Vedant’s TestStream technology, together with our best-in-class services, delivers comprehensive and efficient validation for Cerner Millennium, SCC Soft, and Sunquest blood bank systems.
Vedant's BBV solution extensively covers all areas of the blood bank system — doing much more than just “checking the box” — and conforms with the validation testing elements required under FDA, ISBT, AABB, CAP, Joint Commission, EU and Australian guidelines.
The Vedant Blood Bank Validation Process:
- Project Preparation — This phase includes a kickoff call where the BBV project process is presented, along with team introductions, environment requirements, and client network and blood bank system access. A questionnaire covering functionality used in the blood bank system is provided, and the responses are used to prepare a Risk Evaluation for review and approval.
- Database Review — This phase includes a review of product definitions, product modifications, patient unit compatibility rules, interpretations, preferences, and orders defined in the blood blank system.
- Scenario Customization — This phase includes customizing each scenario - or patient journey - by subject matter expects to match facility-specific client configurations. Each scenario is mapped directly to critical and high risk compliance requirements, thus allowing a regulatory inspector to easily identify exactly where and when a certain functionality was validated.
- Scenario and Solution Execution — This phase includes execution of customized scenarios and the PatientUnit and Interpretation Solutions. The solutions involve large-scale validation and verification of the Patient/Unit Compatibility rules and Interpretations (result reactions), covering thousands of combinations PatientUnit Compatibility and Interpretation Solutions. Screen image captures for every validation workflow action are used as proof of performance. TestStream Validation Reports, Issue Forms, and Information Forms are also generated. This phase also includes the retesting of issues discovered and subsequently addressed during the BBV.
- Review — The phase utilizes a web based reviewer for convenient online review of validation results and reports. This tool allows for capture of reviewer comment and a user digital signature is captured. Clients are able to begin their process as soon as results are posted, thus allowing completed validation elements to be reviewed while the project is in progress.
- Final Documentation — This phase results in the final documentation for the project. Documents included are the Project Overview, Validation Summary, Review Instructions, Requirements Matrix, and Issue/Information Log. All results and final documents are stored on a designated client network location, and all documentation and screen captures are also provided on CDs or DVDs.
Organizations typically also use TestStream on an ongoing basis for service pack regression testing, as well as re-testing and re-validation cycles, at a fraction of the cost of other options. Our HealthAssure™ Seasons for Blood Bank Service provides this regression testing approach, ensuring continuous quality checks and patient safety.
The documentation generated with each test includes:
- Screen image captures for every validation workflow action.
- Digital signature support for test results review.
- Large-scale validation and verification of the Patient/Unit Compatibility rules and Interpretations (result reactions), covering thousands of combinations.
- Each scenario operation mapped directly to compliance requirements, so a regulatory inspector can identify exactly where and when a certain functionality was validated.
Organizations can also use TestStream on an ongoing basis for service pack regression testing as well as re-testing and re-validation cycles at a fraction of the cost of other options.
For more information, download our Blood Bank Validation brochure.
Every part of the Blood Bank Validation is linked to the individual AABB requirements, and the link of requirement, functionality test, and test run is included as part of the results.