HC directs Centre to decide plea seeking minimum standards regarding Sample Collection within 12 weeks
New Delhi: The Delhi High Court bench has recently disposed the plea minimum standards regarding Sample Collection, Sample collection centers and Sample Transport Policy and related issues for all clinical establishments as it noted that the Court neither has the domain knowledge with regard to sample collection nor it has the jurisdiction to set standards or frame the rules.
Disposing of the plea, the bench comprising Justices Manmohan and Saurabh Banerjee has directed the Central Government to consider the petitioner's application as a representation and arrive at a decision within twelve weeks.
"Since the Court neither has the domain knowledge with regard to sample collection nor it has the jurisdiction to set standards or frame the rules, it disposes of the present writ petition along with pending applications with a direction to the Union of India to consider the petitioner’s application being C.M.No.27228/2021 as a representation and to decide the same by way of a reasoned order within twelve weeks after giving an opportunity of hearing to the petitioner," noted the bench.
"This Court clarifies that it has not expressed any opinion on the merit of the controversy and the said application shall be decided on its own merit. The rights and contentions of all the parties are left open," it clarified.
During hearing of the case on January 27, the counsel for the petitioner Dr Rohit Jain had informed the bench that the petitioner has filed a new application seeking elaboration of the prayers namely for establishment of minimum standards for sample collection/sample collection centres and sample transport policy for medical diagnostic laboratories.
"In the last two decades stand-alone Sample collection centers have cropped up across the country...Unfortunately, this critical clinical activity of sample collection is going on uninterrupted without the supervision of a registered Medical Practitioner, a trained nurse, or medical technologists neither Minimum standards for sample collection centers are notified till date," stated the plea.
"Since 46-68% errors in medical laboratory testing are mostly pre-analytical and occur due to compromised sample collection & transport and can be a major risk to patient safety as all the treatment decisions are based on medical reports generated using patient samples," the plea mentioned as it prayed to the court to direct the Union Government authorities for notifying about the minimum standards regarding Sample Collection, Sample collection centers and Sample Transport Policy and related issues for all clinical establishments.
Medical Dialogues had earlier reported that a division bench of the high court, on August 6, 2020, had directed the Delhi government to take action in accordance with law against online health service aggregators, who are operating illegally without any registration, after hearing all the stakeholders.
It had been alleged in the plea that rampant illegal sample collection by online health service aggregators was leading to false-negative COVID-19 results thereby letting loose the coronavirus positive patients in the society and hence, unfortunately, allowing them to transmit or spread the virus.
It further stated that there was an urgent need to restrain the online health aggregators from collecting the diagnostic samples illegally to save innocent people in the interest of the public at large and action may be initiated against them as directed by the court on August 6. However, the petitioner claimed that no action has been taken against the online aggregators by the authorities.
During the hearing of the case on February 14, 2022, the petitioner doctor had informed the HC bench that there was no monitoring of aggregators rendering service in Delhi apropos COVID related tests by Delhi Government. He had further claimed that the service providers who may be located outside the national capital were operating without any supervision by any authority statutory agency or government.
Back then, taking note of the fact that there was no mechanism of oversight by the State government, relating to the collection of blood samples in Delhi for tests, the bench had directed the Delhi Government to formulate and operationalise a regime for surprise checks, inspections, and audits as may be appropriate.
Apart from this, the bench had also directed the GNCTD to publish the requisite standards for collection of samples within one week after due consultation with the Indian Council of Medical Research (ICMR).
Thereafter the High Court bench had directed the Delhi Government and other concerned authorities to file an affidavit explaining the mechanism that is being adopted to comply with the earlier order of the HC, wherein it had initiated action against such service providers who violated law.
To read the order, click on the link below:
https://medicaldialogues.in/pdf_upload/delhi-high-court-order-200101.pdf
