EAGLE’S EYE AND LION’S HEART
Year : 2002 | Volume
: 12 | Issue : 1 | Page : 105--108
Eagle's eye and lion's heart - medicolegal issues in ultrasonography practice
Department of Paediatric Surgery, BYL Nair Hospital, TN Medical College, Mumbai, India
Department of Paediatric Surgery, BYL Nair Hospital, TN Medical College, Mumbai
|How to cite this article:|
Oak S. Eagle's eye and lion's heart - medicolegal issues in ultrasonography practice.Indian J Radiol Imaging 2002;12:105-108
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Oak S. Eagle's eye and lion's heart - medicolegal issues in ultrasonography practice. Indian J Radiol Imaging [serial online] 2002 [cited 2020 Jun 4 ];12:105-108
Available from: http://www.ijri.org/text.asp?2002/12/1/105/28430
(The author is Prof. & Chief of Dept. Paediatric Surgery at BYL Nair Hospital, TN Medical College, Mumbai, and has also got an academic background of General Law, Hospital administration and Human Resource Development.)
The article is based on a Symposium conducted on 30th Sept.2001, Sunday at Hotel Regent in Mumbai Ultrasound Course 2001.
Symposium Participants:- Dr.Sudhakar Sane, Dr. SM Sapatnekar, Dr.Mukund Joshi, Dr.Suresh, Dr.Arun Kinare, Dr.Ambrish Dalal, Dr. Sanjay Oak.
As in all other disciplines of medicine, the field of diagnostic sonography faces its own legal concerns. Rapidly growing sophistication of technology may not be always affordable and available at all corners in a country like ours. Lack of a formal training for specified number of years and absence of a certifying, qualifying examination to pronounce a candidate "ultrasonologist" has even compounded the problem in medico-legal complexities. Lack of proper training is certainly not a defense. Lack of legal knowledge is also not a defense. With widespread application of Ultrasonography as a primary diagnostic modality by clinicians, the responsibility of arriving at a correct diagnosis is increasing. In the areas of obstetrics and antenatal care, sonologists are confronting with medico legal issues that have not previously been challenged the legal system .The lawyers and the courts are also not familiar with adapting the traditional doctrines of medical jurisprudence to this specialty. The millennium is changing and with it the problems associated are also evolving. One cannot just remain complacent by taking a stand that "In India Physicians are demi-Gods" and such issues are only a spectrum of WEST. One should also not take a stand that by discussing and writing such articles; one is opening a Pandora's box. One can not think that "Why wake up a snoring man-eater?" In my opinion it would certainly be prudent to take a cognizance of the changing scenario and pro-act rather than react or retaliate.
MEDICOLEGAL ISSUES IN ULTRASONOGRAPHY
Is "Missed Diagnosis' equivalent to "Medical Negligence"?
Can a mistake of a sonologist be considered as a Tortuous Act?
What are the categories of litigations that may come up?
An Error of Judgement - Does it amount to "Negligence"?
What is a Consent for Sonology?
What is the liability of a sonologist who reports in a Group Practice or
On a film recorded by a technician?
What is a "Wrongful Birth" and "Wrongful Life"?
What is the basis and role of Prenatal Counselling Group?
What is meant by "Standards Of Care"?
What is significance of Documentation, Sign - posting and Report writing?
What are the risk management pointers for antenatal ultrasonography?
How should one report an Obvious Error by an act of Commission by a referring clinician?
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). In any negligence malpractice suit, there are four basic elements. They are duty, breach, proximate causation, and damages. 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 make plaintiff's job easier. 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.
MAJOR CATEGORIES OF TYPES OF LEGAL ACTIONS
Failure to Use Ultrasonography
Procedure related Complications
Sonographer/technician Related Complications.
"Missed diagnosis" are the instances when an ultrasonologist fails to report an anomaly e.g. a twin pregnancy which then subsequently either is picked by a second Ultrasonography done by himself or by a peer or it goes unnoticed and leads to a complicated clinical outcome. An ultrasonologsit can adopt to a defense of "difficult fetal positioning ", "scanty liquor", limitations of the machine etc as his defense arguments but the case will be judged on its own merit and an expert's testimony. If therefore one admits one's mistake timely with honesty, and communicate it to the patient, one may find him/herself in a sounder amicable situation.
It is thus better to be a LION rather than a RABBIT!
The "misreported" category includes those cases where the findings were not missed but incorrectly reported or interpreted. This is an Error Of Judgment and the law would tend to adopt a lenient approach in such cases. Mistakes do happen and nothing is infallible.
The 'invented lesion " category includes those instances where findings were reported when none existed. The "failure to use" category is of more concern to the referring physician than the sonologist. However if in doubt and whenever the conditions demand the sonologist should put it down on the paper as a clear instruction addressed to the patient and also communicate the matter to the referring physician.
Legal actions regarding procedure related complications have arisen when there have been problems during an ultrasound -guided amniocentesis and when ultrasound guidance was not used for this. The issue of informed consent also comes into play here.
One must remember that Consent in the eyes of law is an agreement between two parties. Here the parties are the ultrasonologist and the patient who submits him/herself to the sonological examination. Moreover both the parties of their free will without any force, fraud, coercion, misrepresentation and intimidation arrive at this consent. Consent is of two types-Implied and expressed. Implied consent is unspoken, unwritten. It is expressed by the act of the patient. The very fact that the patient is willing to undergo the sonological examination by the doctor implies the willingness on the part of the patient. However whenever any special procedure is to be performed, e.g. using transvaginal probes, amniocentesis etc, it would be only appropriate that the doctor discusses these methods, explains the procedure, comments about the risks involved and even offer the alternative methods if available. All these are then documented in an Expressed Consent Document, which is signed, by both the doctor (or his assigned officer) and the patient in the presence of competent witnesses. This may perplex the issue in the minds of many sonologists and they would wonder if they need to take an express consent even for a "Routine" USG. They must understand that it is unlikely that the plaintiff will raise the lack of informed consent as an isolated cause for legal action. Most times the informed consent issue is coupled with an action in negligence. Moreover the problems are compounded when there is a gap in the idea about "Scope" of an implied consent in the minds of doctor and the patient.
The real importance of the informed-consent discussion for the physician is in the strengthening of the physician-patient relationship. This dialogue allows the patient the chance to meet the physician who will perform the USG procedure and ask any questions about it while being informed of the risks and alternatives. Therefore the discussion should not be rushed and should not be delegated to another person who may not be even present during the procedure.
In the event of emergency procedures, and when the patients are unable to give consent, the physician may be excused from the discussion. In the case of minors, the consent must be obtained from their lawful guardians.
TECHNICIAN RELATED ISSUES & GROUP PRACTICE
The legal relationship of the sonologist to the technician (sonographer) is governed by the Law Of Agency. 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 practical terms, what it means that you are responsible for torts committed by your employee when he is acting within the "scope of employment". In an Ultrasonology Department or set-up the sonologist is the "captain of the ship". It is he who has to "swim or sink." What is then the responsibility of the principal employer- Hospital Administrator? He will also be held vicariously liable in the events of negligence of hospital employees. 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 what 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.
WHAT CONSTITUTES A BREACH OF THE STANDARD OF CARE?
In the midst of the myriad often-conflicting facts and figures concerning the frequency and nature of medical and radiological errors one question finally emerges: Did or did not the defendant physician breach the standard of care.? The judge or the presiding bench presumably bases their decisions on all the evidence and opinions of expert witnesses presented at trial. Standards of care are not absolute. What the legal system finally expects is that - "An ultrasonologist must employ a reasonable amount of skill and care… which is ordinarily possessed by members of his profession." Courts have frequently used such terms as "reasonable" and "ordinary" as determinants
REASONABLE - "not extreme, not excessive, moderate, not demanding too much, possessing good sound judgment, well balanced, sensible."
ORDINARY - Ordinary is defined as "common, lacking in excellence, not distinguished in any way from others, not above but rather below the average, somewhat inferior level of quality".
Therefore it must be clearly understood that the established standard of care for all professionals is stated as the same degree of knowledge, skill and ability as an ordinarily careful professional would exercise under similar circumstances.
SENSITIVITY AND SPECIFICITY OF THE INSTRUMENTATION
It was truly ironical that a concept of level I and level II studies was introduced few years back. Level I evaluation was only to screen for fetal viability and cursory examination to assess only gross anatomical derangements and level II study was supposed to be more specific and sensitive for anomalies. This is now accepted as a flawed concept. It allows a basic compromise with the quality of patient care and procedure performance.
What complicate the matter still further are the ever-expanding newer generations of sensitive machines. The costs are prohibitively expensive and it seems impossible to update and augment the equipment available to keep up with the technological advances. Some errors and Missed diagnoses could then be blamed on the instrumentation. The other question that is often in the minds of people from remote places is -Would it be fair to compare standards of care between metropolis and mofussil.? Law expects the instrumentation should meet the community standard if not state of the art. Wherever you may be practicing a quality assurance program should be in place and it must be in daily practice as a routine "conduct of the shop". These may very well obviate the question of differences of resolution in earlier generations of machines.
CONCEPTS OF WRONGFUL BIRTH AND WRONGFUL LIFE
These are two other vital concepts applicable to ultrasound practice. Wrongful birth refers to the legal action brought by the parents of a child born because of physician's alleged negligence.
Wrongful life on the other hand is a claim brought by the newborn himself, who alleges that but for the negligence of the physician, he would not have been born at all. This is a serious problem. In my personal practice as a paediatric surgeon , I have experienced grown up paraplegic patients asking this as to why at all they were brought to life. They perhaps would have preferred denial of birth rather than an impaired, ever-dependent existence.
The ultrasound expert is at risk for allegations invoking wrongful life and wrongful life especially when fetal anomalies as grave as spina bifida, missed or misinterpreted. The monetary damages that one may have to award in such instances are likely to be huge because of extraordinary medical expenses related to that particular affliction and the compensation amount could also be heavy to sustain a dependent life.
Vague and meaningless reporting must be avoided. Ultrasonolgists have a tendency of using phrases like;"if clinically warranted"," if clinically indicated may be of value", "would be most helpful", " to be clinically correlated" etc. These phrases are vague, they neither protect or absolve the sonologist of his / her legal liability. Law holds radiologists 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 standardized language in reporting images. A report must describe in its body a complete description of all abnormalities- that is everything that is 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. Radiologists must remember the following aphorism coined by one of their own colleagues:
" Do not let the fear of being wrong rob you of the joy of being right"
A report need not always be brief but it can always be concise. It must also make a mention of salient negative points such as " ……could not be commented upon due to the non favorable fetal positioning.
Features of Good Report Writing
It grabs the attention
Conveys a message
Elicits a response
Res Ipsa Loquitor-When Evidence Speaks For Itself.
What should be an Ultrasonolgists stand in an event of Obvious Error Of Commission by a Clinician? In an immediate postoperative period in an abdominal or pelvic surgery, when the patient is referred for a USG with complaints of tenderness, fever and toxicity, even the clinician has a doubt in mind of a " left over Sponge /Mop or a foreign body". When such a finding is noted in an ultrasound, the sonologist must communicate this back to the clinician instantly and could phrase words like " foreign body reaction" or suggest a possibility of a foreign body within the cavity in a subtle and yet unambiguous manner. Every temptation to "cover up" or "conceal" such a finding must be resisted because here the evidence of the retained foreign body speaks for itself sooner or later and the issue of "negligence" of the clinician is more than obvious. If the sonologist does not report this in his findings, he could be sued as an accomplice to the defendant. Clinician and then defending himself in the court of law would prove to be difficult. Moreover, any delay in reporting such facts can cost the patient his/her life. Therefore while caring for the professional patronage from clinicians, patient interests must also be held uppermost.
The symposium and the article thus highlights the medico-legal aspects of ultrasonography. It is not intended to intimidate a reader but to make him aware of the various complex issues that one might have to face in the future. The reader should therefore never adopt to a policy of Defensive Practice Of Sonography. Mistakes will happen; one must learn to accept them with honest, humble and communicative approach. Whatever we will perform and predict, we will do it without the consideration of any fear or favor. Honesty, Commitment, Application and Integrity are the watchwords for the coming millennium. Let us have an -
Eagle's Eyes And A Lion's Heart.
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