Malpractice claims in interventional radiology: frequency, characteristics and protective measures.

PURPOSE: The use of interventional radiology procedures has considerably increased in recent years, as has the number of related medicolegal litigations. This study aimed to highlight the problems underlying malpractice claims in interventional radiology and to assess the importance of the informed consent process. MATERIALS AND METHODS: The authors examined all insurance claims relating to presumed errors in interventional radiology filed by radiologists over a period of 14 years after isolating them from the insurance database of all radiologists registered with the Italian Society of Medical Radiology (SIRM) between 1 January1993 and 31 December 2006. RESULTS: In the period considered, 98 malpractice claims were filed against radiologists who had performed interventional radiology procedures. In 21 cases (21.4%), the event had caused the patient's death. In >80% of cases, the event occurred in a public facility. The risk of a malpractice claim for a radiologist practising interventional procedures is 47 per 1,000, which corresponds to one malpractice claim for each 231 years of activity. DISCUSSION: Interventional radiology, a discipline with a biological risk profile similar to that of surgery, exposes practitioners to a high risk of medicolegal litigation both because of problems intrinsic to the techniques used and because of the need to operate on severely ill patients with compromised clinical status. CONCLUSIONS: Litigation prevention largely depends on both reducing the rate of medical error and providing the patient with correct and coherent information. Adopting good radiological practices, scrupulous review of procedures and efficiency of the instruments used and audit of organisational and management processes are all factors that can help reduce the likelihood of error. Improving communication techniques while safeguarding the patient's right to autonomy also implies adopting clear and rigorous processes for obtaining the patient's informed consent to the medical procedure.

Clinical Risk Management in radiology. Part II: applied examples and concluding remarks.

With the aim of providing a clearer understanding of the tools used for evaluating risk in the radiological setting and how they are applied, this second part presents two practical examples. The first is a proactive analysis applied to CT, whereas the second is a reactive analysis performed following a sentinel event triggered by a CT study allocated to the wrong patient in the RIS-PACS system.

Clinical Risk Management in radiology. Part I: general background and types of error and their prevention.

The present contribution, presented as an Editorial, addresses the issue of patient safety in Radiology: this topic, of great current National and Regional interest, has stimulated a strong focus on accidents and mistakes in medicine, together with the diffusion of procedures for Risk Management in all health facilities. The possible sources of incidents in the radiological process are exposed, due to human errors and to system errors connected both to the organization and to the dissemination of Information Technology in the Radiological world. It also describes the most common methods and tools for risk analysis in health systems, together with some application examples presented in Part II.

Ethical problems in radiology: medical error and disclosure.

In radiological practice, as in any medical activity, errors are inevitable despite being foreseeable and preventable. The approach to managing medical error and relations with patients prompt the need for resolving the ethical dilemma arising from conflicting legitimate interests. The solution to this dilemma is particularly complex in an environment in which the tendency to sue physicians for civil liability or incriminate them for criminal liability appears to be particularly high. The disclosure of error is undeniably useful in raising patient awareness, reducing their suffering, improving the quality of care and limiting the consequences of the damage. There does not appear to be any evidence to suggest disclosure modifies the probability of litigation against the physician.

Analysis of malpractice claims in mammography: a complex issue.

PURPOSE: The aim of this study was to analyse malpractice claims in mammography, estimate the specific risk of future claims and assess their impact on radiologists and society. MATERIALS AND METHODS: The study considered insurance claims filed by radiologists of the Italian Society of Medical Radiology (SIRM) over a 12.5-year period between 1 January 1993 and 30 June 2005. We isolated claims related to presumed diagnostic errors in mammography. We then estimated the number of claims arising from events in the study period that are expected to be filed over the next few years, before the expiration of the prescriptive period of 10 years. RESULTS: The total number of claims was 1,088. Of these, 302 were caused by alleged diagnostic errors in cases of cancer; 189 (62%) concerned breast cancers and mammographic technique. Assuming a constant frequency of claims filed by radiologists, we expect a further 637 claims relating to the study period, for a total of 1,725 claims, with 178 claims being related to breast imaging. The predicted rate therefore increases to 10.5 per thousand, equal to a risk of one litigation per radiologist per 10 years of work. CONCLUSIONS: The analysis uncovered a complex problem: although radiologists save many lives through the radiographic diagnosis of breast cancer and consequently contribute to the welfare of society, in practice, they can face real or alleged errors, with serious judicial consequences. Awareness of professional risk in current society may represent a valuable reference for choosing and planning to work in radiology.

The legal implications of error in radiology.

Evaluation of the legal implications of error in radiology and therefore the assessment of criminal and civil liability in the practice of the profession requires an analysis of how the public perception of the right to health has radically changed. This change has initiated a defensive approach to medicine and radiology that tends to be oriented towards precautionary measures, with a proliferation of often unnecessary imaging studies. In radiology, errors of omission or commission are frequent. A critical appraisal of the different types of error in radiology will help practitioners undertake the essential corrective measures. Through analysis of several cases derived from legal or insurance proceedings brought against radiologists, the most common forms of error are described, and their implications for criminal and civil liability are illustrated, although it is emphasised that the existence of an error does not always translate into the presence of malpractice.

Malpractice stress syndrome in radiologists and radiotherapists: perceived causes and consequences.

PURPOSE: Radiology is among the specialties with an increasing risk of litigation. Regardless of the outcome of legal proceedings, physicians who are sued usually perceive the claim as an assault on their integrity and may suffer psychological or physical effects known as "malpractice stress syndrome". MATERIALS AND METHODS: Two hundred and six radiologists and 108 radiotherapists responded to a questionnaire containing specific items concerning their perception of malpractice stress and their opinions about the causes of clinical errors, as well as an assessment of work satisfaction and general health. RESULTS: One third of physicians had been sued for malpractice. Age was significantly related to the occurrence of malpractice litigation. Radiological errors were purportedly related to occupational discomfort, and the latter variable was significantly associated with work dissatisfaction and a low level of psychological and physical well-being. CONCLUSIONS: Radiologists are well acquainted with medical malpractice and its causes; however, they have limited familiarity with clinical risk management practices and often ignore procedures of informed consent. A targeted educational effort is required to overcome these shortcomings.

A 12-year follow-up study of malpractice claims against radiologists in Italy.

PURPOSE: Malpractice claims filed against radiologists have become a relevant phenomenon in Italy and are a real risk in the radiologists' professional activity. MATERIALS AND METHODS: Insurance claims of Italian radiologists over the 1993-2004 period were anonymously assessed. A total of 990 insurance claims were classified according to cause: (1) missed diagnosis, (2) complications of the radiological procedure, (3) failure to order further radiological examinations, (4) radiation treatment, (5) slip-and-fall injuries, (6) miscellaneous causes. RESULTS: A total of 990 claims were filed during the period, with most claims being filed a considerable time after the event. As a consequence, the estimated incidence may be 44 per 1,000. In other words, 44% of Italian radiologists have received, or will receive, a summons regarding their professional activity of the past 10 years. Misdiagnosis made up the first and most important claim category. Missed abnormalities on breast radiographs accounted for the greatest percentage of cases. Missed bone abnormalities were the following most common diagnostic errors. Complications following interventional procedures accounted for 10% of all cases. A few cases resulted from the radiologist's failure to order further diagnostic examinations. Lastly, radiologists were frequently named as one of multiple defendants, together with medical (or surgical) doctors, in cases of patient death in roughly 6% of all cases. CONCLUSIONS: The risk of medical malpractice litigation for Italian radiologists is by now comparable to that for American radiologists. Strict adherence to radiological standards may be a means of reducing the risk of legal action and obviating litigation.

Risk management in radiotherapy: analysis of insurance claims.

PURPOSE: The purpose of this study was to analyse risk factors in radiotherapy with regard to those where protocols have been implemented for their prevention and those that are known but still present, thus requiring attention and remedial measures. MATERIALS AND METHODS: To demonstrate the existence of risk factors that have not been eliminated and that cause damage in radiotherapy practice, we examined insurance claims related to such radiotherapy procedures. Analysis of the claims made over a 10-year period was performed on the basis of radiotherapists (256 in 2004) insured with the professional association. The total number of claims in the 10-year period was 26. RESULTS: The type of claim was examined in each of the 26 cases, with as many as 15 being related to radiotherapy injury to tissues surrounding the neoplasm, thus confirming this to be the most frequent cause for insurance claims. The other 11 causes are also reported. CONCLUSIONS: Now that the historical causes of error that led to incorrect radiotherapy treatment have been eliminated through strict adherence to protocols, risk management in radiotherapy identifies side effects as the main source of risk for patients and physicians. Data analysis confirms the need to implement risk management procedures in radiotherapy in which insurance claims (15/26 cases) are motivated by side effects of treatment.

[Liability claims in radiology: an 8-year follow-up and future projections]. / Denunce di responsabilità civile in radiologia. Otto anni di osservazione e proiezioni future.

AIM: The analysis of the liability claims filed by Italian radiologists over the past 8 years allows us to evaluate past trends and predict the future evolution of litigation in radiology. MATERIAL AND METHODS: The assurance claims of Italian radiologists over the 1993-2000 period were anonymously evaluated. A total number of 422 claims were classified according to the cause as due to: 1) missed diagnoses; 2) complications; 3) failure to order further radiological examinations; 4) iatrogenic lesions due to radiation therapy; 5) slip-and-fall injuries; 6) miscellaneous cases. The data were analysed using descriptive statistics and curve estimation, i.e. selection of the regression models which best fit the observed data. RESULTS: Claims showed a linear increase from 1993 to 2000; however exponential increase could not be ruled out. The incidence risk-rate of claims rose over 45 per thousand persons/year. Misdiagnosis represented the first and most important claim category (>60% of total). Missed bone and joint abnormalities accounted for the greatest percentage of cases (37.8%). Missed abnormalities on breast and chest radiographs were the following most common diagnostic errors (25.2% and 15.0%, respectively). Within this class of claims, missed malignant lesions of the breast showed the greatest increase in number. Claims alleging complications resulting from radiological examinations or procedures were 13% of all cases. These complications mostly occurred following administration of i.v. contrast medium, or due to interventional procedures, or barium edema. Slip-and-fall accounted for 6% of cases. A few cases (0.7%) resulted from failure of the radiologist to order further diagnostic examinations. Finally, in roughly 12% of all cases, the radiologists were named as one of multiple defendants, together with medical doctors or other clinicians, in cases of patient's death. CONCLUSIONS: The risk of being sued for Italian radiologists is now comparable to that radiologists in the United States. Strict adherence to radiological standards will probably not be sufficient to reduce the risk of being sued. Special legislative measures may be required to obviate litigation.

[Complaints against radiologists in Italy]. / Denunce contro i radiologi in Italia.

INTRODUCTION: Legal claims against radiologists are a relevant phenomenon also in our country and represent an increasing risk for a radiologist's professional activity. MATERIAL AND METHODS: We reviewed the 1993-1998 insurance claims against Italian radiologists. We found 259 claims subdivided by type into: 1) misdiagnosis; 2) complications of the examination; 3) missed referral for further examinations/treatment; 4) (non)ionizing radiation treatment; 5) slip-and-fall injuries; 6) miscellaneous cases. All claims were reviewed anonymously. RESULTS AND DISCUSSION: Most of the 259 malpractice claims were filed late after the event, which makes the actual incidence of the phenomenon difficult to evaluate. Nevertheless the incidence of malpractice claims can be estimated at 32 per thousand people a year, meaning that an Italian radiologist's risk of being sued by a patient at least once in his/her professional life exceeds 1. Alleged misdiagnosis was the most frequent claim category. Missed bone abnormalities of any type, including fractures, dislocations, malignant lesions and other nonspecific conditions accounted for 52.9% of cases. Missed abnormalities on breast and chest examinations accounted for 17.5% and 15.3%, respectively. Within this claim category, missed breast lesions exhibited the most increasing trend. Alleged complications from radiological examinations accounted for 20% of cases and mostly involved i.v. contrast agent administration, interventional procedures and barium enema. Slip-and-fall injuries, where the patients falls off the examination table, slips on the floor, bumps into a piece of equipment and so on, accounted for 7% of cases. Missed referral to further examinations accounted for 1.5% only. Finally, radiologists were frequently sued as one of many defendants, together with medical/surgical doctors, in case of patient's death, in 20% of all cases. CONCLUSIONS: Italian radiologists currently run the same risk of being sued for malpractice as their American colleagues. Strict compliance with radiological standards is recommended to try to decrease the risk and to obviate litigation.

Diagnostic imaging of euthyroid goiter.

In diffuse or nodular euthyroid goiter, diagnostic imaging is indicated to define, by sonography, the morphology, size and structure of the goiter and to evaluate, by scintigraphy, the regional thyroid function. The instrumental diagnosis of thyroid nodule is essentially based on sonography, scintigraphy and (US-guided) needle aspiration cytology. The evaluation of some sonographic findings (echogenicity, calcification, lesion margins and presence of peripheral ring) may direct to the differentiation of a benign or malignant lesion. The role of color Doppler in the characterization of thyroid nodules is still controversial. Scintigraphy provides information on nodular function, being also the only exam able to show the presence of autonomously functioning thyroid tissue ("hot" nodule), whose diagnosis allows to rule out the presence of thyroid carcinoma with a very strong probability. In intrathoracic goiter, CT and MRI and indicated to show the continuity with the cervical thyroid and to define the relationships with adjacent structures. Radioiodine scintigraphy shows with high (> 90%) diagnostic accuracy the thyroid nature of a mediastinal mass (plunging goiter).

[Malpractice claims against radiologists in Italy. Trends in 1993-1995]. / Denunce di responsabilità civile contro i radiologi in Italia. Andamento del fenomeno nel triennio 1993-1995.

The insurance claims against Italian radiologists over a three-year period (1993-1995) were anonymously reviewed, based on pertinent data provided by the Insurance Company of the Italian Society of Medical Radiology. The incidence risk-rate of claims was 11.4 per thousand persons/year. The overall claims rate increased in 1995. Alleged malpractice accounted for more than 85% of the claims. Misdiagnosis represented the first and most important claim category (43.4% of the total). The most common misdiagnosis was the failure to diagnose fracture or dislocation. The second most common plaintiff's misdiagnosis argument was the failure to diagnose breast cancer. The second most frequent claim category (35.8%) were complications, frequently occurring during interventional radiology and contrast media injection. A minority of claims (11.3%) originated from patient injury occurring in the radiology department during exam execution. Finally, radiologists were frequently sued together with medical (or surgical) doctors in case of patient death, according to an Italian law (Art. 589 P.C.). Claims were more frequent in public health services and they were mostly related to emergency examinations and interventional procedures.

[Occupational risk among magnetic resonance workers. Analysis of the literature]. / Il rischio professionale negli addetti alla Risonanza Magnetica. Analisi della letteratura.

It was observed that "medical diagnosis utilizing Magnetic Resonance (MR) scanners may be one of the first modalities in which there is more risk for the operator of the equipment than for the patient" (Young, 1984). Despite this statement, only a few studies have been devoted to the assessment of occupational hazard in MR imaging personnel. The principal features associated with MR systems are: static magnetic fields, time-varying magnetic fields, and radiofrequency irradiation. Potential medical effects related to these hazards are reviewed. Static magnetic fields are known to induce in vitro changes in enzyme kinetics, orientation changes of macromolecules and subcellular components, distortion of ion currents and magnetohydrodynamic effects. Possible mechanisms for static magnetic field bioeffects include the exertion of magnetic forces, the induction of voltages, and other mechanisms (proton tunneling, ion cyclotron resonance) that are yet scarcely known. Human epidemiological studies on static magnetic fields are mainly based on subjective observations, and lack adequate control for confounding factors. Time-varying magnetic fields in the extremely-low frequency range have been associated with both occupational and non-occupational adverse health effects. Exposure to electromagnetic fields in office workers has been related to an increased rate of abortion; the vast majority of studies in this field, however, did not reach any significant result. Many literature reports support the evidence of an elevation of cancer risk in subjects exposed to residential and occupational ELF fields. Although such observations are not yet proved, the alleged occupational risk in magnetic fields exposure should induce to optimize exposure in MR imaging workers.

[Integrated diagnostic imaging in the study of tumors of the periskeletal soft tissues]. / Iter diagnostico integrato nello studio dei tumori dei tessuti molli perischeletrici.

Integrated diagnostic imaging is nowadays an extremely valuable tool in the study of periskeletal soft tissue tumors, relative to their diagnosis, prognosis and treatment. In the past, difficulties arose from the complex embryogenetic factors causing the tumors, from the different growth patterns and courses of the lesions themselves, and finally from poor development of technology specifically designed to study the soft tissues. Today, such new imaging methods as CT and MRI exhibit special features allowing the accurate study of the soft tissues and their conditions. The basic method to investigate the relationship of soft tissues to skeleton is still conventional radiology--or xeroradiography--with the soft-ray technique. However, its limitations are well known. US, with the appropriate probes and the correct technique, with comparative and dynamic studies, yields precise information, especially relative to benign tumors. CT allows not only lesion but also tumor staging, together with the study of adjacent structures; moreover, CT angiography provides accurate information as to tumor vascularization. The role of MRI, though still debated, looks extremely promising. Finally, as for angiography, the method has been replaced by newer technologies and thus limited to preoperative vascular mapping.

[Ultrasonography in the monitoring of internal biliary drainage using an endoscopically inserted prosthesis]. / L'ecografia nel controllo dei drenaggi biliari interni mediante endoprotesi per via endoscopica.

Endoscopic retrograde biliary drainage by means of transtumoral endoprostheses is an effective technique for palliative decompression of malignant biliary obstruction. However, serial follow-up is required for an early detection of eventual long-term complications. In the present study 37 patients with malignant biliary obstruction, treated by endoscopic insertion of one or more biliary stents, were prospectively evaluated by sonography, with serial clinical and US examinations up to 10 months. In our experience, sonography could correctly identify both the endoprostheses and their location in the biliary tract. Most important, sonography has proved to be a sensitive method to detect possible stent dysfunctions, besides providing with information about the progression of the underlying malignancy.