13.6 Test procedure
Test procedures must:
13.6.1 Be validated before being introduced into routine use.
13.6.2 Be written in the form of standard operating procedures.
13.6.3 Be performed in compliance with the standard operating procedures.
13.6.4 Be monitored and reviewed.
13.6.5 Be performed by trained staff and the training records must be maintained.
13.6.6 Include the recording of test results.
13.7 Reporting of results
13.7.1 The report must indicate the result of each and every test, by a system that provides positive sample identification.
13.7.2 Reporting a series of tests by an 'assumed negative' procedure is potentially dangerous and not acceptable.
13.7.3 The acceptance and release of test results will be the responsibility of designated personnel of proven proficiency.
13.7.4 Information must be archived.
13.8 Release of tested components
13.8.1 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.
13.8.2 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.
13.9 Laboratory test categories
Laboratory tests include the following categories:
13.9.1 Mandatory tests – required as part of the criteria for release of all blood donations and components for clinical use. Currently these are ABO and D blood grouping and irregular red cell antibody screening.
13.9.2 Additional tests – undertaken in special circumstances:
increase the safety of transfusion for susceptible patients or clinical effectiveness of specific transfusions, e.g. by providing HbS screened red cells
whilst not required for all blood donations or components, when such tests are performed to meet a specific need the results are an essential part of the criteria for release of that component.