What is EN ISO 22870:2012?

EN ISO 22870:2012 is an international standard that specifies requirements for medical laboratories performing point-of-care testing (POCT). Point-of-care testing refers to medical diagnostic tests that are conducted near the patient, rather than in a central laboratory. This standard sets out guidelines to ensure the accuracy, reliability, and quality of POCT results. It covers various aspects such as personnel qualifications, equipment maintenance, quality control, and result documentation.

Why is EN ISO 22870:2012 important?

Point-of-care testing plays a crucial role in delivering fast and accurate medical test results, especially in emergency situations or remote locations where access to centralized laboratories may be limited. The implementation of EN ISO 22870:2012 ensures that healthcare professionals can trust the results obtained from POCT devices and make informed clinical decisions. By adhering to this standard, medical laboratories can demonstrate their commitment to providing high-quality care and contributing to patient safety.

Key requirements of EN ISO 22870:2012

EN ISO 22870:2012 outlines several essential requirements for POCT laboratories. Firstly, it emphasizes the need for qualified personnel who receive appropriate training in performing tests, interpreting results, and managing potential errors. Additionally, the standard requires regular calibration and maintenance of POCT equipment to guarantee accurate and reliable measurements. Quality control procedures, including internal and external proficiency testing, must be implemented to monitor the performance of the laboratory. Finally, the standard highlights the importance of proper record-keeping, ensuring traceability, and data protection.

The benefits of complying with EN ISO 22870:2012

Compliance with EN ISO 22870:2012 brings numerous benefits to both the healthcare facility and patients. By following standardized procedures, medical laboratories can enhance the consistency and reliability of their test results, leading to improved patient care and treatment outcomes. The standard also promotes best practices in terms of personnel training, equipment maintenance, and quality control, which ultimately contribute to patient safety. Furthermore, adherence to this international standard enhances the credibility and reputation of a medical laboratory and fosters trust among healthcare providers and patients alike.