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Blood Bank system validation is driven, in part, by the American Association of Blood Banks (AABB) for the purpose of mitigating safety risks to patients through best practices and other mechanisms to effectively govern quality.

The AABB’s Quality Management Subcommittee (QMS) spearheads the development of quality standards and guidance to ensure that all quality management concepts incorporate a consistent message. Within the QMS, the Blood Bank/Transfusion Service (BB/TS) Standards Program Unit (SPU) most recently developed a 29th edition of Standards for Blood Banks and Transfusion Services (BB/TS Standards) outlining 10 Quality System Essentials that healthcare organizations should follow.

Healthcare organizations that meet the highest standards for Blood Bank quality and safety adhere to the guidelines established by the AABB.  In order to ensure that your systems comply with the AABB standards, you must meet these requirements:

  • Organizations must demonstrate that they have followed and documented processes for:
      • Risk analysis, training, validation, implementation, and evaluation of postimplementation performance
      • System maintenance and operation
      • Display and verification of data before final acceptance, when data are added, or when data are amended.
      • Evaluation, authorization, and documentation of modifications to the system
  • In addition, organizations must maintain records of:
      • Validation of system software, hardware, databases, user-defined tables, electronic data transfer, and/or electronic data receipt. 

Performing these required functions and providing the required documentation can be a daunting task for any organization.  However, TestStream from Vedant can streamline and dramatically reduce the time, resources, and costs typically associated with meeting these requirements.

TestStream allows you to test every core functionality in your healthcare systems.  In particular, you’ll be able to:

  • understand all the configuration variables and code or database changes
  • evaluate ALL patient/product compatability and Interpretations interaction permutations for every validation
  • utilize scenario solutions to provide detailed normal patient/product workflow journeys throughout the applications
  • implement scenario solutions to validate worst case, requirements based patient and product journeys throughout the applications
  • produce screen image captures for every significant validation workflow step
  • provide digital signature support for test results review
  • leverage built-in error analysis and risk-assessment tools to quickly and easily prepare your systems for production
  • provide detailed reports, mapping validation test results to requirements  

Once initial testing and validation is completed, organizations can continue to take advantage of TestStream’s powerful capabilities in an ongoing basis for patch management regression testing as well as re-testing and re-validation cycles, all at a fraction of the cost of any other option.

If you are faced with the challenge of meeting AABB system requirements, contact us today to learn more about how Vedant can help you achieve compliance in a fraction of the time and cost of any other option.