Statement of the German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists on Requirements for the Performance and Reporting of MR Imaging Examinations Outside of Radiology

Abstract

Background Magnetic Resonance Imaging (MRI) is a very innovative, but at the same time complex and technically demanding diagnostic method in radiology. It plays an increasing role in high-quality and efficient patient management. Quality assurance in MRI is of utmost importance to avoid patient risks due to errors before and during the examination and when reporting the results. Therefore, MRI requires higher physician qualification and expertise than any other diagnostic imaging technique in medicine. This holds true for indication, performance of the examination itself, and in particular for image evaluation and writing of the report. In Germany, the radiologist is the only specialist who is systematically educated in all aspects of MRI during medical specialty training and who must document a specified, high number of examinations during this training. However, also non-radiologist physicians are increasingly endeavoring to conduct and bill MRI examinations on their own.

Method In this position statement, the following aspects of quality assurance for MRI examinations and billing by radiologists and non-radiologist physician specialists are examined scientifically: Requirements for specialist physician training, MRI risks and contraindications, radiation protection in the case of non-ionizing radiation, application of MR contrast agents, requirements regarding image quality, significance of image artifacts and incidental findings, image evaluation and reporting, interdisciplinary communication and multiple-eyes principle, and impact on healthcare system costs.

Conclusion The German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists are critical with regard to MRI performance by non-radiologists in the interest of quality standards, patient welfare, and healthcare payers. The 24-month additional qualification in MRI as defined by the physician specialization regulations (Weiterbildungsordnung) through the German state medical associations (Landesärztekammern) is the only competence-based and quality-assured training program for board-certified specialist physicians outside radiology. This has to be required as the minimum standard for performance and reporting of MRI exams. Exclusively unstructured MRI training outside the physician specialization regulations has to be strictly rejected for reasons of patient safety. The performance and reporting of MRI examinations must be reserved for adequately trained and continuously educated specialist physicians.

Key Points:

• MR imaging plays an increasing role due to its high diagnostic value and serves as the reference standard in many indications.

• MRI is a complex technique that implies patient risks in case of inappropriare application or lack of expertise.

• In Germany, the radiologist is the only specialist physician that has been systematically trained in all aspects of MRI such as indication, performance, and reporting of examinations in specified, high numbers.

• The only competence-based and quality-assured MRI training program for specialist physicians outside radiology is the 24-month additional qualification as defined by the regulations through the German state medical associations.

• In view of quality-assurance and patient safety, a finalized training program following the physician specialization regulations has to be required for the performance and reporting of MRI examinations.

Citation Format

• Hunold P, Bucher AM, Sandstede J et al. Statement of the German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists on Requirements for the Performance and Reporting of MR Imaging Examinations Outside of Radiology. Fortschr Röntgenstr 2021; 193: 1050 – 1060

Key words

magnetic resonance imaging - specialist physician training - requirements - risks and contraindications - reporting

Publication History

Received: 08 March 2021

Accepted: 16 March 2021

Article published online:
08 April 2021

• References

• 1 Röntgendiagnostik: Häufigkeit und Strahlenexposition. Bundesamt für Strahlenschutz. Im Internet: https://www.bfs.de/DE/themen/ion/anwendung-medizin/diagnostik/roentgen/haeufigkeit-exposition.html
• 2 Bundesärztekammer. (Muster-)Weiterbildungsordnung 2018 in der Fassung vom 12./13.11.2020. 2020: 450 . Im Internet: https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/Weiterbildung/20201112_13_MWBO-2018.pdf
• 3 Delfino JG, Krainak DM, Flesher SA. et al MRI‐related FDA adverse event reports: A 10‐yr review. Med Phys 2019; 46: 5562-5571 . Im Internet: https://onlinelibrary.wiley.com/doi/10.1002/mp.13768
• 4 Shellock FG. Reference Manual for Magnetic Resonance Safety, Implants, and Devices: 2020 Edition. Biomedical Research Publishing Group; 2020
• 5 Sommer T, Luechinger R, Barkhausen J. et al Positionspapier der Deutschen Röntgengesellschaft (DRG) zu MR-Untersuchungen bei Patienten mit Herzschrittmachern. Rofo 2015; 187: 777-787
• 6 Schick F. MRT-Wechselwirkungen mit magnetisch aktivem und elektrisch leitfähigem Material. Radiologe 2019; 59: 860-868
• 7 NiSG – Gesetz zum Schutz vor nichtionisierender Strahlung bei der Anwendung am Menschen 2009. Im Internet: http://www.gesetze-im-internet.de/nisg/
• 8 NiSV – Verordnung zum Schutz vor schädlichen Wirkungen nichtionisierender Strahlung bei der Anwendung am Menschen. Im Internet: https://www.gesetze-im-internet.de/nisv/
• 9 Strahlenschutzaspekte medizinischer Anwendungen nichtionisierender Strahlung: Fachgespräch des Ausschusses „Nichtionisierender Strahlen“ der Strahlenschutzkommission am 24./25. August 2009. Berlin: Schnelle Verlag; 2012
• 10 Empfehlungen zur sicheren Anwendung magnetischer Resonanzverfahren in der medizinischen Diagnostik: Empfehlungen der Strahlenschutzkommission. Verabschiedet in der 180. Sitzung der SSK am 19./20. September 2002. München: Urban und Fischer; 2003
• 11 Wahsner J, Gale EM, Rodríguez-Rodríguez A. et al Chemistry of MRI Contrast Agents: Current Challenges and New Frontiers. Chem Rev 2019; 119: 957-1057
• 12 Uhlig J, Lücke C, Vliegenthart R. et al Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72839 patients. Eur Radiol 2019; 29: 3686-3695
• 13 Behzadi AH, Zhao Y, Farooq Z. et al Immediate Allergic Reactions to Gadolinium-based Contrast Agents: A Systematic Review and Meta-Analysis. Radiology 2018; 286: 731
• 14 McDonald JS, Hunt CH, Kolbe AB. et al Acute Adverse Events Following Gadolinium-based Contrast Agent Administration: A Single-Center Retrospective Study of 281 945 Injections. Radiology 2019; 292: 620-627
• 15 Walker DT, Davenport MS, McGrath TA. et al Breakthrough Hypersensitivity Reactions to Gadolinium-based Contrast Agents and Strategies to Decrease Subsequent Reaction Rates: A Systematic Review and Meta-Analysis. Radiology 2020; 296: 312-321
• 16 Mandlik V, Prantl L, Schreyer AG. Kontrastmittel-Paravasat bei CT und MRT – Aktuelle Literaturübersicht und Behandlungsstrategien. Rofo 2019; 191: 25-32
• 17 Mathur M, Jones JR, Weinreb JC. Gadolinium Deposition and Nephrogenic Systemic Fibrosis: A Radiologist’s Primer. Radiographics 2020; 40: 153-162
• 18 Gulani V, Calamante F, Shellock FG. et al Gadolinium deposition in the brain: summary of evidence and recommendations. Lancet Neurol 2017; 16: 564-570
• 19 American College of Radiology, Committee on Drugs and Contrast Media. ACR manual on contrast media 2015. Im Internet: http://www.acr.org/~/link.aspx?_id=29C40D1FE0EC4E5EAB6861BD213793E5&_z=z
• 20 Jendrissek KA, Hotfiel T, Swoboda B. et al Pigmentierte villonoduläre Synovialitis: Eine seltene Differenzialdiagnose der synovialen Gelenkschwellung. Z Rheumatol 2016; 75: 157-165 . Im Internet: http://link.springer.com/10.1007/s00393-015-0028-4
• 21 Rimola J, Forner A, Tremosini S. et al Non-invasive diagnosis of hepatocellular carcinoma ⩽2cm in cirrhosis. Diagnostic accuracy assessing fat, capsule and signal intensity at dynamic MRI. Journal of Hepatology 2012; 56: 1317-1323 Im Internet: https://linkinghub.elsevier.com/retrieve/pii/S016882781200089X
• 22 Forner A, Vilana R, Ayuso C. et al Diagnosis of hepatic nodules 20 mm or smaller in cirrhosis: Prospective validation of the noninvasive diagnostic criteria for hepatocellular carcinoma. Hepatology 2007; 47: 97-104 . Im Internet: http://doi.wiley.com/10.1002/hep.21966
• 23 Roller FC, Fuest S, Meyer M. et al Assessment of Cardiac Involvement in Fabry Disease (FD) with Native T1 Mapping. Fortschr Röntgenstr 2019; 191: 932-939 . Im Internet: http://www.thieme-connect.de/DOI/DOI?10.1055/a-0836-2723
• 24 Deborde E, Dubourg B, Bejar S. et al Differentiation between Fabry disease and hypertrophic cardiomyopathy with cardiac T1 mapping. Diagnostic and Interventional Imaging 2020; 101: 59-67 . Im Internet: https://linkinghub.elsevier.com/retrieve/pii/S2211568419302013
• 25 Stadler A, Schima W, Ba-Ssalamah A. et al Artifacts in body MR imaging: their appearance and how to eliminate them. Eur Radiol 2007; 17: 1242-1255
• 26 Dietrich O, Reiser MF, Schoenberg SO. Artifacts in 3-T MRI: physical background and reduction strategies. Eur J Radiol 2008; 65: 29-35
• 27 Palsdottir HB, Hardarson S, Petursdottir V. et al Incidental Detection of Renal Cell Carcinoma is an Independent Prognostic Marker: Results of a Long-Term, Whole Population Study. Journal of Urology 2012; 187: 48-53 . Im Internet: http://www.jurology.com/doi/10.1016/j.juro.2011.09.025
• 28 Hancock SB, Georgiades CS. Kidney Cancer. The Cancer Journal 2016; 22: 387-392 . Im Internet: http://journals.lww.com/00130404-201611000-00005
• 29 Weiner C. Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (December 2013 Report of the Presidential Commission for the Study of Bioethical Issues). American Journal of Epidemiology 2014; 180: 562-564 . Im Internet: https://academic.oup.com/aje/article-lookup/doi/10.1093/aje/kwu217
• 30 Zugni F, Padhani AR, Koh DM. et al Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects of the general population: review and recommendations. Cancer Imaging 2020; 20: 34
• 31 O’Sullivan JW, Muntinga T, Grigg S. et al Prevalence and outcomes of incidental imaging findings: umbrella review. BMJ 2018; k2387 DOI: 10.1136/bmj.k2387.
• 32 Daher RT, Daher MT, Daher RT. et al Magnetic resonance imaging of the spine in a pediatric population: incidental findings. Radiol Bras 2020; 53: 301-305
• 33 Park HJ, Jeon YH, Rho MH. et al Incidental findings of the lumbar spine at MRI during herniated intervertebral disk disease evaluation. Am J Roentgenol 2011; 196: 1151-1155
• 34 Kozyrev DA, Constantini S, Tsering D. et al Pediatric posterior fossa incidentalomas. Childs Nerv Syst 2020; 36: 601-609
• 35 Maxwell AWP, Keating DP, Nickerson JP. Incidental abdominopelvic findings on expanded field-of-view lumbar spinal MRI: frequency, clinical importance, and concordance in interpretation by neuroimaging and body imaging radiologists. Clin Radiol 2015; 70: 161-167
• 36 DIN 25300-1:2018-05, Prozesse in der Radiologie_- Teil_1: Befundung eines bildgebenden oder bildgestützten Verfahrens. Beuth Verlag GmbH; Im Internet: https://www.beuth.de/de/-/-/281037633
• 37 European Society of Radiology (ESR). Good practice for radiological reporting. Guidelines from the European Society of Radiology (ESR). Insights Imaging 2011; 2: 93-96
• 38 Radiologische Befundung. Im Internet: https://www.befundung.drg.de/de-DE/3233/radiologische-befundung/
• 39 BGH, 26.01.2016 – VI ZR 146/14. 2016.
• 40 Frahm W, Walter A. Arzthaftungsrecht. 6. Auflage. Karlsruhe: VVW; 2018
• 41 OLG Schleswig, 24.06.2005 – Az.: 4 U 10/04. 2005.
• 42 Dendl LM, Teufel A, Schleder S. et al Analyse radiologischer Röntgendemonstrationen und deren Auswirkungen auf Therapie und Behandlungskonzepte in der Inneren Medizin. Rofo 2017; 189: 239-246
• 43 BVerfG, 17.06.1999–1 BvR 1500/97. 1999.
• 44 BSG, 31.01.2001 – B 6 KA 24/00 R. 2001.
• 45 Teschers SF. Qualitätskontrolle in der ambulanten bildgebenden Diagnostik in NRW 2011. Im Internet: https://repository.publisso.de/resource/frl:4310774
• 46 Hillman BJ, Olson GT, Griffith PE. et al Physicians’ utilization and charges for outpatient diagnostic imaging in a Medicare population. JAMA 1992; 268: 2050-2054
• 47 Levin DC, Merrill C. Sosman Lecture. The practice of radiology by nonradiologists: cost, quality, and utilization issues. Am J Roentgenol 1994; 162: 513-518
• 48 Sunshine JH, Bansal S, Evens RG. Radiology performed by nonradiologists in the United States: who does what?. Am J Roentgenol 1993; 161: 419-429 ; discussion 430–431
• 49 Schmidt C, Mohr A, Möller J. et al Radiologie unter Managed-Care-Bedingungen. Einsparpotenziale aus Sicht einer Krankenversicherung in den USA. Rofo 2003; 175: 1198-1206
• 50 Bundesärztekammer. Leitlinien der Bundesärztekammer zur Qualitätssicherung der Magnet-Resonanz-Tomographie. Deutsches Ärzteblatt 2000; 97: A2557-A2568 . Im Internet: https://www.aerzteblatt.de/archiv/24432/Bekanntmachungen-Leitlinien-der-Bundesaerztekammer-zur-Qualitaetssicherung-der-Magnet-Resonanz-Tomographie