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Specification for testing of quality control in helical tomotherapy unit
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Basic data
| Standard ID | WS 533-2017 (WS533-2017) |
| Description (Translated English) | Specification for testing of quality control in helical tomotherapy unit |
| Sector / Industry | Health Industry Standard |
| Classification of Chinese Standard | C57 |
| Date of Issue | 2017-05-18 |
| Date of Implementation | 2017-11-01 |
| Regulation (derived from) | State-Health-Communication (2017) 4 |
| Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China |
WS 533-2017: Specification for testing of quality control in helical tomotherapy unit
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Requirements for patient radiation protection in clinical nuclear medicine
ICS 13.280
C 57
WS
People's Republic of China Health Industry Standard
Protection requirements for clinical nuclear medicine patients
2017-05-18 released
2017-11-01 implementation
Issued by the National Health and Family Planning Commission of the People's Republic of China
Table of contents
Foreword...II
1 Scope...1
2 Normative references...1
3 Terms and definitions...1
4 General requirements...1
5 Judgment of Legitimacy...2
6 Optimization of Radiation Protection...3
7 Constraints on Medical Exposure Dose...4
8 Investigation and treatment of abnormal medical exposure...4
9 Records and archives...5
Appendix A (Normative Appendix) Quality Control of Medical Exposure...6
Appendix B (Normative Appendix) Recommendations on the period of breastfeeding interruption for women undergoing clinical nuclear medicine diagnosis and treatment...7
Appendix C (Normative Appendix) Suggested Fractions of Adult Dose for Children...8
Appendix D (Normative Appendix) Method for Estimating Patient Dose...10
Appendix E (Normative Appendix) Guidelines for Medical Exposure...32
Appendix F (Normative Appendix) Recommendations for the period when women undergoing clinical nuclear medicine treatment to avoid pregnancy...35
Appendix G (Normative Appendix) Dose Constraint and Dose Estimation...36
References...41
Foreword
Chapters 4 to 5 of this standard are mandatory, and the rest are recommended.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is transformed from GB 16361-2012 "Specifications for Patient Protection and Quality Control in Clinical Nuclear Medicine". With GB 16361-2012
In comparison, the main technical changes are as follows.
-Amend the standard name to "Clinical Nuclear Medicine Patient Protection Requirements";
- Deleted the content related to the quality control of clinical nuclear medicine equipment;
--Deleted the general requirements for drug quality control and related content, and retained the quality control requirements for the dosage of radiopharmaceuticals;
--Added the specific algorithm of children's radiopharmaceutical dosage;
--Added specific methods for discharge management of nuclear medicine patients;
--Added the fetal dose calculation method;
--Added the guiding suggestions for the level of children's medical exposure guidance;
--Detailed regulations and control methods for the dose restriction of visitors and family members.
Drafting organizations of this standard. Institute of Radiation Medicine, Chinese Academy of Medical Sciences, Tumor Hospital of Chinese Academy of Medical Sciences, Chinese Disease Prevention and Control
Center for Radiation Protection and Nuclear Safety Medicine, Sichuan Provincial Center for Disease Control and Prevention.
The main drafters of this standard. Zhang Liangan, Geng Jianhua, Zhang Wenyi, Ding Yanqiu, Jiao Ling, He Ling, Yang Yi.
The previous editions of the standard replaced by this standard are as follows.
--GB 16361-1996;
--GB 16361-2012.
Protection requirements for clinical nuclear medicine patients
1 Scope
This standard specifies the legality judgment of clinical nuclear medicine, the optimization of radiological protection, medical exposure dose constraints and the investigation of abnormal medical exposure
Patient protection requirements in terms of handling and handling.
This standard applies to the use of radionuclides in the diagnosis and treatment of clinical nuclear medicine, excluding the case of implantation of radioactive seed sources.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies to this document.
GBZ 120 Radiological Protection Standard for Clinical Nuclear Medicine
GBZ 179 Basic requirements for radiation protection from medical exposure
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Radiopharmaceutical
Any chemical compound containing radioactive atoms for the purpose of diagnosing or treating human diseases or physiological conditions. When applying radiopharmaceuticals,
Not only should its chemical and biological properties be considered like any other medicine, but also its radiation protection and safety issues.
3.2
Radiochemical purity
In a certain radiopharmaceutical that exists in a specific chemical form, the mass of the radionuclide in that specific chemical form
The percentage of the total mass of radionuclides.
4 General requirements
4.1 Requirements for clinical nuclear medicine diagnosis and treatment units
4.1.1 The nuclear medicine unit should develop a comprehensive quality assurance program, which includes at least the content recommended in A.1 in Appendix A.
4.1.2 The nuclear medicine unit shall establish and improve the management system and operation process including patient protection. The management system and operation process shall at least include
Including the contents recommended in A.2 in Appendix A.
4.1.3 It should be equipped with nuclear medicine diagnosis and treatment equipment (including related auxiliary equipment), radiation protection and
Radiopharmaceutical dosage quality control equipment, personal protective equipment.
4.1.4 According to the specifications in Appendix A, the activity meter should be used to conduct sampling quality control test on the activity of the applied radionuclide, and the accuracy of the sampling measurement
It should be better than 5%; the activity meter should be verified or calibrated regularly in accordance with relevant national regulations, and a qualified and valid verification or calibration certificate should be obtained.
4.1.5 Various workplaces and corresponding protective facilities that are compatible with their service items and comply with GBZ 120 protection requirements shall be set up; strengthen;
Management of patients after injection or oral administration of radiopharmaceuticals.
4.1.6 A radiological protection and quality assurance management organization should be established, and various medical technicians should strictly follow the protection and safety requirements in their work
And quality control requirements, and assume corresponding responsibilities.
4.1.7 In response to possible failures or errors in the implementation of diagnosis and treatment, emergency plans should be formulated, and emergency training and drills should be conducted.
The consequences of failures or mistakes are minimized.
4.2 Requirements for clinical nuclear medicine practitioners and related personnel
4.2.1 Radiopharmaceutical diagnosis and treatment applications and radiopharmaceutical prescriptions issued by licensed physicians should strictly grasp the indications and be sensitive to clinical nuclear medicine diagnosis and treatment
Strictly control this type of diagnosis and treatment.
4.2.2 Nuclear medicine professional practitioners should review the legitimacy of the radiopharmaceutical diagnosis and treatment applications and prescriptions issued on a case-by-case basis, paying particular attention to pregnancy
Women and breastfeeding women patients.
4.2.3 Before the implementation of clinical nuclear medicine diagnosis and treatment, practicing physicians, nurses and clinical nuclear medicine technicians have the responsibility to report possible risks verbally or in writing
Inform patients or their families in the form.
4.2.4 Practicing physicians and other related staff should not only possess the corresponding professional skills, but also receive nuclear medicine diagnosis and treatment techniques such as protective knowledge
Technical training.
5 Judgment of legitimacy
5.1 General requirements
5.1.1 All new clinical nuclear medicine diagnosis and treatment technologies and methods, the clinical nuclear medicine department should pass the legitimacy judgment before using it; it has been judged as
With proper techniques and methods, when new or important evidence is obtained and needs to be re-judged, it shall be re-judged for its legitimacy.
5.1.2 Clinical nuclear medicine physicians should master the characteristics and indications of various medical imaging diagnosis and treatment technologies, and strictly control their indications when using them.
Surrounding. Even if the new technologies and methods have been judged on the legitimacy, they should be judged separately before being used for new indications.
5.1.3 Before prescribing radiopharmaceutical diagnosis and treatment applications and radiopharmaceutical prescriptions, medical practitioners should pay attention to review the data of previous patient examinations and try their best
Avoid unnecessary duplicate inspections.
5.1.4 In order to avoid accidental radiation exposure to fetuses, embryos and babies, the patient should be asked whether they are pregnant or breast-feeding. And will be related to
The consultation instructions are posted in prominent locations in the clinical nuclear medicine department, especially at the entrance and waiting area.
5.1.5 In addition to the provisions of this standard, it shall also meet other requirements of the legitimacy judgment in GBZ 179.
5.2 Judgment of legitimacy in diagnosis
5.2.1 Except for clinical indications and the use of radiopharmaceutical diagnostic techniques, it is advisable to avoid the use of diagnostics for pregnant and possibly pregnant women as much as possible
Sexual radiopharmaceuticals; if necessary, the patient should be informed of the potential risk to the fetus.
5.2.2 Except for clinical indications and the use of radiopharmaceutical diagnostic techniques, the use of radiopharmaceuticals for lactating women should be avoided as much as possible; if
When it must be used, patients should be advised to stop breastfeeding appropriately according to the recommendations in Appendix B.
5.2.3 Except for clinical indications and the use of radiopharmaceutical diagnostic techniques, it is generally not appropriate to perform radionuclide imaging examinations on children.
If this kind of examination is required for children, the dosage of radiopharmaceuticals should be reduced according to the recommendations in Appendix C, and it should be possible to choose radioactive drugs with a short half-life
Nuclide.
5.3 Judgment of legitimacy in treatment
5.3.1 Unless it is a life-saving situation, women who are pregnant and likely to become pregnant should not be treated with radiopharmaceuticals, especially those containing I-131
And P-32 radiopharmaceuticals. When radiopharmaceutical treatment is used to save lives, the dose to the fetus should be measured according to the method in Appendix D
Assess and inform the patient that the fetus may be at risk.
5.3.2 Unless it is a life-saving situation, radiopharmaceutical therapy should be avoided as far as possible for breastfeeding women; if it is necessary to use it, it should be recommended
It is recommended that patients stop breastfeeding appropriately according to the recommendations in Appendix B.
6 Optimization of radiation protection
6.1 General requirements
6.1.1 When reviewing radiopharmaceutical diagnosis and treatment applications and prescriptions, clinical nuclear medicine practitioners should adopt the following measures to ensure that the dose received by patients is as low as possible.
Possible low.
a) Choose appropriate radiopharmaceuticals and their administration activity according to the physical characteristics of different patients, paying special attention to children and organ damage
Injured patient;
b) For non-examined organs, methods of blocking the absorption of radiopharmaceuticals should be used as much as possible, and the elimination should be accelerated;
c) Pay attention to the use of appropriate image acquisition and processing techniques;
d) Fully use the existing information to avoid all unnecessary repeated exposure;
e) Reference should be made to the corresponding medical exposure guidance level in Appendix E.
6.1.2 There should be procedures for verifying radiopharmaceutical diagnosis and treatment applications and prescriptions.
6.1.3 Written and oral guidance should be provided to patients who have been administered radiopharmaceuticals so that they can effectively reduce the cost to the family after they are discharged from the hospital.
The exposure caused by workers, nursing staff and the public, especially minors and pregnant women.
6.2 Optimization requirements in diagnosis
6.2.1 The following optimization measures should be noted and taken during clinical nuclear medicine diagnosis of patients.
a) Before using radiodiagnostic drugs, there should be procedures to determine the identity of the patient, the preparation of the patient before administration, and the procedure for administration;
b) For each diagnostic procedure, appropriate consideration should be given to the level of medical exposure guidance related to the procedure (Appendix E);
c) The relevant information of the patient should be recorded in detail;
d) Appropriate data collection conditions should be selected so that the patient can receive the lowest dose while achieving the necessary diagnostic expectations. example
For example, in order to obtain the best quality image, the collimator, energy window, matrix scale, acquisition time and magnification factor should be appropriately selected.
And related parameters of single photon emission computed tomography (SPECT) or positron emission computed tomography (PET)
Number and amplification factor;
e) When using dynamic analysis, in order to obtain the best quality image, the number of frames, time interval and other parameters should also be appropriately selected;
f) Ensure that the surface or other parts of the collimator are not contaminated by radioactivity;
g) After the diagnosis, especially in the short time after the examination, patients (especially children) should be encouraged to drink more water and excrete more
Speed up the kidneys to excrete radiopharmaceuticals.
6.2.2 When Tc-99m and its radiopharmaceuticals are used for nuclear medicine diagnosis, a smaller dosage and a longer imaging time can be used directly.
For optimization, it is usually not necessary to estimate the fetal exposure dose;
If the infant is ingested, the fetal exposure dose should be evaluated in accordance with Appendix D to avoid accidental exposure.
6.3 Optimization requirements in treatment
6.3.1 For women who have been treated with radiopharmaceuticals, follow the recommendations in Appendix F to avoid pregnancy for a period of time.
6.3.2 Men who have been treated with I-131 (iodine), P-32 (phosphate) or Sr-89 (strontium chloride) take contraceptive measures for 4 months.
6.3.3 When performing nuclear medicine treatment on patients, the following optimization measures should be adopted.
a) Before using radiotherapy drugs, there should be a process of determining the identity of the patient, preparing the patient before applying the drug, and applying the relevant information;
b) Before administering radiopharmaceuticals to women, ask to confirm whether the patient is pregnant or breastfeeding;
c) Special attention should be paid to prevent radioactive contamination caused by the patient's vomit and excrement.
6.4 Patient dose management
6.4.1 It should be ensured that the activity of the radiopharmaceutical administered to each patient is consistent with the prescribed amount, and should be recorded when taking the drug.
6.4.2 During the treatment procedure, a person with specialized knowledge should evaluate and record the radiation dose of each treatment, especially
Doses to infants and fetuses.
6.4.3 When a dose assessment is required, it should be carried out according to the method recommended in Appendix D.
6.5 Guidance level of medical exposure
6.5.1 Practicing physicians should refer to the medical exposure guidance level (see Appendix E) to ensure the rationality of the radiopharmaceutical administration activity.
6.5.2 The principles for using the guidance level are as follows.
a) When the patient's dose or application activity is significantly lower than the corresponding guidance level, and it is unable to provide useful diagnostic information or bring prognosis to the patient
Corrective actions should be taken as needed in case of long-term medical benefits;
b) When the patient's dose or application activity significantly exceeds the corresponding guidance level, it should be considered whether the guidance level has not reached the optimization of radiation protection,
Or whether medical practice activities are maintained at an appropriate and good level;
c) Appendix E gives the guidance level of general adult patients, and also gives the guidance level of general children; these guidance levels are correct
Generally speaking, it is only for reference. The physician performing the diagnostic examination should base on the patient’s physique, pathological condition, and body size.
Determine the reasonable dosage based on specific conditions such as age.
7 Medical exposure dose constraints
7.1 Relevant radiation protection measures should be provided to visitors and family members (such as limiting the time of contact with or approaching the patient,
Distance, etc.) and the corresponding written instructions on radiological protection, and restrict the dose received, so that during the diagnosis or treatment of the patient,
And the exposure of visitors and family members after discharge from the hospital is at the lowest possible level.
7.2 G.1 in Appendix G gives the reference value of dose control, and the dose received by the personnel who know and voluntarily support the patient, condolences and visitors should be
To be restrained, especially in patients with I-131 for hyperthyroidism and thyroid cancer treatment, Sr-89 and Re-188 to relieve pain of bone metastases, in the patient’s diagnosis
The dose received during the examination or treatment should not exceed 3mSv. The dose to infants and children who visit patients who have ingested radiopharmaceuticals should be restricted
Below 1mSv.
7.3 For patients who received I-131 treatment, their internal radioactivity fell below 400 MBq before being discharged from the hospital.
Patients treated with sexual drugs can only be discharged when the radioactivity in the patient's body is lower than the requirements of G.2 in Appendix G. Patient's body activity detection control should
Follow the method recommended in G.3.
7.4 For patients with hyperthyroidism and thyroid cancer, reasonable restrictions and reasonable restrictions on contact with colleagues and relatives and public places should be given in accordance with G.4 in Appendix G when discharged from the hospital.
Written recommendations on protective measures (limiting contact time and distance, etc.).
8 Investigation and treatment of abnormal medical exposure
8.1 The following events and accidents are abnormal medical exposures.
a) In any radionuclide therapy, there is an error in the identification of the patient or target tissue, or the drugs used, the dose, or the divided dose of the dose
The circumstances given are substantially different from those prescribed by the practicing doctor;
b) The dosage of any diagnostic drug is far greater than the prescribed value, or repeated irradiation for many times, or greatly exceeds the set guidance level;
c) Any equipment failure, accident, error or accident that causes the patient to be irradiated inconsistent with the diagnosis and treatment plan, or otherwise
Potential exposure that occurs normally.
8.2 In response to the above-mentioned abnormal medical exposures, nuclear medicine units should conduct the following investigations and treatments.
a) Calculate or estimate the dose received by the patient and its distribution;
b) Corrective measures required to prevent the recurrence of similar incidents, and immediately organize and implement all corrective measures;
c) A written report should be submitted to the regulatory agency as soon as possible after the investigation, stating the cause of the incident and the contents of a) and b) above;
d) Patients and their doctors should be informed of the incident.
9 Records and archives
9.1 The relevant records of nuclear medicine units shall include at least the following contents.
a) The name, type, route of administration, method of divided administration and administration activity of the radiopharmaceutical administered by each patient;
b) The name, type, route of administration, method of divided administration and administration activity of radiopharmaceuticals administered by volunteers in medical research.
9.2 The nuclear medicine unit shall establish a radiopharmaceutical use file, which includes the source and main characteristics of the radiopharmaceutical, quality testing, storage,
Records of use process and disposal of radioactive waste. The main characteristics of the following radiopharmaceuticals should be recorded.
a) For granular radiopharmaceuticals, strictly control the particle size. For example, when using macromer albumin (MAA), in order to avoid
For pulmonary embolism, 90% of its particle size should be controlled within the range of 10μm90μm, and the maximum should not exceed 150μm.
b) Radiopharmaceutical products should have labels and descriptions of heat source reaction results, radiochemical purity analysis results, and sterilization effects. In addition,
The following should also be identified.
1) The chemical form of radionuclides and drugs;
2) Total activity;
3) Activity measurement time;
4) The name and address of the manufacturer;
5) Validity period;
6) Batch number and batch code can be traced;
7) In the case of solution, indicate the total volume;
8) Other related parameters.
The nuclear medicine unit shall keep the above-mentioned records for a specified period of time and provide them for effective use.
Appendix A
(Normative appendix)
Quality control of medical exposure
A.1 Medical exposure quality assurance program
The medical exposure quality assurance program should include at least the following contents.
a) For new or repaired imaging devices and irradiating devices, the relevant physical parameters should be measured before use, and they should be determined later
Period measurement
b) Related physical parameters and clinical methods used in patient diagnosis or treatment;
c) Standardized procedures for written records and operations (such as patient's medical history and signs, diagnosis summary, indications and contraindications, etc.);
d) Verification procedures for confirming that the radiopharmaceuticals used and their use procedures are consistent with the prescriptions issued by medical practitioners;
e) Dosimetry and monitoring instrument calibration and working conditions verification procedures;
f) Procedures for regular hearing and review of the established quality assurance program.
A.2 Management system and operation process
The management system and operating procedures shall at least include the following.
a) Diagnosis and treatment application and prescription procedures (including the patient's medical history and physical signs, diagnosis summary, indications and contraindications, etc.);
b) Radiopharmaceutical use procedures (including reliable application procedures and quality control of drug administration, patient information and identification, etc.);
c) Clinical work procedures (including radiopharmaceutical preparation and transportation, clinical environment, patient transportation and preparation, equipment operation, procurement
Procedures and waste disposal etc.);
d) Technical training and experience collection procedures (including training and experience collection of all relevant personnel);
e) Data analysis and processing procedures (including processing procedures, equipment performance, data accuracy and completeness, etc.);
f) Results reporting procedures (including data and image analysis, results and further suggestions, etc.).
A.3 Quality control test of radiopharmaceutical dosage
The activity meter is used for sampling and quality control testing of the dosage of radiopharmaceuticals. Figure A.1 is a schematic diagram of a typical activity meter measurement device. except
In addition to regular calibration according to relevant national regulations, the stability of the activity meter should be checked once a week.
Appendix B
(Normative appendix)
Suggestions on t...
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