M Neelam Kachhap examines the field of diagnostic ultrasonography, ethical issues connected to this subject and the legal premise under which it is supposed to be practised
Medico-legal cases are on the rise in India. Although all fields of medicine attract medico-legal attention, recently, the field of diagnostic sonography has been in the public-eye. The medico-legal limelight is focussed on ultrasonography and sonologists, thanks to the recent media attention and celebrity talk show on female foeticide. Sex determination and subsequent female foeticide is an inhumane as well as illegal act. However, the issue of sex determination is only one of the many legalities associated with ultrasonography since it has vast applications in diagnostic imaging.
From soft tissue imaging to treatment of lesions, today ultrasonography is used for a variety of purposes in medicine. Thus a sonologist could face the court, not only for violating The Pre-conception and Pre-natal Diagnostic Techniques (PC/PNDT) Act but also for a lot of reasons like missed diagnosis, invented lesions, misreported lesions, etc.
Ignorance is not bliss
India has witnessed rapid developments in healthcare practice, with newer technologies and interventions promising better outcomes for patients. Informed patients are expecting more from doctors, leading to increasing dissatisfaction on the patients' part. In these times, where medico-legal cases against doctors are witnessing a sharp rise, being abreast of the fast changing laws has become even more important. Despite this, there are many sonologists who are not acquainted with the legalities of ultrasonography. "Most sonologists are unaware of the categories of litigation arising out of medico-legal issues in ultrasonography," says Dr Madhavan Unni, Professor and Consultant Radiologist, Kerala Institute of Medical Sciences (KIMS), Kerala. Seconding this, Dr Priya Chudgar, Senior Consultant Radiologist, Kohinoor Hospital, Mumbai avers, "To err is human and radiologists are also human beings. It is not uncommon in radiology practice to miss a diagnosis." Ignorance of law is not a defence. One cannot stand in court and say, 'I was unaware of the law'. It is upto the individual doctors to keep abreast of the rapidly changing laws and indemnify themselves. Like medicine, law also has its own language which needs to be comprehended by the doctors to fully understand the impact.
The most common complaint registered against a doctor is of medical negligence. But, does it apply to sonologists? Yes, it does! "A mistake committed by the sonologist during the course of his professional duty, could be considered as a 'Tortuous Act',” opines Diljeet Titus, Founder, law firm Titus & Co, New Delhi.
The laws governing medical negligence are, by far and large, a section of Law of Tort, in addition to Indian Contract Act. "Tort is a civil wrong, as opposed to a criminal wrong where a defendant breaches a duty to the plaintiff (complainant). Negligence may be defined as 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”. The definition involves three constituents of negligence: a legal duty to exercise the due care; breach of the said duty; consequential damage," explains Sajid Mohamed, Partner, PDS & Associates, Mumbai. He adds that to be successful, the plaintiff must establish that the defendant (sonologist) owed a duty of certain care towards the patient, this duty was breached, and this breach resulted in the immediate proximate damage to the patient directly or indirectly. At times one feels that the plaintiff has a difficult task to prove this, but in reality it is a doctor's own lack of proper documentation and non-observance of standard operating procedures (SOPs), which makes it easier for the plaintiff to establish negligence on the part of the doctor. Duty of care is established as soon as the patient walks into
a doctor's clinic and
submits him/herself to examination. A doctor-patient relationship thereby comes in to existence.
The Supreme Court in Laxman v. Trimbak, held, “The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person, when consulted by a patient owes him certain duties viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor very low degree of care and competence judged in the light
of the particular circumstances of each case is what the law requires.”
Other than negligence there are other legalities in ultrasonography such as missed diagnosis, invented lesions, and misreported lesions. "Missed diagnosis in ultrasonography is a disease/lesion which could not be interpreted properly, and reported appropriately by the sonographer, in spite
of it being there and is
obvious when another sonographer does the ultrasound scan with reasonable skill and care within reasonable time from the first scan," informs Dr Unni.
"Radiologic errors are of two types: cognitive, in which an abnormality is seen but its nature is misinterpreted, and perceptual or the ‘miss’, in which a radiologic abnormality is simply not seen by the radiologist on initial interpretation. The perceptual variety accounts for approximately 80 per cent of all radiologic errors. Because radiologic errors are common, and allegations that a diagnostic error has been committed account for 70 per cent of all medical malpractice lawsuits filed against radiologists, it is no wonder that radiologists are being forced into the courtroom as defendants in malpractice actions with disconcertingly high frequency," elaborates Dr Chudgar.
"The Supreme Court of India, in Jacob Mathew v. State of Punjab (2005) 6 SCC 1, held that, “A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. 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. “Accordingly, we believe that ‘missed diagnosis’ could be equivalent to
‘medical negligence’ in the eyes of law if the
test described above is proven. Examples of missed diagnosis are instances when an ultrasonologist fails to report an anomaly e.g. a twin pregnancy which is then subsequently picked by a second ultrasonography done by himself or
by a peer or something
that goes unnoticed and leads to a complicated
clinical outcome. In such cases, a ultrasonologist
has the right to adopt
a defence of "difficult foetal positioning", "scanty liquor", limitations of
the machine etc., but
the case will be judged
on its own merit and
an expert's testimony,”
says Titus. Invented lesions are instances where findings were reported when none existed. Misreported lesions are cases where the
findings were not missed but incorrectly reported or interpreted.
Does consent matter in ultrasonography?
The element of consent is a critical issue in medical treatment. In an article 'Consent and medical treatment: The legal paradigm in India', Dr Omprakash V Nandimath, Associate Professor, National Law School of India University, Bangalore, says that the patient has a legal right to autonomy and self determination enshrined within Article 21 of the Indian Constitution. He can refuse treatment except in an emergency situation where consent is not needed. The consent obtained should be legally valid. A doctor who treats without valid consent will be liable under the tort and criminal laws. The law presumes the doctor to be
in a dominating position, hence the consent should be obtained after providing all the necessary information.
"This may perplex many sonologists who may wonder if they need to take an express consent even for a "routine" ultrasonography. However, they must appreciate that it is likely that a plaintiff will raise the lack of informed consent as a cause for legal action coupled with an action in negligence. The problem would be compounded when there is a gap in the understanding of an implied consent in the mind of doctor and the patient. Thus, it is always useful to have a clearly written consent outlining all terms and exceptions. In emergency procedures, when patients are unable to give consent, a physician may be excused from such discussion or obtaining consent. In case of minors, consent must be obtained from their lawful guardians,” adds Titus.
Legal responsibility in group practice
Usually sonologists practising in a group or under an employee are also liable to the law. "The legal relationship of the sonologist to the technician (sonographer) is governed by the law of agency," says Mohamed. He adds, "The agent (sonographer) is a person who by a contractual relationship acts for, or under the control of, or by the direction of a principal (sonologist). In a private clinic, the sonographer will be the direct employee of the physician. It is extremely important that the physician never delegate his or her duties to the sonographer. It is the physician's duty to give the diagnosis. In a group practice, as far as possible, one should report on the procedure that one has performed. If the fiduciary relationship is in the capacity of partners in a group, then the responsibility will be jointly as well as severally." However, Dr Chudgar paints a different picture. "In the current Indian setting of sonography practice, technicians do not play an important role,
as most ultrasounds are
performed by radiologists. However this may be
an issue in group practice.
It needs to be clarified beforehand with separate indemnity insurance and thus prime responsibility
is on the signing person," she admits.
Documentation is the holy grail of medico-legal issues. It is of utmost importance to either incriminate or release the sonologist from any kind of legality. Therefore, it is very important to maintain
proper documentation. "Ultrasound report is a
scientific professional opinion. It has to be written, documented and signed with extreme care.
It should not be taken as
a document for legal
purpose, by a layman or person unable to understand its technical limitations," warns Dr Unni.
Dr Chudgar agrees, "Documentation and archiving are extremely
crucial for every radiology report, so as for sonography. It works as best
evidence for medico legal issues. If patient is
uncooperative or body habits make it difficult for complete evaluation, it
is necessary to mention
in reports. Many times some organs are partially obscured by bowel gas or not optimally evaluated due to patient related limitations, note of same can
be made in report. In case
any doubt, differential
diagnosis can be given or
clinical/pathological correlation can be recommended. It is important to understand that radiological tests are adjunct to clinical
diagnosis and not final authority. Every modality has its limitations, for
e.g. bowel pathologies
are not always detected on
ultrasonography. Clinicians need to be aware of such issues. Also radiologists should take complete responsibility of their reports. It is important to check every report and sign it personally. These precautions will surely reduce errors."
Providing the legal aspect Titus says, "The documentation process and sign-posting are of crucial importance in the medical field. With regards to report writing, vague and meaningless reporting must be avoided.” Mohammed adds, “Law holds sonologist responsible for lapses in their own conduct, irrespective of any liability that might be imposed on other physicians. Clinicians often receive reports which are described with wide variation and there is lack of uniformity in the terminologies used.” “National associations of ultrasonologists should formulate a lexicon of terminologies and definitions to provide standardised language in reporting images. A report must describe in its body a complete description of all abnormalities - that is everything seen by the eyes - but
in the conclusion should
discuss only those findings that are important to arrive
at the inference. When rendering radiology reports, radiologists should refrain from
hedging, defined as the making of calculatedly noncommittal or ambiguous statements,” he advises.
Every sonologist should understand the sources of error in sonography and the elements of negligence that form the basis of litigation. Errors happen; what is
important is to learn to accept them with honest, humble and communicative approach and to be alert. Frequent errors need to be uncovered and highlighted, in order to
prevent repetition of the