Analytical Science and Patient Safety
Clinical scientists have the power to improve patient safety – and it’s our job to help
Michael Schubert, Editor of The Pathologist, interviews Gareth McKeeman
What is your role in the lab?
I’m a consultant clinical scientist specializing in clinical biochemistry. I work at a National Health Service (NHS) hospital laboratory within the Belfast Health and Social Care Trust. As a Clinical Scientist, I’m responsible for providing clinical and scientific leadership and oversight across different areas of clinical biochemistry, including the General Chemistry (Automation Laboratory) and Regional Immunoproteins lab. Clinical biochemistry is one of many disciplines within pathology, and incorporates a number of specialist areas, such as toxicology, pediatric metabolics and screening, endocrinology, and trace elements, as well as the two areas mentioned above.
There are three hospitals incorporated within my Trust. We have a general biochemistry (automated) lab across each of the three sites, set up as a hub-and-spoke model, with two smaller “hot” labs and a main site where regional services are based. We handle approximately 130,000 samples per month in our clinical biochemistry lab, and approximately 5,000 samples on a normal working day in the general biochemistry (automated) section.
We use variations of spectrophotometric analysis (endpoint and rate assays), electrochemistry (using ion-specific electrodes), immunoturbidimetry, and immunoassays (competitive and sandwich), as well as osmometry, electrophoresis, high-performance LC- and GC-MS, and inductively coupled plasma-tandem MS, to report on samples across primary and secondary care. One of my main roles is to ensure that appropriate methods are used, and that they are performed to the standards required for patient management. I must maintain insight into the common problems that can occur with such analyses to provide appropriate guidance to both laboratory staff and service users.
Many of the tasks we perform in the hospital laboratory focus on quality management and service monitoring and review. Daily internal quality control (IQC) monitoring is key, and we have different IQC regimes for different tests. In fact, our general automation lab produces up to 2,500 IQC data points per day – a significant amount of information for review. Development and implementation of software to assist with the collation and review of IQC data has significantly improved the process, allowing us to track and trend analyzer performance across all three lab sites.
Important components of this work include regular monitoring of potential differences in results for the same test across the lab network, assessing measurement uncertainty, and using a scientific approach to develop goals for acceptable performance for many of our quantitative tests (taking into account analytical performance, biological variation, and clinical need). We can also use the data we obtain to develop and review appropriate Westgard rules for IQC acceptance and rejection using sigma metrics methodology.
The validation and verification of new tests or equipment is another important task that requires assessment of assay precision, bias, and linearity to ensure tests meet performance targets. Once methods have been developed and introduced, we initiate appropriate quality assurance procedures, incorporating IQC and external monitoring. We also set key performance and assurance indicators, monitor them frequently, and perform regular audits to assess ongoing compliance against set standards.
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