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Regulations

Immunohaematology Regulatory

Immunohaematology involves the diagnostic testing of a therapeutic product – blood. Seqirus is committed to meeting and exceeding regulatory compliance requirements.

Principles of Quality Control and Quality Assurance

Quality Control (QC) involves the management of the testing process. It includes controlling the testing environment to ensure that tests are reproducible, accurate and sensitive. QC of reagents should be a regular part of immunohaematology laboratory testing and should encompass tests for avidity, specificity and sensitivity.

While reagent QC is vital, it will not control and monitor all aspects of the testing process. For QC to be effective, it should be capable of detecting, monitoring and correcting all potential errors and be an integral part of a managed Quality Assurance (QA) system.

QA involves the management, monitoring and control of the entire process of providing a service. In blood transfusion, this includes all of the processes from the initial medical decision to transfuse and the collection of the sample, through to the final outcome of transfusion. QA is a control, review and action process and should be integrated into medical and laboratory policy. QA should also involve participation in an external QA programme to allow laboratory performance to be compared and benchmarked with other external institutions.