Custom Solutions

Pre-Validation Testing begins with a comprehensive database review that evaluates the system build and client specific software settings for errors, omissions and adherence to regulatory guidelines.

The BC Solutions team provides a summary of findings uncovered during the database review to the end user. Based on this information, the end user will perform the necessary adjustments to database settings prior to executing formal testing procedures. Systematic testing of database table settings are then performed providing verification of build compliance in specified categories.

BC Solutions has identified areas of Blood Bank software configuration that are “high risk” or “high build”. These are areas of configuration where build errors can negatively affect patient safety or where table builds require an unusually high amount of specific data that may be prone to manual data entry errors.

Orders

Verification that orders and product requests are functioning as expected. Verification that when orders are placed in the Blood Bank software Orders application, they include all defined order components and can be accessed in the appropriate result entry application.

Receipt of Blood Products

Verification that defined product codes can be successfully received into Blood Bank inventory and that system default settings are applied to products upon receipt as expected. Verification that barcodes can be accepted using ICCBBA guidelines for the use of ISBT 128 barcodes. Testing includes receipt of Autologous, Directed, and Divided Products.

Product Modifications

Verification that defined product modifications such as Thawing, Irradiation, Dividing, and Pooling can be performed according to client’s procedures. Verification that ICCBBA guidelines for modification of blood products has been followed. Label verification of modified products is performed as needed.

Logic Tables and Test Interpretations

Verification of each valid line of logic defined for selected tables. Testing selections include ABORh tests, Antibody Screens, DATs, Crossmatch tests, and Unit Confirmation tests where logic tables are used to determine interpretation. Additionally, testing includes up to 10% invalid lines of logic designed to produce warnings and messages for invalid results.

ABORh Compatibility Testing

Verification of compatibility settings for all standard patient blood types. compatibility will be demonstrated in the appropriate application(s) for all product groups (Red Cells, Plasma, Cryoprecipitate, Platelets, etc.) and can also include Autologous and/or Directed products and Neonatal compatibilities where indicated.

Systems Integration Testing and Validation are performed by developing and executing test plans that ensure set-up is complete, and the interface is working as designed. This process ensures that the “bridge” between systems or devices is functioning as expected.

System testing such as unit testing (configuration testing), interface testing, and workflow testing are performed as pre-validation activities. The end user often perform edits or changes to the build if any unfavorable results are found to prepare the system for the final validation.

Examples of what we test include:

• Blood Bank Instrument Interface Validation – Validation of data interfaces (bi-directional) between Blood Establishment Computer Systems and Blood Bank testing analyzers.
• Donor System interfaces with transfusion services or testing laboratories.
• Mapped Record Interface Testing – Verification of mapped codes from laboratory system (LIS) to other interfaced record keeping systems (EMR, HIS, Data Repository) to ensure like to like relationships exist between mapped codes and that mapped records/results are transferred across interface(s) as expected without corruption.
• Billing Testing – Verification of billing codes across Interfaces between blood banks, laboratories, and hospital billing services.

Time and resources are at a premium. Talk to us about your challenges and needs. We can find the right consultants to work for you.

• Project Management
• System Selection Consulting
• Compliance Plans
• Mock Inspection Audits
• Training Services
• On Site Consulting