New resolution on clinical analysis tests in Brazil: what has changed?

The Brazilian Health Regulatory Agency’s (Anvisa) recently published Board Resolution (RDC) No. 786/2023 sets out technical and sanitary requirements for running clinical laboratories, pathology laboratories and other services that carry out clinical analysis test-related activities. This includes (but is not limited to) biological, microbiological, immunological, chemical, biochemical, immunohematology, hematological, cytological, anatomopathological, genetic, molecular biology, cell biology, mycology, parasitology, toxicology, urinalysis or other tests on biological material of human origin.

The resolution became effective on August 1, 2023, repealing and fully replacing Anvisa’s RDC No. 302/2005 and significantly expanding the list of tests allowed in pharmacies and drugstores. This issue has been the subject of extensive debate over the last four years, including three targeted consultations, two sector dialogues, one public consultation (CP No. 912/2020), and two public hearings.

RDC No. 786/2023 modernizes certain concepts and requirements that had become outdated. It updates criteria concerning physical infrastructure, material resources, organization, contracting, management and education of personnel, quality management programs, process management, technologies, risks and waste, and management of operational processes involving the pre-analytical, analytical, and post-analytical phases.

New definitions

The resolution includes new terms that are important for interpreting clinical analysis regulations, the following of which are particularly relevant:

• Type I Services: cover pharmacies and isolated practices – defined as establishments that provide specialized assistance under the technical supervision of a legally qualified health professional. This type of service does not include venipuncture and arterial puncture; receiving or forwarding biological material for clinical analysis tests; and clinical analysis tests that require an instrument for reading, interpreting, and viewing results, among others.

Type I facilities above are prohibited from conducting clinical analysis tests that require instruments for reading, interpreting and viewing the results; sending or receiving biological material for clinical analysis tests; conducting clinical analysis tests that require reading, interpreting and viewing the results; safekeeping, storing or transporting biological material; carrying out activities related to the pre-analytical phase (except for collecting biological material); venipuncture and arterial puncture; clinical analysis tests that use in-house methodologies; and clinical analysis tests that use urine as biological material.

However, Type I facilities that have entered into a supervision agreement with Type III facilities may carry out clinical analysis tests requiring instruments for reading, interpreting and displaying the results, so long as they meet the following requirements: the instrument describes the results as reagent, non-reagent, or invalid, or presents them as a direct value; the instrument does not require the preparation of a reagent or the use of reagent water produced in the service; the instrument does not require remote reading, interpretation and visualization of the results; the instrument’s calibration is checked on the instrument itself in accordance with the manufacturer’s manual; the instrument conducts all stages of the clinical analysis test’s operational processes in loco; and the instrument uses an in vitro diagnostic product that requires primary biological material.

• Type II Services: associated with ‘collection point’ establishments that provide biological sample collection and storage services to just one clinical laboratory, which they are linked to either from a corporate or contractual standpoint. Beyond the same tests authorized for Type I Services, establishments conducting Type II Services can also carry out in-person testing at the time samples are collected. However, they are prohibited from carrying out the analytical phase of clinical analysis tests using in-house methodologies.
• Type III Services: cover clinical laboratories – defined as places that carry out activities related to clinical analysis tests, comprising the pre-analytical, analytical and post-analytical phases; as well as pathology laboratories – now defined as establishments that conduct anatomopathological, biopsy and cytopathological diagnostic procedures, including fine needle aspiration, immunohistochemistry, immunofluorescence and molecular pathology in the pre-analytical, analytical and post-analytical phases. These establishments will be able to carry out all clinical analysis tests, as well as send biological material for clinical analysis testing by a support laboratory (i.e., one that analyzes biological material sent by a Type III Service).
• Mobile Clinical Analysis Service: conducts clinical analysis test-related activities outside a fixed location. Type II or Type III Mobile Clinical Analysis Services must be linked to a Type III Service with a fixed location. Mobile services are not permitted to provide any form of assistance while on the move, and must carry out checks on the instruments they use after they are set up at the locations where the service stops to provide assistance. Such services must also keep records of any assistance provided.
• Clinical Analysis Test: a set of processes aimed at determining the value or characteristics of a property.
• Primary biological material: human tissue or fluids such as excrement, body fluids, cells, organs or other fluids either directly of human origin or isolated from the human body that have not undergone changes to their natural state or have not been subjected to preparation for analysis, for example via centrifugation, filtration, cooling, heating, homogenization, transfers, among other activities.

Furthermore, the resolution updated certain definitions in RDC No. 302/2005, of which the main ones were:

• Biological material or biological sample: human tissue or fluids such as excrement, body fluids, cells, organs or other fluids either directly of human origin or isolated from the human body.
• In-house methodology: any analytical methodology, reagents or analytical systems developed, produced and validated by a Type III Service establishment for use in its own facilities, and applied in research or to support diagnosis and treatment.

Please note that only Type III Service establishments can develop and use in-house methodologies – it is forbidden to sell, pass on, donate or deliver reagents or any products stemming from this operation for consumption. Establishments must demonstrate that their in-house methodologies are suitable on scientific and operational grounds, either via a validation study, guides or national standards.

Minimum contractual requirements

RDC No. 786/2023 contains a specific chapter that provides for minimum requirements when drafting contracts for clinical analysis test-related activities, covering subjects such as:

• The obligations, responsibilities and roles of the parties involved;
• Requisitions of documents proving the parties’ compliance with sanitary regulations;
• Control and qualification criteria for the different stages of the clinical analysis testing chain;
• Record keeping for traceability control; and
• Compliance with all the requirements of the analytical, pre-analytical and post-analytical phases.

Other new developments

The new resolution permits the Ministry of Health and health departments at the state, municipal or federal district level to determine other scenarios for clinical analysis testing within the scope of public health promotion and protection policies, provided these comply with requirements set out in the resolution itself. In these cases, clinical analysis testing in an external environment must be conducted by a registered provider and local health authorities must be notified.

Service providers must also implement information systems policies establishing how to input, access, and modify patients’ and professionals’ data and exam results – including information about the date, time, location, and user who entered or changed the data.

In addition, establishments must develop systematized processes for releasing test results and patient reports (whether automatically or manually); an information privacy and confidentiality policy; and a defined, documented system for protecting against unauthorized access.

Amendments to Anvisa RDC No. 44/2009

RDC No. 786/2023 has significantly impacted the pharmaceutical services sector by amending RDC No. 44/2009, which sets out good practices for pharmacies and drugstores’ pharmaceutical services. The new wording establishes that pharmaceutical care services include home pharmaceutical care, measuring physiological parameters, conducting clinical analysis tests and administering medicines, allowing for a wide range of tests in pharmacies (Type I Services).

Unlike the previous version, the amended resolution no longer establishes an exhaustive list of which tests can be carried out as Type I Services. According to the Brazilian Association of Pharmacies and Drugstores (Abrafarma), the new rule will allow the following tests to be carried out under this classification:

According to RDC No. 786/2023, physiological measurements and the carrying out of clinical analysis tests in these establishments must not be for diagnostic purposes.

Rules on physical infrastructure

Establishments providing services covered by RDC No. 786/2023 must also observe rules regarding physical infrastructure at locations where clinical analysis testing is conducted when:

• renovating or expanding existing services;
• building new facilities; or
• Adapting establishments that were not originally designed to provide health services or that have had the function of one or more of their environments change.

For more information, please contact Mattos Filho’s Life Sciences & Healthcare practice area.