International Society of Blood Transfusion (ISBT) Validation Guidelines and Validation of ISBT 128
Program Code: 427-TC
Tuesday, October 26, 2004
4:00 PM to 5:30 PM (ET)

SPEAKERS
Robin F. Nozick, MT(ASCP), R.F. Nozick & Associates
Patricia Distler, MS, MT(ASCP)SBB, ICCBBA

DESCRIPTION
The ISBT Validation Guideline portion of this session will present the guidelines developed by a group of international professionals to address validation of automated systems in blood banks. The guidelines will be reviewed including planning for validation, performing appropriate validations and maintaining the validated state.
The Validation of ISBT 128 topic will include a discussion on the extent of validation required to convert to the ISBT 128 labeling standard from Codabar. The extent to which ISBT 128 will need to be validated depends on the extent to which the process control features of ISBT 128 are utilized within a facility. These process control features will be discussed.

OBJECTIVES

• List Process Control Functionalities of the ISBT 128 labeling standard that can be utilized in blood centers and transfusion services
• Discuss the extent of validation that must be performed based on which process control features of ISBT 128 are utilized
• Answer the question: what is necessary to perform a thorough validation for automated systems in blood banking?
• Evaluate your compliance with guidelines and, at a minimum, create a basic gap analysis that identifies deficiencies
• Identify the documents that you will need to document the validation process and to document that an automated system is in a state of control

AUDIENCE
Technologists, Managers/Supervisors

PROGRAM LEVEL
Intermediate