ACCREDITATION ISSUES
A service that simplifies ISO15189:2012compliance and UKAS inspections
An introduction to a ground-breaking toolkit now available that aims to ease the burden of the many standards with which laboratories must comply, and reduce the stress associated with the regular accreditation visits
If you ask a laboratory manager about ISO15189:2012 and inspections by the United Kingdom Accreditation Service (UKAS), the response may be guarded. Improving the quality of patient care is paramount for NHS pathologists – yet even the most efficient laboratory will say that meeting this standard's exacting requirements can be arduous, time- consuming and stressful. By comparison, if you were to ask a Stago customer running their accreditation tools on one of the STA Max generation systems (pictured), the answer might be a little different. Its software is able to pull information from the analyser and produce UKAS-ready reports for all ISO15189 requirements. This is actioned at speed, with full traceability; and offers such detail that customers consider Stago’s accreditation service a “valued ally”, taking some of the stress out of accreditation reporting, especially noticeable during the COVID crisis. The NHS focus on process
improvement is also driven in part by the need for compliance with accreditation requirements, especially for quality assessment. This emphasises the importance of standardisation as a means of reducing controllable errors. For example, ISO15189 requires that variability is assessed when verifying an assay or when acceptance testing is carried out on a new batch of reagent. Standardising this
WWW.PATHOLOGYINPRACTICE.COM MAY 2021
exacting process can easily be achieved when tools to carry this out are embedded in the software. Figures 1–3 illustrate the results for repeatability, reproducibility and method comparison, respectively.
Holistic, continuous support As its goal, UKAS aims to create confidence in the quality of products and services on which we rely. Inspections can never be taken lightly as they risk accreditation being suspended if quality management practices are assessed as underperforming. They are time-consuming, placing additional pressure on maintaining workflows and turnaround time (TAT) targets. Furthermore, laboratories must be ready to demonstrate continuing improvement and have the competence of staff regularly assessed and matched against their peers. As experts in global haemostasis assays
The STA R Max3 analyser from Stago.
Easing burden of compliance The STA Max generation systems have extensive embedded support with onboard resources such as the audit trail function (providing full traceability including sample, reagents, consumables and operator), method validation and verification, as well as all aspects of quality control management. Stago’s full suite of tools runs either on
Coag.One, designed for laboratory networks, or on STA Coag Expert for standalone systems.
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and instrumentation, Stago has taken up the challenge and stepped in with an accreditation and quality management service to lessen the entire burden for its laboratory customers. The company goes far beyond the key areas that incur UKAS inspection – such as external quality assessment, internal quality control, standard operating procedures, and personnel training and the assessment of competence.
Stago also places great emphasis on assisting laboratories with performance verification and continuous performance monitoring. As part of this, the company provides ongoing training courses both for basic users as well as more senior staff who need to understand the full capabilities of the software. A standout feature for customers is the way the data manager frees valuable staff resources, with autovalidation tools to speed up TAT. For specialist laboratories, Stago’s expert rules for factor assays enable users to regularly adapt pathology practices to maintain efficiency. A laboratory no longer needs to allocate a specialist biomedical scientist to run factor assays. Stago’s expert rules simplify this, speeding up the flow of information to clinicians (Figs 3 and 4).
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