MCI Board of Governors Clarify on Who Can sign Laboratory Reports

The High court directed the Medical Council of India to decide on the matter and respond to the petitioner.

Responding to Association of Medical Biochemists of India in the matter, the MCI Board of Governors, upon the direction of the High Court of Delhi, recently issued an order detailing the entire issue and communicating their decision. The order stated 

It is brought to your attention that the that the observation of the Hon'ble Supreme Court, in its judgment dated 12.12.2017 that only Pathologists, registered with the State Medical Councils can sign the Laboratory Reports, has to be understood in the background of the matters being considered for adjudication. The issue before the Hon'ble Supreme Court, was in reference with and restricted to Pathologists, evidently so, since the original matter filed before the Hon'ble High Court of Gujarat being Special Civil Application No. 17485/2006 had been preferred by the Association of Pathologists. The judgment of the Hon'ble Supreme Court dated 12.12.2017, has to be seen in a holistic manner in order to ascertain its true meaning and has to be understood, keeping in mind the underlying reason behind the same, which being that any person possessing inadequate knowledge / qualification, should not independently conduct and / or sign the Laboratory Reports

 Therefore, any person who is a Registered Medical Practitioner, having the requisite Postgraduate Medical Qualification in Pathology,Microbiology, Biochemistry, may sign / counter sign Laboratory Reports. However, it has to be borne in mind that, the Registered Medical Practitioner shall sign / counter sign the Laboratory Reports in their respective field of specialization / subject. That is to say that a Pathologist shall sign / countersign a Pathological Report, a Microbiologist shall sign / countersign a Microbiological Report and a Biochemist shall sign / countersign a Biochemical Report, so on and so forth.

The court further referred to the amendment to the Clinical Establishment Rules, 2012 that was notified by the Ministry of Health and Family Welfare, Government of India, on 21.05.18, adding

This amendment clearly lists the type of laboratories, their scope of services and the qualifications of the authorized signatories for each type of laboratory. Further, it clearly  distinguishes between an "authorized signatory" who is essentially responsible for the authenticity of the laboratory test report and the essential qualifications of the individuals where-ever interpretation of the lab results or opinion thereon are required. With reference to the latter, for a basic composite type of laboratory it has to be a registered medical practitioner with an MBBS qualification; for medium and advanced type of laboratories the authorized signatory should have Doctor of Medicine (MD) or Diplomate of National Board (DNB) in Pathology or Biochemistry or Medical Microbiology or Laboratory Medicine or Diploma in Clinical Pathology or Bachelor of Medicine and Bachelor of Surgery (MBBS) with Doctor of Philosophy (PhD) in any of the subjects above.

Disposing off the ambiguity with the order, the MCI stated  that the authorised signatory of the laboratory test report should be in conformity with the Rules laid down by the Ministry of Health and Family Welfare, Government of India under the Clinical Establishment Rules, 2012