Decree No. 410 / 2012 Coll.
Decree on the establishment of rules and procedures for medical exposure
Valid
Order
Effective from 01.12.2012
Text versions:
01.12.2012
30.11.2012
410
DECLARATION
of 21 November 2012
laying down rules and procedures for medical exposure
In agreement with the State Office for Nuclear Safety, the Ministry of Health provides, pursuant to § 95 (4) of Act No. 373 / 2011 Coll., on Specific Health Services ("the Act '), for the implementation of § 72 (3) of the Act:
This decree implements the relevant provisions of the European Union1) and provides for
(a) rules on the protection of the health of persons against the risks arising from ionising radiation in connection with medical exposure;
(b) the rules and procedures for the radiation protection of persons in medical exposure not covered by national radiological standards.
Scope and method of optimisation of radiation protection in medical exposure
In order to optimise radiation protection in medical exposure, the following procedures shall be ensured in addition to those laid down by the law governing the peaceful use of nuclear energy and ionising radiation2:
(a) in the field of radiodiagnostic, including interventional radiology and cardiology, the imaging method shall be used in such a way that the tissue doses are as low as possible without limiting the acquisition of the necessary radiodiagnostic information;
(b) only the necessary amount of radionuclide on the required purity and activity is applied to nuclear medicine, which guarantees sufficient diagnostic information at the lowest possible radiation burden of the patient;
(c) in the field of radiotherapy, care shall be taken to ensure that medical exposure is directed towards the target tissue volume to which radiation treatment is directed; The exposure of the target tissue volume shall be performed only to the extent necessary to achieve the required therapeutic effect and the exposure of other tissues shall be as low as reasonably achievable without limiting the therapeutic benefit.
Content of the activities of the prescribing physician and practitioner involved in the medical exposure
(1) Indicating physician and practitioner in the context of the medical exposure justification process
(a) it shall always take into account the effects, benefits and risks of available methods which lead to the same objective but do not involve any exposure to ionising radiation or cause lower exposure to ionising radiation;
(b) before each use of the source of ionising radiation, ask the patient for medical exposure to previous applications of radionuclides and ionising radiation which might be relevant to the investigation or treatment under consideration; in women of child-bearing potential, it also asks questions about pregnancy or breast-feeding; the data found that may be relevant to the investigation or treatment under consideration shall be recorded in the patient's medical file.
(2) The physician should also
(a) if it recommends the performance of a medical exposure, the application for a medical exposure shall specify, in addition to the formalities laid down by the legislation governing the content and particulars of the medical document3):
1. clinical diagnosis and numerical diagnosis according to the International Statistical Classification List of Diseases and Associated Health Problems;
2. information on the facts relevant for the performance of the patient's medical exposure,
3. the objective, the expected benefit and justification of the medical exposure requirement;
4. data on previous uses of radionuclides and ionising radiation which may be relevant for the examination or treatment considered,
(b) it shall process a specific written justification if it is on the verification of the non-established method with medical radiation for which a binding opinion of the State Nuclear Safety Authority is not delivered pursuant to Article 36 of the Act.
(3) The applicant expert will also assess the target and expected benefits of the requested medical exposure and the implementation of the exposure
(a) approve; in such a case, in accordance with local radiological standards, the workplace, the specific source of ionising radiation, the date and time for performing the medical exposure; or
(b) reject; in which case, it shall state this in the information on the examination or treatment; and
add its name, names, and surname, date and signature as appropriate; the information on the examination or treatment in electronic form shall be accompanied by its recognised electronic signature.
Rules and procedures for the radiation protection of persons exposed to medical and legal procedures without medical indication
Only recognised medical procedures shall be used for the exposure of a person under medical law without medical indication. The specific nature of the purpose of the exposure, which is not a diagnostic or therapeutic benefit, including a direct benefit to the health of the person undergoing the exposure, shall be taken into account when determining whether the exposure is justified under medical law. The dose or exposure parameters enabling the estimation of the dose or activity determined and applied in the context of the medical exposure shall be recorded in the medical file of the person referred to in the first sentence.
Rules and procedures for radiation protection in medical exposure in occupational medical services and preventive medical care
(1) Medical exposure of a person in the framework of occupational medical services and preventive health care, including search tests, shall be subject to recognised medical procedures only. When determining whether the exposure is justified, account shall be taken of the specific nature of the purpose of the exposure, which is the detection of the disease. The dose or irradiance parameters enabling the estimation of the dose or activity identified and applied as part of the medical exposure shall be recorded in the patient-led medical file.
(2) Medical exposure as part of preventive care, including newly introduced search tests, can only be performed if an optimisation study shows that the social benefits of preventive care will be higher than the possible damage caused by ionising radiation.
(3) An optimisation study is a procedure that ensures the justification and optimisation of radiation exposure in medical exposure, which is part of preventive care, including search tests, and is carried out before the inclusion of medical exposure in preventive care procedures. In particular, during the process of the optimisation study, the expected number of people exposed to medical exposure, the expected success of the detection of the disease sought and its treatment and the expected number of people likely to suffer from stochastic effects of ionising radiation is compared. At the same time, it is assessed whether the same purpose can be achieved by using a method without ionising radiation.
(4) The optimisation study shall be repeated if there is a significant deviation from the indicators on which the study was based during the provision of preventive health care.
Rules and procedures for the radiation protection of persons in the framework of the voluntary participation of healthy persons or patients in the medical verification of non-established methods associated with medical radiation
(1) Medical exposure of persons as part of the voluntary participation of healthy persons or patients (hereinafter referred to as "medical exposure of a person") in the medical verification of non-established methods with medical exposure may be carried out where:
(a) such persons are informed in writing of the risk of exposure and the provision of information has been recorded in the medical file kept on them;
(b) the participation of such persons is voluntary and their consent to the exposure is expressed in writing.
The dose or irradiance parameters enabling the estimation of the dose or activity applied under the medical exposure shall be recorded in the medical file.
(2) The medical exposure of persons participating in the verification of the non-established method with a medical exposure for which a binding opinion of the State Nuclear Safety Authority is not delivered pursuant to Paragraph 36 of the Act may be carried out provided that the rules and procedures referred to in paragraph 1 are complied with, and
(a) the following optimisation limits are complied with:
1. diagnostic reference level (4); or
2. an effective dose per individual of 1 mSv per calendar year but not more than 10 mSv for 10 consecutive calendar years;
(b) the assessment has been made and the medical file has given written reasons as to whether another non-ionising radiation method can be used; and
(c) the specific written justification referred to in Article 3 (2) (b) has been prepared.
Radiation protection rules and procedures for patients exposed during pregnancy and breast-feeding
Medical exposure during pregnancy may be performed only in urgent cases or for reasons of indication for delivery; it is necessary to take particular account of the need to obtain the required diagnostic information or therapeutic benefit to be achieved when using sources of ionising radiation. At the same time, a source of ionising radiation and procedures should be chosen to ensure maximum protection of the embryo or foetus. In breast-feeding women, similar attention must be paid to the justification of medical exposure and the assessment of its urgency when testing in nuclear medicine.
Rules and procedures for the radiation protection of a minor patient in the context of his medical examination or treatment
When examining a minor patient, medical exposure may be performed only by appropriate medical means and procedures intended for this patient group. During the medical exposure of a minor patient, attention shall be paid to the evaluation of this exposure.
Rules and procedures for evaluating and complying with local radiological standards
(1) Evaluation of local radiological standards and their compliance with national radiological standards is ensured by carrying out an external clinical audit. The legal person authorised by the Ministry of Health to carry out an external clinical audit under Section 75 of the Act (hereinafter referred to as the "Authorised Person ') shall verify and evaluate whether local radiological standards
(a) are processed in a radiological workplace for each source of ionising radiation and for all standard medical exposure performed therein;
(b) are based on national radiological standards, specific conditions at the workplace of the health establishment and the scope of the health services provided;
(c) contain the correct route of determination and dose assessment for patients or their activity;
(d) contain indication criteria to justify medical exposure;
(e) establish local diagnostic reference levels and determine the way in which they are assessed and recorded in the radiological workplace;
(f) contain requirements for the recording and evaluation of repeated medical exposures of patients and their causes;
(g) contain the requirements for recording, recording and archiving all data needed to determine the dose or activity administered to the patient, in particular:
1. exposure parameters of medical exposure or activity administered to the patient,
2. identification of source of ionising radiation,
3. protocols on long-term stability tests and tests on the operational stability of the source of ionising radiation; and
(h) are regularly updated and revised.
(2) Furthermore, the beneficiary shall verify that the responsible person is established for local radiological standards.
(3) In order to obtain the necessary information, the beneficiary uses:
(a) interviews with the staff of the workplace in which the clinical audit takes place;
(b) a visit to the workplace where the clinical audit is carried out;
(c) the information provided in the questionnaire,
(d) documentary checks;
(e) monitoring the practical implementation of working procedures;
(f) control measurements.
Minimum requirements for staff security of external clinical audit
The external clinical audit for the individual radiological centre being evaluated shall be carried out by:
(a) a doctor with specialised competence in the field
1. radiology and imaging methods for workplaces with diagnostic X-rays;
2. nuclear medicine for nuclear medicine workplace; or
3. radiation oncology for radiotherapeutic workplaces,
(b) a clinical radiological physicist with special competence for radiodiagnostic, radiotherapy or nuclear medicine;
(c) a radiological assistant with specialised competence for the relevant evaluated activity; and
(d) a doctor or health care professional with specialised competence in the relevant field according to the type of workplace being evaluated, where appropriate.
Efficacy
This Decree shall take effect on 1 December 2012.
Minister:
Doc. MUDr. Heger, CSc., v. r.
1) Council Directive 97 / 43 / EC of 30 June 1997 on the protection of the health of persons against the risks arising from ionising radiation in connection with medical radiation and repealing Directive 84 / 466 / Euratom.
2) Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionizing Radiation (Atomic Law) and on the amendment and addition of certain laws, as amended.
3) Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended. Decree No. 98 / 2012 Coll., on Health Documentation.
4) § 2 (hh) of Act No. 18 / 1997 Coll. Decree No. 307 / 2002 Coll., on Radiation Protection, as amended.
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Regulation Information
| Citation | Decree No. 410 / 2012 Coll., laying down rules and procedures for medical exposure |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.11.2012 |
|---|---|
| Effective from | 01.12.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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