Timeline of events regarding signatory role in diagnostic laboratories

Timeline of events regarding signatory role in diagnostic laboratories

Several lakhs of diagnostic laboratories (aka pathology laboratories) exist in India. Only a few are run professionally (Thyrocare, Dr Lal PathLabs, SRL, Apollo, Metropolis etc). The situation is worse in small cities and towns.

In order to maintain quality and standards, accreditation by agencies are followed. National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent body of Quality Council of India is the leading accreditation body in India. Only 1076 "medical labs", including those in the public sector, private sector, and medical colleges are currently accredited for various tests. Accreditation is a voluntary endeavor.

Diagnostic lab reports are routinely signed by doctors (MBBS/DCP/MD/DNB) and clinical scientists (medical M.Sc/Ph.D) in the specialties of Biochemistry and Microbiology. Pathology Reports are exclusively signed by the doctors with MD/DNB/DCP in Pathology.

January 2005 - The Executive Committee of the Medical Council of India (MCI) and the Adhoc Committee appointed by the Supreme Court approved the recommendation of its own ethics committee that persons with M.Sc. qualifications with or without Ph.D are entitled to independently or solely sign a medical Biochemistry report in a clinical laboratory.

August 2010 - In order to bring quality and accountability to the various types of clinical establishments (including labs), union health ministry enacted the Clinical Establishments Act (CEA) 2010. Health being a state subject, it is the prerogative of the states to adopt the central act, modify it or formulate their own. As of now, the central act is applicable only in ten states and six union territories.

May 2012- Rules under the CEA are framed. The National Council for Clinical Establishments is formed.

NABL had prescribed M.Sc qualification for signatory role in the diagnostic laboratories for accreditation in 2013 or earlier.

March 2014- National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in releases a draft on minimum standards for various categories of Clinical Establishments for implementation of the Clinical Establishments Act. Seeks feedback from the stakeholders. It was the first instance to evoke controversy. It excluded the clinical scientists from signatory role. NMMTA objects.

December 2015 -  NMMTA files a grievance with the Health and Family Welfare Department through an online portal. The grievance was forwarded to the MCI, which replied "matter is not under the purview of MCI" and the grievance was closed without addressing the issue.

July 2016- The National M.Sc Medical Teachers' Association (NMMTA) files a Writ Petition in Bangalore High against these guidelines. Union Health Ministry, NABL and MCI are respondents.

August 2016- NABL writes to the MCI asking for its opinion on the qualifications prescribed by it.

December 2016 - Union Health Ministry writes to NABL pressurizing it to fall in line with its guidelines. Seeks response.

January 2017 - NABL responds to the ministry; states that laboratory accreditation is voluntary; it grants accreditation in accordance with International stand ISO 15189. It stressed that the authorized signatories can be M.Sc (non-medical or Medical) with experience in working in clinical laboratory. It added that NABL assesses not just the qualification but also the knowledge and competence of personnel. It said it was awaiting MCI's reply to its letter.

May 2017- Union Health Ministry publishes draft guidelines through a gazette notification and seeks feedback from the stakeholders.

March 2017 - NMMTA members held a protest event "Delhi Chalo" at Delhi. It included dharna, procession, and press conference. Memorandum was submitted to MoHFW.

July 2017 -  MCI responds to NABL letter, replies stating "all lab reports to be signed/countersigned by persons registered with MCI/State Medical Council". NABL writes to all the accredited labs to comply with the MCI "order".

July 2017  -  NMMTA files an online grievance with the PMO, which forwards it to MoHFW. The ministry closes the grievance stating that as per its guidelines tests reports in the basic composite labs which are machine-generated or reports of basic laboratory test where interpretation is not required may be submitted by lab technicians/ Medical Laboratory Scientist.

August 2017 - A team of NMMTA office-bearers meet the top officers at PMO, NITI Aayog, and MoHFW as well as the union health minister and submit memoranda against the CEA guidelines.

August 2017 - Similar WP filed in Delhi High Court by another association of scientists- the Association of Clinical Biochemists and Microbiologists.

September 2017 - Delhi HC rules that the technical reports, which don't contain a diagnosis, can be signed by scientists with M.Sc qualifications. It states, "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". It also added "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".

November 2017 - The union health ministry convenes another meeting of the stakeholders on the issue of signatory roles in the diagnostic laboratories. NMMTA put forth arguments on the eligibility of scientists with medical M.sc qualification.

December 2017 - The Supreme Court while taking up a special leave petition of a dispute between Gujarat's pathologists and laboratory technicians ruled "We dispose of all these special leave petitions and other pending applications, if any, by taking a view that the stand of the Medical Council of India that Laboratory Report can be countersigned only by a registered medical practitioner with a post graduate qualification in pathology is correct". Scientists with M.Sc/Ph.D were not a party to this case and hence their qualification was not contested.

December 2017 - MCI writes to NABL and all the State Medical Councils to abide by the Supreme Court's ruling.

March 2018 -  NMMTA withdraws its writ petition in the Bangalore High Court frustrated over the delay caused by the respondents in filing replies.

March 2018 - MoHFW convenes a meeting to discuss the Supreme Court's judgment. NMMTA was not invited to the meeting. The subcommittee felt that this judgment overrides the Delhi HC's judgment.

April 2018 - NMMTA files a fresh writ petition in the Delhi High Court over the CEA guidelines for the diagnostic laboratory.

May 2018 - Union Health Ministry publishes the guidelines for diagnostic laboratories through a gazette notification and once again excludes clinical scientists with Medical M.Sc/Ph.D qualifications.

May 2018  - Association of Clinical Biochemists and Microbiologists files a writ petition in the Delhi High Court. Other petitioners join and all cases are subsequently clubbed together.

August 2018 - NMMTA organizes a protest event at Delhi. Its officers bearers meet officials of NITI aayog and MoHFW and submits a memorandum.

August 2018 - NABL convenes a meeting for several stakeholders and decides to stop prescribing eligibility norms for diagnostic labs.

October 2018 -  NMMTA submits MCI a dossier with several documents and evidence supporting the eligibility of scientists to interpret and sign lab reports. Also, the situation and data from other parts of the world are also provided.

December 2018 - NMMTA team visits MCI headquarters and meet BoG's chairman and secretary and requests them to consider the eligibility of scientists.

May 2019 - NMMTA office bearers met the Secretary, & Additional Secretary of MoHFW at New Delhi and requested the ministry to consider their qualifications. A dossier with a variety of documents and evidence was submitted for consideration.

August 2019 - Delhi High Court directs MoHFW to not only consider the representations made but also give hearing to one member of each of the petitioners before reaching a final conclusion.

August 2019: A letter was sent to the Under Secretary of the Ministry of Health and Family Welfare with objections & recommendations on the Human Resource guidelines for the three categories of the diagnostic laboratories. It was requested to include medical M.Sc (with or without Ph.D) as a recognized qualification for all the three categories of the laboratories.

September 2019 - MoHFW convenes another meeting of the stakeholders. NMMTA once again presents its eligibility and requests the ministry to consider M.Sc qualifications.

November 2019: Letter is written to the Board of Governors in supersession of MCI asking them to recognize the qualifications of M.Sc/Ph.D for signing lab reports. A letter is also written to the Union Health Minister asking the ministry to consider M.Sc qualifications for diagnostic labs under CEA.

January 2020 - MoHFW convenes another meeting of the stakeholders. NMMTA argues and gives written submission to include M.sc/Ph.D qualification.

February 2020 - MCI reverses its hostile position and restores the signatory authority to scientists with M.Sc/Ph.D qualifications and writes to MoHFW stating its position.

February 2020 - NMMTA has written to the MoHFW and urged to modify the CEA guidelines based on MCI's letter and provide eligibility to scientists with M.Sc/Ph.D qualifications in Microbiology & Biochemistry in all the three categories of labs to interpret and sign lap reports.

February 2020 – MoHFW updates its human resource guidelines on diagnostic laboratories through a gazette notification wherein signatory grants are given to persons with M.Sc in Medical Microbiology & Medical Biochemistry in all the three categories of labs, although Ph.D is required for medium and advanced labs. Also, the scientists can’t provide any diagnostic opinion.