Doctor NOT essential to run Small path labs: Health ministry Gazette

New Delhi: The central government's recent Gazette notification on path lab rules has indeed become a bone of contention between the medical professionals and the government. As per the new rules, for running small labs, the presence of doctors would not be mandatory, as the manpower requirement for authorized signatory being MCI recognized doctors in such labs has only been kept as desired, not essential

It is reported that Union Health Ministry notified the Clinical Establishments (Central Government) Amendment Rules, 2018 and that has come into force from May 18, 2018. As per the new Rules,

'every clinical establishment engaged in diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment', requires to comply with the minimum standards of facilities and services as specified in the Schedule.

For the first time, based on the scope of services the  Medical Diagnostic Laboratories (or Pathological Laboratories) have been divided into Basic Composite (Small), Medium and Advanced. The Gazette specifies the various tests which are either essential or desired to be conducted at the said laboratories as well as the infrastructure, legal, record keeping and manpower essential for various classifications on the laboratories

The gazette draws important light on the Minimum qualification of Technical Head of Laboratory or Specialist or *Authorised Signatories. The authorized signatory will be liable for the authenticity of the laboratory test report, the Gazette adds.

The rules are drawing flak from the medical fraternity which has alleged laxity in the rules for regulating small labs, which would actually cover the major chunk of the diagnostic tests performed. Unlike medium and advanced labs, small labs now do not face mandatory requirement to have MBBS doctor or pathologist for running the lab, if they are not interpreting the results. 

Alleging that this will allow small labs to be run by nondoctors , will finally promote more quackery in laboratory medicine and will lead to mushrooming of illegal labs in the country, doctors have pointed out that the new rules will eventually put the patient at risk and dilute of the overall quality of care in medical services.

Following is a brief summary of the  three types of labs along with their authorized signatory requirements for the three typed os laboratories

Basic Composite Labs

Simply put, The pathology labs conducting routine biochemistry tests, haematology tests, basic medical microbiology & immunology tests like rapid test (point of care tests) for infection, urine routine examination and microscopy, hanging drop for vibrio cholerae, stool for ova, cyst, etc have been classified as Basic Composite labs.

Authorised Signatory- The Gazette notes the minimum qualification of authorized signatories for such labs is Desirable to be Bachelor of Medicine and Bachelor of Surgery (MBBS) from a recognized university institution. Having said that, the Gazette specifies that **Where ever interpretation of lab results or opinion thereon are required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential

Medium Labs

Medium Labs are those labs that In addition to the tests performed in basic composite laboratory, including tests including Hormone Bioassay, Tumor markers, plasma protein electrophoresis, Coagulation Assay, PAP smear, Fine Needle Aspiration Cytology(FNAC), sputum and CSF cytology and certain Microbiology and Immunology tests including (a) Serological tests for viruses, bacteria, fungi, parasites (b) Cultural Sensitivity tests: Bacterial or fungal (c) Other special stains besides Gram's stain. Moreover, subject to availability of equipment and specialist, they may perform  Histopathology and Molecular Genetics tests, but this is not essential

Authorised Signatory - For such labs it is Essential to 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 (DCP) or Bachelor of Medicine and Bachelor of Surgery (MBBS) with Doctor of Philosophy (PhD) in any of the subjects above. For such labs it is 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 tests means any other apart from routine basic biochemistry, haematology, or medical microbiology tests as listed in basic composite laboratory. Illustration:

(i) Special Tests pertaining to BioChemistry and Microbiology shall be reported by Doctor of Medicine (MD) or diplomate of National Board (DNB) Bio-Chemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) 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) Pathology

Advanced Labs

Advanced Labs are those labs which In addition to tests performed in medium laboratory, additional tests including  (a) coagulation profile, Drug monitoring and toxicology assay, (b)  molecular genetics, tests for detection of inborn errors of metabolism; All other Haematology
tests (besides for medium labs), Histopathology Examination, Molecular genetics, Immuno Cytochemistry, Other biological fluid cytology; Ultrasound or CT guided, FNAC,Immunohisto-chemistry and tests like (a) Culture sensitivity tests for viruses. (b) Real Time Polymerase Chain
Reaction (RTPCR) tests. (c) Tissue diagnosis test for infectious diseases.

Authorised Signatory - Similar to medium labs, For Advanced labs it is Essential to 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 (DCP) or Bachelor of Medicine and Bachelor of Surgery (MBBS) with Doctor of Philosophy (PhD) in any of the subjects above. For such labs it is 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 tests means any other apart from routine basic biochemistry, haematology, or medical microbiology tests as listed in basic composite laboratory. Illustration:

(i) Special Tests pertaining to BioChemistry and Microbiology shall be reported by Doctor of Medicine (MD) or diplomate of National Board (DNB) Bio-Chemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) 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) Pathology

Medical practitioners have also pointed out that the rules stand in violation of recommendations of expert committee, set up by MCI to draft rules to regulate path labs, that made MBBS degree an essential qualification for path labs as well as the Supreme Court order on December 12, 2017 clearly stated that laboratory reports can be countersigned only by a registered medical practitioner with a post-graduate qualification in pathology.

Read Also:Only MCI registered PG Pathology can sign Laboratory Reports-Supreme Court