The Directorate of Public Health and Preventive Medicine canceled permission for a private laboratory to test RT-PCR samples for COVID-19 after spotting discrepancies, including uploading negative results as positive for nearly of 4000 samples and downloading the results of samples received from Kolkata such as those from Kallakurichi.
Public health director TS Selvavinayagam issued an order on Friday revoking the authorization granted to the Medall laboratory to test RT-PCR samples with immediate effect. A public health notice was served on the laboratory under sections of the Tamil Nadu Public Health Act, 1939.
The DPH said that by analyzing the ICMR portal regarding the entry of COVID-19 tested samples, a number of problems were identified in the laboratory – the results of the RT-PCR samples for the tests received from Kolkata have were uploaded as samples from Kallakurichi, and approximately 4,000 samples deemed negative for COVID-19 were uploaded as positive to the ICMR portal on May 19 and 20. Many incomplete details were found in the list of positive cases entered daily.
The lab acted against guidelines issued by the government and ICMR, and operated with “vested interests” and “carelessness,” he noted.
The laboratory did not follow the procedure prescribed by the ICMR and the Indian government. Uploading positive results from samples from outside Tamil Nadu has led to an undue increase in state workload and state positivity, he said.
He added that poor communication of results could lead to a miscalculation of the resource allocation by the Center. The laboratory had hampered measures taken by the Union and state governments to control the pandemic. The upload of negative as well as positive results has led to “undue confusion, panic, anxiety and stress among the general public”. It was an act of nuisance to people for whom erroneous results were reported, he said.
The government suspected a link between the lab and the hospitals, as false reports could have been used to lure patients to hospitals and subsequently earn medical bills. Incomplete details of reports have delayed the identification of positive cases and hampered action taken to contain the spread. He said the lab’s general manager was tasked with providing an explanation to management within three working days of receiving the notice. Further action would be decided after inspection by a public health team.
The laboratory’s response
In a statement released Friday, Medall Healthcare said an encryption error occurred while uploading data to the ICMR server.
“We deeply and unconditionally regret the encryption error that occurred while uploading the data to the ICMR database and have already taken steps to fully and seriously correct it,” he said. .
He said the RT-PCR testing process in the lab was not in question. âIt needs to be clarified and documented that the report generated and shared with clients who took the test was accurate. So the problem is not related to the testing process, its quality or accuracy. The problem was an encryption (technical) error that occurred while uploading data to the ICMR server, âhe said.
When the encryption error is rectified / resolved, it compensates for the problem / challenge caused by the error. The error is corrected in record time, as a priority, he said. Medall Healthcare said its team is working in close coordination with state government officials on the same topic. “We reiterate once again our flawless cooperation with the team sent by the Director of Public Health and Preventive Medicine and that the technical encryption error that caused this is being corrected,” said he declared.