Vedant Health provides comprehensive validations of healthcare clinical information systems. From our signature automated validation technology; TestStream to our Classic Validation, we utilize 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 world, strategic use of applied technology and a unique validation package delivery. Regardless of our best validation approach for your environment, the end result remains the same — the ultimate in clinical system Quality Assurance.

The table below describes the three options available for your next blood bank validation. Each validation goes beyond the FDA requirements and produces digital signature-based results, packaged and reviewed via a safe and secure web-based system. Our cutting-edge Classic Validation is not referred to as "manual testing". Although the workflows are performed manually by our experienced blood bankers (not your "typical" consultants), technology is utilized to provide the same quality package of blood bank results that the inspectors worldwide know and respect.

  TestStream TechnologyClassic ValidationHybrid Approach
Validation Outcome A completely automated three-part approach to validations, covering thousands of Patient/Unit Compatibility Rules, Interpretation Result Reactions, and dozens of AABB requirements-based workflows tested against the client system. Full automation allows for extremely large-scale validation coverage. Our experienced blood bankers use traditional methods along with unique local technology to process through AABB requirements-based workflows. Each workflow result is fully captured via pass/fail reports and screen captures, with documented workflow requirements. Our three-part validation processes through the AABB requirement-based workflows using our personal validation approach, with no hardware requirements. This is followed-up, when possible, with the fully automated Patient/Unit Compatibility and Interpretations solutions that provide thousands of unique rules combinations, for the ultimate in validation coverage.
AABB Requirements-Based
Client-based Hardware Required 
Use of Local (FAT) Client Installation 
Use of Citrix-Based Access 
Client Comments Digital Signature
Web-Based Results Review
Vedant BBV Matrix Deliverable
Final Results DVD Delivery


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 services, deliver comprehensive and efficient OQ (Operational Qualification) validation for Cerner Millennium, SCC Soft, Mediware HCLL (WellSky) and Sunquest blood bank systems.

The Vedant 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 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 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, 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 additionally use TestStream 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.
  • 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.

Vedant - Blood Bank Validation