The Directorate of Public Health and Preventive Medicine has cancelled the permission granted to a private laboratory to test RT-PCR samples for COVID-19 after spotting discrepancies, including uploading of negative results as positive for nearly 4,000 samples and uploading the results of samples received from Kolkata as those from Kallakurichi.
On Friday, Director of Public Health T.S. Selvavinayagam issued an order cancelling the permission granted to Medall Laboratory to test RT-PCR samples with immediate effect. A public health notice has been served on the laboratory under sections of the Tamil Nadu Public Health Act, 1939.
The DPH said on analysing the ICMR portal pertaining to entry of COVID-19 tested samples, a number of issues were identified in the laboratory — the results of RT-PCR samples for testing received from Kolkata were uploaded as samples from Kallakurichi, and around 4,000 samples that were found negative for COVID-19 were uploaded as positive on the ICMR portal on May 19 and 20. A lot of incomplete details were found in the line list of positive cases entered daily.
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The laboratory acted against the guidelines issued by the government and ICMR, and functioned with “vested interest” and “negligent attitude”, he noted.
The laboratory has not followed the due procedure laid down by ICMR and the Government of India. Uploading of positive results of samples from outside Tamil Nadu led to undue increase in the State’s case load and positivity of the State, he said.
He added that wrong reporting of results might cause wrong calculation of resource allocation by the Centre. The laboratory had hindered the steps taken by the Union and State governments in controlling the pandemic. Uploading negative results as positive led to “undue confusion, panic, anxiety and stress among the general public”. This was an act of nuisance for the persons for whom wrong results were declared, he said.
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The government suspected a nexus between the laboratory and hospitals, as wrong reports might have been utilised to draw patients to the hospitals, and subsequently, earn through medical bills. The incomplete details in reports delayed the identification of positive cases and hindered the steps being taken to contain the spread. He said the managing director of the laboratory had been instructed to give an explanation to the directorate within three working days after receipt of the notice. Further action would be decided after an inspection by a public health team.
Lab’s response
In a statement on Friday, Medall Healthcare said an encryption error had occurred while uploading data to the ICMR server.
“We deeply and unconditionally regret the encryption error that occurred while uploading data to the ICMR database and have already taken steps to correct it in full and right earnest,” it said.
It said that the RT-PCR testing process at the laboratory was not in question. “It must be clarified and placed on record that the report generated and shared with customers who took the test was accurate. So the issue is not with the testing process or its quality or accuracy. The issue has been an encryption error (technical) that occurred while uploading the data to the ICMR server,” it said.
When the encryption error is rectified/addressed, it offsets the issue/challenge caused by the error. The error is being rectified in record time, on a priority basis, it said. Medall Healthcare said its team was working in close coordination with State government officials on the same. “We once again reiterate our unstinted co-operation with the team being sent by the Director of Public Health and Preventive Medicine and that the technical encryption error that caused this is being addressed,” it said.