open letter to NABL

The guidelines on the signatory role in diagnostic laboratories have been a contentious issue since 2014. There were no government guidelines on this aspect of diagnostic laboratories. Private as well as government laboratories have appointed persons with M.Sc degree as consultants (Biochemists or Microbiologists) since a very long time. National Accreditation Board for Testing & Calibration Laboratories (NABL), an independent body had framed its own guidelines, which gave signatory rights to persons with M.Sc degrees.

With the formulation of guidelines under the Clinical Establishment Act (CEA) in 2014, a controversy has erupted. Under this guideline, all roles for M.Sc persons in diagnostic laboratories were ignored, giving signatory rights only to doctors registered with medical councils. 

Subsequently, NABL was pressurized to alter its guidelines in tune with CEA's guidelines. For some strange reasons, NABL chose to seek the opinion of Medical Council of India (MCI) on this aspect through several letters since August 2014. When people aggrieved by CEA's discriminating and unjust guidelines pointed at the eligibility provisioned in NABL document 112, the Ministry of Health & Family Welfare (MoHFW) questioned NABL's position and almost asked it to fall in line with CEA's guidelines. Yet, NABL persisted with seeking MCI's response. MCI finally responded in June 2017, which was, unfortunately, in sync with CEA's guidelines. With this reply, the NABL is technically free to modify its guidelines.

The two bodies: MoHFW and MCI appear to have colluded to form an axis of evil with the sole motive to keep non-doctors out of diagnostic laboratories. In the light of recent developments, here is an open letter to the Director of NABL, so that NABL stays away from this axis:

"As clarified in NABL's letter to the MoHFW, NABL has framed its guidelines on signatory by the persons possessing the necessary technical competence/expertise and knowledge on accreditation requirements. 

NABL had sought clarifications from MCI through its letter dated 12-08-2014 whether non-medical persons possessed eligibility to sign laboratory reports. MCI, on its part, after a long delay, superseding view of its own the ethics committee had unethically opined that only those registered with MCI/state medical councils should sign the reports. At the same time, it has skipped answering the three direct questions posed by NABL. 

There are a few issues, NABL must consider before applying changes to the NABL document 112.

1. MCI is a body established by the government for establishing and maintaining high standards of medical education and recognition of medical qualifications in India. It registers doctors to practice in India, in order to protect and promote the health and safety of the public by ensuring proper standards in the practice of medicine. The Indian Medical Council Act 1956 or subsequent amendments do not mention anything about the laboratory practice. Attempts are being made to misrepresent section 15 of IMC Act for this purpose.  Besides, service in the laboratory is not the practice of medicine. MCI, therefore, has no jurisdiction in giving its opinion on diagnostic laboratories as it is outside the domain of its operation. Since MCI has washed its hands off medical M.Sc courses since the 1980s, it has no locus standi on giving its view on the eligibility of medical M.Sc candidates in diagnostic laboratories. In 2005, the MCI under the supervision of the Adhoc committee appointed by the Supreme Court had approved in clear terms that M.Sc, with or without Ph.D are eligible to sign laboratory reports. This was already brought to your notice in previous communications. Therefore, the further insistence of seeking MCI's opinion was totally unnecessary. By issuing a contradictory opinion in 2017, the MCI clearly shows malafide intention.

2. The only government agency that has legal status to formulate guidelines on diagnostic laboratories is the National Council for Clinical Establishments, which was established under the Clinical Establishment Act (CEA). In the month of October 2014, this council framed guidelines for diagnostic laboratories and sought public feedback. It has re-published the draft guidelines in the Gazette recently and again sought public feedback. Even if the CEA's draft guidelines are adopted without modification, its jurisdiction is restricted only to the states that have adopted the central act. Therefore, NABL (a stateless entity) does not come under the jurisdiction of Clinical Establishment Act and is not bound to follow its guidelines or restrict it to only those states where CEA is active.

3. NMMTA has filed a writ petition in the Karnataka High Court against the discriminatory guidelines of the CEA and NABL is one of the respondents in this case. Since the case is ongoing, it would be prudent not to disturb the existing guidelines as mentioned in document 112.

Keeping in mind that accreditation is a voluntary process and that NABL is free to set its own guidelines and the facts that neither MCI nor CEA has jurisdiction to impose its guidelines on NABL, NMMTA implores that the document 112 remains unchanged until the case is disposed off by the court. Taking into account the public benefit and current national requirements, NABL may choose to ignore both the MoHFW and MCI and remain standing tall as a beacon of an impartial accrediting agency."

It must be highlighted here for the readers that MCI's reply to NABL is a communication between two bodies. MCI does not have the mandate to frame guidelines on the diagnostic laboratories in the government or private domain (including teaching hospitals).  Therefore, it must not be applied outside the context. A query has been filed with the MCI under the RTI act to provide documentary evidence supporting its jurisdiction (if any) on diagnostic laboratories. It would be rather unfortunate if people with vested interests start applying this as a diktat from MCI on institutions or bodies other than NABL-accredited ones. Until things become clear, people are requested not to create and spread rumors or start "applying the MCI rules" in laboratories associated with teaching hospitals.