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Flashcards in Automation Deck (16):

What is the reduction of error when using automated vs manual methods?

90-98% reduction of error in routine processing for blood groups


What percentage of ABO grouping errors were due to manual methods based on the SHOT report of 09/10?

greater than 75%


What does ISBT stand for?

International Society for Blood Transfusion


What does BCSH stand for?

British Committee for Standardisation in Haematology


What are the guidelines for ISBT 03/10?

They validate and check the maintenance of automated systems within the lab. They allows users to communicate specific requirement for a system, approved new equipment and can reject equipment or process.


What are the guidelines of BCSH from 06/14?

They validate computer and lab system to ensure they work as programmed. Management of information and implementing new ones in hospital transfusion labs.


What does LIMS stand for?

Laboratory Information Management Systems


What are the key points a lab must follow to maintain quality in a hospital transfusion lab?

Must ensure that all management systems are validated, qualified and have change control policies integrated. Each hospital must develop their own policies for change control. There must be documents showing the intended use and be GMP compliant, the documents must contain the steps of the validation process. Each staff member must be trained and have documented proof of this.


What are the main automated manufactures?

Ortho, Diamed, Grifols, Immucor and Diagast.


What are liquid phase assays?

Samples are incubated with a liquid reagent or cell panels, then are centrifuged through a porous media.


What is the solid phase assay?

This contains antibodies which are coated onto polystyrene wells and reacts with the antigens present in reaction vessels. It has a faster incubation phase and centrifuge is shorter.


What is EI?

This is where the blood is issued without thorough serological analysis, the samples are tested for blood group and antibody screen.


How is EI done?

The LIMS system makes a decision of the EI suitability and cannot be overridden, this validates that the samples are safe to use. If the results are not unambiguous the sample is excluded. If the patient has had a transplant or incompatibility in the last three months this can be completed.


Why is EI done?

There is a 90-95% reduction in request of blood to giving it to patient, there is a reduction in cross matching, storage, movement, wastage and workload.


Is it safe to use EI?

Yes as less blood is required on site, there is reduction in error as it is automated. Also this means there is less of a workload for BMS therefore other duties can be completed to a higher standard so could argue this means they will be safer.


What are the disadvantages of EI?

Electronic issue is expensive, re-validation of LIMS is required constantly for example in an update or testing results from analyser. Lastly it has a chance of not detecting low concentrations of antibodies in sample.