In Focus
Assessing the changing scenario of quality assurance with increasing automation in immunohaematology laboratories
Automation is a journey, not a single step!
There have been rapid advances in technology in blood transfusion with emphasis on quality and safety.
Quality Assurance is a process that allows us to have confidence in our results at a predefined level of quality. Ideal is zero defects throughout the transfusion chain from vein to vein.
Automation of routine blood bank serology was introduced in 1960’s. Its exponential rise and widespread acceptance has been attributed to advantages like reproducibility and traceability of results along with high throughput sample handling.
Types of Automation
While semi-automated systems require an operator intervention for substantial number of processes, a fully automated device manages the complete process from sample loading, reagent handling to result interpretation and interfacing with the Laboratory Information System.
A high throughput fully automated platform helps in preventing near miss events, variations in test result interpretation along with reduced turnaround time (TAT), improving the overall quality of services. However, procuring an automated system, installing, maintaining and training of staff can be a costly endeavour and requires a special set of quality parameters to be fulfilled. Quality Assurance of the three critical phases of an immunohaematology laboratory can be divided into pre-analytical, analytical and post-analytical processes.
Pre-analytical phase
The pre-analytical phase of testing involves sample collection, labelling, transportation, sorting of samples and requesting the required tests. Quality control of samples transported by pneumatic tube system, error-free integration of the LIS for automated tube sorters according to the requested laboratory tests, sample rejection due to improper barcoding or sample volume are important parameters to maintain the ‘downstream’ laboratory efficiency.
Validation of serological tests
Validation of serological tests performed on the automated system requires a comparative study of manually generated test results and those moved to automation e.g. antibody titration from tube method to automated column agglutination testing.
Maintenance of the validated state for the equipment involves calibration, performance monitoring, preventive maintenance, and training/competency evaluation at periodic intervals.
Calibration
Calibration of the equipment is required for a system to run efficiently and optimally according to the manufacturer’s instructions for use and should be traceable to a recognised international standard. Critical parameters for the validity of a test result, e.g., pipetting volume, centrifuge speed and incubator temperature, should be monitored as part of a scheduled preventive maintenance (PM) protocol to ensure detection of avoidable errors.
Calibration and PM also help in maintaining system efficiency by reducing wastage of reagents and consumable and in improving TAT.
Daily quality assurance in the immunohaematology laboratory is to confirm the reliability of the tests. If unexpected results are observed, the problem may be due to improper test performance, faulty equipment or contamination or deterioration of reagents. Most of the automation providers supply comprehensive quality control kits with multiple test specificities unique to their technology and platforms, which can be costly depending on the throughput of the laboratory.
Internal Quality Assessment
This can be a challenge due to differences in the available automated technologies and input variation for semi or fully automated platforms. Due to uniqueness of immunohaematology tests in terms of reagent and temperature requirements, comparative harmonisation of results can be a difficult task.
Analytical phase
The analytical phase includes what is usually considered the "actual" laboratory processes with sensitivity and specificity of reagents being the most profound factors affecting the quality of results. For automated equipment, validation, staff training, and calibration are the factors requiring special attention.
Validation of automated equipment
Validation of automated equipment is a multifaceted process requiring a policy and protocol. Validation process requires an IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) which ensures compliance with standards. It is not just testing of software.
It involves a user requirement and functional design specification, followed by a quality risk assessment (e.g., software glitches, reagent contamination) for the tests to be implemented.
External Quality Assessment (EQA)
External Quality Assessment (EQA) of automated immunohaematology analytical processes must be specifically designed or evaluated for the technology under consideration (e.g. tube or column agglutination testing). It focusses primarily on blood group typing and genotyping, antibody screen and identification.
Post-analytical phase
The post-analytical phase includes result interpretation and transfer of analytical data from the equipment to the laboratory information system. Interfacing at the time of installation helps in integrating various instruments. Through e-connectivity, the system configuration update, performance information and troubleshooting can be done remotely by the provider.
Quality control alerts can be included in the laboratory information systems and helps to create flags or hold data for further review by a laboratory supervisor.
It is important to consider a backup system when testing is completely automated and it should be included in a business continuity plan.
Future considerations
The future may be looking towards having artificial intelligence-based strategies for quality assurance, by facilitating identification of scenarios, capturing test data, unearthing errors at early stages, optimising testing and predicting failure points.
