Clinical Establishments (Central Government) Amendment Rules, 2020.

EXTRAORDINARY PUBLISHED BY AUTHORITY No. 97] NEW DELHI, FRIDAY, FEBRUARY 14, 2020/MAGHA 25, 1941 [PART II—SEC. 3(i)] THE GAZETTE OF INDIA : EXTRAORDINARY 3 [PART II—SEC. 3(i)] THE GAZETTE OF INDIA : EXTRAORDINARY 5 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 14th February, 2020 G.S.R. 115(E).—In exercise of the powers conferred by section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), the Central Government hereby makes the following rules further to amend the Clinical Establishments (Central Government) Rules, 2012, namely:— 1. (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2020. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Clinical Establishments (Central Government) Rules, 2012, in the Schedule for heading at Sl. No. III relating to „HUMAN RESOURCE‟ and the entries relating thereto, the following shall be substituted, namely: - SCHEDULE “III HUMAN RESOURCE a) Minimum qualification of Technical Head of Laboratory or Specialist or Signatories. NOTE: 1. *The authorised signatory will be liable for authenticity of the laboratory report only. 2. Medical tests should normally be undertaken on the advice of a registered medical practitioner. Essential – 1. MBBS registered with MCI or State Medical Council with at least one year training or work experience in a Medical Diagnostic Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation. Those working in Government sector shall be exempted from the aforesaid training or experience or 2. M.Sc in Pathology or Medical Microbiology or Medical Biochemistry from a recognised university or institution with at least three years training or work experience in a Medical Diagnostic Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation shall be entitled to conduct the tests, generate and sign test reports in respect of tests of their respective specialty, without recording any opinion or interpretation of laboratory results. All such test reports generated must Essential – 1. 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 (DCP), registered with MCI or State Medical Council. Or qualification in the field of Pathology or Microbiology or Biochemistry or Genetics or Biotechnology or Immunology or Molecular Biology or Applied Biology from a recognised university or institution and having experience of at least three years post Ph.D in a Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation shall be entitled to conduct the tests, generate, sign and issue test reports in respect of tests of their respective specialty. Or 3. M.Sc. with Ph.D qualification in the field of Pathology or Medical Microbiology or Medical Biochemistry or Medical Genetics or Biotechnology or Immunology or Molecular Biology or Applied Biology from a recognised university or institution and having experience of at least three years post Ph.D in a Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation shall be entitled to Essential – 1. 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 (DCP), registered with MCI or State Medical Council. Or qualification in the field of Pathology or Microbiology or Biochemistry or Genetics or Biotechnology or Immunology or Molecular Biology or Applied Biology from a recognised university or institution and having experience of at least three years post Ph.D in a Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation shall be entitled to conduct the tests, generate, sign and issue test reports in respect of tests of their respective specialty. Or qualification in the field of Pathology or Medical Microbiology or Medical Biochemistry or Medical Genetics or Biotechnology or Immunology or Molecular Biology or Applied Biology from a recognised university or institution and having experience of at least three years post Ph.D in a necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. Note: Laboratory technician with qualification as mentioned in Part III (b) of this Notification working in a Medical Diagnostic Laboratory registered under a Central or State Clinical Establishments Registration Act, as applicable, and a Health care worker in a Government National Health program trained for conducting identified specific tests, may conduct the tests and generate test results which shall be submitted to the signatory authority at Sl. Nos. 1 or 2 as applicable. conduct the tests, generate and sign test reports in respect of tests of their respective specialty, without recording any opinion or interpretation of lab results. All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. Note: Interpretation of lab results or opinion there on, wherever required by the signatory authority at Sl. No.3, such test reports may be co-signed by the signatory authority at Sl. Nos. 1 or 2, after recording opinion or interpretation. Co-signee medical doctor shall be responsible only for the opinion or interpretation given. Desirable: If any special test of other speciality is done, it is desirable that specialist of that subject needs be there on full time or part time or outsourced basis. *Special test means any other apart from routine basic biochemistry, hematology, or medical microbiology tests as listed in basic composite laboratory. Illustration: (i) Special Tests pertaining to Bio-Chemistry and Micro- biology shall be reported by Doctor of Medicine (MD) or Diplomate of National Board and Doctor of Medicine (MD) or Diplomate of National Board (DNB) or Ph.D in Micro-biology respectively. (ii) Biopsies or Cytology specimens has to be reported by a person possessing Doctor of Medicine (MD) or Diplomate of National Board (DNB) or Ph.D in Pathology. Laboratory of same or higher level in a Government or Recognised medical college or hospital or institution or organisation shall be entitled to conduct the tests, generate and sign test reports in respect of tests of their respective specialty, without recording any opinion or interpretation of lab results. All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. Note: Interpretation of lab results or opinion there on, wherever required by the signatory authority at Sl. No.3, such test reports may be co-signed by the signatory authority at Sl. Nos.1 or 2, after recording opinion or interpretation. Co-signee medical doctor shall be responsible only for the opinion or interpretation given. Desirable: If any special test* of other speciality is done, it is desirable that specialist of that subject needs be there on full time or part time or outsourced basis. *Special test means any other apart from routine basic biochemistry, hematology, or medical microbiology tests as listed in basic composite laboratory. Illustration: (i) Special Tests pertaining to Bio-Chemistry and Micro- biology shall be reported by Doctor of Medicine (MD) or Diplomate of National Board (DNB) or Ph.D in Bio- Chemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) or Ph.D in Micro-biology respectively. [PART II—SEC. 3(i)] THE GAZETTE OF INDIA : EXTRAORDINARY 7 (ii) Biopsies or Cytology specimens has to be reported by a person possessing Doctor of Medicine (MD) or Diplomate of National Board (DNB) or Ph.D in Pathology. (b) Number of laboratory technicians with Diploma in Medical Laboratory Technology (DMLT) or Bachelor of Science (B.Sc.) Medical Laboratory Technology (MLT) or Master of Science (M.Sc) Bio-chemistry or Micro biology qualification from a recognised university or institution. Essential: 1 Essential: 2 Essential: 4 (Laboratory Assistant or Laboratory Attendant) Roster of salary of staff. Periodic health check- ups and vaccination of staff. Essential: 1 Essential: 1 Essential: 2”. REKHA SHUKLA, Jt. Secy. Note : The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide notification number G.S.R. 387(E), dated the 23 rd May, 2012 and last amended vide G.S.R. 468 (E), dated the 18 th May, 2018. and Published by the Controller of Publications, Delhi-110054. MANOJ KUMAR VERMA