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July 21, 2020

COVID-19 | Life Sciences & Healthcare - COVID-19 tests

Life Sciences & Healthcare - updated on Jul 21 at 01:07 pm

New Ordinance of the Brazilian Ministry of Health requires that the results of all tests for the novel coronavirus are notified within 24 hours

Ordinance No. 1,792/2020 of the Brazilian Ministry of Health was published in the Federal Official Gazette on July 21, 2020. The rule modifies Ordinance MS No. 356/2020 to determine the obligation to be notified to the Ministry of Health all results of diagnostic tests for SARS-CoV-2/COVID-19 carried out by public, private, university and other laboratories in the entire Brazilian territory.

The Ordinance enters into force on the date of its publication and determines that the notification must be made within 24 hours of the test result, whether it is positive, negative, inconclusive or correlated. The notification must be made through the National Health Data Network (Rede Nacional de Dados em Saúde - RNDS).

There is also no distinction on the testing methodology used. Therefore, the results of all types of tests must be reported. The notification is the responsibility of the managers and of those responsible for the respective laboratories.

If non-compliance with the Ordinance is identified, the infringer will be subject to the penalties set out in items VI, VII, VIII of section 10 of Law No. 6,437/1977, which can be: warning, interdiction, cancellation of license or health authorization, and/or fine. Compliance with the Ordinance will be monitored by the local health manager.

The laboratories will have a period of 15 calendar days, counted from the entry into force of the rules (by August 5, 2020), to make the necessary adjustments to the use of the RNDS. Registration in the system must be done on the website of the Brazilian Ministry of Health.

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