|Year : 2015 | Volume
| Issue : 3 | Page : 129-134
Medico-legal issues in radiology: Indian context
Shoibam Subhaschandra Singh, Naveen Jayaram
Department of Radioiagnosis, Regional Institute of Medical Sciences, Imphal, Manipur, India
|Date of Web Publication||1-Dec-2015|
Shoibam Subhaschandra Singh
Department of Radioiagnosis, Regional Institute of Medical Sciences, Imphal, Manipur
Source of Support: None, Conflict of Interest: None
The growing number of legal issues in the various fields of medical specialities in the current era has been no different in radiology. Errors in diagnosis and interventional procedures are the areas of legal liability in the practice of radiology. The complexity associated with such issues has been the major concern of practicing radiologist. In this article, an attempt has been made to focus the legalities in the field of radiology with emphasis on the Indian set up and existing Laws governing such actions.
Keywords: Legal issue, malpractice, PCPNDT act, radiology
|How to cite this article:|
Singh SS, Jayaram N. Medico-legal issues in radiology: Indian context. J Med Soc 2015;29:129-34
| Introduction|| |
Radiology is a specialized branch of medicine using medical imaging technologies to diagnose and treat patients. Like other specialties, radiologists are also liable to claims of malpractice due to diagnostic errors. Errors in radiology differ from errors in other clinical specialities in that the radiological image is a permanent objective record that can be reviewed to check for missed lesions. Such errors when causes significant damages to the patients, in the form of injury or death, attract malpractice claims. The professional role of the radiologist has evolved with increased involvement in the clinical management of patients. This is especially so with the advances in minimal invasive procedures in interventional radiology. This new area adds to the already existing liability from errors in diagnostic radiology. 
Apart from the medical malpractice, another important area of legal importance for Indian radiologists is Pre-conception and Pre-natal Diagnostic Techniques Act (PCPNDT- Act) which has stringent rules and regulations to curb female feticide. It is very important to follow and strictly adhere to the guidelines laid down under the act to avoid legal actions.
This article focuses on the issues of professional liability in the field of radiology with special reference to Indian set-up.
| Medical Malpractice and Radiology|| |
The current concept of malpractice dates back to 1768 in the publication by Sir William Blackstone's Commentaries on the Laws of England, in which professional malpractice and physicians were linked together.  The term "medical malpractice" refers to the professional negligence of doctors, surgeons, nurses and other healthcare professionals. This is the most common complaint registered against a doctor. 
Medical malpractice is said to have occurred when the healthcare professional discharged a substandard level of care and, as a result of which the patient suffered damages. Thus, the three essential components to prove medical malpractice lawsuits are breach of duty, causation and resulting damage.  Let us consider an example, where a radiologist failed to diagnose a malignant pulmonary nodule which was visible on initial chest x-ray and the cancer went untreated. Five years later, the patient presents with wide spread metastases and dies. In this case, radiologist is responsible for the wrongful death of the person because, detection of malignancy in the initial x-ray would have resulted in seeking medical treatment. This constitutes the breach in the accepted standard of care within the professional field of radiology. 
Study by Whang et al. showed that the most common cause of malpractice claim against radiologists is error in diagnosis i.e. failure to diagnose. This was followed by procedure related complications and next by inadequate communication with either patient or referring physician. The most common procedure related complication included vascular injury during angiography and other interventional procedures. In USA, breast related imaging was the most common organ related malpractice litigation followed by non-spinal and spinal fractures.  Similar observation was also noted by Fileni et al. in malpractice suit against Italian radiologists. However, in their study it was skeletal system followed by breast imaging accounted for the maximum organ related diagnostic errors. 
Radiologic errors in diagnosis can be of two types, cognitive and perceptual errors. Cognitive errors are those in which an abnormality is seen but its nature is misinterpreted. The perceptual errors or the radiologic 'miss', are the one in which a radiologic abnormality is not seen by the radiologist on initial interpretation.  Of the two types, perceptual errors resulting in false-negative errors are the most frequent accounting for 80% and the majority of which includes failure to diagnose breast cancer on mammography, lung nodules on chest x-ray and fractures on skeletal radiographs. Such errors of perception is influenced by multiple factors like lack of knowledge, faulty reasoning, under reading, inadequate exposure, limitation inherent to the diagnostic test, non communication with the referring clinician, no adequate clinical information available etc. Certain psychophysiological factors affecting visual perception like level of observer alertness, workload and fatigue, duration of observer task, distracting factors, conspicuity of abnormality and others also contribute to errors. ,,,
Not all missed findings represent the breach in standard of care. When the radiologist reviews an imaging study obtained with proper technique and exposure and fails to perceive an abnormality, which, in retrospect, is apparent, such 'error in perception' cannot be labeled negligence. This is because, knowing the present anatomic site of the lesion, one may in hindset can easily pick-up the subtle early lesion which was actually beyond the threshold of detection by the radiologist. , This was upheld by the 1992 Delaware State Supreme court decision over a malpractice claim against radiologist and orthopaedician for missing subtle osteosarcoma lesion in the knee x-ray. It was stated that "An 'average' radiologist is expected to diagnose 'obvious' lesions and not the 'subtle' ones. To expect the average radiologist to diagnose all the subtle lesions would be to elevate the average physician to the perfect physician, and perfection is a standard to which no profession can possibly adhere." The final judgment was ruled in favor of radiologist. 
Other infrequent causes of malpractice suits against radiologists includes, failure to alert or communicate with the referring clinicians of important but unsuspected findings, failure on the part of the radiologist to suggest appropriate next procedure when diagnostic specificity is required, incorrect examinations obtained on patients etc. ,
Once a person claims a malpractice who is referred to as 'plaintiff', should establish the existence of all the three elements of malpractice i.e. breach of duty, causation and damages. If any one element is missing, then the malpractice claim is not valid. ,
Radiologist as a defendant in malpractice claim: Do not panic or lose confidence when a malpractice is claimed. One should act calmly. On receiving such court notice, the document should be read carefully to determine the nature of claim. Later, assemble all the related documents i.e. physician referral form, consent form, acquired images, reports etc. Do not alter any medical records. Immediately contact the medical defense lawyer and insurer. An investigation committee will be formed which includes renowned and senior doctors who are experts in the particular discipline. Depending on the committee opinion, if the radiologist is proved negligent, necessary action will be taken up according to the nature of act. ,
In Indian Law, doctors can be held responsible under: ,
- Civil suit consumer court: Consumer protection act (CPA) considers patient seeking medical care as 'consumer' and doctors attending to it as 'service provider'. Though act was passed in 1986, medical services were included under the act in 1992. Hence, doctor-patient relationship/contract is bound to CPA. This is civil remedy where the relief is sought in compensation.
- Case in medical council: A case against a doctor can also be filed in medical council of the concerned system of medicine. Medical Councils do not have powers to award compensation or to imprison. It can only warn the doctor, suspend or revoke the license.
- Case of criminal negligence: The main section under which a criminal case is filed against doctors is Section 304A of the Indian Penal Code which deals with causing death due to rash and negligent act. The punishment is two years imprisonment or fine or both. Other sections include Sec 337 (hurt) and Sec 338 (grievous hurt).
- Law of Torts.
| When is the Medical Professional Prosecuted?|| |
The Supreme Court of India in the case of Dr. Jacob Mathew vs. State of Punjab declared that the professional can be held liable for negligence when:
- He was not possessed of the requisite skill which he professed to have possessed. (and/or),
- He did not exercise, with reasonable competence in the given case, the skill which he did possess.
It was also stated that "The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence." 
In order to protect oneself from malpractice litigation, following points should be remembered: ,,,,,,,,,,,,,
- Always consider the clinical history viz, history of presenting illness, past history and occupational and drug history. If more information is needed, contact the referring physician directly.
- Develop good rapport with the patient.
- To obtain written informed consent after explaining the risks and benefits of the imaging procedure. Explain the limitations associated and available alternatives, if any.
- To confirm that the patient is subjected to the test requested and follow ALARA principle to limit the radiation exposure.
- Date and time of the examination should be documented. Regular check on the computer clocks to be done to avoid out of synchronization with the actual date and time.
- Follow the recommended standard protocols to image the anatomic structure.
- To obtain satisfactory image if the initial image quality is not adequate for interpretation.
- Consider additional views if necessary.
- Systematically evaluate the images so that the lesions do not go unnoticed.
- Always consider and compare previous imaging study if available.
- Do not jump into conclusion or get biased with the previous reports.
- Document the noted abnormality in the report and reach a conclusion.
- Proofread the report. Correct the typographical errors. This written report determines whether the radiologic standard of care is conformed to or breached, once a malpractice lawsuit is filed.
- Suggest further appropriate next step to increase diagnostic specificity, if required.
- Communicate with the referring physician when important unsuspected finding is noted that which require immediate management.
- While examining female patients, male radiologists should ensure that the examination is carried out in the presence of female attendant.
- When the radiologist feel that he is not expertise in the diagnostic or interventional procedure requested, consider seeking the help or referral to another colleague.
- Radiologists should regularly get updated with the new technologies and current practice guidelines.
| Consent In Radiology Practice|| |
Mrs. X who had staghorn calculi in right kidney was referred by her treating urologist to the radiology department for intravenous pyelogram (IVP). On the day of appointment, the radiologist was called to do an IVP on Mrs. X, in between covering two other areas in the diagnostic clinic. The doctor injects the intravenous iodinated contrast and ran off to look for another patient in CT scan. Within few minutes, Mrs. X develops anaphylactic reaction and dies despite the best efforts to revive her by the emergency team. Case was filed against the radiologist by her husband alleging malpractice. Though anaphylactic reaction to contrast agents is one of the common potential complications, radiologist was found guilty and responsible for Mrs. X death for not obtaining informed consent. The litigation was settled by paying the plaintiff huge money. The above illustration emphasizes the importance of obtaining consent which could serve as a defense against the allegations. Two main indications or instances where consent is necessary in the daily radiology practice are before administering an intravenous contrast and before performing any interventional procedures. ,
Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law. In consent, there are four separate but correlated elements that are: Voluntariness, capacity, knowledge and decision-making. It can be either implied or expressed (oral or written). 
Expressed consent includes informed consent, which is the ideal form of consent because it includes all aspects of meaningful decision-making. Informed consent provides the comprehensive information to patients on the imaging procedure to be performed which includes both advantages and potential risks and complications. Standard hospital consent forms will not be considered as consent for diagnostic procedure or therapeutic treatment. ,
Certain necessary steps to be bore in mind while obtaining a legally valid consent: ,,,,,,,,
- Consent should be obtained in an atmosphere as free from coercion as possible.
- Comprehensive consent form should enable balanced judgment by the patient and his/her relative by explaining the procedure, its risks and benefits, as well as any alternatives if available.
- The signature or thumb impression of the patient must be taken.
- In case of legally incompetent patient, the family of the patient becomes the decision maker. Spouses' decision is considered the most important, followed by immediate relatives such as parents, children, and siblings.
- No changes can be made in the form thereafter. Such an attempt raises the possibility of suspicion.
- Preserve the document in the departmental records.
| Pre-Conception and Pre-Natal Diagnostic Techniques Act (PCPNDT Act)|| |
A national law, the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act (PNDT Act), 1994 was enacted to prevent sex determination and came into force on January 1st, 1996. In the meantime, new techniques had been developed that used pre-conception or during-conception sex selection. To bring these new technologies under the purview of the Act, the law was amended in 2003 and is renamed the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act (PCPNDT Act), (effective from February 14, 2003). 
Despite the enactment of the Act in 1996 with subsequent amendment in 2003, the decline in Child Sex Ratio (CSR) from 927 girls per 1000 boys in 2001 to 914 in 2011 was evident, reflecting the continued practice of sex selection.  Hence, the Act was again amended in 2012 with steps towards stronger, rigorous and effective implementation of the Act. 
Why this act?
"An Act to provide for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex linked disorders and for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female feticide; and, for matters connected there with or incidental thereto." This act regulates genetic counseling centers, genetic laboratories and genetic clinics.
"Genetic Clinic" means a clinic, institute, hospital, nursing home or any place, by whatever name called, which is used for conducting pre-natal diagnostic procedures. Use of ultrasound comes under Genetic Clinic.
Who can set up a genetic clinic/ultrasound clinic?
Any person having adequate space and being or employing a Gynecologist having experience of performing at least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis, fetoscopy, fetal skin or organ biopsy or fetal blood sampling etc. under supervision of an experienced gynecologist in these fields, or a Sonologist, Imaging Specialist, Radiologist or Registered Medical Practitioner having post graduate degree or diploma or six months training or one year experience in sonography or image scanning, or a medical geneticist. ,
Guidelines for the use of ultrasound in Genetic Clinic under the Act: ,,,,,,,,,
- Centers where ultrasound is intended to be carried out should get registered, at least 30 days in advance.
- All ultrasound machines available at that center along with the qualified doctors performing USG should be registered on the certificate.
- No doctor other than the one registered in the particular centre is allowed to use the machine.
- In the case of a locum doctor, the doctor's name and personal details, state council registration number, and his/her degree certificate need to be sent to the appropriate authority (AA)/ward office, requesting permission for the use of the machine by the locum on the specified dates.
- The USG machine should not be shifted from one Centre to another.
- Any changes in the center (e.g., change in machine or place of use) should be intimated to the AA 30 days in advance of the expected date of such change.
- Portable ultrasound machines should be used as a part of the registered mobile medical unit, offering other health and medical services. It cannot be used in a vehicle not registered under the Act.
- Registration and practice of sonography by a radiologist/sonologist is restricted to two clinics/facilities within a district. The consulting hours by such medical practitioner should be specified by each clinic/centre.
- Renew the certificate of registration every five years, with application of renewal being applied 30 days before the date of expiry to the AA.
- A copy of PC-PNDT registration certificate should be displayed in reception area and the USG room.
- A copy of PC-PNDT Act booklet should be made available in both the waiting room and USG room.
- Sign in English and in the local language must be displayed, indicating that fetal sex is not disclosed in the clinic.
- Form F must be filled completely. The signed consent of the patient as well as the radiologist signature who performed the procedure should be obtained. A hard copy with patient signature has to be preserved at the clinic when form 'F' is submitted online.
- A monthly report should be submitted to the AA regularly, before the 5 th of every month.
- All the records need to be maintained for a minimum of 2 years. If there is any legal proceeding pending in the court of law, then these records should not be destroyed till the proceedings have been disposed off.
- Advertisement and communication of sex selection is strictly prohibited under the act.
Section 23: If any person acts contrary to the prohibitions listed in the act, he will be liable to be punished with up to 3yrs imprisonment and Rs. 10,000 fine and on subsequent conviction entails, up to 5 yrs imprisonment and Rs. 50,000 fine. The name of the doctor will be reported by the appropriate authority to the State medical council for necessary action which includes suspension of the registration if charges are framed by the court, the suspension to last till the case is disposed of. In case the doctor is convicted, the punishment could include removal of his/her name from the register of the council for a period of 5 years for the first offence, and then permanently for a subsequent offence.
Gravity of the offence is under the act is "Cognizable, Non-bailable and Non-compoundable" i.e. arrest without warrant, non issuance of bail and non allowance for out of court settlement respectively. Total of 1297 cases have been prosecuted under the Act (as on Jan 2013).  Study by Public Health Foundation of India (PHFI) in 2010 had observed that non-registration of the ultrasound clinics accounted for maximum cases of offence under the Act. This was followed in order of frequency by non-maintenance of records, communication of sex and advertisement for sex selection. 
| Conclusion|| |
Radiologists like physicians of other disciplines are at increased risk of being prosecuted by the law for the breach of duty. Legal issues have become significant part of practicing radiologist's world. Two important areas where Indian radiologists need to be cautious include radiologic malpractice and PCPNDT Act. Most of the physicians are unaware of such legal issues and existing laws which govern them. It is thus, essential to have the basic information and knowledge about these issues so as to prevent oneself from professional liability.
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Conflicts of interest
There are no conflicts of interest.
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