ACCREDITATION ISSUES
Yannig Querel, the Stago product manager responsible for instrumentation and IT solutions, explained: “What singles out our approach to accreditation is the way it offers a complete service, aiming to help our customers every step of the way.
“We take an holistic approach, from
providing initial system verification through to full traceability for quality management compliance – and we are
always ready to parachute in Lean Six Sigma green belt experts on improving quality and productivity. “Total support includes continuous
performance monitoring throughout the whole of the contract from our dedicated quality management team. Further, to help with the often stressful competence assessment requirements, we provide staff at all levels with ongoing training and access to eLearning.”
Advanced, intelligent and flexible resource
Fig 1. Details of method repeatability results.
Helen Lewis, the haemostasis manager at Basingstoke and North Hampshire Hospital, considers the accreditation tools to be “ground-breaking”, enabling the laboratory to keep on top of UKAS inspection requirements for ISO15189:2012. Basingstoke is a comprehensive care haemophilia centre, offering an extensive haemostasis, thrombosis and platelet referral service. There are four STA R Max analysers at Basingstoke and a further two at its sister hospital in Winchester. “The accreditation toolkit offers very advanced software that takes the stress and time out of addressing UKAS requirements,” said Ms Lewis. She likes the flexibility of the system including the way third-party data for quality assurance, analyser comparison and assay validation can swiftly be integrated into the automated reporting that the analysers deliver, providing a “full and comprehensive picture. It simply does the hard work for you,” she pointed out. “This enables the laboratory to demonstrate compliance easily and quickly, by accessing the data and then creating exactly the type of report we need. The ability to access retrospective data within seconds is especially important to us.”
At Basingstoke, staff at all levels benefit Fig 2. Details of method reproducibility results.
from ongoing Stago training to keep up to date on new features. This familiarity with the software has enabled the laboratory to adapt workflow practices regularly to maintain efficiency at times of increased workload – alleviating staff and service pressure. This has been especially noticeable, says Ms Lewis, with regard to the impact on their out-of-hours service. “Stago’s accreditation software is not simply an external resource we have to remember to access when the need arises; it is part of our service, fully integrated into how we operate 24 hours a day,” Ms Lewis explained.
“Manual assessment is always subjective and errors can occur when staff are time-pressed. The toolkit has accelerated the availability of our staff, so they can carry out other, urgently needed patient-focused activity. This is vital in a centre of excellence where we are dealing with patients with extremely serious bleeding disorders.”
Fig 3. Details of method comparison results. 16
Benchmark for accreditation reporting The Leicester Royal Infirmary, part of the University Hospitals of Leicester NHS Trust, operates eight STA R Max systems across the different hospitals within the trust. Barbara Hopkins, the infirmary’s haemostasis team leader, has been
MAY 2021
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