| 摘要 |
PROBLEM TO BE SOLVED: To provide a system and a method for assessing statistical and clinical acceptance of new medical service or changes in products used by a clinical laboratory or hospital, and providing documentation of validation.SOLUTION: The system and method includes an information exchange mechanism, such as the Internet, an extranet, compact disk (e.g., CD-ROM) or text-based mechanism to establish a systematic approach between a provider and client for collecting (steps 5, 55), reviewing (steps 30, 80) and providing information (steps 10, 40, 60, 70, 90) to demonstrate the clinical validity of new or modified products. The collected information and user requests are evaluated using tools such as an analytical array to determine required protocols, limits and subsequent tests needed to demonstrate the clinical validity of the products, and thereafter, to provide a report to show the validation of the change. |
