Yes, all laboratory test results must be linked to a report as stipulated in PALC 2025 Standard, Item 10.11, and RDC 786/2023, Section IV, Post-Analytical Phase, which also outlines the issuance of the report and its criteria for release.

Raw data is also a requirement and must be retained for a minimum period of 5 years, in accordance with RDC 786/2023, Article 81, and PALC 2025 Standard, Item 10.4 (K).

Each institution can define its own workflow for sample collection and test execution. Typically, tests requested by occupational medicine are collected through outpatient services and performed in the laboratory. If the option is to perform the COVID-19 rapid test within occupational medicine, this process is considered a POCT and must be linked to the clinical laboratory.

The validation of POCT tests must adhere to the requirements and criteria adopted by the specialty to which the test is linked (e.g., Hematology, Biochemistry…). These specialties, in turn, must support validation by ensuring, when applicable, tests for linearity, accuracy, reproducibility, and precision. Validation references are specific to each area and may be adapted according to the service or the particularities of each test. It is crucial that the validation generates sufficient statistical data to ensure the safety and reliability of the data and the results analyzed.

This is a significant challenge, as some blood gas parameters have low stability and can undergo changes when the sample is exposed to air. Depending on the characteristics of your equipment, if it is portable, it can be moved and gathered in a single location so that the sample can be processed sequentially, following best practices to minimize exposure of the sample to air. The PALC 2025 standard, requirement 11.9, outlines the need for this verification.

Another alternative is to use the results obtained from proficiency testing to verify if there is harmonization between the devices. It is important to note that the data can only be used for harmonization after receiving the provider’s results. This is possible because RDC 786/2023, Article 151, mandates the inclusion of proficiency testing for 100% of the devices.