A standard was approved by the National Health Surveillance Agency (Anvisa) that allows the carrying out of analysis tests clinic in pharmacies and offices, however, only as a screening and not as a substitute for laboratory diagnosis conventional.
The new resolution will take effect on August 1st and establishes a new categorization of services related to clinical analysis exams:
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- Type I service (pharmacies and isolated clinics);
- Type II service (collection points);
- Type III service (clinical laboratories, support laboratories and pathological anatomy laboratories).
In type I and II services, collections and examinations can be carried out on a screening basis, always using primary biological material (human or isolated tissue or fluid). These materials cannot have been altered in their natural state or have undergone preparation procedures for analysis.
In an excerpt from the resolution, Anvisa makes it clear that the authorization does not take away the importance of conventional laboratory tests.
“Thus, the approved norm makes it possible to carry out screening tests in type I and type II services, which do not go beyond the diagnosis conventional laboratory and do not replace it, as their performance is complementary, with different purposes in serving the population", said the entity.
In another section of the text on which the resolution is based, the health surveillance agency made it clear that the service now authorized in pharmacies and clinics should only be part of the analysis process clinic.
“The results of tests performed in type I services should not be used in isolation for clinical decision-making. These tests should be used as a triage to provide an objective starting point in together with the evaluation routine of health professionals, to offer adequate support to patients. Therefore, the result of a rapid test requires the interpretation of health professionals, who must associate it with the individual's clinical data and the performance of other confirmatory laboratory tests", informed to Anvisa.
Also according to the agency, the new resolution brings progress with regard to health support for the population, which will now have access to clinical analysis services facilitated.
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