ある自治体の対応

必要であるが文書による行政指導の対象とはしない。

文書と口頭の行政指導の違い？

No. 363 口頭の行政指導

別の自治体の対応

省令で明示されているので、その装置を使う全て医師を届け出る必要があり、研修医がローテーションで変わった場合にも、そのたびの手続きが必要。

合理化対応案

文理解釈

全ての「エックス線診療に従事する医師」等とは規定されていないので、その装置によるＸ線診療に責任を持つ従事者を届ければよいとしてはどうか。

論理解釈

この規定の背景は、無資格でのＸ線診療の防止であり、医療機関でエックス線診療に従事する医師等の把握を目的にした規定ではない
このため、無資格放射線診療の防止を別の何からの方法で担保されていれば、この規定の相対的な意義が小さくなる
そこで、装置の管理や放射線診療を適切さを別の方法で担保（紛争の防止も兼ねて）してはどうか。
医療法施行規則の改正で医療従事者への研修が義務づけられるようになっており、その受講者名簿の情報でも代用できるかもしれない。

変更解釈

無資格でのＸ線診療の防止が必要ではないと考えられる医療機関での適用を免除してはどうか。

基本的な考え方

放射線診療従事者の放射線安全確保が担保されていることが前提となる。

電子化による実態把握案

韓国のように、放射線診療従事者やＸ線装置をデータベース化し、誰がどの装置を使ったかを把握できるようにする（対策の費用対効果などを検証する必要がある）。

線量の管理

労働安全衛生規則及び電離放射線障害防止規則の一部を改正する省令の施行等（基発 第253 号　平成 13年3月30日）

(3) 事業者は、「5年間」の途中に新たに自らの事業場の管理区域に立ち入ることとなった労働者について、当該「5年間」の始期より当該管理区域に立ち入るまでの被ばく線量を当該労働者が前の事業場から交付された線量の記録(労働者がこれを有していない場合は前の事業場から再交付を受けさせること。)により確認すること。

IAEA

SSG-446

2.31.

Mechanisms for formal recognition of health professionals should be put in place to ensure that only persons with the appropriate competencies are allowed to take on particular roles and responsibilities. In medical uses of ionizing radiation, this applies in particular to persons undertaking the role of radiological medical practitioner, medical radiation technologist or medical physicist. Detailed guidance is provided in paras 2.119–2.137, on education, training, qualifications and competence.

EDUCATION, TRAINING, QUALIFICATION AND COMPETENCE

2.119.

Medical uses of ionizing radiation involve a number of health professionals performing radiological procedures such as diagnostic examinations, interventional procedures and treatment. In each case, the radiation protection and safety associated with the radiological procedure depends greatly on the skills and expertise of those health professionals involved, as the patient is necessarily and deliberately exposed to radiation. In other words, the education, training, qualification and competence of the respective health professionals underpin radiation protection and safety in medical uses of ionizing radiation.

2.120.

GSR Part 3 [3] places great emphasis on education and training for all persons engaged in activities relevant to protection and safety, with the responsibility placed on government to ensure that requirements for education, training, qualification and competence are established and that arrangements are in place for the provision of the necessary education and training. The development and implementation of a national strategy for education and training (see Ref. [35]) that is based on a national needs assessment can be useful in this context. Furthermore, the regulatory body is required to ensure the application of the requirements for education, training, qualification and competence in radiation protection. Such verification should take place when an application for an authorization has been submitted to the regulatory body and during the periodic inspections of the medical radiation facility. Finally, the registrant or licensee of the medical radiation facility has the responsibility to ensure that all the health professionals in that facility with responsibilities for protection and safety have appropriate education, training, qualification and competence.

2.121.

In medical uses of ionizing radiation, medical exposure occurs and occupational and public exposure might occur. For the health professionals involved, it is their education, training, qualification and competence in the medical exposure aspects that are the most critical. To this end, the requirements of GSR Part 3 [3] for the health professionals involved in performing radiological procedures are quite stringent. For each of the key roles of the radiological medical practitioner, the medical radiation technologist, the medical physicist and the radiopharmacist, the definition in GSR Part 3 [3] takes the same form, namely: that the person is a health professional, that they have specialist education and training in the particular discipline (including radiation protection and safety), and that they have been assessed as being competent to carry out that particular role (see Definitions in GSR Part 3 [3] for complete descriptions). The competence of a person is normally assessed by the State through a formal mechanism for registration, accreditation or certification of the particular specialized health professional. States that have yet to develop such a mechanism should assess the education, training and competence of an individual proposed by a licensee to act as a specialized health professional and to decide, on the basis either of international standards or standards of a State where such a system exists, whether the individual can be considered competent.

2.122.

A health professional intending to act in any of the roles of radiological medical practitioner, medical radiation technologist, medical physicist or radiopharmacist can do so only if he or she has the requisite education, training, qualification and competence. It is the responsibility of the registrants and licensees to ensure that their staff meet these requirements, and it is the responsibility of the regulatory body to use the authorization, inspection and enforcement processes to ensure that registrants and licensees discharge their responsibilities in this respect.

2.123.

The institutes and organizations that provide education and training in radiation protection to health professionals should use GSR Part 3 [3] and this Safety Guide as resources on the requirements for radiation protection and safety in medical uses of radiation.
Radiological medical practitioners

2.124.

The term ‘radiological medical practitioner’ is applied to a number of health professionals who independently perform or oversee radiological procedures within a given specialty (see also para. 2.90). Some radiological medical practitioners belong to a specialty with a very long association with medical uses of ionizing radiation, such as radiology, nuclear medicine, radiation therapy and dentistry. In States where there are well established processes in place for education, training, qualification and competence in these specialties, such education, training, qualification and competence includes subjects not only in the specialty itself but also with respect to radiation protection (patient protection and occupational protection). Radiological medical practitioners would typically become registered with the national medical or dental registration board (or a body with a similar function), and competence in the specialty should include competence in radiation protection and safety. The regulatory body and the relevant professional body should periodically review the radiation protection and safety aspects of the education and training to ensure that it is still up to date and relevant. In States where there is a lack of infrastructure for education and training in these specialties, a prospective radiological medical practitioner should gain the necessary education, training and qualification outside the State, both in the specialty itself and in radiation protection and safety. The competence of radiological medical practitioners trained outside the State should be assessed. In this situation the regulatory body should seek advice from the health authority and the relevant professional body (if it exists) with respect to the adequacy of the specialization of the individual and assessment of the individual’s competence with respect to radiation protection and safety may need to be performed by the regulatory body. In time, this approach should develop into a standardized process for dealing with competence assessments.

2.125.

Other specialties, such as orthopaedic surgery and cardiology, have also had a long association with medical uses of ionizing radiation, but radiation protection and safety might not traditionally have been part of the processes for education, training, qualification and competence in the specialty. Still other specialties have a more recent association with medical uses of ionizing radiation, especially with respect to image guided interventional procedures. Radiation protection (patient protection and occupational protection) is often not included in the curriculum for education, training, qualification and competence in these specialties. For specialists from these two groups, additional or separate education and training and credentialing in radiation protection and safety, as it applies to their specialty, may need to be arranged. The relevant professional bodies and the regulatory body should work together in establishing acceptable criteria on education and training in radiation protection and safety, and the means for recognition of competence in radiation protection. The preferred approach is for the relevant professional body to administer the process and to maintain a register of specialists and their radiation protection and safety credentials. Another possibility is the regulatory body taking on the role of overseeing the radiation protection and safety training and recognition processes. A medical radiation facility can adopt a ‘credentialing and privileging’ approach to cover education, training, qualification and competence in radiation protection and safety [36]. In this approach, the prospective radiological medical practitioner would present all their relevant data on training and experience (including in radiation protection and safety), and apply for permission to perform certain medical procedures involving radiological procedures. Detailed guidance on appropriate education and training in radiation protection and safety for various specialties involved in medical use of ionizing radiation is given in Refs [37, 38].

Medical radiation technologists

出典

INTERNATIONAL ATOMIC ENERGY AGENCY, Radiation Protection and Safety in Medical Uses of Ionizing Radiation, IAEA Safety Standards Series No. SSG-46, IAEA, Vienna (2018)