Diagnostic labs will soon have to follow standards for sample collection, transport: Here’s why the Govt move is important

Why were norms not followed uniformly?

In 2018, the government had notified that collection centres should be part of the main laboratories and that the parent laboratories should be held accountable for their compliance of norms. The notification had clarified that collection centres would not be registered separately but as a component of the main laboratory. However, in the absence of clear-cut standards, even adherence to this provision remains scarce, with registration of standalone collection centres in various states.

In November 2020, amid Covid-19, the National Accreditation Board for Testing and Calibration Laboratories, a board under Quality Control of India (QCI), had flagged that “there are mismatches in the declaration (of samples) made by (accredited) lab to NABL and the actual collection centres/facilities/sources of collection which are available on their websites or other documents.” At the time, it had advised labs to declare all sample collection centres/facilities/sources in 30 days. It had further cautioned that “any sample collection not under the responsibility of the lab and not covered under its (quality) management system is non-compliant with the accreditation norms and liable to action by NABL.” It had further advised all labs to review such arrangements to ensure these are in line with norms for accreditation.

Who flagged the gaps?

In 2019, pathologist Dr Rohit Jain moved the Delhi High Court, challenged the Clinical Establishments (Central Government) Amendment Rules 2018, especially on the aspect of minimum standards for signatory authority in diagnostic laboratories. He sought implementation of a 2017 order of the Supreme Court, which said that a lab report should be counter-signed only by a registered medical practitioner with a post graduate qualification in pathology.

At the time, he also sought guidelines on minimum standards for medical diagnostic labs with regard to sample collection centres, sample transport, electronic signatures on pathological reports by authorised signatories, number of pathology labs a pathologist can visit in a day and on daily internal quality control.

In February 2020, the Centre notified the Clinical Establishment (Central Government) Amendment Rules 2020, under which, according to Dr Jain, “unqualified and unregistered non-medical persons viz MSc/PhD were authorised to issue pathology reports without the signature/counter signature of a pathologist.”

Apart from challenging these amended rules, Dr Jain also moved court in August 2021, highlighting an RT-PCR testing scam in Kumbh Mela where reportedly about one lakh fake tests were conducted on devotees after intermediaries were given contracts. “The accused diagnostic labs in Delhi and Haryana were able to collect samples and conduct a huge number of tests where they have no sample collection centres at Uttarakhand. It is clear that a scam of such enormity has only been possible because of the lack of essential minimum standards on the issue of sample collection/sample collection centres and sample transport policy,” Dr Jain had argued in his submission. He had also highlighted that the accused labs were not registered under the Act either.

In 2023, the Delhi High Court directed the Centre to consider Dr Jain’s plea as a representation and decide within three months. In May 2023, the government held a meeting under the chairmanship of the Additional Director-General of Health Services, New Delhi, where Dr Jain too was invited to make his representation.

They decided to constitute four sub-committees of experts — pathology, biochemistry, hematology and microbiology – to define standards of procedure (SOPs) for sample collection, collection centres and sample transport policy.

However, these guidelines weren’t notified. So a year later, in May 2024, Dr Jain moved the Delhi High Court again, accusing the government of wilful disobedience of the court’s order.

Where do matters stand now?

The Ministry of Health and Family Welfare has now told the Delhi High Court that it is in the process of notifying the minimum clinical standards for handling and transport of diagnostic samples, with the policy currently undergoing legal vetting by the Legislative Department of Ministry of Law and Justice.

It also told the court that currently the guidelines of ICMR-National Institute of Virology (NIV) are in place, which include rules for collection, packaging and transport of specimens for testing for high-risk viral pathogens, as well as guidelines for collection, packaging and transport for the COVID-19 virus.

According to MOHFW, the subject experts held “detailed internal deliberations for formulating minimum standards for sample collection and sample transport policy,” following which the draft minimum standards were technically finalized and were also technically approved by the Director General of Health Services (DGHS).

“The minimum standards for sample collection centres, as approved by the NCCE, are in the advanced stages of being notified in the Gazette of India. The draft minimum standards for sample collection centres are currently under legal vetting by the Legislative Department of the Ministry of Law and Justice,” the MOHFW said in its submission.

The National Council for Clinical Establishments (NNCE), a statutory body under the Clinical Establishments Act, is working with the aim of developing minimum standards and their periodic review. Taking the ministry’s submission on record, the court instructed that the standards be notified expeditiously, with a direction that the process “may be accomplished within the next three months.”