GB 16361-2012Specification for patient radiological protection and quality control in nuclear medicine (English PDF)

4.1 Clinical nuclear medicine diagnosis and treatment units

4.1.1 clinical nuclear medicine diagnosis and treatment unit (hereinafter referred to as nuclear medicine units) should follow the "radiation medical management regulations" for clinical Practicing nuclear medicine diagnosis and treatment conditions (hereinafter referred to as clinics) provided personnel and equipment, and other related requirements, and GB 18871- 2002 GB Z179 and other related technical standards.

4.1.2 should be equipped to adapt its services and the performance of qualified nuclear medicine diagnostic equipment (including related auxiliary equipment), and protection of patients Quality control testing equipment, personal protective equipment.

4.1.3 in accordance with relevant regulations, regularly test equipment for verification or calibration, to obtain competent and effective verification or calibration certificate. When it is detected Instrument after major repairs, you should re-test or calibration.

4.1.4 should be set to adapt its services and meet the protection requirements of GB Z120 laboratory examination room, injection rooms, treatment ward And waiting areas and other workplaces and their corresponding protection facilities.

4.1.5 It should be noted configured to adapt its services and reasonable structure of various professionals, including enforcement of the Nuclear Medicine have qualified Industry, physicians and clinical nuclear medicine technician, etc., and they are active in patient protection and safety and quality control knowledge, training and assessment.

4.1.6 There shall be established radiological protection and quality assurance management organizations, various medical technicians in their work should strictly follow the protection and safety to Demand and quality control requirements, and undertake corresponding responsibilities.

4.1.7 should develop the Nuclear Medicine Clinic quality assurance program, including strengthening the establishment of a sound management system, including the protection of patients, from the management system Ensure the correct implementation of the Nuclear Medicine Clinic of the degree and quality control procedures.

4.1.8 should be possible for the implementation of treatment failures or mistakes, development of contingency plans, and training and emergency drills will likely The consequences of failure or error is minimized.

4.2 Requirements for clinical nuclear medicine practitioners and associated personnel

4.2.1 only with a qualified medical practitioner to the patient prescribing radiation therapy and should be administered to the patient by virtue of prescription treatment Therapeutic radiopharmaceuticals.

4.2.2 The practitioner should be the legitimacy to judge case by case, only to meet the requirements of the legitimacy of radiopharmaceuticals to issue medical prescriptions.

4.2.3 practitioners and related personnel should be strictly controlled indications, should clinical nuclear medicine diagnosis and treatment when administered to a patient sensitive radiopharmaceuticals strict control.

4.2.4 Before the implementation of the Nuclear Medicine Clinic, practitioners and stakeholders have a responsibility to possible risks to patients orally or in writing inform Or their families.

5 patient protection and safety requirements

5.1 Justification judgment

5.1.1 In determining the nuclear medicine clinic should first make a legitimacy judgment, to ensure that the expected benefits of treatment according to clinical need will exceed the Treatment may bring potential danger.

5.1.2 All new clinical nuclear medicine techniques and methods of treatment, should be made through the use of pre-judging the legitimacy; it has been judged proper technical and square Law, when made new or important evidence and the need to re-judgment, they should re legitimacy judgment.

5.1.3 clinical nuclear medicine physicians should have the corresponding characteristics of medical diagnostic imaging technology and its indications, its use should be strictly controlled indications range. Even if new clinical nuclear medicine techniques and methods has been done to judge the legitimacy, in for new indications shall also be carried out prior to the legitimacy judgment.

5.1.4 diagnostic radiopharmaceuticals, reference should guide the level of medical exposure, using expected to reach the minimum discharge required diagnostic purposes Radionuclide administered amount. And note view past patient examination data, in order to avoid unnecessary duplication of tests.

5.1.5 lactating and pregnant women administered diagnostic radiopharmaceuticals, should pay special attention to the legitimacy of judgment. Because the special needs of pregnant women pregnant When women perform imaging, we should assess the absorbed dose to the fetus suffered.

5.1.6 unless it is life-saving situations, pregnant women should not receive treatment radiopharmaceuticals, particularly those containing 131I and 32P of radiopharmaceuticals. Therapeutic radiopharmaceuticals, should normally be at the end of pregnancy and lactation were. When life-saving drugs and radioactive therapy, if the fetus Accept the dose does not exceed 100mGy, may not terminate the pregnancy.

5.1.7 In order to avoid fetal and embryonic accidental radiation exposure, whether pregnant patients respond to an inquiry, inspection and evaluation. And will have Off advisory note posted in clinical nuclear medicine departments of the place, especially the entrance and waiting area.

5.1.8 only if there is significant clinical indications only can children in radionuclide imaging examination, and should be based on the child's weight, body The surface area or other applicable guidelines to minimize the amount of radioactive drug administration should be as short as possible to select the half-life of the radionuclide.

5.1.9 In addition to the above provisions, it should also meet other requirements in GB Z179 legitimacy judgment.

5.2.1 General requirements

5.2.1.1 practitioner when issued radiopharmaceutical prescription should be.

a) In the diagnosis can achieve the desired objective case, the patients received a dose as low as possible;

b) To make full use of existing information, to avoid all unnecessary duplication of irradiation;

c) there should be an actual medical exposure of nuclear medicine and radiopharmaceutical treatment prescription consistent verification procedures;

d) in the implementation of nuclear medicine diagnostic tests, should refer to the appropriate medical exposure guidance levels (see Appendix A).

5.2.1.2 practitioners, technicians and other imaging staff can be reached in an acceptable image quality, the patient should take By dose as low as possible. Therefore, we should adopt the following measures.

a) Depending on the choice of appropriate characteristics of patients administered radiopharmaceutical and its activity are available, particularly for children and organ Patients with functional impairment;

b) non-blocking inspection organs using a radioactive drug absorption, and speed up the process;

c) Note that the use of appropriate image acquisition and processing technology;

d) practicing physicians, technicians and other imaging staff, in addition should have the appropriate professional skills, but also accept nuclear medicine diagnosis and treatment Quality control and technical training requirements and protection of knowledge.

5.2.1.3 unless there was a clear clinical indications for pregnant women receive treatment when administered radiopharmaceuticals should control. Women Administration of radiopharmaceuticals should be avoided during pregnancy.

5.2.2 diagnostic nuclear medicine in clinical optimization requirements

5.2.2.1 should technical specifications and related standards establish operating conditions, nuclear medicine equipment, in order to obtain the best image when, Patients receiving the smallest dose.

5.2.2.2 Nuclear Medicine staff to deal with the patient has been administered radiopharmaceuticals provide written and oral guidance, so that they are also after discharge Can effectively limit their exposure suffered by nurses and the public to reduce their family members, if not adults and pregnant women, in particular, his or her spouse Close.

5.3 Guidance Levels for Medical Exposure 5.3.1

5.3.2 practitioners should refer to the principles guiding the use of medical exposure level (see Appendix A) to ensure that the activity of the co-administered reason.

5.3.2 Guidance Levels for the following principles.

a) When the dose or activity significantly lower than the corresponding level of guidance, can not provide useful diagnostic information to patients or doctors expected When treatment benefits should be required to take corrective action;

b) When the dose or activity significantly exceeds the appropriate level of guidance, you should consider whether the guidance has reached the level of radiation protection optimization, or Medicine Practice activities are held in a good level;

c) in Appendix A of the guidance applies only to the le...