GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

3.2.06 Instructions on radiation protection

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Regulation of responsibilities, personal monitoring, equipment management, instructions, etc., as prescribed in the StrlSchV

1 Radiation protection officer

The person responsible for radiation protection at the HOSPITAL in accordance with Section 29 (1) StrlSchV and Section 13 (1) RöV is the managing director. The person responsible for radiation protection may appoint authorised radiation protection representatives.

2 Radiation protection officer

(can be omitted if only a few radiation protection officers are appointed. The person responsible for radiation protection is then the direct addressee of all documents that are to be sent to the radiation protection officer).

1. the radiation protection officer assumes the duties and tasks of the radiation protection officer. He is obliged to implement his instructions and those of the supervisory authority. He appoints the required number of radiation protection officers on behalf of the radiation protection officer and monitors their activities. Further details on the duties of the radiation protection officers can be found in their job description.

2 The radiation protection officer is directly assigned to the radiation protection officer. He shall submit an annual written activity report to the latter.

3. the Radiation Protection Officer shall have the authority to inspect all documents relating to radiation protection and to inspect all equipment and rooms to the extent he deems necessary for the performance of his duties. The Managing Directors, the Department Directors and the Radiation Protection Officers of the HOSPITAL shall support the Radiation Protection Officer in the performance of his work.

4. the Radiation Protection Officer shall attend the meetings of the Budget Committee and the Equipment Committee in an advisory capacity insofar as radiation protection issues are concerned.

3 Radiation protection officer

1. in accordance with the regulation of management tasks, the department directors propose who is to be appointed as radiation protection officer. In the case of core clinics and core institutes without departments, the managing director proposes the radiation protection officers.

2. the written appointment of the radiation protection officer shall be made by the radiation protection officer, specifying the scope of duties and internal decision-making and indicating the criteria and possible consequences of their responsibility (e.g. fine for an administrative offence). The Managing Director and the Department Director shall each receive a copy of the written appointment.

3. radiation protection officers are responsible for compliance with the Radiation Protection Ordinance, the X-Ray Ordinance, the associated guidelines and the orders and requirements issued by the supervisory authorities and brought to the attention of the radiation protection officers, as well as these instructions, within the decision-making area assigned to them.

Irrespective of their position under employment law, they are therefore authorised to issue instructions on radiation protection to all members of the relevant institute or specialist area.

They can order measures, make decisions, give instructions, regulate access to monitoring and control areas and withdraw the work permit from persons who deliberately or through gross negligence violate the regulations or show that they do not have the necessary basic knowledge.

4. the radiation protection officers must inform the radiation protection officer immediately of all relevant events in their area and support the radiation protection officer in his activities.

In the event of a fire, the radiation protection officer must inform the fire brigade about radioactive substances at the site of the fire in accordance with the fire protection guidelines of the HOSPITAL.

5. the radiation protection officers in accordance with the X-ray Ordinance keep lists of all doctors in their department who are qualified in radiation protection. A copy of the certificate of competence is sent to the radiation protection officer.

6. the radiation protection officers must inform the radiation protection officer immediately of any defects that impair radiation protection and of any incidents, damage or accidents that could lead to radiation damage.

7. the radiation protection officers are responsible for the radiation protection documentation and records that must be kept in accordance with StrlSchV and RöV. When a department ceases to operate, the radiation protection documents must be handed over to the radiation protection officer for archiving as required by law.

8. the radiation protection officers forward the necessary notifications and licence applications in accordance with the StrlSchV and the RöV to the radiation protection officer. The radiation protection officers in accordance with the RöV compile the documents for quality assurance in accordance with § 16 RöV, which the radiation protection officer forwards to the medical centre.

4 Radiation protection working group

1. to support the work of the radiation protection officer, the radiation protection officers and the radiation protection authorised representative, a "radiation protection working group" is set up for selected topics. It is formed by the radiation protection officer on specific topics and convened in writing.

2 The composition of a working group depends on the problem to be solved. Other members (such as radiation protection officers, occupational safety specialists, radioisotope purchasing, representatives of the authorities, company doctors, representatives of the technical department) are invited by the permanent members of the working group (radiation protection officers, staff councils) on a topic-related basis. Additional guests may be invited at the request of a member.

3. the working group discusses all matters relating to radiation protection in the areas of occupational health and safety, patient protection, environmental protection and civil protection. It proposes measures to the person responsible for radiation protection that are suitable for achieving these protection goals.

5 Activities requiring authorisation and notification

In the case of activities requiring authorisation and notification in accordance with the Radiation Protection Ordinance (StrlSchV) and the Radiological Protection Ordinance (RöV), notifications or applications for authorisation must be made via the radiation protection officer. These activities may only be carried out once a valid licence or notification has been issued. The handling of radioactive substances requires the prior approval of the responsible radiation protection officer.

6 Private treatment, personally authorised ancillary activity, beds in use

In the case of private treatment, medical treatment on the basis of personal authorisation by the health insurance funds and the use of occupied beds, the right to issue instructions to staff and the householder's or operator's rights remain with the HOSPITAL. The doctor who invoices treatment privately or on the basis of an authorisation by a health insurance company or who uses occupied beds must follow the instructions of the radiation protection officer, the radiation protection officer and the responsible radiation protection officer.

7 Obligations of the members of the KRANKENHAUS to co-operate

All members and employees of the University Hospital Eppendorf who handle radioactive materials or operate systems for the generation of ionising radiation or X-ray systems or interference sources are obliged to do so,

- to inform the responsible radiation protection officers about the type and scope of their current and planned work with radioactive substances or ionising radiation and to obtain their approval for measures;

- the StrlSchV and the RöV must be observed;

- to provide the responsible radiation protection officers with all necessary information and to follow their instructions;

- to inform the responsible radiation protection officer of any contamination, dose exceedances, incidents, damage and accidents;

- to support the Radiation Protection Officer in his work with information and advice and in other ways

8 Access restrictions - activity requirements

1. access regulations to the operational monitoring areas, X-ray rooms and control areas are determined by the responsible radiation protection officers. The necessary prerequisites for this are that the regulations on the

- medical supervision,

- physical personal dose control and

- legal access restrictions are fulfilled.

2. working group leaders must inform the responsible radiation protection officer of employees and students as well as trainees who are intended for an activity in which they will be exposed to radiation in good time before commencing their activity. They must also inform the radiation protection officer immediately when they cease work. The radiation protection officers shall arrange for the necessary personal protective measures to be taken (e.g. preventive medical check-ups).

9 Special events

1 The Radiation Protection Officer must be informed immediately if the following events come to light:

- discovery, loss, theft, fire, water damage, violence, insofar as radioactive materials or X-ray sources are affected;

- Release of radioactive substances with waste water or exhaust air if limit values according to § 46 StrlSchV could be exceeded;

- Accidents or incidents, regardless of any immediate measures;

- possible or actual incorporation of radioactive substances;

- Contamination of persons or objects outside radiation protection areas, operational monitoring areas or X-ray rooms;

- Values for the personal dose of more than 1 mSv (0.1rem) per month;

- Defects in X-ray and irradiation equipment and sources of interference that may impair radiation protection.

2. the authorised radiation protection officer immediately informs the radiation protection officer and the responsible radiation protection officer.

10 Final provisions

If necessary, special procedural instructions can be defined in writing for certain activities.edit

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