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EXTERNAL QUALITY ASSESSMENT


Masterclass in immunology, immunochemistry and allergy quality assessment


The latest UK NEQAS Immunology, Immunochemistry and Allergy quality assessment masterclass, held recently in Sheffield, highlights the learning outcomes that participants can achieve as a result of attendance at one of these one-day events. Paul Masters reports.


External quality assessment (EQA) is a key component of a laboratory’s quality management system (QMS). However, many laboratories fail to take full advantage of the information provided in EQA reports and are unsure how to respond when poor performance is identified. Historically, the knowledge and skills resided in one or two senior individuals in any given laboratory, who were seen as the local experts and who devoted much of their time to EQA. However, with the inexorable reduction in staff over the past two decades, much of this expertise has been lost to the profession and has not been passed on to the current generation, which is both a threat and an opportunity. As with quality management as a whole,


EQA should not be seen as belonging to one or two people, but should be a core function of everyone who works in the laboratory. The more people who take ownership of the EQA process, the more value the laboratory will accrue. Good EQA performance is seen increasingly as a benchmark for laboratory quality, and poor performance is a threat to a laboratory’s reputation, whether or not it impacts on the quality of its clinical results. Providers of EQA have an obligation to provide education to their users, as well as samples and reports. With this is in mind, UK NEQAS for Immunology, Immunochemistry and Allergy (IIA) launched a series of one-day educational quality assessment masterclasses in 2014. The first of these was held at Sheffield


Hallam University to coincide with the annual 242


participants’ meeting held the following day. Subsequently, two more were held in 2015, and it is planned to hold two more in 2016, all in Sheffield. The format builds on the successful online interpretative EQA (iEQA) case-based system, which UK NEQAS IIA has developed over the past few years. Over the day, the participants are provided with four cases, each based around a problem identified by EQA. All the information required to troubleshoot the problem is available by clicking through links in the iEQA system. Cases are worked through for about 10 minutes by the participants on their own, followed by group discussion led by two mentors. Each pair of mentors consists of a member of the IIA team who constructed the case, plus a ‘buddy’ who is a consultant scientist or doctor. The information available to work through includes past and previous EQA performance, method datasheets, internal QC charts, method validation and verification data. The cases are based on real problems, but


extended to illustrate specific points and cover different assays in the IIA repertoire. The level is designed to be useful to all grades of staff, either as new knowledge or as a refresher in how to get the most from EQA. Although the cases refer to specific assays, the principles involved in investigating the problems are applicable to all assays. At the end of each case, participants should be able to complete a root cause analysis form in the format provided by UK NEQAS IIA that satisfies both the EQA provider and the local QMS.


Clinical context My viewpoint of the masterclasses is based on my role as one of the ‘buddies’. I am a consultant chemical pathologist working in two district general hospital (DGH) biochemistry departments with an interest in proteins, and Chair of the UK NEQAS IIA Immunochemistry Steering Committee. My role is to provide some clinical context to the discussion and help the participants understand what the effect of poor EQA might be on patient care. As is illustrated in some of the cases, investigation of poor performance often turns up other areas of concern. The primary EQA problem itself may not have direct impact on patients, but the secondary issues may well do so.


Case-based approach The iEQA software is a web-based scheme to develop individual clinical and scientific interpretative skills. The system promotes reflective learning for all grades of staff. Participants are able to access laboratory data from all disciplines, together with radiology reports and clinical history in order to formulate a diagnosis and produce a clinically useful interpretative comment to add to the laboratory results. When used in the masterclass setting, each


case is based on a specific quality assessment issue. The range of information available would be expected to be readily accessible in a service laboratory (and one question for participants to ask themselves is “where would I find this in my own laboratory?”). The tabs available to click include previous EQA reports, internal quality control (QC) charts, method validation and verification data, assay information sheets, kit inserts, and other information. The iEQA cases remain open to participants for a couple of days after the masterclass, giving delegates the opportunity to revisit the cases and consolidate learning. Several laboratories have chosen to enrol in the full iEQA scheme after using it in the masterclasses. The cases have been designed to illustrate


MAY 2016 THE BIOMEDICAL SCIENTIST


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