[Cites 0, Cited by 0]
[Entire Act]
Union of India - Section
Section 9 in The Clinical Establishments (Central Government) Rules, 2012
9. Other conditions for registration and continuation of clinical establishments.
- For registration and continuation, every clinical establishment shall fulfill the following conditions, namely :-| (1) | (2) | (3) | (4) | (5) |
| III | Human Resource | |||
| (a) Minimumqualification of Technical Head of Laboratory or Specialist or*Authorised Signatories.NOTE:1. *The authorisedsignatory will be liable for authenticity of the laboratoryreport only.2. Medical tests should normally be undertakenon the advice of a registered medical practitioner. | Essential -1. MBBS registeredwith MCI or State Medical Council with at least one year trainingor work experience in a Medical Diagnostic Laboratory of same orhigher level in a Government or Recognised medical college orhospital or institution or organisation.Those working inGovernment sector shall be exempted from the aforesaid trainingor experienceOR2. M.Sc in Pathologyor Medical Microbiology or Medical Biochemistry from a recogniseduniversity or institution with at least three years training orwork experience in a Medical Diagnostic Laboratory of same orhigher level in a Government or Recognised medical college orhospital or institution or organisation shall be entitled toconduct the tests, generate and sign test reports in respect oftests of their respective specialty, without recording anyopinion or interpretation of laboratory results.All such test reportsgenerated must necessarily bear a disclaimer to the effect thatthe reports are strictly for the use of medical practitioners andare not medical diagnosis as such.Note:Laboratory technician withqualification as mentioned in Part III (b) of this Notificationworking in a Medical Diagnostic Laboratory registered under aCentral or State Clinical Establishments Registration Act, asapplicable, and a Health care worker in a Government NationalHealth program trained for conducting identified specific tests,may conduct the tests and generate test results which shall besubmitted to the signatory authority at Sl. Nos. 1 or 2 asapplicable. | Essential -1. Doctor of Medicine(MD) or Diplomate of National Board (DNB) in Pathology orBiochemistry or Medical Microbiology or Laboratory Medicine orDiploma in Clinical Pathology (DCP), registered with MCI or StateMedical Council.Or2. MBBS with Ph.Dqualification in the field of Pathology or Microbiology orBiochemistry or Genetics or Biotechnology or Immunology orMolecular Biology or Applied Biology from a recognised universityor institution and having experience of at least three years postPh.D in a Laboratory of same or higher level in a Government orRecognised medical college or hospital or institution ororganisation shall be entitled to conduct the tests, generate,sign and issue test reports in respect of tests of theirrespective specialty.Or3. M.Sc. with Ph.Dqualification in the field of Pathology or Medical Microbiologyor Medical Biochemistry or Medical Genetics or Biotechnology orImmunology or Molecular Biology or Applied Biology from arecognised university or institution and having experience of atleast three years post Ph.D in a Laboratory of same or higherlevel in a Government or Recognised medical college or hospitalor institution or organisation shall be entitled to conduct thetests, generate and sign test reports in respect of tests oftheir respective specialty, without recording any opinion orinterpretation of lab results.All such test reportsgenerated must necessarily bear a disclaimer to the effect thatthe reports are strictly for the use of medical practitioners andare not medical diagnosis as such.Note:Interpretation oflab results or opinion there on, wherever required by thesignatory authority at Sl. No.3, such test reports may beco-signed by the signatory authority at Sl. Nos. 1 or 2, afterrecording opinion or interpretation. Co-signee medical doctorshall be responsible only for the opinion or interpretationgiven.Desirable:If any special testof other speciality is done, it is desirable that specialist ofthat subject needs be there on full time or part time oroutsourced basis.*Special test meansany other apart from routine basic biochemistry, hematology, ormedical microbiology tests as listed in basic compositelaboratory.Illustration:(i) Special Testspertaining to Bio-Chemistry and Microbiology shall be reported byDoctor of Medicine (MD) or Diplomate of National Board (DNB) orPh.D in Bio-Chemistry and Doctor of Medicine (MD) or Diplomate ofNational Board (DNB) or Ph.D in Micro-biology respectively.(ii) Biopsies or Cytology specimens has to bereported by a person possessing Doctor of Medicine (MD) orDiplomate of National Board (DNB) or Ph.D in Pathology. | Essential -1. Doctor of Medicine(MD) or Diplomate of National Board (DNB) in Pathology orBiochemistry or Medical Microbiology or Laboratory Medicine orDiploma in Clinical Pathology (DCP), registered with MCI or StateMedical CouncilOr2. MBBS with Ph.Dqualification in the field of Pathology or Microbiology orBiochemistry or Genetics or Biotechnology or Immunology orMolecular Biology or Applied Biology from a recognised universityor institution and having experience of at least three years postPh.D in a Laboratory of same or higher level in a Government orRecognised medical college or hospital or institution ororganisation shall be entitled to conduct the tests, generate,sign and issue test reports in respect of tests of theirrespective specialty. Or3. M.Sc. with Ph.Dqualification in the field of Pathology or Medical Microbiologyor Medical Biochemistry or Medical Genetics or Biotechnology orImmunology or Molecular Biology or Applied Biology from arecognised university or institution and having experience of atleast three years post Ph.D in a Laboratory of same or higherlevel in a Government or Recognised medical college or hospitalor institution or organisation shall be entitled to conduct thetests, generate and sign test reports in respect of tests oftheir respective specialty, without recording any opinion orinterpretation of lab results.All such test reportsgenerated must necessarily bear a disclaimer to the effect thatthe reports are strictly for the use of medical practitioners andare not medical diagnosis as such.Note:Interpretation of labresults or opinion there on, wherever required by the signatoryauthority at Sl. No.3, such test reports may be co-signed by thesignatory authority at Sl. Nos.1 or 2, after recording opinion orinterpretation.Co-signee medicaldoctor shall be responsible only for the opinion orinterpretation given.Desirable:If any special test*of other speciality is done, it is desirable that specialist ofthat subject needs be there on full time or part time oroutsourced basis.*Special test meansany other apart from routine basic biochemistry, hematology, ormedical microbiology tests as listed in basic compositelaboratory.Illustration:(i) Special Testspertaining to Bio-Chemistry and Microbiology shall be reported byDoctor of Medicine (MD) or Diplomate of National Board (DNB) orPh.D in Bio- Chemistry and Doctor of Medicine (MD) or Diplomateof National Board (DNB) or Ph.D in Micro-biology respectively.(ii) Biopsies or Cytology specimens has to bereported by a person possessing Doctor of Medicine (MD) orDiplomate of National Board (DNB) or Ph.D in Pathology. | |
| (b) Number of laboratory technicians withDiploma in Medical Laboratory Technology (DMLT) or Bachelor ofScience (B.Sc.) Medical Laboratory Technology (MLT) or Master ofScience (M.Sc) Bio-chemistry or Micro biology qualification froma recognised university or institution. | Essential: 1 | Essential: 2 | Essential: 4 | |
| (c) Support staff (Laboratory Assistant orLaboratory Attendant) Roster of salary of staff. Periodic healthcheck- ups and vaccination of staff. | Essential: 1 | Essential: 1 | Essential: 2 |