Saturday, September 30, 2017

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.

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