AUTHENTICATION OF NEUROTOLOGICAL INVESTIGATIONS
Dr Anirban Biswas
One of the most commendable and praiseworthy moves of the Medical Council of India (MCI) has been to ensure that all laboratory investigations are supervised and countersigned by a medical graduate registered under the Medical Council of India. When a patient comes to the doctor, the overall well-being of the patient is the responsibility of the doctor as the patient has reposed faith on the doctor. It is the doctor’s liability to ensure that the investigations and treatment are ethically and correctly carried out according to set medical principles/ guidelines and that the highest standards of diagnosis and treatment are received by the patient. This requires monitoring by credible and authorised regulatory institutions like the Medical Council of India (MCI) and this is the basic purpose of the MCI. However until somebody registered with the MCI is involved in doling out each and every medical service it is not possible for the MCI to ensure that standard and ethical practice methods have been strictly followed. So the supervision and involvement of a medical graduate registered with the MCI is essential in all medical services especially all diagnostic services as very often many medical diagnostic tests/ services are carried out by technicians without medical supervision. Registering councils like the MCI who ensure that correct and standardised medical practices are followed can fix responsibility on the doctor only, as only qualified doctors who have attained the requsite medical training are registered under the Medical Council. Any medical service meted out by a technician or a paramedic (who are obviously nor registered with the MCI) cannot be monitored by MCI and no action can be taken by the Medical council as the technician is not registered by the MCI. In case a patient has any genuine grievance and / or has been duped by unscrupulous third parties it is the Medical Council that has to institute corrective measures and the MCI is responsible for it. This is very important for all medical diagnostic tests. This not only ensures that correct testing processes have been followed but also ensures that the treating clinician is basing his diagnosis (and hence therapy) on reliable and correct medical reports and not on fictitious medical reports. If medical reports are erroneously and/or unscrupulously done, the entire objective of scientific and rational treatment is defeated. The ultimate beneficiary of the process is the patient.
Nowhere this is truer than in the practice of NEUROTOLOGY which is the specialised medical discipline to diagnose and treat patients suffering from balance disorders and hearing disorders.ENT specialists, neurologists, neurotologists and physicians have to treat a lot of patients who present with vertigo and deafness. Most of such patients require high tech investigations like Videonystagmography (VNG), Video Head Impulse Test (VHIT), Vestibular Evoked Myogenic Potentials (cervical and ocular VEMP), Subjective Visual Vertical test (SVV), Dynamic Visual Acuity test (DVA) Electrocochleography (ECochG) and other Evoked Potential tests and also basic audiological tests like PT Audiometry, Tympanometry BERA OAE etc. It would be prudent and a step in the right direction if the MCI makes it mandatory that all audio-vestibular tests especially the vestibulometric test reports (the investigations for vertigo and imbalance that are essential for the rational management of balance disorders) are supervised and countersigned by registered medical graduates. Currently most vestibulometric investigations of all patients presenting with balance disorders are carried out without any medical supervision and by untrained technicians and sometimes audiologists who have no insight into the nuances of the vestibular system. Erroneous vestibulometric reports and even erroneous audiological reports are extremely common and all clinicians will vouch that most vestibulometric reports that they come across (except those done or supervised by medical doctors and carried out in registered medical clinics) are erroneously done and wrongly interpreted. Due to this the treatment of the balance disorder patients become a challenge and quite often due to erroneous reports, wrong treatment is meted out to the patient. The clinical anatomy and physiology of the vestibular system is one of the most difficult parts of the human biological system. Only a medical graduate who has undergone rigorous training in anatomy and physiology as well as training in the clinical disciplines of neurology and otology can comprehend the nuances of this complex system. The complexities of the vestibular system are not something that technicians without a complete medical background can comprehend and do justice to. Medical bodies like IMA, IAOHNS, ISO , AOI, NES as well as patient’s organisations hence should approach the Medical Council of India as well as the Ministry of Health Govt of India and ensure that all vestibulometric reports and also all audiological reports are countersigned by a registered medical graduate and all tests are done under their direct supervision. Audiological and vestibulometric reports not signed and validated by a registered medical graduate should not be accepted. If this is not immediately implemented all neurotological patients will continue to get a very raw deal.
A communication on a court case on the said matter dated 15th Sept as received from the President of IMA South Kolkata Dr R D Dubey:-
An MBBS/MD degree must to sign lab reports In a judgement in Association of Clinical Biochemists and Microbiologists ACBM (Regd) & Anr Vs Union of India & Ors delivered September 15, 2017, the Delhi High Court agreed with a Medical Council of India (MCI) notification that “all lab reports to be signed/countersigned by persons registered with MCI/State Medical Council”. The Medical Council of India (MCI) had issued a notification to this regard vide a letter No. MCI - 211(2))(Gen.)/2014-Ethics/ 118642 dated 14.06.2017, which had been contested by the Association of Clinical Biochemists and Microbiologists, who petitioned that “the said letter was without jurisdiction and deprived members of their association of their valuable right to conduct their trade and profession”. The Association of Clinical Biochemists and Microbiologists stated before the Court that “the members of the petitioner association are highly qualified persons and are engaged in the activity of laboratory testing. Since members of the petitioner association do not hold degree of MBBS and/or MD Degrees, they are not entered in the register maintained by the MCI or State Medical Councils. The petitioners state that the work of conducting laboratory test and submitting reports thereof is essentially a skilled task for which the members of the petitioner association are amply qualified and it is not necessary that the test report submitted by them be countersigned by a medical practitioner whose name is entered in the medical register. It is further stated that respondent no.3 (National Accreditation Board for Testing and Calibrating Laboratories) is competent to provide accreditation to pathology laboratories and no accreditation from MCI is required”. Referring to the Clinical Establishments (Registration and Regulation) Act, 2010, the Counsel appearing for MCI had submitted that “the said Act provides a comprehensive legal framework for registration of a clinical establishments. Section 3 of the said Act provides for establishment of a National Council which consists of representatives of various bodies including the Secretary General of Quality Council of India. The said National Council is inter alia charged with the function of prescribing the minimum standards of facilities and services; and (ii) minimum requirement of personnel, in a clinical establishment”. He also stated that the IMC Act did not provide for any framework for prescribing the standards for technicians engaged in a pathology laboratory. As per Clause (c) of Section 15(2) IMC Act, “No person other than a medical practitioner enrolled on a State Medical Register shall be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law to be signed or authenticated by a duly qualified medical practitioner.” Citing this, the MCI Counsel had further submitted, “the members of the petitioner association were not entitled to sign any medical fitness certificate and a pathology report would fall within the scope of a medical certificate, if there is any expression of opinion and/or indicative diagnosis… it is in this context that MCI had issued the impugned communication insisting that a pathology report be countersigned by a medical practitioner”. Section 15(3) IMC Act has defined punishment for violation of the above as follows: “Any person who acts in contravention of any provision of sub-section (2) shall be punished with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both”. Court observations “It is apparent from the above that no person other than a duly qualified medical practitioner is entitled to sign any medical report. Thus, members of petitioner association cannot sign a medical report or a medical certificate. However, the same does not preclude the members of the petitioner association to give a technical report as to the tests conducted by them. Plainly, such report can only be for consumption of medical practitioners and pathologists. The said report cannot be treated as diagnosis of any medical condition. Thus, there can be no objection if the technical report submitted by the qualified technicians indicates the result of their tests or the technical analysis of the samples, as long as the members of the petitioner association refrain from expressing any medical opinion or holding out the technical result of the medical tests conducted by them as a diagnosis of any medical condition.” “This Court is also of the view that although members of the petitioner association are not precluded from acting as a laboratory technicians and submitting the result of tests conducted by them, adequate safeguard must be maintained to ensure that the reports submitted by them are not mistaken as medical certificates or diagnostic reports as that would, concededly, violate Section 15(2)(d) of the IMC Act, 1956. Thus, it would be apposite that all test reports must necessarily bear a disclaimer to the effect that the report are strictly for the use of medical practitioners and pathologists and the reports are not medical diagnostic results. Any pathological report which purports to record any opinion or to indicate any diagnosis must necessarily be co-signed by a qualified medical practitioner.” After examining three questions (as below), the Ethics Committee had decided that “All lab reports to be signed/countersigned by persons registered with MCI/State Medical Council.” 1. “Whether the M.Sc with PhD candidates who as a matter of fact are not registered with MCI are eligible to sign medical laboratory reports? 2. Can persons holding MBBS degree registered with MCI/State Medical Council sign the medical test reports? 3. Can PhD (Medical Microbiology, Medical Biochemistry, Life Sciences, Applied Biology, Cytogenetics, Biotechnology) in relevant discipline be allowed to sign medical test reports? If not, Can the same be allowed if they are co-authorised with a person registered with MCI/State Medical Council?” Taking note of this decision of the MCI Executive Committee, the Court said, “You are therefore requested to kindly abide the above said decision of the Council and widely publicise the above decision to all the concerned.” “The said decision of the Executive answers question nos.2 and 3 in the affirmative and there can be no dispute that MCI's decision in this regard is in conformity with the provisions of Section 15(2)(d) of the IMC Act and cannot be faulted.” “Insofar as the first question is concerned - that is, whether M.Sc/PHD candidates, who are not registered with MCI, are eligible to sign medical laboratory reports - the same must be answered in the negative as has been done by MCI. However, MCI decision in this regard must be read in the context. The expression "medical laboratory reports" as used in the first question cannot be misunderstood to mean test reports which merely indicate the result of tests and/or the manner in which, the tests are conducted.” “The expression "medical laboratory reports" must in the context of the impugned communication, be understood to mean reports that contain medical diagnostic results and/or an opinion with regard to the tests results. A technical report stating test results and indicating the analysis of samples without recording any opinion thereon, would not fall within the scope of medical laboratory reports as contemplated under the impugned communication.” The Court disposed of the petition stating that “The impugned communication, thus, cannot be understood in a wider sense as urged by the petitioner and must be read in the restrictive manner as indicated above. The petitioners can have no grievance if the impugned communication is read in the manner as indicated above and, therefore, no further orders are required to be passed in this petition.” IMA Viewpoint • Accurate interpretation of lab reports is very important as they affect clinical decision making. • Only a doctor can put a clinical context to the ‘numbers’ in the report and determine if the test result corresponds to the clinical situation of the patient or if the test needs to be repeated or the results are as expected if it is a follow-up test or if any additional test is required further to it. • Only doctors of modern medicine with MBBS/MD degree can sign medical lab reports. • Non MBBS can only write the values of the test results, BUT not the interpretation of those values. For instance, they can write result of a blood sugar test as 90 mg/dL, but cannot give the reference range as this would mean interpretation of the result. Another example can be, they can give the result of a Widal test, but cannot write positive or negative.
My personal view on this:-
This is a very valid and landmark decision of the honourable High Court. Many many thanks for informing us in details about this. The importance and relevance of the medical profession is being undermined by the over-enthusiasm and aggressive attitude of these paramedics and that is happening in all branches of medical science especially so in the sub-specialities.Organisations like the MCI and professional bodies like IMA and the specialist doctor's associations and societies must work in unison to put these paramedics in place, If Lab technicians try to equate themselves with pathologists who have toiled 5-7 yrs learning the nuances of the human biology or if optometrists equate themselves with ophthalmologists, if physiotherapists equate themselves with orthopaedic surgeons or specialists in physical medicine or if audiologists try to equate themselves with ENT specialists/ neurotologists and neurologists then the interests of patients will be compromised and this is tantamount to cheating / misrepresentation. Many naive and gullible patients are misled by medical diagnosis given by these paramedics who are primarily technicians trained to help doctors only in the technical aspects of the diagnosis and treatment. The IMA view point as published in the mail sent by you is very valid.
The paramedic courses were started on the recommendations of the MCI for the specific purpose of being a technical help and not a medical help to the medical profession but if they overstep their jurisdiction and try to do the job that the medical profession is supposed to perform then it jeopardises the medical ecosystem and the structure on which the medical system works. If the home-maker in a family hires a house maid to do the household chores like washing the dishes or cleaning the floor, it is for the purpose of being a help to the home-maker so that the home-maker can better utilise the time in running the household more efficiently. But the house maid remains a maid and does not become the home-maker even though the home-maker may offer some liberties. The maid is supposed to work only under the supervision of the home-maker and take orders from the home-maker, the decisions of running the household rests with the home-maker only. Just because the maid is there it does not mean that the homemaker loses control of the kitchen or of the house and the home-maker can always do a better job than the maid. However if the maid thinks that she is more important than the home-maker and tries to displace the home-maker then the family is doomed. Sometime back the audiologist's association applied to the Rehabilitation Council of India saying that ENT doctors and neurologists should not be allowed to do audiological tests; so much is the audacity. The medical profession must understand this and take necessary measures before allowing the paramedics become a Frankenstein.