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Delhi High Court issues notices to Central & Delhi govts over CEA Rules 2018
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Laxmi Yadav, Mumbai
February 25 , 2019
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The Delhi High Court has issued notices to Union health and family
welfare ministry and directorate general of health services of Delhi
government on a public interest litigation (PIL) challenging the
constitutional validity of Clinical Establishments (Central Government)
Amendment Rules, 2018 as it has no mention of signatory authority in
basic composite laboratories (small labs) thus violating the Supreme
Court order and Article 21 of the Constitution.
The High Court
also issued notice to National Accreditation Board for Testing and
Calibration Laboratories (NABL) and Insurance Regulatory and Development
Authority of India (IRDAI) in this regard.
On December 12, 2018
the government of National Capital Territory of Delhi issued a public
notice seeking implementation of the new categorization brought about by
the CEA Rules, 2018 to be implemented by all clinical establishments.
The NABL has also incorporated the CEA Rules 2018 in its document NABL
112 which specified criteria for accreditation of medical laboratories.
IRDAI has also issued a circular to insurance companies asking them to
follow the said rules while clearing claims.
The PIL was filed by Dr Rohit Jain, founder member of Forum of Practicing Pathologists.
The
petitioner stated that CEA Rules 2018 effective May 18, 2018 divided
pathology laboratories into three categories namely, basic composite,
medium and advanced, based on the kinds of tests which can be performed
in such labs and the minimum standards for such categories of labs are
prescribed under a schedule.
Under Column 3 of the Schedule
titled as ‘human resource’ for ‘basic composite lab’ the qualification
for an authorized signatory/technical head/specialist in a basic
composite lab and the qualification of MBBS is prescribed as ‘desirable’
for such signatory of laboratory reports with a rider stating that
‘wherever interpretation of lab results or opinion there on are
required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS)
medical practitioner is essential.'
Therefore, effectively no
minimum standard has been prescribed for who can be the ‘authorized
signatory’ of a report of laboratory test performed in a basic composite
lab.
It is absurd that any ailing person would require a mere
‘technical report’ containing bare values and not have the same analyzed
by a pathologist who would refer the patient to obtain requisite
specialist doctor, further tests or immediate health aid after analyzing
such values.
Under the garb of allowing non-medical persons to
sign technical reports the impugned rules blatantly promote quackery,
contravene the settled position of law, time and again reiterated and
affirmed by several high courts, adopted by the Medical Council of India
and further upheld by the apex court vide orders dated December 12,
2017 and July 10, 2018, he pointed.
Dr Jain stated that the
amended rules further failed to prescribe relevant guidelines on crucial
issues related to pathology laboratories viz. sample collection
centres, sample transport, usage of scanned/electronic signatures by
pathologists; number of laboratories a pathologist ought to be allowed
to visit in a day; daily internal quality control and regulation of
insurance claims.
The petitioner appealed to the high court to
declare the Clinical Establishment Amendment Rules 2018 as
unconstitutional and direct the health ministry to formulate relevant
guidelines regarding aforesaid issues concerning pathology laboratories.
Meanwhile,
he sought direction from the high court to the Union health ministry,
Delhi government, NABL and IRDA to implement the order passed by the
apex court during the pend ency of present proceedings.
The CEA
Rules 2018 have been notified by the central government and as such is
already adopted by 11 states and all Union territories (except Delhi)
and is likely to be adopted by more states. Moreover, the issue of
illegal pathology laboratories and other ancillary issues raised by way
of the present petition concerns the entire nation and also requires
central guidelines, he added.
Eighty per cent diagnostic
laboratories in India are basic composite labs (defined in the CEA Rules
2018) amenable to the access of all of the Indian population, he
pointed out.
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