Standard procedures must ensure that blood and blood components cannot be released for issue until all the required laboratory tests (mandatory and additional) have been completed, documented and approved within a validated system of work. Compliance with this requirement may be achieved by the use of a computer program, or suite of programs, which requires the input of valid and acceptable test results for all the mandatory and additional laboratory tests before permitting, or withholding, the release of each individual unit.
Where a computer-based system has failed, compliance may be achieved by the use of a system, which requires documented approval for the release of each unit, by a designated person.