All screening must be performed within Blood Safety and Quality Regulations1 (BSQR) compliant laboratories and meet any other appropriate regulatory requirements.
Secure and effective procedures must be in place to ensure that:
All assays used must be UKCA or CE marked and must have been assessed in respect of sensitivity and, if appropriate or necessary, specificity, and deemed suitable by the UK Blood and Tissue Establishments kit evaluation groups (NHSBT KEG or SNBTS MTEG) for the detection of the required markers in the donation types being screened. Unless specifically validated for alternative use/performance, test kits and reagents must be stored and used according to the manufacturer’s instructions.
Each new manufacturer’s lot of each assay must be assessed prior to being accepted and put into use (Lot Release Testing - LRT). Each additional delivery of an existing lot should be assessed before use (Delivery Acceptance Testing - DAT). Each manufacturer’s batch/lot of microbiology test kits must be shown to conform with nationally established minimum criteria for specificity and sensitivity prior to being accepted for use for screening.
Additionally, all testing laboratories must ensure that the expected standard of performance of the assays used is being achieved through the use of the appropriate Quality Control (QC) samples and the statistical monitoring of assay control and QC sample results. Appropriate reactivity with manufacturers’ and QC samples must be demonstrated with every series of tests. All test procedures must be documented, and an inventory maintained of kits and reagents in stock, including supplier, batch number, expiry date, date of receipt, version number of product insert and record of pre-acceptance testing.
Procedures must ensure the traceability of the batch number and manufacturer of kits and reagents and the serial number of equipment used to test every donation.
Equipment must be validated, calibrated and maintained. Appropriate records for these activities must be made and retained as defined in extant regulations (currently 30 years).
A series/batch of tests is defined as the number of tests set up at the same time, under the same conditions and processed in a similar manner:
The laboratory final output should indicate the result of every test performed, using a system that provides positive sample identification. Each test result should be recorded by a system that does not require transcription. If manual completion of screening is performed it must be thoroughly documented and controlled and the results handled electronically following the same basic principles applied to fully automated testing.
Standard procedures must ensure that no donations, or components/products prepared from them, can 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 can only be achieved by the use of a validated computerised system that requires the input of valid and acceptable test results for all the mandatory and required laboratory tests to permit the release of each individual donation.