METHOD AND SYSTEM FOR VALIDATING CHANGES IN MEDICAL PRACTICE, PROCEDURES AND PRODUCT CHOICE

摘要

A system and method for assessing the statistical and clinical acceptance of a new medical service or changes in products used by a clinical laboratory or hospital, and providing documentation of validation. The system and method includes an information exchange mechanism, such as an internet, extranet, compact disc (e.g., CD-ROM) or text-based mechanism to establish a systematic approach between a provider and client for collecting, reviewing and providing information 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 products, and thereafter, to provide a report to show validation of the change.

主权项

1. A computer-implemented method for assessing statistical and/or clinical acceptance of a change in a clinical practice or medical product comprising:
providing an electronic medium for exchanges between a client and a provider; receiving a request from said client via said electronic medium for a need to validate a change in at least one of a clinical practice and product, wherein said change can require a showing of validated results; selecting via a computer from stored predetermined elements in a memory device a number of designated predetermined elements that relate to testing the change requested by the user, the computer generating an analytical array containing the designated predetermined elements applicable to validation of the change requested by said client,
the stored predetermined elements comprising information relating to chemistry analytes and methodologies for their use in validation testing, andthe designated predetermined elements comprising selected ones of the stored predetermined elements relating to at least two or more of a selected analytes, a selected patient population, and instruments and/or reagents used for validating the change requested by the user; providing a reply from said provider via said electronic medium, including said analytical array to validate said proposed change; reviewing a request from said client via said electronic medium that identifies at least one of the elements from said analytical array chosen by said client based upon said client's specific needs; generating via the computer a testing protocol that minimizes testing required to validate said proposed change by researching at least one database comprising information that includes existing validation information and comparing said at least one of the elements chosen by said client with said existing validation information to determine relevant information and information gaps which require testing, wherein at least one of said information gaps comprises validation information chosen by said client and not found in existing validation information of said database, such that said chosen validation information cannot be provided to said client, and generating via the computer notice of the information gaps; and providing said relevant information and the notice of information gaps which require testing to said client via said electronic medium for review.