The National Health Surveillance Agency (Anvisa) approved a rule that allows clinical analysis tests to be carried out in pharmacies and offices. Examinations should be performed in these spaces only for screening purposes and do not replace conventional laboratory diagnosis.
The resolution takes effect on August 1st and defines a new categorization of health services that carry out activities related to clinical analysis tests: type I service (pharmacies and isolated clinics); type II service (collection points); and type III service (clinical laboratories, support laboratories and pathological anatomy laboratories).
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Type I and II services are qualified to carry out collections and examinations of clinical analyzes on a screening basis from primary biological material (tissue or fluid constituting the human organism or isolated from these that has not undergone alterations in its natural state or that has not was subjected to activities aimed at preparing for the analysis), provided that all stages of the examination are carried out after collection at the establishment itself.
“Thus, the approved norm makes it possible to carry out screening tests in type I and type II services, which do not go beyond conventional laboratory diagnosis and do not replace it, since their performance is complementary, with different purposes in serving the population”, highlighted Anvisa.
“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 conjunction with the routine assessment of healthcare professionals, to provide 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”, reinforces Anvisa.
In a note, the agency assesses that the new norm represents an important advance in relation to the expansion of the list of services performed in pharmacies and offices, in order to allow better access of the population to health care, as well as guarantee the quality of exams. clinical trials in the country.
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