BC Solutions

ISBT 128 Services

Site Impact Evaluation

Determine the impact of ISBT 128 implementation on the site,  system, people, and processes. The evaluation includes the blood bank, nursing department, emergency room, and operating room.

Configuration and Set-up

Build and define the information needed for the system to be ISBT 128 compliant in both MOCK (TEST) and PROD (LIVE).

Unit Testing on the Configuration

Testing covers all functions where components will be used.

Functional Training

Includes the blood bank, nursing, emergency room, and operating room staff, plus any other functional areas affected by the ISBT 128 implementation. Overview of ISBT 128 from US Consensus Standard etc. dependent on the job category.

Hardware and Software Installation

Installation of bar code readers, plus 3rd party software and hardware required for the ISBT 128 implementation. Installs include bar code reading wands and scanners, bar code printers, and Hematrax system.

Validation Plans Development

Plans are created using the ICCBBA Standard for Version 2, U.S. Consensus Document based on the specifications provided by the software vendors.

Validation Plans Implementation

RFN personnel travel and work on site for 3-days to implement IQ, OQ, and PQ plans.

Installation Qualification (IQ) protocol includes the tests for all types of devices used by client and validate that the bar code readers and printers:

• Functions as specified by manufacturer and performs satisfactorily
• Reads ISBT 128
• Auto discriminates between ISBT 128 and Codabar
• Reads concatenated labels

Operational Qualification (OQ) protocol includes tests that validate the bar coded data is accepted and correctly interprets:

• All routine ABO/Rh possibilities in the blood bank
• All product codes including first alpha character, four character product code, donation type, division if applicable, and split if applicable.
• Expiration date/time labels
• Any special testing labels used by the client i.e. CMV, HLA, Red Cell Antigens
• All donation types: homologous, autologous, directed, etc.
• Valid and invalid data identifiers

Performance Qualification (PQ) protocol includes tests that validate the personnel have the knowledge and ability to:

• Scan normal labels and find and interpret eye readable information
• Scan damaged, frozen, and wrinkled labels
• Scan test tube labels
• Scan concatenated labels
• Enter check characters and flag characters if necessary