Quality Assurance Flashcards
Define Quality Control
Operational Techniques and activities used to fulfill the requirements for quality
Define positive control in Transfusion
A cell which expresses the antigen being tested for
What is the purpose of having a positive control?
Controls for the sensitivity of the test and see if it is capable of detecting weakest expression of antigen
Define a negative control in Transfusion
A cell which does not express the antigen being tested.
What is the purpose of a negative control?
Controls specificity of the test and ensures the test is not giving false positives
What is the purpose of adding Daily controls in blood banking?
Ensure our reagents and procedures are working correctly.
Define auto controls
Patient’s own cell plus patient’s own serum to check of autoantibodies
Define Coombs control cells
D positive cells sensitised with anti-D in the antiglobulin test to ensure free AHG present in the test
Define Reagent control
Commercial reagent which contains the suspending medium but not the antibody for an antibody reagent to check for non-specific agglutination
Define Quality Assurance
Planned system activities implemented within the quality system to provide confidence that requirements for quality will be fulfilled.
Define Quality System
Organisational structure, procedures, processes, and resources needed to implement quality management
Define Quality Management
Activities of the management function that determine the quality policy
What is GMP
Good Manufacturing Practice which is audited by the MedSafe division of Ministry of Health
What is ISO15189?
International Standard Standard 15189 is audited by International Accreditation New Zealand and provides a list of conditions that clinical laboratories must comply with
What is a quality officer in NZBS?
An independent role that oversees quality systems within the organisation.
