7.8 Component release
All components must be appropriately labelled in accordance with these guideline specifications including those general guidelines outlined in Section 7.5 and Chapters 25 and 27.
Standard procedures must ensure that blood and blood components cannot be released to stock until all the required laboratory tests, mandatory and additional, have been completed, documented and approved within a validated system of work and it has been ascertained that conditions of production and storage have been satisfactory. Compliance with these requirements 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 required laboratory tests before permitting, or withholding, the release of each individual unit.
Where a computer-based system is not used or is temporarily unavailable, documented approval for the release of each individual unit should be by a designated person.
All biohazard donations and components otherwise unsuitable for issue should be reconciled and accounted for, preferably prior to releasing blood components to stock.
7.9 Release of components which do not conform to specified requirements
Blood and/or blood components may be issued for research, reagent and, in exceptional cases, for therapeutic use when they do not conform to specified requirements. Each blood establishment must have written instructions on the procedure which detail the circumstances under which such concessionary issues can be made and the procedures to be followed.
For major non-conformances in components intended for therapeutic use (e.g. an HLA-matched platelet that is significantly below specified cell counts, extension of shelf life for an autologous donation or, in extreme circumstances, donor sample not tested for mandatory microbiological marker, etc.) the instructions should, as a minimum, include the following:
that such component issues are authorised by a blood establishment consultant to the relevant registered medical practitioner
that the reason for the issue is fully documented
that a verbal and written warning indicating an increased level of risk is given by a blood establishment consultant to the receiving registered medical practitioner who should sign a statement indicating that he/she is willing to accept these risks
that the name of the recipient is entered on the issue documentation
that the component is clearly identified with a label indicating that it does not conform to specification, the details of the non-conformance, the name of the recipient and that it must not be used for any other patient.
Issues of non-conforming components should be subjected to a formal review process.
Minor non-conformances in components intended for therapeutic use (e.g. non-critical blood pack faults, minor label issues) should be referred for assessment by the quality manager.