It has been more than 30 years since the first medical tests were performed outside of conventional clinical laboratories. Today, point-of-care testing (POCT) is estimated to grow on average more than 10% per year, on track to reach 37 billion USD by 2021.
As more and more laboratory services move outside the traditional workspace, the laboratory professionals face the challenge of ensuring the quality and regulatory compliance of these services. It is a mandatory requirement to ensure the proper use of POCT devices, which may only be used by trained and competent personnel and only when POCT devices operate within QC limits.
From the regulatory perspective, diagnostic tests are not differentiated based on where they are performed. It is therefore the responsibility of the healthcare institution to show that POC tests were performed in accordance with best laboratory practices and established quality systems for diagnostics tests.
Nowadays it is unimaginable that a POCT device would not be connected to a healthcare IT system. Manual input of test results into patient’s EHR and documentation to ensure regulatory compliance simply leaves too much room for error and it also results in a large amount of paperwork. POCT device manufacturers simply must provide a standardized communication interface to their POCT devices to enable operator management, downloads of patient and QC results and the ability for monitoring the use of these devices. Otherwise, they risk getting their products off the table even before the procurement process starts.
Comtrade has developed a standard connectivity framework that ensures medical devices have full connectivity to healthcare IT systems. Implementation of the POCT1-A2 standard as a building block, offers the manufacturers of medical devices the optimal way to add support for POCT1-A2 communication protocol to their devices quickly and efficiently.