X-ray facilities for teleradiology and screening; application for authorization to operate.

If you wish to operate an X-ray facility for teleradiology or screening, you must apply for a permit from the competent authority.

Description

Teleradiology

If you operate an X-ray facility and the expert physician is not at the place of performance during the examination, the operation is only possible within the framework of teleradiology. For this purpose, a permit is required.

The authorization can only be granted if a physician with specialized knowledge (teleradiologist) is available to provide the justifying indication and to perform a timely diagnosis based on the X-ray images transmitted to him.

At the site of the technical performance of the X-ray examination, a physician with knowledge/partial expertise in radiation protection must be available to support the teleradiologist and an MTRA.

These requirements must be contractually regulated between the operator of the X-ray facility and the teleradiologist.

Screening

Anyone who operates an X-ray facility in connection with screening must apply for a permit in accordance with Section 19 (2) of the German Radiation Protection Act (StrlSchG) due to the special conditions for this operation (no justifiable indication required, higher demands on image quality and the reporting physician).

Approval can only be granted if evidence of the physicians responsible for the program, the other participating physicians, the X-ray facilities, any biopsy facilities and reporting facilities can be provided.

The corresponding requirements are to be contractually regulated between the physicians responsible for the program and the other participating physicians. Furthermore, an approval of the Association of Statutory Health Insurance Physicians of Bavaria for the assumption of the care assignment by the physicians responsible for the program must be submitted.

You should submit the application for approval via the online procedure. The necessary documents/evidence can also be uploaded and transmitted here.

Prerequisites

The permit application and the required documents and evidence must be submitted to the competent authority.

    Procedure

    You make the application for approval and submit it together with the required documents/evidence.

    The Government of Lower Franconia Trade Inspectorate (X-ray Competence Center) checks the application and the documents for completeness and correctness. If the submitted documents are complete and plausible, the requested permit will be issued by the responsible authority.

    To ensure that your application is processed as quickly as possible, we recommend using the online procedure.

    Deadlines

    none

    Required documents

    • Required Documents:

      Application for authorization for teleradiology

      • List of authorized persons for technical implementation (MTRA) with proof of authorization according to MTA law and, if applicable, proof of updating
      • List of teleradiologists with certificates of radiation protection expertise and proof of updating, if applicable
      • List of physicians at the examination site with proof of knowledge in radiation protection or corresponding expertise and, if necessary, proof of updating.
        Furthermore, the instruction of these persons for the performance of examinations within the scope of teleradiology must be confirmed by a teleradiologist.
      • Proof of a medical physics expert who can be consulted during operation of the X-ray facility.
      • Cooperation agreement between the operator of the X-ray facility and the cooperation partner for teleradiology.
      • Radiation protection instructions and work instructions for carrying out teleradiology
      • Copy of the expert inspection report of the X-ray facility used for teleradiology
      • List and locations of the image reproduction devices of the teleradiologists
      • Proof of testing of the image reproduction devices of the teleradiologists according to DIN 6868-157
      • Evidence for testing the data transmission links to the locations of the image reproduction devices of the teleradiologists according to DIN 6868-159
      • Designation of the responsible teleradiologist(s)
      • Designation of the radiation protection officer(s) (SSB) for the operation of the X-ray equipment intended for teleradiology.
      • Justification for the extended teleradiology operation (see also separate form), if this is requested.

      Application for approval for screening

      • List of x-ray facilities, x-ray-assisted biopsy equipment, stand-alone reporting facilities, and physicians working in the screening unit.
      • Printout of the approval of the Kassenärztliche Vereinigung Bayerns (Association of Statutory Health Insurance Physicians of Bavaria) regarding the assumption of the care mandate.
      • Proof of certification or current recertification of the screening unit by the Mammography Cooperation Association.
      • Prints of the notification confirmations (or approvals) for the curative operation of all X-ray equipment/X-ray-assisted biopsy equipment used in the screening unit.
      • If applicable, orders for the required radiation safety officers for screening operations with respect to each screening facility.
      • Prints of the cooperation agreements (memoranda of understanding) between the radiation protection officers of the mammography X-ray facilities used in the screening unit and the program manager (PVA) concerning the assignment of duties and the performance of all responsibilities and powers, including the necessary regulations concerning the authority to issue instructions within the scope of the screening operation by the PVA(s).
      • Evidence of compliance with the requirements of No. 6.5.2 PAS (Publicly Available Specification) 1054 (Requirements and test procedures for digital mammography facilities).

    Online procedures

    Fees

    • The costs for the approval depend on the respective administrative effort incurred. They amount to between 250 and 500 EUR per application.

    Legal bases

    Links to more information

    Related issues

    Status:12.06.2023

    Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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    • Online transactions, Bavaria-wide
    • Online transactions, locally limited
    • Form, Bavaria-wide
    • Form, locally limited
    • Prefillable Form, Bavaria-wide
    • Legal bases, Bavaria-wide
    • Legal bases, locally limited
    • Fees, Bavaria-wide
    • Fees, locally limited
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