Why minimum standards for handling diagnostic samples are important

These are also not uniformly enforced owing to gaps in the law governing labs and sample collection centres, as well as its enforcement. Medical professionals have long been calling for reform; the MoHFW’s soon-to-be-notified policy seeks to answer this call.

Current loopholes

Beyond lack of comprehensive clinical guidelines, experts have pointed to a couple of significant loopholes vis-à-vis the medical testing ecosystem.

🔴 First is the continued existence of standalone collection centres.

In 2018, the Centre had notified that sample collection centres should be part of the main laboratories, and that the parent laboratories should be held accountable for their compliance of norms. But in the absence of clear-cut standards, standalone collection centres continue to be registered in various states, posing a fundamental problem when it comes to ensuring compliance with clinical standards.

In November 2020, the National Accreditation Board for Testing and Calibration Laboratories (NABL) 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 advised labs to declare all sample collection centres within 30 days, and 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.” The MoHFW’s new policy will likely address this issue.

🔴 Experts have also called for revisiting current laws guiding “who” can collect samples and issue reports. In 2019, pathologist Dr Rohit Jain moved the Delhi High Court, challenging the Clinical Establishments (Central Government) Amendment Rules 2018, specifically on minimum requirements for signatory authorities 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.

But the Centre’s Clinical Establishment (Central Government) Amendment Rules 2020 did not address the issue, allowing “unqualified and unregistered non-medical persons viz MSc/PhD were authorised to issue pathology reports without the signature/counter signature of a pathologist,” according to Jain.

One man’s fight

Jain challenged these amended rules, and in August 2021, also moved court highlighting an RT-PCR testing “scam” during the Kumbh Mela in Haridwar that year where one lakh fake tests were reportedly conducted on devotees by unqualified intermediaries.

“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,” Jain had argued in his submission.

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

After the meeting, the government 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.

When these guidelines were not notified even a year later, Jain in May 2024 moved the Delhi High Court again, accusing the government of wilful disobedience of the court’s order. It is in this matter that the MoHFW has now assured the court that a policy will be notified at the earliest.

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”.