Comprehensive, efficient blood bank validation

Vedant Health provides comprehensive validations of healthcare clinical information systems. Utilizing our signature intelligent automated validation technology, TestStream, we couple our experienced healthcare personnel to produce world class validations. Vedant Health has set the standard for exceptional blood bank validations due to our acute attention to detail, decades of validation experience across the globe, strategic use of applied technology and a unique validation package delivery. The end result ensures the ultimate in clinical system Quality Assurance.

Vedant Health’s Blood Bank Validation Services extensively covers all areas of the blood bank system — doing much more than just “checking the box”, conforming with the validation testing mandates required under FDA, ISBT, AABB, CAP, Joint Commission, EU and Australian guidelines. Our best-in-class service delivers comprehensive and efficient OQ (Operational Qualification) validation for Cerner Millennium and Sunquest blood bank systems.

The Vedant Health Blood Bank Validation Process:

• Project Preparation — We start with a kickoff call where our 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 — Includes a review of product definitions, product modifications, patient unit compatibility rules, interpretations, preferences, and orders defined in the blood blank system.
• Scenario Customization — Includes customizing each scenario (patient journey) by subject matter experts 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 Execution — Includes execution of customized scenarios. Screen image captures for every validation workflow action are used as proof of performance. 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.
• (TestStream-Based) Solution Execution — Includes execution of the Patient/Unit 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 of Patient/Unit Compatibility and Interpretations. As with the workflow-based scenario executions, 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 — Utilizes our web based reviewer interface 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, Pass/Fail Reports, color screen captures and an Issue/Information Log. All results and final documents are stored on a designated client network location. Additionally, all documentation and screen captures are also provided on DVDs or USB drives along with a proprietary reviewer for regulatory inspection.

Organizations also use TestStream for the constant vendor software and build update 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.
• Each scenario operation mapped directly to compliance requirements, so a regulatory inspector can identify exactly where and when a certain functionality was validated.
• TestStream-Based — Large-scale validation and verification of the Patient/Unit Compatibility Rules and Interpretations (result reactions), covering thousands of combinations.

For more information, download our Blood Bank Validation brochure.

Every part of our 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.