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Compliance

ISBT

The International Society of Blood Transfusion (ISBT) actively reinforces quality management practices for blood bank transfusion systems.  The Society supports organizations striving to provide the highest levels of patient safety in the use of these systems.

In order to ensure that organizations succeed in achieving the goals of quality and patient safety, the ISBT provides guidelines for effective and safe administration of blood bank transfusion systems. These guidelines require that Blood Banks must validate computer systems that are considered to be critical.

Validation of critical systems must be driven by user requirements specifications to ensure that the system behaves as expected across user types. In order for systems to be validated according to ISBT requirements, they must meet the following criteria:  

  • The system must be successfully qualified via Installation Qualification, Operational Qualification, and Performance Qualification.
  • The system must be tested according to documented validation protocols or predefined acceptance criteria
  • All  test results should be retained as proof of the validation directly as testing occurs – this includes screen prints, reports, queries, etc.
  • Validation reports must be compiled and maintained
  • The Validation state must be maintained  

Vedant’s Blood Bank Validation (BBV) solution encompasses a wide array of vendor blood bank systems while supporting a number of methodologies. Built upon TestStream, the BBV includes numerous vendor-specific validation configuration libraries out-of-the-box to deliver help deliver comprehensive and efficient validation. In addition, you’ll be able to:  

  • identify and 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

Using TestStream, you’ll be able to move beyond representative sampling to achieve true validation for all combinations of patient types and blood products. 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.

Contact us today to learn more about how Vedant can help you meet ISBT guidelines in a fraction of the time and cost of any other solution.