Higher Specialist Biomedical Scientist at Nottingham University Hospitals NHS Trust Charlotte Atkin walks us through the process of implementing a new system in her laboratory.
The introduction of new analytical equipment and assays is commonplace in labs as we react to both the demands of healthcare and the development of new technology. We are constantly in a cycle of improvement to ensure the best service provision for our patients.
The Routine Clinical Chemistry department across Queen’s Medical Centre and Nottingham City Hospital is no stranger to this process, having just gone through the implementation of new main chemistry analysers. Following the end of current supplier contracts, we had the opportunity to fully reimagine the department with the latest developments in automation. Modernisation of the department sees new analysers sitting on a fully automated and tracked pre- and post-analytical system, which runs throughout the lab in collaboration with Haematology and Specimen Reception.
Prior to go-live in April 2021, the analysers in use were Beckman AU5800 for chemistry and Siemens Centaur immunoassay. Credit to the team, who ensured the turnaround of patient samples despite the labour-intensive process of having to take the samples off the chemistry analysers and walk them over to load them on the separate immunoassay analyser – no small feat with 4000 patient requests per day. The Chemistry department put out for tender and the awarded contract saw the introduction of three Abbott Alinity ci-series units at each hospital site. There can’t be enough said for the collaboration and communication required by all during the change implementation. The lab teams, service managers, consultants, clinical team, Abbott, quality, training, IT, health and safety, office, and finance departments all pulled together to make this possible.
The verification process
A gap analysis was performed, which evaluated assay characteristics for any significant changes in practice. The findings were used to inform additional studies required during the verification period. Factors considered were traceability, reference ranges/assay bias, measuring range, assay volume, measuring units, sample type and stability. Examples of significant changes included the move away from the BNP assay, which was the only option available on the Centaur, to NTpro-BNP, which is the preferred analyte as per the National Institute of Health and Care Excellence guidelines.
Another example is the change in reference values for CA19-9 tumour marker, which shows a significant positive bias on the new method due to assay signal. It is clear, therefore, that planning and preparation are key, as well as communication with our service users to give them ample time to prepare.
“It is clear, therefore, that planning and preparation are key, as well as communication with service users to give ample time to prepare”
Precision studies were carried out by Abbott application specialists using third-party quality control (QC). QC run-up, along with all subsequent patient comparisons and external quality assurance (EQA) were performed on all relevant modules across all analysers. Although not how the laboratory planned to operate at go-live, this would come in useful in the future should assays need to move about between analysers, either temporarily due to downtime, or more permanently when assessing workflow and efficiency.
For months preceding installation, worklists of data were run to identify suitable samples from which to take excess serum for patient comparison studies. Volumes were calculated, accounting for dead volume, test volume and dilution requirements. Aliquots of these samples were frozen into labelled batches that were thawed, mixed and centrifuged for re-analysis. An average of 30 samples were tested for each assay. These studies, including any extras that were identified during the gap analysis stage, were assessed against the pre-determined acceptance criteria.
EQA providers were contacted, and additional material was requested to be used for work-up. We now had a new method group to sit in, and three previous distributions were analysed against the new method mean.
Engaging the team
If good management ensures a smooth project, then it is good leadership that brings the team along with you. The success of the project is the laboratory’s success, and we strive to make sure that we move forward together, learning and working towards our common objectives together, and most importantly, celebrating together.
“If good management ensures a smooth project, then good leadership brings the team along with you”
Leaving work one day and returning the next to completely new analysers can spark a mixture of feelings, ranging from excitement to apprehension. Staff need to feel confident in the new system and it is vital that those turning up on the very first set of night shifts on new equipment feel familiarity with both analyser and middleware, as well as being reassured that should they require support, there are clear communication channels.
One of the main challenges when bringing about this level of change is training. Abbott provided key user training that was then cascaded down within the department using a basic checklist addressing software and hardware elements, as well as common maintenance tasks and calibration and QC requesting.
The 5×5 precision studies that were carried out by Abbott provided another great opportunity for staff engagement. Several members of staff were able to work alongside the application specialist and get hands-on training with the analyser and exposure to the validation and verification process.
All the while in the background a whole host of new documentation was being written, including standard operating procedures, COSHH for all new reagents and solutions, training plans and competencies, reference sheets and many more. Documents were allocated for the team to author – a great way to learn about the new systems before go-live and the creation of a new document from scratch is always something to be proud of. To raise employee improvement suggestions is encouraged, and formally logged on the quality management system as we promote a supportive culture of empowerment and shared leadership.
The track
At the time of writing, the fully automated and tracked system is live at Queen’s Medical Centre and is about to be rolled out at Nottingham City Hospital. Lanes of interlocking track and analytical modules create a circuit within the department as cars shuttle individual samples between bulk loading bays, online centrifugation, analysers, aliquoting, and online storage. Screens and schematics of the track are displayed for quick identification of any traffic jams and errors.
Now more than ever it is necessary to look outside our own chemistry microsystem and into the wider team as we work jointly to improve workflow on the track along with our colleagues in Specimen Reception and Haematology. The last step of the project, due to be implemented later this year, will see the arrival of a Tempus connection module, a point-to-point air tube system that allows A&E to send samples directly onto the track, ready for analysis.
Modernisation will enable financial savings while improving quality. Staff time will be freed up for key scientific activities, and the continual review and refinement of track programming will allow for the most efficient workflow to be sought. Ultimately, we seek benefits to patient care from the improved turnaround of samples and a laboratory environment in which our team can thrive.
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