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.
Excellent information on your blog,Quite interesting and nice topic chosen for the post Nice Post keep it up.Excellent post.I want to thank you for this informative post. I really appreciate sharing this great post. Keep up your work.
ReplyDeletepharmacogenetic testing cost