1.30: Medicolegal aspects in radiology

Nidhi Prabhakar, Chirag Ahuja, Veenu Singla, Tulika Singh

Medico legal Awareness is a must for every Doctor

V P Singh

Medical malpractice and radiology

Since times immemorial, the medical professionals have been guided and bound by the Hippocratic principles. The primary tenet has always been “primum non-nocere,” meaning first, do no harm. The moral principles of practicing medicine are ingrained into us right from medical school and get strengthened during the residency-training period. The “professional ethics,” as this practice is rightly called are a set of moral principles that govern a person’s behavior during one’s professional activity. These principles are much more important to doctors than other professions, simply because the patient completely lets his health and well-being in our hands expecting us to fulfill his medical expectations to the best of our abilities. However, there are times when there occurs an apparent breach in this understanding between the doctor and patient which may lead to the generation of various law-suits and claims, more so from the patient. The causes can be multifold ranging from the limited awareness of the patients regarding their disease processes, the expectation of complete cure when none exists, issues of increased treatment costs, and at times, suboptimal treatment provision.

The medical profession has lately been equated with other professions in the service industry, with the relationship between doctors and patients being compared to providers and customers. This has created a dent in the doctor–patient relationship, which was previously based on trust and faith. There have been increased incidents of violence towards doctors, which has adversely affected the morale of these professionals. Ironically, to keep themselves safe, there have been reports of physicians playing safe by referring complex emergency cases to higher centres, fearing backlash from the attendants in case the clinical condition of the patient deteriorates under their care. This is ultimately leading to a compromise in patient care with mutual trust taking a beating. A famous example has been a significant reduction in the imaging specialists reading mammograms in the west because stricter laws have held them responsible even for the tiniest of the shortcomings, e.g. delayed communication with the referring physician regarding the image interpretation. We, as radiologists, need to be equipped with the latest knowledge of medicolegal information to safeguard our interests while at the same time being vigilant towards our duties and responsibilities.

Medical/radiological (mal)practice

According to Merriam Webster dictionary, malpractice refers to a dereliction of professional duty or a failure to exercise an ordinary degree of professional skill or learning by one rendering professional services which result in injury, loss, or damage. In simple words, one has committed malpractice if one has not carried out one’s duties befitting a particular profession to the best of one’s implied ability. It is of utmost importance to be true and committed to one’s profession. Any breach in the core principles governing good clinical and radiological practice may cause a practitioner to be judged by courts based on principles of autonomy, individual dignity, beneficence, non-maleficence, justice, prudence and accountability. It becomes imperative for the practicing radiologist to be aware of the legal issues that need to be fulfilled while practicing one’s field. The following section briefs about the various aspects one needs to understand to be able to practice better.

Provider–consumer relationship

In the medical domain, doctor–patient relationship had been of pious trust, faith and understanding since times immemorial. It had been beyond the boundaries of consumerism for a very long time. However, with people’s expectations rising and tolerance and patience decreasing to the lowest levels, an element of expectation has come into play especially when it seems to the patient that the medical service that they are seeking is being paid for. This is not completely non-warranted too as the patient puts complete trust and faith in the treating doctor whom he approaches. The doctor thus should be empathetic and truthful to the patient and his self, lest he induces harm on the patient and his reputation.

Another aspect that the practicing radiologist must realize is that the confidentiality of the patient who seeks opinion is important and related medical information should not be disclosed to the public at all costs unless required by legal experts. Thus, all reports pertaining to the patient’s radiological examination should be conveyed or handed over to the patient or the referring physician. Needless to say that investigations should be done based on the patient’s medical requirements. Unnecessary revenue-generating imaging tests should not be encouraged. The same should also be conveyed to the referring clinician who inadvertently or purposefully does so.

The radiologist is required to maintain the dignity of one’s profession by taking a written informed consent before any investigation, explaining the examination in detail, performing the imaging in a conducive patient-friendly manner, e.g. performing transvaginal ultrasound after detailed communication and in presence of a female attendant and not disclosing specific information to the patient or his/her attendants which is banned by law, e.g. sex determination during an obstetric ultrasound examination. One should not give way to emotional, financial or social pressures.

Radiation protection

The branch of radiology goes hand-in-hand with radiation as many of the investigations are based on X-ray emissions. It thus becomes imperative for the radiologist to be careful while investigating patients while at the same time take appropriate strategies to mitigate the harmful effects of radiation to the patient, staff and himself. The exponential increase in radiological examinations over the last decade has added to the insult with radiology now accounting for over 98% of manmade human radiation exposure. The onus of referring for a particular examination lies on the physician; however, if the radiologist believes that the required examination is not required or another examination with fewer radiation effects will do a better job, it is one’s duty to convey it to the referring physician. Also, for patients undergoing multiple follow-up radiological examinations involving radiation, the radiologist must come to the fore-front and advise the clinician on the aspect of radiation hazards and analyze the risk–benefit ratio before performing the said investigation. Pregnant patients should be discouraged to undergo X-ray based examination unless necessary for life-threatening indications. It is one’s duty to ensure regular maintenance checks of X-ray/Computed Tomography (CT) scanners, compliance with radiation badge requirements for self and staff, and avoid excessive radiation to the patient. He should adhere to the principle of ALARA (as low as reasonably achievable). Herein, 3A’s play a prominent role namely awareness (to patients, physicians and allied professionals), appropriateness of investigations assigned to a patient, and audit of the effectiveness of the referral processes.

The staff should be provided lead aprons, protective gloves, lead screens and personalized radiation dose monitoring equipment. The pregnant staff should be delegated radiation-free duties due to obvious reasons. It is recommended that the radiation records of the departmental personnel should be retained until the entire tenure of staff’s employment with some recommending even until 75 years of age. It is also wise to transfer these records to the next employer in case an employee switches jobs.

Protecting the general public in the vicinity of the radiological practice is also the radiologist’s concern and duty. Erecting and displaying appropriate signage outside places of radiation (radiographic and CT equipment) is warranted. The attendants should be asked to stay in waiting areas and should be allowed only in special conditions that too with full radiation protection with lead shields/aprons. It is advisable to employ a radiation safety officer for micro-management of radiation issues. Periodic surveillance of radiation levels should be mandatory in the workplace.

Intervention radiology practice

With the advent of Interventional Radiology (IR) as a distinct sub-speciality of radiology, the medicolegal concerns have increased for the speciality as the former involves direct patient interaction and treatment modalities immediately affecting patients. The risks related to IR practice match with that of surgery than to diagnostic radiology. Thus, IR specialist needs to be much more readable and learned regarding legal principles of medicine. The most important aspect for an IR practitioner is to develop a rapport with the patient who has been referred for the procedure. The nature of the disease, available treatment options, need for the interventional procedure including its risks and benefits need to be discussed with the attendants before obtaining written consent. The procedure should be performed to the best of one’s ability in congruence with regional and international practice guidelines. A special mention of the senior’s responsibility for the patient outcome is necessary wherein the principle of vicarious responsibility or “respondeat superior” holds true for all consequences related to the procedure performed by one’s subordinate.

Legal aspects in radiology

With the consumer–provider relationship gaining momentum in medical practice, the physician community has fallen under constant surveillance. It has become of utmost importance to be aware of the current standing with respect to legal medicine. The media has added fuel to fire by emotionally highlighting the medicolegal relevance of error in medical practice, a practice that has increased the distance between the patients and doctors.

The perception of the public has changed from being respectful to provocative with a heightened expectation of a right to health care. There is reluctance in accepting disease as a biological event by patients with a growing conviction of omnipotence of medicine and resorting to medical malpractice suits. This has led the medical providers to be on the defensive for the simple reason to save themselves. Pertaining to radiology, the malpractice lawsuits can be against errors in diagnosis, an act of commission or omission during an interventional procedure, failing to inform the relevant critical finding to the treating physician and misappropriate use of modalities, in that order of frequency.

In diagnostic radiology, errors may result either due to an inappropriate organization or management processes or in image perception/interpretation, the latter being the human error. Radiological diagnosis may thus either reflect perceptive error (inability to register an abnormal radiological finding) or interpretative/cognitive error (failure to correctly interpret a radiological finding due to insufficient knowledge or experience).

Consumer Protection Act

The previous Consumer Protection Act (COPRA) came into being in 1986 with the latest one being passed in 2019. The Consumer Protection Act, 2019 was notified on 15-07-2020 and came into force on 24-07-2020. It is aimed at protecting the interests of consumers. The services that come under the purview of this act may be defined as “service of any description which is made available to potential users and includes, but not limited to, the provision of facilities in connection with banking, financing, insurance, transport, processing, a supply of electrical or other energy, telecom, boarding or lodging or both, housing construction, entertainment, amusement or the purveying of news or other information, but does not include the rendering of any service free of charge or under a contract of personal service”. The term “healthcare” was removed from the final definition of services as mentioned in the act after multiple objections by the medical fraternity. However, the further perusal of the wording of the definition reveals the phrase “includes but not limited to”. This implies that healthcare may still be included under the ambit of the consumer protection act as a service. The COPRA 2019 has left this open to judicial interpretation. The doctor–patient relationship is also established as a consumer provider. As a provider, the radiologist is liable to be prosecuted if negligence is proved during one’s practice. This might seemingly be harsh on us but one has to live with it, providing the best possible health care to “our” patients but maintaining our legal safety at the same time. It is also advisable to get indemnity cover for oneself to safeguard from the hefty financial liability that may arise at times.

When is the medical professional prosecuted?

“Negligence is the breach of a duty caused by the omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs would do or doing something which a prudent and reasonable man would not do”. When applied to the medical field this statement may simply be read as an act or an omission by a doctor that deviates from the accepted standard level of medical care.

A doctor may be prosecuted for negligence under both civil and criminal law. He/she may also face disciplinary action by the Indian Medical Council.

Civil liability may be pursued under

(a) Tortious liability (Law of torts)
(b) Medical Negligence under Consumer Protection Act

In cases of civil negligence, the erring physician must provide monetary compensation to the patient or dependents of the deceased.

There are three components of negligence:

(1) The doctor has a legal duty to exercise due care towards a patient under his/her management within the scope of the duty
(2) There must be a breach of the above-mentioned duty
(3) There must be damage as a consequence of the act

Negligence can only be acted upon when damage occurs. All three requirements must be satisfied in the court of law.

A doctor must have a reasonable degree of skill and knowledge while treating a patient and must exercise a reasonable degree of care. The standard of care that is expected from a medical professional is “that of a reasonable average.”

The Supreme Court, in Indian Medical Association versus V.P. Shantha and Ors has clarified that any patient treated at either private or government hospital may approach the consumer forum for damages under the Consumer Protection Act, 1986. Any consultation, diagnosis or treatment is considered as a service under this act (except where the service is given without charges to every patient).

Criminal liability is affixed as per the provisions of the Indian Penal Code, 1860 (IPC). These do not differentiate between medical or non-medical negligence. For example, section 304A IPC may be used to deal with a death in a road traffic accident or due to medical negligence. Similarly sections 337 (causing hurt) and 338 (Causing grievous hurt) may also be used in medical negligence.

There are no clear cut criteria to differentiate civil versus criminal negligence. In the Jacob Mathew v. State of Punjab case, the supreme court has stated that the expression “rash and negligent act” occurring in section 304-A of the IPC should be qualified by the word “grossly” To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which has resulted was most likely imminent.

No large studies have evaluated the causes of malpractice litigation amongst Indian radiologists. However, research on malpractice in the United States has shown that the most common cause of malpractice litigation against radiologists was erroneous diagnosis followed by procedural complications and inadequate communication. Errors related to imaging findings of the breast were found to be the most common cause of litigation. In Italy and Europe, the incidence of malpractice litigation per year ranged from 3.6% to 12.6%. Fileni et al. reported that most of the insurance claims against radiologists in Italy involved interventional procedures. In a more recent study regarding litigation for malpractice in radiology in the Netherlands Kwee et al. observed that most of the cases were in breast and musculoskeletal radiology (18.8%). Other specialties that were commonly involved included interventional radiology, head and neck imaging, and abdominal imaging (each 12.5%) followed by neuroradiology, vascular imaging and chest imaging. While analyzing litigations in image-guided procedures in the United States, Branach et al. have reported that litigation was most common for complications related to angiography. Most of the complaints were regarding complications that occurred either during or within 3 days of the procedure. Research from United Kingdom has revealed that the foremost reasons for litigation in interventional radiology are substandard technique (49%), bleeding post-procedure (22%) and Consent related (12%).

A radiologist’s report is a legal document that will determine whether he/she has followed the required standard of care. Basic errors in radiology reporting can be reduced by strictly following certain basic principles, which are highlighted in Table 1.30.1. To protect themselves from litigation, radiologists should abide by the 5 Cs, namely compassion, competence, care, communication, and clarity.

TABLE 1.30.1

Important Points to be Considered While Writing a Radiology Report

1	Start by grossly studying the images, even prior to obtaining clinical information and before referring to previous reports.
2	Revise in your mind the technical aspects of image acquisition, e.g. positioning in radiography, pulse sequences in MRI, etc.
3	Return to the image and follow a patterned approach in looking at the images after checking the patient data. Try to create a three-dimensional image.
4	Once the abnormality is found, determine the anatomy and radiopathology of the abnormality.
5	Final mental conclusion is often based on image interpretation with the knowledge of the suspected disease pertaining to its incidence in the area.
6	Write the report after giving it a title and description of the image view, e.g. chest X-ray PA view. It is also important to indicate the techniques used, e.g. sequences acquired in MRI.
7	Proof read the report for typographical errors.
8	Don’t hesitate to issue addendums in case one finds new findings, previously missed.
9	Miscellaneous a. Report should be crisp and not too lengthy. b. Negative reporting is also important especially if the clinical information is suggestive but imaging is negative. c. Patient information and clinical details should be verified. d. Use familiar words and get anatomical terms right. e. Recommend further diagnostic investigations, if diagnosis is inconclusive.

Compassion

• It is the responsibility of any radiologist to form a good working relationship with a patient. This is even more important in interventional radiology. As a doctor, one must show empathy towards all patients.

Competence

• Standardized imaging protocols should be used in each case.
• One must perform adequate quality control for each imaging study and repeat the study/views as necessary. Additional sequences/cross-modality imaging should be used as and when needed. For example, in cases of breast lumps, screening sonography is essential along with a mammography X-ray for a complete diagnosis.
• All images should be evaluated in a systematic manner to minimize misdiagnosis.
• A radiologist should always be updated with recent guidelines and technologies.
• A radiologist should not hesitate to seek help/opinions from other colleagues if he/she does not have expertise in a particular area.

Care

• A radiologist must ensure that all patients are subjected to the requested test.
• Radiation exposure must be minimized.
• Always ask for LMP from female patients.
• The date and time of the examination should be documented in the report. The computerized clocks on CT/MRI/X-ray machines should be periodically checked.
• The name and identification details mentioned in the films provided to the patient and the report must be the same.
• Care must be taken while writing the site/side/level of a lesion in the report.
• Comparison with previous studies is a must. At the same time, one must not be biased by the diagnosis in previous reports.
• Proof read the report at the end before dispatch.
• While examining female patients, male radiologists should ensure that the examination is carried out in the presence of a female attendant.

Communication

• Always consider the clinical history carefully. If more information is needed, talk to the patient or contact the referring physician directly.
• Always discuss with the patient each step of the procedure/study that is to be performed.
• Suggest further appropriate evaluation mode to reach the diagnosis as and when necessary.
• Communicate all urgent and important unsuspected findings which require urgent management with the referring physician directly. If one cannot reach a particular physician, then the patient may also be explained regarding the urgency of a diagnosis.

A complete informed consent is also an indispensable part of a doctor’s armamentarium against litigation. This will be discussed in the subsequent section.

Consent in radiology practice

Consent may be defined as providing permission for something to happen or an agreement to do something. The key elements of consent in medical practice are

1. Voluntary nature.
2. It must be informed – what is going to be done, why is it being done, what will be the result (including possible risks), what will happen if it is not done and what are the alternatives.
3. It must be given in writing by a person who has the capacity to give it and should be witnessed preferably by a person unrelated to both the parties.

Informed consent is one of the most important aspects of patient treatment. Putting in simple words, consent is the process wherein the patient is given an opportunity to understand the need, expected results, efficacy and side effects of any procedure/scan. The following points highlight the various aspects related to consent, which should be strictly followed by the radiologist before embarking on any procedure.

1. Consent acquisition results from an ethical obligation and a legal compulsion.
2. The radiologist who would be carrying out the procedure should preferably take the consent. Though ethically, his subordinate or assistant may fill his shoes, it may create legal problems if any complications arise.
3. The patient should be communicated and discussed in detail about the relevant issues pertaining to the procedure in the language that he or she can understand and comprehend.
4. Only in cases where the patient is not neurological intact to understand and comprehend the consequences of the procedure should the next kin be informed in detail and consent obtained from him/her.
5. Complete freedom should be given to the patient to make an informed choice.
6. The patient should be informed about the alternative procedures available and should be encouraged to seek a second opinion from another professional in the same field if he/she desires.
7. A written consent form needs to be signed by the patient who is in a good state of mind and consciousness while agreeing for the procedure/scan.
8. The consent form should have extensive, appropriate and significant details relating to the scan requirement, nature of the procedure, expected results and adverse effects.
9. The final consent on which the patient signs should be in the patient’s language to prevent any misinterpretation.
10. The consent document should be signed by a witness who can identify the patient.
11. The consent can be by signature or thumb impression.
12. The signed consent form needs to be stored for a sufficient period (a minimum of 3 years) for individual physicians as per MCI guidelines.
13. The process of consent may not be required in an emergency when a life-saving procedure is required, while the patient is not in a position to give consent and no guardian is identifiable; this protection is given under Section 88 of the Indian Penal Code.