ACCREDITATION ISSUES
120 100 80 60 40 20 0
0 5 10 15 20 Dilution (1/X)
Fig 4. The consistency of the corrected results at different dilutions – known as parallelism. Here, the results demonstrate the absence of inhibitor. The Stago algorithm auto-verifies the results.
working with the STA Coag Expert since early 2019 and places great emphasis on quality management.
“In a specialty laboratory like ours, we have a lot of different tests to verify, say around 30, and we have to do this process every time we set up a new test or batch,” she said. “That’s time-consuming for everyone and we have to do this while maintaining our regular workflow. “Our quality team must be ready
to produce extensive reports for UKAS showing that we are fully compliant. It’s a massive job for any NHS laboratory. Being able to report and access performance data quickly is therefore essential. That’s the reason we use Stago’s accreditation tools across the key areas of repeatability, reproducibility and measurement of uncertainty. These are the benchmark for any laboratory measuring its performance against its NHS peers. “Stago accreditation tools certainly help to ease the burden of our compliance requirements in these key areas. They save time and minimise the manual reporting we previously might have had to undertake when compiling our UKAS reports.” Leicester took advantage of the
accreditation toolkit as soon as it upgraded to STA R Max generation analysers. “Stago has written them in line with UKAS requirements and they are incorporated in the Coag Expert software. All we have to do is instruct the instrument which tools to action,” added Ms Hopkins.
Simplifying the complex During the past year, with COVID placing an extra burden on many haemostasis laboratories, the value of Stago’s data management resource has certainly come into its own. “Supporting us every step of the way, when we most needed that support,” said Lenka Mercer, senior biomedical scientist in coagulation at the Royal Sussex County Hospital, part
l Calibration result l Patient result l Corrected calibration l Corrected patient result
140 120 100 80 60 40 20 0
25 30 35 40 0 20 40
l Calibration result l Patient result l Corrected calibration l Corrected patient result
60 80 100 120 140 160 180 Dilution (1/X)
Fig 5. In the presence of an inhibitor the corrected results increase with the dilution factor, as shown by the divergence between the sample and the calibration curve’s corrected results. Here, the algorithm automatically reports non-parallelism when inhibitor is present.
of the University Hospitals Sussex NHS Foundation Trust.
“During the first wave of the virus, we
were learning so much about the risks of clotting. We needed the bigger picture – and fast. Being able to quickly track, compare and report trends and patterns in levels of markers such as D-dimer can make a difference to outcomes.” The Brighton team runs the software on a daily basis and also relies on it for monitoring quality control trends and detecting shifting patterns, both internally and across users globally. Ms Mercer sees Stago as a leader in “added value IT tools”; and is actively involved in encouraging staff to embrace the software’s potential.
“It does so much, but it would be a mistake to view this as a complex resource – it’s the opposite. Far more than just innovative software, Stago’s accreditation toolkit simplifies the complex,” she explained.
“It delivers precision and accuracy at its best, and is simple to use even for those with no previous experience. Whatever the complexity of the challenges we set, it responds with speed and ingenuity in the way it reports data back to us. This would previously not have been possible without time-intensive assessment which drained staff resources.”
Shawn Cotton, the trust’s specialist services manager for coagulation, agreed. “Stago’s accreditation tools have become a valued ally in helping us demonstrate how well this laboratory complies,” he said.
University Hospitals Sussex is a recent
merger of Brighton and Sussex University Hospital and Western Hospitals NHS Trusts and part of an initiative within the Pathology Network to improve haemophilia and coagulation services throughout the south-east. “Delivering excellence of care and enhanced safety
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for haemophilia patients within the region is an important objective of the Network. To achieve this, we need increased confidence in our results,” Mr Cotton explained.
“Stago has created a system that not
only improves our workflow but enables our compliance obligations to be handled quickly and easily – with far greater accuracy.”
Balance of quality and efficiency The value of accreditation resources is defined by UKAS as providing the evidence for making “informed and effective procurement decisions. It enables healthcare commissioners to achieve a careful balance between raising the quality of care and reducing risk – while delivering laboratory efficiency and productivity”.
These objectives underpin the vision of Stago. “We not only provide the resources to help our customers improve their efficiency, we enable the quality, robustness and reproducibility of their results to be officially recognised by the UK’s accreditation body,” explained Mr Querel. “Further, they can maintain the highest
professional standards, by measuring themselves against their NHS peers, as well as other pathology colleagues globally. “By removing more of the burden
of reporting compliance, Stago enables customers to focus on what is most important to them, caring for patients and supporting their clinical colleagues.”
PPi
Factor assay result (%)
Factor assay result (%)
PATHOLOGY IN PRACTICE
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