Our Process
Validation of blood bank software is required by the FDA (CGMP, 21CFR 211.68), AABB, CAP, CLIA, TJC (formerly JCAHO) and various state agencies. These organizations require that changes to blood bank processes, information systems and software be validated prior to being placed into production or operation.
TxMS’ comprehensive validation process uses proprietary customized scripts to test all major areas of blood bank and donor room information system functionality. Our validation process tests the display of warning/error messages, use of valid entries/interpretations and accuracy of storage/retrieval of patient & blood component data. Each test script is organized with clearly defined purpose, scope, testing scenarios, instructions, validation steps and pass/fail criteria. We customize the scripts for each client to reflect the actual operations, workflow and terminology of each facility. This customized approach makes it easier for your blood bank and medical staff to understand, review and approve the new processes and results.
The TxMS team conducts validations for Sunquest, MEDITECH and Mediware HCLL (Certified partner vendor) blood bank and donor systems.
Key Steps for a TxMS-Conducted Validation
- Gather in-depth information on client operations, assess database structures and review Standard Operating Procedures (SOPs) to design appropriate test plan
- Prepare detailed proposal and contract
- Establish a secure, remote connection to your blood bank information system
- Confirm completed blood bank system build (system database, blood bank database and required testing)
- Determine client team, implement project tracking system and establish conference call schedule and feedback mechanism
- Customize the validation test scripts, adapted to each client’s specific workflow and terminology. (NOTE: For shared system hospitals, minor system upgrades and backup systems testing, cost effective “functional only” scripts that just test each blood bank module for typical, daily workflow functionality might be recommended.)
- Conduct weekly conference calls to discuss and document project status, exceptions and “events” encountered, problem resolution and vendor “client notifications” and “product safety notices”
- Submit the customized scripts for client review, comments and final approval before beginning the actual validation
- Perform validation processes and document system responses via screenshots for each validation script and step
- Perform quality control audit to confirm the accuracy of validation outcomes and system responses
- Complete validation project (submit electronic copy of final scripts, screenshots, event log, and pre-validation maintenance/dictionary files, etc.)
Client-Managed Validation Alternative
If you have blood bank personnel with the time and experience to carry out your own system validation, TxMS can aid you by offering our comprehensive, up-to-date validation script package for your staff to execute. This can accelerate your testing process by allowing you to start immediately with a fully developed test plan. It will lead to a more successful outcome since you will be using our latest testing methods, proven at numerous blood banks nationwide. Also, our scripts will provide a structure for internal user training and documentation of competency.
To make the process even more effective for you, we can customize your scripts with your site specific data and terminology, as well as QC test. This approach saves you even more time while alerting you to any pre-validation systems issues that may require attention. Either way, TxMS has the right package for your blood bank system validation needs.
Data Conversion
Managing legacy data is a challenge when converting to a new information system. It is critical that demographic data, transfusion history, patient blood problems (antigen/antibody issues; special requirements) and blood product utilization are properly captured and converted. TxMS can assist with this process. Data will be extracted from the existing system and then converted either for importing into the new system or developed into a stand-alone custom database. Test files are prepared prior to completing the conversion. The converted data is validated using selected test patients who need particular transfusion requirements, historical information (e.g., ABO/Rh type), and random selection of patients and blood components.
