The final language of the AABB standard 5.1.6.3.1(1) will read: Labeling of blood and component containers shall be in conformance with the most recent version of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128.9 (United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 - 11/2005.)
S&P Consultants, Inc. can support implementation of ISBT for Cerner® Blood Bank systems and provide our clients with the testing documentation required by the FDA and the AABB. Our Blood Bank ISBT Implementation and Support Service is specifically designed for clients like you, utilizing Cerner's Classic™ and HNA Millennium® Blood Bank modules.
S&P's three step approach will result in clear and concise testing documents. These testing documents can be used by the client to analyze the testing and for all regulatory agencies to quickly review the testing performed. Our goal is to work with you to:
Thoroughly implement and test the functionality of ISBT
Verify and validate each application for ISBT
Document all testing steps and observations
Our Project Manager Services will provide for the management of the Client and S&P resources as well as the creation of all test plans and compilation of testing documentation. An onsite visit would be required to perform the final validation of hardware.
Our ISBT Design and Validation Service is the manual execution of the test scripts. All test scripts are documented with screen prints, or relative output, and any identified issues are analyzed, documented and resolved, where able.
For more information, please contact S&P to discuss our services and options for your needs.
Cerner, Classic and HNA Millennium are registered trademarks of Cerner Corporation and/or its subsidiaries. S&P Consultants, Inc. is not sponsored by and/or affiliated with Cerner Corporation.