glasses, laboratory overalls, shoes, appropriate personal dosemeters, lead containers to store radioactive isotopes on transport.

- The medical establishment managers shall ensure the adequate supply of such means.

XI. INVESTIGATION OF MEDICAL RADIATION-RELATED ACCIDENTS CAUSED TO PATIENTS

1. The radiation section managers shall have to immediately investigate the following incidents:

a) Conducting radiotherapy on the wrong patients, wrong parts, with wrong radioactive drugs and wrong doses with value remarkably different from the value prescribed by doctors.

b) The radio diagnostic dose is much greater than the prescribed level or the repeated radio diagnostic dose greatly exceeds the prescribed level.

c) Any damage of equipment, any accident, accidental errors and all other contingencies which may expose the patients to radiation doses in great excess of the prescribed level.

2. After investigating the above-said incidents, the radiation section managers shall have to:

a) Organize the recalculation or re-evaluation of doses received from patients.

b) Work out remedial measures to treat and save the patients and to prevent re-occurence of incident.

c) Immediately report in writing to the superior agencies after investigating and making conclusion on the causes of the incidents. In case of serious consequences, to report them to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

d) Inform patients of the incidents.

XII. ARCHIVE

1. The radiation sections shall have to preserve and archive the following records on patients for at least five years:

a) In radioactive diagnosis: necessary information (electric voltage, electric current, duration) for subsequent evaluation of doses, including the number of radioscopies, the date of radioscopy and/or photography.

b) In nuclear medicine: Assorted radioactive drugs already used and their radioactive intensity, their use date.

c) In radiotherapy: Description of radiated areas, dose at focal point of the radiated area, doses at other related organs, the number of radioscopies, the date of radioscopy.

2. The radiation sections shall have to keep the results of machine rectification, periodical examinations, relevant physio-parameters selected in radiotherapy for at least five years.

3. The duration of archiving health records and standard dose records of radiation personnel shall comply with the provisions at Clause 5, Article 9 of Decree No.50/1998/ND-CP of July 16, 1998 of the Government.

XIII. ORGANIZATION OF IMPLEMENTATION

1. The Science, Technology and Environment Services of the provinces and centrally-run cities shall perform the State management function in supervising and inspecting the observance of radiation safety at radiation sections in their respective localities.

2. The radiation sections which have already put into operation or are storing or using radiation equipment, closed radioactive sources, open radioactive source and/or radioactive wastes before the issuance of this circular, shall, within 90 days after the circular takes effect, have to fill in the procedures for declaration, then the procedures to apply for the permits as provided for at Section III of this Circular.

Pending the granting of permits, such radiation sections may continue using the above-mentioned radiation equipment and radioactive substances.

Within three years after the circular takes effect, any radiation sections which still fail to meet the conditions prescribed in Sections II, IV, V, VI, VII, VIII, X and XII shall have to comply with the provisions of this Circular.

3. The Health Ministry shall nominate medical examination and treatment establishments to monitor the health of patients who have been over-X rayed and suffered from disease caused by radiation.

4. After the private and/or foreign-invested radiation establishments obtain all radiation safety permits as provided for in Section III of this Circular, the Health Ministry or the provincial/municipal Health Services shall consider the granting of certificates of law-prescribed qualifications and conditions for the practice of private medical and pharmaceutical occupations as well as for foreign-invested medical examination and treatment.

XIV. IMPLEMENTATION EFFECT

This Circular takes effect 15 days after its signing

Any problems arise in the course of implementation should be promptly reported to the two ministries for settlement.

For the Minister of Science, Technology and Environment

Vice Minister

For the Health Minister

Vice Minister

APPENDIX 5

Radiation danger signboard

The signboard is in triangle (with size, scales inscribed in the drawing).

D- (diameter of a circle between the three sides).

The circle, the three sides and the edge frame are in red on yellow background. Letters inscribed in the notice box are in black on white background. (clearly inscribed: X ray or radioactive rays).

APPENDIX 6

The maximum radioactive intensity for discharged patients who have been treated with radioactive pharmaceuticals